Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial.

PubMed

Arabi, Yaseen; Al-Hameed, Fahad; Burns, Karen E A; Mehta, Sangeeta; Alsolamy, Sami; Almaani, Mohammed; Mandourah, Yasser; Almekhlafi, Ghaleb A; Al Bshabshe, Ali; Finfer, Simon; Alshahrani, Mohammed; Khalid, Imran; Mehta, Yatin; Gaur, Atul; Hawa, Hassan; Buscher, Hergen; Arshad, Zia; Lababidi, Hani; Al Aithan, Abdulsalam; Jose, Jesna; Abdukahil, Sheryl Ann I; Afesh, Lara Y; Dbsawy, Maamoun; Al-Dawood, Abdulaziz

2018-03-15

The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%. Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data. ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.

A randomized controlled study of socioeconomic support to enhance tuberculosis prevention and treatment, Peru

PubMed Central

Tovar, Marco A; Huff, Doug; Boccia, Delia; Montoya, Rosario; Ramos, Eric; Datta, Sumona; Saunders, Matthew J; Lewis, James J; Gilman, Robert H; Evans, Carlton A

2017-01-01

Abstract Objective To evaluate the impact of socioeconomic support on tuberculosis preventive therapy initiation in household contacts of tuberculosis patients and on treatment success in patients. Methods A non-blinded, household-randomized, controlled study was performed between February 2014 and June 2015 in 32 shanty towns in Peru. It included patients being treated for tuberculosis and their household contacts. Households were randomly assigned to either the standard of care provided by Peru’s national tuberculosis programme (control arm) or the same standard of care plus socioeconomic support (intervention arm). Socioeconomic support comprised conditional cash transfers up to 230 United States dollars per household, community meetings and household visits. Rates of tuberculosis preventive therapy initiation and treatment success (i.e. cure or treatment completion) were compared in intervention and control arms. Findings Overall, 282 of 312 (90%) households agreed to participate: 135 in the intervention arm and 147 in the control arm. There were 410 contacts younger than 20 years: 43% in the intervention arm initiated tuberculosis preventive therapy versus 25% in the control arm (adjusted odds ratio, aOR: 2.2; 95% confidence interval, CI: 1.1–4.1). An intention-to-treat analysis showed that treatment was successful in 64% (87/135) of patients in the intervention arm versus 53% (78/147) in the control arm (unadjusted OR: 1.6; 95% CI: 1.0–2.6). These improvements were equitable, being independent of household poverty. Conclusion A tuberculosis-specific, socioeconomic support intervention increased uptake of tuberculosis preventive therapy and tuberculosis treatment success and is being evaluated in the Community Randomized Evaluation of a Socioeconomic Intervention to Prevent TB (CRESIPT) project. PMID:28479622

A randomized controlled study of socioeconomic support to enhance tuberculosis prevention and treatment, Peru.

PubMed

Wingfield, Tom; Tovar, Marco A; Huff, Doug; Boccia, Delia; Montoya, Rosario; Ramos, Eric; Datta, Sumona; Saunders, Matthew J; Lewis, James J; Gilman, Robert H; Evans, Carlton A

2017-04-01

To evaluate the impact of socioeconomic support on tuberculosis preventive therapy initiation in household contacts of tuberculosis patients and on treatment success in patients. A non-blinded, household-randomized, controlled study was performed between February 2014 and June 2015 in 32 shanty towns in Peru. It included patients being treated for tuberculosis and their household contacts. Households were randomly assigned to either the standard of care provided by Peru's national tuberculosis programme (control arm) or the same standard of care plus socioeconomic support (intervention arm). Socioeconomic support comprised conditional cash transfers up to 230 United States dollars per household, community meetings and household visits. Rates of tuberculosis preventive therapy initiation and treatment success (i.e. cure or treatment completion) were compared in intervention and control arms. Overall, 282 of 312 (90%) households agreed to participate: 135 in the intervention arm and 147 in the control arm. There were 410 contacts younger than 20 years: 43% in the intervention arm initiated tuberculosis preventive therapy versus 25% in the control arm (adjusted odds ratio, aOR: 2.2; 95% confidence interval, CI: 1.1-4.1). An intention-to-treat analysis showed that treatment was successful in 64% (87/135) of patients in the intervention arm versus 53% (78/147) in the control arm (unadjusted OR: 1.6; 95% CI: 1.0-2.6). These improvements were equitable, being independent of household poverty. A tuberculosis-specific, socioeconomic support intervention increased uptake of tuberculosis preventive therapy and tuberculosis treatment success and is being evaluated in the Community Randomized Evaluation of a Socioeconomic Intervention to Prevent TB (CRESIPT) project.

Installing the Communities that Care Prevention System: Implementation Progress and Fidelity in a Randomized Controlled Trial

ERIC Educational Resources Information Center

Quinby, Rose K.; Hanson, Koren; Brooke-Weiss, Blair; Arthur, Michael W.; Hawkins, J. David; Fagan, Abigail A.

2008-01-01

This article describes the degree to which high fidelity implementation of the Communities That Care (CTC) prevention operating system was reached during the first 18 months of intervention in 12 communities in the Community Youth Development Study, a 5-year group randomized controlled trial designed to test the efficacy of the CTC system. CTC…

The Long-Term Effectiveness of a Selective, Personality-Targeted Prevention Program in Reducing Alcohol Use and Related Harms: A Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Newton, Nicola C.; Conrod, Patricia J.; Slade, Tim; Carragher, Natacha; Champion, Katrina E.; Barrett, Emma L.; Kelly, Erin V.; Nair, Natasha K.; Stapinski, Lexine; Teesson, Maree

2016-01-01

Background: This study investigated the long-term effectiveness of Preventure, a selective personality-targeted prevention program, in reducing the uptake of alcohol, harmful use of alcohol, and alcohol-related harms over a 3-year period. Methods: A cluster randomized controlled trial was conducted to assess the effectiveness of Preventure.…

Primary Prevention of Parent-Child Conflict and Abuse in Iranian Mothers: A Randomized-Controlled Trial

ERIC Educational Resources Information Center

Oveisi, Sonia; Ardabili, Hassan Eftekhare; Dadds, Mark R.; Majdzadeh, Reza; Mohammadkhani, Parvaneh; Rad, Javad Alaqband; Shahrivar, Zahra

2010-01-01

Objective: The aim of this study was to assess whether primary health care settings can be used to engage and provide a preventive intervention to mothers of young children. Methods: Two hundred and twenty-four mothers who had come to the health centers were randomly assigned to either control group (CG: n=116) or intervention group (IG: n = 108).…

Randomized Controlled Evaluation of the "Too Good for Drugs" Prevention Program: Impact on Adolescents at Different Risk Levels for Drug Use

ERIC Educational Resources Information Center

Hall, Bruce W.; Bacon, Tina P.; Ferron, John M.

2013-01-01

Sixth graders participating in the "Too Good for Drugs" (TGFD) prevention program in comparison to 6th graders not participating show different results by student risk level. Sixth graders from 20 middle schools were randomly assigned to receive the intervention and those from 20 paired middle schools assigned to serve as controls (N =…

Internet-Based Personalized Feedback to Reduce 21st-Birthday Drinking: A Randomized Controlled Trial of an Event-Specific Prevention Intervention

ERIC Educational Resources Information Center

Neighbors, Clayton; Lee, Christine M.; Lewis, Melissa A.; Fossos, Nicole; Walter, Theresa

2009-01-01

This article presents an initial randomized controlled trial of an event-specific prevention intervention. Participants included 295 college students (41.69% male, 58.31% female) who intended to consume 2 or more drinks on their 21st birthday. Participants completed a screening/baseline assessment approximately 1 week before they turned 21 and…

School-Based Prevention of Depressive Symptoms: A Randomized Controlled Study of the Effectiveness and Specificity of the Penn Resiliency Program

ERIC Educational Resources Information Center

Gillham, Jane E.; Reivich, Karen J.; Freres, Derek R.; Chaplin, Tara M.; Shatte, Andrew J.; Samuels, Barbra; Elkon, Andrea G. L.; Litzinger, Samantha; Lascher, Marisa; Gallop, Robert; Seligman, Martin E. P.

2007-01-01

The authors investigated the effectiveness and specificity of the Penn Resiliency Program (PRP; J. E. Gillham, L. H. Jaycox, K. J. Reivich, M. E. P. Seligman, & T. Silver, 1990), a cognitive-behavioral depression prevention program. Children (N = 697) from 3 middle schools were randomly assigned to PRP, Control (CON), or the Penn Enhancement …

Efficacy of smoking prevention program 'Smoke-free Kids': study protocol of a randomized controlled trial

PubMed Central

2009-01-01

Background A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands. Methods/Design A randomized controlled trial is conducted among 9 to 11-year old children of primary schools. Participants are randomly assigned to the intervention and control conditions. The intervention program consists of five printed activity modules designed to improve parenting skills specific to smoking prevention and parent-child communication regarding smoking. These modules will include additional sheets with communication tips. The modules for the control condition will include solely information on smoking and tobacco use. Initiation of cigarette smoking (first instance of puffing on a lighted cigarette), susceptibility to cigarette smoking, smoking-related cognitions, and anti-smoking socialization will be the outcome measures. To collect the data, telephone interviews with mothers as well as with their child will be conducted at baseline. Only the children will be examined at post-intervention follow-ups (6, 12, 24, and 36 months after the baseline). Discussion This study protocol describes the design of a randomized controlled trial that will evaluate the effectiveness of a home-based smoking prevention program. We expect that a significantly lower number of children will start smoking in the intervention condition compared to control condition as a direct result of this intervention. If the program is effective, it is applicable in daily live, which will facilitate implementation of the prevention protocol. Trial registration Netherlands Trial Register NTR1465 PMID:20025727

Effect of decision aid for breast cancer prevention on decisional conflict in women with a BRCA1 or BRCA2 mutation: a multisite, randomized, controlled trial.

PubMed

Metcalfe, Kelly A; Dennis, Cindy-Lee; Poll, Aletta; Armel, Susan; Demsky, Rochelle; Carlsson, Lindsay; Nanda, Sonia; Kiss, Alexander; Narod, Steven A

2017-03-01

Women with a BRCA1 or BRCA2 mutation are at high risk for breast cancer and must make important decisions about breast cancer prevention and screening. In the current study, we report a multisite, randomized, controlled trial evaluating the effectiveness of a decision aid for breast cancer prevention in women with a BRCA mutation with no previous diagnosis of cancer. Within 1 month of receiving a positive BRCA result, women were randomized to receive either usual care (control group) or decision aid (intervention group). Participants were followed at 3, 6, and 12 months; were asked about preventive measures; and completed standardized questionnaires assessing decision making and psychosocial functioning. One hundred fifty women were randomized. Mean cancer-related distress scores were significantly lower in the intervention group compared with the control group at 6 months (P = 0.01) and at 12 months postrandomization (P = 0.05). Decisional conflict scores declined over time for both groups and at no time were there statistical differences between the two groups. The decision aid for breast cancer prevention in women with a BRCA1 or BRCA2 mutation is effective in significantly decreasing cancer-related distress within the year following receipt of positive genetic test results.Genet Med 19 3, 330-336.

Action seniors! - secondary falls prevention in community-dwelling senior fallers: study protocol for a randomized controlled trial.

PubMed

Liu-Ambrose, Teresa; Davis, Jennifer C; Hsu, Chun Liang; Gomez, Caitlin; Vertes, Kelly; Marra, Carlo; Brasher, Penelope M; Dao, Elizabeth; Khan, Karim M; Cook, Wendy; Donaldson, Meghan G; Rhodes, Ryan; Dian, Larry

2015-04-10

Falls are a 'geriatric giant' and are the third leading cause of chronic disability worldwide. About 30% of community-dwellers over the age of 65 experience one or more falls every year leading to significant risk for hospitalization, institutionalization, and even death. As the proportion of older adults increases, falls will place an increasing demand and cost on the health care system. Exercise can effectively and efficiently reduce falls. Specifically, the Otago Exercise Program has demonstrated benefit and cost-effectiveness for the primary prevention of falls in four randomized trials of community-dwelling seniors. Although evidence is mounting, few studies have evaluated exercise for secondary falls prevention (that is, preventing falls among those with a significant history of falls). Hence, we propose a randomized controlled trial powered for falls that will, for the first time, assess the efficacy and efficiency of the Otago Exercise Program for secondary falls prevention. A randomized controlled trial among 344 community-dwelling seniors aged 70 years and older who attend a falls prevention clinic to assess the efficacy and the cost-effectiveness of a 12-month Otago Exercise Program intervention as a secondary falls prevention strategy. Participants randomized to the control group will continue to behave as they did prior to study enrolment. The economic evaluation will examine the incremental costs and benefits generated by using the Otago Exercise Program intervention versus the control. The burden of falls is significant. The challenge is to make a difference - to discover effective, ideally cost-effective, interventions that prevent injurious falls that can be readily translated to the population. Our proposal is very practical - the exercise program requires minimal equipment, the physical therapist expertise is widely available, and seniors in Canada and elsewhere have adopted the program and complied with it. Our innovation includes applying the intervention to a targeted high-risk population, aiming to provide the best value for money. Given society's limited financial resources and the known and increasing burden of falls, there is an urgent need to test this feasible intervention which would be eminently ready for roll out. ClinicalTrials.gov Protocol Registration System: NCT01029171; registered 7 December 2009.

Randomized controlled trial comparing tailoring methods of multimedia-based fall prevention education for community-dwelling older adults.

PubMed

Schepens, Stacey L; Panzer, Victoria; Goldberg, Allon

2011-01-01

We attempted to determine whether multimedia fall prevention education using different instructional strategies increases older adults' knowledge of fall threats and their fall prevention behaviors. Fifty-three community-dwelling older adults were randomized to iwo educational groups or a control group. Multimedia-based educational interventions to increase fall threats knowledge and encourage fall prevention behaviors had two tailoring strategies: (1) improve content realism for individual learners (authenticity group) and (2) highlight program goals and benefits while using participants' content selections (motivation group). Knowledge was measured at baseline and 1-mo follow-up. Participants recorded prevention behaviors for 1 mo. Intervention group participants showed greater knowledge gains and posttest knowledge than did control group participants. The motivation group engaged in more prevention behaviors over 1 mo than did the other groups. Tailoring fall prevention education by addressing authenticity and motivation successfully improved fall threats knowledge. Combining motivational strategies with multimedia education increased the effectiveness of the intervention in encouraging fall prevention behaviors.

Universal-Based Prevention of Syndromal and Subsyndromal Social Anxiety: A Randomized Controlled Study

ERIC Educational Resources Information Center

Aune, Tore; Stiles, Tore C.

2009-01-01

This article reports results from a universal preventive program aimed at (a) reducing social anxiety and (b) preventing the development of syndromal social anxiety among a population-based sample of older children and young adolescents during a 1-year period. Pupils (N = 1,748) from 2 counties were cluster randomized to either an intervention or…

A Randomized Controlled Trial of a Parent-Centered Intervention in Preventing Substance Use and HIV Risk Behaviors in Hispanic Adolescents

ERIC Educational Resources Information Center

Prado, Guillermo; Pantin, Hilda; Briones, Ervin; Schwartz, Seth J.; Feaster, Daniel; Huang, Shi; Sullivan, Summer; Tapia, Maria I.; Sabillon, Eduardo; Lopez, Barbara; Szapocznik, Jose

2007-01-01

The present study evaluated the efficacy of Familias Unidas + Parent-Preadolescent Training for HIV Prevention (PATH), a Hispanic-specific, parent-centered intervention, in preventing adolescent substance use and unsafe sexual behavior. Two hundred sixty-six 8th-grade Hispanic adolescents and their primary caregivers were randomly assigned to 1 of…

Combined universal and selective prevention for adolescent alcohol use: a cluster randomized controlled trial.

PubMed

Teesson, M; Newton, N C; Slade, T; Carragher, N; Barrett, E L; Champion, K E; Kelly, E V; Nair, N K; Stapinski, L A; Conrod, P J

2017-07-01

No existing models of alcohol prevention concurrently adopt universal and selective approaches. This study aims to evaluate the first combined universal and selective approach to alcohol prevention. A total of 26 Australian schools with 2190 students (mean age: 13.3 years) were randomized to receive: universal prevention (Climate Schools); selective prevention (Preventure); combined prevention (Climate Schools and Preventure; CAP); or health education as usual (control). Primary outcomes were alcohol use, binge drinking and alcohol-related harms at 6, 12 and 24 months. Climate, Preventure and CAP students demonstrated significantly lower growth in their likelihood to drink and binge drink, relative to controls over 24 months. Preventure students displayed significantly lower growth in their likelihood to experience alcohol harms, relative to controls. While adolescents in both the CAP and Climate groups demonstrated slower growth in drinking compared with adolescents in the control group over the 2-year study period, CAP adolescents demonstrated faster growth in drinking compared with Climate adolescents. Findings support universal, selective and combined approaches to alcohol prevention. Particularly novel are the findings of no advantage of the combined approach over universal or selective prevention alone.

A randomized trial comparing digital video disc with written delivery of falls prevention education for older patients in hospital.

PubMed

Hill, Anne-Marie; McPhail, Steven; Hoffmann, Tammy; Hill, Keith; Oliver, David; Beer, Christopher; Brauer, Sandra; Haines, Terry P

2009-08-01

To compare the effectiveness of a digital video disc (DVD) with that of a written workbook delivering falls prevention education to older hospital patients on self-perceived risk of falls, perception of falls epidemiology, knowledge of prevention strategies, and motivation and confidence to engage in self-protective strategies. To compare the effect of receiving either education approach versus no education on patients' perception of falls epidemiology. Randomized trial (DVD vs workbook) with additional quasi-experimental control group. Geriatric, medical, and orthopedic wards in Perth and Brisbane, Australia. One hundred (n=51 DVD, n=49 workbook) hospital inpatients aged 60 and older receiving an intervention (mean age 75.3+/-10.1) and 122 in the control group (mean age 79.3+/-8.3). Participants randomly assigned to receive identical educational material on falls prevention delivered on a DVD or in a workbook. Control group received usual care. Custom-designed survey addressing elements of the Health Belief Model of health behavior change. Participants randomized to DVD delivery had a higher self-perceived risk of falling (P=.04) and higher levels of confidence (P=.03) and motivation (P=.04) to engage in self-protective strategies than participants who received the workbook. A higher proportion of participants who received either form of the education provided "desired" responses than of control group participants across all knowledge items (P<.001). Delivery of falls prevention education on a DVD compared to a written workbook is more likely to achieve important changes in parameters likely to affect successful uptake of falls prevention messages in the hospital setting.

Educational and Skills-Based Interventions to Prevent Relationship Violence in Young People

ERIC Educational Resources Information Center

Fellmeth, Gracia; Heffernan, Catherine; Nurse, Joanna; Habibula, Shakiba; Sethi, Dinesh

2015-01-01

Objectives: To assess the efficacy of educational and skills-based interventions to prevent relationship and dating violence in adolescents and young adults. Methods: We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, PsycINFO, and other databases for randomized, cluster-randomized, and quasi-randomized…

Strategies to retain participants in a long-term HIV prevention randomized controlled trial: Lessons from the MINTS-II study

PubMed Central

Horvath, Keith J.; Nygaard, Kate; Danilenko, Gene P.; Goknur, Sinan; Oakes, J. Michael; Rosser, B.R. Simon

2012-01-01

Achieving satisfactory retention in online HIV prevention trials typically have proved difficult, particularly over extended timeframes. The overall aim of this study was to assess factors associated with retention in the Men’s INTernet Study II (MINTS-II), a randomized controlled trial of a sexual risk reduction intervention for men who have sex with men. Participants were recruited via e-mails and banner advertisements in December, 2007 to participate in the MINTS-II Sexpulse intervention and followed over a 12-month period. Retention across the treatment and control arms was 85.2% at 12 months. Factors associated with higher retention included: randomization to the control arm, previous participation in a study by the research team, e-mail and telephone reminders to complete a survey once it was available to take, and fewer e-mail contacts between surveys. The results provide evidence that achieving satisfactory retention is possible in online HIV prevention trials, and suggest best practices for maximizing retention. PMID:21538084

Prebiotic-supplemented partially hydrolysed cow's milk formula for the prevention of eczema in high-risk infants: a randomized controlled trial.

PubMed

Boyle, R J; Tang, M L-K; Chiang, W C; Chua, M C; Ismail, I; Nauta, A; Hourihane, J O B; Smith, P; Gold, M; Ziegler, J; Peake, J; Quinn, P; Rao, R; Brown, N; Rijnierse, A; Garssen, J; Warner, J O

2016-05-01

Prevention guidelines for infants at high risk of allergic disease recommend hydrolysed formula if formula is introduced before 6 months, but evidence is mixed. Adding specific oligosaccharides may improve outcomes. To evaluate whether partially hydrolysed whey formula containing oligosaccharides (0.8 g/100 ml) (pHF-OS) can prevent eczema in high-risk infants [ISRCTN65195597]. We conducted a parallel-group, multicentre, randomized double-blind controlled trial of pHF-OS vs standard cow's milk formula. Infants with a family history of allergic disease were randomized (stratified by centre/maternal allergy) to active (n = 432) or control (n = 431) formula until 6 months of age if formula was introduced before 18 weeks. Primary outcome was cumulative incidence of eczema by 12 months in infants randomized at 0-4 weeks (375 pHF-OS, 383 control). Secondary outcomes were cumulative incidence of eczema by 12 or 18 months in all infants randomized, immune markers at 6 months and adverse events. Eczema occurred by 12 months in 84/293 (28.7%) infants allocated to pHF-OS at 0-4 weeks of age, vs 93/324 (28.7%) control (OR 0.98 95% CI 0.68, 1.40; P = 0.90), and 107/347 (30.8%) pHF-OS vs 112/370 (30.3%) control in all infants randomized (OR 0.99 95% CI 0.71, 1.37; P = 0.94). pHF-OS did not change most immune markers including total/specific IgE; however, pHF-OS reduced cow's milk-specific IgG1 (P < 0.0001) and increased regulatory T-cell and plasmacytoid dendritic cell percentages. There was no group difference in adverse events. pHF-OS does not prevent eczema in the first year in high-risk infants. The immunological changes found require confirmation in a separate cohort. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Meta-analysis of randomized controlled trials comparing 17α-hydroxyprogesterone caproate and vaginal progesterone for the prevention of recurrent spontaneous preterm delivery.

PubMed

Oler, Elizabeth; Eke, Ahizechukwu C; Hesson, Ashley

2017-07-01

Vaginal progesterone and 17α-hydroxyprogesterone (17α-OHP) are both used to prevent preterm delivery in women who have experienced spontaneous preterm delivery (SPTD) previously. Randomized trial data of the comparative effectiveness of these interventions have been mixed. To compare the efficacy of intramuscular 17α-OHP and vaginal progesterone in the prevention of recurrent SPTD. Cochrane Central Register of Controlled Trials, African Journals Online, Embase, Google Scholar, ISI Web of Science, LILACS, CINAHL, PubMed, and registers of ongoing trials were searched using keywords related to 17α-OHP, vaginal progesterone, and preterm delivery. Randomized controlled trials published between January 1, 1966, and November 30, 2016, comparing 17α-OHP and vaginal progesterone for the prevention of recurrent SPTD during singleton pregnancies were included. Study data were extracted and meta-analyses were performed when outcomes were comparable. The meta-analyses included data from three randomized trials. Lower rates of SPTD before 34 weeks (relative risk 0.71, 95% confidence interval 0.53-0.95) and before 32 weeks (relative risk 0.62, 95% confidence interval 0.40-0.94) of pregnancy were observed among patients treated with vaginal progesterone. Vaginal progesterone and 17α-OHP were comparable for the prevention of recurrent SPTD in singleton pregnancies; vaginal progesterone could be superior. © 2017 International Federation of Gynecology and Obstetrics.

The short-term efficacy of vena cava filters for the prevention of pulmonary embolism in patients with venous thromboembolism receiving anticoagulation: Meta-analysis of randomized controlled trials.

PubMed

Jiang, Jun; Jiao, Yuanyong; Zhang, Xiwei

2017-10-01

Objectives To perform a meta-analysis of randomized controlled trials assessing the effectiveness of inferior vena cava filters in patients with deep vein thrombosis for preventing pulmonary embolism. Method Relevant randomized controlled trials of inferior vena cava filters for the prevention of pulmonary embolism were identified by searching electronic databases updated in February 2016. Relative risks of recurrent pulmonary embolism, recurrent deep vein thrombosis, and mortality at three months were analyzed. Results Three published randomized controlled trials were included involving a total of 863 deep vein thrombosis patients. No significant differences were detected with inferior vena cava filters placement with regard to the incidence of recurrent pulmonary embolism or fatal pulmonary embolism. There were also no significant differences in the incidence of recurrent deep vein thrombosis or mortality with inferior vena cava filters placement at three months. Conclusions Inferior vena cava filter in addition to anticoagulation was not associated with a reduction in the incidence of recurrent pulmonary embolism as compared with anticoagulation alone in patients with deep vein thrombosis in the short term.

Randomized Controlled Trial Comparing Tailoring Methods of Multimedia-Based Fall Prevention Education for Community-Dwelling Older Adults

PubMed Central

Schepens, Stacey L.; Panzer, Victoria; Goldberg, Allon

2012-01-01

OBJECTIVE We attempted to determine whether multimedia fall prevention education using different instructional strategies increases older adults’ knowledge of fall threats and their fall prevention behaviors. METHOD Fifty-three community-dwelling older adults were randomized to two educational groups or a control group. Multimedia-based educational interventions to increase fall threats knowledge and encourage fall prevention behaviors had two tailoring strategies: (1) improve content realism for individual learners (authenticity group) and (2) highlight program goals and benefits while using participants’ content selections (motivation group). Knowledge was measured at baseline and 1-mo follow-up. Participants recorded prevention behaviors for 1 mo. RESULTS Intervention group participants showed greater knowledge gains and posttest knowledge than did control group participants. The motivation group engaged in more prevention behaviors over 1 mo than did the other groups. CONCLUSION Tailoring fall prevention education by addressing authenticity and motivation successfully improved fall threats knowledge. Combining motivational strategies with multimedia education increased the effectiveness of the intervention in encouraging fall prevention behaviors. PMID:22214115

Saving and Empowering Young Lives in Europe (SEYLE): a randomized controlled trial

PubMed Central

2010-01-01

Background There have been only a few reports illustrating the moderate effectiveness of suicide-preventive interventions in reducing suicidal behavior, and, in most of those studies, the target populations were primarily adults, whereas few focused on adolescents. Essentially, there have been no randomized controlled studies comparing the efficacy, cost-effectiveness and cultural adaptability of suicide-prevention strategies in schools. There is also a lack of information on whether suicide-preventive interventions can, in addition to preventing suicide, reduce risk behaviors and promote healthier ones as well as improve young people's mental health. The aim of the SEYLE project, which is funded by the European Union under the Seventh Framework Health Program, is to address these issues by collecting baseline and follow-up data on health and well-being among European adolescents and compiling an epidemiological database; testing, in a randomized controlled trial, three different suicide-preventive interventions; evaluating the outcome of each intervention in comparison with a control group from a multidisciplinary perspective; as well as recommending culturally adjusted models for promoting mental health and preventing suicidal behaviors. Methods and design The study comprises 11,000 adolescents emitted from randomized schools in 11 European countries: Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain, with Sweden serving as the scientific coordinating center. Each country performs three active interventions and one minimal intervention as a control group. The active interventions include gatekeeper training (QPR), awareness training on mental health promotion for adolescents, and screening for at-risk adolescents by health professionals. Structured questionnaires are utilized at baseline, 3- and 12-month follow-ups in order to assess changes. Discussion Although it has been reported that suicide-preventive interventions can be effective in decreasing suicidal behavior, well-documented and randomized studies are lacking. The effects of such interventions in terms of combating unhealthy lifestyles in young people, which often characterize suicidal individuals, have never been reported. We know that unhealthy and risk-taking behaviors are detrimental to individuals' current and future health. It is, therefore, crucial to test well-designed, longitudinal mental health-promoting and suicide-preventive interventions by evaluating the implications of such activities for reducing unhealthy and risk behaviors while concurrently promoting healthy ones. Trial registration The German Clinical Trials Register, DRKS00000214. PMID:20388196

Saving and empowering young lives in Europe (SEYLE): a randomized controlled trial.

PubMed

Wasserman, Danuta; Carli, Vladimir; Wasserman, Camilla; Apter, Alan; Balazs, Judit; Bobes, Julia; Bracale, Renata; Brunner, Romuald; Bursztein-Lipsicas, Cendrine; Corcoran, Paul; Cosman, Doina; Durkee, Tony; Feldman, Dana; Gadoros, Julia; Guillemin, Francis; Haring, Christian; Kahn, Jean-Pierre; Kaess, Michael; Keeley, Helen; Marusic, Dragan; Nemes, Bogdan; Postuvan, Vita; Reiter-Theil, Stella; Resch, Franz; Sáiz, Pilar; Sarchiapone, Marco; Sisask, Merike; Varnik, Airi; Hoven, Christina W

2010-04-13

There have been only a few reports illustrating the moderate effectiveness of suicide-preventive interventions in reducing suicidal behavior, and, in most of those studies, the target populations were primarily adults, whereas few focused on adolescents. Essentially, there have been no randomized controlled studies comparing the efficacy, cost-effectiveness and cultural adaptability of suicide-prevention strategies in schools. There is also a lack of information on whether suicide-preventive interventions can, in addition to preventing suicide, reduce risk behaviors and promote healthier ones as well as improve young people's mental health.The aim of the SEYLE project, which is funded by the European Union under the Seventh Framework Health Program, is to address these issues by collecting baseline and follow-up data on health and well-being among European adolescents and compiling an epidemiological database; testing, in a randomized controlled trial, three different suicide-preventive interventions; evaluating the outcome of each intervention in comparison with a control group from a multidisciplinary perspective; as well as recommending culturally adjusted models for promoting mental health and preventing suicidal behaviors. The study comprises 11,000 adolescents emitted from randomized schools in 11 European countries: Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain, with Sweden serving as the scientific coordinating center. Each country performs three active interventions and one minimal intervention as a control group. The active interventions include gatekeeper training (QPR), awareness training on mental health promotion for adolescents, and screening for at-risk adolescents by health professionals. Structured questionnaires are utilized at baseline, 3- and 12-month follow-ups in order to assess changes. Although it has been reported that suicide-preventive interventions can be effective in decreasing suicidal behavior, well-documented and randomized studies are lacking. The effects of such interventions in terms of combating unhealthy lifestyles in young people, which often characterize suicidal individuals, have never been reported. We know that unhealthy and risk-taking behaviors are detrimental to individuals' current and future health. It is, therefore, crucial to test well-designed, longitudinal mental health-promoting and suicide-preventive interventions by evaluating the implications of such activities for reducing unhealthy and risk behaviors while concurrently promoting healthy ones. The German Clinical Trials Register, DRKS00000214.

The crime prevention value of hot spots policing.

PubMed

Braga, Anthony A

2006-08-01

This paper reviews the available research evidence on the effectiveness of hot spots policing programs in reducing crime and disorder. The research identified five randomized controlled experiments and four non-equivalent control group quasi-experiments evaluating the effects of hot spots policing interventions on crime. Seven of nine selected evaluations reported noteworthy crime and disorder reductions. Meta-analyses of the randomized experiments revealed statistically significant mean effect sizes favoring hot spots policing interventions in reducing citizen calls for service in treatment places relative to control places. When immediate spatial displacement was measured, it was very limited and unintended crime prevention benefits were associated with the hot spots policing programs. The results of this review suggest that hot spots policing is an effective crime prevention strategy.

Dissonance and Healthy Weight Eating Disorder Prevention Programs: Long-Term Effects from a Randomized Efficacy Trial

ERIC Educational Resources Information Center

Stice, Eric; Marti, C. Nathan; Spoor, Sonja; Presnell, Katherine; Shaw, Heather

2008-01-01

Adolescent girls with body dissatisfaction (N = 481, SD = 1.4) were randomized to a dissonance-based thin-ideal internalization reduction program, healthy weight control program, expressive writing control condition, or assessment-only control condition. Dissonance participants showed significantly greater decreases in thin-ideal internalization,…

Healthy Homes/Healthy Kids: A Randomized Trial of a Pediatric Primary Care Based Obesity Prevention Intervention for At-Risk 5-10 Year Olds

PubMed Central

Sherwood, Nancy E.; Levy, Rona L.; Langer, Shelby L.; Senso, Meghan M.; Crain, A. Lauren; Hayes, Marcia G.; Anderson, Julie D.; Seburg, Elisabeth M.; Jeffery, Robert W.

2014-01-01

Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important public health priority. The goal of the Healthy Homes/Healthy Kids (HHHK 5-10) randomized controlled trial is to evaluate the efficacy of a relatively low-cost primary care-based obesity prevention intervention aimed at 5 to 10 year old children who are at risk for obesity. Four hundred twenty one parent/child dyads were recruited and randomized to either the obesity prevention arm or a contact control condition that focuses on safety and injury prevention. The HHHK 5-10 obesity prevention intervention combines brief counseling with a pediatric primary care provider during routine well-child visits and follow-up telephone coaching that supports parents in making home environmental changes to support healthful eating, activity patterns, and body weight. The contact control condition combines the same provider counseling with telephone coaching focused on safety and injury prevention messages. This manuscript describes the study design and baseline characteristics of participants enrolled in the HHHK 5-10 trial. PMID:23816490

Outcomes of an HIV Prevention Peer Group Intervention for Rural Adults in Malawi

ERIC Educational Resources Information Center

Kaponda, Chrissie P. N.; Norr, Kathleen F.; Crittenden, Kathleen S.; Norr, James L.; McCreary, Linda L.; Kachingwe, Sitingawawo I.; Mbeba, Mary M.; Jere, Diana L. N.; Dancy, Barbara L.

2011-01-01

This study used a quasi-experimental design to evaluate a six-session peer group intervention for HIV prevention among rural adults in Malawi. Two rural districts were randomly assigned to intervention and control conditions. Independent random samples of community adults compared the districts at baseline and at 6 and 18 months postintervention.…

Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents Outperforms Two Alternative Interventions: A Randomized Efficacy Trial

ERIC Educational Resources Information Center

Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

2008-01-01

In this depression prevention trial, 341 high-risk adolescents (mean age = 15.6 years, SD = 1.2) with elevated depressive symptoms were randomized to a brief group cognitive-behavioral (CB) intervention, group supportive-expressive intervention, bibliotherapy, or assessment-only control condition. CB participants showed significantly greater…

Randomized Trials on Consider This, a Tailored, Internet-Delivered Smoking Prevention Program for Adolescents

ERIC Educational Resources Information Center

Buller, David B.; Borland, Ron; Woodall, W. Gill; Hall, John R.; Hines, Joan M.; Burris-Woodall, Patricia; Cutter, Gary R.; Miller, Caroline; Balmford, James; Starling, Randall; Ax, Bryan; Saba, Laura

2008-01-01

The Internet may be an effective medium for delivering smoking prevention to children. Consider This, an Internet-based program, was hypothesized to reduce expectations concerning smoking and smoking prevalence. Group-randomized pretest-posttest controlled trials were conducted in Australia (n = 2,077) and the United States (n = 1,234) in schools…

Prevention of low back pain and its consequences among nurses’ aides in elderly care: a stepped-wedge multi-faceted cluster-randomized controlled trial

PubMed Central

2013-01-01

Background A high prevalence of low back pain has persisted over the years despite extensive primary prevention initiatives among nurses’ aides. Many single-faceted interventions addressing just one aspect of low back pain have been carried out at workplaces, but with low success rate. This may be due to the multi-factorial origin of low back pain. Participatory ergonomics, cognitive behavioral training and physical training have previously shown promising effects on prevention and rehabilitation of low back pain. Therefore, the main aim of this study is to examine whether a multi-faceted workplace intervention consisting of participatory ergonomics, physical training and cognitive behavioral training can prevent low back pain and its consequences among nurses’ aides. External resources for the participating workplace and a strong commitment from the management and the organization support the intervention. Methods/design To overcome implementation barriers within usual randomized controlled trial designed workplace interventions, this study uses a stepped-wedge cluster-randomized controlled trial design with 4 groups. The intervention is delivered to the groups at random along four successive time periods three months apart. The intervention lasts three months and integrates participatory ergonomics, physical training and cognitive behavioral training tailored to the target group. Local physiotherapists and occupational therapists conduct the intervention after having received standardized training. Primary outcomes are low back pain and its consequences measured monthly by text messages up to three months after initiation of the intervention. Discussion Intervention effectiveness trials for preventing low back pain and its consequences in workplaces with physically demanding work are few, primarily single-faceted, with strict adherence to a traditional randomized controlled trial design that may hamper implementation and compliance, and have mostly been unsuccessful. By using a stepped wedge design, and obtain high management commitment and support we intend to improve implementation and aim to establish the effectiveness of a multi-faceted intervention to prevent low back pain. This study will potentially provide knowledge of prevention of low back pain and its consequences among nurses’ aides. Results are expected to be published in 2015–2016. Trial registration The study is registered as ISRCTN78113519. PMID:24261985

How has the economic downturn affected communities and implementation of science-based prevention in the randomized trial of communities that care?

PubMed

Kuklinski, Margaret R; Hawkins, J David; Plotnick, Robert D; Abbott, Robert D; Reid, Carolina K

2013-06-01

This study examined implications of the economic downturn that began in December 2007 for the Community Youth Development Study (CYDS), a longitudinal randomized controlled trial of the Communities That Care (CTC) prevention system. The downturn had the potential to affect the internal validity of the CYDS research design and implementation of science-based prevention in study communities. We used archival economic indicators and community key leader reports of economic conditions to assess the extent of the economic downturn in CYDS communities and potential internal validity threats. We also examined whether stronger economic downturn effects were associated with a decline in science-based prevention implementation. Economic indicators suggested the downturn affected CYDS communities to different degrees. We found no evidence of systematic differences in downturn effects in CTC compared to control communities that would threaten internal validity of the randomized trial. The Community Economic Problems scale was a reliable measure of community economic conditions, and it showed criterion validity in relation to several objective economic indicators. CTC coalitions continued to implement science-based prevention to a significantly greater degree than control coalitions 2 years after the downturn began. However, CTC implementation levels declined to some extent as unemployment, the percentage of students qualifying for free lunch, and community economic problems worsened. Control coalition implementation levels were not related to economic conditions before or after the downturn, but mean implementation levels of science-based prevention were also relatively low in both periods.

How Has the Economic Downturn Affected Communities and Implementation of Science-Based Prevention in the Randomized Trial of Communities That Care?

PubMed Central

Kuklinski, Margaret R.; Hawkins, J. David; Plotnick, Robert D.; Abbott, Robert D.; Reid, Carolina K.

2013-01-01

This study examined implications of the economic downturn that began in December 2007 for the Community Youth Development Study (CYDS), a longitudinal randomized controlled trial of the Communities That Care (CTC) prevention system. The downturn had the potential to affect the internal validity of the CYDS research design and implementation of science-based prevention in study communities. We used archival economic indicators and community key leader reports of economic conditions to assess the extent of the economic downturn in CYDS communities and potential internal validity threats. We also examined whether stronger economic downturn effects were associated with a decline in science-based prevention implementation. Economic indicators suggested the downturn affected CYDS communities to different degrees. We found no evidence of systematic differences in downturn effects in CTC compared to control communities that would threaten internal validity of the randomized trial. The Community Economic Problems scale was a reliable measure of community economic conditions, and it showed criterion validity in relation to several objective economic indicators. CTC coalitions continued to implement science-based prevention to a significantly greater degree than control coalitions 2 years after the downturn began. However, CTC implementation levels declined to some extent as unemployment, the percentage of students qualifying for free lunch, and community economic problems worsened. Control coalition implementation levels were not related to economic conditions before or after the downturn, but mean implementation levels of science-based prevention were also relatively low in both periods. PMID:23054169

Circadian Genes and Risk for Prostate Cancer

DTIC Science & Technology

2011-09-01

placebo-controlled clinical trial to determine if finasteride (an inhibitor of androgen bioactivation) could prevent prostate cancer. In Year 3 of the...risk. Our study is nested within the Prostate Cancer Prevention Trial (PCPT), a randomized placebo-controlled clinical trial to determine if finasteride

Episodic migraines in children: limited evidence on preventive pharmacological treatments.

PubMed

Shamliyan, Tatyana A; Kane, Robert L; Ramakrishnan, Rema; Taylor, Frederick R

2013-10-01

The authors conducted a systematic literature review of preventive pharmacological treatments for episodic childhood migraines searching several databases through May 20, 2012. Episodic migraine prevention was examined in 24 publications of randomized controlled trials that enrolled 1578 children in 16 nonrandomized studies. Single randomized controlled trials provided low-strength evidence that propranolol would result in complete cessation of migraine attacks in 713 per 1000 children treated (95% confidence interval, 452-974); trazodone and nimodipine decreased migraine days, while topiramate, divalproex, and clonidine were no more effective than placebo in preventing migraines. Migraine prevention with multidisciplinary drug management was not sustained at 6 months. Divalproex resulted in treatment discontinuation due to adverse effects, and topiramate increased the risk of paresthesia, upper respiratory tract infection, and weight loss. Long-term preventive benefits and improvement in disability and quality of life are unknown. No studies examined quality of life or provided evidence for individualized treatment decisions.

Effectiveness of a 12-week school-based educational preventive programme on weight and fasting blood glucose in "at-risk" adolescents of type 2 diabetes mellitus: Randomized controlled trial.

PubMed

Bani Salameh, Ayman; Al-Sheyab, Nihaya; El-Hneiti, Mamdouh; Shaheen, Abeer; Williams, Leonie M; Gallagher, Robyn

2017-06-01

To assess the effectiveness of a 12-week school-based educational preventive programme for type 2 diabetes by change in weight and fasting blood glucose level in Jordanian adolescents. Sixteen percent of Jordanian adults have obesity-related type 2 diabetes and 5.6% of obese adolescents examined, however one-third unexamined. Rates in Arabic countries will double in 20 years, but this can be prevented and reversed by controlling obesity. A single-blinded randomized controlled trial was conducted in 2 unisex high schools in Irbid, Jordan, in 2012. Intervention and control participants, aged 12 to 18 years, were visibly overweight/obese. They were randomly allocated to the intervention (n = 205) or control (n = 196) groups. At-risk students were assessed before and after the 12-week intervention, for change in weight and fasting blood glucose level following preventive instruction and parent-supported changes. Mean age of participants was 15.3 years with equal percentages of both males (49.4%) and females. Post intervention, the intervention group, demonstrated statistically significant reductions: mean difference of 3.3 kg in weight (P < .000) and 1.36 mg/dL (0.075 mmol/L) in fasting blood glucose (P < .000). School-based early prevention intervention effectively reduced weight and fasting blood glucose in Jordanian at-risk adolescents. © 2017 John Wiley & Sons Australia, Ltd.

A Randomized Controlled Trial of Familias Unidas for Hispanic Adolescents With Behavior Problems

PubMed Central

Pantin, Hilda; Prado, Guillermo; Lopez, Barbara; Huang, Shi; Tapia, Maria I.; Schwartz, Seth J.; Sabillon, Eduardo; Brown, C. Hendricks; Branchini, Jennifer

2009-01-01

Objective To evaluate the efficacy of Familias Unidas, a Hispanic-specific, parent-centered intervention, in preventing/reducing adolescent substance use, unsafe sexual behavior, and externalizing disorders. Methods A total of 213 8th grade Hispanic adolescents with behavior problems and their primary caregivers were assigned randomly to one of two conditions: Familias Unidas or Community Control. Participants were assessed at baseline and at 6, 18, and 30 months post baseline. Results Results showed that, relative to a Community Control condition, Familias Unidas was efficacious in preventing or reducing externalizing disorders, preventing and reducing substance use, and in reducing unsafe sexual behavior. The effects of Familias Unidas on these outcomes were partially mediated by improvements in family functioning. Conclusions These findings suggest that parent-centered intervention is an efficacious strategy for preventing/reducing specific health risk behaviors in Hispanic adolescents with behavior problems. PMID:19834053

Effectiveness of a Technology-Based Injury Prevention Program for Enhancing Mothers’ Knowledge of Child Safety: Protocol for a Randomized Controlled Trial

PubMed Central

Chow, Chun Bong; Wong, Wilfred Hing-Sang; Leung, Wing Cheong; Tang, Mary Hoi-Yin; Chan, Ko Ling; Or, Calvin KL; Li, Tim MH; Ho, Frederick Ka Wing; Lo, Daniel

2016-01-01

Background Provision of anticipatory guidance for parents is recommended as an effective strategy to prevent injuries among young children. Technology-based anticipatory guidance has been suggested to reinforce the effectiveness of injury prevention and improve parents’ knowledge of child safety. Objective This study aims to examine the effectiveness of a technology-based injury prevention program with parental anticipatory guidance for enhancing mothers’ knowledge of child safety. Methods In this randomized controlled trial, 308 mothers will be recruited from the antenatal clinics and postnatal wards of two major public hospitals in Hong Kong. Participating mothers will be randomly assigned into intervention and control groups. Mothers in the intervention group will be given free access to a technology-based injury prevention program with anticipatory guidance, whereas mothers in the control group will be given a relevant booklet on parenting. The injury prevention program, available as a website or on a mobile app, includes behavioral components based on the Theory of Planned Behavior. The primary outcome measure will be the change in the mother’s knowledge of child safety. The secondary outcome measures will be age-appropriate domestic safety knowledge, attitudes, intentions, perceived behavioral control, and self-reported behavior related to home safety practice. We will also determine dose-response relationships between the outcome measures and the website and mobile app usage. Results Enrolment of participants will begin in October 2016. Results are expected by June 2018. Conclusions Parents will be able to easily access the domestic injury prevention website to find information regarding child injury prevention. It is anticipated that the technology-based intervention will help parents improve their knowledge of child safety and raise their awareness about the consequences of domestic injuries and the importance of prevention. Trial Registration Clinicaltrials.gov Clinicaltrials.gov NCT02835768; http://clinicaltrials.gov/ct2/show/NCT02835768 (Archived by WebCite at http://www.webcitation/6lbXYM6b9) PMID:27799138

Effects of unipedal standing balance exercise on the prevention of falls and hip fracture among clinically defined high-risk elderly individuals: a randomized controlled trial.

PubMed

Sakamoto, Keizo; Nakamura, Toshitaka; Hagino, Hiroshi; Endo, Naoto; Mori, Satoshi; Muto, Yoshiteru; Harada, Atsushi; Nakano, Tetsuo; Itoi, Eiji; Yoshimura, Mitsuo; Norimatsu, Hiromichi; Yamamoto, Hiroshi; Ochi, Takahiro

2006-10-01

The aim of this study was to assess the effectiveness of the unipedal standing balance exercise for 1 min to prevent falls and hip fractures in high-risk elderly individuals with a randomized controlled trial. This control study was designed as a 6-month intervention trial. Subjects included 553 clinically defined high-risk adults who were living in residences or in the community. They were randomized to an exercise group and a control group. Randomization to the subjects was performed by a table of random numbers. A unipedal standing balance exercise with open eyes was performed by standing on each leg for 1 min three times per day. As a rule, subjects of the exercise group stood on one leg without holding onto any support, but unstable subjects were permitted to hold onto a bar during the exercise time. Falls and hip fractures were reported by nurses, physical therapists, or facility staff with a survey sheet every month. This survey sheet was required every month for both groups. Registered subjects were 553 persons ranging in age from 37 to 102 years (average, 81.6 years of age). Twenty-six subjects dropped out. The number of falls and hip fractures for the 6-month period after the trial for 527 of the 553 subjects for whom related data were available were assessed. The exercise group comprised 315 subjects and the control group included 212 subjects. The cumulative number of falls of the exercise group, with 1 multiple faller omitted, was 118, and the control group recorded 121 falls. A significant intergroup difference was observed. However, the cumulative number of hip fractures was only 1 case in both groups. This difference was not statistically significant. The unipedal standing balance exercise is effective to prevent falls but was not shown to be statistically significant in the prevention of hip fracture in this study.

Beta Blockers for the Prevention of Acute Exacerbations of COPD

DTIC Science & Technology

2017-10-01

beta blockers , cardiovascular disease , COPD, exacerbation , metoprolol succinate, placebo- controlled, randomized 16. SECURITY CLASSIFICATION OF...basis. KEYWORDS: beta blockers cardiovascular disease COPD exacerbation metoprolol succinate placebo-controlled randomized...pulmonary disease (COPD)-related morbidity, mortality and healthcare costs are due to acute exacerbations, but existing medications have only a

Preventing patient-to-worker violence in hospitals: outcome of a randomized controlled intervention

PubMed Central

Arnetz, Judith E.; Hamblin, Lydia; Russell, Jim; Upfal, Mark J.; Luborsky, Mark; Janisse, James; Essenmacher, Lynnette

2016-01-01

Objective To evaluate the effects of a randomized controlled intervention on the incidence of patient-to-worker (Type II) violence and related injury in hospitals. Methods Forty-one units across 7 hospitals were randomized into intervention (n=21) and control (n=20) groups. Intervention units received unit-level violence data to facilitate development of an action plan for violence prevention; no data were presented to control units. Main outcomes were rates of violent events and injuries across study groups over time. Results Six months post-intervention, incident rate ratios of violent events were significantly lower on intervention units compared to controls (IRR 0.48, 95% CI 0.29-0.80). At 24 months, the risk for violence-related injury was lower on intervention units, compared to controls (IRR 0.37, 95% CI 0.17-0.83). Conclusion This data-driven, worksite-based intervention was effective in decreasing risks of patient-to-worker violence and related injury. PMID:28045793

76 FR 48164 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

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76 FR 44336 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-25

... using a prospective experimental design (multiple baselines across groups with randomization). The costs... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-11-11FE] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...

Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial.

PubMed

Grunfeld, Eva; Manca, Donna; Moineddin, Rahim; Thorpe, Kevin E; Hoch, Jeffrey S; Campbell-Scherer, Denise; Meaney, Christopher; Rogers, Jess; Beca, Jaclyn; Krueger, Paul; Mamdani, Muhammad

2013-11-20

Primary care provides most of the evidence-based chronic disease prevention and screening services offered by the healthcare system. However, there remains a gap between recommended preventive services and actual practice. This trial (the BETTER Trial) aimed to improve preventive care of heart disease, diabetes, colorectal, breast and cervical cancers, and relevant lifestyle factors through a practice facilitation intervention set in primary care. Pragmatic two-way factorial cluster RCT with Primary Care Physicians' practices as the unit of allocation and individual patients as the unit of analysis. The setting was urban Primary Care Team practices in two Canadian provinces. Eight Primary Care Team practices were randomly assigned to receive the practice-level intervention or wait-list control; 4 physicians in each team (32 physicians) were randomly assigned to receive the patient-level intervention or wait-list control. Patients randomly selected from physicians' rosters were stratified into two groups: 1) general and 2) moderate mental illness. The interventions involved a multifaceted, evidence-based, tailored practice-level intervention with a Practice Facilitator, and a patient-level intervention involving a one-hour visit with a Prevention Practitioner where patients received a tailored 'prevention prescription'. The primary outcome was a composite Summary Quality Index of 28 evidence-based chronic disease prevention and screening actions with pre-defined targets, expressed as the ratio of eligible actions at baseline that were met at follow-up. A cost-effectiveness analysis was conducted. 789 of 1,260 (63%) eligible patients participated. On average, patients were eligible for 8.96 (SD 3.2) actions at baseline. In the adjusted analysis, control patients met 23.1% (95% CI: 19.2% to 27.1%) of target actions, compared to 28.5% (95% CI: 20.9% to 36.0%) receiving the practice-level intervention, 55.6% (95% CI: 49.0% to 62.1%) receiving the patient-level intervention, and 58.9% (95% CI: 54.7% to 63.1%) receiving both practice- and patient-level interventions (patient-level intervention versus control, P < 0.001). The benefit of the patient-level intervention was seen in both strata. The extra cost of the intervention was $26.43CAN (95% CI: $16 to $44) per additional action met. A Prevention Practitioner can improve the implementation of clinically important prevention and screening for chronic diseases in a cost-effective manner.

Worksite Environmental Interventions for Obesity Prevention and Control: Evidence from Group Randomized Trials.

PubMed

Fernandez, Isabel Diana; Becerra, Adan; Chin, Nancy P

2014-06-01

Worksites provide multiple advantages to prevent and treat obesity and to test environmental interventions to tackle its multiple causal factors. We present a literature review of group-randomized and non-randomized trials that tested worksite environmental, multiple component interventions for obesity prevention and control paying particular attention to the conduct of formative research prior to intervention development. The evidence on environmental interventions on measures of obesity appears to be strong since most of the studies have a low (4/8) and unclear (2/8) risk of bias. Among the studies reviewed whose potential risk of bias was low, the magnitude of the effect was modest and sometimes in the unexpected direction. None of the four studies describing an explicit formative research stage with clear integration of findings into the intervention was able to demonstrate an effect on the main outcome of interest. We present alternative explanation for the findings and recommendations for future research.

Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial.

PubMed

Matsuoka, Yutaka; Nishi, Daisuke; Yonemoto, Naohiro; Hamazaki, Kei; Matsumura, Kenta; Noguchi, Hiroko; Hashimoto, Kenji; Hamazaki, Tomohito

2013-01-05

Preclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the secondary prevention of PTSD following accidental injury, as compared with placebo. This paper describes the rationale and protocol of this trial. The Tachikawa Project for Prevention of Posttraumatic Stress Disorder with Polyunsaturated Fatty Acid (TPOP) is a double-blinded, parallel group, randomized controlled trial to assess whether omega-3 fatty acid supplementation can prevent PTSD symptoms among accident-injured patients consecutively admitted to an intensive care unit. We plan to recruit accident-injured patients and follow them prospectively for 12 weeks. Enrolled patients will be randomized to either the omega-3 fatty acid supplement group (1,470 mg docosahexaenoic acid and 147 mg eicosapentaenoic acid daily) or placebo group. Primary outcome is score on the Clinician-Administered PTSD Scale (CAPS). We will need to randomize 140 injured patients to have 90% power to detect a 10-point difference in mean CAPS scores with omega-3 fatty acid supplementation compared with placebo. Secondary measures are diagnosis of PTSD and major depressive disorder, depressive symptoms, physiologic response in the experiment using script-driven imagery and acoustic stimulation, serum brain-derived neurotrophic factor, health-related quality of life, resilience, and aggression. Analyses will be by intent to treat. The trial was initiated on December 13 2008, with 104 subjects randomized by November 30 2012. This study promises to be the first trial to provide a novel prevention strategy for PTSD among traumatized people. ClinicalTrials.gov Identifier NCT00671099.

Rationale and baseline characteristics of PREVENT: a second-generation intervention trial in subjects at-risk (prodromal) of developing first-episode psychosis evaluating cognitive behavior therapy, aripiprazole, and placebo for the prevention of psychosis.

PubMed

Bechdolf, Andreas; Müller, Hendrik; Stützer, Hartmut; Wagner, Michael; Maier, Wolfgang; Lautenschlager, Marion; Heinz, Andreas; de Millas, Walter; Janssen, Birgit; Gaebel, Wolfgang; Michel, Tanja Maria; Schneider, Frank; Lambert, Martin; Naber, Dieter; Brüne, Martin; Krüger-Özgürdal, Seza; Wobrock, Thomas; Riedel, Michael; Klosterkötter, Joachim

2011-09-01

Antipsychotics, cognitive behavioral therapy (CBT), and omega-3-fatty acids have been found superior to control conditions as regards prevention of psychosis in people at-risk of first-episode psychosis. However, no large-scale trial evaluating the differential efficacy of CBT and antipsychotics has been performed yet. In PREVENT, we evaluate CBT, aripiprazole, and clinical management (CM) as well as placebo and CM for the prevention of psychosis in a randomized, double-blind, placebo-controlled trial with regard to the antipsychotic intervention and a randomized controlled trial with regard to the CBT intervention with blinded ratings. The hypotheses are first that CBT and aripiprazole and CM are superior to placebo and CM and second that CBT is not inferior to aripiprazole and CM combined. The primary outcome is transition to psychosis. By November 2010, 156 patients were recruited into the trial. The subjects were substantially functionally compromised (Social and Occupational Functioning Assessment Scale mean score 52.5) and 78.3% presented with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition axis I comorbid diagnosis. Prior to randomization, 51.5% of the participants preferred to be randomized into the CBT arm, whereas only 12.9% preferred pharmacological treatment. First, assessments of audiotaped treatment sessions confirmed the application of CBT-specific skills in the CBT condition and the absence of those in CM. The overall quality rating of the CBT techniques applied in the CBT condition was good. When the final results of the trial are available, PREVENT will substantially expand the current limited evidence base for best clinical practice in people at-risk (prodromal) of first-episode psychosis.

An intervention to improve program implementation: findings from a two-year cluster randomized trial of Assets-Getting To Outcomes

PubMed Central

2013-01-01

Background Studies have shown that communities have not always been able to implement evidence-based prevention programs with quality and achieve outcomes demonstrated by prevention science. Implementation support interventions are needed to bridge this gap between science and practice. The purpose of this article is to present two-year outcomes from an evaluation of the Assets Getting To Outcomes (AGTO) intervention in 12 Maine communities engaged in promoting Developmental Assets, a positive youth development approach to prevention. AGTO is an implementation support intervention that consists of: a manual of text and tools; face-to-face training, and onsite technical assistance, focused on activities shown to be associated with obtaining positive results across any prevention program. Methods This study uses a nested and cross-sectional, cluster randomized controlled design. Participants were coalition members and program staff from 12 communities in Maine. Each coalition nominated up to five prevention programs to participate. At random, six coalitions and their respective 30 programs received the two-year AGTO intervention and the other six maintained routine operations. The study assessed prevention practitioner capacity (efficacy and behaviors), practitioner exposure to and use of AGTO, practitioner perceptions of AGTO, and prevention program performance. Capacity of coalition members and performance of their programs were compared between the two groups across the baseline, one-, and two-year time points. Results We found no significant differences between AGTO and control group’s prevention capacity. However, within the AGTO group, significant differences were found between those with greater exposure to and use of AGTO. Programs that received the highest number of technical assistance hours showed the most program improvement. Conclusions This study is the first of its kind to show that use of an implementation support intervention-AGTO -yielded improvements in practitioner capacity and consequently in program performance on a large sample of practitioners and programs using a randomized controlled design. ClinicalTrials.gov identifier NCT00780338 PMID:23924279

Prevention Service System Transformation Using "Communities That Care"

ERIC Educational Resources Information Center

Brown, Eric C.; Hawkins, J. David; Arthur, Michael W.; Briney, John S.; Fagan, Abigail A.

2011-01-01

This study examines prevention system transformation as part of a community-randomized controlled trial of Communities That Care (CTC). Using data from surveys of community leaders, we examine differences between CTC and control communities 4.5 years after CTC implementation. Significantly higher levels of adopting a science-based approach to…

Effectiveness of a Cognitive Behavioral Therapy-Based Indicated Prevention Program for Children with Elevated Anxiety Levels: a Randomized Controlled Trial.

PubMed

van Starrenburg, Manon L A; Kuijpers, Rowella C M W; Kleinjan, Marloes; Hutschemaekers, Giel J M; Engels, Rutger C M E

2017-01-01

Childhood anxiety is a problem not only because of its negative consequences on the well-being of children but also because of its adverse effects on society and its role in mental disorders later in life. Adequate prevention might be the key in tackling this problem. The effectiveness of Coping Cat, as an indicated CBT-based prevention program in Dutch primary school children, was assessed by means of a randomized controlled trial. In total, 141 children aged 7-13 with elevated levels of anxiety and their mothers were included and randomly assigned to an intervention group and a waiting list control group. After screening, all participants completed baseline, post-intervention, and 3-month follow-up assessments. The results showed that Coping Cat, as an indicated prevention program, reduces children's self-reported anxiety symptoms, with Cohen's effect size d of 0.66 at the 3-month follow-up. A moderating effect was found for baseline anxiety level; specifically, children with high levels of baseline anxiety who received the Coping Cat program had lower anxiety levels at follow-up compared to children with high levels of anxiety in the control condition. No moderating effects of gender or age were found. An unexpected decline in anxiety levels from screening to pre-assessment was found in both groups, and this decline was stronger in the experimental group. These promising results warrant the implementation of Coping Cat as an indicated prevention program.

Interventions to reduce sexual risk behaviors among youth in alternative schools: a randomized controlled trial.

PubMed

Coyle, Karin K; Glassman, Jill R; Franks, Heather M; Campe, Shannon M; Denner, Jill; Lepore, Gina M

2013-07-01

This paper presents results from a randomized controlled trial that assessed the short- and longer-term impact of a skills-based HIV/STI/pregnancy prevention curriculum, service learning, and the combination. The study featured a four-arm experimental design involving 47 classrooms (765 youth) from continuation high schools. Classrooms were randomly assigned to one of four conditions: (1) HIV/STI/pregnancy prevention curriculum only; (2) service learning only; (3) HIV/STI/pregnancy prevention curriculum plus service learning; or (4) an attention control curriculum. Students completed 3 surveys over 18 months. Multi-level analysis was used to adjust for the correlation among students within the same classroom and school, and the correlation of repeated measurements. Participants were 53% male (mean age: 16.2 years). The majority of youth reported being Hispanic/Latino or African-American (37.9% and 22.3%, respectively). Students in the HIV/STI/pregnancy prevention curriculum condition were less likely to have vaginal intercourse without a condom in the 3 months prior to the survey [odds ratio (OR) = .58, p = .04]; these effects diminished by final follow-up. The program also significantly reduced students' exposure to risky situations. These changes were not significant in the service learning only or combined intervention conditions relative to control. This study is one of a few controlled studies of HIV/STI and pregnancy prevention programs in continuation settings, and suggests the curriculum was effective in changing selected risk behaviors in the short term. Copyright © 2013 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Estimates of Intraclass Correlation for Variables Related to Behavioral HIV/STD Prevention in a Predominantly African American and Hispanic Sample of Young Women

ERIC Educational Resources Information Center

Pals, Sherri L.; Beaty, Brenda L.; Posner, Samuel F.; Bull, Sheana S.

2009-01-01

Studies designed to evaluate HIV and STD prevention interventions often involve random assignment of groups such as neighborhoods or communities to study conditions (e.g., to intervention or control). Investigators who design group-randomized trials (GRTs) must take the expected intraclass correlation coefficient (ICC) into account in sample size…

Effect of health promotion and fluoride varnish on dental caries among Australian Aboriginal children: results from a community-randomized controlled trial*

PubMed Central

Slade, Gary D; Bailie, Ross S; Roberts-Thomson, Kaye; Leach, Amanda J; Raye, Iris; Endean, Colin; Simmons, Bruce; Morris, Peter

2011-01-01

Objectives We tested a dental health program in remote Aboriginal communities of Australia's Northern Territory, hypothesizing that it would reduce dental caries in preschool children. Methods In this 2-year, prospective, cluster-randomized, concurrent controlled, open trial of the dental health program compared to no such program, 30 communities were allocated at random to intervention and control groups. All residents aged 18–47 months were invited to participate. Twice per year for 2 years in the 15 intervention communities, fluoride varnish was applied to children's teeth, water consumption and daily tooth cleaning with toothpaste were advocated, dental health was promoted in community settings, and primary health care workers were trained in preventive dental care. Data from dental examinations at baseline and after 2 years were used to compute net dental caries increment per child (d3mfs). A multi-level statistical model compared d3mfs between intervention and control groups with adjustment for the clustered randomization design; four other models used additional variables for adjustment. Results At baseline, 666 children were examined; 543 of them (82%) were re-examined 2 years later. The adjusted d3mfs increment was significantly lower in the intervention group compared to the control group by an average of 3.0 surfaces per child (95% CI = 1.2, 4.9), a prevented fraction of 31%. Adjustment for additional variables yielded caries reductions ranging from 2.3 to 3.5 surfaces per child and prevented fractions of 24–36%. Conclusions These results corroborate findings from other studies where fluoride varnish was efficacious in preventing dental caries in young children. PMID:20707872

Enhancing HIV Communication between Parents and Children: Efficacy of the Parents Matter! Program

ERIC Educational Resources Information Center

Miller, Kim S.; Lin, Carol Y.; Poulsen, Melissa N.; Fasula, Amy; Wyckoff, Sarah C.; Forehand, Rex; Long, Nicholas; Armistead, Lisa

2011-01-01

We examine efficacy of the Parents Matter! Program (PMP), a program to teach African-American parents of preadolescents sexual communication and HIV-prevention skills, through a multicenter, randomized control trial. A total of 1115 parent-child participants were randomized to one of three intervention arms (enhanced, brief, control). Percentages…

School-Based Violence Prevention Programs: Systematic Review of Secondary Prevention Trials.

ERIC Educational Resources Information Center

Mytton, Julie A.; DiGuiseppi, Carolyn; Gough, David A.; Taylor, Rod S.; Logan, Stuart

2002-01-01

Conducted a systematic review and meta-analysis of randomized controlled secondary prevention trials to explore the effects of school-based violence prevention programs on aggressive and violent behavior in children at high risk for violence. Results indicated that such programs produced modest reductions in aggressive and violent behaviors in…

Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy | Division of Cancer Prevention

Cancer.gov

RATIONALE: Acupressure wristbands may prevent or reduce nausea and caused by chemotherapy. It is not yet known whether standard care is more effective with or without acupressure wristbands in controlling acute and delayed nausea. PURPOSE: This randomized phase III trial is studying how well acupressure wristbands work with or without standard care in controlling nausea in

Smoking relapse-prevention intervention for cancer patients: Study design and baseline data from the surviving SmokeFree randomized controlled trial.

PubMed

Díaz, Diana B; Brandon, Thomas H; Sutton, Steven K; Meltzer, Lauren R; Hoehn, Hannah J; Meade, Cathy D; Jacobsen, Paul B; McCaffrey, Judith C; Haura, Eric B; Lin, Hui-Yi; Simmons, Vani N

2016-09-01

Continued smoking after a cancer diagnosis contributes to several negative health outcomes. Although many cancer patients attempt to quit smoking, high smoking relapse rates have been observed. This highlights the need for a targeted, evidence-based smoking-relapse prevention intervention. The design, method, and baseline characteristics of a randomized controlled trial assessing the efficacy of a self-help smoking-relapse prevention intervention are presented. Cancer patients who had recently quit smoking were randomized to one of two conditions. The Usual Care (UC) group received the institution's standard of care. The smoking relapse-prevention intervention (SRP) group received standard of care, plus 8 relapse-prevention booklets mailed over a 3month period, and a targeted educational DVD developed specifically for cancer patients. Four hundred and fourteen participants were enrolled and completed a baseline survey. Primary outcomes will be self-reported smoking status at 6 and 12-months after baseline. Biochemical verification of smoking status was completed for a subsample. If found to be efficacious, this low-cost intervention could be easily disseminated with significant potential for reducing the risk of negative cancer outcomes associated with continued smoking. Copyright © 2016 Elsevier Inc. All rights reserved.

Chieh Mei Ching Yi: A randomized controlled trial of a culturally tailored HIV prevention intervention for Chinese massage parlor women in Los Angeles.

PubMed

Takahashi, Lois M; Tobin, Karin E; To, Stacy; Ou, Samuel; Ma, Chui Hing Helen; Ao, Fiona Ka Wa; Candelario, Jury

2013-12-01

Asian heterosexual women in the U.S. have experienced relative rising HIV case rates, but there remain few studies and no evidence-based interventions that focus on this population. This study was a randomized controlled trial of a gender and ethnically tailored HIV prevention intervention for monolingual Chinese-speaking women who work as masseuses in Los Angeles. The intervention was two group-based sessions focused on HIV risk and prevention knowledge and condom skills. The control condition was a single-session HIV review. Participants were recruited using newspaper advertisements and referrals from agencies and massage schools. Two hundred women were randomly assigned to one of each condition. Retention in both conditions exceeded 90% at 3-month follow-up. Participants in both conditions demonstrated increases in knowledge on how to use male and female condoms. These effects were sustained at 3-month follow-up. The results highlight the possible efficacy of a one-workshop intervention in increasing HIV knowledge, but that more intensive participant interaction may be needed for improved condom use knowledge.

Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial.

PubMed

Arabi, Yaseen M; Alsolamy, Sami; Al-Dawood, Abdulaziz; Al-Omari, Awad; Al-Hameed, Fahad; Burns, Karen E A; Almaani, Mohammed; Lababidi, Hani; Al Bshabshe, Ali; Mehta, Sangeeta; Al-Aithan, Abdulsalam M; Mandourah, Yasser; Almekhlafi, Ghaleb; Finfer, Simon; Abdukahil, Sheryl Ann I; Afesh, Lara Y; Dbsawy, Maamoun; Sadat, Musharaf

2016-08-03

Venous thromboembolism (VTE) remains a common problem in critically ill patients. Pharmacologic prophylaxis is currently the standard of care based on high-level evidence from randomized controlled trials. However, limited evidence exists regarding the effectiveness of intermittent pneumatic compression (IPC) devices. The Pneumatic compREssion for preventing VENous Thromboembolism (PREVENT trial) aims to determine whether the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis alone in critically ill patients reduces the risk of VTE. The PREVENT trial is a multicenter randomized controlled trial, which will recruit 2000 critically ill patients from over 20 hospitals in three countries. The primary outcome is the incidence of proximal lower extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the scans are blinded to intervention allocation, whereas the patients and caregivers are unblinded. The trial has 80 % power to detect a 3 % absolute risk reduction in proximal DVT from 7 to 4 %. The first patient was enrolled in July 2014. As of May 2015, a total of 650 patients have been enrolled from 13 centers in Saudi Arabia, Canada and Australia. The first interim analysis is anticipated in July 2016. We expect to complete recruitment by 2018. Clinicaltrials.gov: NCT02040103 (registered on 3 November 2013). Current controlled trials: ISRCTN44653506 (registered on 30 October 2013).

High School Students With Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention.

PubMed

Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G; Fall, Anna-Mária; Schnakenberg, Jennifer B

2015-01-01

A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state accountability test and were randomly assigned to one of three treatment conditions and a business as usual (BAU) condition: reading without dropout prevention, reading with dropout prevention, dropout prevention without reading, or a BAU condition. Findings from the 2-year reading intervention (reading with and without dropout prevention combined and BAU) are reported in this article. Students in reading treatment compared to students in BAU demonstrated significant gains on reading comprehension (effect size = .43), and improved reading was associated with better grades in social studies. Findings from this study provide a rationale for further implementation and investigation of intensive intervention for high school students with reading difficulties. © Hammill Institute on Disabilities 2014.

School-based prevention of depressive symptoms: A randomized controlled study of the effectiveness and specificity of the Penn Resiliency Program.

PubMed

Gillham, Jane E; Reivich, Karen J; Freres, Derek R; Chaplin, Tara M; Shatté, Andrew J; Samuels, Barbra; Elkon, Andrea G L; Litzinger, Samantha; Lascher, Marisa; Gallop, Robert; Seligman, Martin E P

2007-02-01

The authors investigated the effectiveness and specificity of the Penn Resiliency Program (PRP; J. E. Gillham, L. H. Jaycox, K. J. Reivich, M. E. P. Seligman, & T. Silver, 1990), a cognitive-behavioral depression prevention program. Children (N = 697) from 3 middle schools were randomly assigned to PRP, Control (CON), or the Penn Enhancement Program (PEP; K. J. Reivich, 1996; A. J. Shatté, 1997), an alternate intervention that controls for nonspecific intervention ingredients. Children's depressive symptoms were assessed through 3 years of follow-up. There was no intervention effect on average levels of depressive symptoms in the full sample. Findings varied by school. In 2 schools, PRP significantly reduced depressive symptoms across the follow-up relative to both CON and PEP. In the 3rd school, PRP did not prevent depressive symptoms. The authors discuss the findings in relation to previous research on PRP and the dissemination of prevention programs. Copyright 2007 APA, all rights reserved.

School-Based Prevention of Depressive Symptoms: A Randomized Controlled Study of the Effectiveness and Specificity of the Penn Resiliency Program

PubMed Central

Gillham, Jane E.; Reivich, Karen J.; Freres, Derek R.; Chaplin, Tara M.; Shatté, Andrew J.; Samuels, Barbra; Elkon, Andrea G. L.; Litzinger, Samantha; Lascher, Marisa; Gallop, Robert; Seligman, Martin E. P.

2015-01-01

The authors investigated the effectiveness and specificity of the Penn Resiliency Program (PRP; J. E. Gillham, L. H. Jaycox, K. J. Reivich, M. E. P. Seligman, & T. Silver, 1990), a cognitive–behavioral depression prevention program. Children (N = 697) from 3 middle schools were randomly assigned to PRP, Control (CON), or the Penn Enhancement Program (PEP; K. J. Reivich, 1996; A. J. Shatté, 1997), an alternate intervention that controls for nonspecific intervention ingredients. Children’s depressive symptoms were assessed through 3 years of follow-up. There was no intervention effect on average levels of depressive symptoms in the full sample. Findings varied by school. In 2 schools, PRP significantly reduced depressive symptoms across the follow-up relative to both CON and PEP. In the 3rd school, PRP did not prevent depressive symptoms. The authors discuss the findings in relation to previous research on PRP and the dissemination of prevention programs. PMID:17295559

Economic evaluations and their use in infection prevention and control: a narrative review.

PubMed

Rennert-May, Elissa; Conly, John; Leal, Jenine; Smith, Stephanie; Manns, Braden

2018-01-01

The objective of this review is to provide a comprehensive overview of the different types of economic evaluations that can be utilized by Infection Prevention and Control practitioners with a particular focus on the use of the quality adjusted life year, and its associated challenges. We also highlight existing economic evaluations published within Infection Prevention and Control, research gaps and future directions. Narrative Review. To date the majority of economic evaluations within Infection Prevention and Control are considered partial economic evaluations. Acknowledging the challenges, which include variable utilities within infection prevention and control, a lack of randomized controlled trials, and difficulty in modelling infectious diseases in general, future economic evaluation studies should strive to be consistent with published guidelines for economic evaluations. This includes the use of quality adjusted life years. Further research is required to estimate utility scores of relevance within Infection Prevention and Control.

Major Depression Can Be Prevented

ERIC Educational Resources Information Center

Munoz, Ricardo F.; Beardslee, William R.; Leykin, Yan

2012-01-01

The 2009 Institute of Medicine report on prevention of mental, emotional, and behavioral disorders (National Research Council & Institute of Medicine, 2009b) presented evidence that major depression can be prevented. In this article, we highlight the implications of the report for public policy and research. Randomized controlled trials have shown…

Tailored Education for Older Patients to Facilitate Engagement in Falls Prevention Strategies after Hospital Discharge—A Pilot Randomized Controlled Trial

PubMed Central

Hill, Anne-Marie; Etherton-Beer, Christopher; Haines, Terry P.

2013-01-01

Background The aims of the study were to evaluate the effect of providing tailored falls prevention education in hospital on: i) engagement in targeted falls prevention behaviors in the month after discharge: ii) patients’ self-perceived risk and knowledge about falls and falls prevention strategies after receiving the education. Methods A pilot randomized controlled trial (n = 50): baseline and outcome assessments conducted by blinded researchers. Participants: hospital inpatients 60 years or older, discharged to the community. Participants were randomized into two groups. The intervention was a tailored education package consisting of multimedia falls prevention information with trained health professional follow-up, delivered in addition to usual care. Outcome measures were engagement in falls prevention behaviors in the month after discharge measured at one month after discharge with a structured survey, and participants’ knowledge, confidence and motivation levels before and after receiving the education. The feasibility of providing the intervention was examined and falls outcomes (falls, fall-related injuries) were also collected. Results Forty-eight patients (98%) provided follow-up data. The complete package was provided to 21 (84%) intervention group participants. Participants in the intervention group were significantly more likely to plan how to safely restart functional activities [Adjusted odds ratio 3.80, 95% CI (1.07, 13.52), p = 0.04] and more likely to complete other targeted behaviors such as completing their own home exercise program [Adjusted odds ratio 2.76, 95% CI (0.72, 10.50), p = 0.14] than the control group. The intervention group was significantly more knowledgeable, confident and motivated to engage in falls prevention strategies after receiving the education than the control group. There were 23 falls (n = 5 intervention; n = 18 control) and falls rates were 5.4/1000 patient days (intervention); 18.7/1000 patient days (control). Conclusion This tailored education was received positively by older people, resulted in increased engagement in falls prevention strategies after discharge and is feasible to deliver to older hospital patients. Trial registration The study was registered with the Australian New Zealand Clinical Trials Registry; ACTRN12611000963921 on 8th November 2011. PMID:23717424

Efficacy of a church-based lifestyle intervention programme to control high normal blood pressure and/or high normal blood glucose in church members: a randomized controlled trial in Pretoria, South Africa.

PubMed

Pengpid, Supa; Peltzer, Karl; Skaal, Linda

2014-06-06

In persons 15 years and above in South Africa the prevalence of pre-diabetes and diabetes has been estimated at 9.1% and 9.6%, respectively, and the prevalence of systolic prehypertension and hypertension, 38.2% and 24.6%, respectively. Elevated blood glucose and elevated blood pressure are prototype of preventable chronic cardiovascular disease risk factors.Lifestyle interventions have been shown to control high normal blood pressure and/or high normal blood glucose. This study proposes to evaluate the efficacy of a community (church)-based lifestyle intervention programme to control high normal blood pressure and/or high normal blood glucose in church members in a randomized controlled trial in Gauteng, South Africa. The objectives are to: (1) measure non-communicable diseases profile, including hypertension and diabetes, health behaviours, weight management and psychological distress of church members; (2) measure the reduction of blood glucose and blood pressure levels after the intervention; (3) prevent the development of impaired glucose tolerance; (4) compare health behaviours, weight management and psychological distress, blood glucose and blood pressure levels between intervention and control groups, and within group during 6, 12, 24 and 36 months during and post intervention. The study will use a group-randomized design, recruiting 300 church members from 12 churches. Churches will be randomly assigned to experimental and control conditions. Lifestyle interventions may prevent from the development of high blood pressure and/or diabetes. The findings will impact public health and will enable the health ministry to formulate policy related to lifestyle interventions to control blood pressure and glucose. PACTR201105000297151.

Web-based proactive system to improve breast cancer screening: a randomized controlled trial.

PubMed

Chaudhry, Rajeev; Scheitel, Sidna M; McMurtry, Erin K; Leutink, Dorinda J; Cabanela, Rosa L; Naessens, James M; Rahman, Ahmed S; Davis, Lynn A; Stroebel, Robert J

2007-03-26

Screening mammography is recommended for early detection of breast cancer but screening rates remain suboptimal. A primary care portal for a large academic primary practice was developed for all preventive services. Another Web-based system (PRECARES [PREventive CAre REminder System]) was developed for appointment secretaries to manage proactive breast cancer screening. Female patients aged 40 to 75 years were randomly assigned to a control group (usual care) and an intervention group. For the intervention group, 2 monthly letters inviting patients to undergo mammography were sent starting 3 months before they were due for annual screening, followed by a telephone call to nonresponding patients. A subgroup of women employees was further randomized to receive a reminder by either US mail or e-mail. Of the total eligible population of 6665 women identified as having consented to participate in research, 3339 were randomly assigned to the control group and 3326 to the intervention group. The screening rate for annual mammography was 64.3% for the intervention group and 55.3% for the control group (P <.001). There were no significant differences between the 2 groups for any of the other adult preventive services. For the employee subgroup, the screening rate was 57.5% for the control group, 68.1% for the US mail group, and 72.2% for the e-mail group (intervention vs control, P <.001; e-mail vs US mail; P = .24). The breast cancer screening rate improved significantly with the practice redesign of having appointment secretaries proactively manage breast cancer screening needs.

Effectiveness of cefoxitin on preventing endometritis after uterine curettage for spontaneous incomplete abortion: a randomized controlled trial study.

PubMed

Titapant, Vitaya; Cherdchoogieat, Panida

2012-11-01

There are only few studies concerning the usage of antibiotics in preventing endometritis after uterine curettage for spontaneous first trimester incomplete abortion and no conclusion can be demonstrated To investigate the effectiveness of prophylactic cefoxitin in preventing endometritis after uterine curettage for spontaneous first trimester incomplete abortion. Eighty-four women with spontaneous first trimester incomplete abortion were randomly allocated into two groups using a computer-generated random number list and the allocation concealment was maintained using a sealed opaque envelope. The patients in the study group were given 1 g of cefoxitin while the patients in the control group were given 0.1 ml of vitamin B complex intravenously 20 minutes prior to curettage. Uterine curettage was performed after intravenous sedation and analgesic drugs were administered. The patients were evaluated on the first, third and seventh day after uterine curettage. Seventy-nine cases had completed the study protocol. There were no statistically significant differences in demographic data and details of uterine curettage between both groups. Two cases of endometritis were found in the control group but none in the study group. However the difference did not reach the statistical significance (p = 0.241). Prophylactic cefoxitin is not effective in preventing endometritis after uterine curettage for spontaneous first trimester incomplete abortion.

Learning From Past Failures of Oral Insulin Trials.

PubMed

Michels, Aaron W; Gottlieb, Peter A

2018-07-01

Very recently one of the largest type 1 diabetes prevention trials using daily administration of oral insulin or placebo was completed. After 9 years of study enrollment and follow-up, the randomized controlled trial failed to delay the onset of clinical type 1 diabetes, which was the primary end point. The unfortunate outcome follows the previous large-scale trial, the Diabetes Prevention Trial-Type 1 (DPT-1), which again failed to delay diabetes onset with oral insulin or low-dose subcutaneous insulin injections in a randomized controlled trial with relatives at risk for type 1 diabetes. These sobering results raise the important question, "Where does the type 1 diabetes prevention field move next?" In this Perspective, we advocate for a paradigm shift in which smaller mechanistic trials are conducted to define immune mechanisms and potentially identify treatment responders. The stage is set for these interventions in individuals at risk for type 1 diabetes as Type 1 Diabetes TrialNet has identified thousands of relatives with islet autoantibodies and general population screening for type 1 diabetes risk is under way. Mechanistic trials will allow for better trial design and patient selection based upon molecular markers prior to large randomized controlled trials, moving toward a personalized medicine approach for the prevention of type 1 diabetes. © 2018 by the American Diabetes Association.

[Transcultural prevention of alcohol-related disorders : effects of a culture- and migration-sensitive approach in elderly migrants with respect to attitudes and behavior: a cluster randomized controlled trial].

PubMed

Bermejo, Isaac; Frank, F; Komarahadi, F; Albicker, J; Ries, Z; Kriston, L; Härter, M

2015-07-01

For migrants who are older than 50, alcohol frequently becomes a problem. Simultaneously alcohol-related prevention measures only reach this group insufficiently. Therefore, a transcultural concept for preventing alcohol-related disorders in elderly (≥ 45 years) migrants has been developed. The transcultural concept, which consisted of a prevention event as well as a cultural and language-sensitive information booklet, was evaluated in a cluster-randomized controlled trial (n = 310 immigrants). As a control condition there was a prevention event with materials from Deutsche Hauptstelle für Suchtfragen (German Centre for Addiction Issues). Data were obtained before and after the event, as well as after 6 months. All materials were available both in German and in Russian, Italian, Spanish and Turkish. Directly after the event, as well as 6 months thereafter, the transcultural approach was rated significantly better than the general prevention event. 73.4 % of the participants read the cultural and migration-sensitive booklet, whereas only 21.2 % in the control condition (p = 0.0001). Furthermore, significantly more participants of the transcultural approach reported a reduced alcohol consumption (49.4 vs. 16.7 %; p = 0.004) after 6 months. The consideration of diversity with respect to cultural, migration-related, socio demographic und linguistic aspects improves the effectiveness of prevention measures.

Elearning approaches to prevent weight gain in young adults: A randomized controlled study.

PubMed

Nikolaou, Charoula Konstantia; Hankey, Catherine Ruth; Lean, Michael Ernest John

2015-12-01

Preventing obesity among young adults should be a preferred public health approach given the limited efficacy of treatment interventions. This study examined whether weight gain can be prevented by online approaches using two different behavioral models, one overtly directed at obesity and the other covertly. A three-group parallel randomized controlled intervention was conducted in 2012-2013; 20,975 young adults were allocated a priori to one control and two "treatment" groups. Two treatment groups were offered online courses over 19 weeks on (1) personal weight control ("Not the Ice Cream Van," NTICV) and, (2) political, environmental, and social issues around food ("Goddess Demetra," "GD"). Control group received no contact. The primary outcome was weight change over 40 weeks. Within-group 40-week weight changes were different between groups (P < 0.001): Control (n = 2,134): +2.0 kg (95% CI = 1.5, 2.3 kg); NTICV (n = 1,810): -1.0 kg (95% CI = -1.3, -0.5); and GD (n = 2,057): -1.35 kg (95% CI = -1.4 to -0.7). Relative risks for weight gain vs. NTICV = 0.13 kg (95% CI = 0.10, 0.15), P < 0.0001; GD = 0.07 kg (95% CI = 0.05, 0.10), P < 0.0001. Both interventions were associated with prevention of the weight gain observed among control subjects. This low-cost intervention could be widely transferable as one tool against the obesity epidemic. Outside the randomized controlled trial setting, it could be enhanced using supporting advertising and social media. © 2015 The Obesity Society.

A video-based transdiagnostic REBT universal prevention program for internalizing problems in adolescents: study protocol of a cluster randomized controlled trial.

PubMed

Păsărelu, Costina Ruxandra; Dobrean, Anca

2018-04-13

Internalizing problems are the most prevalent mental health problems in adolescents. Transdiagnostic programs are promising manners to treat multiple problems within the same protocol, however, there is limited research regarding the efficacy of such programs delivered as universal prevention programs in school settings. Therefore, the present study aims to investigate the efficacy of a video-based transdiagnostic rational emotive behavioral therapy (REBT) universal prevention program, for internalizing problems. The second objective of the present paper will be to investigate the subsequent mechanisms of change, namely maladaptive cognitions. A two-arm parallel randomized controlled trial will be conducted, with two groups: a video-based transdiagnostic REBT universal prevention program and a wait list control. Power analysis indicated that the study will involve 338 participants. Adolescents with ages between 12 and 17 years old, from several middle schools and high schools, will be invited to participate. Assessments will be conducted at four time points: baseline (T 1 ), post-intervention (T 2 ), 3 months follow-up (T 3 ) and 12 months follow-up (T 4 ). Intent-to-treat analysis will be used in order to investigate significant differences between the two groups in both primary and secondary outcomes. This is the first randomized controlled trial that aims to investigate the efficacy and mechanisms of change of a video-based transdiagnostic REBT universal prevention program, delivered in a school context. The present study has important implications for developing efficient prevention programs, interactive, that will aim to target within the same protocol both anxiety and depressive symptoms. ClinicalTrials.gov: NCT02756507 . Registered on 25 April 2016.

A school-based peer-led smoking prevention intervention with extracurricular activities: the LILT-LdP cluster randomized controlled trial design and study population.

PubMed

Bosi, Sandra; Gorini, Giuseppe; Tamelli, Marco; Monti, Claudia; Storani, Simone; Carreras, Giulia; Martini, Andrea; Allara, Elias; Angelini, Paola; Faggiano, Fabrizio

2013-01-01

Few school programs are effective in preventing adolescents' tobacco smoking initiation. The "Lega contro i Tumori - Luoghi di Prevenzione" is a cluster randomized controlled trial designed to evaluate a school-based peer-led smoking prevention intervention with extracurricular activities for students aged 14-15 years. This paper presents the study design and the baseline characteristics of the study population. Twenty secondary schools located in the Reggio Emilia province took part in the study. Five schools were excluded because they already participated in smoking prevention interventions. The schools were randomized to control or intervention arms. The study population consisted of students attending the first grade. Components of the intervention included 1) the out-of-school "Smoking Prevention Tour" (SPT) at the "Luoghi di Prevenzione" Center, a 4-hour (4 sessions) extracurricular activity; 2) the "Smoke-free Schools" intervention, combining a life-skills-based peer-led intervention at school, an in-depth lesson on one of the SPT sessions, and enforcement surveillance of the school antismoking policy. Tobacco use was studied through a questionnaire administered before and 6 months after the intervention. Eleven high schools and 9 vocational secondary schools took part in the study for a total of 2,476 out of 3,050 eligible students (81.2%). The proportions of respondents in high schools and vocational secondary schools were 90.9% and 64.5%, respectively (P <0.001). Intervention and control arms showed a different distribution of gender and school type, whereas no difference was observed in any tobacco-use characteristic. This study is one of the few Italian trials to evaluate the effectiveness of a school-based program for preventing smoking initiation.

Cancer Screening Knowledge Changes: Results from a Randomized Control Trial of Women with Developmental Disabilities

ERIC Educational Resources Information Center

Parish, Susan L.; Rose, Roderick A.; Luken, Karen; Swaine, Jamie G.; O'Hare, Lindsey

2012-01-01

Background: Women with developmental disabilities are much less likely than nondisabled women to receive cervical and breast cancer screening according to clinical guidelines. One barrier to receipt of screenings is a lack of knowledge about preventive screenings. Method: To address this barrier, we used a randomized control trial (n = 175 women)…

Medial tibial stress syndrome: evidence-based prevention.

PubMed

Craig, Debbie I

2008-01-01

Thacker SB, Gilchrist J, Stroup DF, Kimsey CD. The prevention of shin splints in sports: a systematic review of literature. Med Sci Sports Exerc. 2002;34(1):32-40. Among physically active individuals, which medial tibial stress syndrome (MTSS) prevention methods are most effective to decrease injury rates? Studies were identified by searching MEDLINE (1966-2000), Current Contents (1996-2000), Biomedical Collection (1993-1999), and Dissertation Abstracts. Reference lists of identified studies were searched manually until no further studies were identified. Experts in the field were contacted, including first authors of randomized controlled trials addressing prevention of MTSS. The Cochrane Collaboration (early stage of Cochrane Database of Systematic Reviews) was contacted. Inclusion criteria included randomized controlled trials or clinical trials comparing different MTSS prevention methods with control groups. Excluded were studies that did not provide primary research data or that addressed treatment and rehabilitation rather than prevention of incident MTSS. A total of 199 citations were identified. Of these, 4 studies compared prevention methods for MTSS. Three reviewers independently scored the 4 studies. Reviewers were blinded to the authors' names and affiliations but not the results. Each study was evaluated independently for methodologic quality using a 100-point checklist. Final scores were averages of the 3 reviewers' scores. Prevention methods studied were shock-absorbent insoles, foam heel pads, Achilles tendon stretching, footwear, and graduated running programs. No statistically significant results were noted for any of the prevention methods. Median quality scores ranged from 29 to 47, revealing flaws in design, control for bias, and statistical methods. No current evidence supports any single prevention method for MTSS. The most promising outcomes support the use of shock-absorbing insoles. Well-designed and controlled trials are critically needed to decrease the incidence of this common injury.

[Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial].

PubMed

Schneider, Franciane; Danski, Mitzy Tannia Reichembach; Vayego, Stela Adami

2015-04-01

To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27) and experimental (24). There is statistically significant evidence (p-value = 0.0120) that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402). Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

Headache cessation by an educational intervention in grammar schools: a cluster randomized trial.

PubMed

Albers, L; Heinen, F; Landgraf, M; Straube, A; Blum, B; Filippopulos, F; Lehmann, S; Mansmann, U; Berger, U; Akboga, Y; von Kries, R

2015-02-01

Headache is a common health problem in adolescents. There are a number of risk factors for headache in adolescents that are amenable to intervention. The aim of the study was to assess the effectiveness of a low-level headache prevention programme in the classroom setting to prevent these risk factors. In all, 1674 students in 8th-10th grade at 12 grammar schools in greater Munich, Germany, were cluster randomized into intervention and control groups. A standardized 60-min prevention lesson focusing on preventable risk factors for headache (physical inactivity, coffee consumption, alcohol consumption and smoking) and providing instructions on stress management and neck and shoulder muscle relaxation exercises was given in a classroom setting. Seven months later, students were reassessed. The main outcome parameter was headache cessation. Logistic regression models with random effects for cluster and adjustment for baseline risk factors were calculated. Nine hundred students (intervention group N = 450, control group N = 450) with headache at baseline and complete data for headache and confounders were included in the analysis. Headache cessation was observed in 9.78% of the control group compared with 16.22% in the intervention group (number needed to treat = 16). Accounting for cluster effects and confounders, the probability of headache cessation in the intervention group was 1.77 (95% confidence interval = [1.08; 2.90]) higher than in the control group. The effect was most pronounced in adolescents with tension-type headache: odds ratio = 2.11 (95% confidence interval = [1.15; 3.80]). Our study demonstrates the effectiveness of a one-time, classroom-based headache prevention programme. © 2014 EAN.

Training pharmacy workers in recognition, management, and prevention of STDs: district-randomized controlled trial.

PubMed Central

Garcia, Patricia; Hughes, James; Carcamo, Cesar; Holmes, King K.

2003-01-01

OBJECTIVES: To determine the effectiveness of an intervention for pharmacy workers in improving their recognition and management of sexually transmitted disease (STD) syndromes. METHODS: We randomly selected 14 districts (total population nearly 4 million) from the 24 districts of low socioeconomic status in Lima, Peru. We randomly assigned paired districts to receive training and support for management and prevention of STDs or a control intervention about management of diarrhoea. The STD intervention included interactive luncheon seminars on recognition and management of four STD syndromes (urethral discharge, vaginal discharge, genital ulcers, and pelvic inflammatory disease) and STD/HIV prevention counselling; monthly pharmacy visits by "prevention salespersons" who distributed materials that included "STD/HIV prevention packets" containing information, condoms, and cards given to patients for referral of their sex partners; and workshops for physicians on managing patients with STD syndromes referred from pharmacies. Standardized simulated patients visited pharmacies in intervention and control districts at one, three, and six months after training to assess outcomes. FINDINGS: Standardized simulated patients reported significantly better recognition and management (appropriate antimicrobial regimens provided for discharge syndromes and referral to specially trained physicians for genital ulcers or pelvic inflammatory disease) by pharmacy workers of all four STD syndromes. They also reported significantly more frequent recommendations for use of condoms and treatment of partners at pharmacies in intervention districts than in control districts (by "intention-to-train" analyses, P<0.05 for 47/48 primary outcome comparisons). CONCLUSION: Training was feasible and effectively improved pharmacy workers' practices. PMID:14758407

Role of supplemental calcium in the recurrence of colorectal adenomas: a metaanalysis of randomized controlled trials.

PubMed

Shaukat, Aasma; Scouras, Nicole; Schünemann, Holger J

2005-02-01

Colorectal adenomas are neoplastic growths that are important targets for chemoprevention. Dietary calcium is thought to play an important role in chemoprevention. However, the role of calcium supplementation for preventing recurrence of adenomas is controversial. We performed a systematic review and meta-analysis to study the role of calcium supplementation in preventing recurrence of adenomas. We searched electronic bibliographic databases (Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, CINAHL, EMBASE, and MEDLINE) and contacted authors to identify potentially eligible studies. We identified three trials including 1,485 subjects with previously removed adenomas who were randomized to calcium versus placebo supplementation. The study endpoint was recurrence of adenomas at the end of 3-4 yr in 1,279 patients who completed the trials. We found that the recurrence of adenomas was significantly lower in subjects randomized to calcium supplementation (RR: 0.80, CI: 0.68, 0.93; p-value = 0.004). This systematic review and meta-analysis suggest that calcium supplementation prevents recurrent colorectal adenomas.

A Randomized Controlled Trial to Test the Effectiveness of an Immersive 3D Video Game for Anxiety Prevention among Adolescents

PubMed Central

Scholten, Hanneke; Malmberg, Monique; Lobel, Adam; Engels, Rutger C. M. E.; Granic, Isabela

2016-01-01

Adolescent anxiety is debilitating, the most frequently diagnosed adolescent mental health problem, and leads to substantial long-term problems. A randomized controlled trial (n = 138) was conducted to test the effectiveness of a biofeedback video game (Dojo) for adolescents with elevated levels of anxiety. Adolescents (11–15 years old) were randomly assigned to play Dojo or a control game (Rayman 2: The Great Escape). Initial screening for anxiety was done on 1,347 adolescents in five high schools; only adolescents who scored above the “at-risk” cut-off on the Spence Children Anxiety Survey were eligible. Adolescents’ anxiety levels were assessed at pre-test, post-test, and at three month follow-up to examine the extent to which playing Dojo decreased adolescents’ anxiety. The present study revealed equal improvements in anxiety symptoms in both conditions at follow-up and no differences between Dojo and the closely matched control game condition. Latent growth curve models did reveal a steeper decrease of personalized anxiety symptoms (not of total anxiety symptoms) in the Dojo condition compared to the control condition. Moderation analyses did not show any differences in outcomes between boys and girls nor did age differentiate outcomes. The present results are of importance for prevention science, as this was the first full-scale randomized controlled trial testing indicated prevention effects of a video game aimed at reducing anxiety. Future research should carefully consider the choice of control condition and outcome measurements, address the potentially high impact of participants’ expectations, and take critical design issues into consideration, such as individual- versus group-based intervention and contamination issues. PMID:26816292

Design, randomization and methodology of the TriAtiva Program to reduce obesity in school children in Southern Brazil.

PubMed

Friedrich, Roberta R; Caetano, Lisandrea C; Schiffner, Mariana D; Wagner, Mário B; Schuch, Ilaine

2015-04-11

The prevalence of child obesity in Brazil has increased rapidly in recent decades. There is, therefore, an urgent need to develop effective strategies to prevent and control child obesity. In light of these considerations, an intervention program with a focus on nutrition education and physical activity was developed for to prevent and control obesity in schools. The intervention was called the TriAtiva Program: Education, Nutrition and Physical Activity. This article describes the design, randomization and method used to evaluate the TriAtiva program. This randomized controlled cluster trial was performed in 12 municipal schools in the city of Porto Alegre/RS (six schools in the intervention group and six control schools) which offered first- through fourth grade, during one school year. The TriAtiva Program was implemented through educational activities related to healthy eating and physical activity, creating an environment which promoted student health while involving the school community and student families. The primary outcome of the present study was body mass, while its secondary outcomes were waist circumference, percent body fat, blood pressure and behavioural variables such as eating habits and physical activity levels, as well as the prevalence, incidence and remission rates of obesity. The intervention was developed based on a comprehensive review of controlled trials of similar design. The TriAtiva Program: Education, Nutrition and Physical Activity was the first study in Southern Brazil to use a randomized controlled design to evaluate an intervention involving both nutrition education and physical activity in schools. Our results will contribute to the development of future interventions aimed at preventing and controlling child obesity in schools, especially in Brazil. Brazilian Clinical Trials Registry (REBEC) number RBR2xx2z4.

Short-Term Impact of a Teen Pregnancy-Prevention Intervention Implemented in Group Homes.

PubMed

Oman, Roy F; Vesely, Sara K; Green, Jennifer; Fluhr, Janene; Williams, Jean

2016-11-01

Youth living in group home settings are at significantly greater risk for sexual risk behaviors; however, there are no sexual health programs designed specifically for these youth. The study's purpose was to assess the effectiveness of a teen pregnancy-prevention program for youth living in group home foster care settings and other out-of-home placements. The study design was a cluster randomized controlled trial involving youth (N = 1,037) recruited from 44 residential group homes located in California, Maryland, and Oklahoma. Within each state, youth (mean age = 16.2 years; 82% male; 37% Hispanic, 20% African-American, 20% white, and 17% multiracial) in half the group homes were randomly assigned to the intervention group (n = 40 clusters) and the other half were randomly assigned to a control group that offered "usual care" (n = 40 clusters). The intervention (i.e., Power Through Choices [PTC]) was a 10-session, age-appropriate, and medically accurate sexual health education program. Compared to the control group, youth in the PTC intervention showed significantly greater improvements (p < .05) from preintervention to postintervention in all three knowledge areas, one of two attitude areas, all three self-efficacy areas, and two of three behavioral intention areas. This is the first published randomized controlled trial of a teen pregnancy-prevention program designed for youth living in foster care settings and other out-of-home placements. The numerous significant improvements in short-term outcomes are encouraging and provide preliminary evidence that the PTC program is an effective pregnancy-prevention program. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Fall risk and incidence reduction in high risk individuals with multiple sclerosis: a pilot randomized control trial.

PubMed

Sosnoff, Jacob J; Moon, Yaejin; Wajda, Douglas A; Finlayson, Marcia L; McAuley, Edward; Peterson, Elizabeth W; Morrison, Steve; Motl, Robert W

2015-10-01

To determine the feasibility of three fall prevention programs delivered over 12 weeks among individuals with multiple sclerosis: (A) a home-based exercise program targeting physiological risk factors; (B) an educational program targeting behavioral risk factors; and (C) a combined exercise-and-education program targeting both factors. Randomized controlled trial. Home-based training with assessments at research laboratory. A total of 103 individuals inquired about the investigation. After screening, 37 individuals with multiple sclerosis who had fallen in the last year and ranged in age from 45-75 years volunteered for the investigation. A total of 34 participants completed postassessment following the 12-week intervention. Participants were randomly assigned into one of four conditions: (1) wait-list control (n = 9); (2) home-based exercise (n = 11); (3) education (n = 9); or (4) a combined exercise and education (n = 8) group. Before and after the 12-week interventions, participants underwent a fall risk assessment as determined by the physiological profile assessment and provided information on their fall prevention behaviors as indexed by the Falls Prevention Strategy Survey. Participants completed falls diaries during the three-months postintervention. A total of 34 participants completed postintervention testing. Procedures and processes were found to be feasible. Overall, fall risk scores were lower in the exercise groups (1.15 SD 1.31) compared with the non-exercise groups (2.04 SD 1.04) following the intervention (p < 0.01). There was no group difference in fall prevention behaviors (p > 0.05). Further examination of home-based exercise/education programs for reducing falls in individuals with multiple sclerosis is warranted. A total of 108 participants would be needed in a larger randomized controlled trial.ClinicalTrials.org #NCT01956227. © The Author(s) 2014.

Is Office-Based Counseling About Media Use, Timeouts, and Firearm Storage Effective? Results From a Cluster-Randomized, Controlled Trial

PubMed Central

Barkin, Shari L.; Finch, Stacia A.; Ip, Edward H.; Scheindlin, Benjamin; Craig, Joseph A.; Steffes, Jennifer; Weiley, Victoria; Slora, Eric; Altman, David; Wasserman, Richard C.

2015-01-01

Objective The objective of this study was to determine whether patients' families' violence-prevention behaviors would be affected by their primary care practitioner's use of a violence-prevention clinical intervention during the routine well-child examination. Methods In this cluster-randomized, controlled trial (2002–2006), 137 Pediatric Research in Office Settings practices were randomly assigned and initiated patient recruitment for either an office-based violence-prevention intervention or a control group (educational handout on literacy promotion provided). Primary caregivers of children who were aged 2 to 11 years and presented for a well-child visit were surveyed at baseline and 1 and 6 months. Practitioners were trained to (1) review a parent previsit summary regarding patient-family behavior and parental concern about media use, discipline strategies, and children's exposure to firearms, (2) counsel using brief principles of motivational interviewing, (3) identify and provide local agency resources for anger and behavior management when indicated, and (4) instruct patient-families on use of tangible tools (minute timers to monitor media time/timeouts and firearm cable locks to store firearms more safely where children live or play). Main outcomes were change over time in self-reported media use < 120 minutes per day, use of timeouts, and use of firearm cable locks. Results Generalized estimating equation analysis revealed a significant effect at 6 months for decreased media use and safer firearm storage. The intervention group compared with the control group showed an increase in limiting media use to < 120 minutes per day. There was no significant effect for timeout use. There was a substantial increase in storing firearms with cable locks for the intervention group versus a decrease for the control group. Conclusions This randomized, controlled trial demonstrated decreased media exposure and increased safe firearm storage as a result of a brief office-based violence-prevention approach. PMID:18595960

Is office-based counseling about media use, timeouts, and firearm storage effective? Results from a cluster-randomized, controlled trial.

PubMed

Barkin, Shari L; Finch, Stacia A; Ip, Edward H; Scheindlin, Benjamin; Craig, Joseph A; Steffes, Jennifer; Weiley, Victoria; Slora, Eric; Altman, David; Wasserman, Richard C

2008-07-01

The objective of this study was to determine whether patients' families' violence-prevention behaviors would be affected by their primary care practitioner's use of a violence-prevention clinical intervention during the routine well-child examination. In this cluster-randomized, controlled trial (2002-2006), 137 Pediatric Research in Office Settings practices were randomly assigned and initiated patient recruitment for either an office-based violence-prevention intervention or a control group (educational handout on literacy promotion provided). Primary caregivers of children who were aged 2 to 11 years and presented for a well-child visit were surveyed at baseline and 1 and 6 months. Practitioners were trained to (1) review a parent previsit summary regarding patient-family behavior and parental concern about media use, discipline strategies, and children's exposure to firearms, (2) counsel using brief principles of motivational interviewing, (3) identify and provide local agency resources for anger and behavior management when indicated, and (4) instruct patient-families on use of tangible tools (minute timers to monitor media time/timeouts and firearm cable locks to store firearms more safely where children live or play). Main outcomes were change over time in self-reported media use <120 minutes per day, use of timeouts, and use of firearm cable locks. Generalized estimating equation analysis revealed a significant effect at 6 months for decreased media use and safer firearm storage. The intervention group compared with the control group showed an increase in limiting media use to <120 minutes per day. There was no significant effect for timeout use. There was a substantial increase in storing firearms with cable locks for the intervention group versus a decrease for the control group. This randomized, controlled trial demonstrated decreased media exposure and increased safe firearm storage as a result of a brief office-based violence-prevention approach.

Circadian Genes and Risk for Prostate Cancer

DTIC Science & Technology

2009-03-01

a randomized placebo-controlled clinical trial to determine if finasteride (an inhibitor of androgen bioactivation) could prevent prostate cancer... finasteride  (an inhibitor of androgen bioactivation) could  prevent prostate cancer. Included in our study are approximately 1,800 case‐control pairs

Tissue angiotensin-converting enzyme inhibitors for the prevention of cardiovascular disease in patients with diabetes mellitus without left ventricular systolic dysfunction or clinical evidence of heart failure: a pooled meta-analysis of randomized placebo-controlled clinical trials.

PubMed

Saha, S A; Molnar, J; Arora, R R

2008-01-01

The aim of this study was to determine the role of tissue angiotensin-converting enzyme (ACE) inhibitors in the prevention of cardiovascular disease in patients with diabetes mellitus without left ventricular systolic dysfunction or clinical evidence of heart failure in randomized placebo-controlled clinical trials using pooled meta-analysis techniques. Randomized placebo-controlled clinical trials of at least 12 months duration in patients with diabetes mellitus without left ventricular systolic dysfunction or heart failure who had experienced a prior cardiovascular event or were at high cardiovascular risk were selected. A total of 10 328 patients (43 517 patient-years) from four selected trials were used for meta-analysis. Relative risk estimations were made using data pooled from the selected trials and statistical significance was determined using the Chi-squared test (two-sided alpha error <0.05). The number of patients needed to treat was also calculated. Tissue ACE inhibitors significantly reduced the risk of cardiovascular mortality by 14.9% (p = 0.022), myocardial infarction by 20.8% (p = 0.002) and the need for invasive coronary revascularization by 14% (p = 0.015) when compared to placebo. The risk of all-cause mortality also tended to be lower among patients randomized to tissue ACE inhibitors, whereas the risks of stroke and hospitalization for heart failure were not significantly affected. Treating about 65 patients with tissue ACE inhibitors for about 4.2 years would prevent one myocardial infarction, whereas treating about 85 patients would prevent one cardiovascular death. Pooled meta-analysis of randomized placebo-controlled trials suggests that tissue ACE inhibitors modestly reduce the risk of myocardial infarction and cardiovascular death and tend to reduce overall mortality in diabetic patients without left ventricular systolic dysfunction or heart failure.

A Randomized Trial of the Effect of Centralized Reminder/Recall on Immunizations and Preventive Care Visits for Adolescents

PubMed Central

Szilagyi, Peter G.; Albertin, Christina; Humiston, Sharon G.; Rand, Cynthia M.; Schaffer, Stanley; Brill, Howard; Stankaitis, Joseph; Yo, Byung-Kwang; Blumkin, Aaron; Stokley, Shannon

2015-01-01

Objective To assess the impact of a managed care-based patient reminder/recall system on immunization rates and preventive care visits among low-income adolescents. Methods We conducted a randomized controlled trial between December 2009 and December 2010 that assigned adolescents aged 11–17 years to one of three groups: mailed letter, telephone reminders, or control. Publicly insured youths (n = 4, 115) were identified in 37 participating primary care practices. The main outcome measures were immunization rates for routine vaccines (meningococcus, pertussis, HPV) and preventive visit rates at study end. Results Intervention and control groups were similar at baseline for demographics, immunization rates, and preventive visits. Among adolescents who were behind at the start, immunization rates at study end increased by 21% for mailed (P < .01 vs control), 17% for telephone (P < .05), and 13% for control groups. The proportion of adolescents with a preventive visit (within 12 months) was: mailed (65%; P <.01), telephone (63%; P <.05), and controls (59%). The number needed to treat for an additional fully vaccinated adolescent was 14 for mailed and 25 for telephone reminders; for an additional preventive visit, it was 17 and 29. The intervention cost $18.78 (mailed) or $16.68 (phone) per adolescent per year to deliver. The cost per additional adolescent fully vaccinated was $463.99 for mailed and $714.98 for telephone; the cost per additional adolescent receiving a preventive visit was $324.75 and $487.03. Conclusions Managed care-based mail or telephone reminder/recall improved adolescent immunizations and preventive visits, with modest costs and modest impact. PMID:23510607

A randomized trial of the effect of centralized reminder/recall on immunizations and preventive care visits for adolescents.

PubMed

Szilagyi, Peter G; Albertin, Christina; Humiston, Sharon G; Rand, Cynthia M; Schaffer, Stanley; Brill, Howard; Stankaitis, Joseph; Yoo, Byung-Kwang; Blumkin, Aaron; Stokley, Shannon

2013-01-01

To assess the impact of a managed care-based patient reminder/recall system on immunization rates and preventive care visits among low-income adolescents. We conducted a randomized controlled trial between December 2009 and December 2010 that assigned adolescents aged 11-17 years to one of three groups: mailed letter, telephone reminders, or control. Publicly insured youths (n = 4115) were identified in 37 participating primary care practices. The main outcome measures were immunization rates for routine vaccines (meningococcus, pertussis, HPV) and preventive visit rates at study end. Intervention and control groups were similar at baseline for demographics, immunization rates, and preventive visits. Among adolescents who were behind at the start, immunization rates at study end increased by 21% for mailed (P < .01 vs control), 17% for telephone (P < .05), and 13% for control groups. The proportion of adolescents with a preventive visit (within 12 months) was: mailed (65%; P < .01), telephone (63%; P < .05), and controls (59%). The number needed to treat for an additional fully vaccinated adolescent was 14 for mailed and 25 for telephone reminders; for an additional preventive visit, it was 17 and 29. The intervention cost $18.78 (mailed) or $16.68 (phone) per adolescent per year to deliver. The cost per additional adolescent fully vaccinated was $463.99 for mailed and $714.98 for telephone; the cost per additional adolescent receiving a preventive visit was $324.75 and $487.03. Managed care-based mail or telephone reminder/recall improved adolescent immunizations and preventive visits, with modest costs and modest impact. Copyright © 2013 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol

PubMed Central

Azar, Kristen MJ; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

2015-01-01

Background In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Objective Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Methods Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. Results A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. Conclusions The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes. Trial Registration ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6U8ODy1vo). PMID:25608692

Calcium supplementation for the prevention of colorectal adenomas: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Bonovas, Stefanos; Fiorino, Gionata; Lytras, Theodore; Malesci, Alberto; Danese, Silvio

2016-05-14

To determine the efficacy of calcium supplementation in reducing the recurrence of colorectal adenomas. We conducted a systematic review and meta-analysis of published studies. We searched PubMed, Scopus, the Cochrane Library, the WHO International Clinical Trials Registry Platform, and the ClinicalTrials.gov website, through December 2015. Randomized, placebo-controlled trials assessing supplemental calcium intake for the prevention of recurrence of adenomas were eligible for inclusion. Two reviewers independently selected studies based on predefined criteria, extracted data and outcomes (recurrence of colorectal adenomas, and advanced or "high-risk" adenomas), and rated each trial's risk-of-bias. Between-study heterogeneity was assessed, and pooled risk ratio (RR) estimates with their 95% confidence intervals (95%CI) were calculated using fixed- and random-effects models. To express the treatment effect in clinical terms, we calculated the number needed to treat (NNT) to prevent one adenoma recurrence. We also assessed the quality of evidence using GRADE. Four randomized, placebo-controlled trials met the eligibility criteria and were included. Daily doses of elemental calcium ranged from 1200 to 2000 mg, while the duration of treatment and follow-up of participants ranged from 36 to 60 mo. Synthesis of intention-to-treat data, for participants who had undergone follow-up colonoscopies, indicated a modest protective effect of calcium in prevention of adenomas (fixed-effects, RR = 0.89, 95%CI: 0.82-0.96; random-effects, RR = 0.87, 95%CI: 0.77-0.98; high quality of evidence). The NNT was 20 (95%CI: 12-61) to prevent one colorectal adenoma recurrence within a period of 3 to 5 years. On the other hand, the association between calcium treatment and advanced adenomas did not reach statistical significance (fixed-effects, RR = 0.92, 95%CI: 0.75-1.13; random-effects, RR = 0.92, 95%CI: 0.71-1.18; moderate quality of evidence). Our results suggest a modest chemopreventive effect of calcium supplements against recurrent colorectal adenomas over a period of 36 to 60 mo. Further research is warranted.

Calcium supplementation for the prevention of colorectal adenomas: A systematic review and meta-analysis of randomized controlled trials

PubMed Central

Bonovas, Stefanos; Fiorino, Gionata; Lytras, Theodore; Malesci, Alberto; Danese, Silvio

2016-01-01

AIM: To determine the efficacy of calcium supplementation in reducing the recurrence of colorectal adenomas. METHODS: We conducted a systematic review and meta-analysis of published studies. We searched PubMed, Scopus, the Cochrane Library, the WHO International Clinical Trials Registry Platform, and the ClinicalTrials.gov website, through December 2015. Randomized, placebo-controlled trials assessing supplemental calcium intake for the prevention of recurrence of adenomas were eligible for inclusion. Two reviewers independently selected studies based on predefined criteria, extracted data and outcomes (recurrence of colorectal adenomas, and advanced or “high-risk” adenomas), and rated each trial’s risk-of-bias. Between-study heterogeneity was assessed, and pooled risk ratio (RR) estimates with their 95% confidence intervals (95%CI) were calculated using fixed- and random-effects models. To express the treatment effect in clinical terms, we calculated the number needed to treat (NNT) to prevent one adenoma recurrence. We also assessed the quality of evidence using GRADE. RESULTS: Four randomized, placebo-controlled trials met the eligibility criteria and were included. Daily doses of elemental calcium ranged from 1200 to 2000 mg, while the duration of treatment and follow-up of participants ranged from 36 to 60 mo. Synthesis of intention-to-treat data, for participants who had undergone follow-up colonoscopies, indicated a modest protective effect of calcium in prevention of adenomas (fixed-effects, RR = 0.89, 95%CI: 0.82-0.96; random-effects, RR = 0.87, 95%CI: 0.77-0.98; high quality of evidence). The NNT was 20 (95%CI: 12-61) to prevent one colorectal adenoma recurrence within a period of 3 to 5 years. On the other hand, the association between calcium treatment and advanced adenomas did not reach statistical significance (fixed-effects, RR = 0.92, 95%CI: 0.75-1.13; random-effects, RR = 0.92, 95%CI: 0.71-1.18; moderate quality of evidence). CONCLUSION: Our results suggest a modest chemopreventive effect of calcium supplements against recurrent colorectal adenomas over a period of 36 to 60 mo. Further research is warranted. PMID:27182169

Preventing Depression in Final Year Secondary Students: School-Based Randomized Controlled Trial

PubMed Central

Perry, Yael; Werner-Seidler, Aliza; Calear, Alison; Mackinnon, Andrew; King, Catherine; Scott, Jan; Merry, Sally; Fleming, Theresa; Stasiak, Karolina; Batterham, Philip J

2017-01-01

Background Depression often emerges for the first time during adolescence. There is accumulating evidence that universal depression prevention programs may have the capacity to reduce the impact of depression when delivered in the school environment. Objective This trial investigated the effectiveness of SPARX-R, a gamified online cognitive behavior therapy intervention for the prevention of depression relative to an attention-matched control intervention delivered to students prior to facing a significant stressor—final secondary school exams. It was hypothesized that delivering a prevention intervention in advance of a stressor would reduce depressive symptoms relative to the control group. Methods A cluster randomized controlled trial was conducted in 10 government schools in Sydney, Australia. Participants were 540 final year secondary students (mean 16.7 [SD 0.51] years), and clusters at the school level were randomly allocated to SPARX-R or the control intervention. Interventions were delivered weekly in 7 modules, each taking approximately 20 to 30 minutes to complete. The primary outcome was symptoms of depression as measured by the Major Depression Inventory. Intention-to-treat analyses were performed. Results Compared to controls, participants in the SPARX-R condition (n=242) showed significantly reduced depression symptoms relative to the control (n=298) at post-intervention (Cohen d=0.29) and 6 months post-baseline (d=0.21) but not at 18 months post-baseline (d=0.33). Conclusions This is the first trial to demonstrate a preventive effect on depressive symptoms prior to a significant and universal stressor in adolescents. It demonstrates that an online intervention delivered in advance of a stressful experience can reduce the impact of such an event on the potential development or exacerbation of depression. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12614000316606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365986 (Archived by WebCite at http://www.webcitation.org/ 6u7ou1aI9) PMID:29097357

Blood Pressure Reduction and Secondary Stroke Prevention: A Systematic Review and Metaregression Analysis of Randomized Clinical Trials.

PubMed

Katsanos, Aristeidis H; Filippatou, Angeliki; Manios, Efstathios; Deftereos, Spyridon; Parissis, John; Frogoudaki, Alexandra; Vrettou, Agathi-Rosa; Ikonomidis, Ignatios; Pikilidou, Maria; Kargiotis, Odysseas; Voumvourakis, Konstantinos; Alexandrov, Anne W; Alexandrov, Andrei V; Tsivgoulis, Georgios

2017-01-01

Current recommendations do not specifically address the optimal blood pressure (BP) reduction for secondary stroke prevention in patients with previous cerebrovascular events. We conducted a systematic review and metaregression analysis on the association of BP reduction with recurrent stroke and cardiovascular events using data from randomized controlled clinical trials of secondary stroke prevention. For all reported events during each eligible study period, we calculated the corresponding risk ratios to express the comparison of event occurrence risk between patients randomized to antihypertensive treatment and those randomized to placebo. On the basis of the reported BP values, we performed univariate metaregression analyses according to the achieved BP values under the random-effects model (Method of Moments) for those adverse events reported in ≥10 total subgroups of included randomized controlled clinical trials. In pairwise meta-analyses, antihypertensive treatment lowered the risk for recurrent stroke (risk ratio, 0.73; 95% confidence interval, 0.62-0.87; P<0.001), disabling or fatal stroke (risk ratio, 0.71; 95% confidence interval, 0.59-0.85; P<0.001), and cardiovascular death (risk ratio, 0.85; 95% confidence interval, 0.75-0.96; P=0.01). In metaregression analyses, systolic BP reduction was linearly related to the lower risk of recurrent stroke (P=0.049), myocardial infarction (P=0.024), death from any cause (P=0.001), and cardiovascular death (P<0.001). Similarly, diastolic BP reduction was linearly related to a lower risk of recurrent stroke (P=0.026) and all-cause mortality (P=0.009). Funnel plot inspection and Egger statistical test revealed no evidence of publication bias. The extent of BP reduction is linearly associated with the magnitude of risk reduction in recurrent cerebrovascular and cardiovascular events. Strict and aggressive BP control seems to be essential for effective secondary stroke prevention. © 2016 American Heart Association, Inc.

The preventive effect of the bounding exercise programme on hamstring injuries in amateur soccer players: the design of a randomized controlled trial.

PubMed

Van de Hoef, S; Huisstede, B M A; Brink, M S; de Vries, N; Goedhart, E A; Backx, F J G

2017-08-22

Hamstring injuries are the most common muscle injury in amateur and professional soccer. Most hamstring injuries occur in the late swing phase, when the hamstring undergoes a stretch-shortening cycle and the hamstring does a significant amount of eccentric work. The incidence of these injuries has not decreased despite there being effective injury prevention programmes focusing on improving eccentric hamstring strength. As this might be because of poor compliance, a more functional injury prevention exercise programme that focuses on the stretch-shortening cycle might facilitate compliance. In this study, a bounding exercise programme consisting of functional plyometric exercises is being evaluated. A cluster-randomized controlled trial (RCT). Male amateur soccer teams (players aged 18-45 years) have been randomly allocated to intervention and control groups. Both groups are continuing regular soccer training and the intervention group is additionally performing a 12-week bounding exercise programme (BEP), consisting of a gradual build up and maintenance programme for the entire soccer season. The primary outcome is hamstring injury incidence. Secondary outcome is compliance with the BEP during the soccer season and 3 months thereafter. Despite effective hamstring injury prevention programmes, the incidence of these injuries remains high in soccer. As poor compliance with these programmes may be an issue, a new plyometric exercise programme may encourage long-term compliance and is expected to enhance sprinting and jumping performance besides preventing hamstring injuries. NTR6129 . Retrospectively registered on 1 November 2016.

The YouthMood Project: A Cluster Randomized Controlled Trial of an Online Cognitive Behavioral Program with Adolescents

ERIC Educational Resources Information Center

Calear, Alison L.; Christensen, Helen; Mackinnon, Andrew; Griffiths, Kathleen M.; O'Kearney, Richard

2009-01-01

The aim in the current study was to investigate the effectiveness of an online, self-directed cognitive-behavioral therapy program (MoodGYM) in preventing and reducing the symptoms of anxiety and depression in an adolescent school-based population. A cluster randomized controlled trial was conducted with 30 schools (N = 1,477) from across…

Project SUCCESS' Effects on Substance Use-Related Attitudes and Behaviors: A Randomized Controlled Trial in Alternative High Schools

ERIC Educational Resources Information Center

Clark, Heddy Kovach; Ringwalt, Chris L.; Shamblen, Stephen R.; Hanley, Sean M.

2011-01-01

Using a randomized controlled effectiveness trial, we examined the effects of Project SUCCESS on a range of secondary outcomes, including the program's mediating variables. Project SUCCESS, which is based both on the Theory of Reasoned Action and on Cognitive Behavior Theory, is a school-based substance use prevention program that targets…

A Randomized Trial of a Multifaceted Intervention to Reduce Falls among Community-Dwelling Adults

ERIC Educational Resources Information Center

Fox, Patrick J.; Vazquez, Laurie; Tonner, Chris; Stevens, Judy A.; Fineman, Norman; Ross, Leslie K.

2010-01-01

Using a randomized controlled trial, we tested the efficacy of a fall prevention intervention to reduce falls among adults in a community-based health promotion program. Adults aged 65 and older within two counties were recruited (control n = 257; intervention n = 286). After 12 months, there was a significant decrease in the number of falls in…

Hands4U: the effects of a multifaceted implementation strategy on hand eczema prevalence in a healthcare setting. Results of a randomized controlled trial.

PubMed

van der Meer, Esther W C; Boot, Cécile R L; van der Gulden, Joost W J; Knol, Dirk L; Jungbauer, Frank H W; Coenraads, Pieter Jan; Anema, Johannes R

2015-05-01

Healthcare workers have an increased risk of developing hand eczema. A multifaceted implementation strategy was developed to implement a guideline to prevent hand eczema among healthcare workers. To investigate the effects of the implementation strategy on self-reported hand eczema and preventive behaviour. A randomized controlled trial was performed. A total of 48 departments (n = 1649) were randomly allocated to the multifaceted implementation strategy or the control group. The strategy consisted of education, participatory working groups, and role models. Outcome measures were self-reported hand eczema and preventive behaviour. Data were collected at baseline, and 3, 6, 9 and 12 months of follow-up. Participants in the intervention group were significantly more likely to report hand eczema [odds ratio (OR) 1.45; 95% confidence interval (CI) 1.03-2.04], and they reported significantly less hand washing (B, - 0.38; 95%CI: - 0.48 to - 0.27), reported significantly more frequent use of a moisturizer (B, 0.30; 95%CI: 0.22-0.39) and were more likely to report wearing cotton undergloves (OR 6.33; 95%CI: 3.23-12.41) than participants in the control group 12 months after baseline. The strategy implemented can be used in practice, as it showed positive effects on preventive behaviour. More research is needed to investigate the unexpected effects on hand eczema. © 2014 The Authors. Contact Dermatitis published by John Wiley & Sons Ltd.

Renin-angiotensin system inhibitors prevent the recurrence of atrial fibrillation: a meta-analysis of randomized controlled trials.

PubMed

Han, Min; Zhang, Yong; Sun, Shujuan; Wang, Zhongsu; Wang, Jiangrong; Xie, Xinxing; Gao, Mei; Yin, Xiangcui; Hou, Yinglong

2013-10-01

This study was designed to assess whether angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) could prevent the recurrence of atrial fibrillation (AF). A systemic literature search of PubMed, EMBASE, and Cochrane Controlled Trials Register till 2012 was performed to identify randomized controlled trials involving the prevention of recurrence of AF with renin-angiotensin system blockade therapy. Subgroup analysis and meta-regression were performed. Publication bias was checked through funnel plot and Egger's test. Twenty-one randomized controlled trials including 13,184 patients with AF were identified. Overall, the recurrence of AF was significantly reduced in patients using ACEI/ARBs [odds ratio (OR), 0.43; 95% confidence interval (CI), 0.32-0.56; P < 0.00001], especially both in irbesartan subgroup (OR, 0.38; 95% CI, 0.21-0.68; P = 0.001) and in patients receiving antiarrhythmic drug (AAD) (OR, 0.37; 95% CI, 0.29-0.48; P < 0.00001), and there was no significant difference between ACEIs and ARBs (ACEIs: OR, 0.42; 95% CI, 0.31-0.57 and ARBs: OR, 0.42; 95% CI, 0.31-0.57). Moreover, it was found that the benefits of ACEI/ARBs revealed positive correlation to systolic blood pressure (regression coefficient: -0.0700257, P = 0.000) in no-AAD users. ACEI/ARBs are effective on the secondary prevention of AF, especially in patients receiving AAD and suffering from hypertension.

The Strong African American Families Program: Translating Research into Prevention Programming

ERIC Educational Resources Information Center

Brody, Gene H.; Murry, Velma McBride; Gerrard, Meg; Gibbons, Frederick X.; Molgaard, Virginia; McNair, Lily; Brown, Anita C.; Wills, Thomas A.; Spoth, Richard L.; Luo, Zupei; Chen, Yi-fu; Neubaum-Carlan, Eileen

2004-01-01

A randomized prevention trial contrasted families who took part in the Strong African American Families Program (SAAF), a preventive intervention for rural African American mothers and their 11-year-olds, with control families. SAAF is based on a contextual model positing that regulated, communicative parenting causes changes in factors protecting…

Random pulse generator

NASA Technical Reports Server (NTRS)

Lindsey, R. S., Jr. (Inventor)

1975-01-01

An exemplary embodiment of the present invention provides a source of random width and random spaced rectangular voltage pulses whose mean or average frequency of operation is controllable within prescribed limits of about 10 hertz to 1 megahertz. A pair of thin-film metal resistors are used to provide a differential white noise voltage pulse source. Pulse shaping and amplification circuitry provide relatively short duration pulses of constant amplitude which are applied to anti-bounce logic circuitry to prevent ringing effects. The pulse outputs from the anti-bounce circuits are then used to control two one-shot multivibrators whose output comprises the random length and random spaced rectangular pulses. Means are provided for monitoring, calibrating and evaluating the relative randomness of the generator.

[KAP research and intervention effects of health education on prevention and control of occupational diseases in occupational groups in Jinzhou, China].

PubMed

Wang, D H; Liu, X L; Quan, J K

2016-04-20

To investigate the current status of knowledge, attitude, and practice (KAP)on the prevention and control of occupational diseases in occupational groups in Jinzhou, China, and to evaluate the intervention effects of health education. Using the cluster random sampling method, 1000 workers who underwent occupational health examination in Jinzhou Center for Disease Control and Prevention from September 2014 to April 2015 were enrolled in this study. They were equally and randomly divided into intervention group and control group. The intervention group received health education for 6 months through bulletin board, promotion materials, expert lecture, Q&A session, and other relevant educational events. The questionnaire survey was performed before and after intervention. The control group received the questionnaire survey but not the health education. The overall awareness rate of prevention and control knowledge was 75.34% in 990 workers in Jinzhou, China. After the intervention, the intervention group had a significantly higher awareness rate of prevention and control knowledge than the control group (89.87%~98.86% vs 71.25%~80.82%, P<0.05); the intervention group had a significantly higher attitude accuracy for" whether occupational health examination is necessary or not" and " is willing to received the training on occupational health knowledge" than the control group(χ(2)=57.857, P<0.05; χ(2)=70.683, P<0.05); and the intervention group had a significantly higher rate of correct behavior for" whether help the business management personnel to carry out the prevention and control of occupational diseases or not" and"whether actively understand the occupational hazards of job" (χ(2)=102.186, P<0.05; χ(2)=91.159, P<0.05). Health education can significantly increase the awareness rate of prevention and control knowledge on occupational diseases in occupational groups in Jinzhou, China. However, the more structured and longterm comprehensive intervention is necessary for improving their attitude and behavior.

Corticosteroid Administration to Prevent Complications of Anterior Cervical Spine Fusion: A Systematic Review

PubMed Central

Zadegan, Shayan Abdollah; Jazayeri, Seyed Behnam; Abedi, Aidin; Bonaki, Hirbod Nasiri; Vaccaro, Alexander R.; Rahimi-Movaghar, Vafa

2017-01-01

Study Design: Systematic review. Objectives: Anterior cervical approach is associated with complications such as dysphagia and airway compromise. In this study, we aimed to systematically review the literature on the efficacy and safety of corticosteroid administration as a preventive measure of such complications in anterior cervical spine surgery with fusion. Methods: Following a systematic literature search of MEDLINE, Embase, and Cochrane databases in July 2016, all comparative human studies that evaluated the effect of steroids for prevention of complications in anterior cervical spine surgery with fusion were included, irrespective of number of levels and language. Risk of bias was assessed using MINORS (Methodological Index for Non-Randomized Studies) checklist and Cochrane Back and Neck group recommendations, for nonrandomized and randomized studies, respectively. Results: Our search yielded 556 articles, of which 9 studies (7 randomized controlled trials and 2 non–randomized controlled trials) were included in the final review. Dysphagia was the most commonly evaluated complication, and in most studies, its severity or incidence was significantly lower in the steroid group. Although prevertebral soft tissue swelling was less commonly assessed, the results were generally in favor of steroid use. The evidence for airway compromise and length of hospitalization was inconclusive. Steroid-related complications were rare, and in both studies that evaluated the fusion rate, it was comparable between steroid and control groups in long-term follow-up. Conclusions: Current literature supports the use of steroids for prevention of complications in anterior cervical spine surgery with fusion. However, evidence is limited by substantial risk of bias and small number of studies reporting key outcomes. PMID:29796378

Fibrin Sealants in Dura Sealing: A Systematic Literature Review

PubMed Central

2016-01-01

Background Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. Methods A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. Results A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. Conclusions A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety. PMID:27119993

Fibrin Sealants in Dura Sealing: A Systematic Literature Review.

PubMed

Esposito, Felice; Angileri, Filippo Flavio; Kruse, Peter; Cavallo, Luigi Maria; Solari, Domenico; Esposito, Vincenzo; Tomasello, Francesco; Cappabianca, Paolo

2016-01-01

Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety.

Effectiveness of peer-led dissonance-based eating disorder prevention groups: results from two randomized pilot trials.

PubMed

Stice, Eric; Rohde, Paul; Durant, Shelley; Shaw, Heather; Wade, Emily

2013-05-01

The present preliminary trials tested whether undergraduate peer leaders can effectively deliver a dissonance-based eating disorder prevention program, which could facilitate broad dissemination of this efficacious intervention. In Study 1, female undergraduates (N=171) were randomized to peer-led groups, clinician-led groups, or an educational brochure control condition. In Study 2, which improved a design limitation of Study 1 by using completely parallel outcome measures across conditions, female undergraduates (N=148) were randomized to either immediate peer-led groups or a waitlist control condition. In Study 1, participants in peer- and clinician-led groups showed significantly greater pre-post reductions in risk factors and eating disorder symptoms than controls (M d=.64 and .98 respectively), though clinician- versus peer-led groups had higher attendance and competence ratings, and produced stronger effects at posttest (M d=.32) and at 1-year follow-up (M d=.26). In Study 2, participants in peer-led groups showed greater pre-post reductions in all outcomes than waitlist controls (M d=.75). Results provide novel evidence that dissonance-based eating disorder prevention groups led by undergraduate peers are feasible and produce greater reductions in eating disorder risk factors and symptoms than minimal-intervention control conditions, but indicate that effects are smaller for peer- versus clinician-led groups. Copyright © 2013 Elsevier Ltd. All rights reserved.

Translating a Fall Prevention Intervention Into Practice: A Randomized Community Trial

PubMed Central

Peterson, Donna J.; Christiansen, Ann L.; Mahoney, Jane; Laud, Purushottam; Layde, Peter M.

2015-01-01

Objectives. We examined whether community translation of an effective evidence-based fall prevention program via standard monetary support can produce a community-wide reduction in fall injuries in older adults and evaluated whether an enhanced version with added technical support and capacity building amplified the fall reduction effect. Methods. We completed a randomized controlled community trial among adults aged 65 and older in (1) 10 control communities receiving no special resources or guidance on fall prevention, (2) 5 standard support communities receiving modest funding to implement Stepping On, and (3) 5 enhanced support communities receiving funding and technical support. The primary outcome was hospital inpatient and emergency department discharges for falls, examined with Poisson regression. Results. Compared with control communities, standard and enhanced support communities showed significantly higher community-wide reductions (9% and 8%, respectively) in fall injuries from baseline (2007–2008) to follow-up (2010–2011). No significant difference was found between enhanced and standard support communities. Conclusions. Population-based fall prevention interventions can be effective when implemented in community settings. More research is needed to identify the barriers and facilitators that influence the successful adoption and implementation of fall prevention interventions into broad community practice. PMID:25602891

Translating a Fall Prevention Intervention Into Practice: A Randomized Community Trial.

PubMed

Guse, Clare E; Peterson, Donna J; Christiansen, Ann L; Mahoney, Jane; Laud, Purushottam; Layde, Peter M

2015-07-01

We examined whether community translation of an effective evidence-based fall prevention program via standard monetary support can produce a community-wide reduction in fall injuries in older adults and evaluated whether an enhanced version with added technical support and capacity building amplified the fall reduction effect. We completed a randomized controlled community trial among adults aged 65 and older in (1) 10 control communities receiving no special resources or guidance on fall prevention, (2) 5 standard support communities receiving modest funding to implement Stepping On, and (3) 5 enhanced support communities receiving funding and technical support. The primary outcome was hospital inpatient and emergency department discharges for falls, examined with Poisson regression. Compared with control communities, standard and enhanced support communities showed significantly higher community-wide reductions (9% and 8%, respectively) in fall injuries from baseline (2007-2008) to follow-up (2010-2011). No significant difference was found between enhanced and standard support communities. Population-based fall prevention interventions can be effective when implemented in community settings. More research is needed to identify the barriers and facilitators that influence the successful adoption and implementation of fall prevention interventions into broad community practice.

Periprocedural effects of statins on the incidence of contrast-induced acute kidney injury: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Cheungpasitporn, Wisit; Thongprayoon, Charat; Kittanamongkolchai, Wonngarm; Edmonds, Peter J; O'Corragain, Oisin A; Srivali, Narat; Ungprasert, Patompong; Erickson, Stephen B

2015-05-01

The reports on the efficacy of statins for the prevention of contrast-induced acute kidney injury (CIAKI) remain controversial. The objective of this meta-analysis was to assess the effect of statins for the prevention of CIAKI. Comprehensive literature searches for randomized controlled trials (RCTs) of periprocedural statin treatment for prevention of CIAKI were performed using MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials Systematic Reviews and clinicaltrials.gov from inception until May 2014. The primary outcome was the incidence of CIAKI. Thirteen prospective RCTs were included in our analysis. Of 5803 patients with contrast exposures, 304 patients (5.2%) had CIAKI. Patients in the statin group had an overall lower incidence of CIAKI (3.6%) compared to the control group (6.9%). Intravenous (IV) fluid hydration was used in both groups of all included studies for prevention of CIAKI. There was a significant protective effect of periprocedural statins on the incidence of CIAKI when compared to the control group [risk ratios (RRs): 0.49; 95% CI: 0.37-0.66, I(2) of 25%]. Our study demonstrates a statistically significant protective effect of statin treatment during procedures with contrast exposures. This finding suggests the use of statins in addition to standard IV crystalloid hydration may be beneficial in the prevention of CIAKI.

Translational models of infection prevention and control: lessons from studying high risk aging populations.

PubMed

Mody, Lona

2018-06-13

The present review describes our research experiences and efforts in advancing the field of infection prevention and control in nursing facilities including postacute and long-term care settings. There are over two million infections in postacute and long-term care settings each year in the United States and $4 billion in associated costs. To define a target group most amenable to infection prevention and control interventions, we sought to quantify the relation between indwelling device use and microbial colonization in nursing facility patients. Using various methodologies including survey methods, observational epidemiology, randomized controlled studies, and collaboratives, we showed that indwelling device type is related to the site of multidrug-resistant organism (MDRO) colonization; multianatomic site colonization with MDROs is common; community-associated methicillin-resistant Staphylococcus aureus (MRSA) appeared in the nursing facility setting almost immediately following its emergence in acute care; (4) MDRO prevalence and catheter-associated infection rates can be reduced through a multimodal targeted infection prevention intervention; and (5) using a collaborative approach, such an intervention can be successfully scaled up. Our work advances the infection prevention field through translational research utilizing various methodologies, including quantitative and qualitative surveys, patient-oriented randomized controlled trials, and clinical microbiologic and molecular methods. The resulting interventions employ patient-oriented methods to reduce infections and antimicrobial resistance, and with partnerships from major national entities, can be implemented nationally.

Randomized, Prospective Comparison of Ursodeoxycholic Acid for the Prevention of Gallstones after Sleeve Gastrectomy.

PubMed

Adams, Lindsay B; Chang, Craig; Pope, Janet; Kim, Yeonsoo; Liu, Pei; Yates, Amy

2016-05-01

Several studies have examined the role of ursodeoxycholic acid (UDCA) for the prevention of cholelithiasis (gallstones) following rapid weight loss from restrictive diets, vertical band gastroplasty, and Roux-en-Y gastric bypass. However, to date, there have been no prospective, controlled studies examining the role of UDCA for the prevention of gallstones following sleeve gastrectomy (SG). This study was conducted to identify the effectiveness of UDCA for prevention of gallstones after SG. Following SG, eligible patients were randomized to a control group who did not receive UDCA treatment or to a group who were prescribed 300 mg UDCA twice daily for 6 months. Gallbladder ultrasounds were performed preoperatively and at 6 and 12 months postoperatively. Patients with positive findings preoperatively were excluded from the study. Compliance with UDCA was assessed. Between December 2011 and April 2013, 37 patients were randomized to the UDCA treatment arm and 38 patients were randomized to no treatment. At baseline, the two groups were similar. At 6 months, the UDCA group had a statistically significant lower incidence of gallstones (p = 0.032). Analysis revealed no significant difference in gallstones between the two groups at 1 year (p = 0.553 and p = 0.962, respectively). The overall gallstone formation rate was 29.8%. The incidence of gallstones is higher than previously estimated in SG patients. UDCA significantly lowers the gallstone formation rate at 6 months postoperatively.

Prevention of generalized anxiety disorder using a web intervention, iChill: randomized controlled trial.

PubMed

Christensen, Helen; Batterham, Philip; Mackinnon, Andrew; Griffiths, Kathleen M; Kalia Hehir, Kanupriya; Kenardy, Justin; Gosling, John; Bennett, Kylie

2014-09-02

Generalized Anxiety Disorder (GAD) is a high prevalence, chronic disorder. Web-based interventions are acceptable, engaging, and can be delivered at scale. Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety, or the factors that improve effectiveness and engagement. The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults, and to determine the role of telephone and email reminders. A 5-arm randomized controlled trial with 558 Internet users in the community, recruited via the Australian Electoral Roll, was conducted with 6- and 12-month follow-up. Five interventions were offered over a 10-week period. Group 1 (Active website) received a combined intervention of psycho-education, Internet-delivered Cognitive Behavioral Therapy (ICBT) for anxiety, physical activity promotion, and relaxation. Group 2 (Active website with telephone) received the identical Web program plus weekly telephone reminder calls. Group 3 (Active website with email) received the identical Web program plus weekly email reminders. Group 4 (Control) received a placebo website. Group 5 (Control with telephone) received the placebo website plus telephone calls. Main outcome measures were severity of anxiety symptoms as measured by the GAD 7-item scale (GAD-7) (at post-test, 6, and 12 months). Secondary measures were GAD caseness, measured by the Mini International Neuropsychiatric Interview (MINI) at 6 months, Centre for Epidemiologic Studies-Depression scale (CES-D), Anxiety Sensitivity Index (ASI), Penn State Worry Questionnaire (PSWQ), and Days out of Role. GAD-7 symptoms reduced over post-test, 6-month, and 12-month follow-up. There were no significant differences between Group 4 (Control) and Groups 1 (Active website), 2 (Active website with telephone), 3 (Active website with email), or 5 (Control with telephone) at any follow-up. A total of 16 cases of GAD were identified at 6 months, comprising 6.7% (11/165) from the Active groups (1, 2, 3) and 4.5% (5/110) from the Control groups (4, 5), a difference that was not significant. CES-D, ASI, and PSWQ scores were significantly lower for the active website with email reminders at post-test, relative to the control website condition. Indicated prevention of GAD was not effective in reducing anxiety levels, measured by GAD-7. There were significant secondary effects for anxiety sensitivity, worry, and depression. Challenges for indicated prevention trials are discussed. International Standard Randomized Controlled Trial Number (ISRCTN): 76298775; http://www.controlled-trials.com/ISRCTN76298775 (Archived by WebCite at http://www.webcitation.org/6S9aB5MAq).

Effects of the SAFE Children preventive intervention on developmental trajectories of attention-deficit/hyperactivity disorder symptoms.

PubMed

Fowler, Patrick J; Henry, David B; Schoeny, Michael; Gorman-Smith, Deborah; Tolan, Patrick H

2014-11-01

This study examined whether a family-based preventive intervention for inner-city children entering the first grade could alter the developmental course of attention-deficit/hyperactivity disorder (ADHD) symptoms. Participants were 424 families randomly selected and randomly assigned to a control condition (n = 192) or Schools and Families Educating Children (SAFE) Children (n = 232). SAFE Children combined family-focused prevention with academic tutoring to address multiple developmental-ecological needs. A booster intervention provided in the 4th grade to randomly assigned children in the initial intervention (n =101) evaluated the potential of increasing preventive effects. Follow-up occurred over 5 years with parents and teachers reporting on attention problems. Growth mixture models identified multiple developmental trajectories of ADHD symptoms. The initial phase of intervention placed children on more positive developmental trajectories for impulsivity and hyperactivity, demonstrating the potential for ADHD prevention in at-risk youth, but the SAFE Children booster had no additional effect on trajectory or change in ADHD indicators.

A Controlled Trial of a Novel Primary Prevention Program for Lyme Disease and Other Tick-Borne Illnesses

ERIC Educational Resources Information Center

Daltroy, Lawren H.; Phillips, Charlotte; Lew, Robert; Wright, Elizabeth; Shadick, Nancy A.; Liang, Matthew H.

2007-01-01

To evaluate a theory-based educational program to prevent Lyme disease and other tick-borne illnesses (TBI), a randomized controlled trial of an educational program was delivered to ferry passengers traveling to an endemic area in southeastern Massachusetts. Rates of TBI and precautionary and tick check behaviors were measured over three summers…

Effects of a prevention program for divorced families on youth cortisol reactivity 15 years later

PubMed Central

Luecken, Linda J.; Hagan, Melissa J.; Mahrer, Nicole E.; Wolchik, Sharlene A.; Sandler, Irwin N.; Tein, Jenn-Yun

2015-01-01

Objective We examined whether an empirically-based, randomized controlled trial of a preventive intervention for divorced mothers and children had a long-term impact on offspring cortisol regulation. Design Divorced mothers and children (age 9-12) were randomly assigned to a literature control condition or the 11-week New Beginnings Program (NBP), a family-focused group preventive intervention for mothers and children in newly divorced families. Main Outcome Measures Fifteen years after the trial, offspring salivary cortisol (n=161) was measured before and after a social stress task. Results Multilevel mixed models were used to predict cortisol from internalizing symptoms, externalizing symptoms, group assignment and potential moderators of intervention effects. Across the sample, higher externalizing symptoms were associated with lower cortisol reactivity. There was a significant group by age interaction such that older offspring in the control group had higher reactivity relative to the intervention group, and younger offspring in the control group exhibited a decline across the task relative to younger offspring in the intervention group. Conclusions Preventive interventions for youth from divorced families may have a long-term impact on cortisol reactivity to stress. Results highlight the importance of examining moderators of program effects. PMID:25367835

Short-term intake of a Japanese-style healthy lunch menu contributes to prevention and/or improvement in metabolic syndrome among middle-aged men: a non-randomized controlled trial

PubMed Central

2014-01-01

Background Metabolic syndrome is now widely appreciated as a cluster of metabolic abnormalities such as visceral obesity, hypertension, hyperglycemia and dyslipidemia. To date, incidence of metabolic syndrome is continuously increasing worldwide. In addition, low vegetable consumption has recently become a serious issue in Japan. Furthermore, Japan is facing a shortfall in places offering food that can help prevent metabolic syndrome in the first place. Our study is designed to influence these developments. We conducted a non-randomized controlled trial by offering a Japanese-style healthy lunch menu to middle-aged men in a workplace cafeteria. This menu was designed to prevent and reduce metabolic syndrome. Methods This intervention study took the form of a non-randomized controlled trial. Participants chose the control or intervention group. The control group consumed their habitual lunches without restriction and only nutrient contents were assessed. The intervention group received a Japanese-style healthy lunch at a workplace cafeteria for 3 months. The participants worked in offices at a city hall and mostly had low levels of physical activity. Data of 35 males (control group: 7 males, intervention group: 28 males, mean age: 47.2 ± 7.9 years) were collected and analyzed. Results We obtained an effective outcome by demonstrating that ongoing intake of a Japanese-style healthy lunch decreased blood pressure and serum lipids and increased plasma ghrelin levels. The results grew more pronounced as intake of Japanese-style healthy lunches increased in frequency. Conclusions This study presents new empirical data as a result of an original intervention program undertaken in Japan. A Japanese-style healthy lunch menu containing many vegetables consumed can help prevent and/or improve metabolic syndrome. PMID:24673894

The Spanish Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: Study Protocol for a Cluster Randomized Controlled Trial.

PubMed

García-Escalera, Julia; Valiente, Rosa M; Chorot, Paloma; Ehrenreich-May, Jill; Kennedy, Sarah M; Sandín, Bonifacio

2017-08-21

Anxiety and depression are common, impairing conditions that evidence high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) is one of the few existing resources aimed at applying transdiagnostic treatment principles to target core dysfunctions associated with both anxiety and depression within a single protocol. To our knowledge, this is the first study examining the efficacy of the UP-A adapted as a universal preventive intervention program. The primary aim of this study is to examine whether the Spanish version of the UP-A is more effective than a waitlist (WL) control group in reducing and preventing symptoms of anxiety and depression when employed as a universal, classroom-based preventive intervention. The secondary aim is to investigate changes in a broad range of secondary outcome measures, including negative and positive affect, anxiety sensitivity, emotional avoidance, top problems ratings, school grades, depression and anxiety-related interference, self-esteem, life satisfaction, quality of life, conduct problems, hyperactivity/inattention symptoms, peer problems, prosocial behavior, school adjustment, and discipline problems. Other aims are to assess a range of possible predictors of intervention effects and to examine the feasibility and the acceptability of implementing UP-A in a prevention group format and in a school setting. A cluster, randomized, WL, controlled trial design with classroom as the unit of randomization was used in this study. Five classes including a total of 152 adolescents were randomized to the experimental or WL control groups. Participants in the experimental group received 9 55-minute sessions delivered by advanced doctoral and masters students in clinical psychology. The WL control group will receive the intervention once the 3-month follow-up assessment is completed. We have recruited participants to the cluster randomized controlled trial (RCT) and have conducted the intervention with the experimental group. We expect the WL control group to complete the intervention in July 2017. Data analysis will take place during the second semester of 2017. We expect the experimental group to outperform the WL control group at post-intervention and 3-month follow-up. We also expect the WL control group to show improvements in primary and secondary outcome measures after receiving the intervention. Results will have implications for researchers, families, and education providers. Clinicaltrials.gov NCT03123991; https://clinicaltrials.gov/ct2/show/NCT03123991 (Archived by WebCite at http://www.webcitation.org/6qp7GIzcR). ©Julia García-Escalera, Rosa M Valiente, Paloma Chorot, Jill Ehrenreich-May, Sarah M Kennedy, Bonifacio Sandín. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.08.2017.

The Spanish Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: Study Protocol for a Cluster Randomized Controlled Trial

PubMed Central

García-Escalera, Julia; Valiente, Rosa M; Ehrenreich-May, Jill; Kennedy, Sarah M; Sandín, Bonifacio

2017-01-01

Background Anxiety and depression are common, impairing conditions that evidence high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) is one of the few existing resources aimed at applying transdiagnostic treatment principles to target core dysfunctions associated with both anxiety and depression within a single protocol. To our knowledge, this is the first study examining the efficacy of the UP-A adapted as a universal preventive intervention program. Objective The primary aim of this study is to examine whether the Spanish version of the UP-A is more effective than a waitlist (WL) control group in reducing and preventing symptoms of anxiety and depression when employed as a universal, classroom-based preventive intervention. The secondary aim is to investigate changes in a broad range of secondary outcome measures, including negative and positive affect, anxiety sensitivity, emotional avoidance, top problems ratings, school grades, depression and anxiety-related interference, self-esteem, life satisfaction, quality of life, conduct problems, hyperactivity/inattention symptoms, peer problems, prosocial behavior, school adjustment, and discipline problems. Other aims are to assess a range of possible predictors of intervention effects and to examine the feasibility and the acceptability of implementing UP-A in a prevention group format and in a school setting. Methods A cluster, randomized, WL, controlled trial design with classroom as the unit of randomization was used in this study. Five classes including a total of 152 adolescents were randomized to the experimental or WL control groups. Participants in the experimental group received 9 55-minute sessions delivered by advanced doctoral and masters students in clinical psychology. The WL control group will receive the intervention once the 3-month follow-up assessment is completed. Results We have recruited participants to the cluster randomized controlled trial (RCT) and have conducted the intervention with the experimental group. We expect the WL control group to complete the intervention in July 2017. Data analysis will take place during the second semester of 2017. Conclusions We expect the experimental group to outperform the WL control group at post-intervention and 3-month follow-up. We also expect the WL control group to show improvements in primary and secondary outcome measures after receiving the intervention. Results will have implications for researchers, families, and education providers. Trial Registration Clinicaltrials.gov NCT03123991; https://clinicaltrials.gov/ct2/show/NCT03123991 (Archived by WebCite at http://www.webcitation.org/6qp7GIzcR) PMID:28827212

Using a web-based game to prevent posttraumatic stress in children following medical events: design of a randomized controlled trial.

PubMed

Marsac, Meghan L; Kohser, Kristen L; Winston, Flaura K; Kenardy, Justin; March, Sonja; Kassam-Adams, Nancy

2013-01-01

Medical events including acute illness and injury are among the most common potentially traumatic experiences for children. Despite the scope of the problem, only limited resources are available for prevention of posttraumatic stress symptoms (PTSS) after pediatric medical events. Web-based programs provide a low-cost, accessible means to reach a wide range of families and show promise in related areas of child mental health. To describe the design of a randomized controlled trial that will evaluate feasibility and estimate preliminary efficacy of Coping Coach, a web-based preventive intervention to prevent or reduce PTSS after acute pediatric medical events. Seventy children and their parents will be randomly assigned to either an intervention or a waitlist control condition. Inclusion criteria require that children are aged 8-12 years, have experienced a medical event, have access to Internet and telephone, and have sufficient competency in the English language to complete measures and understand the intervention. Participants will complete baseline measures and will then be randomized to the intervention or waitlist control condition. Children in the intervention condition will complete module 1 (Feelings Identification) in the hospital and will be instructed on how to complete modules 2 (Appraisals) and 3 (Avoidance) online. Follow-up assessments will be conducted via telephone at 6, 12, and 18 weeks after the baseline assessment. Following the 12-week assessment, children in the waitlist control condition will receive instructions for completing the intervention. Primary study outcomes include data on intervention feasibility and outcomes (child appraisals, coping, PTSS and health-related quality of life). Results will provide data on the feasibility of the implementation of the Coping Coach intervention and study procedures as well as estimations of efficacy to determine sample size for a larger study. Potential strengths and limitations of this design are discussed.

Using a web-based game to prevent posttraumatic stress in children following medical events: design of a randomized controlled trial

PubMed Central

Marsac, Meghan L.; Kohser, Kristen L.; Winston, Flaura K.; Kenardy, Justin; March, Sonja; Kassam-Adams, Nancy

2013-01-01

Background Medical events including acute illness and injury are among the most common potentially traumatic experiences for children. Despite the scope of the problem, only limited resources are available for prevention of posttraumatic stress symptoms (PTSS) after pediatric medical events. Web-based programs provide a low-cost, accessible means to reach a wide range of families and show promise in related areas of child mental health. Objectives To describe the design of a randomized controlled trial that will evaluate feasibility and estimate preliminary efficacy of Coping Coach, a web-based preventive intervention to prevent or reduce PTSS after acute pediatric medical events. Method Seventy children and their parents will be randomly assigned to either an intervention or a waitlist control condition. Inclusion criteria require that children are aged 8–12 years, have experienced a medical event, have access to Internet and telephone, and have sufficient competency in the English language to complete measures and understand the intervention. Participants will complete baseline measures and will then be randomized to the intervention or waitlist control condition. Children in the intervention condition will complete module 1 (Feelings Identification) in the hospital and will be instructed on how to complete modules 2 (Appraisals) and 3 (Avoidance) online. Follow-up assessments will be conducted via telephone at 6, 12, and 18 weeks after the baseline assessment. Following the 12-week assessment, children in the waitlist control condition will receive instructions for completing the intervention. Results Primary study outcomes include data on intervention feasibility and outcomes (child appraisals, coping, PTSS and health-related quality of life). Discussion Results will provide data on the feasibility of the implementation of the Coping Coach intervention and study procedures as well as estimations of efficacy to determine sample size for a larger study. Potential strengths and limitations of this design are discussed. PMID:23898396

A Web-Based and Mobile Health Social Support Intervention to Promote Adherence to Inhaled Asthma Medications: Randomized Controlled Trial

PubMed Central

Koufopoulos, Justin T; Conner, Mark T; Gardner, Peter H

2016-01-01

Background Online communities hold great potential as interventions for health, particularly for the management of chronic illness. The social support that online communities can provide has been associated with positive treatment outcomes, including medication adherence. There are few studies that have attempted to assess whether membership of an online community improves health outcomes using rigorous designs. Objective Our objective was to conduct a rigorous proof-of-concept randomized controlled trial of an online community intervention for improving adherence to asthma medicine. Methods This 9-week intervention included a sample of asthmatic adults from the United Kingdom who were prescribed an inhaled corticosteroid preventer. Participants were recruited via email and randomized to either an “online community” or “no online community” (diary) condition. After each instance of preventer use, participants (N=216) were required to report the number of doses of medication taken in a short post. Those randomized to the online community condition (n=99) could read the posts of other community members, reply, and create their own posts. Participants randomized to the no online community condition (n=117) also posted their medication use, but could not read others’ posts. The main outcome measures were self-reported medication adherence at baseline and follow-up (9 weeks postbaseline) and an objective measure of adherence to the intervention (visits to site). Results In all, 103 participants completed the study (intervention: 37.8%, 39/99; control: 62.2%, 64/117). MANCOVA of self-reported adherence to asthma preventer medicine at follow-up was not significantly different between conditions in either intention-to-treat (P=.92) or per-protocol (P=.68) analysis. Site use was generally higher in the control compared to intervention conditions. Conclusions Joining an online community did not improve adherence to preventer medication for asthma patients. Without the encouragement of greater community support or more components to sustain engagement over time, the current findings do not support the use of an online community to improve adherence. ClinicalTrial International Standard Randomized Controlled Trial Number (ISRCTN): 29399269; http://www.isrctn.com/ISRCTN29399269/29399269 (Archived by WebCite at http://www.webcitation.org/6fUbEuVoT) PMID:27298211

Right versus left atrial pacing in patients with sick sinus syndrome and paroxysmal atrial fibrillation (Riverleft study): study protocol for randomized controlled trial.

PubMed

Ramdjan, Tanwier T T K; van der Does, Lisette J M E; Knops, Paul; Res, Jan C J; de Groot, Natasja M S

2014-11-17

The incidence of sick sinus syndrome will increase due to population ageing. Consequently, this will result in an increase in the number of pacemaker implantations. The atrial lead is usually implanted in the right atrial appendage, but this position may be ineffective for prevention of atrial fibrillation. It has been suggested that pacing distally in the coronary sinus might be more successful in preventing atrial fibrillation episodes. The aim of this trial is to study the efficacy of distal coronary sinus versus right atrial appendage pacing in preventing atrial fibrillation episodes in patients with sick sinus syndrome. This study is designed as a multicenter, randomized controlled trial. Patients with sick sinus syndrome and at least one atrial fibrillation episode of 30 seconds or more in the six months before recruitment will be eligible for participation in this study.All participants will be randomized between pacing distally in the coronary sinus and right atrial appendage. Randomization is stratified for all participating centers. Conventional dual-chamber pacemakers with advanced home monitoring functionality will be implanted. The ventricular lead will be implanted in the right ventricular apex. The first three months of the 36-month follow-up period are considered as run-in time. During the pre-randomization visit and follow-up, an interview, electrocardiogram and pacemaker assessment will be performed, prescribed antiarrhythmic medication will be reviewed and patients will be asked to complete an SF-36 questionnaire. An echocardiographic examination will be conducted in the pre-randomization phase and at the end of each follow-up year. Home monitoring will be used to send daily reports in case of atrial fibrillation episodes. This randomized controlled trial is the first in which home monitoring will be used to compare atrial fibrillation recurrences between pacing in the distal coronary sinus or right atrial appendage. Home monitoring gives the opportunity to accurately detect atrial fibrillation episodes and to study characteristics of atrial fibrillation episodes. Should distal coronary sinus pacing significantly diminish atrial fibrillation recurrences, this study will redefine the preferential location of an atrial lead for preventive pacing. Current Controlled Trials ISRCTN65911661, registered on 8 July 2013.

Considering Culturally Relevant Parenting Practices in Intervention Development and Adaptation: A Randomized Controlled Trial of the Black Parenting Strengths and Strategies (BPSS) Program

ERIC Educational Resources Information Center

Coard, Stephanie I.; Foy-Watson, Shani; Zimmer, Catherine; Wallace, Amy

2007-01-01

A randomized prevention pilot trial compared caregivers who participated in the Black Parenting Strengths and Strategies (BPSS) Program with control caregivers. BPSS is a strengths- and culturally based parenting program designed to improve aspects of parenting associated with the early development of conduct problems and the promotion of social…

Substance Use and Delinquency among Middle School Girls in Foster Care: A Three-Year Follow-Up of a Randomized Controlled Trial

ERIC Educational Resources Information Center

Kim, Hyoun K.; Leve, Leslie D.

2011-01-01

Objective: The present study evaluated the efficacy of the Middle School Success intervention (MSS) for reducing substance use and delinquency among girls in foster care, using a randomized controlled trial design. The program was designed to fill a service gap during the summer prior to the middle school transition and to prevent delinquency,…

A Randomized Controlled Trial Evaluation of "Time to Read", a Volunteer Tutoring Program for 8- to 9-Year-Olds

ERIC Educational Resources Information Center

Miller, Sarah; Connolly, Paul

2013-01-01

Tutoring is commonly employed to prevent early reading failure, and evidence suggests that it can have a positive effect. This article presents findings from a large-scale ("n" = 734) randomized controlled trial evaluation of the effect of "Time to Read"--a volunteer tutoring program aimed at children aged 8 to 9 years--on…

Partially Nested Randomized Controlled Trials in Education Research: A Guide to Design and Analysis. NCER 2014-2000

ERIC Educational Resources Information Center

Lohr, Sharon; Schochet, Peter Z.; Sanders, Elizabeth

2014-01-01

Suppose an education researcher wants to test the impact of a high school drop-out prevention intervention in which at-risk students attend classes to receive intensive summer school instruction. The district will allow the researcher to randomly assign students to the treatment classes or to the control group. Half of the students (the treatment…

A Randomized Controlled Trial of a Home-Visiting Intervention Aimed at Preventing Relationship Problems in Depressed Mothers and Their Infants

ERIC Educational Resources Information Center

van Doesum, Karin T. M.; Riksen-Walraven, J. Marianne; Hosman, Clemens M. H.; Hoefnagels, Cees

2008-01-01

This study examined the effect of a mother-baby intervention on the quality of mother-child interaction, infant-mother attachment security, and infant socioemotional functioning in a group of depressed mothers with infants aged 1-12 months. A randomized controlled trial compared an experimental group (n = 35) receiving the intervention (8-10 home…

Adolescent pregnancy prevention: An abstinence-centered randomized controlled intervention in a Chilean public high school.

PubMed

Cabezón, Carlos; Vigil, Pilar; Rojas, Iván; Leiva, M Eugenia; Riquelme, Rosa; Aranda, Waldo; García, Carlos

2005-01-01

To evaluate the efficacy of an abstinence-centered sex education program in adolescent pregnancy prevention, the TeenSTAR Program was applied in a high school in Santiago, Chile. A total of 1259 girls from a Santiago high school were divided into three cohorts depending on the year they started high school: the 1996 cohort of 425 students, which received no intervention; the 1997 cohort, in which 210 students received an intervention and 213 (control group) did not; and the 1998 cohort, in which 328 students received an intervention and 83 (control group) did not. Students were randomly assigned to control and intervention groups in these cohorts, before starting with the program. We conducted a prospective, randomized study using the application of the TeenSTAR sex education program during the first year of high school to the intervention groups in the 1997 and 1998 cohorts. All cohorts were followed up for 4 years; pregnancy rates were recorded and subsequently contrasted in the intervention and control groups. Pregnancy rates were measured and Risk Ratio with 95% confidence interval were calculated for intervention and control groups in each cohort. Pregnancy rates for the intervention and control groups in the 1997 cohort were 3.3% and 18.9%, respectively (RR: 0.176, CI: 0.076-0.408). Pregnancy rates for the intervention and control groups in the 1998 cohort were 4.4% and 22.6%, respectively (RR 0.195, CI: 0.099-0.384). The abstinence-centered TeenSTAR sex education intervention was effective in the prevention of unintended adolescent pregnancy.

The Science of Cancer Prevention

Cancer.gov

The science of cancer prevention is described by Dr. Barnett S. Kramer, M.D., M.P.H., director of the Division of Cancer Prevention, National Cancer Institute (NCI). The Division of Cancer Prevention administers a broad spectrum of research that spans basic pre-clinical, laboratory research, supportive and palliative care research, early detection, and randomized controlled clinical trials. The Division also supports the Cancer Prevention Fellowship Program and is devoted to the balanced communication of scientific results.

The Potential of Coaching as a Strategy to Improve the Effectiveness of School-Based Substance Use Prevention Curricula

ERIC Educational Resources Information Center

Ringwalt, Christopher L.; Pankratz, Melinda M.; Hansen, William B.; Dusenbury, Linda; Jackson-Newsom, Julia; Giles, Steven M.; Brodish, Paul H.

2009-01-01

Research-based substance use prevention curricula typically yield small effects when implemented by school teachers under real-world conditions. Using a randomized controlled trial, the authors examined whether expert coaching improves the effectiveness of the All Stars prevention curriculum. Although a positive effect on students' cigarette use…

Postpartum Depression Prevention for Reservation-Based American Indians: Results from a Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Ginsburg, Golda S.; Barlow, Allison; Goklish, Novalene; Hastings, Ranelda; Baker, Elena Varipatis; Mullany, Britta; Tein, Jenn-Yun; Walkup, John

2012-01-01

Background: Postpartum depression is a devastating condition that affects a significant number of women and their offspring. Few preventive interventions have targeted high risk youth, such as American Indians (AIs). Objective: To evaluate the feasibility of a depression prevention program for AI adolescents and young adults. Methods: Expectant AI…

A randomized controlled trial to increase information, motivation, and behavioral skills in Ugandan adolescents

PubMed Central

Ybarra, Michele L.; Korchmaros, Josephine D.; Prescott, Tonya L.; Birungi, Ruth

2015-01-01

Background One in twenty-five Ugandan adolescents is HIV positive. Purpose Examine the impact of an Internet-based HIV prevention program on Information-Motivation-Behavior Skills Model-related constructs. Methods Three hundred and sixty-six sexually experienced and inexperienced students 12-18+ years-old in Mbarara, Uganda were randomly assigned to: the five-lesson CyberSenga program or treatment-as-usual. Half of the intervention participants were further randomized to a booster session. Assessments were collected at three and six months post-baseline. Results Participants’ HIV-related information improved over time at a greater rate for the intervention groups compared to the control group. Motivation for condom use changed to a greater degree over time for the intervention group – especially those in the intervention+booster group - compared to the control group. Behavioral skills for condom use, and motivation and behavioral skills for abstinence were statistically similar over time for both groups. Conclusions CyberSenga improves HIV preventive information and motivation to use condoms. PMID:25633626

Health and loyalty promotion visits for new enrollees: results of a randomized controlled trial.

PubMed

Thompson, M; Gee, S; Larson, P; Kotz, K; Northrop, L

2001-01-01

Managed care needs effective and efficient ways to orient new members, enhance trust and loyalty, and offer prevention and self-care education and services. Recent adult enrollees of Kaiser Permanente (Northern California) were randomly assigned to one of three intervention conditions (n = 286) (individual visit with a physician, physician visit plus a visit with a health educator, a group visit of eight new members led by a physician and health educator) or a random control group (n = 278). Outcomes were gauged via pre- and post-visit questionnaires and a 20-min telephone survey at baseline and at a 6-month follow-up. Compared to controls, attendees of the three interventions had higher satisfaction, self-rated prevention knowledge, acceptance of health plan guidelines, and were more likely to plan to remain in the health plan. Group visit attendees stood out as experiencing the greatest benefits and were especially likely to report saving a telephone call or visit to their doctor by using a self-care handbook.

A systematic review of randomized controlled trials of interventions designed to decrease child abuse in high-risk families

PubMed Central

Levey, Elizabeth J.; Gelaye, Bizu; Bain, Paul; Rondon, Marta B.; Borba, Christina P.C.; Henderson, David C.; Williams, Michelle A.

2017-01-01

Child abuse is a global problem, and parents with histories of childhood abuse are at increased risk of abusing their offspring. The objective of this systematic review is to provide a clear overview of the existing literature of randomized controlled trials evaluating the effectiveness of interventions to prevent child abuse. PubMed, PsychINFO, Web of Science, Sociological Abstracts, and CINAHL were systematically searched and expanded by hand search. This review includes all randomized controlled trials (RCTs) of interventions designed to prevent abuse among mothers identified as high-risk. Of the eight studies identified, only three found statistically significant reductions in abuse by any measure, and only two found reductions in incidents reported to child protective services. While much has been written about child abuse in high-risk families, few RCTs have been performed. Only home visitation has a significant evidence base for reducing child abuse, and the findings vary considerably. Also, data from low- and middle-income countries are limited. PMID:28110205

Effect of an environmental school-based obesity prevention program on changes in body fat and body weight: a randomized trial.

PubMed

Williamson, Donald A; Champagne, Catherine M; Harsha, David W; Han, Hongmei; Martin, Corby K; Newton, Robert L; Sothern, Melinda S; Stewart, Tiffany M; Webber, Larry S; Ryan, Donna H

2012-08-01

This study tested the efficacy of two school-based programs for prevention of body weight/fat gain in comparison to a control group, in all participants and in overweight children. The Louisiana (LA) Health study utilized a longitudinal, cluster randomized three-arm controlled design, with 28 months of follow-up. Children (N = 2,060; mean age = 10.5 years, SD = 1.2) from rural communities in grades 4-6 participated in the study. Seventeen school clusters (mean = 123 children/cluster) were randomly assigned to one of three prevention arms: (i) primary prevention (PP), an environmental modification (EM) program, (ii) primary + secondary prevention (PP+SP), the environmental program with an added classroom and internet education component, or (iii) control (C). Primary outcomes were changes in percent body fat and BMI z scores. Secondary outcomes were changes in behaviors related to energy balance. Comparisons of PP, PP+SP, and C on changes in body fat and BMI z scores found no differences. PP and PP+SP study arms were combined to create an EM arm. Relative to C, EM decreased body fat for boys (-1.7 ± 0.38% vs. -0.14 ± 0.69%) and attenuated fat gain for girls (2.9 ± 0.22% vs. 3.93 ± 0.37%), but standardized effect sizes were relatively small (<0.30). In conclusion, this school-based EM programs had modest beneficial effects on changes in percent body fat. Addition of a classroom/internet program to the environmental program did not enhance weight/fat gain prevention, but did impact physical activity and social support in overweight children.

Effect of an Environmental School-based Obesity Prevention Program On Changes in Body Fat and Body Weight: A Randomized Trial

PubMed Central

Williamson, D.A.; Champagne, C.M.; Harsha, D.; Han, H.; Martin, C.K.; Newton, R.L.; Sothern, M.; Stewart, T.M.; Webber, L.S.; Ryan, D.

2012-01-01

This study tested the efficacy of two school-based programs for prevention of body weight/fat gain in comparison to a control group, in all participants and in overweight children. The Louisiana (LA) Health study utilized a longitudinal, cluster randomized 3-arm controlled design, with 28 months of follow-up. Children (N=2060; M age = 10.5 years, SD = 1.2) from rural communities in Grades 4 to 6 participated in the study. 17 school clusters (M = 123 children/cluster) were randomly assigned to one of three prevention arms: 1) Primary Prevention (PP), an environmental modification program, 2) Primary + Secondary Prevention (PP+SP), the environmental program with an added classroom and internet education component, or 3) Control (C). Primary outcomes were changes in percent body fat and body mass index z scores. Secondary outcomes were changes in behaviors related to energy balance. Comparisons of PP, PP+SP, and C on changes in body fat and BMI z scores found no differences. PP and PP+SP study arms were combined to create an environmental modification arm (EM). Relative to C, EM decreased body fat for boys (−1.7% ± 0.38% versus −0.14% ± 0.69%) and attenuated fat gain for girls (2.9% ± 0.22% versus 3.93% ± 0.37%), but standardized effect sizes were relatively small (< 0.30). In conclusion, this school-based environmental modification programs had modest beneficial effects on changes in percent body fat. Addition of a classroom/internet program to the environmental program did not enhance weight/fat gain prevention, but did impact physical activity and social support in overweight children. PMID:22402733

Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial.

PubMed

Fulkerson, Jayne A; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y

2015-12-15

Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Families (n = 160 8-12-year-old children and their parents/guardians) were randomized to intervention (n = 81) or control (n = 79) groups. Data were collected at baseline (2011-2012), post-intervention (12-months post-baseline) and follow-up (21-months post-baseline). The intervention included ten monthly group sessions (nutrition education; hands-on meal and snack planning, preparation, and skill development; screen time reductions) and five motivational, goal-setting phone calls. The main outcome was child body mass index (BMI) z-score. General linear models, adjusted for baseline values and demographics, showed no significant treatment group differences in BMI z-scores at post-intervention or follow-up; however, a promising reduction in excess weight gain was observed. Post-hoc stratification by pubertal onset indicated prepubescent children in the intervention group had significantly lower BMI z-scores than their control group counterparts. The study used a strong theoretical framework, rigorous design, quality measurement and a program with high fidelity to test a family meals-focused obesity prevention intervention. It showed a modest decrease in excess weight gain. The significant intervention effect among prepubescent children suggests the intervention may be more efficacious among relatively young children, although more research with appropriately powered samples are needed to replicate this finding. This study is registered at www.clinicaltrials.gov NCT01538615. Registered 01/17/2012.

Effect of Vitamin E on Oxaliplatin-induced Peripheral Neuropathy Prevention: A Randomized Controlled Trial.

PubMed

Salehi, Zeinab; Roayaei, Mahnaz

2015-01-01

Peripheral neuropathy is one of the most important limitations of oxaliplatin base regimen, which is the standard for the treatment of colorectal cancer. Evidence has shown that Vitamin E may be protective in chemotherapy-induced peripheral neuropathy. The aim of this study is to evaluate the effect of Vitamin E administration on prevention of oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. This was a prospective randomized, controlled clinical trial. Patients with colorectal cancer and scheduled to receive oxaliplatin-based regimens were enrolled in this study. Enrolled patients were randomized into two groups. The first group received Vitamin E at a dose of 400 mg daily and the second group observed, until after the sixth course of the oxaliplatin regimen. For oxaliplatin-induced peripheral neuropathy assessment, we used the symptom experience diary questionnaire that completed at baseline and after the sixth course of chemotherapy. Only patients with a score of zero at baseline were eligible for this study. Thirty-two patients were randomized to the Vitamin E group and 33 to the control group. There was no difference in the mean peripheral neuropathy score changes (after - before) between two groups, after sixth course of the oxaliplatin base regimen (mean difference [after - before] of Vitamin E group = 6.37 ± 2.85, control group = 6.57 ± 2.94; P = 0.78). Peripheral neuropathy scores were significantly increased after intervention compared with a base line in each group (P < 0.001). The results from this current trial demonstrate a lack of benefit for Vitamin E in preventing oxaliplatin-induced peripheral neuropathy.

Randomized controlled study of customized preventive medicine reminder letters in a community practice.

PubMed Central

Hogg, W. E.; Bass, M.; Calonge, N.; Crouch, H.; Satenstein, G.

1998-01-01

OBJECTIVE: To test the effectiveness of customized, family-oriented reminder letters in activating patients to seek appropriate preventive services. DESIGN: Randomized clinical trial. One group received computer-generated, customized letters explaining recommended preventive procedures for each family member. A second group received a form letter listing recommendations for all preventive procedures for all age and sex groups. A third group (control group) received no letters. SETTING: A private medical centre, without university affiliation, in rural Quebec. PARTICIPANTS: From 8770 patients who met study criteria, 719 families were randomly selected. Data were available for 1971 of 1998 patients in these families. MAIN OUTCOME MEASURES: The Family Received Index is the proportion of all procedures for which a family was overdue that they received. The Family End-of-study Up-to-date Index is the proportion of procedures for which the family was eligible and for which they were up-to-date at the end of the study. RESULTS: The Family Received Index for families mailed customized letters was more than double the index for patients not mailed letters (Kruskal-Wallis P = .0139). Comparison of the Family End-of-study Up-to-date indices also demonstrated that families of patients sent customized letters were more likely to be up-to-date than families not sent letters (Kruskal-Wallis P = .0054). No statistically significant difference appeared between the number of preventive measures received by the control group and the form-letter group. CONCLUSIONS: This study demonstrates a clinically small but statistically significant value to customizing reminder letters. PMID:9481466

Effects of an Updated Preventive Home Visit Program Based on a Systematic Structured Assessment of Care Needs for Ambulatory Frail Older Adults in Japan: A Randomized Controlled Trial.

PubMed

Kono, Ayumi; Izumi, Kyoko; Yoshiyuki, Noriko; Kanaya, Yukiko; Rubenstein, Laurence Z

2016-12-01

The aim of this randomized controlled trial was to determine the effects on functional parameters of an updated preventive home visit program for frail older adults in the Japanese Long-term Care Insurance (LTCI) system. The program included home visits by nurses or care managers every 3 months for 24 months, with a systematic assessment of care needs to prevent functional decline. Eligible participants (N = 360) were randomly assigned to the visit (VG: n = 179) or control group (CG: n = 181). Functional parameters were gathered via mail questionnaires at baseline and at 12- and 24-month follow-ups. Care-need levels in the LTCI were obtained at 12-, 24-, and 36-month follow-ups and the utilization of the LTCI service through 36 months. Participants in VG were significantly more likely to maintain their activities of daily living (ADL) functioning (p = .0113) and less likely to increase care-needs level, compared with CG participants, over 24 months. A generalized linear model showed that the estimate of the effect on increase in care-needs level (ie, functional decline) was -0.53 (p = .042) over 36 months. These results suggest that the updated preventive home visit program could be effective for the prevention of ADL and care-needs deterioration, and these effects could continue up to 1 year after program completion. © The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Leveraging microfinance to impact HIV and financial behaviors among adolescents and their mothers in West Bengal: a cluster randomized trial.

PubMed

Spielberg, Freya; Crookston, Benjamin T; Chanani, Sheila; Kim, Jaewhan; Kline, Sean; Gray, Bobbi L

2013-01-01

Microfinance can be used to reach women and adolescent girls with HIV prevention education. We report findings from a cluster-randomized control trial among 55 villages in West Bengal to determine the impact of non-formal education on knowledge, attitudes and behaviors for HIV prevention and savings. Multilevel regression models were used to evaluate differences between groups for key outcomes while adjusting for cluster correlation and differences in baseline characteristics. Women and girls who received HIV education showed significant gains in HIV knowledge, awareness that condoms can prevent HIV, self-efficacy for HIV prevention, and confirmed use of clean needles, as compared to the control group. Condom use was rare and did not improve for women. While HIV testing was uncommon, knowledge of HIV-testing resources significantly increased among girls, and trended in the positive direction among women in intervention groups. Conversely, the savings education showed no impact on financial knowledge or behavior change.

Medial Tibial Stress Syndrome: Evidence-Based Prevention

PubMed Central

Craig, Debbie I

2008-01-01

Reference: Thacker SB, Gilchrist J, Stroup DF, Kimsey CD. The prevention of shin splints in sports: a systematic review of literature. Med Sci Sports Exerc. 2002;34(1):32–40. Clinical Question: Among physically active individuals, which medial tibial stress syndrome (MTSS) prevention methods are most effective to decrease injury rates? Data Sources: Studies were identified by searching MEDLINE (1966–2000), Current Contents (1996–2000), Biomedical Collection (1993–1999), and Dissertation Abstracts. Reference lists of identified studies were searched manually until no further studies were identified. Experts in the field were contacted, including first authors of randomized controlled trials addressing prevention of MTSS. The Cochrane Collaboration (early stage of Cochrane Database of Systematic Reviews) was contacted. Study Selection: Inclusion criteria included randomized controlled trials or clinical trials comparing different MTSS prevention methods with control groups. Excluded were studies that did not provide primary research data or that addressed treatment and rehabilitation rather than prevention of incident MTSS. Data Extraction: A total of 199 citations were identified. Of these, 4 studies compared prevention methods for MTSS. Three reviewers independently scored the 4 studies. Reviewers were blinded to the authors' names and affiliations but not the results. Each study was evaluated independently for methodologic quality using a 100-point checklist. Final scores were averages of the 3 reviewers' scores. Main Results: Prevention methods studied were shock-absorbent insoles, foam heel pads, Achilles tendon stretching, footwear, and graduated running programs. No statistically significant results were noted for any of the prevention methods. Median quality scores ranged from 29 to 47, revealing flaws in design, control for bias, and statistical methods. Conclusions: No current evidence supports any single prevention method for MTSS. The most promising outcomes support the use of shock-absorbing insoles. Well-designed and controlled trials are critically needed to decrease the incidence of this common injury. PMID:18523568

Effect of probiotics on the incidence of ventilator-associated pneumonia in critically ill patients: a randomized controlled multicenter trial.

PubMed

Zeng, Juan; Wang, Chun-Ting; Zhang, Fu-Shen; Qi, Feng; Wang, Shi-Fu; Ma, Shuang; Wu, Tie-Jun; Tian, Hui; Tian, Zhao-Tao; Zhang, Shu-Liu; Qu, Yan; Liu, Lu-Yi; Li, Yuan-Zhong; Cui, Song; Zhao, He-Ling; Du, Quan-Sheng; Ma, Zhuang; Li, Chun-Hua; Li, Yun; Si, Min; Chu, Yu-Feng; Meng, Mei; Ren, Hong-Sheng; Zhang, Ji-Cheng; Jiang, Jin-Jiao; Ding, Min; Wang, Yu-Ping

2016-06-01

To evaluate the potential preventive effect of probiotics on ventilator-associated pneumonia (VAP). This was an open-label, randomized, controlled multicenter trial involving 235 critically ill adult patients who were expected to receive mechanical ventilation for ≥48 h. The patients were randomized to receive (1) a probiotics capsule containing live Bacillus subtilis and Enterococcus faecalis (Medilac-S) 0.5 g three times daily through a nasogastric feeding tube plus standard preventive strategies or (2) standard preventive strategies alone, for a maximum of 14 days. The development of VAP was evaluated daily, and throat swabs and gastric aspirate were cultured at baseline and once or twice weekly thereafter. The incidence of microbiologically confirmed VAP in the probiotics group was significantly lower than that in the control patients (36.4 vs. 50.4 %, respectively; P = 0.031). The mean time to develop VAP was significantly longer in the probiotics group than in the control group (10.4 vs. 7.5 days, respectively; P = 0.022). The proportion of patients with acquisition of gastric colonization of potentially pathogenic microorganisms (PPMOs) was lower in the probiotics group (24 %) than the control group (44 %) (P = 0.004). However, the proportion of patients with eradication PPMO colonization on both sites of the oropharynx and stomach were not significantly different between the two groups. The administration of probiotics did not result in any improvement in the incidence of clinically suspected VAP, antimicrobial consumption, duration of mechanical ventilation, mortality and length of hospital stay. Therapy with the probiotic bacteria B. Subtilis and E. faecalis are an effective and safe means for preventing VAP and the acquisition of PPMO colonization in the stomach.

Intervening with practitioners to improve the quality of prevention: One year findings from a randomized trial of Assets-Getting To Outcomes

PubMed Central

Chinman, Matthew; Acosta, Joie; Ebener, Patricia; Burkhart, Q; Malone, Patrick; Paddock, Susan M.; Clifford, Michael; Corsello, Maryann; Duffy, Tim; Hunter, Sarah; Jones, Margaret; Lahti, Michel; Phillips, Andrea; Savell, Susan; Scales, Peter C.; Tellett-Royce, Nancy

2013-01-01

There continues to be a gap in prevention outcomes achieved in research trials vs. “real world” practice. This article summarizes interim findings from a randomized trial testing Assets-Getting To Outcomes (AGTO), a two-year intervention to build prevention practitioners’ capacity to implement positive youth development-oriented prevention practices in 12 prevention coalitions in Maine. A survey of coalition members was used to assess change on individual practitioners’ prevention capacity between Baseline and one year later. Structured interviews with 32 program leaders (16 intervention, 16 control) were used to assess changes in prevention practices during the same time period. Change in prevention capacity over time between intervention and control did not differ, however in secondary analyses of only those assigned to the AGTO condition, AGTO users had evidenced greater improvement in their self-efficacy to conduct Assets-based programming and the frequency with which they engaged in AGTO behaviors. Non-users’ self-efficacy of AGTO declined. Interview ratings showed improvement in several key areas of performance among intervention programs. Improvement was associated with the number of technical assistance hours received. These results suggest that, after one year, AGTO is beginning to improve the capacity of community practitioners who make use of it. PMID:23605473

Dietary interventions, lifestyle changes, and dietary supplements in preventing gestational diabetes mellitus: a literature review.

PubMed

Facchinetti, Fabio; Dante, Giulia; Petrella, Elisabetta; Neri, Isabella

2014-11-01

Gestational diabetes mellitus (GDM) is associated with increased rates of fetal morbidity and mortality, both during the pregnancy and in the postnatal life. Current treatment of GDM includes diet with or without medications, but this management is expensive and poorly cost-effective for the health care systems. Strategies to prevent such condition would be preferable with respect to its treatment. The aim of this literature review was to evaluate studies reporting the efficacy of the most used approaches to prevent GDM as well as evidences of efficacy and safety of dietary supplementations. Systematic literature searches were performed in electronic databases, covering the period January 1983 to April 2014. Randomized controlled clinical trials were included. Quality of the articles was evaluated with the Jadad scale. We did not evaluate those articles that were already entered in the most recent systematic reviews, and we completed the research with the trials published thereafter. Of 55 articles identified, 15 randomized controlled trials were eligible. Quality and heterogeneity of the studies cannot allow firm conclusions. Anyway, trials in which only intake or expenditure has been targeted mostly reported negative results. On the contrary, combined lifestyle programs including diet control (orienting food intake, restricting energy intake) associated with moderate but continuous physical activity exhibit better efficacy in reducing GDM prevalence. The results from dietary supplements with myoinositol or probiotics are promising. The actual evidences provide enough arguments for implementing large-scale, high-quality randomized controlled trials looking at the possible benefits of these new approaches for preventing GDM.

The effects of the prevention program 'New Perspectives' (NP) on juvenile delinquency and other life domains: study protocol for a randomized controlled trial.

PubMed

de Vries, Sanne L A; Hoeve, Machteld; Asscher, Jessica J; Stams, Geert Jan Jm

2014-01-01

New Perspectives (NP) is a prevention program aiming to prevent that youth at onset of a criminal career will develop a persistent criminal behaviour pattern. The effects of NP on juvenile delinquency and other life domains are investigated, using a randomized controlled trial (RCT). In the present study at-risk youth aged 12 to 23 years are assigned randomly to the intervention (N = 90, NP) or control condition consisting of care as usual (N = 90, CAU). After screening, random assignment, and consent to participate, adolescents and their parents are requested to complete questionnaires. Data are collected at four points in time: at baseline (before the start of the intervention), after 3 months, after 6 months (post-test) and 1 year after treatment (follow-up). Primary outcome measures include involvement in delinquent behaviour and recidivism. Secondary outcome measures include parenting behaviour, life events, prosocial behaviour, deviant and prosocial peers, externalizing behaviour, cognitive distortions, moral reasoning, self-worth, anxiety, depression, client satisfaction, therapeutic alliance and motivation. Standardized questionnaires and interviews are used to collect data. Moderator analyses will also be conducted in order to examine the influence of ethnic background, gender and age on the program effectiveness. The present study will provide new insights in the effects of a prevention program targeting youth at risk for the development of a persistent criminal career. Dutch trial register number NTR4370. The study is financially supported by a grant from ZonMw, the Dutch Organization for Health research and Development, grant number 157004006. The study is approved by the Ethics Committee of the University of Amsterdam, approval number 2011-CDE-01.

A Randomized Controlled Trial of the First Step to Success Early Intervention: Demonstration of Program Efficacy Outcomes in a Diverse, Urban School District

ERIC Educational Resources Information Center

Walker, Hill M.; Seeley, John R.; Small, Jason; Severson, Herbert H.; Graham, Bethany A.; Feil, Edward G.; Serna, Loretta; Golly, Annemieke M.; Forness, Steven R.

2009-01-01

This article reports on a randomized controlled trial of the First Step to Success early intervention that was conducted over a 4-year period in Albuquerque Public Schools. First Step is a selected intervention for students in Grades 1 through 3 with externalizing behavior problems, and it addresses secondary prevention goals and objectives. It…

The Role of Critical Self-Reflection of Assumptions in an Online HIV Intervention for Men Who Have Sex with Men

ERIC Educational Resources Information Center

Wilkerson, J. Michael; Danilenko, Gene P.; Smolenski, Derek J.; Myer, Bryn B.; Rosser, B. R. Simon

2011-01-01

The Men's INTernet Study II included a randomized controlled trial to develop and test an Internet-based HIV prevention intervention for U.S men who use the Internet to seek sex with men. In 2008, participants (n = 560) were randomized to an online, interactive, sexual risk-reduction intervention or to a wait list null control. After 3 months,…

Effects of a multifactorial injury prevention intervention in physical education teachers: A randomized controlled trial.

PubMed

Vercruysse, Sien; Haerens, Leen; Verhagen, Evert; Goossens, Lennert; De Clercq, Dirk

2016-10-01

Physical education (PE) teachers are at a high risk of musculoskeletal sports or work-related injuries because of the physical activity as inherent part of their profession. Such injuries have a negative impact on work and leisure time activities, and effective injury prevention interventions are needed. The present study aimed at testing the effectiveness of an injury prevention intervention that was developed and optimized according to PE teachers' wishes and values. Fifty-five PE teachers were randomly assigned to intervention or control group. Intervention group teachers engaged in two days of training during which they familiarized with eight injury prevention strategies (seven intrinsic and one extrinsic). A special feature of the intervention was that the way of delivery was based on the self-determination theory in order to stimulate participants' motivation to adhere to the proposed strategies. Prospective registrations during one school year were conducted concerning injuries and preventive behaviours. Results showed that the intervention group teachers had a lower number of injuries per 1000 h time of exposure (TOE) than the controls (INT: 0.49, CON: 1.14 injuries/1000 h TOE, OR: 2.32, 95% CI: 1.06-5.07), and applied a broader variety of strategies including dynamic and static stretching, core stability, balance and strength training, when compared to the controls who mainly engaged in warming-up. In conclusion, with the same amount of time, an injury reduction was found in PE teachers through a more balanced use of provided preventive strategies.

Evaluation of a fall-prevention program in older people after femoral neck fracture: a one-year follow-up.

PubMed

Berggren, M; Stenvall, M; Olofsson, B; Gustafson, Y

2008-06-01

A randomized, controlled fall-prevention study including 199 patients operated on for femoral neck fracture reduced inpatient falls and injuries. No statistically significant effects of the intervention program could be detected after discharge. It seems that fall-prevention must be part of everyday life in fall-prone old people. This study evaluates whether a postoperative multidisciplinary, multifactorial fall-prevention program performed by a geriatric team that reduced inpatient falls and injuries had any continuing effect after discharge. The intervention consisted of staff education, systematic assessment and treatment of fall risk factors and vitamin D and calcium supplementation. The randomized, controlled trial with a one-year follow-up at Umeå University Hospital, Sweden, included 199 patients operated on for femoral neck fracture, aged > or = 70 years. After one year 44 participants had fallen 138 times in the intervention group compared with 55 participants and 191 falls in the control group. The crude postoperative fall incidence was 4.16/1,000 days in the intervention group vs. 6.43/1,000 days in the control group. The incidence rate ratio was 0.64 (95% CI: 0.40-1.02, p = 0.063). Seven new fractures occurred in the intervention group and 11 in the control group. A team applying comprehensive geriatric assessment and rehabilitation, including prevention and treatment of fall-risk factors, reduced inpatient falls and injuries, but no statistically significant effects of the program could be detected after discharge. It seems that fall-prevention must be part of everyday life in fall-prone elderly.

A pilot randomized trial of a cognitive reappraisal obesity prevention program.

PubMed

Stice, Eric; Yokum, Sonja; Burger, Kyle; Rohde, Paul; Shaw, Heather; Gau, Jeff M

2015-01-01

Evaluate a selective obesity prevention program promoting use of cognitive reappraisals to reduce reward region response and increase inhibitory region response to high-fat/high-sugar foods and reduce intake of fat and sugar to prevent blunted reward region response to intake of such foods. Young adults at risk for future weight gain by virtue of weight concerns (N=148) were randomized to this new prevention program (Minding Health), an alternative prevention program promoting participant-driven gradual reductions in caloric intake and increases in physical activity (Healthy Weight), or an obesity education video control condition, completing assessments at pre-, post-, and 6-month follow-up. A subset of Minding Health and control participants completed an fMRI scan at pre- and post-assessing neural response to images of high-fat/sugar foods and to receipt and anticipated receipt of a high-fat/sugar food. Minding Health participants showed significantly greater reductions in body fat than controls and caloric intake from fat and sugar than Healthy Weight participants. Minding Health participants also showed greater activation of an inhibitory control region and reduced activation of an attention/expectation region in response to palatable food images relative to pretest and controls. However, Healthy Weight participants showed greater reductions in BMI and eating disorder symptoms than Minding Health participants. Although the Minding Health intervention produced some of the hypothesized effects, it did not produce lasting reductions in body fat or BMI and showed limited effects on neural responsivity, implying it will be vital to increase the efficacy of this new prevention program. Copyright © 2014 Elsevier Inc. All rights reserved.

Prevention of Alzheimer disease

PubMed Central

Scalco, Monica Zavaloni; van Reekum, Robert

2006-01-01

OBJECTIVE To review the evidence regarding prevention of Alzheimer disease (AD) in order to highlight the role of family medicine. QUALITY OF EVIDENCE Most of the evidence relating to prevention of AD is derived from observational (cross-sectional, case-control, or longitudinal) studies. Evidence from randomized controlled trials (RCTs) is available only for blood pressure control and for hormone replacement therapy for menopausal women. MAIN MESSAGE Many preventive approaches to AD have been identified, but no RCTs support their efficacy. Evidence from RCTs supports the effectiveness of blood pressure control in reducing incidence of AD, but demonstrates that postmenopausal women’s use of estrogen is ineffective in reducing it. Observational studies suggest that some preventive approaches, such as healthy lifestyle, ongoing education, regular physical activity, and cholesterol control, play a role in prevention of AD. These approaches can and should be used for every patient because they carry no significant risk. Currently, no effective pharmacologic interventions have been researched enough to support their use in prevention of AD. CONCLUSION Health professionals should educate patients, especially patients at higher risk of AD, about preventive strategies and potentially modifiable risk factors. PMID:16529393

Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial.

PubMed

Otsuka, Taiga; Kawazoe, Seiji; Nakashita, Shunya; Kamachi, Saori; Oeda, Satoshi; Sumida, Chinatsu; Akiyama, Takumi; Ario, Keisuke; Fujimoto, Masaru; Tabuchi, Masanobu; Noda, Takahiro

2012-08-01

Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography (ERCP). Rectal nonsteroidal anti-inflammatory drugs (specifically, 100 mg of diclofenac or indomethacin) have shown promising prophylactic activity in post-ERCP pancreatitis (PEP). However, the 100-mg dose is higher than that ordinarily used in Japan. We performed a prospective randomized controlled study to evaluate the efficacy of low-dose rectal diclofenac for the prevention of PEP. Patients who were scheduled to undergo ERCP were randomized to receive a saline infusion either with 50 mg of rectal diclofenac (diclofenac group) or without (control group) 30 min before ERCP. The dose of diclofenac was reduced to 25 mg in patients weighing <50 kg. The primary outcome measure was the occurrence of PEP. Enrollment was terminated early because the planned interim analysis found a statistically significant intergroup difference in the occurrence of PEP. A total of 104 patients were eligible for this study; 51 patients received rectal diclofenac. Twelve patients (11.5%) developed PEP: 3.9% (2/51) in the diclofenac group and 18.9% (10/53) in the control group (p = 0.017). After ERCP, the incidence of hyperamylasemia was not significantly different between the two groups. Post-ERCP pain was significantly more frequent in the control group than in the diclofenac group (37.7 vs. 7.8%, respectively; p < 0.001). There were no adverse events related to diclofenac. Low-dose rectal diclofenac can prevent PEP.

Impact Evaluation of Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) Randomized Control Trial

ERIC Educational Resources Information Center

Knowlden, Adam P.; Sharma, Manoj; Cottrell, Randall R.; Wilson, Bradley R. A.; Johnson, Marcus Lee

2015-01-01

Background. The family and home environment is an influential antecedent of childhood obesity. The purpose of this study was to pilot test The Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) intervention; a newly developed, theory-based, online program for prevention of childhood…

Systematic review and meta-analysis of Saccharomyces boulardii in adult patients.

PubMed

McFarland, Lynne V

2010-05-14

This article reviews the evidence for efficacy and safety of Saccharomyces boulardii (S. boulardii) for various disease indications in adults based on the peer-reviewed, randomized clinical trials and pre-clinical studies from the published medical literature (Medline, Clinical Trial websites and meeting abstracts) between 1976 and 2009. For meta-analysis, only randomized, blinded controlled trials unrestricted by language were included. Pre-clinical studies, volunteer studies and uncontrolled studies were excluded from the review of efficacy and meta-analysis, but included in the systematic review. Of 31 randomized, placebo-controlled treatment arms in 27 trials (encompassing 5029 study patients), S. boulardii was found to be significantly efficacious and safe in 84% of those treatment arms. A meta-analysis found a significant therapeutic efficacy for S. boulardii in the prevention of antibiotic-associated diarrhea (AAD) (RR = 0.47, 95% CI: 0.35-0.63, P < 0.001). In adults, S. boulardii can be strongly recommended for the prevention of AAD and the traveler's diarrhea. Randomized trials also support the use of this yeast probiotic for prevention of enteral nutrition-related diarrhea and reduction of Helicobacter pylori treatment-related symptoms. S. boulardii shows promise for the prevention of C. difficile disease recurrences; treatment of irritable bowel syndrome, acute adult diarrhea, Crohn's disease, giardiasis, human immunodeficiency virus-related diarrhea; but more supporting evidence is recommended for these indications. The use of S. boulardii as a therapeutic probiotic is evidence-based for both efficacy and safety for several types of diarrhea.

Systematic review and meta-analysis of Saccharomyces boulardii in adult patients

PubMed Central

McFarland, Lynne V

2010-01-01

This article reviews the evidence for efficacy and safety of Saccharomyces boulardii (S. boulardii) for various disease indications in adults based on the peer-reviewed, randomized clinical trials and pre-clinical studies from the published medical literature (Medline, Clinical Trial websites and meeting abstracts) between 1976 and 2009. For meta-analysis, only randomized, blinded controlled trials unrestricted by language were included. Pre-clinical studies, volunteer studies and uncontrolled studies were excluded from the review of efficacy and meta-analysis, but included in the systematic review. Of 31 randomized, placebo-controlled treatment arms in 27 trials (encompassing 5029 study patients), S. boulardii was found to be significantly efficacious and safe in 84% of those treatment arms. A meta-analysis found a significant therapeutic efficacy for S. boulardii in the prevention of antibiotic-associated diarrhea (AAD) (RR = 0.47, 95% CI: 0.35-0.63, P < 0.001). In adults, S. boulardii can be strongly recommended for the prevention of AAD and the traveler’s diarrhea. Randomized trials also support the use of this yeast probiotic for prevention of enteral nutrition-related diarrhea and reduction of Heliobacter pylori treatment-related symptoms. S. boulardii shows promise for the prevention of C. difficile disease recurrences; treatment of irritable bowel syndrome, acute adult diarrhea, Crohn’s disease, giardiasis, human immunodeficiency virus-related diarrhea; but more supporting evidence is recommended for these indications. The use of S. boulardii as a therapeutic probiotic is evidence-based for both efficacy and safety for several types of diarrhea. PMID:20458757

The Evaluation of School-Based Violence Prevention Programs: A Meta-Analysis

ERIC Educational Resources Information Center

Park-Higgerson, Hyoun-Kyoung; Perumean-Chaney, Suzanne E.; Bartolucci, Alfred A.; Grimley, Diane M.; Singh, Karan P.

2008-01-01

Background: Youth violence and related aggressive behaviors have become serious public health issues with physical, economic, social, and psychological impacts and consequences. This study identified and evaluated the characteristics of successful school-based violence prevention programs. Methods: Twenty-six randomized controlled trial (RCT),…

Randomized Trial of Suicide Gatekeeper Training for Social Work Students

ERIC Educational Resources Information Center

Jacobson, Jodi M.; Osteen, Phillip J.; Sharpe, Tanya L.; Pastoor, Jennifer B.

2012-01-01

Problem: Education and research on social work's role in preventing client suicide is limited. Method: Seventy advanced master of social work students were randomly assigned to either the training group (Question, Persuade, and Referral suicide gatekeeper training) or the control group. Outcomes measured over time included suicide knowledge,…

Fluoride toothpastes for preventing dental caries in children and adolescents.

PubMed

Marinho, V C; Higgins, J P; Sheiham, A; Logan, S

2003-01-01

Fluoride toothpastes have been widely used for over three decades and remain a benchmark intervention for the prevention of dental caries. To determine the effectiveness and safety of fluoride toothpastes in the prevention of caries in children and to examine factors potentially modifying their effect. We searched the Cochrane Oral Health Group's Trials Register (May 2000), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2000), MEDLINE (1966 to January 2000), plus several other databases. We handsearched journals, reference lists of articles and contacted selected authors and manufacturers. Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride toothpaste with placebo in children up to 16 years during at least one year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS). Inclusion decisions, quality assessment and data extraction were duplicated in a random sample of one third of studies, and consensus achieved by discussion or a third party. Authors were contacted for missing data. The primary measure of effect was the prevented fraction (PF) that is the difference in caries increments between the treatment and control groups expressed as a percentage of the increment in the control group. Random effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random effects meta-regression analyses. Seventy-four studies were included. For the 70 that contributed data for meta-analysis (involving 42,300 children) the D(M)FS pooled PF was 24% (95% confidence interval (CI), 21 to 28%; p<0.0001). This means that 1.6 children need to brush with a fluoride toothpaste (rather than a non-fluoride toothpaste) over three years to prevent one D(M)FS in populations with caries increment of 2.6 D(M)FS per year. In populations with caries increment of 1.1 D(M)FS per year, 3.7 children will need to use a fluoride toothpaste for three years to avoid one D(M)FS. There was clear heterogeneity, confirmed statistically (p<0.0001). The effect of fluoride toothpaste increased with higher baseline levels of D(M)FS, higher fluoride concentration, higher frequency of use, and supervised brushing, but was not influenced by exposure to water fluoridation. There is little information concerning the deciduous dentition or adverse effects (fluorosis). Supported by more than half a century of research, the benefits of fluoride toothpastes are firmly established. Taken together, the trials are of relatively high quality, and provide clear evidence that fluoride toothpastes are efficacious in preventing caries.

Caring letters for suicide prevention: implementation of a multi-site randomized clinical trial in the U.S. military and Veteran Affairs healthcare systems.

PubMed

Luxton, David D; Thomas, Elissa K; Chipps, Joan; Relova, Rona M; Brown, Daphne; McLay, Robert; Lee, Tina T; Nakama, Helenna; Smolenski, Derek J

2014-03-01

Caring letters is a suicide prevention intervention that entails the sending of brief messages that espouse caring concern to patients following discharge from treatment. First tested more than four decades ago, this intervention is one of the only interventions shown in a randomized controlled trial to reduce suicide mortality rates. Due to elevated suicide risk among patients following psychiatric hospitalization and the steady increase in suicide rates among the U.S. military personnel, it is imperative to test interventions that may help prevent suicide among high-risk military personnel and veterans. This paper describes the design, methods, study protocol, and regulatory implementation processes for a multi-site randomized controlled trial that aims to evaluate the effectiveness of a caring emails intervention for suicide prevention in the military and VA healthcare systems. The primary outcome is suicide mortality rates to be determined 24 months post-discharge from index hospital stay. Healthcare re-utilization rates will also be evaluated and comprehensive data will be collected regarding suicide risk factors. Recommendations for navigating the military and VA research regulatory processes and implementing a multi-site clinical trial at military and VA hospitals are discussed. Published by Elsevier Inc.

The Effectiveness of Family Interventions in Preventing Adolescent Illicit Drug Use: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

PubMed

Vermeulen-Smit, Evelien; Verdurmen, J E E; Engels, R C M E

2015-09-01

In order to quantify the effectiveness of family interventions in preventing and reducing adolescent illicit drug use, we conducted a systematic review and meta-analysis of randomized controlled trials. We searched the Cochrane Database of Systematic Reviews, Educational Research Information Centre (ERIC), MEDLINE, Embase, and PsycINFO for studies published between 1995 and 2013. Results were described separately for different outcomes (marijuana vs. other illicit drugs) and intervention types (universal, selective, and indicated prevention). Meta-analyses were performed when data were sufficient (e.g., marijuana and other illicit drug initiation in universal samples), using random effect models. Otherwise, we provided narrative reviews (e.g., regarding selective and indicated prevention). Thirty-nine papers describing 22 RCTs were eligible for inclusion. Universal family interventions targeting parent-child dyads are likely to be effective in preventing (OR 0.72; 95 % CI 0.56, 0.94) and reducing adolescent marijuana use, but not in preventing other illicit drugs (OR 0.90; 95 % CI 0.60, 1.34). Among high-risk groups, there is no clear evidence for the effectiveness of family interventions in preventing and reducing illicit drug use and drug disorders. The three small RCTs among substance-(ab)using adolescents gave some indication that programs might reduce the frequency of illicit drug use. Family interventions targeting parent-child dyads are likely to be effective in preventing and reducing adolescent marijuana use in general populations, but no evidence for other illicit drug use was found. We underline the need to strengthen the evidence base with more trials, especially among at-risk populations.

Preventing the development of depression at work: a systematic review and meta-analysis of universal interventions in the workplace

PubMed Central

2014-01-01

Background Depression is a major public health problem among working-age adults. The workplace is potentially an important location for interventions aimed at preventing the development of depression, but to date, the mental health impact of universal interventions in the workplace has been unclear. Method A systematic search was conducted in relevant databases to identify randomized controlled trials of workplace interventions aimed at universal prevention of depression. The quality of studies was assessed using the Downs and Black checklist. A meta-analysis was performed using results from studies of adequate methodological quality, with pooled effect size estimates obtained from a random effects model. Results Nine workplace-based randomized controlled trials (RCT) were identified. The majority of the included studies utilized cognitive behavioral therapy (CBT) techniques. The overall standardized mean difference (SMD) between the intervention and control groups was 0.16 (95% confidence interval (CI): 0.07, 0.24, P = 0.0002), indicating a small positive effect. A separate analysis using only CBT-based interventions yielded a significant SMD of 0.12 (95% CI: 0.02, 0.22, P = 0.01). Conclusions There is good quality evidence that universally delivered workplace mental health interventions can reduce the level of depression symptoms among workers. There is more evidence for the effectiveness of CBT-based programs than other interventions. Evidence-based workplace interventions should be a key component of efforts to prevent the development of depression among adults. PMID:24886246

Effects of a randomized controlled recurrent fall prevention program on risk factors for falls in frail elderly living at home in rural communities.

PubMed

Jeon, Mi Yang; Jeong, HyeonCheol; Petrofsky, Jerrold; Lee, Haneul; Yim, JongEun

2014-11-14

Falling can lead to severe health issues in the elderly and importantly contributes to morbidity, death, immobility, hospitalization, and early entry to long-term care facilities. The aim of this study was to devise a recurrent fall prevention program for elderly women in rural areas. This study adopted an assessor-blinded, randomized, controlled trial methodology. Subjects were enrolled in a 12-week recurrent fall prevention program, which comprised strength training, balance training, and patient education. Muscle strength and endurance of the ankles and the lower extremities, static balance, dynamic balance, depression, compliance with preventive behavior related to falls, fear of falling, and fall self-efficacy at baseline and immediately after the program were assessed. Sixty-two subjects (mean age 69.2±4.3 years old) completed the program--31 subjects in the experimental group and 31 subjects in the control group. When the results of the program in the 2 groups were compared, significant differences were found in ankle heel rise test, lower extremity heel rise test, dynamic balance, depression, compliance with fall preventative behavior, fear of falling, and fall self-efficacy (p<0.05), but no significant difference was found in static balance. This study shows that the fall prevention program described effectively improves muscle strength and endurance, balance, and psychological aspects in elderly women with a fall history.

Tracheal Tube Design and Ventilator-Associated Pneumonia.

PubMed

Rouzé, Anahita; Jaillette, Emmanuelle; Poissy, Julien; Préau, Sébastien; Nseir, Saad

2017-10-01

Microaspiration of contaminated oropharyngeal and gastric secretions is the main mechanism for ventilator-associated pneumonia (VAP) in critically ill patients. Improving the performance of tracheal tubes in reducing microaspiration is one potential means to prevent VAP. The aim of this narrative review is to discuss recent findings on the impact of tracheal tube design on VAP prevention. Several randomized controlled studies have reported that subglottic secretion drainage (SSD) is efficient in VAP prevention. Meta-analyses have reported conflicting results regarding the impact of SSD on duration of mechanical ventilation, and one animal study raised concern about SSD-related tracheal lesions. However, this measure appears to be cost-effective. Therefore, SSD should probably be used in all patients with expected duration of mechanical ventilation > 48 h. Three randomized controlled trials have shown that tapered-cuff tracheal tubes are not useful to prevent VAP and should probably not be used in critically ill patients. Further studies are required to confirm the promising effects of continuous control of cuff pressure, polyurethane-cuffed, silver-coated, and low-volume low-pressure tracheal tubes. There is moderate evidence for the use of SSD and strong evidence against the use of tapered-cuff tracheal tubes in critically ill patients for VAP prevention. However, more data on the safety and cost-effectiveness of these measures are needed. Other tracheal tube-related preventive measures require further investigation. Copyright © 2017 by Daedalus Enterprises.

Efficacy of etanercept in preventing relapse of uveitis controlled by methotrexate.

PubMed

Foster, C Stephen; Tufail, Fehma; Waheed, Nadia Khalida; Chu, David; Miserocchi, Elisabetta; Baltatzis, Stefanos; Vredeveld, Cindy M

2003-04-01

To evaluate the efficacy of etanercept vs placebo in preventing relapses of uveitis in patients taking methotrexate with control of uveitis and whose methotrexate dosage was being tapered. Patients with chronic or recurrent noninfectious uveitis with inflammation controlled by low-dose methotrexate were randomized to either the drug or placebo group in a double-masked manner, given a methotrexate taper schedule, and followed for 24 weeks. The main outcome measures were control of inflammation, visual acuity, and adverse reactions. Data were analyzed both as an attempt-to-treat analysis and an analysis only of those patients who completed the study. A total of 20 patients were randomized to the drug and placebo groups. Relapse of uveitis occurred in 3 of 10 patients in the treatment group and 5 of 10 patients in the control group. Two patients in the treatment group withdrew prematurely from the study due to adverse effects. There was no significant difference between the treatment and placebo groups with regard to the rate of relapse and the final visual acuity. No patient suffered from any irreversible, long-term morbidity or mortality. Etanercept has no significant efficacy over placebo in preventing relapses of uveitis in patients being tapered from methotrexate.

Process evaluation of the Enabling Mothers toPrevent Pediatric Obesity Through Web-Based Learning and Reciprocal Determinism (EMPOWER) randomized control trial.

PubMed

Knowlden, Adam P; Sharma, Manoj

2014-09-01

Family-and-home-based interventions are an important vehicle for preventing childhood obesity. Systematic process evaluations have not been routinely conducted in assessment of these interventions. The purpose of this study was to plan and conduct a process evaluation of the Enabling Mothers to Prevent Pediatric Obesity Through Web-Based Learning and Reciprocal Determinism (EMPOWER) randomized control trial. The trial was composed of two web-based, mother-centered interventions for prevention of obesity in children between 4 and 6 years of age. Process evaluation used the components of program fidelity, dose delivered, dose received, context, reach, and recruitment. Categorical process evaluation data (program fidelity, dose delivered, dose exposure, and context) were assessed using Program Implementation Index (PII) values. Continuous process evaluation variables (dose satisfaction and recruitment) were assessed using ANOVA tests to evaluate mean differences between groups (experimental and control) and sessions (sessions 1 through 5). Process evaluation results found that both groups (experimental and control) were equivalent, and interventions were administered as planned. Analysis of web-based intervention process objectives requires tailoring of process evaluation models for online delivery. Dissemination of process evaluation results can advance best practices for implementing effective online health promotion programs. © 2014 Society for Public Health Education.

Oral Administration to Nursing Women of Lactobacillus fermentum CECT5716 Prevents Lactational Mastitis Development: A Randomized Controlled Trial

PubMed Central

Hurtado, José A.; Maldonado-Lobón, Jose A.; Díaz-Ropero, M. Paz; Flores-Rojas, Katherine; Uberos, José; Leante, José L.; Affumicato, Laura; Couce, María Luz; Garrido, José M.; Olivares, Mónica

2017-01-01

Abstract Objective: The objective of this study is to evaluate the preventive effect of oral administration of Lactobacillus fermentum CECT5716 on mastitis incidence in lactating women. Methods: A randomized double-blinded controlled trial that included 625 women was conducted. Women who received preventive dose of antibiotic in the context of delivery were recruited 1–6 days after childbirth and randomly assigned to a group. Probiotic group received 1 capsule/day containing L. fermentum 3 × 109 CFU, control group received 1 placebo capsule/day containing maltodextrin. The intervention period was 16 weeks. The primary outcome of the study was the incidence of clinical mastitis defined as at least two out of the three breast symptoms (pain, redness, and lump) and at least one of fever or flu-like symptoms (shivering, hot sweats, or aches). Results: Two hundred ninety-one women completed 16 weeks of treatment. Sixteen women in the probiotic group developed mastitis versus 30 women in the control group (odds ratio = 0.531; p = 0.058). Incidence rate of mastitis in the probiotic group was significantly lower than that in the control group (IR = 0.130 in the probiotic group versus IR = 0.263 in the control group; p = 0.021). Therefore, the oral administration of L. fermentum CECT5716 during lactation decreased by 51% the incidence rate of clinical mastitis. Staphylococcus spp. load at the end of intervention was significantly lower in breast milk of women in the probiotic group than in breast milk of women in the control group (p = 0.025). Conclusion: Consumption of the probiotic strain L. fermentum CECT5716 might be used during breastfeeding as an efficient strategy to prevent development of lactational mastitis in women. Trial registration: NCT02203877.

Knowledge Gains Following a Child Sexual Abuse Prevention Program Among Urban Students: A Cluster-Randomized Evaluation

PubMed Central

Dauber, Sarah; Tully, Brenda A.; Hamilton, Paige; Smith, Michael J.; Freeman, Katherine

2015-01-01

Objectives. We evaluated a school-based child sexual abuse (CSA) prevention program, Safe Touches, in a low–socioeconomic status, racially diverse sample. Methods. Participants were 492 second- and third-grade students at 6 public elementary schools in New York City. The study period spanned fall 2012 through summer 2014. We cluster-randomized classrooms to the Safe Touches intervention or control groups and assessed outcomes with the Children’s Knowledge of Abuse Questionnaire. Hierarchical models tested change in children’s knowledge of inappropriate and appropriate touch. Results. The intervention group showed significantly greater improvement than the control group on knowledge of inappropriate touch. Children in second grade and children in schools with a greater proportion of students in general (vs special) education showed greater gains than other participants in knowledge of inappropriate touch. We observed no significant change in knowledge of appropriate touch among control or intervention groups. Conclusions. Young children benefited from a school-based, 1-time CSA prevention program. Future research should explore the efficacy of CSA prevention programs with children before the second grade to determine optimal age for participation. PMID:25973809

A prevention programme for somatoform disorders is effective for affective disorders.

PubMed

García-Campayo, Javier; Arevalo, Elisa; Claraco, Luis Manuel; Alda, Marta; Lopez del Hoyo, Yolanda

2010-04-01

To assess the effectiveness of a psycho-educational programme for the primary prevention of somatoform disorders in healthy primary care patients. Randomized, controlled trial. Participants (N=104) were randomly assigned to: (1) a psycho-educational intervention, or (2) no intervention at all. The primary outcome measure was somatoform disorder psychiatric diagnosis at 5-year follow-up. Secondary outcome measures were hypochondriasis, locus of control and attribution of symptoms and psychological distress. At 3 and 6 months, and 5 years, the intervention group significantly decreased hypochondriasis and somatic attributions; and increased psychological and normalizing attributions and internal locus of control. Five years after baseline, the prevalence of somatoform disorders showed no differences between both groups. Nevertheless, overall psychiatric morbidity was less prevalent in the intervention group (odds ratio: 2.72; 95%CI:1.10-6.72). In addition, a decrease in depression and anxiety subscales and in overall General Health Questionnaire scoring (p<.05) was found in the intervention group. A primary prevention programme for somatization seems to be useful, not to decrease somatoform disorders, but to prevent anxiety and depressive disorders. The effects of overlapping psychobiological mechanisms are discussed. Copyright 2009 Elsevier B.V. All rights reserved.

Less deep vein thrombosis due to transcutaneous fibular nerve stimulation in total knee arthroplasty: a randomized controlled trial.

PubMed

Izumi, Masashi; Ikeuchi, Masahiko; Aso, Koji; Sugimura, Natsuki; Kamimoto, Yuko; Mitani, Tetsuya; Ueta, Tadashi; Sato, Takayuki; Yokoyama, Masataka; Sugiura, Tetsuro; Tani, Toshikazu

2015-11-01

It has been known for years that deep vein thrombi (DVT) start to develop during total joint arthroplasty. Previously, we reported effective prevention of venous stasis by transcutaneous electrical nerve stimulation (TENS). It is hypothesized that TENS might be a thromboprophylactic tool for the limb undergoing surgery. The purpose of this study is to clarify the clinical efficacy and safety of TENS in patients during total knee arthroplasty (TKA). Ninety patients undergoing primary TKA were involved and randomly allocated to the TENS or control group. In the TENS group, electrical stimulation of the common fibular nerve, which produced a brisk dorsiflexion of the ankle, was performed for the operated leg during surgery. In the control group, no electrical stimulation was applied. Serum D-dimer and soluble fibrin monomer complex (SFMC) levels were measured before surgery, immediately after surgery, and post-operative day (POD) 1. Ultrasonography was performed on POD 1. Immediately after surgery, D-dimer and SFMC levels of each group were significantly lower in the TENS group compared with control (p < 0.05). The incidence of DVT was 11 % (five cases) in the TENS group while 31 % (14 cases) in control (p = 0.02). There were no adverse effects related to TENS. TENS during TKA showed significant effects on preventing DVT. Sustaining muscle pump activation during surgery prevented not only venous stasis, but also hypercoagulability of blood. Intraoperative TENS is a safe and novel strategy against early post-operative thromboembolism, which is difficult to be completed through existing prophylaxis after total joint arthroplasty. Randomized controlled trial, Level I.

Effects of a Multifocused Prevention Program on Preschool Children's Competencies and Behavior Problems

ERIC Educational Resources Information Center

Stefan, Catrinel A.; Miclea, Mircea

2013-01-01

This study was designed to assess the effectiveness of a multifocused (child-, teacher- and parent-focused) prevention program for Romanian preschoolers, targeting social--emotional competence development, as well as reduction of behavior problems. Fourteen classrooms were randomly assigned to the intervention and control conditions. Subsequent…

Rape Prevention with College Men: Evaluating Risk Status

ERIC Educational Resources Information Center

Stephens, Kari A.; George, William H.

2009-01-01

This study evaluates the effectiveness of a theoretically based rape prevention intervention with college men who were at high or low risk to perpetrate sexually coercive behavior. Participants (N = 146) are randomly assigned to the intervention or control group. Outcomes include rape myth acceptance, victim empathy, attraction to sexual…

Accelerating Recovery from Poverty: Prevention Effects for Recently Separated Mothers

ERIC Educational Resources Information Center

Forgatch, Marion S.; DeGarmo, David S.

2007-01-01

This study evaluated benefits of a preventive intervention to the living standards of recently separated mothers. In the Oregon Divorce Study's randomized experimental design, data were collected 5 times over 30 months and evaluated with Hierarchical Linear Growth Models. Relative to their no-intervention control counterparts, experimental mothers…

A web-based approach to managing stress and mood disorders in the workforce.

PubMed

Billings, Douglas W; Cook, Royer F; Hendrickson, April; Dove, David C

2008-08-01

To evaluate the effectiveness of a web-based multimedia health promotion program for the workplace, designed to help reduce stress and to prevent depression, anxiety, and substance abuse. Using a randomized controlled trial design, 309 working adults were randomly assigned to the web-based condition or to a wait-list control condition. All participants were assessed on multiple self-reported outcomes at pretest and posttest. Relative to controls, the web-based group reduced their stress, increased their knowledge of depression and anxiety, developed more positive attitudes toward treatment, and adopted a more healthy approach to alcohol consumption. We found that a brief and easily adaptable web-based stress management program can simultaneously reduce worker stress and address stigmatized behavioral health problems by embedding this prevention material into a more positive stress management framework.

A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Rectal Diclofenac and Sublingual Nitroglycerin as a Combined Prophylactic Treatment for Post-ERCP Pancreatitis.

PubMed

Tomoda, Takeshi; Kato, Hironari; Mizukawa, Sho; Muro, Shinichiro; Akimoto, Yutaka; Uchida, Daisuke; Matsumoto, Kazuyuki; Yamamoto, Naoki; Horiguchi, Shigeru; Tsutsumi, Koichiro; Okada, Hiroyuki

2016-01-01

Acute pancreatitis is the major complication of endoscopic retrograde cholangiopancreatography (ERCP). A preliminary research suggested that the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) with nitroglycerin might reduce the incidence of post-ERCP pancreatitis (PEP) more effectively than NSAIDs alone. We conduct a two-arm, multicenter, prospective, randomized, superiority trial to evaluate the additional effect of nitroglycerin for prevention of PEP. A total of 900 patients randomly receive 50 mg diclofenac suppository either alone or with 5 mg isosorbide dinitrate sublingual tablet. The primary endpoint is the occurrence of PEP. This study will clarify whether NSAIDs plus nitroglycerin can prevent PEP.

Design and Recruitment for a Randomized Controlled Trial of Problem-Solving Therapy to Prevent Depression among Older Adults with Need for Supportive Services.

PubMed

Albert, Steven M; King, Jennifer; Dew, Mary Amanda; Begley, Amy; Anderson, Stewart; Karp, Jordan; Gildengers, Ari; Butters, Meryl; Reynolds, Charles F

2016-01-01

Addressing subthreshold depression (indicated prevention) and vulnerabilities that increase the risk of major depression or anxiety disorders (selective prevention) is important for protecting mental health in old age. The Depression-Agency Based Collaborative (Dep-ABC) is a prevention trial involving older adults recruited from aging services sites (home care agencies, senior housing, senior centers) who meet criteria for subthreshold depression and disability. Therefore, the authors examine the effectiveness of partnerships with aging services sites for recruiting at-risk older adults, the quality of recruitment and acceptability of the Dep-ABC assessment and intervention, and the baseline status of participants. Dep-ABC is a single-blind randomized controlled prevention trial set in aging services settings but with centralized screening, randomization, in-home assessments, and follow-up. Its intervention arm involves six to eight sessions of problem-solving therapy, in which older adults aged 60+ learn to break down problems that affect well-being and develop strategies to address them. We examined participation rates to assess quality of recruitment across sites and level of disability according to service use. Dep-ABC randomized 104 participants, 68.4% of eligible older adults. Screening using self-reported disability successfully netted a sample in which 74% received home care agency services, with remaining participants similarly impaired in structured self-reports of impairment and on observed performance tests. Direct outreach to aging services providers is an effective way to identify older adults with service needs at high risk of major depression. Problem-solving therapy is acceptable to this population and can be added to current services. Copyright © 2015 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Design and Recruitment for a Randomized Controlled Trial of Problem Solving Therapy to Prevent Depression among Older Adults with Need for Supportive Services

PubMed Central

Albert, Steven M.; King, Jennifer; Dew, Mary Amanda; Begley, Amy; Anderson, Stewart; Karp, Jordan; Gildengers, Ari; Butters, Meryl; Reynolds, Charles F.

2015-01-01

Background Addressing subthreshold depression (indicated prevention) as well as vulnerabilities that increase the risk of major depression or anxiety disorders (selective prevention) is important for protecting mental health in old age. The Depression-Agency Based Collaborative is a prevention trial involving older adults recruited from aging services sites (home care agencies, senior housing senior centers) who meet criteria for subthreshold depression and disability. Objective To examine (i) the effectiveness of partnerships with aging services sites for recruiting at-risk older adults, (ii) the quality of recruitment and acceptability of the Dep-ABC assessment and intervention, and (iii) the baseline status of participants. Methods Dep-ABC is a single-blind randomized controlled prevention trial set in aging services settings but with centralized screening, randomization, in-home assessments, and follow-up. Its intervention arm involves 6–8 sessions of problem-solving therapy, in which older adults aged 60+ learn to break down problems that affect wellbeing and develop strategies to address them. We examined participation rates to assess quality of recruitment across sites and level of disability according to service use. Results Dep-ABC randomized 104 participants, 68.4% of eligible older adults. Screening using self-reported disability successfully netted a sample in which 74% received home care agency services, with remaining participants similarly impaired in structured self-reports of impairment and on observed performance tests. Conclusions Direct outreach to aging services providers is an effective way to identify older adults with service needs at high risk of major depression. Problem solving therapy is acceptable to this population and can be added to current services. PMID:26706911

Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery: A Randomized Controlled Feasibility Trial.

PubMed

Deschamps, Alain; Hall, Richard; Grocott, Hilary; Mazer, C David; Choi, Peter T; Turgeon, Alexis F; de Medicis, Etienne; Bussières, Jean S; Hudson, Christopher; Syed, Summer; Seal, Doug; Herd, Stuart; Lambert, Jean; Denault, André; Deschamps, Alain; Mutch, Alan; Turgeon, Alexis; Denault, Andre; Todd, Andrea; Jerath, Angela; Fayad, Ashraf; Finnegan, Barry; Kent, Blaine; Kennedy, Brent; Cuthbertson, Brian H; Kavanagh, Brian; Warriner, Brian; MacAdams, Charles; Lehmann, Christian; Fudorow, Christine; Hudson, Christopher; McCartney, Colin; McIsaac, Dan; Dubois, Daniel; Campbell, David; Mazer, David; Neilpovitz, David; Rosen, David; Cheng, Davy; Drapeau, Dennis; Dillane, Derek; Tran, Diem; Mckeen, Dolores; Wijeysundera, Duminda; Jacobsohn, Eric; Couture, Etienne; de Medicis, Etienne; Alam, Fahad; Abdallah, Faraj; Ralley, Fiona E; Chung, Frances; Lellouche, Francois; Dobson, Gary; Germain, Genevieve; Djaiani, George; Gilron, Ian; Hare, Gregory; Bryson, Gregory; Clarke, Hance; McDonald, Heather; Roman-Smith, Helen; Grocott, Hilary; Yang, Homer; Douketis, James; Paul, James; Beaubien, Jean; Bussières, Jean; Pridham, Jeremy; Armstrong, J N; Parlow, Joel; Murkin, John; Gamble, Jonathan; Duttchen, Kaylene; Karkouti, Keyvan; Turner, Kim; Baghirzada, Leyla; Szabo, Linda; Lalu, Manoj; Wasowicz, Marcin; Bautista, Michael; Jacka, Michael; Murphy, Michael; Schmidt, Michael; Verret, Michaël; Perrault, Michel-Antoine; Beaudet, Nicolas; Buckley, Norman; Choi, Peter; MacDougall, Peter; Jones, Philip; Drolet, Pierre; Beaulieu, Pierre; Taneja, Ravi; Martin, Rene; Hall, Richard; George, Ronald; Chun, Rosa; McMullen, Sarah; Beattie, Scott; Sampson, Sonia; Choi, Stephen; Kowalski, Stephen; McCluskey, Stuart; Syed, Summer; Boet, Sylvain; Ramsay, Tim; Saha, Tarit; Mutter, Thomas; Chowdhury, Tumul; Uppal, Vishal; Mckay, William

2016-04-01

Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes. Before a large multicenter randomized controlled trial (RCT) on the impact of preventing desaturations on perioperative outcomes, the authors undertook a randomized prospective, parallel-arm, multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations. Eight Canadian sites randomized 201 patients between April 2012 and October 2013. The primary outcome was the success rate of reversing cerebral desaturations below 10% relative to baseline in the intervention group. Anesthesiologists were blinded to the cerebral saturation values in the control group. Intensive care unit personnel were blinded to cerebral saturation values for both groups. Secondary outcomes included the area under the curve of cerebral desaturation load, enrolment rates, and a 30-day follow-up for adverse events. Cerebral desaturations occurred in 71 (70%) of the 102 intervention group patients and 56 (57%) of the 99 control group patients (P = 0.04). Reversal was successful in 69 (97%) of the intervention group patients. The mean cerebral desaturation load (SD) in the operating room was smaller for intervention group patients compared with control group patients (104 [217] %.min vs. 398 [869] %.min, mean difference, -294; 95% CI, -562 to -26; P = 0.03). This was also true in the intensive care unit (P = 0.02). There were no differences in adverse events between the groups. Study sites were successful in reversal of desaturation, patient recruitment, randomization, and follow-up in cardiac surgery, supporting the feasibility of conducting a large multicenter RCT.

Efficacy of Adolescent Suicide Prevention E-Learning Modules for Gatekeepers: A Randomized Controlled Trial.

PubMed

Ghoncheh, Rezvan; Gould, Madelyn S; Twisk, Jos Wr; Kerkhof, Ad Jfm; Koot, Hans M

2016-01-29

Face-to-face gatekeeper training can be an effective strategy in the enhancement of gatekeepers' knowledge and self-efficacy in adolescent suicide prevention. However, barriers related to access (eg, time, resources) may hamper participation in face-to-face training sessions. The transition to a Web-based setting could address obstacles associated with face-to-face gatekeeper training. Although Web-based suicide prevention training targeting adolescents exists, so far no randomized controlled trials (RCTs) have been conducted to investigate their efficacy. This RCT study investigated the efficacy of a Web-based adolescent suicide prevention program entitled Mental Health Online, which aimed to improve the knowledge and self-confidence of gatekeepers working with adolescents (12-20 years old). The program consisted of 8 short e-learning modules each capturing an important aspect of the process of early recognition, guidance, and referral of suicidal adolescents, alongside additional information on the topic of (adolescent) suicide prevention. A total of 190 gatekeepers (ages 21 to 62 years) participated in this study and were randomized to either the experimental group or waitlist control group. The intervention was not masked. Participants from both groups completed 3 Web-based assessments (pretest, posttest, and 3-month follow-up). The outcome measures of this study were actual knowledge, and participants' ratings of perceived knowledge and perceived self-confidence using questionnaires developed specifically for this study. The actual knowledge, perceived knowledge, and perceived self-confidence of gatekeepers in the experimental group improved significantly compared to those in the waitlist control group at posttest, and the effects remained significant at 3-month follow-up. The overall effect sizes were 0.76, 1.20, and 1.02, respectively, across assessments. The findings of this study indicate that Web-based suicide prevention e-learning modules can be an effective educational method to enhance knowledge and self-confidence of gatekeepers with regard to adolescent suicide prevention. Gatekeepers with limited time and resources can benefit from the accessibility, simplicity, and flexibility of Web-based training. Netherlands Trial Register NTR3625; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3625 (Archived by WebCite at http://www.webcitation.org/6eHvyRh6M).

Role of vitamin K2 in preventing the recurrence of hepatocellular carcinoma after curative treatment: a meta-analysis of randomized controlled trials.

PubMed

Riaz, Irbaz Bin; Riaz, Haris; Riaz, Talha; Rahman, Sophia; Amir, Muhammad; Badshah, Maaz B; Kazi, Abdul Nafey

2012-11-29

Hepatocellular cancer is notorious for recurrence even after curative therapy. High recurrence determines the long term prognosis of the patients. Vitamin K2 has been tested in trials for its effect on prevention of recurrence and improving survival. The results are inconclusive from individual trials and in our knowledge no systematic review which entirely focuses on Vitamin K2 as a chemo preventive agent is available to date. This review is an attempt to pool all the existing trials together and update the existing knowledge on the topic. Medline, Embase and Cochrane Register of Controlled trials were searched for randomized controlled trials where vitamin K2 or its analogues, in any dosage were compared to placebo or No vitamin K2, for participants of any age or sex. Reference lists and abstracts of conference proceedings were searched by hand. Additional papers were identified by a manual search of the references from the key articles. Attempt was made to contact the authors of primary studies for missing data and with the experts in the field.Trials were assessed for inclusion by two independent reviewers. Primary outcomes were recurrence rates and survival rates. There were no secondary outcomes. Data was synthesized using a random effects model and results presented as relative risk with 95% Confidence Intervals. For recurrence of hepatocellular cancer after hepatic resection or local ablative therapy, compared with controls, participants receiving Vitamin K2, pooled relative risks for hepatocellular cancer were 0.60; 95% CI: 0.28-1.28, p = 0.64) at 1 yr 0.66; 95% CI: 0.47-0.91), p = 0.01) at 2 yr; 0.71; 95% CI: 0.58-0.85, p = 0.004) at 3 yr respectively. The results were combined using the random analysis model. Five RCTs evaluated the preventive efficacy of menatetrenone on HCC recurrence after hepatic resection or local ablative therapy. The meta-analysis of all five studies, failed to confirm significantly better tumor recurrence- free survival at 1 year. Improved tumor recurrence at 2nd and 3rd year may be just due to insufficient data. There was no beneficial effect on the overall survival. However, to confirm the beneficial effect or lack of it, large, higher quality randomized controlled trials are still required.

Randomized controlled pilot trial of naloxone‐on‐release to prevent post‐prison opioid overdose deaths

PubMed Central

Parmar, Mahesh K. B.; Strang, John; Choo, Louise; Meade, Angela M.

2016-01-01

Abstract Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug‐related death soon after release from prison. The NALoxone InVEstigation (N‐ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone‐on‐release (NOR) to eligible prisoners in England. Design. Parallel‐group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre‐randomization, release due within 3 months and more than 6 months since previous N‐ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single ‘rescue’ injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self‐questionnaires (RPSQs: 207), NOR‐carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70–74%]; 218 RPSQs were received; NOR‐carriage (95% CI = 63–79%) and overdose presence (95% CI = 75–84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one‐third of NOR administrations were to the ex‐prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take‐home emergency naloxone prior to prison release may be a life‐saving interim measure to prevent heroin overdose deaths among ex‐prisoners and the wider population. PMID:27776382

The Use of Self-Directed Relapse Prevention Booklets to Assist in Maintaining Abstinence after a 6-Week Group Smoking Cessation Treatment Program: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Veldheer, Susan; Hrabovsky, Shari; Yingst, Jessica; Sciamanna, Chris; Berg, Arthur; Foulds, Jonathan

2018-01-01

Background: Identifying effective relapse prevention interventions is a vital step to help smokers maintain abstinence for the long term. Aims: The purpose of this study is to determine if providing recently quit smokers with self-directed relapse prevention booklets is effective at maintaining abstinence after intensive group smoking cessation…

A Family Focused Randomized Controlled Trial to Prevent Adolescent Alcohol and Tobacco Use: The Moderating Roles of Positive Parenting and Adolescent Gender

ERIC Educational Resources Information Center

Jones, Deborah J.; Olson, Ardis L.; Forehand, Rex; Gaffney, Cecelia A.; Zens, Michael S.; Bau, J. J.

2005-01-01

Four years of longitudinal data from 2,153 families with a 5th- or 6th-grade preadolescent participating in a family-focused pediatric primary-care-based prevention program were used to examine whether prevention effects were moderated by positive parenting and/or adolescent gender. Alcohol and tobacco use, internalizing problems, and…

An Integrated Approach to Control Soil-Transmitted Helminthiasis, Schistosomiasis, Intestinal Protozoa Infection, and Diarrhea: Protocol for a Cluster Randomized Trial.

PubMed

Raso, Giovanna; Essé, Clémence; Dongo, Kouassi; Ouattara, Mamadou; Zouzou, Fabien; Hürlimann, Eveline; Koffi, Veronique A; Coulibaly, Gaoussou; Mahan, Virginie; Yapi, Richard B; Koné, Siaka; Coulibaly, Jean Tenena; Meïté, Aboulaye; Guéhi-Kabran, Marie-Claire; Bonfoh, Bassirou; N'Goran, Eliézer Kouakou; Utzinger, Jürg

2018-06-12

The global strategy to control helminthiases (schistosomiasis and soil-transmitted helminthiasis) emphasizes preventive chemotherapy. However, in the absence of access to clean water, improved sanitation, and adequate hygiene, reinfection after treatment can occur rapidly. Integrated approaches might be necessary to sustain the benefits of preventive chemotherapy and make progress toward interruption of helminthiases transmission. The aim of this study was to assess and quantify the effect of an integrated control package that consists of preventive chemotherapy, community-led total sanitation, and health education on soil-transmitted helminthiasis, schistosomiasis, intestinal protozoa infection, and diarrhea in rural Côte d'Ivoire. In a first step, a community health education program was developed that includes an animated cartoon to promote improved hygiene and health targeting school-aged children, coupled with a health education theater for the entire community. In a second step, a cluster randomized trial was implemented in 56 communities of south-central Côte d'Ivoire with 4 intervention arms: (1) preventive chemotherapy; (2) preventive chemotherapy plus community-led total sanitation; (3) preventive chemotherapy plus health education; and (4) all 3 interventions combined. Before implementation of the aforementioned interventions, a baseline parasitologic, anthropometric, and hygiene-related knowledge, attitudes, practices, and beliefs survey was conducted. These surveys were repeated 18 and 39 months after the baseline cross-sectional survey to determine the effect of different interventions on helminth and intestinal protozoa infection, nutritional indicators, and knowledge, attitudes, practices, and beliefs. Monitoring of diarrhea was done over a 24-month period at 2-week intervals, starting right after the baseline survey. Key results from this cluster randomized trial will shed light on the effect of integrated approaches consisting of preventive chemotherapy, community-led total sanitation, and health education against infections with soil-transmitted helminths, schistosomes, an intestinal protozoa and prevention of diarrhea in a rural part of Côte d'Ivoire. The research provided new insights into the acceptability, strengths, and limitations of an integrated community-based control package targeting helminthiases, intestinal protozoa infections, and diarrhea in rural communities of Côte d'Ivoire. In the longer term, the study will allow determining the effect of the integrated control approach on infection patterns with parasitic worms and intestinal protozoa, diarrheal incidence, anthropometric measures, and hygiene-related knowledge, attitudes, practices, and beliefs. International Standard Randomized Controlled Trial Number (ISRCTN): 53102033; http://www.isrctn.com/ISRCTN53102033 (Archived by WebCite at http://www.webcitation.org/6wpnXEiHo). RR1-10.2196/9166. ©Giovanna Raso, Clémence Essé, Kouassi Dongo, Mamadou Ouattara, Fabien Zouzou, Eveline Hürlimann, Veronique A Koffi, Gaoussou Coulibaly, Virginie Mahan, Richard B Yapi, Siaka Koné, Jean Tenena Coulibaly, Aboulaye Meïté, Marie-Claire Guéhi-Kabran, Bassirou Bonfoh, Eliézer Kouakou N'Goran, Jürg Utzinger. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 12.06.2018.

From empower to Green Dot : successful strategies and lessons learned in developing comprehensive sexual violence primary prevention programming.

PubMed

Cook-Craig, Patricia G; Millspaugh, Phyllis H; Recktenwald, Eileen A; Kelly, Natalie C; Hegge, Lea M; Coker, Ann L; Pletcher, Tisha S

2014-10-01

This case study describes Kentucky's partnership with the Centers for Disease Control and Prevention (CDC) EMPOWER (Enhancing and Making Programs Work to End Rape) program to enhance the mission and services of existing rape crisis centers to include comprehensive primary prevention programming to reduce rates of sexual violence perpetration. The planning process and the successful implementation of a statewide, 5-year, randomized control trial study of a bystander prevention program (Green Dot), and its evaluation are described. Lessons learned in generating new questions, seeking funding, building relationships and capacity, and disseminating knowledge are presented. © The Author(s) 2014.

Effect of Vitamin E on Oxaliplatin-induced Peripheral Neuropathy Prevention: A Randomized Controlled Trial

PubMed Central

Salehi, Zeinab; Roayaei, Mahnaz

2015-01-01

Background: Peripheral neuropathy is one of the most important limitations of oxaliplatin base regimen, which is the standard for the treatment of colorectal cancer. Evidence has shown that Vitamin E may be protective in chemotherapy-induced peripheral neuropathy. The aim of this study is to evaluate the effect of Vitamin E administration on prevention of oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. Methods: This was a prospective randomized, controlled clinical trial. Patients with colorectal cancer and scheduled to receive oxaliplatin-based regimens were enrolled in this study. Enrolled patients were randomized into two groups. The first group received Vitamin E at a dose of 400 mg daily and the second group observed, until after the sixth course of the oxaliplatin regimen. For oxaliplatin-induced peripheral neuropathy assessment, we used the symptom experience diary questionnaire that completed at baseline and after the sixth course of chemotherapy. Only patients with a score of zero at baseline were eligible for this study. Results: Thirty-two patients were randomized to the Vitamin E group and 33 to the control group. There was no difference in the mean peripheral neuropathy score changes (after − before) between two groups, after sixth course of the oxaliplatin base regimen (mean difference [after − before] of Vitamin E group = 6.37 ± 2.85, control group = 6.57 ± 2.94; P = 0.78). Peripheral neuropathy scores were significantly increased after intervention compared with a base line in each group (P < 0.001). Conclusions: The results from this current trial demonstrate a lack of benefit for Vitamin E in preventing oxaliplatin-induced peripheral neuropathy. PMID:26682028

A school-based comprehensive lifestyle intervention among chinese kids against obesity (CLICK-Obesity): rationale, design and methodology of a randomized controlled trial in Nanjing city, China.

PubMed

Xu, Fei; Ware, Robert S; Tse, Lap Ah; Wang, Zhiyong; Hong, Xin; Song, Aiju; Li, Jiequan; Wang, Youfa

2012-06-15

The prevalence of childhood obesity among adolescents has been rapidly rising in Mainland China in recent decades, especially in urban and rich areas. There is an urgent need to develop effective interventions to prevent childhood obesity. Limited data regarding adolescent overweight prevention in China are available. Thus, we developed a school-based intervention with the aim of reducing excess body weight in children. This report described the study design. We designed a cluster randomized controlled trial in 8 randomly selected urban primary schools between May 2010 and December 2013. Each school was randomly assigned to either the intervention or control group (four schools in each group). Participants were the 4th graders in each participating school. The multi-component program was implemented within the intervention group, while students in the control group followed their usual health and physical education curriculum with no additional intervention program. The intervention consisted of four components: a) classroom curriculum, (including physical education and healthy diet education), b) school environment support, c) family involvement, and d) fun programs/events. The primary study outcome was body composition, and secondary outcomes were behaviour and behavioural determinants. The intervention was designed with due consideration of Chinese cultural and familial tradition, social convention, and current primary education and exam system in Mainland China. We did our best to gain good support from educational authorities, school administrators, teachers and parents, and to integrate intervention components into schools' regular academic programs. The results of and lesson learned from this study will help guide future school-based childhood obesity prevention programs in Mainland China. ChiCTR-ERC-11001819.

Pressure garment therapy alone and in combination with silicone for the prevention of hypertrophic scarring: randomized controlled trial with intraindividual comparison.

PubMed

Steinstraesser, Lars; Flak, Ewa; Witte, Bernd; Ring, Andrej; Tilkorn, Daniel; Hauser, Jörg; Langer, Stefan; Steinau, Hans-Ulrich; Al-Benna, Sammy

2011-10-01

Published trials evaluating pressure garment and/or silicone therapy as a treatment for hypertrophic burn scarring are of poor quality and highly susceptible to bias. The authors' aim was to compare the efficacy of pressure garment therapy alone and in combination with silicone gel sheet or spray therapy for the prevention of hypertrophic scarring. The authors conducted an open, single-center, randomized controlled study with intraindividual comparison of study preparations and control to standard treatment. Forty-three consecutive patients with two comparable areas of split-thickness graft burn wounds were recruited into the study, and 38 patients were followed up for 18 months. All patients received compression garments and were randomized to one of two treatment groups: (1) self-drying silicone spray and compression versus compression alone and (2) silicone sheeting and compression versus compression alone. Clinical assessment, measurement of scar redness, height, and photographic documentation of each treated area were performed at different visits over an 18-month follow-up period. Significance was tested using repeated-measures analyses and Wilcoxon paired-sample signed rank tests. Use of pressure garment therapy alone produced results equivalent to those of combined silicone and pressure garment therapy in the prevention of hypertrophic scars. The efficacy of silicone spray therapy was comparable to that of silicone gel sheet therapy in the prevention of hypertrophic scars. Patients treated with silicone spray had fewer side effects when compared with the silicone sheet group. Multimodal therapy with silicone and pressure garment therapy failed to prevent hypertrophic scars beyond that observed with pressure garment therapy alone. Therapeutic, II.

Preventing growth in amphetamine use: long-term effects of the Midwestern Prevention Project (MPP) from early adolescence to early adulthood.

PubMed

Riggs, Nathaniel R; Chou, Chih-Ping; Pentz, Mary Ann

2009-10-01

The aim of the current study was to examine the long-term effect of an early adolescent substance abuse prevention program on trajectories and initiation of amphetamine use into early adulthood. Eight middle schools were assigned randomly to a program or control condition. The randomized controlled trial followed participants through 15 waves of data, from ages 11-28 years. This longitudinal study design includes four separate periods of development from early adolescence to early adulthood. The intervention took place in middle schools. A total of 1002 adolescents from one large mid-western US city were the participants in the study. The intervention was a multi-component community-based program delivered in early adolescence with a primary emphasis on tobacco, alcohol and marijuana use. At each wave of data collection participants completed a self-report survey that included questions about life-time amphetamine use. Compared to a control group, participants in the Midwestern Prevention Project (MPP) intervention condition had reduced growth (slope) in amphetamine use in emerging adulthood, a lower amphetamine use intercept at the commencement of the early adulthood and delayed amphetamine use initiation. The pattern of results suggests that the program worked first to prevent amphetamine use, and then to maintain the preventive effect into adulthood. Study findings suggest that early adolescent substance use prevention programs that focus initially on the 'gateway' drugs have utility for long-term prevention of amphetamine use. © 2009 The Authors. Journal compilation © 2009 Society for the Study of Addiction.

Prevention of Mental Health Disorders Using Internet- and Mobile-Based Interventions: A Narrative Review and Recommendations for Future Research

PubMed Central

Ebert, David Daniel; Cuijpers, Pim; Muñoz, Ricardo F.; Baumeister, Harald

2017-01-01

Although psychological interventions might have a tremendous potential for the prevention of mental health disorders (MHD), their current impact on the reduction of disease burden is questionable. Possible reasons include that it is not practical to deliver those interventions to the community en masse due to limited health care resources and the limited availability of evidence-based interventions and clinicians in routine practice, especially in rural areas. Therefore, new approaches are needed to maximize the impact of psychological preventive interventions. Limitations of traditional prevention programs could potentially be overcome by providing Internet- and mobile-based interventions (IMIs). This relatively new medium for promoting mental health and preventing MHD introduces a fresh array of possibilities, including the provision of evidence-based psychological interventions that are free from the restraints of travel and time and allow reaching participants for whom traditional opportunities are not an option. This article provides an introduction to the subject and narratively reviews the available evidence for the effectiveness of IMIs with regard to the prevention of MHD onsets. The number of randomized controlled trials that have been conducted to date is very limited and so far it is not possible to draw definite conclusions about the potential of IMIs for the prevention of MHD for specific disorders. Only for the indicated prevention of depression there is consistent evidence across four different randomized trial trials. The only trial on the prevention of general anxiety did not result in positive findings in terms of eating disorders (EDs), effects were only found in post hoc subgroup analyses, indicating that it might be possible to prevent ED onset for subpopulations of people at risk of developing EDs. Future studies need to identify those subpopulations likely to profit from preventive. Disorders not examined so far include substance use disorders, bipolar disorders, stress-related disorders, phobic disorders and panic disorder, obsessive–compulsive disorder, impulse-control disorders, somatic symptom disorder, and insomnia. In summary, there is a need for more rigorously conducted large scale randomized controlled trials using standard clinical diagnostic instruments for the selection of participants without MHD at baseline and the assessment of MHD onset. Subsequently, we discuss future directions for the field in order to fully exploit the potential of IMI for the prevention of MHD. PMID:28848454

Prevention of Mental Health Disorders Using Internet- and Mobile-Based Interventions: A Narrative Review and Recommendations for Future Research.

PubMed

Ebert, David Daniel; Cuijpers, Pim; Muñoz, Ricardo F; Baumeister, Harald

2017-01-01

Although psychological interventions might have a tremendous potential for the prevention of mental health disorders (MHD), their current impact on the reduction of disease burden is questionable. Possible reasons include that it is not practical to deliver those interventions to the community en masse due to limited health care resources and the limited availability of evidence-based interventions and clinicians in routine practice, especially in rural areas. Therefore, new approaches are needed to maximize the impact of psychological preventive interventions. Limitations of traditional prevention programs could potentially be overcome by providing Internet- and mobile-based interventions (IMIs). This relatively new medium for promoting mental health and preventing MHD introduces a fresh array of possibilities, including the provision of evidence-based psychological interventions that are free from the restraints of travel and time and allow reaching participants for whom traditional opportunities are not an option. This article provides an introduction to the subject and narratively reviews the available evidence for the effectiveness of IMIs with regard to the prevention of MHD onsets. The number of randomized controlled trials that have been conducted to date is very limited and so far it is not possible to draw definite conclusions about the potential of IMIs for the prevention of MHD for specific disorders. Only for the indicated prevention of depression there is consistent evidence across four different randomized trial trials. The only trial on the prevention of general anxiety did not result in positive findings in terms of eating disorders (EDs), effects were only found in post hoc subgroup analyses, indicating that it might be possible to prevent ED onset for subpopulations of people at risk of developing EDs. Future studies need to identify those subpopulations likely to profit from preventive. Disorders not examined so far include substance use disorders, bipolar disorders, stress-related disorders, phobic disorders and panic disorder, obsessive-compulsive disorder, impulse-control disorders, somatic symptom disorder, and insomnia. In summary, there is a need for more rigorously conducted large scale randomized controlled trials using standard clinical diagnostic instruments for the selection of participants without MHD at baseline and the assessment of MHD onset. Subsequently, we discuss future directions for the field in order to fully exploit the potential of IMI for the prevention of MHD.

Life skills, mathematical reasoning and critical thinking: a curriculum for the prevention of problem gambling.

PubMed

Turner, Nigel E; Macdonald, John; Somerset, Matthew

2008-09-01

Previous studies have shown that youth are two to three times more likely than adults to report gambling related problems. This paper reports on the development and pilot evaluation of a school-based problem gambling prevention curriculum. The prevention program focused on problem gambling awareness and self-monitoring skills, coping skills, and knowledge of the nature of random events. The results of a controlled experiment evaluating the students learning from the program are reported. We found significant improvement in the students' knowledge of random events, knowledge of problem gambling awareness and self-monitoring, and knowledge of coping skills. The results suggest that knowledge based material on random events, problem gambling awareness and self-monitoring skills, and coping skills can be taught. Future development of the curriculum will focus on content to expand the students' coping skill options.

Prevention of illicit drug use through a school-based program: results of a longitudinal, cluster-randomized controlled trial.

PubMed

Guo, Jong-Long; Lee, Tzu-Chi; Liao, Jung-Yu; Huang, Chiu-Mieh

2015-03-01

To evaluate the long-term effects of an illicit drug use prevention program for adolescents that integrates life skills into the theory of planned behavior. We conducted a cluster-randomized trial in which 24 participating schools were randomized to either an intervention group (12 schools, n = 1,176 students) or a control group (12 schools, n = 915 students). Participants were grade 7 students. The intervention comprised a main intervention of 10 sessions and two booster interventions. Booster 1 (four sessions) and booster 2 (two sessions) were performed at 6 months and 12 months, respectively, after completion of the main intervention. Assessments were made at baseline, after the main intervention, and after each booster session using specific questionnaires for measuring participants' attitudes, subjective norms, perceived behavioral control, and life skills. Retention rates were 71.9% (845/1,176) in the intervention group and 90.7% (830/915) in the control group after the 12-month follow-up. A significantly lower proportion of intervention group participants reported illicit drug use after the first and second booster sessions compared with control group participants (.1% vs. 1.7% and .2% vs. 1.7%, respectively; both p < .05). Attitudes, subjective norms, perceived behavioral control, life skills, and behavioral intention scores of the intervention group were significantly higher than those of control group after the first and second booster sessions (all p < .001), suggesting that intervention group students tended to avoid drug use. A drug use prevention program integrating life skills into the theory of planned behavior may be effective for reducing illicit drug use and improving planned behavior-related constructs in adolescents. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

A Randomized Controlled Trial Translating the Diabetes Prevention Program to a University Worksite, Ohio, 2012–2014

PubMed Central

Weinhold, Kellie R.; Marrero, David G.; Nagaraja, Haikady N.; Focht, Brian C.; Gascon, Gregg M.

2015-01-01

Introduction Working adults spend much time at the workplace, an ideal setting for wellness programs targeting weight loss and disease prevention. Few randomized trials have evaluated the efficacy of worksite diabetes prevention programs.This study evaluated the efficacy of a worksite lifestyle intervention on metabolic and behavioral risk factors compared with usual care. Methods A pretest–posttest control group design with 3-month follow-up was used. Participants with prediabetes were recruited from a university worksite and randomized to receive a 16-week lifestyle intervention (n = 35) or usual care (n = 34). Participants were evaluated at baseline, postintervention, and 3-month follow-up. Dietary intake was measured by a food frequency questionnaire and level of physical activity by accelerometers. Repeated measures analysis of variance compared the change in outcomes between and within groups. Results Mean (standard error [SE]) weight loss was greater in the intervention (−5.5% [0.6%]) than in the control (−0.4% [0.5%]) group (P < .001) postintervention and was sustained at 3-month follow-up (P < .001). Mean (SE) reductions in fasting glucose were greater in the intervention (−8.6 [1.6] mg/dL) than in the control (−3.7 [1.6] mg/dL) group (P = .02) postintervention; both groups had significant glucose reductions at 3-month follow-up (P < .001). In the intervention group, the intake of total energy and the percentage of energy from all fats, saturated fats, and trans fats decreased, and the intake of dietary fiber increased (all P < .01) postintervention. Conclusion The worksite intervention improved metabolic and behavioral risk factors among employees with prediabetes. The long-term impact on diabetes prevention and program sustainability warrant further investigation. PMID:26605710

Bisphosphonates for prevention of osteopenia in kidney-transplant recipients: a systematic review of randomized controlled trials.

PubMed

Wang, J; Yao, M; Xu, J-h; Shu, B; Wang, Y-j; Cui, X-j

2016-05-01

We conducted a systematic review of randomized controlled trials (RCTs) of bisphosphonates for the prevention of osteopenia in kidney-transplant recipients. Bisphosphonates improved bone mineral density at the lumbar spine and femoral neck after 12 months. However, additional well-designed RCTs are required to determine the optimal treatment strategy. Osteopenic-osteoporotic syndrome is a bone complication of renal transplantation. Bisphosphonates, calcitonin, and vitamin D analogs may be used to prevent or treat osteoporosis or bone loss after renal transplantation. However, there is currently no widely recognized strategy for the prevention of corticosteroid-induced osteoporosis. This study aims to assess the available evidence to guide the targeted use of bisphosphonates for reducing osteoporosis and bone loss in renal-transplant recipients. We searched the Cochrane Central Register of Controlled Trials, PubMed, and EMBASE for randomized controlled trials of bisphosphonates for osteoporosis or bone loss after renal transplantation. A total of 352 abstracts were identified, of which 55 were considered for evaluation and 9 were included in the final analysis. The primary outcome measure was change in the bone mineral density (BMD) of the lumbar spine and femoral neck after 12 months. Data extraction was performed independently by two investigators. BMD at the lumbar spine was improved after treatment with bisphosphonates [9 trials; 418 patients; weighted mean difference (WMD), 0.61; 95 % confidence interval (CI), 0.16-1.06]. Eight trials (406 patients) that reported changes in BMD at the femoral neck also showed improved outcomes after treatment with bisphosphonates (WMD, 0.06; 95 % CI, 0.03-0.09). Bisphosphonates improve BMD at the lumbar spine and femoral neck after 12 months in renal-transplant recipients.

Self-efficacy program to prevent osteoporosis among Chinese immigrants: a randomized controlled trial.

PubMed

Qi, Bing-Bing; Resnick, Barbara; Smeltzer, Suzanne C; Bausell, Barker

2011-01-01

: Recent Chinese immigrants have a low bone mineral density and are at a great risk for developing osteoporosis. The majority of Chinese men and women of all ages have inadequate information about their risks for developing osteoporosis and are seldom involved in preventive activities. : The aim of this study was to evaluate the preliminary effectiveness of an educational intervention based on the self-efficacy theory aimed at increasing the knowledge of osteoporosis and adoption of preventive behaviors, including regular exercise and osteoporosis medication adherence, designed for Chinese immigrants, aged 45 years or above, living in the United States. : A randomized controlled trial was employed, using a repeated-measure design. Foreign-born Mandarin-speaking Asians (n = 110) were recruited to the study, and 83 of them (mean age = 64.08 years, SD = 9.48 years) were assigned randomly to either the intervention group (n = 42) or the attention control group (n = 41). There were 63 (75.9%) women and 20 (24.1%) men. Data were collected at baseline and 2 weeks after the intervention. : The participants who received the intervention had statistically significant improvements (p < .05) at 2 weeks postintervention with respect to osteoporosis-related knowledge, self-efficacy for exercise, and osteoporosis medication adherence. Moreover, the participants in the treatment group spent more time on moderate exercise, had higher energy expenditure on exercise, and had more osteoporosis medication use at 2 weeks postintervention when compared with controls. : The intervention targeting Mandarin-speaking immigrants was effective in increasing the knowledge of osteoporosis and improving the adoption of preventive behaviors. Future research is needed to explore the long-term effect of this intervention on bone health behavior.

Outcomes from a randomized controlled trial of a multi-component alcohol use preventive intervention for urban youth: project northland Chicago.

PubMed

Komro, Kelli A; Perry, Cheryl L; Veblen-Mortenson, Sara; Farbakhsh, Kian; Toomey, Traci L; Stigler, Melissa H; Jones-Webb, Rhonda; Kugler, Kari C; Pasch, Keryn E; Williams, Carolyn L

2008-04-01

The goal of this group-randomized trial was to test the effectiveness of an adapted alcohol use preventive intervention for urban, low-income and multi-ethnic settings. Sixty-one public schools in Chicago were recruited to participate, were grouped into neighborhood study units and assigned randomly to intervention or 'delayed program' control condition. The study sample (n = 5812 students) was primarily African American, Hispanic and low-income. Students, beginning in sixth grade (age 12 years), received 3 years of intervention strategies (curricula, family interventions, youth-led community service projects, community organizing). Students participated in yearly classroom-based surveys to measure their alcohol use and related risk and protective factors. Additional evaluation components included a parent survey, a community leader survey and alcohol purchase attempts. Overall, the intervention, compared with a control condition receiving 'prevention as usual', was not effective in reducing alcohol use, drug use or any hypothesized mediating variables (i.e. related risk and protective factors). There was a non-significant trend (P = 0.066) that suggested the ability to purchase alcohol by young-appearing buyers was reduced in the intervention communities compared to the control communities, but this could be due to chance. Secondary outcome analyses to assess the effects of each intervention component indicated that the home-based programs were associated with reduced alcohol, marijuana and tobacco use combined (P = 0.01), with alcohol use alone approaching statistical significance (P = 0.06). Study results indicate the importance of conducting evaluations of previously validated programs in contexts that differ from the original study sample. Also, the findings highlight the need for further research with urban, low-income adolescents from different ethnic backgrounds to identify effective methods to prevent and reduce alcohol use.

A Randomized Controlled Trial Translating the Diabetes Prevention Program to a University Worksite, Ohio, 2012-2014.

PubMed

Weinhold, Kellie R; Miller, Carla K; Marrero, David G; Nagaraja, Haikady N; Focht, Brian C; Gascon, Gregg M

2015-11-25

Working adults spend much time at the workplace, an ideal setting for wellness programs targeting weight loss and disease prevention. Few randomized trials have evaluated the efficacy of worksite diabetes prevention programs. This study evaluated the efficacy of a worksite lifestyle intervention on metabolic and behavioral risk factors compared with usual care. A pretest-posttest control group design with 3-month follow-up was used. Participants with prediabetes were recruited from a university worksite and randomized to receive a 16-week lifestyle intervention (n = 35) or usual care (n = 34). Participants were evaluated at baseline, postintervention, and 3-month follow-up. Dietary intake was measured by a food frequency questionnaire and level of physical activity by accelerometers. Repeated measures analysis of variance compared the change in outcomes between and within groups. Mean (standard error [SE]) weight loss was greater in the intervention (-5.5% [0.6%]) than in the control (-0.4% [0.5%]) group (P < .001) postintervention and was sustained at 3-month follow-up (P < .001). Mean (SE) reductions in fasting glucose were greater in the intervention (-8.6 [1.6] mg/dL) than in the control (-3.7 [1.6] mg/dL) group (P = .02) postintervention; both groups had significant glucose reductions at 3-month follow-up (P < .001). In the intervention group, the intake of total energy and the percentage of energy from all fats, saturated fats, and trans fats decreased, and the intake of dietary fiber increased (all P < .01) postintervention. The worksite intervention improved metabolic and behavioral risk factors among employees with prediabetes. The long-term impact on diabetes prevention and program sustainability warrant further investigation.

The effect of exercise on prevention of the common cold: a meta-analysis of randomized controlled trial studies.

PubMed

Lee, Hyun Kun; Hwang, In Hong; Kim, Soo Young; Pyo, Se Young

2014-05-01

Because there is no specific treatment for the common cold, many previous studies have focused on prevention of the common cold. There were some studies reporting that regular, moderate-intensity exercise increases immunity and prevents the common cold. We conducted a meta-analysis to determine the effects of exercise on prevention of the common cold. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL for studies released through June 2013. We manually searched the references. Two authors independently extracted the data. To assess the risk of bias of included literature, Cochrane Collaboration's tool for assessing risk of bias was used. Review Manager ver. 5.2 (RevMan, Cochrane Collaboration) was used for statistical analysis. Four randomized controlled trials were identified. A total of 281 participants, 134 in the exercise group and 147 in the control group, were included. The effect of exercise on the prevention of the common cold had a relative risk (RR) of 0.73 (95% confidence interval [CI], 0.56 to 0.95; I(2) = 7%). The mean difference of mean illness days between exercise group and control group was -3.50 (95% CI, -6.06 to -0.94; I(2) = 93%). In the subgroup analysis, the RR of under 16 weeks exercise was 0.79 (95% CI, 0.58 to 1.08). In this meta-analysis, regular, moderate-intensity exercise may have an effect on the prevention of the common cold. But numbers of included studies and participants were too small and quality of included studies was relatively poor. Subsequent well-designed studies with larger sample size are needed to clarify the association.

A systematic review of randomized controlled trials of interventions designed to decrease child abuse in high-risk families.

PubMed

Levey, Elizabeth J; Gelaye, Bizu; Bain, Paul; Rondon, Marta B; Borba, Christina P C; Henderson, David C; Williams, Michelle A

2017-03-01

Child abuse is a global problem, and parents with histories of childhood abuse are at increased risk of abusing their offspring. The objective of this systematic review is to provide a clear overview of the existing literature of randomized controlled trials evaluating the effectiveness of interventions to prevent child abuse. PubMed, PsychINFO, Web of Science, Sociological Abstracts, and CINAHL were systematically searched and expanded by hand search. This review includes all randomized controlled trials (RCTs) of interventions designed to prevent abuse among mothers identified as high-risk. Of the eight studies identified, only three found statistically significant reductions in abuse by any measure, and only two found reductions in incidents reported to child protective services. While much has been written about child abuse in high-risk families, few RCTs have been performed. Only home visitation has a significant evidence base for reducing child abuse, and the findings vary considerably. Also, data from low- and middle-income countries are limited. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

A Prospective Randomized Clinical Trial of a Novel, Noninvasive Perfusion Enhancement System for the Prevention of Hospital-Acquired Sacral Pressure Injuries.

PubMed

Bharucha, Jitendra B; Seaman, Linda; Powers, Michele; Kelly, Erica; Seaman, Rodney; Forcier, Lea; McGinnis, Janice; Nodiff, Isabel; Pawlak, Brooke; Snyder, Samantha; Nodiff, Susan; Patel, Rohan; Squitieri, Rafael; Wang, Lansheng

2018-06-08

The purpose of this study was to determine the effectiveness of a novel, noninvasive perfusion enhancement system versus beds with integrated alternating pressure capabilities for the prevention of hospital-acquired sacral region (sacral, coccygeal, and ischium) pressure injuries in a high-risk, acute care patient population. A prospective randomized trial of high-risk inpatients without preexisting sacral region pressure injuries was conducted. The sample comprised 431 randomly enrolled adult patients in a 300-bed tertiary care community teaching hospital. Subjects were randomly allocated to one of 2 groups: control and experimental. Both groups received "standard-of-care" pressure injury prevention measures per hospital policy, and both were placed on alternating pressure beds during their hospital stays. In addition, patients in the experimental group used a noninvasive perfusion enhancement system placed on top of their alternating pressure beds and recovery chairs throughout their hospital stay. Fischer's exact probability test was used to compare group differences, and odds ratio (OR) were calculated for comparing pressure injury rates in the experimental and control groups. Three hundred ninety-nine patients completed the trial; 186 patients were allocated to the experimental group and 213 patients to the control group. Eleven patients in the control group versus 2 in the experimental group developed hospital-acquired sacral region pressure injuries (51.6% vs 1.07%; P = .024). Control patients were 5.04 times more likely to develop hospital-acquired sacral region pressure injuries (OR = 0.1996; 95% CI, 0.0437-0.9125). Patients using a noninvasive perfusion enhancement system developed significantly fewer hospital-acquired sacral pressure injuries than those using an alternating pressure bed without the perfusion enhancement system. These findings suggest that a perfusion enhancement system enhances the success of use of pressure redistributing beds for prevention of hospital-acquired sacral pressure injuries.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Study protocol of a cluster randomized controlled trial evaluating the efficacy of a comprehensive pressure ulcer prevention programme for private for-profit nursing homes.

PubMed

Kwong, Enid Wai-yung; Lee, Paul Hong; Yeung, Kwan-mo

2016-01-18

Because the demand for government-subsidized nursing homes in Hong Kong outstrips the supply, the number of for-profit private nursing homes has been increasing rapidly. However, the standard of care in such homes is always criticized. Pressure ulcers are a major long-term care issue that is closely associated with the quality of care delivered in nursing home settings. The aim of this study is to evaluate the effectiveness of a pressure ulcer prevention programme for residents in private for-profit nursing homes. This is a two-arm cluster randomized controlled trial with an estimated sample size of 1088 residents and 74 care staff from eight for-profit private nursing homes. Eligible nursing homes will be those classified as category A2 homes in the Enhanced Bought Place Scheme (EBPS), having a capacity of around 130-150 beds, and no structured PU prevention protocol and/or programmes in place. Care staff will be health workers, personal care workers, and nurses who are front-line staff providing direct care to residents. Eight nursing homes will be randomly assigned to either an experimental or control group. The experimental group will be provided with an intensive training programme and will be involved in the implementation of a 16-week pressure ulcer prevention protocol, while the control group will deliver the usual pressure ulcer prevention care. The study outcomes are the pressure ulcer prevention knowledge and skills of the care staff and the prevalence and incidence of pressure ulcers. Data on the knowledge and skills of care staff, and prevalence of pressure ulcer will be collected at the base line, and then at the 8(th) week and at completion of the implementation of the protocol. The assessment of the incidence of pressures will start from before the commencement of the intensive training course to the end of the implementation of the protocol. In view of the negative impact of pressure ulcers, it is important to have an effective and evidence-based pressure ulcer prevention programme to improve preventive care in private for-profit nursing homes. The programme will potentially improve the knowledge and skills of care staff on the prevention of pressure ulcers and also lead to a reduction in the development of pressure ulcers in nursing homes. The Current Controlled Trial is NCT02270385, 18 October 2014.

Effects of medication reviews performed by a physician on treatment with fracture-preventing and fall-risk-increasing drugs in older adults with hip fracture-a randomized controlled study.

PubMed

Sjöberg, Christina; Wallerstedt, Susanna M

2013-09-01

To investigate whether medication reviews increase treatment with fracture-preventing drugs and decrease treatment with fall-risk-increasing drugs. Randomized controlled trial (1:1). Departments of orthopedics, geriatrics, and medicine at Sahlgrenska University Hospital, Gothenburg, Sweden. One hundred ninety-nine consecutive individuals with hip fracture aged 65 and older. Medication reviews, based on assessments of risks of falls and fractures, regarding fracture-preventing and fall-risk-increasing drugs, performed by a physician, conveyed orally and in written form to hospital physicians during the hospital stay, and to general practitioners after discharge. Primary outcomes were changes in treatment with fracture-preventing and fall-risk-increasing drugs 12 months after discharge. Secondary outcomes were falls, fractures, deaths, and physicians' attitudes toward the intervention. At admission, 26% of intervention and 29% of control participants were taking fracture-preventing drugs, and 12% and 11%, respectively, were taking bone-active drugs, predominantly bisphosphonates. After 12 months, 77% of intervention and 58% of control participants were taking fracture-preventing drugs (P = .01), and 29% and 15%, respectively, were taking bone-active drugs (P = .04). Mean number of fall-risk-increasing drugs per participants was 3.1 (intervention) and 3.1 (control) at admission and 2.9 (intervention) and 3.1 (control) at 12 months (P = .62). No significant differences in hard endpoints were found. The responding physicians (n = 65) appreciated the intervention; on a scale from 1 (very bad) to 6 (very good), the median rating was 5 (interquartile range (IQR) 4-6) for the oral part and 5 (IQR 4-5.5) for the text part. Medication reviews performed and conveyed by a physician increased treatment with fracture-preventing drugs but did not significantly decrease treatment with fall-risk-increasing drugs in older adults with hip fracture. Prescribing physicians appreciated this intervention. © 2013, Copyright the Authors Journal compilation © 2013, The American Geriatrics Society.

Rationale and design of the Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research Trial (MANTICORE 101--Breast): a randomized, placebo-controlled trial to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular remodeling among patients with HER2+ early breast cancer using cardiac MRI.

PubMed

Pituskin, Edith; Haykowsky, Mark; Mackey, John R; Thompson, Richard B; Ezekowitz, Justin; Koshman, Sheri; Oudit, Gavin; Chow, Kelvin; Pagano, Joseph J; Paterson, Ian

2011-07-27

MANTICORE 101 - Breast (Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research) is a randomized trial to determine if conventional heart failure pharmacotherapy (angiotensin converting enzyme inhibitor or beta-blocker) can prevent trastuzumab-mediated left ventricular remodeling, measured with cardiac MRI, among patients with HER2+ early breast cancer. One hundred and fifty-nine patients with histologically confirmed HER2+ breast cancer will be enrolled in a parallel 3-arm, randomized, placebo controlled, double-blind design. After baseline assessments, participants will be randomized in a 1:1:1 ratio to an angiotensin-converting enzyme inhibitor (perindopril), beta-blocker (bisoprolol), or placebo. Participants will receive drug or placebo for 1 year beginning 7 days before trastuzumab therapy. Dosages for all groups will be systematically up-titrated, as tolerated, at 1 week intervals for a total of 3 weeks. The primary objective of this randomized clinical trial is to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular remodeling among patients with HER2+ early breast cancer, as measured by 12 month change in left ventricular end-diastolic volume using cardiac MRI. Secondary objectives include 1) determine the evolution of left ventricular remodeling on cardiac MRI in patients with HER2+ early breast cancer, 2) understand the mechanism of trastuzumab mediated cardiac toxicity by assessing for the presence of myocardial injury and apoptosis on serum biomarkers and cardiac MRI, and 3) correlate cardiac biomarkers of myocyte injury and extra-cellular matrix remodeling with left ventricular remodeling on cardiac MRI in patients with HER2+ early breast cancer. Cardiac toxicity as a result of cancer therapies is now recognized as a significant health problem of increasing prevalence. To our knowledge, MANTICORE will be the first randomized trial testing proven heart failure pharmacotherapy in the prevention of trastuzumab-mediated cardiotoxicity. We expect the findings of this trial to provide important evidence in the development of guidelines for preventive therapy. ClinicalTrials.gov: NCT01016886.

The 40-Something randomized controlled trial to prevent weight gain in mid-age women.

PubMed

Williams, Lauren T; Hollis, Jenna L; Collins, Clare E; Morgan, Philip J

2013-10-25

Obesity prevention is a major public health priority. Despite the health risks associated with weight gain, there has been a distinct lack of research into effective interventions to prevent, rather than treat, obesity particularly at high risk life stages such as menopause in women. This paper describes the rationale for and design of a 2-year randomized controlled trial (RCT) (the 40-Something Study) aimed at testing the feasibility and efficacy of a relatively low intensity intervention designed to achieve weight control in non-obese women about to enter the menopause transition. The study is a parallel-group RCT consisting of 12 months of intervention (Phase 1) and 12 months of monitoring (Phase 2). Non-obese pre-menopausal healthy females 44-50 years of age were screened, stratified according to Body Mass Index (BMI) category (18.5-24.9 and 25-29.9 kg/m²) and randomly assigned to one of two groups: motivational interviewing (MI) intervention (n = 28), or a self-directed intervention (SDI) (control) (n = 26). The MI intervention consisted of five consultations with health professionals (four with a Dietitian and one with an Exercise Physiologist) who applied components of MI counselling to consultations with the women over a 12 month period. The SDI was developed as a control and these participants received print materials only. Outcome measures were collected at baseline, three, 12, 18 and 24 months and included weight (primary outcome), waist circumference, body composition, blood pressure, plasma markers of metabolic syndrome risk, dietary intake, physical activity and quality of life. Analysis of covariance will be used to investigate outcomes according to intervention type and duration (comparing baseline, 12 and 24 months). The 40-Something study is the first RCT aimed at preventing menopausal weight gain in Australian women. Importantly, this paper describes the methods used to evaluate whether a relatively low intensity, health professional led intervention will achieve better weight control in pre-menopausal women than a self-directed intervention. The results will add to the scant body of literature on obesity prevention methods at an under-researched high-risk life stage, and inform the development of population-based interventions. ACTRN12611000064909.

Mobile Phone Apps for Preventing Cancer Through Educational and Behavioral Interventions: State of the Art and Remaining Challenges.

PubMed

Coughlin, Steven; Thind, Herpreet; Liu, Benyuan; Champagne, Nicole; Jacobs, Molly; Massey, Rachael I

2016-05-30

Rapid developments in technology have encouraged the use of mobile phones in smoking cessation, promoting healthy diet, nutrition, and physical activity, sun safety, and cancer screening. Although many apps relating to the prevention of cancer and other chronic diseases are available from major mobile phone platforms, relatively few have been tested in research studies to determine their efficacy. In this paper, we discuss issues related to the development and testing of new apps for preventing cancer through smoking cessation, sun safety, and other healthy behaviors, including key methodologic issues and outstanding challenges. An exploratory literature review was conducted using bibliographic searches in PubMed and CINAHL with relevant search terms (eg, smartphones, smoking cessation, cancer prevention, cancer screening, and carcinogens) to identify papers published in English through October 2015. Only 4 randomized controlled trials of the use of mobile phone apps for smoking cessation and 2 trials of apps for sun safety were identified, indicating that it is premature to conduct a systematic search and meta-analysis of the published literature on this topic. Future studies should utilize randomized controlled trial research designs, larger sample sizes, and longer study periods to better establish the cancer prevention and control capabilities of mobile phone apps. In developing new and refined apps for cancer prevention and control, both health literacy and eHealth literacy should be taken into account. There is a need for culturally appropriate, tailored health messages to increase knowledge and awareness of health behaviors such as smoking cessation, cancer screening, and sun safety. Mobile phone apps are likely to be a useful and low-cost intervention for preventing cancer through behavioral changes.

Mobile Phone Apps for Preventing Cancer Through Educational and Behavioral Interventions: State of the Art and Remaining Challenges

PubMed Central

Champagne, Nicole; Jacobs, Molly; Massey, Rachael I

2016-01-01

Background Rapid developments in technology have encouraged the use of mobile phones in smoking cessation, promoting healthy diet, nutrition, and physical activity, sun safety, and cancer screening. Although many apps relating to the prevention of cancer and other chronic diseases are available from major mobile phone platforms, relatively few have been tested in research studies to determine their efficacy. Objective In this paper, we discuss issues related to the development and testing of new apps for preventing cancer through smoking cessation, sun safety, and other healthy behaviors, including key methodologic issues and outstanding challenges. Methods An exploratory literature review was conducted using bibliographic searches in PubMed and CINAHL with relevant search terms (eg, smartphones, smoking cessation, cancer prevention, cancer screening, and carcinogens) to identify papers published in English through October 2015. Results Only 4 randomized controlled trials of the use of mobile phone apps for smoking cessation and 2 trials of apps for sun safety were identified, indicating that it is premature to conduct a systematic search and meta-analysis of the published literature on this topic. Conclusions Future studies should utilize randomized controlled trial research designs, larger sample sizes, and longer study periods to better establish the cancer prevention and control capabilities of mobile phone apps. In developing new and refined apps for cancer prevention and control, both health literacy and eHealth literacy should be taken into account. There is a need for culturally appropriate, tailored health messages to increase knowledge and awareness of health behaviors such as smoking cessation, cancer screening, and sun safety. Mobile phone apps are likely to be a useful and low-cost intervention for preventing cancer through behavioral changes. PMID:27242162

Effects of an Interactive School-Based Program for Preventing Adolescent Sexual Harassment: A Cluster-Randomized Controlled Evaluation Study.

PubMed

de Lijster, Gaby P A; Felten, Hanneke; Kok, Gerjo; Kocken, Paul L

2016-05-01

Many adolescents experience sexual harassment and victims of sexual harassment have higher risks regarding well-being and health behaviors such as higher risks of suicidal thoughts, suicidal ideation and feeling unsafe at school. A peer-performed play and school lessons on preventing sexual harassment behavior were presented to secondary school students. We evaluated its effectiveness, using a cluster-randomized controlled design to assign schools to an experimental condition [n = 14 schools; 431 students (51 % female)] and a control condition [n = 11 schools; 384 students (51 % female)]. To measure the effects of the intervention at first post-test and 6-month follow-up, our multilevel analyses used a two-level random intercept model. Outcome measures were sexual harassment behaviors, behavioral determinants and distal factors influencing these behaviors. At post-test, students in the experimental group reported a reduced intention to commit sexual harassment behavior and higher self-efficacy in rejecting it. At post-test and follow-up there was a significant positive effect on social norms for rejecting sexual harassment behavior. At follow-up, sexual self-esteem was higher in students in the experimental group than in the control group. Effects on these determinants will benefit adolescents' future sexual behaviors. In combination, the play and lessons, possibly together with continued sexual health education and skills programs on social-emotional learning in subsequent school years, have potential for preventing sexual harassment behavior.

TakeCARE, a Video Bystander Program to Help Prevent Sexual Violence on College Campuses: Results of Two Randomized, Controlled Trials

PubMed Central

Jouriles, Ernest N.; McDonald, Renee; Rosenfield, David; Levy, Nicole; Sargent, Kelli; Caiozzo, Christina; Grych, John H.

2015-01-01

Objective The present research reports on two randomized controlled trials evaluating TakeCARE, a video bystander program designed to help prevent sexual violence on college campuses. Method In Study 1, students were recruited from psychology courses at two universities. In Study 2, first-year students were recruited from a required course at one university. In both studies, students were randomly assigned to view one of two videos: TakeCARE or a control video on study skills. Just before viewing the videos, students completed measures of bystander behavior toward friends and ratings of self-efficacy for performing such behaviors. The efficacy measure was administered again after the video, and both the bystander behavior measure and the efficacy measure were administered at either one (Study 1) or two (Study 2) months later. Results In both studies, students who viewed TakeCARE, compared to students who viewed the control video, reported engaging in more bystander behavior toward friends and greater feelings of efficacy for performing such behavior. In Study 1, feelings of efficacy mediated effects of TakeCARE on bystander behavior; this result did not emerge in Study 2. Conclusions This research demonstrates that TakeCARE, a video bystander program, can positively influence bystander behavior toward friends. Given its potential to be easily distributed to an entire campus community, TakeCARE might be an effective addition to campus efforts to prevent sexual violence. PMID:27867694

Prevention and control of neglected tropical diseases: overview of randomized trials, systematic reviews and meta-analyses

PubMed Central

Kappagoda, Shanthi

2014-01-01

Abstract Objective To analyse evidence from randomized controlled trials (RCTs) on the prevention and control of neglected tropical diseases (NTDs) and to identify areas where evidence is lacking. Methods The Cochrane Central Register of Controlled Trials and PubMed were searched for RCTs and the Cochrane Database of Systematic Reviews and PubMed were searched for meta-analyses and systematic reviews, both from inception to 31 December 2012. Findings Overall, 258 RCTs were found on American trypanosomiasis, Buruli ulcer, dengue, geohelminth infection, leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis, rabies, schistosomiasis or trachoma. No RCTs were found on cysticercosis, dracunculiasis, echinococcosis, foodborne trematodes, or human African trypanosomiasis. The most studied diseases were geohelminth infection (51 RCTs) and leishmaniasis (46 RCTs). Vaccines, chemoprophylaxis and interventions targeting insect vectors were evaluated in 113, 99 and 39 RCTs, respectively. Few addressed how best to deliver preventive chemotherapy, such as the choice of dosing interval (10) or target population (4), the population coverage needed to reduce transmission (2) or the method of drug distribution (1). Thirty-one publications containing 32 systematic reviews (16 with and 16 without meta-analyses) were found on American trypanosomiasis, dengue, geohelminths, leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis, schistosomiasis or trachoma. Together, they included only 79 of the 258 published RCTs (30.6%). Of 36 interventions assessed, 8 were judged effective in more than one review. Conclusion Few RCTs on the prevention or control of the principal NTDs were found. Trials on how best to deliver preventive chemotherapy were particularly rare. PMID:24839325

Effectiveness of adolescent suicide prevention e-learning modules that aim to improve knowledge and self-confidence of gatekeepers: study protocol for a randomized controlled trial.

PubMed

Ghoncheh, Rezvan; Kerkhof, Ad J F M; Koot, Hans M

2014-02-08

Providing e-learning modules can be an effective strategy for enhancing gatekeepers' knowledge, self-confidence and skills in adolescent suicide prevention. The aim of this study was to test the effectiveness of an online training program called Mental Health Online which consists of eight short e-learning modules, each capturing an important aspect of the process of recognition, guidance and referral of suicidal adolescents (12-20 years). The primary outcomes of this study are participant's ratings on perceived knowledge, perceived self-confidence, and actual knowledge regarding adolescent suicidality. A randomized controlled trial will be carried out among 154 gatekeepers. After completing the first assessment (pre-test), participants will be randomly assigned to either the experimental group or the waitlist control group. One week after completing the first assessment the experimental group will have access to the website Mental Health Online containing the eight e-learning modules and additional information on adolescent suicide prevention. Participants in both conditions will be assessed 4 weeks after completing the first assessment (post-test), and 12 weeks after completing the post-test (follow-up). At post-test, participants from the experimental group are asked to complete an evaluation questionnaire on the modules. The waitlist control group will have access to the modules and additional information on the website after completing the follow-up assessment. Gatekeepers can benefit from e-learning modules on adolescent suicide prevention. This approach allows them to learn about this sensitive subject at their own pace and from any given location, as long as they have access to the Internet. Given the flexible nature of the program, each participant can compose his/her own training creating an instant customized course with the required steps in adolescent suicide prevention. Netherlands Trial Register NTR3625.

A randomized controlled trial testing the effectiveness of a universal school-based depression prevention program 'Op Volle Kracht' in the Netherlands.

PubMed

Tak, Yuli R; Van Zundert, Rinka Mp; Kuijpers, Rowella Cwm; Van Vlokhoven, Boukje S; Rensink, Hettie Fw; Engels, Rutger Cme

2012-01-10

The incidence of depressive symptoms increases during adolescence, from 10.0% to 24.5% at age 11 to 15, respectively. Experiencing elevated levels of depressive symptoms increases the risk of a depressive disorder in adulthood. A universal school-based depression prevention program Op Volle Kracht (OVK) was developed, based on the Penn Resiliency Program, aimed at preventing the increase of depressive symptoms during adolescence and enhancing positive development. In this study the effectiveness of OVK will be tested and possible mediators of program effects will be focus of study as well. The effectiveness of OVK will be tested in a randomized controlled trial with two conditions, intervention (OVK) and control condition (care as usual). Schools are randomly assigned to research conditions. OVK will be incorporated in the school curriculum, maximizing program attendance. OVK consists of 16 lessons of 50 min, given by trained psychologists to groups of 11-15 students. OVK contains Cognitive Behavioral Therapy, social skills training, problem solving and decision making. Outcomes are measured at 6, 12, 18 and 24 months follow up, to monitor long term program effects. Primary outcome is level of depressive symptoms, secondary outcomes are: anxiety, hopelessness, cognitive bias, substance use, truancy, life satisfaction, coping, self-efficacy, optimism, happiness, friendship, school performance and school attitude. The questionnaires for students will be administered in the school setting. Parents will complete a questionnaire at baseline only. In this paper the study into the effectiveness of the depression prevention program OVK was described. It is expected that OVK will prevent the increase in depressive symptoms during adolescence and enhance positive development in the intervention condition, compared to the control condition. If OVK will be effective, it can be implemented in the school context by which numerous adolescents can be reached. Netherlands Trial Register (NTR): NTR2879.

OSTA program: A French follow up intervention program for suicide prevention.

PubMed

Mouaffak, Fayçal; Marchand, Arnaud; Castaigne, Emmanuelle; Arnoux, Armelle; Hardy, Patrick

2015-12-30

Attempted suicide is a strong risk factor for subsequent suicidal behavior. In recent years, a particular interest has been given to follow-up interventions as a potential effective strategy in preventing recurrent suicidal behavior. We developed a follow-up intervention program called OSTA (organization of a suitable monitoring for suicide attempters) aimed at addressing this issue and tested its effectiveness in a 1-year randomized controlled trial. Individuals who attempted suicide and were admitted to the emergency department (ED) of Bicêtre Hospital (n=320) were randomly allocated to receive either the OSTA program or a control treatment. On an intention to treat basis, the proportion of patients who reattempted suicide did not differ significantly between the interventional group (IG) 14.5% (22/152) and the control group (CG) 14% (21/150). There were also no significant differences, between the two arms, in the number of suicide attempts. Although no significant difference has been found between the OSTA program and the control treatment concerning the rate of suicide reattempts, we believe that further studies should be conducted to test the effectiveness of more standardized follow-up studies in suicide prevention. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Preventing postpartum depression: A meta-analytic review

PubMed Central

Sockol, Laura E.; Epperson, C. Neill; Barber, Jacques P.

2014-01-01

This meta-analysis assessed the efficacy of a wide range of preventive interventions designed to reduce the severity of postpartum depressive symptoms or decrease the prevalence of postpartum depressive episodes. A systematic review identified 37 randomized or quasi-randomized controlled trials in which an intervention was compared to a control condition. Differences between treatment and control conditions in the level of depressive symptoms and prevalence of depressive episodes by 6 months postpartum were assessed in separate analyses. Depressive symptoms were significantly lower at post-treatment in intervention conditions, with an overall effect size in the small range after exclusion of outliers (Hedges' g = 0.18). There was a 27% reduction in the prevalence of depressive episodes in intervention conditions by 6 months postpartum after removal of outliers and correction for publication bias. Later timing of the postpartum assessment was associated with smaller differences between intervention and control conditions in both analyses. Among studies that assessed depressive symptoms using the EPDS, higher levels of depressive symptoms at pre-treatment were associated with smaller differences in depressive symptoms by 6 months postpartum. These findings suggest that interventions designed to prevent postpartum depression effectively reduce levels of postpartum depressive symptoms and decrease risk for postpartum depressive episodes. PMID:24211712

The effectiveness of job rotation to prevent work-related musculoskeletal disorders: protocol of a cluster randomized clinical trial.

PubMed

Comper, Maria Luiza Caires; Padula, Rosimeire Simprini

2014-05-22

Job rotation has often been used in situations where the level of exposure cannot be reduced due to the characteristics of the job or through physical measures. However, the effectiveness of the job rotation strategy at preventing musculoskeletal complaints lacks adequate scientific data. A cluster randomized controlled trial will be used to investigate the effectiveness of job rotation to prevent musculoskeletal disorders in industrial workers. The randomized cluster was based in characteristics of production sectors. A total cluster will be 4 sectors, and 957 workers will be recruited from a textile industry and randomly allocated into intervention or control groups. Both groups will receive training on ergonomics guidelines. In addition, the intervention group will perform job rotation, switching between tasks with low, moderate, and high risk for musculoskeletal complaints. The primary outcome will be the number of working hours lost due to sick leave by musculoskeletal injuries recorded in employee administrative data bases. Secondary outcomes measured via survey include: body parts with musculoskeletal pain, the intensity of this pain, physical workload, fatigue, general health status, physical activity level, and work productivity. Secondary outcome measures will be assessed at baseline and after 3, 6, 9, and 12 months. The cost-effectiveness analysis will be performed from the societal and company perspective. Prevention of work-related musculoskeletal disorders is beneficial for workers, employers, and society. The results of this study will provide new information about the effectiveness of job rotation as a strategy to reduce work-related musculoskeletal disorders. NCT01979731, November 3, 2013.

The effectiveness of job rotation to prevent work-related musculoskeletal disorders: protocol of a cluster randomized clinical trial

PubMed Central

2014-01-01

Background Job rotation has often been used in situations where the level of exposure cannot be reduced due to the characteristics of the job or through physical measures. However, the effectiveness of the job rotation strategy at preventing musculoskeletal complaints lacks adequate scientific data. Methods/Design A cluster randomized controlled trial will be used to investigate the effectiveness of job rotation to prevent musculoskeletal disorders in industrial workers. The randomized cluster was based in characteristics of production sectors. A total cluster will be 4 sectors, and 957 workers will be recruited from a textile industry and randomly allocated into intervention or control groups. Both groups will receive training on ergonomics guidelines. In addition, the intervention group will perform job rotation, switching between tasks with low, moderate, and high risk for musculoskeletal complaints. The primary outcome will be the number of working hours lost due to sick leave by musculoskeletal injuries recorded in employee administrative data bases. Secondary outcomes measured via survey include: body parts with musculoskeletal pain, the intensity of this pain, physical workload, fatigue, general health status, physical activity level, and work productivity. Secondary outcome measures will be assessed at baseline and after 3, 6, 9, and 12 months. The cost-effectiveness analysis will be performed from the societal and company perspective. Discussion Prevention of work-related musculoskeletal disorders is beneficial for workers, employers, and society. The results of this study will provide new information about the effectiveness of job rotation as a strategy to reduce work-related musculoskeletal disorders. Trial registration NCT01979731, November 3, 2013 PMID:24885958

Impact of Two Adolescent Pregnancy Prevention Interventions on Risky Sexual Behavior: A Three-Arm Cluster Randomized Control Trial.

PubMed

Barbee, Anita P; Cunningham, Michael R; van Zyl, Michiel A; Antle, Becky F; Langley, Cheri N

2016-09-01

To test the efficacy of Reducing the Risk (RTR) and Love Notes (LN) on reducing risky sexual behavior among youths yet to experience or cause a pregnancy. The four dependent variables were ever had sex, condom use, birth control use, and number of sexual partners at 3- and 6-month follow-up in a 3-arm cluster randomized controlled trial of 1448 impoverished youths, aged 14 to 19 years, in 23 community-based organizations in Louisville, Kentucky, from September 2011 through March 2014. At 3 and 6 months, compared with the control condition, youths in RTR reported fewer sexual partners and greater use of birth control. At 6 months, LN participants reported greater use of birth control and condoms, fewer sexual partners, and were less likely to have ever had sex compared with the control condition. We provided additional evidence for the continued efficacy of RTR and the first rigorous study of LN, which embeds sex education into a larger curriculum on healthy relationships and violence prevention.

Examining the Preliminary Efficacy of a Dating Violence Prevention Program for Hispanic Adolescents

ERIC Educational Resources Information Center

Gonzalez-Guarda, Rosa Maria; Guerra, Jessica E.; Cummings, Amanda A.; Pino, Karen; Becerra, Maria M.

2015-01-01

The purpose of this study is to evaluate the preliminary efficacy of a dating violence (DV) prevention program for Cuban American adolescents ("JOVEN"/YOUTH: "Juntos Opuestos a la Violence Entre Novios"/Together Against Dating Violence). A randomized-controlled experimental design with a delayed condition was used to evaluate…

Prevention of Heavy Drinking and Associated Negative Consequences Among Mandated and Voluntary College Students.

ERIC Educational Resources Information Center

Fromme, Kim; Corbin, William

2004-01-01

The Lifestyle Management Class (LMC) was evaluated as a universal and targeted alcohol prevention program among voluntary and mandated college students. The relative efficacy of peer- and professional-led group interventions was also tested in this randomized, controlled design. LMC participants showed decreases in driving after drinking relative…

Preventing Adolescents' Externalizing and Internalizing Symptoms: Effects of the Penn Resiliency Program

ERIC Educational Resources Information Center

Cutuli, J. J.; Gillham, Jane E.; Chaplin, Tara M.; Reivich, Karen J.; Seligman, Martin E. P.; Gallop, Robert J.; Abenavoli, Rachel M.; Freres, Derek R.

2013-01-01

This study reports secondary outcome analyses from a past study of the Penn Resiliency Program (PRP), a cognitive-behavioral depression prevention program for middle-school aged children. Middle school students (N = 697) were randomly assigned to PRP, PEP (an alternate intervention), or control conditions. Gillham et al., (2007) reported analyses…

Starting Strong: A School-Based Indicated Prevention Program during the Transition to Kindergarten

ERIC Educational Resources Information Center

Eisenhower, Abbey; Taylor, Heather; Baker, Bruce L.

2016-01-01

Starting Strong in Kindergarten (Starting Strong) is a school-based indicated prevention targeting behavior problems, student-teacher relationships, and parent-school connectedness for children with or at risk for disruptive behavior problems during the transition to kindergarten. By use of a block-randomized, controlled trial to test program…

Tretinoin and the prevention of keratinocyte carcinoma (Basal and squamous cell carcinoma of the skin): a veterans affairs randomized chemoprevention trial.

PubMed

Weinstock, Martin A; Bingham, Stephen F; Digiovanna, John J; Rizzo, Amilcar E; Marcolivio, Kim; Hall, Russell; Eilers, David; Naylor, Mark; Kirsner, Robert; Kalivas, James; Cole, Gary; Vertrees, Julia E

2012-06-01

Keratinocyte carcinoma (KC) is the most common cancer in the United States, with no proven means for prevention other than systemic retinoids, which have significant toxicity, and sunscreen. Topical tretinoin has been used for KC chemoprevention, although this use is unproven. Hence, we conducted the randomized Veterans Affairs Topical Tretinoin Chemoprevention Trial of high-dose topical tretinoin for KC prevention. We randomized 1,131 patients to topical 0.1% tretinoin or a matching vehicle control for 1.5-5.5 years. The primary outcomes were time to development of new basal cell carcinoma (BCC) and new invasive squamous cell carcinoma (SCC) on the face or ears. The effects were not significant (P=0.3 for BCC and P=0.4 for SCC). The proportions of the tretinoin and control groups who developed a BCC at 5 years were 53 and 54% and an invasive SCC at 5 years were 28 and 31%. These differences (95% confidence intervals) were: for BCC, 1.0% (-6.5, 8.6%); for SCC, 3.6% (-3.1, 10.3%). No differences were observed in any cancer-related end points or in actinic keratosis counts. The only quality of life difference was worse symptoms in the tretinoin group at 12 months after randomization. This trial in high-risk patients demonstrates that high-dose topical tretinoin is ineffective at reducing risk of KCs.

A gloomy picture: a meta-analysis of randomized controlled trials reveals disappointing effectiveness of programs aiming at preventing child maltreatment.

PubMed

Euser, Saskia; Alink, Lenneke Ra; Stoltenborgh, Marije; Bakermans-Kranenburg, Marian J; van IJzendoorn, Marinus H

2015-10-18

Consistent findings about the effectiveness of parent programs to prevent or reduce child maltreatment are lacking. In the present meta-analysis we synthesized findings from 27 independent samples from randomized controlled trials (RCTs) on the effectiveness of 20 different intervention programs aimed at (i) preventing the occurrence of child maltreatment in the general population or with at-risk but non-maltreating families, or (ii) reducing the incidence of child maltreatment in maltreating families. A significant combined effect on maltreatment (d = 0.13; N = 4883) disappeared after the trim-and-fill approach that takes into account publication bias against smaller studies without significant outcomes. However, moderator analyses showed that larger effect sizes were found for more recent studies, studies with smaller samples, programs that provide parent training instead of only support, programs that target maltreating instead of at-risk families, and programs with a moderate length (6-12 months) or a moderate number of sessions (16-30). More RCTs are needed to further unravel which factors are associated with program effectiveness. Because currently existing programs appeared to only reduce and not prevent child maltreatment, efforts in the field of preventive intervention should also focus on the development and testing of preventive programs for families at risk for child maltreatment.

Mechanism for prevention of infection in preterm neonates by topical emollients: a randomized, controlled clinical trial.

PubMed

Darmstadt, Gary L; Ahmed, Saifuddin; Ahmed, A S M Nawshad Uddin; Saha, Samir K

2014-11-01

Topical applications of emollients such as sunflower seed oil and Aquaphor have been shown to reduce the incidence of bloodstream infections and mortality of preterm infants in resource-poor settings. The causal mechanism for prevention of infection through cutaneous portals of entry is not well understood. We examined the relationship between skin condition score as a measure of skin barrier integrity and risk for bloodstream infection, and the effect of emollients on that relationship. Data for this study come from a randomized controlled trial of the impact of topical emollient therapy on nosocomial infections in 491 preterm infants <33 weeks gestational age at Dhaka Shishu Hospital, Bangladesh. Latent growth trajectory model with random-coefficient and multivariable logistic regression were utilized. Rate of deterioration of skin condition was significantly lower (P < 0.05) in both emollient arms compared with the untreated control group. Adjusted odds ratio of skin score for infection was 1.32 (95% confidence interval: 1.06-1.65). Emollients reduced the incidence of infection only when the skin had no signs of deterioration [Aquaphor incidence rate ratio: 0.43 (95% confidence interval: 0.19-0.97) and sunflower seed oil incidence rate ratio: 0.46 (95% confidence interval: 0.21-0.99)]. Skin condition deteriorated progressively after birth and compromised skin condition increased the risk of infection. Emollients preserved skin integrity and thus prevented infection in preterm neonates. To optimize benefits of emollients for the prevention of bloodstream infection, use of emollients should begin immediately after birth when the skin is still intact.

Recruitment and Baseline Characteristics of Participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)—A Randomized Controlled Lifestyle Trial †

PubMed Central

Ngandu, Tiia; Lehtisalo, Jenni; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Peltonen, Markku; Solomon, Alina; Ahtiluoto, Satu; Antikainen, Riitta; Hänninen, Tuomo; Jula, Antti; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Rauramaa, Rainer; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia

2014-01-01

Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study population. Potential study participants (age 60–77 years, the dementia risk score ≥6) were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496), 48% (n = 2654) attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1). The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD) age of the randomized participants was 69.4 (4.7) years, Mini-Mental State Examination 26.7 (2.0) points, systolic blood pressure 140.1 (16.2) mmHg, total serum cholesterol 5.2 (1.0) mmol/L for, and fasting glucose 6.1 (0.9) mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons. PMID:25211775

Effects of a Randomized Controlled Recurrent Fall Prevention Program on Risk Factors for Falls in Frail Elderly Living at Home in Rural Communities

PubMed Central

Jeon, Mi Yang; Jeong, HyeonCheol; Petrofsky, Jerrold; Lee, Haneul; Yim, JongEun

2014-01-01

Background Falling can lead to severe health issues in the elderly and importantly contributes to morbidity, death, immobility, hospitalization, and early entry to long-term care facilities. The aim of this study was to devise a recurrent fall prevention program for elderly women in rural areas. Material/Methods This study adopted an assessor-blinded, randomized, controlled trial methodology. Subjects were enrolled in a 12-week recurrent fall prevention program, which comprised strength training, balance training, and patient education. Muscle strength and endurance of the ankles and the lower extremities, static balance, dynamic balance, depression, compliance with preventive behavior related to falls, fear of falling, and fall self-efficacy at baseline and immediately after the program were assessed. Sixty-two subjects (mean age 69.2±4.3 years old) completed the program – 31 subjects in the experimental group and 31 subjects in the control group. Results When the results of the program in the 2 groups were compared, significant differences were found in ankle heel rise test, lower extremity heel rise test, dynamic balance, depression, compliance with fall preventative behavior, fear of falling, and fall self-efficacy (p<0.05), but no significant difference was found in static balance. Conclusions This study shows that the fall prevention program described effectively improves muscle strength and endurance, balance, and psychological aspects in elderly women with a fall history. PMID:25394805

Value for money: economic evaluation of two different caries prevention programmes compared with standard care in a randomized controlled trial.

PubMed

Vermaire, J H; van Loveren, C; Brouwer, W B F; Krol, M

2014-01-01

A cost-effectiveness analysis was conducted during a 3-year randomized controlled clinical trial in a general dental practice in the Netherlands in which 230 6-year-old children (± 3 months) were assigned to either regular dental care, an increased professional fluoride application (IPFA) programme or a non-operative caries treatment and prevention (NOCTP) programme. Information on resource use during the 3-year period was documented by the dental nurse at every patient visit, such as treatment time, travel time and travel distance. Caries increment scores (at D3MFS level) were used to assess effectiveness. Cost calculations were performed using bottom-up micro-costing. Incremental cost-effectiveness ratios (ICERs) were expressed as additional average costs per prevented DMFS. The ICERs compared with regular dental care from a health care system perspective and societal perspective were, respectively, EUR 269 and EUR 1,369 per prevented DMFS in the IPFA programme, and EUR 30 and EUR 100 in the NOCTP programme. The largest investments for the NOCTP group were made in the first year of the study; they decreased in the second and equalled the costs of control group in third year of the study. From both medical and economic points of view, the NOCTP strategy may be considered the preferred strategy for caries prevention.

The study designed by a committee: design of the Multisite Violence Prevention Project.

PubMed

Henry, David B; Farrell, Albert D

2004-01-01

This article describes the research design of the Multisite Violence Prevention Project (MVPP), organized and funded by the National Center for Injury Prevention and Control (NCIPC) at the Centers for Disease Control and Prevention (CDC). CDC's objectives, refined in the course of collaboration among investigators, were to evaluate the efficacy of universal and targeted interventions designed to produce change at the school level. The project's design was developed collaboratively, and is a 2 x 2 cluster-randomized true experimental design in which schools within four separate sites were assigned randomly to four conditions: (1) no-intervention control group, (2) universal intervention, (3) targeted intervention, and (4) combined universal and targeted interventions. A total of 37 schools are participating in this study with 8-12 schools per site. The impact of the interventions on two successive cohorts of sixth-grade students will be assessed based on multiple waves of data from multiple sources of information, including teachers, students, parents, and archival data. The nesting of students within teachers, families, schools and sites created a number of challenges for designing and implementing the study. The final design represents both resolution and compromise on a number of creative tensions existing in large-scale prevention trials, including tensions between cost and statistical power, and between internal and external validity. Strengths and limitations of the final design are discussed.

Effectiveness of depression and anxiety prevention in adolescents with high familial risk: study protocol for a randomized controlled trial.

PubMed

Rasing, Sanne P A; Creemers, Daan H M; Janssens, Jan M A M; Scholte, Ron H J

2013-11-22

Depression and anxiety disorders during adolescence can have detrimental consequences. Both disorders are related to negative outcome in various areas during adolescence and are also predictive of depression and anxiety disorders later in life. Especially parental psychopathology and being female are risk factors that increase the probability of developing one of these disorders during adolescence. Research has shown that prevention programs have promising results, especially for adolescents who have these risk factors. Therefore, in this study, we will focus on the effectiveness of a prevention program 'A jump forward' that has been developed for adolescent girls with a familial risk of depression and/or anxiety. We designed a randomized controlled trial to test the effectiveness of an indicated and selective prevention program aimed at depression and anxiety in adolescent girls. Adolescents aged between 11 and 15 years old with depressive and/or anxiety symptoms and with parents who show indicators of parental psychopathology will be randomly assigned to the experimental (N = 80) or control groups (N = 80). Participants in the experimental group will follow a preventive intervention, consisting of six sessions of 90 minutes each. All participants will complete baseline, intervention phase 1 (after session 2), intervention phase 2 (after session 4), post-intervention, 6 month follow-up, and 12 month follow-up assessments. Furthermore, parents will be asked to complete assessments at baseline, post-intervention, and 12-month follow-up. Primary outcome will be depressive symptoms. Secondary outcomes will be anxiety symptoms, suicidal ideation, response style, negative cognitive errors, parental emotional support and parental control, parental psychopathology, parenting stress and adolescents' depression and anxiety symptoms according to the parents. This paper described the study designed to evaluate a program for preventing depression and/or anxiety in high-risk adolescents over a 12-month follow-up period. If the program showed to be effective in reducing symptoms of depression and anxiety and preventing adolescents from developing clinical levels of these disorders, our results would be relevant to practice. Thus, the intervention could be used on a large scale. Moreover, this study aims to contribute to the evidence-based prevention of depression and anxiety of adolescents. Dutch Trial Register NTR3720.

Relapse prevention interventions for smoking cessation.

PubMed

Hajek, P; Stead, L F; West, R; Jarvis, M

2005-01-25

Several treatments can help smokers make a successful quit attempt, but many initially successful quitters relapse over time. There are interventions designed to help prevent relapse. To assess whether specific interventions for relapse prevention reduce the proportion of recent quitters who return to smoking. We searched the Cochrane Tobacco Addiction group trials register in September 2004 for studies mentioning relapse prevention or maintenance in title, abstracts or keywords. Randomized or quasi-randomized controlled trials of relapse prevention interventions with a minimum follow up of six months. We included smokers who quit on their own, or were undergoing enforced abstinence, or who were participating in treatment programmes. We included trials that compared relapse prevention interventions to a no intervention control, or that compared a cessation programme with additional relapse prevention components to a cessation programme alone. Studies were screened and data extracted by one author and checked by a second. Disagreements were resolved by discussion or referral to a third author. Forty studies met inclusion criteria, but were heterogeneous in terms of populations and interventions. We considered studies that randomized abstainers separately from studies that randomized participants prior to their quit date. We detected no benefit of brief and 'skills-based' relapse prevention interventions for women who had quit smoking due to pregnancy, or for smokers undergoing a period of enforced abstinence. We also failed to detect significant effects in trials in other smokers who had quit on their own or with a formal programme. Amongst trials recruiting smokers and evaluating the effect of additional relapse prevention components we also found no evidence of benefit in any subgroup. We did not find that providing training in skills thought to be needed for relapse avoidance reduced relapse, but most studies did not use experimental designs best suited to the task, and had limited power to detect expected small differences between interventions. At the moment there is insufficient evidence to support the use of any specific intervention for helping smokers who have successfully quit for a short time to avoid relapse. The verdict is strongest for interventions focusing on identifying and resolving tempting situations, as most studies were concerned with these. There is very little research available regarding other approaches. Until more evidence becomes available it may be more efficient to focus resources on supporting the initial cessation attempt rather than on additional relapse prevention efforts.

The process of developing and implementing a telephone-based peer support program for postpartum depression: evidence from two randomized controlled trials

PubMed Central

2014-01-01

Background A randomized controlled trial evaluated the effect of telephone-based peer support on preventing postpartum depression (PPD) among high-risk mothers. The results indicated that support provided by peer volunteers may be an effective preventative strategy. The purpose of this paper is to outline the process of developing, implementing, maintaining, and evaluating the peer support program that we used in this PPD prevention trial. Methods The peer support program had been used successfully in a pilot trial and a previous breastfeeding peer support trial. Based on our experience and lessons learned, we developed a 4-phase, 12-step approach so that the peer support model could be copied and used by different health providers in various settings. We will use the PPD prevention trial to demonstrate the suggested steps. Results The trial aim to prevent the onset of PPD was established. Peer volunteers who previously experienced and recovered from self-reported PPD were recruited and attended a four-hour training session. Volunteers were screened and those identified as appropriate to provide support to postpartum mothers were selected. Women who scored more than 9 on the Edinburgh Postnatal Depression Scale within the first two weeks after childbirth were recruited to participate in the trial and proactive, individualized, telephone-based peer support (mother-to-mother) was provided to those randomized to the intervention group. Peer volunteers maintained the intervention, supported other volunteers, and evaluated the telephone-based support program. Possible negative effects of the intervention were assessed. An in-depth assessment of maternal perspectives of the program at 12 weeks postpartum was performed. Conclusions The 4-phase, 12-step approach delineated in this paper provides clear and concise guidelines for health professionals to follow in creating and implementing community-based, peer-support interventions with the potential to prevent PPD. Trial registration Current Controlled Trials ISRCTN68337727. PMID:24742217

A randomized controlled trial testing the efficacy of a brief cannabis universal prevention program among adolescents in primary care.

PubMed

Walton, Maureen A; Resko, Stella; Barry, Kristen L; Chermack, Stephen T; Zucker, Robert A; Zimmerman, Marc A; Booth, Brenda M; Blow, Frederic C

2014-05-01

To examine the efficacy of a brief intervention delivered by a therapist (TBI) or a computer (CBI) in preventing cannabis use among adolescents in urban primary care clinics. A randomized controlled trial comparing: CBI and TBI versus control. Urban primary care clinics in the United States. Research staff recruited 714 adolescents (aged 12-18 years) who reported no life-time cannabis use on a screening survey for this study, which included a baseline survey, randomization (stratified by gender and grade) to conditions (control; CBI; TBI) and 3-, 6- and 12-month assessments. Using an intent-to-treat approach, primary outcomes were cannabis use (any, frequency); secondary outcomes included frequency of other drug use, severity of alcohol use and frequency of delinquency (among 85% completing follow-ups). Compared with controls, CBI participants had significantly lower rates of any cannabis use over 12 months (24.16%, 16.82%, respectively, P < 0.05), frequency of cannabis use at 3 and 6 months (P < 0.05) and other drug use at 3 months (P < 0.01). Compared with controls, TBI participants did not differ in cannabis use or frequency, but had significantly less other drug use at 3 months (P < 0.05), alcohol use at 6 months (P < 0.01) and delinquency at 3 months (P < 0.01). Among adolescents in urban primary care in the United States, a computer brief intervention appeared to prevent and reduce cannabis use. Both computer and therapist delivered brief interventions appeared to have small effects in reducing other risk behaviors, but these dissipated over time. © 2013 Society for the Study of Addiction.

Does Internet-based cognitive behavioral therapy (iCBT) prevent major depressive episode for workers? A 12-month follow-up of a randomized controlled trial.

PubMed

Imamura, K; Kawakami, N; Furukawa, T A; Matsuyama, Y; Shimazu, A; Umanodan, R; Kawakami, S; Kasai, K

2015-07-01

In this study we investigated whether an Internet-based computerized cognitive behavioral therapy (iCBT) program can decrease the risk of DSM-IV-TR major depressive episodes (MDE) during a 12-month follow-up of a randomized controlled trial of Japanese workers. Participants were recruited from one company and three departments of another company. Those participants who did not experience MDE in the past month were randomly allocated to intervention or control groups (n = 381 for each). A 6-week, six-lesson iCBT program was provided to the intervention group. While the control group only received the usual preventive mental health service for the first 6 months, the control group was given a chance to undertake the iCBT program after a 6-month follow-up. The primary outcome was a new onset of DSM-IV-TR MDE during the 12-month follow-up, as assessed by means of the web version of the WHO Composite International Diagnostic Interview (CIDI), version 3.0 depression section. The intervention group had a significantly lower incidence of MDE at the 12-month follow-up than the control group (Log-rank χ2 = 7.04, p < 0.01). The hazard ratio for the intervention group was 0.22 (95% confidence interval 0.06-0.75), when estimated by the Cox proportional hazard model. The present study demonstrates that an iCBT program is effective in preventing MDE in the working population. However, it should be noted that MDE was measured by self-report, while the CIDI can measure the episodes more strictly following DSM-IV criteria.

Effects of a case management program on patients with oral precancerous lesions: a randomized controlled trial.

PubMed

Lin, Hsiu-Ying; Chen, Shu-Ching; Peng, Hsi-Ling; Chen, Mu-Kuan

2016-01-01

The aim of this study is to identify the effects of a case management program on knowledge about oral cancer, preventive behavior for oral cancer, and level of uncertainty for patients with oral precancerous lesions. A randomized controlled trial was conducted with two groups, using a pre- and posttest design. The experimental group received a case management program and telephone follow-up sessions; the control group received routine care. Patients were assessed at three time points: first visit to the otolaryngology clinic for biopsy examination (T0), and then at 2 weeks (T1) and 4 weeks (T2) after the biopsy examination. Patients in both groups had significantly higher levels of knowledge about oral cancer, preventive behavior for oral cancer, and lower level of uncertainty at T2 compared to T0. At T2, participants in the experimental group had significantly greater knowledge about oral cancer, more preventive behavior for oral cancer, and less uncertainty compared to those in the control group. The case management program with telephone counseling effectively improved knowledge about oral cancer, preventive behavior for oral cancer, and uncertainty levels in patients with oral precancerous lesions in the four weeks after receiving a biopsy examination. The case management program can be applied with positive results to patients receiving different types of cancer screening, including colorectal, breast, and cervical screening.

Preventing smoking relapse via Web-based computer-tailored feedback: a randomized controlled trial.

PubMed

Elfeddali, Iman; Bolman, Catherine; Candel, Math J J M; Wiers, Reinout W; de Vries, Hein

2012-08-20

Web-based computer-tailored approaches have the potential to be successful in supporting smoking cessation. However, the potential effects of such approaches for relapse prevention and the value of incorporating action planning strategies to effectively prevent smoking relapse have not been fully explored. The Stay Quit for You (SQ4U) study compared two Web-based computer-tailored smoking relapse prevention programs with different types of planning strategies versus a control group. To assess the efficacy of two Web-based computer-tailored programs in preventing smoking relapse compared with a control group. The action planning (AP) program provided tailored feedback at baseline and invited respondents to do 6 preparatory and coping planning assignments (the first 3 assignments prior to quit date and the final 3 assignments after quit date). The action planning plus (AP+) program was an extended version of the AP program that also provided tailored feedback at 11 time points after the quit attempt. Respondents in the control group only filled out questionnaires. The study also assessed possible dose-response relationships between abstinence and adherence to the programs. The study was a randomized controlled trial with three conditions: the control group, the AP program, and the AP+ program. Respondents were daily smokers (N = 2031), aged 18 to 65 years, who were motivated and willing to quit smoking within 1 month. The primary outcome was self-reported continued abstinence 12 months after baseline. Logistic regression analyses were conducted using three samples: (1) all respondents as randomly assigned, (2) a modified sample that excluded respondents who did not make a quit attempt in conformance with the program protocol, and (3) a minimum dose sample that also excluded respondents who did not adhere to at least one of the intervention elements. Observed case analyses and conservative analyses were conducted. In the observed case analysis of the randomized sample, abstinence rates were 22% (45/202) in the control group versus 33% (63/190) in the AP program and 31% (53/174) in the AP+ program. The AP program (odds ratio 1.95, P = .005) and the AP+ program (odds ratio 1.61, P = .049) were significantly more effective than the control condition. Abstinence rates and effects differed per sample. Finally, the results suggest a dose-response relationship between abstinence and the number of program elements completed by the respondents. Despite the differences in results caused by the variation in our analysis approaches, we can conclude that Web-based computer-tailored programs combined with planning strategy assignments and feedback after the quit attempt can be effective in preventing relapse 12 months after baseline. However, adherence to the intervention seems critical for effectiveness. Finally, our results also suggest that more research is needed to assess the optimum intervention dose. Dutch Trial Register: NTR1892; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1892 (Archived by WebCite at http://www.webcitation.org/693S6uuPM).

An Evaluation of Two Dating Violence Prevention Programs on a College Campus.

PubMed

Peterson, Kerry; Sharps, Phyllis; Banyard, Victoria; Powers, Ráchael A; Kaukinen, Catherine; Gross, Deborah; Decker, Michele R; Baatz, Carrie; Campbell, Jacquelyn

2016-03-13

Dating violence is a serious and prevalent public health problem that is associated with numerous negative physical and psychological health outcomes, and yet there has been limited evaluation of prevention programs on college campuses. A recent innovation in campus prevention focuses on mobilizing bystanders to take action. To date, bystander programs have mainly been compared with no treatment control groups raising questions about what value is added to dating violence prevention by focusing on bystanders. This study compared a single 90-min bystander education program for dating violence prevention with a traditional awareness education program, as well as with a no education control group. Using a quasi-experimental pre-test/post-test design with follow-up at 2 months, a sample of predominately freshmen college students was randomized to either the bystander (n = 369) or traditional awareness (n = 376) dating violence education program. A non-randomized control group of freshmen students who did not receive any education were also surveyed (n = 224). Students completed measures of attitudes, including rape myth acceptance, bystander efficacy, and intent to help as well as behavioral measures related to bystander action and victimization. Results showed that the bystander education program was more effective at changing attitudes, beliefs, efficacy, intentions, and self-reported behaviors compared with the traditional awareness education program. Both programs were significantly more effective than no education. The findings of this study have important implications for future dating violence prevention educational programming, emphasizing the value of bystander education programs for primary dating violence prevention among college students. © The Author(s) 2016.

The Efficacy of a Universal School-Based Prevention Program for Eating Disorders among German Adolescents: Results from a Randomized-Controlled Trial.

PubMed

Warschburger, Petra; Zitzmann, Jana

2018-06-01

Disordered eating is highly prevalent during adolescence and has a detrimental effect on further development. Effective prevention programs are needed to prevent unhealthy developmental trajectories. This study evaluated the efficacy of the POPS-program (POtsdam Prevention at Schools), a universal school-based eating disorder prevention program for adolescents. In a cluster-randomized design, we compared the intervention group receiving the prevention program to a waiting control group. Outcomes included indicators of disordered eating and relevant risk factors for eating disorders (body dissatisfaction, internalization of the thin ideal, perceived media pressure, perfectionism, emotional element of exercise, social comparison, and perceived teasing). Questionnaires were administered at the start of the intervention, 3 and 12 months post intervention. At baseline, 1112 adolescents aged 10 to 16 years participated (49% girls; 51% intervention group). Intention-to-treat analyses with the complete data set and per-protocol analyses as a completer analysis were performed. The intervention group showed a more favorable course compared to the control group regarding all observed risk factors for eating disorders except for perceived teasing. Effect sizes were small but comparable to other primary prevention programs. At 1-year follow-up, a small but significant effect on disordered eating was observed. Results of the per-protocol analyses were mostly confirmed by the intention-to-treat analyses. Results were promising for both genders although girls benefited more regarding disordered eating and internalization of the thin ideal. Further studies are warranted examining successful program elements and whether gender-specific programs are needed.

Randomized Trial of Healthy Families Arizona: Quantitative and Qualitative Outcomes

ERIC Educational Resources Information Center

LeCroy, Craig Winston; Davis, Melinda F.

2017-01-01

Home visitation has the potential to improve parent, child, and maternal outcomes and has become a widely implemented prevention program across the United States. The purpose of this research was to use a randomized controlled trial to assess the short-term effectiveness of the Arizona Healthy Families program across a range of outcomes. Two…

Preventing Youth Violence and Dropout: A Randomized Field Experiment. NBER Working Paper No. 19014

ERIC Educational Resources Information Center

Heller, Sara; Pollack, Harold A.; Ander, Roseanna; Ludwig, Jens

2013-01-01

Improving the long-term life outcomes of disadvantaged youth remains a top policy priority in the United States, although identifying successful interventions for adolescents--particularly males--has proven challenging. This paper reports results from a large randomized controlled trial of an intervention for disadvantaged male youth grades 7-10…

An Evaluation of Second Step: What Are the Benefits for Youth With and Without Disabilities?

ERIC Educational Resources Information Center

Sullivan, Terri N.; Sutherland, Kevin S.; Farrell, Albert D.; Taylor, Katherine A.

2015-01-01

The impact of a school-based violence prevention program, Second Step, on peer victimization and aggression, and emotion regulation was evaluated among 457 sixth graders. A cluster-randomized trial was conducted with classrooms randomly assigned to intervention (n = 14) or control (n = 14) conditions. A repeated measures analysis of covariance on…

Long-Term Follow-up of Participants with Heart Failure in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

PubMed Central

Piller, Linda B.; Baraniuk, Sarah; Simpson, Lara M.; Cushman, William C.; Massie, Barry M.; Einhorn, Paula T.; Oparil, Suzanne; Ford, Charles E.; Graumlich, James F.; Dart, Richard A.; Parish, David C.; Retta, Tamrat M.; Cuyjet, Aloysius B.; Jafri, Syed Z.; Furberg, Curt D.; Saklayen, Mohammad G.; Thadani, Udho; Probstfield, Jeffrey L.; Davis, Barry R.

2011-01-01

Background In the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), a randomized, double-blind, practice-based, active-control, comparative effectiveness trial in high-risk hypertensive participants, risk of new-onset heart failure (HF) was higher in the amlodipine (2.5-10 mg/day) and lisinopril (10-40 mg/day) arms compared with the chlorthalidone (12.5-25 mg/day) arm . Similar to other studies, mortality rates following new-onset HF were very high (≥50% at 5 years), and were similar across randomized treatment arms. After the randomized phase of the trial ended in 2002, outcomes were determined from administrative databases. Methods and Results Using national databases, post-trial follow-up mortality through 2006 was obtained on participants who developed new-onset HF during the randomized (in-trial) phase of ALLHAT. Mean follow-up for the entire period was 8.9 years. Of 1761 participants with incident HF in-trial, 1348 died. Post-HF all-cause mortality was similar across treatment groups with adjusted hazard ratios (95% confidence intervals) of 0.95 (0.81-1.12) and 1.05 (0.89-1.25), respectively, for amlodipine and lisinopril compared with chlorthalidone, and 10-year adjusted rates of 86%, 87%, and 83%, respectively. All-cause mortality rates were also similar among those with reduced ejection fractions (84%) and preserved ejection fractions (81%) with no significant differences by randomized treatment arm. Conclusions Once HF develops, risk of death is high and consistent across randomized treatment groups. Measures to prevent the development of HF, especially blood pressure control, must be a priority if mortality associated with development of HF is to be addressed. PMID:21969009

Response-Order Effects in Survey Methods: A Randomized Controlled Crossover Study in the Context of Sport Injury Prevention.

PubMed

Chan, Derwin K; Ivarsson, Andreas; Stenling, Andreas; Yang, Sophie X; Chatzisarantis, Nikos L; Hagger, Martin S

2015-12-01

Consistency tendency is characterized by the propensity for participants responding to subsequent items in a survey consistent with their responses to previous items. This method effect might contaminate the results of sport psychology surveys using cross-sectional design. We present a randomized controlled crossover study examining the effect of consistency tendency on the motivational pathway (i.e., autonomy support → autonomous motivation → intention) of self-determination theory in the context of sport injury prevention. Athletes from Sweden (N = 341) responded to the survey printed in either low interitem distance (IID; consistency tendency likely) or high IID (consistency tendency suppressed) on two separate occasions, with a one-week interim period. Participants were randomly allocated into two groups, and they received the survey of different IID at each occasion. Bayesian structural equation modeling showed that low IID condition had stronger parameter estimates than high IID condition, but the differences were not statistically significant.

Effect of peer education on stroke prevention: the prevent recurrence of all inner-city strokes through education randomized controlled trial.

PubMed

Kronish, Ian M; Goldfinger, Judith Z; Negron, Rennie; Fei, Kezhen; Tuhrim, Stanley; Arniella, Guedy; Horowitz, Carol R

2014-11-01

Efforts to reduce disparities in recurrent stroke among Black and Latino stroke survivors have met with limited success. We aimed to determine the effect of peer education on secondary stroke prevention among predominantly minority stroke survivors. Between 2009 and 2012, we enrolled 600 stroke or transient ischemic attack survivors from diverse, low-income communities in New York City into a 2-arm randomized clinical trial that compared a 6 week (1 session/week), peer-led, community-based, stroke prevention self-management group workshop (N=301) to a wait-list control group (N=299). The primary outcome was the proportion with a composite of controlled blood pressure (<140/90 mm Hg), low-density lipoprotein cholesterol <100 mg/dL, and use of antithrombotic medications at 6 months. Secondary outcomes included control of the individual stroke risk factors. All analyses were by intent-to-treat. There was no difference in the proportion of intervention and control group participants achieving the composite outcome (34% versus 34%; P=0.98). The proportion with controlled blood pressure at 6 months was greater in the intervention group than in the control group (76% versus 67%; P=0.02). This corresponded to a greater change in systolic blood pressure in the intervention versus control group (-3.63 SD, 19.81 mm Hg versus +0.34 SD, 23.76 mm Hg; P=0.04). There were no group differences in the control of cholesterol or use of antithrombotics. A low-cost peer education self-management workshop modestly improved blood pressure, but not low-density lipoprotein cholesterol or antithrombotic use, among stroke and transient ischemic attack survivors from vulnerable, predominantly minority urban communities. http://www.clinicaltrials.gov/show/NCT0102727. Unique identifier: NCT01027273. © 2014 American Heart Association, Inc.

Art therapy and music reminiscence activity in the prevention of cognitive decline: study protocol for a randomized controlled trial.

PubMed

Mahendran, Rathi; Rawtaer, Iris; Fam, Johnson; Wong, Jonathan; Kumar, Alan Prem; Gandhi, Mihir; Jing, Kenny Xu; Feng, Lei; Kua, Ee Heok

2017-07-12

Attention has shifted to the use of non-pharmacological interventions to prevent cognitive decline as a preventive strategy, as well as for those at risk and those with mild cognitive impairment. Early introduction of psycho-social interventions can address cognitive decline and significantly impact quality of life and the wellbeing of elderly individuals. This pilot study explores the feasibility of using art therapy and music reminiscence activity to improve the cognition of community living elderly with mild cognitive impairment. This open-label, interventional study involves a parallel randomized controlled trial design with three arms (two intervention arms and a control group) over a nine-month period. Participants will be community-living elderly individuals aged 60-85 years, both genders, who meet predefined inclusion and exclusion criteria. In the initial three months, interventions will be provided weekly and for the remaining six months fortnightly. A sample size of 90 participants is targeted based on expected neuropsychological test performance, a primary outcome measure, and drop-out rates. The randomization procedure will be carried out via a web-based randomization system. Interventions will be provided by trained staff with a control group not receiving any intervention but continuing life as usual. Assessments will be done at baseline, three months, and nine months, and include neuroimaging to measure cerebral changes and neuropsychological tests to measure for changes in cognition. Secondary outcome measures will include mood changes in anxiety and depression and telomere lengths. Statistical analysis will be undertaken by statisticians; all efficacy analysis will be carried out on an intention-to-treat basis. Primary and secondary outcomes will be modeled using the linear mixed model for repeated measurements and further analysis may be undertaken to adjust for potential confounders. This will be the first study to compare the effectiveness of art therapy and music reminiscence activity in a randomized controlled trial. We expect that the trial will provide useful evidence for developing psychosocial interventions for the elderly with mild cognitive impairment. The study was registered on 7 July 2016 at Clinical Trials.gov, a service of the US National Institute of Health ( NCT02854085 ), retrospectively.

Predictors of prevention failure in college students participating in two indicated depression prevention programs.

PubMed

Blanco, Vanessa; Rohde, Paul; Vázquez, Fernando L; Otero, Patricia

2014-04-04

The purpose of this study was to identify subgroups of university students with the highest likelihood of remaining at elevated levels of depressive symptoms six months following the receipt of a depressive prevention intervention on the basis of known risk factors and participation in one of two depression prevention programs. Data from a randomized controlled trial evaluating depression prevention among 133 college students with elevated depressive symptoms were analyzed. Participants were randomized to a cognitive-behavioral or relaxation training group preventive intervention. Classification tree analysis showed that older age was the strongest risk factor for persistently elevated depression. Additional risk factors were: (1) for younger students, fewer daily pleasant activities; (2) for those with higher level of pleasant activities, higher level of stressful events; and (3) for those with higher level of stressful events, lower assertiveness. Results offer directions for prevention foci, identify specific subgroups of college students to target for depression prevention efforts, and suggest that research aim to help older, non-traditional students or graduating students manage the transition from college to the work force.

Predictors of Prevention Failure in College Students Participating in Two Indicated Depression Prevention Programs

PubMed Central

Blanco, Vanessa; Rohde, Paul; Vázquez, Fernando L.; Otero, Patricia

2014-01-01

The purpose of this study was to identify subgroups of university students with the highest likelihood of remaining at elevated levels of depressive symptoms six months following the receipt of a depressive prevention intervention on the basis of known risk factors and participation in one of two depression prevention programs. Data from a randomized controlled trial evaluating depression prevention among 133 college students with elevated depressive symptoms were analyzed. Participants were randomized to a cognitive-behavioral or relaxation training group preventive intervention. Classification tree analysis showed that older age was the strongest risk factor for persistently elevated depression. Additional risk factors were: (1) for younger students, fewer daily pleasant activities; (2) for those with higher level of pleasant activities, higher level of stressful events; and (3) for those with higher level of stressful events, lower assertiveness. Results offer directions for prevention foci, identify specific subgroups of college students to target for depression prevention efforts, and suggest that research aim to help older, non-traditional students or graduating students manage the transition from college to the work force. PMID:24714056

Prevention of EP Migratory Contamination in a Cluster Randomized Trial to Increase tPA Use in Stroke (The INSTINCT Trial)

PubMed Central

Weston, Victoria C.; Meurer, William J.; Frederiksen, Shirley M.; Fox, Allison K.; Scott, Phillip A.

2016-01-01

Objectives Cluster randomized trials (CRTs) are increasingly utilized to evaluate quality improvement interventions aimed at healthcare providers. In trials testing emergency department interventions, migration of emergency physicians (EPs) between hospitals is an important concern, as contamination may affect both internal and external validity. We hypothesized that geographically isolating emergency departments would prevent migratory contamination in a CRT designed to increase ED delivery of tPA in stroke (The INSTINCT Trial). Methods INSTINCT was a prospective, cluster randomized, controlled trial. 24 Michigan community hospitals were randomly selected in matched pairs for study. Contamination was defined at the cluster level, with substantial contamination defined a priori as >10% of EPs affected. Non-adherence, total crossover (contamination + non-adherence), migration distance and characteristics were determined. Results 307 emergency physicians were identified at all sites. Overall, 7 (2.3%) changed study sites. 1 moved between control sites, leaving 6 (2.0%) total crossovers. Of these, 2 (0.7%) moved from intervention to control (contamination) and 4 (1.3%) moved from control to intervention (non-adherence). Contamination was observed in 2 of 12 control sites, with 17% and 9% contamination of the total site EP workforce at follow-up, respectively. Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites. Conclusion The mobile nature of emergency physicians should be considered in the design of quality improvement CRTs. Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design. PMID:25440230

"Healthy Habits, Healthy Girls-Brazil": an obesity prevention program with added focus on eating disorders.

PubMed

Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva; Thompson, Debbe; Nicklas, Theresa; Baranowski, Tom

2018-05-05

To evaluate the immediate post-intervention and 6-month post-intervention effects of a Brazilian school-based randomized controlled trial for girls targeting shared risk factors for obesity and disordered eating. Total of 253 girls, mean of 15.6 (0.05) years from 1st to 3rd grades of high school participated in this 6-month school-based cluster randomized controlled trial. "Healthy Habits, Healthy Girls-Brazil (H3G-Brazil)", originally developed in Australia, emphasized 10 key nutrition and physical activity (PA) messages delivered over 6 months. Disordered eating prevention procedures, i.e., prevention of weight-teasing, body satisfaction, and unhealthy weight control behavior, were added to the intervention. Body dissatisfaction, unhealthy weight control behaviors and social cognitive-related diet, and physical activity variables were assessed at baseline, immediate post-intervention, and 6-month post-intervention. Intervention effects were determined by one-way analysis of covariance or logistic regression, after checking for the clustering effects of school. The control group did not receive intervention prior to follow-up assessment. A conservative significance level was set at p < 0.01. Beneficial effects were detected for PA social support (F = 6.005, p = 0.01), and healthy eating strategies (F = 6.08, p = 0.01) immediate post-intervention; and healthy eating social support (F = 14.731, p = 0.00) and healthy eating strategies (F = 5.812, p = 0.01) at 6-month post-intervention. Intervention group was more likely to report unhealthy weight control behaviors (OR = 1.92, 95% CI 1.15-3.21, p = 0.01) at 6-month post-intervention. No other significant immediate or 6-month post effects were detected. H3G-Brazil demonstrated positive 6-month effects on some social cognitive variables but an adverse effect on unhealthy weight control behaviors. Thus, this study was not able to achieve synergy by combining obesity and disordered eating prevention procedures in an intervention among low-income girls in Brazil. Level I: cluster randomized controlled trial.

Effects of a randomized controlled trial to assess the six-months effects of a school based smoking prevention program in Saudi Arabia.

PubMed

Mohammed, Mutaz; Eggers, Sander Matthijs; Alotaiby, Fahad F; de Vries, Nanne; de Vries, Hein

2016-09-01

To examine the efficacy of a smoking prevention program which aimed to address smoking related cognitions and smoking behavior among Saudi adolescents age 13 to 15. A randomized controlled trial was used. Respondents in the experimental group (N=698) received five in-school sessions, while those in the control group (N=683) received no smoking prevention information (usual curriculum). Post-intervention data was collected six months after baseline. Logistic regression analysis was applied to assess effects on smoking initiation, and linear regression analysis was applied to assess changes in beliefs and analysis of covariance (ANCOVA) was used to assess intervention effects. All analyses were adjusted for the nested structure of students within schools. At post-intervention respondents from the experimental group reported in comparison with those from the control group a significantly more negative attitude towards smoking, stronger social norms against smoking, higher self-efficacy towards non-smoking, more action planning to remain a non-smoker, and lower intentions to smoke in the future. Smoking initiation was 3.2% in the experimental group and 8.8% in the control group (p<0.01). The prevention program reinforced non-smoking cognitions and non-smoking behavior. Therefore it is recommended to implement the program at a national level in Saudi-Arabia. Future studies are recommended to assess long term program effects and the conditions favoring national implementation of the program. Copyright © 2016 Elsevier Inc. All rights reserved.

Development and validation of measures to assess prevention and control of AMR in hospitals.

PubMed

Flanagan, Mindy; Ramanujam, Rangaraj; Sutherland, Jason; Vaughn, Thomas; Diekema, Daniel; Doebbeling, Bradley N

2007-06-01

The rapid spread of antimicrobial resistance (AMR) in the US hospitals poses serious quality and safety problems. Expert panels, identifying strategies for optimizing antibiotic use and preventing AMR spread, have recommended hospitals undertake efforts to implement specific evidence-based practices. To develop and validate a measurement scale for assessing hospitals' efforts to implement recommended AMR prevention and control measures. Surveys were mailed to infection control professionals in a national sample of 670 US hospitals stratified by geographic region, bedsize, teaching status, and VA affiliation. : Four hundred forty-eight infection control professionals participated (67% response rate). Survey items measured implementation of guideline recommendations, practices for AMR monitoring and feedback, AMR-related outcomes (methicillin-resistant Staphylococcus aureus prevalence and outbreaks [MRSA]), and organizational features. "Derivation" and "validation" samples were randomly selected. Exploratory factor analysis was performed to identify factors underlying AMR prevention and control efforts. Multiple methods were used for validation. We identified 4 empirically distinct factors in AMR prevention and control: (1) practices for antimicrobial prescription/use, (2) information/resources for AMR control, (3) practices for isolating infected patients, and (4) organizational support for infection control policies. The Prevention and Control of Antimicrobial Resistance scale was reliable and had content and construct validity. MRSA prevalence was significantly lower in hospitals with higher resource/information availability and broader organizational support. The Prevention and Control of Antimicrobial Resistance scale offers a simple yet discriminating assessment of AMR prevention and control efforts. Use should complement assessment methods based exclusively on AMR outcomes.

A meta-analysis of anxiety symptom prevention with cognitive-behavioral interventions.

PubMed

Zalta, Alyson K

2011-06-01

This meta-analysis assessed efficacy of cognitive-behavioral interventions in preventing anxiety symptoms. A systematic review identified 15 independent pretest-posttest randomized or quasi-randomized efficacy trials for analysis. At posttest, intervention groups demonstrated significantly greater symptom reduction compared to control groups resulting in weighted mean effect sizes (Hedges' g) of 0.25 for general anxiety, 0.24 for disorder-specific symptoms, and 0.22 for depression after the removal of outliers. These effects appeared to diminish over 6- and 12-month follow-up. Exploratory moderator analyses indicated that individually administered media interventions were more effective than human-administered group interventions at preventing general anxiety and depression symptoms. Implications of current findings are discussed with attention to existing gaps in the literature.

Case-Control Study of Injury Intervention for Preschool Children in Henggang, Shenzhen.

PubMed

Wang, Hong; Liu, Yi-Xin; Deng, Wen-Jiao; Yang, Wei-Jian; Wang, Fang

2015-10-01

To explore effective interventions for child accidental injury prevention and to reduce the incidence of injury. Cluster random sampling method was adopted, and children in 19 kindergartens in Henggang, Shenzhen and their parents were selected as the objects of study. Nineteen kindergartens were randomly divided into intervention group and control group to carry out the injury intervention case-control study. Through a series of interventions, there were certain effects. After the end of the project, the injury incidence rates of the intervention group and the control group were 4.91%, 10.64%, and the difference was significant; the average costs of treatment for injuries of the intervention group and the control group were 168.4 Yuan and 206.8 Yuan, and the difference was statistically significant; compared with before the implementation of the project, the rate of various types of injuries after the end of the project declined, in which, the rate of mechanical injury, pet bites, accidental falls, burns, and traffic accidents decreased significantly. The differences were significant. Injury interventions can effectively prevent and control the occurrence of injury.

Mind-Body Training for At-Risk Populations: Preventive Medicine at its Best.

PubMed

Elder, Charles

2017-01-01

This article is a companion to "Transcendental meditation and reduced trauma symptoms in female inmates: A randomized controlled pilot study," available at: www.thepermanentejournal.org/issues/2017/6290-meditation.html, and on page 39 and to "Reduced trauma symptoms and perceived stress in male prison inmates through the Transcendental Meditation program: A randomized controlled trial," available at: www.thepermanentejournal.org/issues/2016/fall/6227-incarcerated-healthcare.html and in the Fall 2016 issue of The Permanente Journal.

Effectiveness of heat moisture exchangers (hmes) in preventing perioperative hypothermia among adult patients undergoing abdominal surgery under general endotracheal anaesthesia.

PubMed

Anaegbu, Nc; Olatosi, Oj; Tobi, Ku

2013-01-01

Heat Moisture Exchangers (HMEs) conserve heat and moisture during expiration and make this available to inspired gases during subsequent inspiration. We sought to evaluate the effectiveness of HMEs in the prevention of perioperative hypothermia in patients scheduled for abdominal surgery under general anaesthesia relaxant technique with endotrachael intubation (GART.) Lagos University Teaching Hospital, in Modular theatre, Anaesthesia unit. The study was a randomized, controlled, longitudinal, interventional study Methods: 100 ASA I, II and III patients aged 18 to 65 years scheduled for abdominal surgery under GART were randomly assigned to 2 groups, groups H and C. Group H had HMEs, while group C served as controls. Core temperature measured using tympanic probe was every 10 minutes till end of anaesthesia Data from total 99 patients, 49 in group H and 50 in group C were eventually analysed. Although patients in both groups developed hypothermia in the course of anaesthesia, core temperature was significantly lower p< 0.05 after one hour in the control group than the intervention group. The use of HMEs during general anaesthesia with endotrachael intubation did not prevent hypothermia but resulted in higher core temperature and should be part of a multimodal approach in the prevention of perioperative hypothermia. Heat Moisture Exchangers, General endotracheal anaesthesia, Hypothermia, abdominal surgery.

Omega-3 supplementation to prevent recurrent preterm birth: a systematic review and metaanalysis of randomized controlled trials.

PubMed

Saccone, Gabriele; Berghella, Vincenzo

2015-08-01

The purpose of this study was to evaluate the efficacy of omega-3 supplementation for the prevention of recurrent preterm birth (PTB) in asymptomatic singleton gestations with previous PTB. We searched fish oil, long chain polyunsaturated fatty acids, pregnancy, and omega-3 in MEDLINE, OVID, Scopus, ClinicalTrials.gov, the PROSPERO International Prospective Register of Systematic Reviews, EMBASE, and the Cochrane Central Register of Controlled Trials from inception of each database to December 2014 with no limit for language. In addition the reference lists of all identified articles were examined to identify studies that were not captured by electronic searches. We performed a metaanalysis of randomized controlled trials of asymptomatic singleton gestations with previous PTB who were assigned randomly to prophylactic omega-3 supplementation vs control (either placebo or no treatment). The primary outcome was predefined as PTB at <37 weeks of gestation. The pooled results were reported as relative risk (RR) with 95% confidence interval (95% CI). The protocol of this review was registered with PROSPERO (registration number: CRD42015016371). Two randomized controlled trials that included 1080 women were analyzed. The mean gestational age at randomization was approximately 134 days in both groups (mean difference, 0.01 days; 95% CI, -0.13 to 0.14). Women who received omega-3 had similar rates of PTB at <37 weeks of gestation (34.5% vs 39.8%; RR, 0.81; 95% CI, 0.59-1.12) and PTB at <34 weeks of gestation (12.0% vs 15.4%; RR, 0.62; 95% CI, 0.26-1.46) compared with control subjects. The omega-3 groups had a statistically significantly longer latency (mean difference, 2.10 days; 95% CI, 1.98-2.22) and higher birthweight (mean difference, 102.52 g; 95% CI, 20.09-184.95) compared with control subjects; the other secondary outcomes (which included gestational age at delivery, spontaneous PTB at <37 and 34 weeks of gestation, admission to the intensive care unit, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, and perinatal death) were similar. Omega-3 supplementation during pregnancy does not prevent recurrent PTB in asymptomatic singleton gestations with previous PTB. The benefits in longer latency and higher birth weight may deserve further study. Copyright © 2015 Elsevier Inc. All rights reserved.

Design of the Prevention of Adult Caries Study (PACS): A randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries

PubMed Central

2010-01-01

Background Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited. Methods/Design The Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered. Discussion This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States. Trial Registration Number NCT00357877 PMID:20923557

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: an update to the study protocol for a randomized controlled trial.

PubMed

Shih, Sophy T F; Davis-Lameloise, Nathalie; Janus, Edward D; Wildey, Carol; Versace, Vincent L; Hagger, Virginia; Asproloupos, Dino; O'Reilly, Sharleen L; Phillips, Paddy A; Ackland, Michael; Skinner, Timothy; Oats, Jeremy; Carter, Rob; Best, James D; Dunbar, James A

2014-06-30

The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial (RCT) that aims to assess the effectiveness of a structured diabetes prevention intervention for women who had gestational diabetes. The original protocol was published in Trials (http://www.trialsjournal.com/content/14/1/339). This update reports on an additional exclusion criterion and change in first eligibility screening to provide greater clarity. The new exclusion criterion "surgical or medical intervention to treat obesity" has been added to the original protocol. The risks of developing diabetes will be affected by any medical or surgical intervention as its impact on obesity will alter the outcomes being assessed by MAGDA-DPP. The screening procedures have also been updated to reflect the current recruitment operation. The first eligibility screening is now taking place either during or after pregnancy, depending on recruitment strategy. Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.

Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS).

PubMed

Clark, Florence; Pyatak, Elizabeth A; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B; Garber, Susan L; Diaz, Jesus; Florindez, Lucia I; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

2014-04-01

Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination. We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings. Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.

Internet-Delivered Parenting Program for Prevention and Early Intervention of Anxiety Problems in Young Children: Randomized Controlled Trial.

PubMed

Morgan, Amy J; Rapee, Ronald M; Salim, Agus; Goharpey, Nahal; Tamir, Elli; McLellan, Lauren F; Bayer, Jordana K

2017-05-01

The Cool Little Kids parenting group program is an effective intervention for preventing anxiety disorders in young children who are at risk because of inhibited temperament. The program has six group sessions delivered by trained psychologists to parents of 3- to 6-year-old children. An online adaptation (Cool Little Kids Online) has been developed to overcome barriers to its wide dissemination in the community. This study tested the efficacy of Cool Little Kids Online in a randomized controlled trial. A total of 433 parents of a child aged 3 to 6 years with an inhibited temperament were randomized to the online parenting program or to a 24-week waitlist. The online program has 8 interactive modules providing strategies that parents can implement with their child to manage their child's avoidant coping, reduce parental overprotection, and encourage child independence. Parents were provided telephone consultation support with a psychologist when requested. Parents completed self-report questionnaires at baseline and at 12 and 24 weeks after baseline. The intervention group showed significantly greater improvement over time in child anxiety symptoms compared to the control group (d = 0.38). The intervention group also showed greater reductions in anxiety life interference (ds = 0.33-0.35) and lower rates of anxiety disorders than the control group (40% versus 54%), but there were minimal effects on broader internalizing symptoms or overprotective parenting. Results provide empirical support for the efficacy of online delivery of the Cool Little Kids program. Online dissemination may improve access to an evidence-based prevention program for child anxiety disorders. Clinical trial registration information-Randomised Controlled Trial of Cool Little Kids Online: A Parenting Program to Prevent Anxiety Problems in Young Children; http://www.anzctr.org.au/; 12615000217505. Copyright © 2017 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Relapse prevention interventions for smoking cessation.

PubMed

Hajek, Peter; Stead, Lindsay F; West, Robert; Jarvis, Martin; Hartmann-Boyce, Jamie; Lancaster, Tim

2013-08-20

A number of treatments can help smokers make a successful quit attempt, but many initially successful quitters relapse over time. Several interventions have been proposed to help prevent relapse. To assess whether specific interventions for relapse prevention reduce the proportion of recent quitters who return to smoking. We searched the Cochrane Tobacco Addiction Group trials register in May 2013 for studies mentioning relapse prevention or maintenance in title, abstracts or keywords. Randomized or quasi-randomized controlled trials of relapse prevention interventions with a minimum follow-up of six months. We included smokers who quit on their own, were undergoing enforced abstinence, or were participating in treatment programmes. We included trials that compared relapse prevention interventions with a no intervention control, or that compared a cessation programme with additional relapse prevention components with a cessation programme alone. Studies were screened and data extracted by one review author, and checked by a second. Disagreements were resolved by discussion or by referral to a third review author. Sixty-three studies met inclusion criteria but were heterogeneous in terms of populations and interventions. We considered 41 studies that randomly assigned abstainers separately from studies that randomly assigned participants before their quit date.Upon looking at studies of behavioural interventions that randomly assigned abstainers, we detected no benefit of brief and 'skills-based' relapse prevention methods for women who had quit smoking because of pregnancy, or for smokers undergoing a period of enforced abstinence during hospitalisation or military training. We also failed to detect significant effects of behavioural interventions in trials in unselected groups of smokers who had quit on their own or through a formal programme. Amongst trials randomly assigning smokers before their quit date and evaluating the effects of additional relapse prevention components, we found no evidence of benefit of behavioural interventions or combined behavioural and pharmacotherapeutic interventions in any subgroup. Overall, providing training in skills thought to be needed for relapse avoidance did not reduce relapse, but most studies did not use experimental designs best suited to the task and had limited power to detect expected small differences between interventions. For pharmacological interventions, extended treatment with varenicline significantly reduced relapse in one trial (risk ratio (RR) 1.18, 95% confidence interval (CI) 1.03 to 1.36). Pooling of six studies of extended treatment with bupropion failed to detect a significant effect (RR 1.15, 95% CI 0.98 to 1.35). Two small trials of oral nicotine replacement treatment (NRT) failed to detect an effect, but treatment compliance was low, and in two other trials of oral NRT in which short-term abstainers were randomly assigned, a significant effect of intervention was noted. At the moment, there is insufficient evidence to support the use of any specific behavioural intervention to help smokers who have successfully quit for a short time to avoid relapse. The verdict is strongest for interventions focused on identifying and resolving tempting situations, as most studies were concerned with these. Little research is available regarding other behavioural approaches.Extended treatment with varenicline may prevent relapse. Extended treatment with bupropion is unlikely to have a clinically important effect. Studies of extended treatment with nicotine replacement are needed.

Improving the outcome of infants born at <30 weeks' gestation - a randomized controlled trial of preventative care at home

PubMed Central

2009-01-01

Background Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems. Methods/Design We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm (<30 weeks of gestational age) and their families, compared with standard medical follow-up. The aim of the program, delivered over nine sessions by a team comprising a physiotherapist and psychologist, is to improve infant development (cognitive, motor and language), behavioral regulation, caregiver-child interactions and caregiver mental health at 24 months' corrected age. The infants will be stratified by severity of brain white matter injury (assessed by magnetic resonance imaging) at term equivalent age, and then randomized. At 12 months' corrected age interim outcome measures will include motor development assessed using the Alberta Infant Motor Scale and the Neurological Sensory Motor Developmental Assessment. Caregivers will also complete a questionnaire at this time to obtain information on behavior, parenting, caregiver mental health, and social support. The primary outcomes are at 24 months' corrected age and include cognitive, motor and language development assessed with the Bayley Scales of Infant and Toddler Development (Bayley-III). Secondary outcomes at 24 months include caregiver-child interaction measured using an observational task, and infant behavior, parenting, caregiver mental health and social support measured via standardized parental questionnaires. Discussion This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program in the first year after discharge home designed to improve cognitive, motor and behavioral outcomes of very preterm children and caregiver mental health at two-years' corrected age. Clinical Trial Registration Number ACTRN12605000492651 PMID:19954550

Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE): A Cluster-Randomized Pragmatic Trial of a Multifactorial Fall Injury Prevention Strategy: Design and Methods.

PubMed

Bhasin, Shalender; Gill, Thomas M; Reuben, David B; Latham, Nancy K; Gurwitz, Jerry H; Dykes, Patricia; McMahon, Siobhan; Storer, Thomas W; Duncan, Pamela W; Ganz, David A; Basaria, Shehzad; Miller, Michael E; Travison, Thomas G; Greene, Erich J; Dziura, James; Esserman, Denise; Allore, Heather; Carnie, Martha B; Fagan, Maureen; Hanson, Catherine; Baker, Dorothy; Greenspan, Susan L; Alexander, Neil; Ko, Fred; Siu, Albert L; Volpi, Elena; Wu, Albert W; Rich, Jeremy; Waring, Stephen C; Wallace, Robert; Casteel, Carri; Magaziner, Jay; Charpentier, Peter; Lu, Charles; Araujo, Katy; Rajeevan, Haseena; Margolis, Scott; Eder, Richard; McGloin, Joanne M; Skokos, Eleni; Wiggins, Jocelyn; Garber, Lawrence; Clauser, Steven B; Correa-De-Araujo, Rosaly; Peduzzi, Peter

2017-10-14

Fall injuries are a major cause of morbidity and mortality among older adults. We describe the design of a pragmatic trial to compare the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy to an enhanced usual care. Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) is a 40-month cluster-randomized, parallel-group, superiority, pragmatic trial being conducted at 86 primary care practices in 10 healthcare systems across USA. The 86 practices were randomized to intervention or control group using covariate-based constrained randomization, stratified by healthcare system. Participants are community-living persons, ≥70 years, at increased risk for serious fall injuries. The intervention is a co-management model in which a nurse Falls Care Manager performs multifactorial risk assessments, develops individualized care plans, which include surveillance, follow-up evaluation, and intervention strategies. Control group receives enhanced usual care, with clinicians and patients receiving evidence-based information on falls prevention. Primary outcome is serious fall injuries, operationalized as those leading to medical attention (non-vertebral fractures, joint dislocation, head injury, lacerations, and other major sequelae). Secondary outcomes include all fall injuries, all falls, and well-being (concern for falling; anxiety and depressive symptoms; physical function and disability). Target sample size was 5,322 participants to provide 90% power to detect 20% reduction in primary outcome rate relative to control. Trial enrolled 5451 subjects in 20 months. Intervention and follow-up are ongoing. The findings of the STRIDE study will have important clinical and policy implications for the prevention of fall injuries in older adults. © The Author 2017. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

"Open mesh" or "strictly selected population" recruitment? The experience of the randomized controlled MeMeMe trial.

PubMed

Cortellini, Mauro; Berrino, Franco; Pasanisi, Patrizia

2017-01-01

Among randomized controlled trials (RCTs), trials for primary prevention require large samples and long follow-up to obtain a high-quality outcome; therefore the recruitment process and the drop-out rates largely dictate the adequacy of the results. We are conducting a Phase III trial on persons with metabolic syndrome to test the hypothesis that comprehensive lifestyle changes and/or metformin treatment prevents age-related chronic diseases (the MeMeMe trial, EudraCT number: 2012-005427-32, also registered on ClinicalTrials.gov [NCT02960711]). Here, we briefly analyze and discuss the reasons which may lead to participants dropping out from trials. In our experience, participants may back out of a trial for different reasons. Drug-induced side effects are certainly the most compelling reason. But what are the other reasons, relating to the participants' perception of the progress of the trial which led them to withdraw after randomization? What about the time-dependent drop-out rate in primary prevention trials? The primary outcome of this analysis is the point of drop-out from trial, defined as the time from the randomization date to the withdrawal date. Survival functions were non-parametrically estimated using the product-limit estimator. The curves were statistically compared using the log-rank test ( P =0.64, not significant). Researchers involved in primary prevention RCTs seem to have to deal with the paradox of the proverbial "short blanket syndrome". Recruiting only highly motivated candidates might be useful for the smooth progress of the trial but it may lead to a very low enrollment rate. On the other hand, what about enrolling all the eligible subjects without considering their motivation? This might boost the enrollment rate, but it can lead to biased results on account of large proportions of drop-outs. Our experience suggests that participants do not change their mind depending on the allocation group (intervention or control). There is no single answer to sort out the short blanket syndrome.

Effectiveness of school- and family-based interventions to prevent gaming addiction among grades 4–5 students in Bangkok, Thailand

PubMed Central

Apisitwasana, Nipaporn; Perngparn, Usaneya; Cottler, Linda B

2018-01-01

Purpose This study aimed to assess the effectiveness of Participatory Learning School and Family Based Intervention Program for Preventing Game Addiction by Developing Self-Regulation of gaming addiction among students of grades 4 and 5 in Bangkok. Methods A quasi-experimental study was implemented among students of grades 4 and 5 at primary schools in Bangkok selected through multistage random sampling. Two comparable schools were randomly assigned to either the intervention or control group. Then, 310 students in the randomly selected classrooms were allocated to each group. The intervention group received the self-regulation program with school and family involvement to prevent gaming addiction. Master teachers attended in-house training on prevention of gaming addiction in children. Parents of these children received a gaming addiction prevention manual and guidelines. The program lasted 8 weeks. The control group received no intervention. Knowledge and Attitude About Gaming Questionnaire, Game Addiction Screening Test (GAST), and Game Addiction Protection Scale were utilized to assess subjects at baseline, immediately after, and 3 months post-intervention. Descriptive statistics, chi-square, and independent t-test were used to describe characteristics of the participants, and repeated measures ANOVA was analyzed to test the effectiveness of the intervention. Results The findings revealed that there were significant differences in knowledge, attitude, self-regulation, and gaming addiction behaviors (p < 0.05) immediately and 3 months post-intervention. Positive effects of the intervention included increase in knowledge, attitude, and self-regulation, whereas the GAST score was significantly decreased (p < 0.05) immediately and 3 months after the program. Conclusion The program based on self-regulation and school and family participation is effective for preventing gaming addiction in students of grades 4 and 5 in Bangkok, Thailand. PMID:29695939

Effectiveness of school- and family-based interventions to prevent gaming addiction among grades 4-5 students in Bangkok, Thailand.

PubMed

Apisitwasana, Nipaporn; Perngparn, Usaneya; Cottler, Linda B

2018-01-01

This study aimed to assess the effectiveness of Participatory Learning School and Family Based Intervention Program for Preventing Game Addiction by Developing Self-Regulation of gaming addiction among students of grades 4 and 5 in Bangkok. A quasi-experimental study was implemented among students of grades 4 and 5 at primary schools in Bangkok selected through multistage random sampling. Two comparable schools were randomly assigned to either the intervention or control group. Then, 310 students in the randomly selected classrooms were allocated to each group. The intervention group received the self-regulation program with school and family involvement to prevent gaming addiction. Master teachers attended in-house training on prevention of gaming addiction in children. Parents of these children received a gaming addiction prevention manual and guidelines. The program lasted 8 weeks. The control group received no intervention. Knowledge and Attitude About Gaming Questionnaire, Game Addiction Screening Test (GAST), and Game Addiction Protection Scale were utilized to assess subjects at baseline, immediately after, and 3 months post-intervention. Descriptive statistics, chi-square, and independent t -test were used to describe characteristics of the participants, and repeated measures ANOVA was analyzed to test the effectiveness of the intervention. The findings revealed that there were significant differences in knowledge, attitude, self-regulation, and gaming addiction behaviors ( p < 0.05) immediately and 3 months post-intervention. Positive effects of the intervention included increase in knowledge, attitude, and self-regulation, whereas the GAST score was significantly decreased ( p < 0.05) immediately and 3 months after the program. The program based on self-regulation and school and family participation is effective for preventing gaming addiction in students of grades 4 and 5 in Bangkok, Thailand.

Impact of School-Based HIV Prevention Program in Post-Conflict Liberia

ERIC Educational Resources Information Center

Atwood, Katharine A.; Kennedy, Stephen B.; Shamblen, Steve; Tegli, Jemee; Garber, Salome; Fahnbulleh, Pearl W.; Korvah, Prince M.; Kolubah, Moses; Mulbah-Kamara, Comfort; Fulton, Shannon

2012-01-01

This paper presents findings of a feasibility study to adapt and evaluate the impact of an evidence-based HIV prevention intervention on sexual risk behaviors of in-school 6th grade youth in post-conflict Liberia (n = 812). The study used an attention-matched, group randomized controlled trial. Four matched pairs of elementary/middle schools in…

School-Based Education Programs for the Prevention of Child Sexual Abuse: A Cochrane Systematic Review and Meta-Analysis

ERIC Educational Resources Information Center

Walsh, Kerryann; Zwi, Karen; Woolfenden, Susan; Shlonsky, Aron

2018-01-01

Objective: To assess evidence of the effectiveness of school-based education programs for the prevention of child sexual abuse (CSA). The programs deliver information about CSA and strategies to help children avoid it and encourage help seeking. Methods: Systematic review including meta-analysis of randomized controlled trials (RCTs), cluster…

Fast Track Randomized Controlled Trial to Prevent Externalizing Psychiatric Disorders: Findings from Grades 3 to 9

ERIC Educational Resources Information Center

Journal of the American Academy of Child & Adolescent Psychiatry, 2007

2007-01-01

Objective: This study tests the efficacy of the Fast Track Program in preventing antisocial behavior and psychiatric disorders among groups varying in initial risk. Method: Schools within four sites (Durham, NC; Nashville, TN; Seattle, WA; and rural central Pennsylvania) were selected as high-risk institutions based on neighborhood crime and…

Evaluation of a Sexual Abuse Prevention Education for Chinese Preschoolers

ERIC Educational Resources Information Center

Zhang, Wenjing; Chen, Jingqi; Feng, Yanan; Li, Jingyi; Liu, Chengfeng; Zhao, Xiaoxia

2014-01-01

Objectives: The purpose of this study was to test the feasibility of a sexual abuse prevention education in a sample of Chinese preschool children in Beijing, China. Method: One hundred and fifty preschool children were randomly assigned to either the intervention group (N = 78) or the wait-list control group (N = 72). Children were posttested on…

Obesity Prevention Programs for Children and Youth: Why Are Their Results so Modest?

ERIC Educational Resources Information Center

Thomas, Helen

2006-01-01

The purpose of this paper is to critically reflect upon the mixed/modest results of the primary studies related to the effectiveness of physical activity enhancement and improving nutritional intake in obesity prevention programs for children and youth. The results of a recent review of this topic that included 57 randomized controlled trials…

Efficacy of a First-Grade Responsiveness-to-Intervention Prevention Model for Struggling Readers

ERIC Educational Resources Information Center

Gilbert, Jennifer K.; Compton, Donald L.; Fuchs, Douglas; Fuchs, Lynn S.; Bouton, Bobette; Barquero, Laura A.; Cho, Eunsoo

2013-01-01

This randomized control trial examined the efficacy of a multitiered supplemental tutoring program within a first-grade responsiveness-to-intervention prevention model. Struggling first-grade readers (n = 649) were screened and progress monitored at the start of the school year. Those identified as unresponsive to general education Tier 1 (n =…

Gender-Specific HIV Prevention with Urban Early-Adolescent Girls: Outcomes of the Keepin' It Safe Program

ERIC Educational Resources Information Center

Di Noia, Jennifer; Schinke, Steven P.

2007-01-01

This study evaluates the efficacy of Keepin' It Safe, a theory-based, gender-specific, CD-ROM-mediated HIV prevention program for urban, early adolescent girls. Intervention effects were examined in a randomized, pretest-posttest wait-list control-group design. Changes in HIV/AIDS knowledge, protective attitudes, and skills for reducing HIV…

A Randomized Controlled Trial of an Online Relapse Prevention Program for Adolescents in Substance Abuse Treatment

ERIC Educational Resources Information Center

Trudeau, Kimberlee J.; Black, Ryan A.; Kamon, Jody L.; Sussman, Steve

2017-01-01

Background: An Internet-based relapse prevention supplement to adolescent substance abuse treatment programming is a promising modality to reinforce treatment gains and enhance recovery; however, an evidence base is lacking. Objective: To assess the efficacy of the online Navigating my Journey (NmJ) program. Methods: 129 adolescent-aged…

Circadian Genes and Risk for Prostate Cancer

DTIC Science & Technology

2010-09-01

determine if finasteride (an inhibitor of androgen bioactivation) could prevent prostate cancer. In Year 2 of the award, we were approved by the...Trial (PCPT), a randomized placebo‐ controlled clinical trial to determine if  finasteride  (an inhibitor of androgen bioactivation) could  prevent

National Implementation of an Evidence-Based HIV Prevention and Reproductive Health Program for Bahamian Youth

ERIC Educational Resources Information Center

Knowles, Valerie; Kaljee, Linda; Deveaux, Lynette; Lunn, Sonja; Rolle, Glenda; Stanton, Bonita

2012-01-01

A wide range of behavioral prevention interventions have been demonstrated through longitudinal, randomized controlled trials to reduce sexual risk behaviors. Many of these interventions have been made available at little cost for implementation on a public health scale. However, efforts to utilize such programs typically have been met with a…

Supporting Families in a High-Risk Setting: Proximal Effects of the SAFEChildren Preventive Intervention

ERIC Educational Resources Information Center

Tolan, Patrick; Gorman-Smith, Deborah; Henry,David

2004-01-01

Four hundred twenty-four families who resided in inner-city neighborhoods and had a child entering 1st grade were randomly assigned to a control condition or to a family-focused preventive intervention combined with academic tutoring. SAFEChildren, which was developed from a developmental-ecological perspective, emphasizes developmental tasks and…

[Investigation on knowledge of malaria prevention and control in residents of Suining County].

PubMed

Tang, Yue-e

2014-08-01

To understand the status of knowledge of malaria prevention and control in residents of Suining County, so as to provide the reference for improving the implementation of malaria elimination. Nine villages in 3 townships (3 villages per township) were randomly selected as the study areas, and 200 residents aged above 15 years of each village were investigated with questionnaire for the knowledge of malaria prevention and control. The awareness rates of "malaria transmission way", main symptoms of malaria", "life-threatening of falciparum malaria", "how to treat malaria", and "how to prevent malaria" were 96.27%, 95.01%, 81.46%, 98.19% and 96.27%, respectively. There were no significant differences between the different genders and among the different areas (all P >0.05), but there were significant differences among different age groups (all P <0.05). The awareness of malaria prevention and control in residents of Suining County is relatively high, which means the health education is effective.

Topical fluoride (toothpastes, mouthrinses, gels or varnishes) for preventing dental caries in children and adolescents.

PubMed

Marinho, V C C; Higgins, J P T; Logan, S; Sheiham, A

2003-01-01

Topical fluoride therapy (TFT) in the form of varnish, gel, mouthrinse or toothpaste has been used extensively as a caries-preventive intervention for over three decades. To determine the effectiveness and safety of fluoride varnishes, gels, mouthrinses, and toothpastes in the prevention of dental caries in children and to examine factors potentially modifying their effect. We searched the Cochrane Oral Health Group's Trials Register (May 2000), CENTRAL (The Cochrane Library Issue 2, 2000), MEDLINE (1966 to January 2000), plus several other databases. We handsearched journals, reference lists of articles and contacted selected authors and manufacturers. Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride varnish, gel, mouthrinse, or toothpaste with placebo or no treatment in children up to 16 years during at least 1 year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS). Inclusion decisions, quality assessment and data extraction were duplicated in a random sample of one third of studies, and consensus achieved by discussion or a third party. Authors were contacted for missing data. The primary measure of effect was the prevented fraction (PF) that is the difference in mean caries increments between the treatment and control groups expressed as a percentage of the mean increment in the control group. Random effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random effects metaregression analyses. There were 144 studies included. For the 133 that contributed data for meta-analysis (involving 65,169 children) the D(M)FS pooled prevented fraction estimate was 26% (95% CI, 24% to 29%; p < 0.0001). There was substantial heterogeneity, confirmed statistically (p < 0.0001), but the direction of effect was consistent. The effect of topical fluoride varied according to type of control group used, type of TFT used, mode/setting of TFT use, initial caries levels and intensity of TFT application, but was not influenced by exposure to water fluoridation or other fluoride sources. D(M)FS PF was on average 14% (95% CI, 5% to 23%; p = 0.002) higher in non-placebo controlled trials, 14% (95% CI, 2% to 26%; p = 0.25) higher in fluoride varnish trials compared with all others, and 10% (95% CI, -17% to -3%; p = 0.003) lower in trials of unsupervised home use compared with self applied supervised and operator-applied. There was a 0.7% increase in the PF per unit increase in baseline caries (95% CI, 0.2% to 1.2%; p = 0.004). The benefits of topical fluorides have been firmly established on a sizeable body of evidence from randomized controlled trials. While the formal examination of sources of heterogeneity between studies has been important in the overall conclusions reached, these should be interpreted with caution. We were unable to reach definite conclusions about any adverse effects that might result from the use of topical fluorides, because data reported in the trials are scarce.

Moderators of two indicated cognitive-behavioral depression prevention approaches for adolescents in a school-based effectiveness trial.

PubMed

Brière, Frédéric N; Rohde, Paul; Shaw, Heather; Stice, Eric

2014-02-01

Our aim was to identify moderators of the effects of a cognitive behavioral group-based prevention program (CB group) and CB bibliotherapy, relative to an educational brochure control condition and to one another, in a school-based effectiveness randomized controlled prevention trial. 378 adolescents (M age = 15.5, 68% female) with elevated depressive symptoms were randomized in one of three conditions and were assessed at pretest, posttest, and 6-month follow-up. We tested the moderating effect of three individual (baseline depressive symptoms, negative attributional style, substance use), three environmental (negative life events, parental support, peer support), and two sociodemographic (sex, age) characteristics. Baseline depressive symptoms interacted with condition and time. Decomposition indicated that elevated baseline depressive symptoms amplified the effect of CB bibliotherapy at posttest (but not 6-month follow-up) relative to the control condition, but did not modify the effect of CB group relative to the control condition or relative to bibliotherapy. Specifically, CB bibliotherapy resulted in lower posttest depressive symptoms than the control condition in individuals with elevated, but not average or low baseline symptoms. We found no interaction effect for other putative moderators. Our findings suggest that bibliotherapy is effective only in participants who have elevated depressive symptoms at baseline. The fact that no study variable moderated the effects of CB group, which had a significant main effect in reducing depressive symptoms relative to the control condition, suggests that this indicated prevention intervention is effective for a wide range of adolescents. Copyright © 2013 Elsevier Ltd. All rights reserved.

Moderators of two Indicated Cognitive-Behavioral Depression Prevention Approaches for Adolescents in a School-Based Effectiveness Trial

PubMed Central

Brière, Frédéric N.; Rohde, Paul; Shaw, Heather; Stice, Eric

2014-01-01

Objective Our aim was to identify moderators of the effects of a cognitive behavioral group-based prevention program (CB group) and CB bibliotherapy, relative to an educational brochure control condition and to one another, in a school-based effectiveness randomized controlled prevention trial. Method 378 adolescents (M age = 15.5, 68% female) with elevated depressive symptoms were randomized in one of three conditions and were assessed at pretest, posttest, and 6-month follow-up. We tested the moderating effect of three individual (Baseline Depressive Symptoms, Negative Attributional Style, Substance Use), three environmental (Negative Life Events, Parental Support, Peer Support), and two sociodemographic (Sex, Age) characteristics. Results Baseline Depressive Symptoms interacted with Condition and Time. Decomposition indicated that elevated baseline depressive symptoms amplified the effect of CB bibliotherapy at posttest (but not 6-month follow-up) relative to the control condition, but did not modify the effect of CB group relative to the control condition or relative to bibliotherapy. Specifically, CB bibliotherapy resulted in lower posttest depressive symptoms than the control condition in individuals with elevated, but not average or low baseline symptoms. We found no interaction effect for other putative moderators. Conclusions Our findings suggest that bibliotherapy is effective only in participants who have elevated depressive symptoms at baseline. The fact that no study variable moderated the effects of CB group, which had a significant main effect in reducing depressive symptoms relative to the control condition, suggests that this indicated prevention intervention is effective for a wide range of adolescents. PMID:24418653

Lower reinjury rate with a coach-controlled rehabilitation program in amateur male soccer: a randomized controlled trial.

PubMed

Hägglund, Martin; Waldén, Markus; Ekstrand, Jan

2007-09-01

Soccer injuries are common, and athletes returning to play after injury are especially at risk. Few studies have investigated how to prevent reinjury. The rate of reinjury is reduced using a coach-controlled rehabilitation program. Randomized controlled trial; Level of evidence, 1. Twenty-four male amateur soccer teams were randomized into an intervention (n = 282) and control group (n = 300). The intervention was implemented by team coaches and consisted of information about risk factors for reinjury, rehabilitation principles, and a 10-step progressive rehabilitation program including return to play criteria. During the 2003 season, coaches reported individual exposure and all time loss injuries were evaluated by a doctor and a physiotherapist. Four teams (n = 100) withdrew from the study after randomization, leaving 10 teams with 241 players for analysis in both groups. There were 90 injured players (132 injuries) in the intervention group, and 10 of these (11%) suffered 14 reinjuries during the season. In the control group, 23 of 79 injured players (29%) had 40 recurrences (134 injuries). A Cox regression analysis showed a 66% reinjury risk reduction in the intervention group for all injury locations (hazard ratio [HR] 0.34, 95% confidence interval [CI] 0.16-0.72, P = .0047) and 75% for lower limb injuries (HR 0.25, 95% CI 0.11-0.57, P < .001). The preventive effect was greatest within the first week of return to play. Injured players in the intervention group complied with the intervention for 90 of 132 injuries (68%). The reinjury rate in amateur male soccer players was reduced after a controlled rehabilitation program implemented by coaches.

Practices that minimize trauma to the genital tract in childbirth: a systematic review of the literature.

PubMed

Renfrew, M J; Hannah, W; Albers, L; Floyd, E

1998-09-01

Trauma to the genital tract commonly occurs at birth, and can cause short- and long-term morbidity. Clinical measures to reduce its occurrence have not been fully identified. A systematic review of the English language literature was conducted to describe the current state of knowledge on reduction of genital tract trauma before planning a large randomized controlled trial of ways to prevent such trauma. Randomized trials and other published reports were identified from relevant databases and hand searches. Studies were reviewed and assessed using a structured format. A total of 77 papers and chapters were identified and placed into 5 categories after critical review: 25 randomized trials, 4 meta-analyses, 4 prospective studies, 36 retrospective studies, and 8 descriptions of practice from textbooks. The available evidence is conclusive in favor of restricted use of episiotomy. The contribution of maternal characteristics and attitudes to intact perineum has not been investigated. Several other topics warrant further study, including maternal position, style of pushing, and antenatal perineal massage. Strong opinions and sparse data exist regarding the role of hand maneuvers by the birth attendant for perineal management and birth of the baby. This became the topic of the planned randomized controlled trial, which was completed; results will be published soon. The case for restricting the use of episiotomy is conclusive. Several other clinical factors warrant investigation, including the role of hand maneuvers by the birth attendant in preventing birth trauma. A large randomized controlled trial will report on this topic.

Interatrial septum versus right atrial appendage pacing for prevention of atrial fibrillation : A meta-analysis of randomized controlled trials.

PubMed

Zhang, L; Jiang, H; Wang, W; Bai, J; Liang, Y; Su, Y; Ge, J

2017-07-28

Interatrial septum (IAS) pacing seems to be a promising strategy for the prevention of atrial fibrillation (AF); however, studies have yielded conflicting results. This meta-analysis was to compare IAS with right atrial appendage (RAA) pacing on the prevention of postpacing AF occurrence. Pubmed, MEDLINE, EMBASE and Web of Science databases were searched through October 2016 for randomized controlled trials comparing IAS with RAA pacing on the prevention of AF. Data concerning study design, patient characteristics and outcomes were extracted. Risk ratio (RR), weighted mean differences (WMD) or standardized mean differences (SMD) were calculated using fixed or random effects models. A total of 12 trials involving 1146 patients with dual-chamber pacing were included. Although IAS was superior to RAA pacing in terms of reducing the number of AF episodes (SMD = -0.29, P = 0.05), AF burden (SMD = -0.41, P = 0.008) and P -wave duration (WMD = -34.45 ms, P < 0.0001), neither permanent AF occurrence (RR = 0.94, P = 0.58) nor recurrences of AF (RR = 0.88, P = 0.36) were reduced by IAS pacing. Nevertheless, no differences were observed concerning all-cause death (RR = 1.04, P = 0.88), procedure-related events (RR = 1.17, P = 0.69) and pacing parameters between IAS and RAA pacing in the follow-up period. IAS pacing is safe and as well tolerated as RAA pacing. Although IAS pacing may fail to prevent permanent AF occurrence and recurrences of AF, it is able to not only improve interatrial conduction, but also reduce AF burden.

Diabetes Prevention Program (DPP)

MedlinePlus

... mass index of 35 or higher. DPP Study Design The DPP was a randomized, controlled clinical trial ... by several earlier small-scale studies. DPPOS Study Design The DPPOS follow-up study started in 2002. ...

Prophylaxis of Radiation-Induced Nausea and Vomiting Using 5-Hydroxytryptamine-3 Serotonin Receptor Antagonists: A Systematic Review of Randomized Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Salvo, Nadia; Doble, Brett; Khan, Luluel

Purpose: To systematically review the effectiveness and safety of 5-hydroxytryptamine-3 receptor antagonists (5-HT3 RAs) compared with other antiemetic medication or placebo for prophylaxis of radiation-induced nausea and vomiting. Methods and Materials: We searched the following electronic databases: MEDLINE, Embase, the Cochrane Central Register of Controlled Clinical Trials, and Web of Science. We also hand-searched reference lists of included studies. Randomized, controlled trials that compared a 5-HT3 RA with another antiemetic medication or placebo for preventing radiation-induced nausea and vomiting were included. We excluded studies recruiting patients receiving concomitant chemotherapy. When appropriate, meta-analysis was conducted using Review Manager (v5) software. Relativemore » risks were calculated using inverse variance as the statistical method under a random-effects model. We assessed the quality of evidence by outcome using the Grading of Recommendations Assessment, Development, and Evaluation approach. Results: Eligibility screening of 47 articles resulted in 9 included in the review. The overall methodologic quality was moderate. Meta-analysis of 5-HT3 RAs vs. placebo showed significant benefit for 5-HT3 RAs (relative risk [RR] 0.70; 95% confidence interval [CI] 0.57-0.86 for emesis; RR 0.84, 95% CI 0.73-0.96 for nausea). Meta-analysis comparing 5-HT3 RAs vs. metoclopramide showed a significant benefit of the 5-HT3 RAs for emetic control (RR 0.27, 95% CI 0.15-0.47). Conclusion: 5-Hydroxytryptamine-3 RAs are superior to placebo and other antiemetics for prevention of emesis, but little benefit was identified for nausea prevention. 5-Hydroxytryptamine-3 RAs are suggested for prevention of emesis. Limited evidence was found regarding delayed emesis, adverse events, quality of life, or need for rescue medication. Future randomized, controlled trials should evaluate different 5-HT3 antiemetics and new agents with novel mechanisms of action such at the NK{sub 1} receptor antagonists to determine the most effective drug. Delayed nausea and vomiting should be a focus of future study, perhaps concentrating on the palliative cancer population.« less

The Danish Cardiovascular Screening Trial (DANCAVAS): study protocol for a randomized controlled trial.

PubMed

Diederichsen, Axel Cosmus Pyndt; Rasmussen, Lars Melholt; Søgaard, Rikke; Lambrechtsen, Jess; Steffensen, Flemming Hald; Frost, Lars; Egstrup, Kenneth; Urbonaviciene, Grazina; Busk, Martin; Olsen, Michael Hecht; Mickley, Hans; Hallas, Jesper; Lindholt, Jes Sanddal

2015-12-05

The significant increase in the average life expectancy has increased the societal challenge of managing serious age-related diseases, especially cancer and cardiovascular diseases. A routine check by a general practitioner is not sufficient to detect incipient cardiovascular disease. Population-based randomized clinically controlled screening trial. 45,000 Danish men aged 65-74 years living on the Island of Funen, or in the surrounding communities of Vejle and Silkeborg. No exclusion criteria are used. One-third will be invited to cardiovascular seven-faceted screening examinations at one of four locations. The screening will include: (1) low-dose non-contrast CT scan to detect coronary artery calcification and aortic/iliac aneurysms, (2) brachial and ankle blood pressure index to detect peripheral arterial disease and hypertension, (3) a telemetric assessment of the heart rhythm, and (4) a measurement of the cholesterol and plasma glucose levels. Up-to-date cardiovascular preventive treatment is recommended in case of positive findings. To investigate whether advanced cardiovascular screening will prevent death and cardiovascular events, and whether the possible health benefits are cost effective. Registry-based follow-up on all cause death (primary outcome), and costs after 3, 5 and 10 years (secondary outcome). Each of the 45,000 individuals is, by EPIDATA, given a random number from 1-100. Those numbered 67+ will be offered screening; the others will act as a control group. Only those randomized to the screening will be invited to the examination;the remaining participants will not. Numbers randomized: A total of 45,000 men will be randomized 1:2. Recruitment: Enrollment started October 2014. A 5% reduction in overall mortality (HR=0.95), with the risk for a type 1 error=5% and the risk for a type II error=80%, is expected. We expect a 2-year enrollment, a 10-year follow-up, and a median survival of 15 years among the controls. The attendance to screening is assumed to be 70%. The primary aim of this so far stand-alone population-based, randomized trial will be to evaluate the health benefits and costeffectiveness of using non-contrast full truncus computer tomography (CT) scans (to measure coronary artery calcification (CAC) and identify aortic/iliac aneurysms) and measurements of the ankle brachial blood pressure index (ABI) as part of a multifocal screening and intervention program for CVD in men aged 65-74. Attendance rate and compliance to initiated preventive actions must be expected to become of major importance. Current Controlled Trials: ISRCTN12157806 (21 March 2015).

A Hybrid Web-Based and In-Person Self-Management Intervention to Prevent Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): Protocol for a Pilot Single-Blind Randomized Controlled Trial

PubMed Central

2017-01-01

Background Acute pain frequently transitions to chronic pain after major lower extremity trauma (ET). Several modifiable psychological risk and protective factors have been found to contribute to, or prevent, chronic pain development. Some empirical evidence has shown that interventions, including cognitive and behavioral strategies that promote pain self-management, could prevent chronic pain. However, the efficacy of such interventions has never been demonstrated in ET patients. We have designed a self-management intervention to prevent acute to chronic pain transition after major lower extremity trauma (iPACT-E-Trauma). Objective This pilot randomized controlled trial (RCT) aims to evaluate the feasibility and research methods of the intervention, as well as the potential effects of iPACT-E-Trauma, on pain intensity and pain interference with daily activities. Methods A 2-arm single-blind pilot RCT will be conducted. Participants will receive the iPACT-E-Trauma intervention (experimental group) or an educational pamphlet (control group) combined with usual care. Data will be collected at baseline, during iPACT-E-Trauma delivery, as well as at 3 and 6 months post-injury. Primary outcomes are pain intensity and pain interference with daily living activities at 6 months post-injury. Secondary outcomes are pain self-efficacy, pain acceptance, pain catastrophizing, pain-related fear, anxiety and depression symptoms, health care service utilization, and return to work. Results Fifty-three patients were recruited at the time of manuscript preparation. Comprehensive data analyses will be initiated in July 2017. Study results are expected to be available in 2018. Conclusions Chronic pain is an important problem after major lower ET. However, no preventive intervention has yet been successfully proven in these patients. This study will focus on developing a feasible intervention to prevent acute to chronic pain transition in the context of ET. Findings will allow for the refinement of iPACT-E-Trauma and methodological parameters in prevision of a full-scale multi-site RCT. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 91987302; http://www.controlled-trials.com/ISRCTN91987302 (Archived by WebCite at http://www.webcitation.org/6rR8G2vMs) PMID:28652226

A multi-faceted tailored strategy to implement an electronic clinical decision support system for pressure ulcer prevention in nursing homes: a two-armed randomized controlled trial.

PubMed

Beeckman, Dimitri; Clays, Els; Van Hecke, Ann; Vanderwee, Katrien; Schoonhoven, Lisette; Verhaeghe, Sofie

2013-04-01

Frail older people admitted to nursing homes are at risk of a range of adverse outcomes, including pressure ulcers. Clinical decision support systems are believed to have the potential to improve care and to change the behaviour of healthcare professionals. To determine whether a multi-faceted tailored strategy to implement an electronic clinical decision support system for pressure ulcer prevention improves adherence to recommendations for pressure ulcer prevention in nursing homes. Two-armed randomized controlled trial in a nursing home setting in Belgium. The trial consisted of a 16-week implementation intervention between February and June 2010, including one baseline, four intermediate, and one post-testing measurement. Primary outcome was the adherence to guideline-based care recommendations (in terms of allocating adequate pressure ulcer prevention in residents at risk). Secondary outcomes were the change in resident outcomes (pressure ulcer prevalence) and intermediate outcomes (knowledge and attitudes of healthcare professionals). Random sample of 11 wards (6 experimental; 5 control) in a convenience sample of 4 nursing homes in Belgium. In total, 464 nursing home residents and 118 healthcare professionals participated. The experimental arm was involved in a multi-faceted tailored implementation intervention of a clinical decision support system, including interactive education, reminders, monitoring, feedback and leadership. The control arm received a hard-copy of the pressure ulcer prevention protocol, supported by standardized 30 min group lecture. Patients in the intervention arm were significantly more likely to receive fully adequate pressure ulcer prevention when seated in a chair (F=16.4, P=0.003). No significant improvement was observed on pressure ulcer prevalence and knowledge of the professionals. While baseline attitude scores were comparable between both groups [exp. 74.3% vs. contr. 74.5% (P=0.92)], the mean score after the intervention was 83.5% in the experimental group vs. 72.1% in the control group (F=15.12, P<0.001). The intervention was only partially successful to improve the primary outcome. Attitudes improved significantly while the knowledge of the healthcare workers remained unsatisfactorily low. Further research should focus on the underlying reasons for these findings. Copyright © 2012 Elsevier Ltd. All rights reserved.

A Tailored Web-based Advice Tool for Skiers and Snowboarders: Protocol for a Randomized Controlled Trial.

PubMed

Kemler, Ellen; Gouttebarge, Vincent

2018-01-17

Being active in sports has many positive health effects. The direct effects of engaging in regular physical activity are particularly apparent in the prevention of several chronic diseases, including cardiovascular disease, diabetes, cancer, hypertension, obesity, depression, and osteoporosis. Besides the beneficial health effects of being active, sports participation is unfortunately also associated with a risk of injuries. In the case of many sports injuries (eg, winter sports) preventive measures are not compulsory, which means that a behavioral change in sports participants is necessary to increase the use of effective measures, and subsequently prevent or reduce injuries in sports. The evidence-based Wintersportklaar online intervention has been developed to stimulate injury preventive behavior among skiers and snowboarders. In this article, the design of the effectiveness study will be described. A randomized controlled trial with a follow-up period of four months during the winter sport season will be conducted. The participants consist of inexperienced skiers and snowboarders. At baseline, skiers and snowboarders in the intervention and control groups are asked to report the injury preventive measures they usually take during their preparation for their winter sport holiday. One and three months after baseline, skiers and snowboarders are asked to report retrospectively in detail what measures they took regarding injury prevention during their current winter sport preparation and winter sport holiday. Descriptive analyses (mean, standard deviation, frequency, range) are conducted for the different baseline variables in both study groups. To evaluate the success of the randomization, baseline values are analyzed for differences between the intervention and control groups (chi square, independent T tests and/or Mann-Whitney test). Chi square tests and/or logistic regression analyses are used to analyze behavioral change according to the intention to treat principle (as initially assigned). The project was funded in 2016 and enrolment was completed in 2017. Data analysis is currently under way and the first results are expected to be submitted for publication in 2018. To combat the negative side effects of sports participation, the use of injury preventive measures is desirable. As the use of injury prevention is usually not compulsory in skiing and snowboarding, a behavioral change is necessary to increase the use of effective injury preventive measures in winter sports. Dutch Trial Registry NTR6233; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6233 (Archived by WebCite at  http://www.webcitation.org/6wXZPzjUi). ©Ellen Kemler, Vincent Gouttebarge. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 17.01.2018.

Pharmacy-randomized intervention delivering HIV prevention services during the syringe sale to people who inject drugs in New York City.

PubMed

Lewis, Crystal Fuller; Rivera, Alexis V; Crawford, Natalie D; DeCuir, Jennifer; Amesty, Silvia

2015-08-01

Pharmacy syringe access may be an opportunity to provide HIV prevention resources to persons who inject drugs (PWID). We examined the impact of a pharmacy-randomized intervention to reduce injection risk among PWID in New York City. Pharmacies (n=88) were randomized into intervention, primary control, and secondary control arms. Intervention pharmacies received in-depth harm reduction training, recruited syringe customers who inject drugs into the study, and provided additional services (i.e., HIV prevention/medical/social service referrals, syringe disposal containers, and harm reduction print materials). Primary control pharmacies recruited syringe customers who inject drugs and did not offer additional services, and secondary control pharmacies did not recruit syringe customers (and are not included in this analysis) but participated in a pharmacy staff survey to evaluate intervention impact on pharmacy staff. Recruited syringe customers underwent a baseline and 3-month follow-up ACASI. The intervention effect on injection risk/protective behavior of PWID was examined. A total of 482 PWID completed baseline and follow-up surveys. PWID were mostly Hispanic/Latino, male, and mean age of 43.6 years. After adjustment, PWID in the intervention arm were more likely to report always using a sterile syringe vs. not (PR=1.24; 95% CI: 1.04-1.48) at 3-month follow-up. These findings present evidence that expanded pharmacy services for PWID can encourage sterile syringe use which may decrease injection risk in high HIV burdened Black and Latino communities. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Randomized Trial of Behavioral Activation, Cognitive Therapy, and Antidepressant Medication in the Prevention of Relapse and Recurrence in Major Depression

ERIC Educational Resources Information Center

Dobson, Keith S.; Hollon, Steven D.; Dimidjian, Sona; Schmaling, Karen B.; Kohlenberg, Robert J.; Gallop, Robert J.; Rizvi, Shireen L.; Gollan, Jackie K.; Dunner, David L.; Jacobson, Neil S.

2008-01-01

This study followed treatment responders from a randomized controlled trial of adults with major depression. Patients treated with medication but withdrawn onto pill-placebo had more relapse through 1 year of follow-up compared to patients who received prior behavioral activation, prior cognitive therapy, or continued medication. Prior…

A Randomized Trial of a Computer-Assisted Tutoring Program Targeting Letter-Sound Expression

ERIC Educational Resources Information Center

DuBois, Matthew R.; Volpe, Robert J.; Hemphill, Elizabeth M.

2014-01-01

Given that many schools have limited resources and a high proportion of students who present with deficits in early literacy skills, supports aimed at preventing reading failure must be simple and efficient and generate meaningful changes in student learning. We used a randomized group design with a wait-list control to extend the work of Volpe,…

Evaluation of a Randomized Intervention to Delay Sexual Initiation among Fifth-Graders Followed through the Sixth Grade

ERIC Educational Resources Information Center

Koo, Helen P.; Rose, Allison; El-Khorazaty, M. Nabil; Yao, Qing; Jenkins, Renee R.; Anderson, Karen M.; Davis, Maurice; Walker, Leslie R.

2011-01-01

US adolescents initiate sex at increasingly younger ages, yet few pregnancy prevention interventions for children as young as 10-12 years old have been evaluated. Sixteen Washington, DC schools were randomly assigned to intervention versus control conditions. Beginning in 2001/02 with fifth-grade students and continuing during the sixth grade,…

Can Distance Learning Improve Smoking Cessation Advice in Family Practice? A Randomized Trial.

ERIC Educational Resources Information Center

Young, Jane M.; Ward, Jeanette

2002-01-01

Family physicians were randomly assigned either to a distance learning module (n=26) or preventive care guidelines (n=27) on smoking cessation. No differences appeared in knowledge or attitudes. The distance group had significantly greater change in self-rated competence, but the magnitude of change was not greater than that of the control group.…

Prevention of Recurrent Foot Ulcers With Plantar Pressure–Based In-Shoe Orthoses: The CareFUL Prevention Multicenter Randomized Controlled Trial

PubMed Central

Ulbrecht, Jan S.; Hurley, Timothy; Mauger, David T.

2014-01-01

OBJECTIVE To assess the efficacy of in-shoe orthoses that were designed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes, peripheral neuropathy, and a history of similar prior ulceration. RESEARCH DESIGN AND METHODS Single-blinded multicenter randomized controlled trial with subjects randomized to wear shape- and pressure-based orthoses (experimental, n = 66) or standard-of-care A5513 orthoses (control, n = 64). Patients were followed for 15 months, until a study end point (forefoot plantar ulcer or nonulcerative plantar forefoot lesion) or to study termination. Proportional hazards regression was used for analysis. RESULTS There was a trend in the composite primary end point (both ulcers and nonulcerative lesions) across the full follow-up period (P = 0.13) in favor of the experimental orthoses. This trend was due to a marked difference in ulcer occurrence (P = 0.007) but no difference in the rate of nonulcerative lesions (P = 0.76). At 180 days, the ulcer prevention effect of the experimental orthoses was already significant (P = 0.003) when compared with control, and the benefit of the experimental orthoses with respect to the composite end point was also significant (P = 0.042). The hazard ratio was 3.4 (95% CI 1.3–8.7) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study. CONCLUSIONS We conclude that shape- and barefoot plantar pressure–based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current standard-of-care orthoses, but they did not significantly reduce nonulcerative lesions. PMID:24760263

Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial.

PubMed

Ulbrecht, Jan S; Hurley, Timothy; Mauger, David T; Cavanagh, Peter R

2014-07-01

To assess the efficacy of in-shoe orthoses that were designed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes, peripheral neuropathy, and a history of similar prior ulceration. Single-blinded multicenter randomized controlled trial with subjects randomized to wear shape- and pressure-based orthoses (experimental, n = 66) or standard-of-care A5513 orthoses (control, n = 64). Patients were followed for 15 months, until a study end point (forefoot plantar ulcer or nonulcerative plantar forefoot lesion) or to study termination. Proportional hazards regression was used for analysis. There was a trend in the composite primary end point (both ulcers and nonulcerative lesions) across the full follow-up period (P = 0.13) in favor of the experimental orthoses. This trend was due to a marked difference in ulcer occurrence (P = 0.007) but no difference in the rate of nonulcerative lesions (P = 0.76). At 180 days, the ulcer prevention effect of the experimental orthoses was already significant (P = 0.003) when compared with control, and the benefit of the experimental orthoses with respect to the composite end point was also significant (P = 0.042). The hazard ratio was 3.4 (95% CI 1.3-8.7) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study. We conclude that shape- and barefoot plantar pressure-based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current standard-of-care orthoses, but they did not significantly reduce nonulcerative lesions. © 2014 by the American Diabetes Association.

Maternal vitamin D supplementation during pregnancy prevents vitamin D deficiency in the newborn: an open-label randomized controlled trial.

PubMed

Rodda, C P; Benson, J E; Vincent, A J; Whitehead, C L; Polykov, A; Vollenhoven, B

2015-09-01

To determine whether maternal vitamin D supplementation, in the vitamin D deficient mother, prevents neonatal vitamin D deficiency. Open-label randomized controlled trial. Metropolitan Melbourne, Australia, tertiary hospital routine antenatal outpatient clinic. Seventy-eight women with singleton pregnancies with vitamin D deficiency/insufficiency (serum 25-OH Vit D < 75 nmol/l) at their first antenatal appointment at 12-16-week gestation were recruited. Participants were randomized to vitamin D supplementation (2000-4000 IU cholecalciferol) orally daily until delivery or no supplementation. The primary outcome was neonatal serum 25-OH vit D concentration at delivery. The secondary outcome was maternal serum 25-OH vit D concentration at delivery. Baseline mean maternal serum 25-OH vit D concentrations were similar (P = 0·9) between treatment (32 nmol/l, 95% confidence interval 26-39 nmol/l) and control groups (33 nmol/l, 95% CI 26-39 nmol/l). Umbilical cord serum 25-OH vit D concentrations at delivery were higher (P < 0·0001) in neonates of treatment group mothers (81 nmol/l, 95% CI; 70-91 nmol/l) compared with neonates of control group mothers (42 nmol/l, 95% CI; 34-50 nmol/l) with a strongly positive correlation between maternal serum 25-OH Vit D and umbilical cord serum 25-OH vit D concentrations at delivery (Spearman rank correlation coefficient 0·88; P < 0·0001). Mean maternal serum 25-OH Vit D concentrations at delivery were higher (P < 0·0001) in the treatment group (71 nmol/l, 95% CI; 62-81 nmol/l) compared with the control group (36 nmol/l, 95% CI; 29-42 nmol/l). Vitamin D supplementation of vitamin D deficient pregnant women prevents neonatal vitamin D deficiency. © 2015 John Wiley & Sons Ltd.

Saccharomyces boulardii for the prevention of antibiotic-associated diarrhea in adult hospitalized patients: a single-center, randomized, double-blind, placebo-controlled trial.

PubMed

Pozzoni, Pietro; Riva, Alessia; Bellatorre, Alessandro Giacco; Amigoni, Maria; Redaelli, Elena; Ronchetti, Anna; Stefani, Mariangela; Tironi, Rosangela; Molteni, Edoardo Ennio; Conte, Dario; Casazza, Giovanni; Colli, Agostino

2012-06-01

Antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) are common complications of antibiotic use. Probiotics were effective in preventing AAD and CDAD in several randomized controlled trials. This study was aimed at testing the effect of Saccharomyces boulardii on the occurrence of AAD and CDAD in hospitalized patients. A single-center, randomized, double-blind, placebo-controlled, parallel-group trial was performed. Patients being prescribed antibiotics or on antibiotic therapy for <48 h were eligible. Exclusion criteria were ongoing diarrhea, recent assumption of probiotics, lack of informed consent, inability to ingest capsules, and severe pancreatitis. Patients received a capsule containing S. boulardii or an indistinguishable placebo twice daily within 48 h of beginning antibiotic therapy, continued treatment for 7 days after antibiotic withdrawal, and were followed for 12 weeks after ending antibiotic treatment. Of 562 consecutive eligible patients, 275 patients aged 79.2 ± 9.8 years (134 on placebo) were randomized and 204 aged 78.4 ± 10.0 years (98 on placebo) completed the follow-up. AAD developed in 13.3% (13/98) of the patients receiving placebo and in 15.1% (16/106) of those receiving S. boulardii (odds ratio for S. boulardii vs. placebo, 1.16; 95% confidence interval (CI), 0.53-2.56). Five cases of CDAD occurred, 2 in the placebo group (2.0%) and 3 in the probiotic group (2.8%; odds ratio for S. boulardii vs. placebo, 1.40; 95% CI, 0.23-8.55). There was no difference in mortality rates (12.7% vs. 15.6%, P=0.60). In elderly hospitalized patients, S. boulardii was not effective in preventing the development of AAD.

Effectiveness of Intraoral Chlorhexidine Protocols in the Prevention of Ventilator-Associated Pneumonia: Meta-Analysis and Systematic Review.

PubMed

Villar, Cristina C; Pannuti, Claudio M; Nery, Danielle M; Morillo, Carlos M R; Carmona, Maria José C; Romito, Giuseppe A

2016-09-01

Ventilator-associated pneumonia (VAP) is common in critical patients and related with increased morbidity and mortality. We conducted a systematic review and meta-analysis, with intention-to-treat analysis, of randomized controlled clinical trials that assessed the effectiveness of different intraoral chlorhexidine protocols for the prevention of VAP. Search strategies were developed for the MEDLINE, EMBASE, and LILACS databases. MeSH terms were combined with Boolean operators and used to search the databases. Eligible studies were randomized controlled trials of mechanically ventilated subjects receiving oral care with chlorhexidine or standard oral care protocols consisting of or associated with the use of a placebo or no chemicals. Pooled estimates of the relative risk and corresponding 95% CIs were calculated with random effects models, and heterogeneity was assessed with the Cochran Q statistic and I(2). The 13 included studies provided data on 1,640 subjects that were randomly allocated to chlorhexidine (n = 834) or control (n = 806) treatments. A preliminary analysis revealed that oral application of chlorhexidine fails to promote a significant reduction in VAP incidence (relative risk 0.80, 95% CI 0.59-1.07, I(2) = 45%). However, subgroup analyses showed that chlorhexidine prevents VAP development when used at 2% concentration (relative risk 0.53, 95% CI 0.31-0.91, I(2) = 0%) or 4 times/d (relative risk 0.56, 95% CI 0.38-0.81, I(2) = 0%). We found that oral care with chlorhexidine is effective in reducing VAP incidence in the adult population if administered at 2% concentration or 4 times/d. Copyright © 2016 by Daedalus Enterprises.

Safety and effectiveness of antiretroviral drugs during pregnancy, delivery and breastfeeding for prevention of mother-to-child transmission of HIV-1: the Kesho Bora Multicentre Collaborative Study rationale, design, and implementation challenges.

PubMed

2011-01-01

To evaluate strategies to reduce HIV-1 transmission through breastfeeding, a multicentre study including a nested randomized controlled trial was implemented in five research sites in West, East and South Africa (The Kesho Bora Study). The aim was to optimize the use of antiretroviral (ARV) drugs during pregnancy, delivery and breastfeeding to prevent mother-to-child transmission of HIV-1 (PMTCT) and to preserve the health of the HIV-1-infected mother. The study included long-term ARV treatment for women with advanced disease, and short-course ARV prophylaxis stopped at delivery for women with early disease. Women with intermediate disease participated in a randomized controlled trial to compare safety and efficacy of triple-ARV prophylaxis prolonged during breastfeeding with short-course ARV prophylaxis stopped at delivery. Between January 2005 and August 2008 a total of 1140 women were enrolled. This paper describes the study design, interventions and protocol amendments introduced to adapt to evolving scientific knowledge, international guidelines and availability of ARV treatment. The paper highlights the successes and challenges during the conduct of the trial. The Kesho Bora Study included one of the few randomized controlled trials to assess safety and efficacy of ARV prophylaxis continued during breastfeeding and the only randomized trial to assess maternal prophylaxis started during pregnancy. The findings have been important for informing international and national guidelines on MTCT prevention in developing countries where, due to poverty, lack of reliable and affordable supply of replacement feed and stigma associated with HIV/AIDS, HIV-infected women have little or no option other than to breastfeed their infants. (ISRCTN71468401). Copyright © 2010 Elsevier Inc. All rights reserved.

SPECT Analysis of Cardiac Perfusion Changes After Whole-Breast/Chest Wall Radiation Therapy With or Without Active Breathing Coordinator: Results of a Randomized Phase 3 Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zellars, Richard, E-mail: zellari@jhmi.edu; Bravo, Paco E.; Tryggestad, Erik

2014-03-15

Purpose: Cardiac muscle perfusion, as determined by single-photon emission computed tomography (SPECT), decreases after breast and/or chest wall (BCW) irradiation. The active breathing coordinator (ABC) enables radiation delivery when the BCW is farther from the heart, thereby decreasing cardiac exposure. We hypothesized that ABC would prevent radiation-induced cardiac toxicity and conducted a randomized controlled trial evaluating myocardial perfusion changes after radiation for left-sided breast cancer with or without ABC. Methods and Materials: Stages I to III left breast cancer patients requiring adjuvant radiation therapy (XRT) were randomized to ABC or No-ABC. Myocardial perfusion was evaluated by SPECT scans (before andmore » 6 months after BCW radiation) using 2 methods: (1) fully automated quantitative polar mapping; and (2) semiquantitative visual assessment. The left ventricle was divided into 20 segments for the polar map and 17 segments for the visual method. Segments were grouped by anatomical rings (apical, mid, basal) or by coronary artery distribution. For the visual method, 2 nuclear medicine physicians, blinded to treatment groups, scored each segment's perfusion. Scores were analyzed with nonparametric tests and linear regression. Results: Between 2006 and 2010, 57 patients were enrolled and 43 were available for analysis. The cohorts were well matched. The apical and left anterior descending coronary artery segments had significant decreases in perfusion on SPECT scans in both ABC and No-ABC cohorts. In unadjusted and adjusted analyses, controlling for pretreatment perfusion score, age, and chemotherapy, ABC was not significantly associated with prevention of perfusion deficits. Conclusions: In this randomized controlled trial, ABC does not appear to prevent radiation-induced cardiac perfusion deficits.« less

Efficacy of Adolescent Suicide Prevention E-Learning Modules for Gatekeepers: A Randomized Controlled Trial

PubMed Central

Gould, Madelyn S; Twisk, Jos WR; Kerkhof, Ad JFM; Koot, Hans M

2016-01-01

Background Face-to-face gatekeeper training can be an effective strategy in the enhancement of gatekeepers’ knowledge and self-efficacy in adolescent suicide prevention. However, barriers related to access (eg, time, resources) may hamper participation in face-to-face training sessions. The transition to a Web-based setting could address obstacles associated with face-to-face gatekeeper training. Although Web-based suicide prevention training targeting adolescents exists, so far no randomized controlled trials (RCTs) have been conducted to investigate their efficacy. Objective This RCT study investigated the efficacy of a Web-based adolescent suicide prevention program entitled Mental Health Online, which aimed to improve the knowledge and self-confidence of gatekeepers working with adolescents (12-20 years old). The program consisted of 8 short e-learning modules each capturing an important aspect of the process of early recognition, guidance, and referral of suicidal adolescents, alongside additional information on the topic of (adolescent) suicide prevention. Methods A total of 190 gatekeepers (ages 21 to 62 years) participated in this study and were randomized to either the experimental group or waitlist control group. The intervention was not masked. Participants from both groups completed 3 Web-based assessments (pretest, posttest, and 3-month follow-up). The outcome measures of this study were actual knowledge, and participants’ ratings of perceived knowledge and perceived self-confidence using questionnaires developed specifically for this study. Results The actual knowledge, perceived knowledge, and perceived self-confidence of gatekeepers in the experimental group improved significantly compared to those in the waitlist control group at posttest, and the effects remained significant at 3-month follow-up. The overall effect sizes were 0.76, 1.20, and 1.02, respectively, across assessments. Conclusions The findings of this study indicate that Web-based suicide prevention e-learning modules can be an effective educational method to enhance knowledge and self-confidence of gatekeepers with regard to adolescent suicide prevention. Gatekeepers with limited time and resources can benefit from the accessibility, simplicity, and flexibility of Web-based training. Trial Registration Netherlands Trial Register NTR3625; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3625 (Archived by WebCite at http://www.webcitation.org/6eHvyRh6M) PMID:26825006

Milrinone, a phosphodiesterase III inhibitor, prevents reduction of jugular bulb saturation during rewarming from hypothermic cardiopulmonary bypass.

PubMed

Iritakenishi, T; Hayashi, Y; Yamanaka, H; Kamibayashi, T; Ueda, K; Mashimo, T

2012-01-01

Inadequate cerebral oxygen balance during cardiopulmonary bypass may cause neuropsychological dysfunction. Milrinone, a phosphodiesterase III inhibitor, augments cerebral blood flow by direct vasodilatation. We conducted a prospective, randomized study in patients undergoing cardiac surgery with cardiopulmonary bypass to clarify the clinical efficacy of milrinone in the imbalance of cerebral oxygen supply and demand during the rewarming period of cardiopulmonary bypass. This is a prospective, randomized and placebo-controlled study. After anesthesia, a 5.5 F fiberoptic oximeter catheter was inserted into the right jugular bulb retrogradely for monitoring the jugular venous oxyhemoglobin saturation (SjO(2)). Patients were randomly assigned to two groups, one receiving a continuous infusion of milrinone, 0.5 µg/kg/min during hypothermic cardiopulmonary bypass, and the other receiving saline as control. Milrinone significantly prevented the reduction of the jugular venous oxyhemoglobin saturation at 10 minutes from the start of rewarming compared with the control group, but did not do so from 10 to 20 minutes after rewarming. Milrinone suppresses the reduction of SjO(2) and improves the balance of cerebral oxygen supply and demand during the early rewarming period of hypothermic cardiopulmonary bypass.

Evaluation of a sexual health approach to prevent HIV among low income, urban, primarily African American women: results of a randomized controlled trial.

PubMed

Robinson, Beatrice Bean E; Uhl, Gary; Miner, Michael; Bockting, Walter O; Scheltema, Karen E; Rosser, B R Simon; Westover, Bonita

2002-06-01

This randomized controlled trial evaluated an innovative culturally specific sexual health intervention-targeting, but not limited to, low-income African American women-in which HIV and sexually transmitted disease prevention strategies were combined with comprehensive sexuality education. The intervention was delivered and evaluated in community-based settings to 218 participants randomly assigned to treatment or a no-treatment control group. Participants were interviewed at pretest and 3 and 9 months after the intervention to assess changes in both sexuality and HIV risk variables. The intervention was effective in improving sexual anatomy knowledge at both 3- and 9-month follow-up. For a subset of women engaging in unprotected sex at pretest, the intervention group reported an increase in positive attitudes toward the female condom at 9-month follow-up. Reasons for the weak treatment effect are discussed in the context of challenges inherent in conducting community-based research with high-risk populations and sensitive topics. Recommendations are provided for improving sample attrition, statistical power, and response bias and for altering the intervention so as to strengthen its impact.

Linking Implementation Process to Intervention Outcomes in a Middle School Obesity Prevention Curriculum, "Choice, Control and Change"

ERIC Educational Resources Information Center

Gray, Heewon Lee; Contento, Isobel R.; Koch, Pamela A.

2015-01-01

This study investigates the link between process evaluation components and the outcomes of a school-based nutrition curriculum intervention, "Choice, Control and Change". Ten New York City public middle schools were recruited and randomly assigned into intervention or control condition. The curriculum was to improve sixth to seventh…

Screening and treating Chlamydia trachomatis genital infection to prevent pelvic inflammatory disease: interpretation of findings from randomized controlled trials.

PubMed

Gottlieb, Sami L; Xu, Fujie; Brunham, Robert C

2013-02-01

We critically reviewed randomized controlled trials evaluating chlamydia screening to prevent pelvic inflammatory disease (PID) and explored factors affecting interpretation and translation of trial data into public health prevention. Taken together, data from these trials offer evidence that chlamydia screening and treatment is an important and useful intervention to reduce the risk of PID among young women. However, the magnitude of benefit to be expected from screening may have been overestimated based on the earliest trials. It is likely that chlamydia screening programs have contributed to declines in PID incidence through shortening prevalent infections, although the magnitude of their contribution remains unclear. Program factors such as screening coverage as well as natural history factors such as risk of PID after repeat chlamydia infection can be important in determining the impact of chlamydia screening on PID incidence in a population. Uptake of chlamydia screening is currently suboptimal, and expansion of screening among young, sexually active women remains a priority. To reduce transmission and repeat infections, implementation of efficient strategies to treat partners of infected women is also essential. Results of ongoing randomized evaluations of the effect of screening on community-wide chlamydia prevalence and PID will also be valuable.

Impulsive lifestyle counseling to prevent dropout from treatment for substance use disorders in people with antisocial personality disorder: A randomized study.

PubMed

Thylstrup, Birgitte; Hesse, Morten

2016-06-01

Patients with antisocial personality disorder in outpatient treatment for substance use disorders are at high risk of drop-out. Using a randomized design, this study tested the impact of adding a brief psycho-educational program, the Impulsive Lifestyle Counseling program, to outpatient substance abuse treatment in order to prevent treatment dropout. Patients (N=175) were recruited from 13 municipal treatment centers in Denmark, and assigned to treatment as usual or to the experimental condition. In all, 172 patients could be included in the analyses. In the intent-to-treat analysis, the risk of treatment dropout was reduced among patients randomized to the experimental program (hazard ratio=0.63, p=.031), after controlling for age, gender, and substitution treatment status. The study supported the efficacy of the Impulsive Lifestyle Counseling program as a method for preventing treatment dropout for patients with comorbid antisocial personality disorder in substance abuse treatment. Trial registration #ISRCTN67266318. Copyright © 2016 Elsevier Ltd. All rights reserved.

No evidence of benefit from class-II compression stockings in the prevention of lower-limb lymphedema after inguinal lymph node dissection: results of a randomized controlled trial.

PubMed

Stuiver, M M; de Rooij, J D; Lucas, C; Nieweg, O E; Horenblas, S; van Geel, A N; van Beurden, M; Aaronson, N K

2013-09-01

Graduated compression stockings have been advocated for prevention of lymphedema after inguinal lymph node dissection (ILND) although scientific evidence of their efficacy in preventing lymphedema is lacking. The primary objective of this study was to assess the efficacy of class II compression stockings for the prevention of lymphedema in cancer patients following ILND. Secondary objectives were to investigate the influence of stockings on the occurrence of wound complications and genital edema, health-related quality of life (HRQoL) and body image. Eighty patients (45 with melanoma, 35 with urogenital tumors) who underwent ILND at two specialized cancer centers were randomly allocated to class II compression stocking use for six months or to a usual care control group. Lymphedema of the leg and genital area, wound complications, HRQoL, and body image were assessed at regular intervals prior to and up to 12 months after ILND. No significant differences were observed between groups in the incidence of edema, median time to the occurrence of edema, incidence of genital edema, frequency of complications, HRQoL, or body image. Based on the results of the current study, routine prescription of class II graduated compression stockings after ILND should be questioned and alternative prevention strategies should be considered.

A worksite prevention program for construction workers: design of a randomized controlled trial.

PubMed

Oude Hengel, Karen M; Joling, Catelijne I; Proper, Karin I; Blatter, Birgitte M; Bongers, Paulien M

2010-06-14

A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program compared with usual care for construction workers. The study is designed as a randomized controlled trial with a follow-up of one year. Employees eligible for this study are construction workers performing actual construction work. The worksite intervention will be compared with usual care. This intervention was developed by using the Intervention Mapping approach and consists of the following components: (1) two individual training sessions of a physical therapist to lower the physical workload, (2) a Rest-Break tool to improve the balance between work and recovery, and (3) two empowerment training sessions to increase the influence of the construction workers at the worksite. Outcome measures are assessed at baseline, 3, 6, and 12 months. The primary outcome measures of this study are work ability and health-related quality of life. Secondary outcome measures include need for recovery, musculoskeletal complaints, work engagement and self efficacy. Cost-effectiveness will be evaluated from the company perspective. Moreover, a process evaluation will be conducted. The feasibility of the intervention and the study has been enhanced by creating an intervention program that explicitly appeals to construction workers and will not interfere too much with the ongoing construction. The feasibility and effectiveness of this worksite prevention program will be investigated by means of an effect- and a process evaluation. If proven effective, this worksite prevention program can be implemented on a larger scale within the construction industry. NTR1278.

Efficacy of a new sealant to prevent white spot lesions during fixed orthodontic treatment : A 12-month, single-center, randomized controlled clinical trial.

PubMed

Hammad, Shaza M; Knösel, Michael

2016-11-01

White spot lesions (WSLs) are an undesirable side effect of fixed orthodontic appliance therapy and are reported to occur in 2-96 % of orthodontic patients. In this study, the efficacy of a new sealant to prevent WSLs during fixed orthodontic treatment was compared to a control group that did not receive sealant. For this 2-arm parallel-group randomized trial, 50 subjects aged 12-18 years (mean age 14.57 ± 2.04 years) were recruited from the orthodontics department at Mansoura University, Egypt. Eligibility criteria were no restorations, no active WSLs or caries, and adequate oral hygiene. Subjects were randomized in a 1:1 ratio to one of the two arms prior to undergoing fixed orthodontic treatment, namely a single application of SeLECT Defense™ sealant during the bracketing appointment or no sealant (control arm). Instructions and dentifrices for local home fluoridation regimen were identical in both groups. Oral hygiene was assessed using the Approximal Plaque Index (API) at specified time intervals. Dental photographs were taken for blinded WSLs assessment; inter- and intra-operator error were also calculated. Categorical data were tested using the χ 2 test, and a logistic regression model was adopted to detect associations between decalcification (WSLs), sealant application, and oral hygiene status. Only excellent or good oral hygiene were independent prognostic factors for preventing severe WSLs (p = 0.035). No significant effect on caries incidence was observed for the sealant. In combination with adequate oral hygiene SeLECT Defense™ helps to reduced the frequency of WSLs. However, the sealat showed no significant effect as sole preventive strategy.

Community-based randomized controlled trial of diabetes prevention study for high-risk individuals of type 2 diabetes: lifestyle intervention using web-based system.

PubMed

Cha, Seon-Ah; Lim, Sun-Young; Kim, Kook-Rye; Lee, Eun-Young; Kang, Borami; Choi, Yoon-Hee; Yoon, Kun-Ho; Ahn, Yu-Bae; Lee, Jin-Hee; Ko, Seung-Hyun

2017-05-05

The trend of increasing numbers of patients with type 2 diabetes emphasizes the need for active screening of high-risk individuals and intensive lifestyle modification (LSM). The community-based Korean Diabetes Prevention Study (C-KDPS) is a randomized controlled clinical trial to prevent type 2 diabetes by intensive LSM using a web-based program. The two public healthcare centers in Korea are involved, and 420 subjects are being recruited for 6 months and will be followed up for 22 months. The participants are allocated randomly to intensive LSM (18 individual sessions for 24 weeks) and usual care (control group). The major goals of the C-KDPS lifestyle intervention program are: 1) a minimum of 5-7% loss of initial body weight in 6 months and maintenance of this weight loss, 2) increased physical activity (≥ 150 min/week of moderate intensity activity), 3) balanced healthy eating, and 4) quitting smoking and alcohol with stress management. The web-based program includes education contents, video files, visit schedules, and inter-communicable keeping track sites. Primary outcomes are the diagnoses of newly developed diabetes. A 75-g oral glucose tolerance test with hemoglobin A1c level determination and cardiovascular risk factor assessment is scheduled at 6, 12, 18, and 22 months. Active screening of high-risk individuals and an effective LSM program are an essential prerequisite for successful diabetes prevention. We hope that our C-KDPS program can reduce the incidence of newly developed type 2 diabetes and be implemented throughout the country, merging community-based public healthcare resources and a web-based system. Clinical Research Information Service (CRIS), Republic of Korea (No. KCT0001981 ). Date of registration; July 28, 2016.

Effect of Maintenance Therapy with Isoxsuprine in the Prevention of Preterm Labor: Randomized controlled trial

PubMed Central

Alavi, Azin; Rajaee, Minoo; Amirian, Malihe; Mahboobi, Hamidreza; Jahanshahi, Keramat Allah; Faghihi, Armaghan

2015-01-01

Background: Isoxsuprine (Vasodilan) is a beta-adrenergic that directly affects the vascular smooth muscle and results in peripheral vascular dilation. Isoxsuprine relaxes the uterine smooth muscles and is used for treatment of pre-term labor and dysmenorrhea. Isoxsuprine is used extensively in hospitals and private clinics in Iran; however, few studies have reported its safety and efficacy in the prevention of pre-term labor. Objective: The aim of this study was to assess the effect of maintenance therapy with oral isoxsuprine for the prevention of pre-term labor. Methods: We undertook a blinded prospective randomized trial of 70 women with singleton pregnancies who presented in pre-term labor between 26 to 34 weeks of gestation. After arresting the contractions with intravenous magnesium sulfate, the patients were randomized into two groups, with the treatment group receiving oral isoxsuprine until 34 weeks of gestation. Response to treatment was assessed by the progression of the pregnancies in both groups. The data were analyzed using SPSS software. Results: Our results showed that 14 (40%) of the patients in the case group and 12 (34.29%) of patients in the control group had pre-term births, and there was no significant difference between the two groups (P=0.621). Also four women (11.43%) in the case group and five women (14.29%) in the control group delivered before 34 weeks (P=0.721). Conclusion: Oral isoxsuprine was not effective as a maintenance treatment in preventing pre-term births or in delaying delivery until after 34 weeks. Larger studies are needed to identify the best treatment for pre-term labor. PMID:26396726

Atrial fibrillation detected by continuous electrocardiographic monitoring using implantable loop recorder to prevent stroke in individuals at risk (the LOOP study): Rationale and design of a large randomized controlled trial.

PubMed

Diederichsen, Søren Zöga; Haugan, Ketil Jørgen; Køber, Lars; Højberg, Søren; Brandes, Axel; Kronborg, Christian; Graff, Claus; Holst, Anders Gaarsdal; Nielsen, Jonas Bille; Krieger, Derk; Svendsen, Jesper Hastrup

2017-05-01

Atrial fibrillation (AF) increases the rate of stroke 5-fold, and AF-related strokes have a poorer prognosis compared with non-AF-related strokes. Atrial fibrillation and stroke constitute an intensifying challenge, and health care organizations are calling for awareness on the topic. Previous studies have demonstrated that AF is often asymptomatic and consequently undiagnosed. The implantable loop recorder (ILR) allows for continuous, long-term electrocardiographic monitoring with daily transmission of arrhythmia information, potentially leading to improvement in AF detection and stroke prevention. The LOOP study is an investigator-initiated, randomized controlled trial with 6,000 participants randomized 3:1 to a control group or to receive an ILR with continuous electrocardiographic monitoring. Participants are identified from Danish registries and are eligible for inclusion if 70years or older and previously diagnosed as having at least one of the following conditions: hypertension, diabetes mellitus, heart failure, or previous stroke. Exclusion criteria include history of AF and current oral anticoagulation treatment. When an AF episode lasting ≥6minutes is detected, oral anticoagulation will be initiated according to guidelines. Expected follow-up is 4years. The primary end point is time to stroke or systemic embolism, whereas secondary end points include time to AF diagnosis and death. The LOOP study will evaluate health benefits and cost-effectiveness of ILR as a screening tool for AF to prevent stroke in patients at risk. Secondary objectives include identification of risk factors for the development of AF and characterization of arrhythmias in the population. The trial holds the potential to influence the future of stroke prevention. Copyright © 2017 Elsevier Inc. All rights reserved.

A worksite prevention program for construction workers: design of a randomized controlled trial

PubMed Central

2010-01-01

Background A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program compared with usual care for construction workers. Methods The study is designed as a randomized controlled trial with a follow-up of one year. Employees eligible for this study are construction workers performing actual construction work. The worksite intervention will be compared with usual care. This intervention was developed by using the Intervention Mapping approach and consists of the following components: (1) two individual training sessions of a physical therapist to lower the physical workload, (2) a Rest-Break tool to improve the balance between work and recovery, and (3) two empowerment training sessions to increase the influence of the construction workers at the worksite. Outcome measures are assessed at baseline, 3, 6, and 12 months. The primary outcome measures of this study are work ability and health-related quality of life. Secondary outcome measures include need for recovery, musculoskeletal complaints, work engagement and self efficacy. Cost-effectiveness will be evaluated from the company perspective. Moreover, a process evaluation will be conducted. Discussion The feasibility of the intervention and the study has been enhanced by creating an intervention program that explicitly appeals to construction workers and will not interfere too much with the ongoing construction. The feasibility and effectiveness of this worksite prevention program will be investigated by means of an effect- and a process evaluation. If proven effective, this worksite prevention program can be implemented on a larger scale within the construction industry. Trial Registration NTR1278 PMID:20546568

Low dose aspirin in the prevention of recurrent spontaneous preterm labour - the APRIL study: a multicenter randomized placebo controlled trial.

PubMed

Visser, Laura; de Boer, Marjon A; de Groot, Christianne J M; Nijman, Tobias A J; Hemels, Marieke A C; Bloemenkamp, Kitty W M; Bosmans, Judith E; Kok, Marjolein; van Laar, Judith O; Sueters, Marieke; Scheepers, Hubertina; van Drongelen, Joris; Franssen, Maureen T M; Sikkema, J Marko; Duvekot, Hans J J; Bekker, Mireille N; van der Post, Joris A M; Naaktgeboren, Christiana; Mol, Ben W J; Oudijk, Martijn A

2017-07-14

Preterm birth (birth before 37 weeks of gestation) is a major problem in obstetrics and affects an estimated 15 million pregnancies worldwide annually. A history of previous preterm birth is the strongest risk factor for preterm birth, and recurrent spontaneous preterm birth affects more than 2.5 million pregnancies each year. A recent meta-analysis showed possible benefits of the use of low dose aspirin in the prevention of recurrent spontaneous preterm birth. We will assess the (cost-)effectiveness of low dose aspirin in comparison with placebo in the prevention of recurrent spontaneous preterm birth in a randomized clinical trial. Women with a singleton pregnancy and a history of spontaneous preterm birth in a singleton pregnancy (22-37 weeks of gestation) will be asked to participate in a multicenter, randomized, double blinded, placebo controlled trial. Women will be randomized to low dose aspirin (80 mg once daily) or placebo, initiated from 8 to 16 weeks up to maximal 36 weeks of gestation. The primary outcome measure will be preterm birth, defined as birth at a gestational age (GA) < 37 weeks. Secondary outcomes will be a composite of adverse neonatal outcome and maternal outcomes, including subgroups of prematurity, as well as intrauterine growth restriction (IUGR) and costs from a healthcare perspective. Preterm birth will be analyzed as a group, as well as separately for spontaneous or indicated onset. Analysis will be performed by intention to treat. In total, 406 pregnant women have to be randomized to show a reduction of 35% in preterm birth from 36 to 23%. If aspirin is effective in preventing preterm birth, we expect that there will be cost savings, because of the low costs of aspirin. To evaluate this, a cost-effectiveness analysis will be performed comparing preventive treatment with aspirin with placebo. This trial will provide evidence as to whether or not low dose aspirin is (cost-) effective in reducing recurrence of spontaneous preterm birth. Clinical trial registration number of the Dutch Trial Register: NTR 5675 . EudraCT-registration number: 2015-003220-31.

Two-Year Outcomes of a Randomized, Family-Based Substance Use Prevention Trial for Asian American Adolescent Girls

PubMed Central

Fang, Lin; Schinke, Steven P.

2014-01-01

Asian Americans have been largely ignored in the prevention outcome literature. In this study, we tested a parent-child program with a sample of Asian American adolescent girls and their mothers, and evaluated the program’s efficacy on decreasing girls’ substance use, and modifying risk and protective factors at individual, family, and peer levels. One hundred and eight Asian American mother-daughter dyads recruited through online advertisements and from community service agencies were randomly assigned to an intervention arm (n = 56) or to a test-only control arm (n = 52). The intervention consisted of a nine-session substance abuse prevention program, delivered entirely online. Guided by family interaction theory, the prevention program aimed to strengthen the quality of girls’ relationships with their mothers while increasing girls’ resilience to resist substance use. Intent-to-treat analyses showed that at 2-year follow-up, intervention-arm dyads had significantly higher levels of mother-daughter closeness, mother-daughter communication, maternal monitoring, and family rules against substance use compared to the control-arm dyads. Intervention-arm girls also showed sustained improvement in self-efficacy and refusal skills, and had lower intentions to use substances in the future. Most important, intervention-arm girls reported fewer instances of alcohol and marijuana use, and prescription drug misuse relative to the control-arm girls. The study suggests that a culturally generic, family-based prevention program was efficacious in enhancing parent-child relationships, improving girls’ resiliency, and preventing substance use behaviors among Asian American girls. PMID:23276322

Two-year outcomes of a randomized, family-based substance use prevention trial for Asian American adolescent girls.

PubMed

Fang, Lin; Schinke, Steven P

2013-09-01

Asian Americans have been largely ignored in the prevention outcome literature. In this study, we tested a parent-child program with a sample of Asian American adolescent girls and their mothers, and evaluated the program's efficacy on decreasing girls' substance use and modifying risk and protective factors at individual, family, and peer levels. A total of 108 Asian American mother-daughter dyads recruited through online advertisements and from community service agencies were randomly assigned to an intervention arm (n = 56) or to a test-only control arm (n = 52). The intervention consisted of a nine-session substance abuse prevention program, delivered entirely online. Guided by family interaction theory, the prevention program aimed to strengthen the quality of girls' relationships with their mothers while increasing girls' resilience to resist substance use. Intent-to-treat analyses showed that at 2-year follow-up, intervention-arm dyads had significantly higher levels of mother-daughter closeness, mother-daughter communication, maternal monitoring, and family rules against substance use compared with the control-arm dyads. Intervention-arm girls also showed sustained improvement in self-efficacy and refusal skills and had lower intentions to use substances in the future. Most important, intervention-arm girls reported fewer instances of alcohol and marijuana use and prescription drug misuse relative to the control-arm girls. The study suggests that a culturally generic, family-based prevention program was efficacious in enhancing parent-child relationships, improving girls' resiliency, and preventing substance use behaviors among Asian American girls. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Promoting adaptive emotion regulation and coping in adolescence: a school-based programme.

PubMed

Horn, Andrea B; Pössel, Patrick; Hautzinger, Martin

2011-03-01

Particularly in adolescence, fostering adaptive emotion regulation is an important aim in health promotion. Expressive writing in combination with psycho-education on emotion regulation seems especially appropriate to serve this aim. In this study, school classes were randomly assigned either to a prevention (N = 208) or to a non-treatment control group (N = 151). The prevention group showed significant improvements regarding negative affect, grades, and days absent compared to the control-group. A combination of expressive writing with elements of psycho-education of emotion regulation might be an effective preventive tool, as it seems to improve psychosocial adjustment by establishing functional emotion regulation strategies.

Reduced frequency and severity of residential fires following delivery of fire prevention education by on-duty fire fighters: cluster randomized controlled study.

PubMed

Clare, Joseph; Garis, Len; Plecas, Darryl; Jennings, Charles

2012-04-01

In 2008, Surrey Fire Services, British Columbia, commenced a firefighter-delivered, door-to-door fire-prevention education and smoke alarm examination/installation initiative with the intention of reducing the frequency and severity of residential structure fires in the City of Surrey. High-risk zones within the city were identified and 18,473 home visits were undertaken across seven temporal delivery cohorts (13.8% of non-apartment dwellings in the city). The frequency and severity of fires pre- and post- the home visit intervention was examined in comparison to randomized high-risk cluster controls. Overall, the frequency of fires was found to have reduced in the city overall, however, the reduction in the intervention cohorts was significantly larger than for controls. Furthermore, when fires did occur within the intervention cohorts, smoke detectors were activated more frequently and the fires were confined to the object of origin more often post-home visits. No equivalent pattern was observed for the cluster control. On-duty fire fighters can reduce the frequency and severity of residential fires through targeted, door-to-door distribution of fire prevention education in high-risk areas. Copyright © 2012 Elsevier Ltd. All rights reserved.

Evaluation of a Technology-Based Adaptive Learning and Prevention Program for Stress Response-A Randomized Controlled Trial.

PubMed

Wesemann, Ulrich; Kowalski, Jens T; Jacobsen, Thomas; Beudt, Susan; Jacobs, Herbert; Fehr, Julia; Büchler, Jana; Zimmermann, Peter L

2016-08-01

To prevent deployment-related disorders, Chaos Driven Situations Management Retrieval System (CHARLY), a computer-aided training platform with a biofeedback interface has been developed. It simulates critical situations photorealistic for certain target and occupational groups. CHARLY was evaluated as a 1.5 days predeployment training method comparing it with the routine training. The evaluation was carried out for a matched random sample of N = 67 soldiers deployed in Afghanistan (International Security Assistance Force). Data collection took place before and after the prevention program and 4 to 6 weeks after deployment, which included mental state, post-traumatic stress disorder (PTSD) symptoms, knowledge of and attitude toward PTSD, and deployment-specific stressors. CHARLY has been significantly superior to the control group in terms of psychoeducation and attitude change. As to the mental state, both groups showed a significant increase in stress after deployment with significant lower increase in CHARLY. For PTSD-specific symptoms, CHARLY achieved a significant superiority. The fact that PTSD-specific scales showed significant differences at the end of deployment substantiates the validity of a specifically preventive effect of CHARLY. The study results tentatively indicate that highly standardized, computer-based primary prevention of mental disorders in soldiers on deployment might be superior to other more personal and less standardized forms of prevention. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

A Randomized Control Trial for Evaluating Efficacies of Two Online Cognitive Interventions With and Without Fear-Appeal Imagery Approaches in Preventing Unprotected Anal Sex Among Chinese Men Who Have Sex with Men.

PubMed

Lau, Joseph T F; Lee, Annisa L; Tse, Wai S; Mo, Phoenix K H; Fong, Francois; Wang, Zixin; Cameron, Linda D; Sheer, Vivian

2016-09-01

Fear appeal approach has been used in health promotion, but its effectiveness has been mixed. It has not been well applied to HIV prevention among men who have sex with men (MSM). The present study developed and evaluated the relative efficacy of three online interventions (SC: STD-related cognitive approach, SCFI: STD-related cognitive plus fear appeal imagery approach, Control: HIV-related information based approach) in reducing prevalence of unprotected anal intercourse (UAI) among 396 MSM using a randomized controlled trial design. Participants' levels of fear-related emotions immediately after watching the assigned intervention materials were also assessed. Participants were evaluated at baseline and 3 months after the intervention. Results showed that participants in the SCFI scored significantly higher in the instrument assessing fear after the watching the intervention materials. However, no statistically significant differences were found across the three groups in terms of UAI at Month 3. Some significant within-group reductions in some measures of UAI were found in three groups. Further studies are warranted to test the role of fear appeal in HIV prevention.

Performance aspects of an injury prevention program: a ten-week intervention in adolescent female football players.

PubMed

Steffen, K; Bakka, H M; Myklebust, G; Bahr, R

2008-10-01

The injury rate in football is high, and effective injury prevention methods are needed. An exercise program, the "11," has been designed to prevent the most common injury types in football. However, the effect of such a program on performance is not known. The aim of this randomized-controlled trial was to investigate the effect of the "11" on performance after a 10-week training period. Thirty-four adolescent female football players were randomly assigned to either an intervention (n=18) or a control group (n=16). The "11" is a 15-min program consisting of ten exercises for core stability, lower extremity strength, balance and agility. Performance tests included isokinetic and isometric strength protocols for the quadriceps and hamstrings, isometric hip adduction and abduction strength, vertical jump tests, sprint running and soccer skill tests. There was no difference between the intervention and control groups in the change in performance from the pre- to post-test for any of the tests used. In conclusion, no effect was observed on a series of performance tests in a group of adolescent female football players using the "11" as a structured warm-up program.

Efficacy of Single-dose and 2-dose Intravenous Administration of Ramosetron in Preventing Postoperative Nausea and Vomiting After Laparoscopic Gynecologic Operation: A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial.

PubMed

Lee, Banghyun; Kim, Kidong; Suh, Dong Hoon; Shin, Hyun-Jung; No, Jae Hong; Lee, Jung Ryeol; Jee, Byung Chul; Hwang, Jung Won; Do, Sang Hwan; Kim, Yong Beom

2017-06-01

This randomized trial investigated whether a 2-dose administration of intravenous ramosetron (5-hydroxytryptamine type 3 receptor antagonist) is more effective than a single-dose administration in preventing postoperative nausea and vomiting (PONV) in 89 patients who were scheduled to undergo laparoscopic operation for benign gynecologic diseases and to receive intravenous patient-controlled analgesia for relief of postoperative pain. After assignment at a ratio of 1:1, intravenous ramosetron (0.3 mg) was initially administered at the end of skin closure in all patients. Thereafter, ramosetron (0.3 mg) and placebo were administered to the study and control groups, respectively, at 4 hours after the operation. The baseline and operative characteristics were similar between the groups. The incidence of PONV during the 24-hour period after operation which was assessed as the primary endpoint did not differ between the groups. No serious adverse events occurred in either group. A 2-dose administration of intravenous ramosetron may not be superior to a single-dose administration in preventing PONV in patients undergoing laparoscopic operation for benign gynecologic diseases.

Determinants of Dropout and Nonadherence in a Dementia Prevention Randomized Controlled Trial: The Prevention of Dementia by Intensive Vascular Care Trial.

PubMed

Beishuizen, Cathrien R L; Coley, Nicola; Moll van Charante, Eric P; van Gool, Willem A; Richard, Edo; Andrieu, Sandrine

2017-07-01

To explore and compare sociodemographic, clinical, and neuropsychiatric determinants of dropout and nonadherence in older people participating in an open-label cluster-randomized controlled trial-the Prevention of Dementia by Intensive Vascular care (preDIVA) trial-over 6 years. Secondary analysis. One hundred sixteen general practices in the Netherlands. Community-dwelling individuals aged 70 to 78 (N = 2,994). Nurse-led multidomain intervention targeting cardiovascular risk factors to prevent dementia. The associations between participant baseline sociodemographic (age, sex, education), clinical (medical history, disability, cardiovascular risk), neuropsychiatric (depressive symptoms (Geriatric Depression Scale-15), and cognitive (Mini-Mental State Examination)) characteristics and dropout from the trial and nonadherence to the trial intervention were explored using multilevel logistic regression models. Older age, poorer cognitive function, more symptoms of depression, and greater disability were the most important determinants of dropout of older people. The presence of cardiovascular risk factors was not associated with dropout but was associated with nonadherence. Being overweight was a risk factor for nonadherence, whereas people with high blood pressure or a low level of physical exercise adhered better to the intervention. The association between poorer cognitive function and symptoms of depression and dropout was stronger in the control group than in the intervention group, and vice versa for increased disability. In a large dementia prevention trial with 6-year follow-up, dropout was associated with older age, poorer cognitive function, symptoms of depression, and disability at baseline. These findings can help to guide the design of future dementia prevention trials in older adults. The associations found between cardiovascular risk factors and nonadherence need to be confirmed in other older populations receiving cardiovascular prevention interventions. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

Optimizing Implementation of Obesity Prevention Programs: A Qualitative Investigation Within a Large-Scale Randomized Controlled Trial.

PubMed

Kozica, Samantha L; Teede, Helena J; Harrison, Cheryce L; Klein, Ruth; Lombard, Catherine B

2016-01-01

The prevalence of obesity in rural and remote areas is elevated in comparison to urban populations, highlighting the need for interventions targeting obesity prevention in these settings. Implementing evidence-based obesity prevention programs is challenging. This study aimed to investigate factors influencing the implementation of obesity prevention programs, including adoption, program delivery, community uptake, and continuation, specifically within rural settings. Nested within a large-scale randomized controlled trial, a qualitative exploratory approach was adopted, with purposive sampling techniques utilized, to recruit stakeholders from 41 small rural towns in Australia. In-depth semistructured interviews were conducted with clinical health professionals, health service managers, and local government employees. Open coding was completed independently by 2 investigators and thematic analysis undertaken. In-depth interviews revealed that obesity prevention programs were valued by the rural workforce. Program implementation is influenced by interrelated factors across: (1) contextual factors and (2) organizational capacity. Key recommendations to manage the challenges of implementing evidence-based programs focused on reducing program delivery costs, aided by the provision of a suite of implementation and evaluation resources. Informing the scale-up of future prevention programs, stakeholders highlighted the need to build local rural capacity through developing supportive university partnerships, generating local program ownership and promoting active feedback to all program partners. We demonstrate that the rural workforce places a high value on obesity prevention programs. Our results inform the future scale-up of obesity prevention programs, providing an improved understanding of strategies to optimize implementation of evidence-based prevention programs. © 2015 National Rural Health Association.

A Randomized Educational Intervention Trial to Determine the Effect of Online Education on the Quality of Resident-Delivered Care.

PubMed

Dolan, Brigid M; Yialamas, Maria A; McMahon, Graham T

2015-09-01

There is limited research on whether online formative self-assessment and learning can change the behavior of medical professionals. We sought to determine if an adaptive longitudinal online curriculum in bone health would improve resident physicians' knowledge, and change their behavior regarding prevention of fragility fractures in women. We used a randomized control trial design in which 50 internal medicine resident physicians at a large academic practice were randomized to either receive a standard curriculum in bone health care alone, or to receive it augmented with an adaptive, longitudinal, online formative self-assessment curriculum delivered via multiple-choice questions. Outcomes were assessed 10 months after the start of the intervention. Knowledge outcomes were measured by a multiple-choice question examination. Clinical outcomes were measured by chart review, including bone density screening rate, calculation of the fracture risk assessment tool (FRAX) score, and rate of appropriate bisphosphonate prescription. Compared to the control group, residents participating in the intervention had higher scores on the knowledge test at the end of the study. Bone density screening rates and appropriate use of bisphosphonates were significantly higher in the intervention group compared with the control group. FRAX score reporting did not differ between the groups. Residents participating in a novel adaptive online curriculum outperformed peers in knowledge of fragility fracture prevention and care practices to prevent fracture. Online adaptive education can change behavior to improve patient care.

Effectiveness of a Dissonance-Based Eating Disorder Prevention Program for Ethnic Groups in Two Randomized Controlled Trials

PubMed Central

Stice, Eric; Marti, C. Nathan; Cheng, Zhen Hadassah

2014-01-01

Objective As young women from certain ethnic minority groups have reported less pursuit of the thin ideal and body dissatisfaction than European American young women we tested whether a dissonance-based prevention program designed to reduce thin-ideal internalization among women with body dissatisfaction is less effective for the former relative to the later groups. We also tested whether intervention effects are larger when participants from minority groups worked with a facilitator matched versus not matched on ethnicity. Method In Study 1, 426 female undergraduates (M age = 21.6, SD = 5.6) were randomized to clinician-led Body Project groups or an educational control group. In Study 2, 189 female undergraduates were randomized to peer-led Body Project groups or a waitlist control condition. Results Although there was some variation in risk factor scores across ethnic groups, ethnic minority participants did not demonstrate consistently higher or lower risk relative to European American participants. Intervention effects did not significantly differ for participants from minority groups versus European American participants in either trial. There was no evidence that effects were significantly larger when minority participants and facilitators were matched on ethnicity. Conclusions Results suggest that the Body Project is similarly effective for African American, Asian American, European American, and Hispanic female college students, and when participants and facilitators are matched or not on minority ethnicity status, implying that this prevention program can be broadly disseminated in this population. PMID:24655465

A Randomized Educational Intervention Trial to Determine the Effect of Online Education on the Quality of Resident-Delivered Care

PubMed Central

Dolan, Brigid M.; Yialamas, Maria A.; McMahon, Graham T.

2015-01-01

Background There is limited research on whether online formative self-assessment and learning can change the behavior of medical professionals. Objective We sought to determine if an adaptive longitudinal online curriculum in bone health would improve resident physicians' knowledge, and change their behavior regarding prevention of fragility fractures in women. Methods We used a randomized control trial design in which 50 internal medicine resident physicians at a large academic practice were randomized to either receive a standard curriculum in bone health care alone, or to receive it augmented with an adaptive, longitudinal, online formative self-assessment curriculum delivered via multiple-choice questions. Outcomes were assessed 10 months after the start of the intervention. Knowledge outcomes were measured by a multiple-choice question examination. Clinical outcomes were measured by chart review, including bone density screening rate, calculation of the fracture risk assessment tool (FRAX) score, and rate of appropriate bisphosphonate prescription. Results Compared to the control group, residents participating in the intervention had higher scores on the knowledge test at the end of the study. Bone density screening rates and appropriate use of bisphosphonates were significantly higher in the intervention group compared with the control group. FRAX score reporting did not differ between the groups. Conclusions Residents participating in a novel adaptive online curriculum outperformed peers in knowledge of fragility fracture prevention and care practices to prevent fracture. Online adaptive education can change behavior to improve patient care. PMID:26457142

Efficacy of fluoride varnish for preventing white spot lesions and gingivitis during orthodontic treatment with fixed appliances-a prospective randomized controlled trial.

PubMed

Kirschneck, Christian; Christl, Jan-Joachim; Reicheneder, Claudia; Proff, Peter

2016-12-01

The development of white spot lesions around orthodontic brackets and gingivitis is a common problem during orthodontic treatment with fixed appliances. This prospective randomized double-blind controlled clinical trial investigated the preventive efficacy of a one-time application of two commonly used fluoride varnishes in patients with low to moderate caries risk. Ninety adolescent orthodontic patients with a low to moderate caries risk were prospectively randomized to three groups of 30 patients each: (1) standardized dental hygiene with fluoride toothpaste and one-time application of placebo varnish (control) or (2) of elmex® fluid or (3) of Fluor Protector S on all dental surfaces at the start of fixed therapy. The extent of enamel demineralization and gingivitis was determined with the ICDAS and the gingivitis index (GI) at baseline and after 4, 12, and 20 weeks. Each treatment group showed a significant increase of the ICDAS index, but not of the GI over the course of time with no significant intergroup differences detectable. A one-time application of fluoride varnish at the start of orthodontic treatment did not provide any additional preventive advantage over sufficient dental hygiene with fluoride toothpaste with regard to formation of white spots and gingivitis in patients with a low to moderate caries risk. In dental practice, patients often receive an application of fluoride varnish at the start of orthodontic treatment with fixed appliances. However, the efficacy of this procedure is still unclear.

Effectiveness of a dissonance-based eating disorder prevention program for ethnic groups in two randomized controlled trials.

PubMed

Stice, Eric; Marti, C Nathan; Cheng, Zhen Hadassah

2014-04-01

As young women from certain ethnic minority groups have reported less pursuit of the thin ideal and body dissatisfaction than European American young women we tested whether a dissonance-based prevention program designed to reduce thin-ideal internalization among women with body dissatisfaction is less effective for the former relative to the later groups. We also tested whether intervention effects are larger when participants from minority groups worked with a facilitator matched versus not matched on ethnicity. In Study 1, 426 female undergraduates (M age=21.6, SD=5.6) were randomized to clinician-led Body Project groups or an educational control group. In Study 2, 189 female undergraduates were randomized to peer-led Body Project groups or a waitlist control condition. Although there was some variation in risk factor scores across ethnic groups, ethnic minority participants did not demonstrate consistently higher or lower risk relative to European American participants. Intervention effects did not significantly differ for participants from minority groups versus European American participants in either trial. There was no evidence that effects were significantly larger when minority participants and facilitators were matched on ethnicity. Results suggest that the Body Project is similarly effective for African American, Asian American, European American, and Hispanic female college students, and when participants and facilitators are matched or not on minority ethnicity status, implying that this prevention program can be broadly disseminated in this population. Copyright © 2014 Elsevier Ltd. All rights reserved.

A randomized, controlled trial of disability prevention in frail older patients screened in primary care: the FRASI study. Design and baseline evaluation.

PubMed

Bandinelli, Stefania; Lauretani, Fulvio; Boscherini, Vittorio; Gandi, Francesca; Pozzi, Martina; Corsi, Anna Maria; Bartali, Benedetta; Lova, Raffaello Molino; Guralnik, Jack M; Ferrucci, Luigi

2006-10-01

We describe the enrollment and intervention phases of FRASI (FRAilty, Screening and Intervention), a randomized controlled trial aimed at preventing ADL disability in frail older persons screened in primary care. Patients, 70-85 years old, non-disabled and noncognitively impaired, were screened for frailty (score < or = 9 on the Short Physical Performance Battery, SPPB) during primary care visits. Of 447 eligible persons, 410 came to the study clinic and 251 were randomized into treatment (n=126) and control groups (n=125). The active group received an intensive medical intervention, and sixteen 90-minute supervised exercise sessions over 8 weeks. The primary outcome was time to ADL disability onset or death in the 12-month period after study enrollment. The two study arms were similar for demographics, cognitive function, physical function and health status. Compared with a population-based sample selected according to FRASI inclusion criteria except SPPB score, FRASI participants had significantly worse health and functional status. Restricting the comparison to persons with SPPB < or = 9, all differences disappeared. The 99 participants (78.6% of 126) who completed the intervention participated in a mean of 15.3+/-1.6 exercise sessions. Screening in primary care for non-disabled, older persons with SPPB < or = 9 yields individuals with substantial morbidity, impairments and functional limitations that can be successfully involved in an intensive medical and exercise intervention. Whether such an intervention effectively prevents new disability remains to be confirmed.

Evaluation of Brief Group-Administered Instruction for Parents to Prevent or Minimize Sleep Problems in Young Children with Down Syndrome

ERIC Educational Resources Information Center

Stores, Rebecca; Stores, Gregory

2004-01-01

Background: The study concerns the unknown value of group instruction for mothers of young children with Down syndrome (DS) in preventing or minimizing sleep problems. Method: (1) Children with DS were randomly allocated to an Instruction group (given basic information about children's sleep) and a Control group for later comparison including…

Collaborative Evaluation of a High School Prevention Curriculum: How Methods of Collaborative Evaluation Enhanced a Randomized Control Trial to Inform Program Improvement

ERIC Educational Resources Information Center

Orsini, Muhsin Michael; Wyrick, David L.; Milroy, Jeffrey J.

2012-01-01

Blending high-quality and rigorous research with pure evaluation practice can often be best accomplished through thoughtful collaboration. The evaluation of a high school drug prevention program (All Stars Senior) is an example of how perceived competing purposes and methodologies can coexist to investigate formative and summative outcome…

Preventing Behavior Problems among Elementary Schoolchildren: Impact of a Universal School-Based Program in China

ERIC Educational Resources Information Center

Hong, Lin; Yufeng, Wang; Agho, Kingsley; Jacobs, Jennifer

2011-01-01

Background: To evaluate the effect on problem behaviors of a universal school-based prevention curriculum of third grade students. Methods: Six regular classes in 1 elementary school were randomly assigned to an intervention (n = 208) or control (n = 209) group. A 13-session program was offered to students in the intervention group. The Achenbach…

Effectiveness of a Theory-Based Risk Reduction HIV Prevention Program for Rural Vietnamese Adolescents

ERIC Educational Resources Information Center

Kaljee, Linda M.; Genberg, Becky; Riel, Rosemary; Cole, Matthew; Tho, Le Huu; Thoa, Le Thi Kim; Stanton, Bonita; Li, Xiaoming; Minh, Tuong Tan

2005-01-01

As of April 2003, 64,801 HIV cases have been documented in Vietnam (Policy Project 2003), 53.9% of which are among individuals 20-29 years of age. Although HIV education efforts have increased, there remains a need for proven effective programs. We present findings from a randomized-controlled effectiveness trial of an HIV prevention program for…

Colorectal Chemoprevention with Calcium and Vitamin D | Division of Cancer Prevention

Cancer.gov

In this application we propose to complete CA098286, a double-blind, randomized, controlled trial of supplementation with vitamin D and/or calcium for the prevention of colorectal adenomas. The study builds on extensive epidemiological and experimental data indicating that both vitamin D and calcium have anti-neoplastic effects in the large bowel and that these agents

A Mediation Analysis of a Tobacco Prevention Program for Adolescents in India: How Did Project MYTRI Work?

ERIC Educational Resources Information Center

Stigler, Melissa Harrell; Perry, Cheryl L.; Smolenski, Derek; Arora, Monika; Reddy, K. Srinath

2011-01-01

This article presents the results of a mediation analysis of Project MYTRI (Mobilizing Youth for Tobacco Related Initiatives in India), a randomized, controlled trial of a multiple-component, school-based tobacco prevention program for sixth- to ninth-graders (n = 14,085) in Delhi and Chennai, India. A mediation analysis identifies "how"…

Mediating Factors of a School-Based Multi-Component Smoking Prevention Intervention: The LdP Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Carreras, G.; Bosi, S.; Angelini, P.; Gorini, G.

2016-01-01

The aim of this study was to investigate factors mediating the effects of Luoghi di Prevenzione (LdP) smoking prevention intervention based on social competence and social influence approaches, and characterized by peer-led school-based interventions, out-of-school workshops, school lessons, and by enforcing the school anti-smoking policy.…

A Family and Community Focused Lifestyle Program Prevents Weight Regain in Pacific Islanders: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Kaholokula, Joseph Keawe'aimoku; Mau, Marjorie K.; Efird, Jimmy T.; Leake, Anne; West, Margaret; Palakiko, Donna-Marie; Yoshimura, Sheryl R.; Kekauoha, B. Puni; Rose, Charles; Gomes, Henry

2012-01-01

Preventing weight regain after the loss of excess weight is challenging for people, especially for ethnic minorities in the United States. A 6-month weight loss maintenance intervention designed for Pacific Islanders, called the PILI Lifestyle Program (PLP), was compared with a 6-month standard behavioral weight loss maintenance program (SBP) in a…

Estimating intervention effects of prevention programs: Accounting for noncompliance

PubMed Central

Stuart, Elizabeth A.; Perry, Deborah F.; Le, Huynh-Nhu; Ialongo, Nicholas S.

2010-01-01

Individuals not fully complying with their assigned treatments is a common problem encountered in randomized evaluations of behavioral interventions. Treatment group members rarely attend all sessions or do all “required” activities; control group members sometimes find ways to participate in aspects of the intervention. As a result, there is often interest in estimating both the effect of being assigned to participate in the intervention, as well as the impact of actually participating and doing all of the required activities. Methods known broadly as “complier average causal effects” (CACE) or “instrumental variables” (IV) methods have been developed to estimate this latter effect, but they are more commonly applied in medical and treatment research. Since the use of these statistical techniques in prevention trials has been less widespread, many prevention scientists may not be familiar with the underlying assumptions and limitations of CACE and IV approaches. This paper provides an introduction to these methods, described in the context of randomized controlled trials of two preventive interventions: one for perinatal depression among at-risk women and the other for aggressive disruptive behavior in children. Through these case studies, the underlying assumptions and limitations of these methods are highlighted. PMID:18843535

The role of nitrates in the prevention of preeclampsia: an update.

PubMed

Kalidindi, Madhavi; Velauthar, Luxmi; Khan, Khalid; Aquilina, Joseph

2012-12-01

Defective nitric oxide synthesis and nitric oxide-mediated vasodilatation is widely documented in the pathophysiology of preeclampsia, a leading cause of maternal and perinatal morbidity and mortality worldwide. Several studies demonstrated the beneficial role of nitric oxide agents, especially glyceryl trinitrate and L-arginine in reducing the blood pressure and improving the uteroplacental blood flow velocities. However, there is insufficient evidence on the efficacy and safety of these agents in the prevention of preeclampsia and its complications, as there are very few randomized controlled trials with small number of women. The aim of this review is to summarize and evaluate the role of nitrates in the prevention of preeclampsia based on the available evidence in the literature till date and suggestions for future research. Supplementation with L-arginine and antioxidant vitamins reduced the incidence of preeclampsia in women at high risk of preeclampsia [P < 0.001, absolute risk reduction 0.17 (confidence interval 0.12-0.21)]. On the basis of the recent evidence, nitric oxide agents may be beneficial in the prevention of preeclampsia. Randomized controlled trials initiated in the first trimester and using long-acting nitrates are needed in high-risk women to validate these findings.

Prevention of emergency physician migratory contamination in a cluster randomized trial to increase tissue plasminogen activator use in stroke (the INSTINCT trial).

PubMed

Weston, Victoria C; Meurer, William J; Frederiksen, Shirley M; Fox, Allison K; Scott, Phillip A

2014-12-01

Cluster randomized trials (CRTs) are increasingly used to evaluate quality improvement interventions aimed at health care providers. In trials testing emergency department (ED) interventions, migration of emergency physicians (EPs) between hospitals is an important concern, as contamination may affect both internal and external validity. We hypothesized that geographically isolating EDs would prevent migratory contamination in a CRT designed to increase ED delivery of tissue plasminogen activator (tPA) in stroke (the INSTINCT trial). INSTINCT was a prospective, cluster randomized, controlled trial. Twenty-four Michigan community hospitals were randomly selected in matched pairs for study. Contamination was defined at the cluster level, with substantial contamination defined a priori as greater than 10% of EPs affected. Nonadherence, total crossover (contamination+nonadherence), migration distance, and characteristics were determined. Three hundred seven EPs were identified at all sites. Overall, 7 (2.3%) changed study sites. One moved between control sites, leaving 6 (2.0%) total crossovers. Of these, 2 (0.7%) moved from intervention to control (contamination); and 4 (1.3%) moved from control to intervention (nonadherence). Contamination was observed in 2 of 12 control sites, with 17% and 9% contamination of the total site EP workforce at follow-up, respectively. Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites. The mobile nature of EPs should be considered in the design of quality improvement CRTs. Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design. Copyright © 2014 Elsevier Inc. All rights reserved.

Application of quadratic optimization to supersonic inlet control

NASA Technical Reports Server (NTRS)

Lehtinen, B.; Zeller, J. R.

1971-01-01

The application of linear stochastic optimal control theory to the design of the control system for the air intake (inlet) of a supersonic air-breathing propulsion system is discussed. The controls must maintain a stable inlet shock position in the presence of random airflow disturbances and prevent inlet unstart. Two different linear time invariant control systems are developed. One is designed to minimize a nonquadratic index, the expected frequency of inlet unstart, and the other is designed to minimize the mean square value of inlet shock motion. The quadratic equivalence principle is used to obtain the best linear controller that minimizes the nonquadratic performance index. The two systems are compared on the basis of unstart prevention, control effort requirements, and sensitivity to parameter variations.

Preoperative exercise training prevents functional decline after lung resection surgery: a randomized, single-blind controlled trial.

PubMed

Sebio García, Raquel; Yáñez-Brage, Maria Isabel; Giménez Moolhuyzen, Esther; Salorio Riobo, Marta; Lista Paz, Ana; Borro Mate, Jose María

2017-08-01

To investigate the effects of a preoperative pulmonary rehabilitation programme in patients with lung cancer undergoing video-assisted thoracic surgery. Randomized, single-blind controlled trial. Teaching hospital. Patients with suspected or confirmed lung cancer undergoing video-assisted thoracic surgery. Participants were randomized to either a prehabilitation group or a control group. Participants in the prehabilitation group underwent a combination of moderate endurance and resistance training plus breathing exercises three to five times per week. The primary outcome of the study was exercise capacity. Secondary outcomes were muscle strength (Senior Fitness Test), health-related quality of life (Short-Form 36) and the postoperative outcomes. Patients were evaluated at baseline (before randomization), presurgery (only the prehabilitation group), after surgery and three months post-operatively. A total of 40 patients were randomized and 22 finished the study (10 in the prehabilitation group and 12 in the control group). Three patients were lost to follow-up at three months. After the training, there was a statistically significant improvement in exercise tolerance (+397 seconds, p = 0.0001), the physical summary component of the SF-36 (+4.4 points, p = 0.008) and muscle strength ( p < 0.01). There were no significant differences between groups after surgery. However, three months postoperatively, significant differences were found in the mean change of exercise capacity ( p = 0.005), physical summary component ( p = 0.001) and upper and lower body strength ( p = 0.045 and p = 0.002). A pulmonary rehabilitation programme before video-assisted thoracic surgery seems to improve patients' preoperative condition and may prevent functional decline after surgery. Clinical Registration Number: NCT01963923 (Registration date 10/10/2013).

The 40-Something randomized controlled trial to prevent weight gain in mid-age women

PubMed Central

2013-01-01

Background Obesity prevention is a major public health priority. Despite the health risks associated with weight gain, there has been a distinct lack of research into effective interventions to prevent, rather than treat, obesity particularly at high risk life stages such as menopause in women. This paper describes the rationale for and design of a 2-year randomized controlled trial (RCT) (the 40-Something Study) aimed at testing the feasibility and efficacy of a relatively low intensity intervention designed to achieve weight control in non-obese women about to enter the menopause transition. Methods and design The study is a parallel-group RCT consisting of 12 months of intervention (Phase 1) and 12 months of monitoring (Phase 2). Non-obese pre-menopausal healthy females 44–50 years of age were screened, stratified according to Body Mass Index (BMI) category (18.5-24.9 and 25–29.9 kg/m2) and randomly assigned to one of two groups: motivational interviewing (MI) intervention (n = 28), or a self-directed intervention (SDI) (control) (n = 26). The MI intervention consisted of five consultations with health professionals (four with a Dietitian and one with an Exercise Physiologist) who applied components of MI counselling to consultations with the women over a 12 month period. The SDI was developed as a control and these participants received print materials only. Outcome measures were collected at baseline, three, 12, 18 and 24 months and included weight (primary outcome), waist circumference, body composition, blood pressure, plasma markers of metabolic syndrome risk, dietary intake, physical activity and quality of life. Analysis of covariance will be used to investigate outcomes according to intervention type and duration (comparing baseline, 12 and 24 months). Discussion The 40-Something study is the first RCT aimed at preventing menopausal weight gain in Australian women. Importantly, this paper describes the methods used to evaluate whether a relatively low intensity, health professional led intervention will achieve better weight control in pre-menopausal women than a self-directed intervention. The results will add to the scant body of literature on obesity prevention methods at an under-researched high-risk life stage, and inform the development of population-based interventions. Trial registration ACTRN12611000064909 PMID:24156558

Intravenous N-Acetylcysteine for Prevention of Contrast-Induced Nephropathy: A Meta-Analysis of Randomized, Controlled Trials

PubMed Central

Sun, Zikai; Fu, Qiang; Cao, Longxing; Jin, Wen; Cheng, LingLing; Li, Zhiliang

2013-01-01

Background Contrast-induced nephropathy (CIN) is one of the common causes of acute renal insufficiency after contrast procedures. Whether intravenous N-acetylcysteine (NAC) is beneficial for the prevention of contrast-induced nephropathy is uncertain. In this meta-analysis of randomized controlled trials, we aimed to assess the efficacy of intravenous NAC for preventing CIN after administration of intravenous contrast media. Study Design Relevant studies published up to September 2012 that investigated the efficacy of intravenous N-acetylcysteine for preventing CIN were collected from MEDLINE, OVID, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, and the conference proceedings from major cardiology and nephrology meetings. The primary outcome was CIN. Secondary outcomes included renal failure requiring dialysis, mortality, and length of hospitalization. Data were combined using random-effects models with the performance of standard tests to assess for heterogeneity and publication bias. Meta-regression analyses were also performed. Results Ten trials involving 1916 patients met our inclusion criteria. Trials varied in patient demographic characteristics, inclusion criteria, dosing regimens, and trial quality. The summary risk ratio for contrast-induced nephropathy was 0.68 (95% CI, 0.46 to 1.02), a nonsignificant trend towards benefit in patients treated with intravenous NAC. There was evidence of significant heterogeneity in NAC effect across studies (Q = 17.42, P = 0.04; I2 = 48%). Meta-regression revealed no significant relation between the relative risk of CIN and identified differences in participant or study characteristics. Conclusion This meta-analysis showed that research on intravenous N-acetylcysteine and the incidence of CIN is too inconsistent at present to warrant a conclusion on efficacy. A large, well designed trial that incorporates the evaluation of clinically relevant outcomes in participants with different underlying risks of CIN is required to more adequately assess the role for intravenous NAC in CIN prevention. PMID:23383076

Primary prevention of overweight in preschool children, the BeeBOFT study (breastfeeding, breakfast daily, outside playing, few sweet drinks, less TV viewing): design of a cluster randomized controlled trial.

PubMed

Raat, Hein; Struijk, Mirjam K; Remmers, Teun; Vlasblom, Eline; van Grieken, Amy; Broeren, Suzanne M L; te Velde, Saskia J; Beltman, Maaike; Boere-Boonekamp, Magda M; L'Hoir, Monique P

2013-10-19

Two overweight prevention interventions were developed to be offered by preventive Youth Health Care (YHC) in addition to the currently applied overweight prevention protocol to parents of 0-3 year old children. The two interventions aim to support parents of preschool children to realize healthy child nutrition and activity behaviors of their young child. The aim of this study is to assess the effects of the two overweight prevention interventions with regard to child health behaviors and child Body Mass Index. A cluster randomized controlled trial was conducted among parents and their preschool children who attend one of 51 participating YHC teams. The teams were randomly allocated to one of the two intervention groups, or to the control group (care as usual).The 'BBOFT+' intervention focuses on effective child rearing by parents from birth onwards by enlarging parental skills concerning healthy behavioural life-style habits. Parents who are allocated to the 'E-health4Uth Healthy toddler' intervention group, at the child age of circa 18 and 24 months old, are invited to complete an online E-health module providing tailored health education regarding healthy child nutrition and activity behaviors. The E-health messages are discussed and reinforced during the subsequent regularly scheduled visits by YHC professionals, and were repeated after 4 weeks.The primary outcome measures at child age 3 years are: overweight inducing/reducing behaviors, (for 'BBOFT+' only) healthy sleep, Body Mass Index and prevalence of overweight and obesity. Secondary outcome measures are attitudes and other cognitive characteristics of the parents regarding the overweight-related behaviors of their child, parenting styles and practices, and health-related quality of life of the children. We hypothesize that the use of the additional interventions will result in a healthier lifestyle of preschool children and an improved BMI and less development of overweight and obesity compared to usual care. Nederlands Trial Register NTR1831.

Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial: Post-Intervention Results

PubMed Central

Fitzgibbon, M. L.; Stolley, M. R.; Schiffer, L.; Braunschweig, C. L.; Gomez, S. L.; Van Horn, L.; Dyer, A.

2013-01-01

The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the 9 schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the 9 control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and post-intervention. At post-intervention, children in the intervention schools engaged in more moderate-to vigorous physical activity than children in the control schools (difference between adjusted group means=7.46 min/day, p=.02). Also, children in the intervention group had less total screen time (−27.8 min/day, p=.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision. PMID:21193852

Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial: postintervention results.

PubMed

Fitzgibbon, Marian L; Stolley, Melinda R; Schiffer, Linda A; Braunschweig, Carol L; Gomez, Sandra L; Van Horn, Linda; Dyer, Alan R

2011-05-01

The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the nine schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the nine control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and postintervention. At postintervention, children in the intervention schools engaged in more moderate-to-vigorous physical activity (MVPA) than children in the control schools (difference between adjusted group means = 7.46 min/day, P = 0.02). Also, children in the intervention group had less total screen time (-27.8 min/day, P = 0.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not on diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision.

Evaluation of Yoga for Preventing Adolescent Substance Use Risk Factors in a Middle School Setting: A Preliminary Group-Randomized Controlled Trial

PubMed Central

LoRusso, Amanda; Shin, Sunny H.; Khalsa, Sat Bir S.

2016-01-01

Adolescence is a key developmental period for preventing substance use initiation, however prevention programs solely providing educational information about the dangers of substance use rarely change adolescent substance use behaviors. Recent research suggests that mind–body practices such as yoga may have beneficial effects on several substance use risk factors, and that these practices may serve as promising interventions for preventing adolescent substance use. The primary aim of the present study was to test the efficacy of yoga for reducing substance use risk factors during early adolescence. Seventh-grade students in a public school were randomly assigned by classroom to receive either a 32-session yoga intervention (n = 117) in place of their regular physical education classes or to continue with physical-education-as-usual (n = 94). Participants (63.2 % female; 53.6 % White) completed pre- and post-intervention questionnaires assessing emotional self-regulation, perceived stress, mood impairment, impulsivity, substance use willingness, and actual substance use. Participants also completed questionnaires at 6-months and 1-year post-intervention. Results revealed that participants in the control condition were significantly more willing to try smoking cigarettes immediately post-intervention than participants in the yoga condition. Immediate pre- to post-intervention differences did not emerge for the remaining outcomes. However, long-term follow-up analyses revealed a pattern of delayed effects in which females in the yoga condition, and males in the control condition, demonstrated improvements in emotional self-control. The findings suggest that school-based yoga may have beneficial effects with regard to preventing males' and females' willingness to smoke cigarettes, as well as improving emotional self-control in females. However additional research is required, particularly with regard to the potential long-term effects of mind–body interventions in school settings. The present study contributes to the literature on adolescence by examining school-based yoga as a novel prevention program for substance use risk factors. PMID:27246653

Evaluation of Yoga for Preventing Adolescent Substance Use Risk Factors in a Middle School Setting: A Preliminary Group-Randomized Controlled Trial.

PubMed

Butzer, Bethany; LoRusso, Amanda; Shin, Sunny H; Khalsa, Sat Bir S

2017-03-01

Adolescence is a key developmental period for preventing substance use initiation, however prevention programs solely providing educational information about the dangers of substance use rarely change adolescent substance use behaviors. Recent research suggests that mind-body practices such as yoga may have beneficial effects on several substance use risk factors, and that these practices may serve as promising interventions for preventing adolescent substance use. The primary aim of the present study was to test the efficacy of yoga for reducing substance use risk factors during early adolescence. Seventh-grade students in a public school were randomly assigned by classroom to receive either a 32-session yoga intervention (n = 117) in place of their regular physical education classes or to continue with physical-education-as-usual (n = 94). Participants (63.2 % female; 53.6 % White) completed pre- and post-intervention questionnaires assessing emotional self-regulation, perceived stress, mood impairment, impulsivity, substance use willingness, and actual substance use. Participants also completed questionnaires at 6-months and 1-year post-intervention. Results revealed that participants in the control condition were significantly more willing to try smoking cigarettes immediately post-intervention than participants in the yoga condition. Immediate pre- to post-intervention differences did not emerge for the remaining outcomes. However, long-term follow-up analyses revealed a pattern of delayed effects in which females in the yoga condition, and males in the control condition, demonstrated improvements in emotional self-control. The findings suggest that school-based yoga may have beneficial effects with regard to preventing males' and females' willingness to smoke cigarettes, as well as improving emotional self-control in females. However additional research is required, particularly with regard to the potential long-term effects of mind-body interventions in school settings. The present study contributes to the literature on adolescence by examining school-based yoga as a novel prevention program for substance use risk factors.

A randomized trial of motivational interviewing and facilitated contraceptive access to prevent rapid repeat pregnancy among adolescent mothers.

PubMed

Stevens, Jack; Lutz, Robyn; Osuagwu, Ngozi; Rotz, Dana; Goesling, Brian

2017-10-01

Most interventions designed to reduce teen pregnancy rates have not focused on pregnant and/or parenting adolescents. Therefore, a large randomized controlled trial was conducted regarding a motivational interviewing program entitled Teen Options to Prevent Pregnancy in a low-income sample of adolescent mothers. This program recommended monthly sessions between a participant and a registered nurse over 18 months. This program also featured facilitated birth control access through transportation assistance and a part-time contraceptive clinic. The impact of this program on rapid repeat pregnancies at 18 months after enrollment was evaluated. Five hundred ninety-eight adolescent females were enrolled from 7 obstetrics-gynecology clinics and 5 postpartum units of a large hospital system in a Midwestern city. Each participant was enrolled at least 28 weeks pregnant or less than 9 weeks postpartum. Each participant was randomized to either the Teen Options to Prevent Pregnancy intervention or a usual-care control condition. Intervention participants averaged 4.5 hours of assistance. Participants were contacted by blinded research staff at 6 and 18 months to complete self-report surveys. Differences in outcomes between the intervention and control groups were assessed using ordinary least-squares regression. There was an 18.1% absolute reduction in self-reported repeat pregnancy in the intervention group relative to the control group (20.5% vs 38.6%%; P < .001). There was a 13.7% absolute increase in self-reported long-acting reversible contraception use in the intervention group relative to the control group (40.2% vs 26.5%, P = .002). There was no evidence of harmful effects of the intervention on sexual risk behaviors, such as having sexual intercourse without a condom or greater number of partners. The Teen Options to Prevent Pregnancy program represents one of the few evidence-based interventions to reduce rapid repeat teen pregnancy. This relatively brief intervention may be a viable alternative to more time-intensive programs that adolescent mothers may be unable or unwilling to receive. Copyright © 2017 Elsevier Inc. All rights reserved.

A behavioral strategy to minimize air pollution exposure in pregnant women: a randomized controlled trial.

PubMed

Araban, Marzieh; Tavafian, Sedigheh Sadat; Zarandi, Saeed Motesaddi; Hidarnia, Ali Reza; Burri, Andrea; Montazeri, Ali

2017-04-04

Pregnant women and their fetus belong to a sensitive group in response to air pollution hazards. The aim of this study was to evaluate the effectiveness of a theory-based educational program to change pollution exposure behavior in pregnant women. In this randomized controlled trial, pregnant women attending a prenatal clinic in Tehran, Iran were selected and randomized into the experimental and control groups. The inclusion criteria were age between 18 and 35 years, having a history of pregnancies without adverse outcomes and not suffering from chronic diseases. Data collected at baseline and 2-month follow-up. At baseline face-to-face interviews were conducted using a valid and reliable questionnaire including items on demographic characteristics, stages of change, self-efficacy, decisional balance and practice regarding air pollution preventive behaviors. The intervention composed of three parts: motivational interviewing, a booklet and daily small message service (SMS). The control group received no intervention except receiving usual care. Follow-up data were collected after the intervention. Data were analyzed performing t-test, Mann-Whitney U test, and chi-squared. In all the data for 104 pregnant women (53 in the intervention and 51 in the control group) were analyzed. The mean age of participants was 27.2 (SD = 4.11) years and it was 22.89 (SD = 8.75) weeks for gestational age. At baseline there were no significant statistical differences between intervention and control groups on the study measures while we found significant group differences in terms of stages of change, self-efficacy, perceived benefits and practice regarding air pollution preventive behaviors at follow-up assessment (P < 0.05). The findings indicated that the TTM-based intervention was effective in increasing air pollution preventive behaviors among pregnant women. This study provided a framework to modify some psychosocial determinants of air pollution preventive behavior other than knowledge using constructs of Transtheoretical model of behavior change, additionally results suggests the importance of education and makes enlightenment of the air pollution risk knowledge accelerate. IRCT2012091010804N1.

Improving Herpes Zoster Vaccination Rates Through Use of a Clinical Pharmacist and a Personal Health Record

PubMed Central

Otsuka, Shelley H.; Tayal, Neeraj H.; Porter, Kyle; Embi, Peter J.; Beatty, Stuart J.

2014-01-01

BACKGROUND Preventative health services, including herpes zoster vaccination rates, remain low despite known benefits. A new care model to improve preventative health services is warranted. The objective of this study is to investigate whether the functions of an electronic medical record, in combination with a pharmacist as part of the care team, can improve the herpes zoster vaccination rate. METHODS This study was a 6-month, randomized controlled trial at a General Internal Medicine clinic at The Ohio State University. The 2589 patients aged 60 years and older without documented herpes zoster vaccination in the electronic medical record were stratified on the basis of activated personal health record status, an online tool used to share health information between patient and provider. Of the 674 personal health record users, 250 were randomized to receive information regarding the herpes zoster vaccination via an electronic message and 424 were randomized to standard of care. Likewise, of the 1915 nonpersonal health record users, 250 were randomized to receive the same information via the US Postal Service and 1665 were randomized to standard of care. After pharmacist chart review, eligible patients were mailed a herpes zoster vaccine prescription. Herpes zoster vaccination rates were compared by chi-square tests. RESULTS Intervention recipients had significantly higher vaccination rates than controls in both personal health record (relative risk, 2.7; P = .0007) and nonpersonal health record (relative risk, 2.9; P = .0001) patient populations. CONCLUSIONS Communication outside of face-to-face office visits, by both personal health record electronic message and information by mail, can improve preventative health intervention rates compared with standard care. PMID:23830534

The Effects of Coach Training on Fear of Failure in Youth Swimmers: A Latent Growth Curve Analysis from a Randomized, Controlled Trial

ERIC Educational Resources Information Center

Conroy, David E.; Coatsworth, Douglas J.

2004-01-01

The present study was a randomized trial of the efficacy of psychosocial and injury prevention-based coach training programs for reducing fear of failure (FF) among youth swimmers aged 7 to 18 years. Results revealed that (a) psychosocial training increased coaches' use of reward/reinforcement, (b) the FF measure demonstrated strong factorial…

A Randomized Controlled Trial of Interventions to Impede Date Palm Sap Contamination by Bats to Prevent Nipah Virus Transmission in Bangladesh

PubMed Central

Khan, Salah Uddin; Gurley, Emily S.; Hossain, M. Jahangir; Nahar, Nazmun; Sharker, M. A. Yushuf; Luby, Stephen P.

2012-01-01

Background Drinking raw date palm sap is a risk factor for human Nipah virus (NiV) infection. Fruit bats, the natural reservoir of NiV, commonly contaminate raw sap with saliva by licking date palm’s sap producing surface. We evaluated four types of physical barriers that may prevent bats from contacting sap. Methods During 2009, we used a crossover design and randomly selected 20 date palm sap producing trees and observed each tree for 2 nights: one night with a bamboo skirt intervention applied and one night without the intervention. During 2010, we selected 120 trees and randomly assigned four types of interventions to 15 trees each: bamboo, dhoincha (local plant), jute stick and polythene skirts covering the shaved part, sap stream, tap and collection pot. We enrolled the remaining 60 trees as controls. We used motion sensor activated infrared cameras to examine bat contact with sap. Results During 2009 bats contacted date palm sap in 85% of observation nights when no intervention was used compared with 35% of nights when the intervention was used [p<0.001]. Bats were able to contact the sap when the skirt did not entirely cover the sap producing surface. Therefore, in 2010 we requested the sap harvesters to use larger skirts. During 2010 bats contacted date palm sap [2% vs. 83%, p<0.001] less frequently in trees protected with skirts compared to control trees. No bats contacted sap in trees with bamboo (p<0.001 compared to control), dhoincha skirt (p<0.001) or polythene covering (p<0.001), but bats did contact sap during one night (7%) with the jute stick skirt (p<0.001). Conclusion Bamboo, dhoincha, jute stick and polythene skirts covering the sap producing areas of a tree effectively prevented bat-sap contact. Community interventions should promote applying these skirts to prevent occasional Nipah spillovers to human. PMID:22905160

Efficacy of a 3 month training program on the jump-landing technique in jump-landing sports. Design of a cluster randomized controlled trial

PubMed Central

2010-01-01

Background With the relatively high rate of injuries to the lower extremity due to jump-landing movement patterns and the accompanied high costs, there is need for determining potential preventive programs. A program on the intervention of jump-landing technique is possibly an important preventative measure since it appeared to reduce the incidence of lower extremity injuries. In real life situations, amateur sports lack the infrastructure and funds to have a sports physician or therapist permanently supervising such a program. Therefore the current prevention program is designed so that it could be implemented by coaches alone. Objective The objective of this randomized controlled trial is to evaluate the effect of a coach supervised intervention program targeting jump-landing technique on the incidence of lower extremity injuries. Methods Of the 110 Flemish teams of the elite division, 24 teams are included and equally randomized to two study groups. An equal selection of female and male teams with allocation to intervention and control group is obtained. The program is a modification of other prevention programs previously proven to be effective. All exercises in the current program are adjusted so that a more progressive development in the exercise is presented. Both the control and intervention group continue with their normal training routine, while the intervention group carries out the program on jump-landing technique. The full intervention program has a duration of three months and is performed 2 times a week during warm-up (5-10 min). Injuries are registered during the entire season. Discussion The results of this study can give valuable information on the effect of a coach supervised intervention program on jump-landing technique and injury occurrence. Results will become available in 2011. Trial registration Trial registration number: NTR2560 PMID:21144030

Evaluation of a multimodal school-based depression and suicide prevention program among Dutch adolescents: design of a cluster-randomized controlled trial.

PubMed

Gijzen, Mandy W M; Creemers, Daan H M; Rasing, Sanne P A; Smit, Filip; Engels, Rutger C M E

2018-05-10

Since 2010, suicide has been the most important cause of mortality in youth aged 15 to 29 years in the Netherlands. Depression is an important risk factor for suicidal behaviors (i.e., suicide ideation, deliberate self-harm, planning, and suicide attempts) in adolescents. Adolescents who develop depressive symptoms, are also at risk for adult depression. This developmental continuity is especially noticeable in adolescents compared to other age groups; therefore, it is necessary to develop preventive strategies for teens. This study will test a multimodal school-based approach to suicide and depression prevention, which integrates universal and targeted approaches and includes various stakeholders (schools, adolescents, parents, and mental health professionals) simultaneously. We will perform a cluster randomized controlled trial (RCT) with an intervention and control condition to test the effectiveness of a school-based multimodal stepped-prevention program for depression and suicidal behaviors in adolescents. Adolescents in their second year of secondary education will participate in the study. The participants in the intervention condition will receive the entire multimodal stepped-preventive program comprising early screening and detection of suicidal behaviors and depressive symptoms, a safety net consisting of gatekeepers at school, followed by universal and indicated prevention. The participants in the control condition will undergo only the screening and the safety net of gatekeepers at schools. They will complete assessments at baseline, post-intervention, and 6, 12, and 24-month follow-up. Primary outcome will be suicidal behaviors measured at 12-months follow-up. Additionally, the present study will identify mechanisms that mediate and moderate the program effects and test the effect of the program on various secondary outcomes. If the school-based multimodal stepped-prevention program proves to be effective, it could be implemented in schools on a large scale. The study is registered in the Dutch Trial Register ( NTR6622 ).

Prevention and Treatment of White Spot Lesions During and After Treatment with Fixed Orthodontic Appliances: a Systematic Literature Review.

PubMed

Lopatiene, Kristina; Borisovaite, Marija; Lapenaite, Egle

2016-01-01

The aim of the systematic literature review is to update the evidence for the prevention of white spot lesions, using materials containing fluoride and/or casein phosphopeptide-amorphous calcium phosphate during and after treatment with fixed orthodontic appliances. Information search for controlled studies on humans published between January 2008 and February 2016 was performed in PubMed, ScienceDirect, Embase, The Cochrane Library. Inclusion criteria were: the English language, study on humans, patients undergoing orthodontic treatment with fixed appliances, randomized or quasi-randomized controlled clinical studies fluoride-containing product or casein derivates used throughout the appliance therapy or straightaway after debonding. 326 articles were reviewed (Embase 141, PubMed 129, ScienceDirect 41, Cochrane 15). Twelve clinical studies fulfilled all inclusion criteria. Use of fluoridated toothpaste had a remineralizing effect on white spot lesions (WSLs) (P < 0.05); fluoride varnish and casein supplements were effective in prevention and early treatment of WSLs (P < 0.05). Early detection of white spot lesions during orthodontic treatment would allow implementing preventive measures to control the demineralization process before lesions progress. The systemic review has showed that the usage of fluoride and casein supplements in ameliorating white spot lesions during and after fixed orthodontic treatment is significantly effective. However the use of casein phosphopeptide-amorphous calcium phosphate can be more beneficial than fluoride rinse in the reduction of demineralization spots.

Long-term outcome of a randomized controlled universal prevention trial through a positive parenting program: is it worth the effort?

PubMed

Hahlweg, Kurt; Heinrichs, Nina; Kuschel, Annett; Bertram, Heike; Naumann, Sebastian

2010-05-16

Approximately 20% of children experience internalizing or externalizing DSM-IV-TR disorders. This prevalence rate cannot be reduced through treatment only. Effective preventive interventions are therefore urgently needed. The aim of the current investigation is to evaluate the two-year efficacy of the group Triple P parenting program administered universally for the prevention of child behavior problems. Based on their respective preschool, N = 280 families were randomly assigned either to the parent training or to the control group. The efficacy was analyzed using multi-source assessments, including questionnaires by mother and father, behavioral observation of mother-child interaction, and teacher evaluations. At the 2-year follow-up, both parents in the Triple P intervention reported significant reductions in dysfunctional parenting behavior, and mothers also an increase in positive parenting behavior. In addition, mothers reported significant reductions in internalizing and externalizing child behavior. Single-parent mothers in the Triple P intervention did not report significant changes in parenting or child problem behavior which is primarily due to inexplicable high positive effects in single parent mothers of the control group. Neither mother-child interactions nor teacher ratings yielded significant results. The results support the long-term efficacy of the Triple P - group program as a universal prevention intervention for changing parenting behavior in two-parent households, but not necessarily in single-parent mothers.

The Study Designed by a Committee

PubMed Central

Henry, David B.; Farrell, Albert D.

2009-01-01

This article describes the research design of the Multisite Violence Prevention Project (MVPP), organized and funded by the National Center for Injury Prevention and Control (NCIPC) at the Centers for Disease Control and Prevention (CDC). CDC's objectives, refined in the course of collaboration among investigators, were to evaluate the efficacy of universal and targeted interventions designed to produce change at the school level. The project's design was developed collaboratively, and is a 2 × 2 cluster-randomized true experimental design in which schools within four separate sites were assigned randomly to four conditions: (1) no-intervention control group, (2) universal intervention, (3) targeted intervention, and (4) combined universal and targeted interventions. A total of 37 schools are participating in this study with 8–12 schools per site. The impact of the interventions on two successive cohorts of sixth-grade students will be assessed based on multiple waves of data from multiple sources of information, including teachers, students, parents, and archival data. The nesting of students within teachers, families, schools and sites created a number of challenges for designing and implementing the study. The final design represents both resolution and compromise on a number of creative tensions existing in large-scale prevention trials, including tensions between cost and statistical power, and between internal and external validity. Strengths and limitations of the final design are discussed. PMID:14732183

YAG laser peripheral iridotomy for the prevention of pigment dispersion glaucoma a prospective, randomized, controlled trial.

PubMed

Scott, Andrew; Kotecha, Aachal; Bunce, Catey; Balidis, Miltos; Garway-Heath, David F; Miller, Michael H; Wormald, Richard

2011-03-01

To test the hypothesis that neodymium:yttrium-aluminum-garnet (Nd:YAG) laser peripheral iridotomy (LPI) significantly reduces the incidence of conversion from pigment dispersion syndrome (PDS) with ocular hypertension (OHT) to pigmentary glaucoma (PG). Prospective, randomized, controlled 3-year trial. One hundred sixteen eyes of 116 patients with PDS and OHT. Patients were assigned randomly either to Nd:YAG LPI or to a control group (no laser). The primary outcome measure was conversion to PG within 3 years, based on full-threshold visual field (VF) analysis using the Ocular Hypertension Treatment Study criteria. Secondary outcome measures were whether eyes required topical antiglaucoma medications during the study period and the time to conversion or medication. Fifty-seven patients were randomized to undergo laser treatment and 59 were randomized to no laser (controls). Age, gender, spherical equivalent refraction, and intraocular pressure at baseline were similar between groups. Outcome data were available for 105 (90%) of recruited subjects, 52 in the laser treatment group and 53 in the no laser treatment group. Patients were followed up for a median of 35.9 months (range, 10-36 months) in the laser arm and 35.9 months (range, 1-36 months) in the control arm. Eight eyes (15%) in the laser group and 3 eyes (6%) in the control group converted to glaucoma in the study period. The proportion of eyes started on medical treatment was similar in the 2 groups: 8 eyes (15%) in the laser group and 9 eyes (17%) in the control group. Survival analyses showed no evidence of any difference in time to VF progression or commencement of topical therapy between the 2 groups. Cataract extraction was performed on 1 patient in the laser group and in 1 patient in the control group during the study period (laser eye at 18 months; control eye at 34 months). This study suggests that there was no benefit of Nd:YAG LPI in preventing progression from PDS with OHT to PG within 3 years of follow-up. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Design of a randomized trial of diabetes genetic risk testing to motivate behavior change: the Genetic Counseling/lifestyle Change (GC/LC) Study for Diabetes Prevention.

PubMed

Grant, Richard W; Meigs, James B; Florez, Jose C; Park, Elyse R; Green, Robert C; Waxler, Jessica L; Delahanty, Linda M; O'Brien, Kelsey E

2011-10-01

The efficacy of diabetes genetic risk testing to motivate behavior change for diabetes prevention is currently unknown. This paper presents key issues in the design and implementation of one of the first randomized trials (The Genetic Counseling/Lifestyle Change (GC/LC) Study for Diabetes Prevention) to test whether knowledge of diabetes genetic risk can motivate patients to adopt healthier behaviors. Because individuals may react differently to receiving 'higher' vs 'lower' genetic risk results, we designed a 3-arm parallel group study to separately test the hypotheses that: (1) patients receiving 'higher' diabetes genetic risk results will increase healthy behaviors compared to untested controls, and (2) patients receiving 'lower' diabetes genetic risk results will decrease healthy behaviors compared to untested controls. In this paper we describe several challenges to implementing this study, including: (1) the application of a novel diabetes risk score derived from genetic epidemiology studies to a clinical population, (2) the use of the principle of Mendelian randomization to efficiently exclude 'average' diabetes genetic risk patients from the intervention, and (3) the development of a diabetes genetic risk counseling intervention that maintained the ethical need to motivate behavior change in both 'higher' and 'lower' diabetes genetic risk result recipients. Diabetes genetic risk scores were developed by aggregating the results of 36 diabetes-associated single nucleotide polymorphisms. Relative risk for type 2 diabetes was calculated using Framingham Offspring Study outcomes, grouped by quartiles into 'higher', 'average' (middle two quartiles) and 'lower' genetic risk. From these relative risks, revised absolute risks were estimated using the overall absolute risk for the study group. For study efficiency, we excluded all patients receiving 'average' diabetes risk results from the subsequent intervention. This post-randomization allocation strategy was justified because genotype represents a random allocation of parental alleles ('Mendelian randomization'). Finally, because it would be unethical to discourage participants to participate in diabetes prevention behaviors, we designed our two diabetes genetic risk counseling interventions (for 'higher' and 'lower' result recipients) so that both groups would be motivated despite receiving opposing results. For this initial assessment of the clinical implementation of genetic risk testing we assessed intermediate outcomes of attendance at a 12-week diabetes prevention course and changes in self-reported motivation. If effective, longer term studies with larger sample sizes will be needed to assess whether knowledge of diabetes genetic risk can help patients prevent diabetes. We designed a randomized clinical trial designed to explore the motivational impact of disclosing both higher than average and lower than average genetic risk for type 2 diabetes. This design allowed exploration of both increased risk and false reassurance, and has implications for future studies in translational genomics.

Vitamin D and Cancer Prevention

MedlinePlus

... D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin ... the National Cancer Institute.” Please note that blog posts that are written by individuals from outside the ...

How to Prevent Diabetes: MedlinePlus Health Topic

MedlinePlus

... to 10 percent of your current weight. For example, if you weigh 200 pounds, your goal would ... 2 diabetes mellitus: A... Article: Design of a comparative effectiveness randomized controlled trial testing a... Article: Effect ...

Screening for Anal Cancer in HIV Positive Patients: Should We Make It A Standard-of-care?

PubMed

Xu, Jian; Zhou, Haiyang

2017-09-27

Anal cancer is biological similar to cervical cancer, and is preceded by anal intraepithelial neoplasia (AIN). Screening for AIN and treatments to reduce the risk of anal cancer are not established as guidelines of care for HIV-infected patients. It is mainly because screening and treating of AIN is not yet proven to reduce the incidence of anal cancer. The present study preliminarily demonstrated that a successful screening program in preventing squamous cell anal cancer in HIV positive patients. The authors achieved their purpose of controlling the evolution of all abnormalities identified during the anal cancer screening, preventing AIN to progress towards anal cancer, and reversing any form of AIN by surgery, ablation or medical therapy. Randomized controlled multi-center trials with a large sample size should be carried out to validate the study results. It is wise for the physicians to actively screen and treat AIN in HIV-infected patients whenever possible unless the results of randomized controlled study demonstrate that doing so is inappropriate.

The effectiveness of a web-based Dutch parenting program to prevent overweight in children 9-13 years of age: study protocol for a two-armed cluster randomized controlled trial.

PubMed

Ruiter, Emilie L M; Fransen, Gerdine A J; Molleman, Gerard R M; van der Velden, Koos; Engels, Rutger C M E

2015-02-14

Although parental support is an important component in overweight prevention programs for children, current programs pay remarkably little attention to the role of parenting. To close this gap, we developed a web-based parenting program for parents entitled "Making a healthy deal with your child". This e-learning program can be incorporated into existing prevention programs, thereby improving these interventions by reinforcing the role of parenting and providing parents with practical tools for use in everyday situations in order to stimulate a healthy lifestyle. Here, we report the research design of a study to determine the effectiveness of our e-learning program. The effectiveness of an e-learning program was studied in a two-armed cluster randomized controlled trial. Parents of children 9-13 years of age who live in the Nijmegen region, the Netherlands, and who participated in the existing school-based overweight prevention program "Scoring for Health" were invited to participate in this study. Our goal was to recruit 322 parent-child dyads. At the school grade level, parents were randomly assigned to either the intervention group (which received e-learning and a brochure) or the control group (which received only the brochure); the participants were stratified by ethnicity. Measurements were taken from both the parents and the children at baseline, and then 5 and 12 months after baseline. Primary outcomes included the child's dietary and sedentary behavior, and level of physical activity. Secondary outcomes included general parenting style, specific parenting practices (e.g., set of rules, modeling, and monitoring), and parental self-efficacy. We hypothesize that children of parents who follow the e-learning program will have a healthier diet, will be less sedentary, and will have a higher level of physical activity compared to the children in the control group. If the e-learning program is found to be effective, it can be incorporated into existing overweight prevention programs for children (e.g., "Scoring for Health"), as well as activities regarding Youth Health Care. Dutch Trial Register: NTR3938 . Date of registration: April 7(th), 2013.

Efficacy of intermittent preventive treatment of malaria with sulphadoxine-pyrimethamine in preventing anaemia in pregnancy among Nigerian women.

PubMed

Asa, O O; Onayade, A A; Fatusi, A O; Ijadunola, K T; Abiona, T C

2008-11-01

To evaluate the efficacy of intermittent preventive treatment of malaria using sulphadoxine-pyrimethamine (SP) in the prevention of anaemia in women of low parity in a low socio-economic, malaria endemic setting. The study design was an open randomized control trial comparing anaemia incidence among pregnant women on intermittent presumptive treatment of malaria with SP with those on chloroquine (CQ). A total of 352 primigravid and secondigravid women between 16 and 30 weeks gestation receiving antenatal care at the Primary Health Care Center, Enuwa in Ile-Ife, Osun State, Nigeria were serially recruited and randomly allocated into experimental and control groups of 176 each. The experimental group received SP (to a maximum of three doses depending on the gestational age at enrollment into the study) while the control group had treatment doses of CQ at recruitment and subsequently only if they had symptoms suggestive of malaria. The primary outcome measure was anaemia (haematocrit<30) at 34 weeks of gestation. At recruitment and 34 weeks gestation, there was no statistically significant difference between the experimental and control group in terms of socio-demographic characteristics and past medical history. Thirty-three (22.6%) and 52 (37.1%) women in the study and control groups, respectively, had anaemia (protective efficacy 49.5%, p=0.01). With multivariate analysis, controlling for the possible confounding effects of education, parity, haemoglobin level at booking and malaria parasitaemia in peripheral blood, the difference in the incidence of anaemia in the two groups remained significant (p=0.01; odds ratio=0.5; 95% confidence interval=0.29-0.85). The IPT regime with sulphadoxine-pyrimethamine is an effective, practicable strategy to decrease risk of anaemia in women of low parity residing in areas endemic for malaria.

Sexual Harassment Prevention Initiatives: Quantitative and Qualitative Approaches

DTIC Science & Technology

2010-10-28

design , and the time series with nonequivalent control group design . The experimental research approach will randomly assign participants...Leedy & Ormrod, 2005). According to Fife- Schaw (2006) there are three quasi-experimental designs : the nonequivalent control group design , the time...that have controlled and isolated variables. A specific quantitative approach available to the researcher is the use of surveys. Surveys, in

Efficacy of Intensive Control of Glucose in Stroke Prevention: A Meta-Analysis of Data from 59197 Participants in 9 Randomized Controlled Trials

PubMed Central

Zhang, Chi; Zhou, Yu-Hao; Xu, Chun-Li; Chi, Feng-Ling; Ju, Hai-Ning

2013-01-01

Background The efficacy of treatments that lower glucose in reducing the risk of incident stroke remains unclear. We therefore did a systematic review and meta-analysis to evaluate the efficacy of intensive control of glucose in the prevention of stroke. Methodology/Principal Findings We systematically searched Medline, EmBase, and the Cochrane Library for trials published between 1950 and June, 2012. We included randomized controlled trials that reported on the effects of intensive control of glucose on incident stroke compared with standard care. Summary estimates of relative risk (RR) reductions were calculated with a random effects model, and the analysis was further stratified by factors that could affect the treatment effects. Of 649 identified studies, we included nine relevant trials, which provided data for 59197 patients and 2037 events of stroke. Overall, intensive control of glucose as compared to standard care had no effect on incident stroke (RR, 0.96; 95%CI 0.88–1.06; P = 0.445). In the stratified analyses, a beneficial effect was seen in those trials when body mass index (BMI) more than 30 (RR, 0.86; 95%CI: 0.75–0.99; P = 0.041). No other significant differences were detected between the effect of intensive control of glucose and standard care when based on other subset factors. Conclusions/Significance Our study indicated intensive control of glucose can effectively reduce the risk of incident stroke when patients with BMI more than 30. PMID:23372729

Physical Unclonable Function with Multiplexing Units and its Evaluation

NASA Astrophysics Data System (ADS)

Yoshikawa, Masaya; Asai, Toshiya; Shiozaki, Mitsuru; Fujino, Takeshi

Recently, semiconductor counterfeiting has become an increasingly serious problem. Therefore, techniques to prevent the counterfeit by using random characteristic patterns that are difficult to control artificially have attracted attention. The physical unclonable function (PUF) is one of the techniques. It is a method to derive ID information peculiar to a device by detecting random physical features that cannot be controlled during the device's manufacture. Because information such as the ID information is difficult to replicate, PUF is used as a technique to prevent counterfeiting. Several studies have been reported on PUF. Arbiter PUF, which utilizes the difference in signal propagation delay between selectors, is the typical method of composing PUF using delay characteristics. This paper proposed a new PUF which is based on the arbiter PUF. The proposed PUF introduces new multiplexing selector units. It attempts to generate an effective response using the orders of three signal arrivals. Experiments using FPGAs verify the validity of the proposed PUF. Although Uniqueness is deteriorated, Correctness, Steadiness, Randomness and Resistance against the machine learning attacks are improved in comparison with conventional one.

Stochastic resonance whole-body vibration improves postural control in health care professionals: a worksite randomized controlled trial.

PubMed

Elfering, Achim; Schade, Volker; Stoecklin, Lukas; Baur, Simone; Burger, Christian; Radlinger, Lorenz

2014-05-01

Slip, trip, and fall injuries are frequent among health care workers. Stochastic resonance whole-body vibration training was tested to improve postural control. Participants included 124 employees of a Swiss university hospital. The randomized controlled trial included an experimental group given 8 weeks of training and a control group with no intervention. In both groups, postural control was assessed as mediolateral sway on a force plate before and after the 8-week trial. Mediolateral sway was significantly decreased by stochastic resonance whole-body vibration training in the experimental group but not in the control group that received no training (p < .05). Stochastic resonance whole-body vibration training is an option in the primary prevention of balance-related injury at work. Copyright 2014, SLACK Incorporated.

School-based suicide prevention programmes: the SEYLE cluster-randomised, controlled trial.

PubMed

Wasserman, Danuta; Hoven, Christina W; Wasserman, Camilla; Wall, Melanie; Eisenberg, Ruth; Hadlaczky, Gergö; Kelleher, Ian; Sarchiapone, Marco; Apter, Alan; Balazs, Judit; Bobes, Julio; Brunner, Romuald; Corcoran, Paul; Cosman, Doina; Guillemin, Francis; Haring, Christian; Iosue, Miriam; Kaess, Michael; Kahn, Jean-Pierre; Keeley, Helen; Musa, George J; Nemes, Bogdan; Postuvan, Vita; Saiz, Pilar; Reiter-Theil, Stella; Varnik, Airi; Varnik, Peeter; Carli, Vladimir

2015-04-18

Suicidal behaviours in adolescents are a major public health problem and evidence-based prevention programmes are greatly needed. We aimed to investigate the efficacy of school-based preventive interventions of suicidal behaviours. The Saving and Empowering Young Lives in Europe (SEYLE) study is a multicentre, cluster-randomised controlled trial. The SEYLE sample consisted of 11,110 adolescent pupils, median age 15 years (IQR 14-15), recruited from 168 schools in ten European Union countries. We randomly assigned the schools to one of three interventions or a control group. The interventions were: (1) Question, Persuade, and Refer (QPR), a gatekeeper training module targeting teachers and other school personnel, (2) the Youth Aware of Mental Health Programme (YAM) targeting pupils, and (3) screening by professionals (ProfScreen) with referral of at-risk pupils. Each school was randomly assigned by random number generator to participate in one intervention (or control) group only and was unaware of the interventions undertaken in the other three trial groups. The primary outcome measure was the number of suicide attempt(s) made by 3 month and 12 month follow-up. Analysis included all pupils with data available at each timepoint, excluding those who had ever attempted suicide or who had shown severe suicidal ideation during the 2 weeks before baseline. This study is registered with the German Clinical Trials Registry, number DRKS00000214. Between Nov 1, 2009, and Dec 14, 2010, 168 schools (11,110 pupils) were randomly assigned to interventions (40 schools [2692 pupils] to QPR, 45 [2721] YAM, 43 [2764] ProfScreen, and 40 [2933] control). No significant differences between intervention groups and the control group were recorded at the 3 month follow-up. At the 12 month follow-up, YAM was associated with a significant reduction of incident suicide attempts (odds ratios [OR] 0·45, 95% CI 0·24-0·85; p=0·014) and severe suicidal ideation (0·50, 0·27-0·92; p=0·025), compared with the control group. 14 pupils (0·70%) reported incident suicide attempts at the 12 month follow-up in the YAM versus 34 (1·51%) in the control group, and 15 pupils (0·75%) reported incident severe suicidal ideation in the YAM group versus 31 (1·37%) in the control group. No participants completed suicide during the study period. YAM was effective in reducing the number of suicide attempts and severe suicidal ideation in school-based adolescents. These findings underline the benefit of this universal suicide preventive intervention in schools. Coordination Theme 1 (Health) of the European Union Seventh Framework Programme. Copyright © 2015 Elsevier Ltd. All rights reserved.

Design of a comparative effectiveness randomized controlled trial testing a faith-based Diabetes Prevention Program (WORD DPP) vs. a Pacific culturally adapted Diabetes Prevention Program (PILI DPP) for Marshallese in the United States.

PubMed

McElfish, Pearl Anna; Long, Christopher R; Kaholokula, Joseph Keawe'aimoku; Aitaoto, Nia; Bursac, Zoran; Capelle, Lucy; Laelan, Melisa; Bing, Williamina Ioanna; Riklon, Sheldon; Rowland, Brett; Ayers, Britni L; Wilmoth, Ralph O; Langston, Krista N; Schootman, Mario; Selig, James P; Yeary, Karen Hye-Cheon Kim

2018-05-01

Pacific Islander populations, including Marshallese, face a disproportionately high burden of health disparities relative to the general population. A community-based participatory research (CBPR) approach was utilized to engage Marshallese participants in a comparative effectiveness trial testing 2 Diabetes Prevention Program (DPP) interventions designed to reduce participant's weight, lower HbA1c, encourage healthy eating, and increase physical activity. To compare the effectiveness of the faith-based (WORD) DPP to the culturally adapted (Pacific Culturally Adapted Diabetes Prevention Program [PILI]) DPP, a clustered randomized controlled trial (RCT) with 384 Marshallese participants will be implemented in 32 churches located in Arkansas, Kansas, Missouri, and Oklahoma. Churches will be randomly assigned to WORD DPP arm or to PILI DPP arm. WORD DPP focuses on connecting faith and health to attain a healthy weight, eat healthy, and be more physically active. In contrast, PILI DPP is a family and community focused DPP curriculum specifically adapted for implementation in Pacific Islander communities. PILI focuses on engaging social support networks to maintain a healthy weight, eat healthy, and be more physically active. All participants are assessed at baseline, immediate post intervention, and 12 months post intervention. Both interventions aim to cause weight loss through improving physical activity and healthy eating, with the goal of preventing the development of T2D. The clustered RCT will determine which intervention is most effective with the Marshallese population. The utilization of a CBPR approach that involves local stakeholders and engages faith-based institutions in Marshallese communities will increase the potential for success and sustainability. This study is registered at clinicaltrials.gov (NCT03270436).

Design of a comparative effectiveness randomized controlled trial testing a faith-based Diabetes Prevention Program (WORD DPP) vs. a Pacific culturally adapted Diabetes Prevention Program (PILI DPP) for Marshallese in the United States

PubMed Central

McElfish, Pearl Anna; Long, Christopher R.; Kaholokula, Joseph Keawe‘aimoku; Aitaoto, Nia; Bursac, Zoran; Capelle, Lucy; Laelan, Melisa; Bing, Williamina Ioanna; Riklon, Sheldon; Rowland, Brett; Ayers, Britni L.; Wilmoth, Ralph O.; Langston, Krista N.; Schootman, Mario; Selig, James P.; Yeary, Karen Hye-cheon Kim

2018-01-01

Abstract Background: Pacific Islander populations, including Marshallese, face a disproportionately high burden of health disparities relative to the general population. Objectives: A community-based participatory research (CBPR) approach was utilized to engage Marshallese participants in a comparative effectiveness trial testing 2 Diabetes Prevention Program (DPP) interventions designed to reduce participant's weight, lower HbA1c, encourage healthy eating, and increase physical activity. Design: To compare the effectiveness of the faith-based (WORD) DPP to the culturally adapted (Pacific Culturally Adapted Diabetes Prevention Program [PILI]) DPP, a clustered randomized controlled trial (RCT) with 384 Marshallese participants will be implemented in 32 churches located in Arkansas, Kansas, Missouri, and Oklahoma. Churches will be randomly assigned to WORD DPP arm or to PILI DPP arm. Methods: WORD DPP focuses on connecting faith and health to attain a healthy weight, eat healthy, and be more physically active. In contrast, PILI DPP is a family and community focused DPP curriculum specifically adapted for implementation in Pacific Islander communities. PILI focuses on engaging social support networks to maintain a healthy weight, eat healthy, and be more physically active. All participants are assessed at baseline, immediate post intervention, and 12 months post intervention. Summary: Both interventions aim to cause weight loss through improving physical activity and healthy eating, with the goal of preventing the development of T2D. The clustered RCT will determine which intervention is most effective with the Marshallese population. The utilization of a CBPR approach that involves local stakeholders and engages faith-based institutions in Marshallese communities will increase the potential for success and sustainability. This study is registered at clinicaltrials.gov (NCT03270436). PMID:29742712

Efficacy of amiodarone and lidocaine for preventing ventricular fibrillation after aortic cross-clamp release in open heart surgery: a meta-analysis of randomized controlled trials.

PubMed

Zheng, Yong; Gu, Qiang; Chen, Hong-Wu; Peng, Huai-Ming; Jia, Dong-Yu; Zhou, Yu; Xiang, Mei-Xiang

The relative preventative efficacy of amiodarone and lidocaine for ventricular fibrillation (VF) after release of an aortic cross-clamp (ACC) during open heart surgery has not been determined. This meta-analysis was designed to systematically evaluate the influence of amiodarone, lidocaine, or placebo on the incidence of VF after ACC. Prospective randomized controlled trials (RCTs) that compared the VF-preventative effects of amiodarone with lidocaine, or amiodarone or lidocaine with placebo were included. PubMed, EMBASE, and the Cochrane Library were searched for relevant RCTs. Fixed or randomized effect models were applied according to the heterogeneity of the data from the selected studies. We included eight RCTs in the analysis. Pooled results suggested that the preventative effects of amiodarone and lidocaine were comparable (relative risk (RR)=1.12, 95% confidence interval (CI): 0.70 to 1.80, P=0.63), but both were superior to the placebo (amiodarone, RR=0.71, 95% CI: 0.51 to 1.00, P=0.05; lidocaine, RR=0.63, 95% CI: 0.46 to 0.88, P=0.006). The percentage of patients requiring electric defibrillation counter shocks (DCSs) did not differ significantly among patients administered amiodarone (RR=0.21, 95% CI: 0.04 to 1.19, P=0.08), lidocaine (RR=2.44, 95% CI: 0.13 to 44.02, P=0.55), or the placebo (RR=0.56, 95% CI: 0.25 to 1.25, P=0.16). Amiodarone and lidocaine are comparably effective in preventing VF after ACC, but the percentage of patients who subsequently require DCSs does not differ among those administered amiodarone, lidocaine, or placebo.

Facilitating sunscreen use in women by a theory-based online intervention: a randomized controlled trial.

PubMed

Craciun, Catrinel; Schüz, Natalie; Lippke, Sonia; Schwarzer, Ralf

2012-03-01

This study compares a motivational skin cancer prevention approach with a volitional planning and self-efficacy intervention to enhance regular sunscreen use. A randomized controlled trial (RCT) was conducted with 205 women (mean age 25 years) in three groups: motivational; volitional; and control. Sunscreen use, action planning, coping planning and coping self-efficacy were assessed at three points in time. The volitional intervention improved sunscreen use. Coping planning emerged as the only mediator between the intervention and sunscreen use at Time 3. Findings point to the role played by coping planning as an ingredient of sun protection interventions.

Evaluation of a Drowning Prevention Program Based on Testimonial Videos: A Randomized Controlled Trial

PubMed Central

Pang, Shulan; Schwebel, David C.

2016-01-01

Objective Unintentional drowning is the most common cause of childhood death in rural China. Global intervention efforts offer mixed results regarding the efficacy of educational programs. Methods Using a randomized controlled design, we evaluated a testimonial-based intervention to reduce drowning risk among 280 3rd- and 4th-grade rural Chinese children. Children were randomly assigned to view either testimonials on drowning risk (intervention) or dog-bite risk (control). Safety knowledge and perceived vulnerability were measured by self-report questionnaires, and simulated behaviors in and near water were assessed with a culturally appropriate dollhouse task. Results Children in the intervention group had improved children’s safety knowledge and simulated behaviors but not perceived vulnerability compared with controls. Conclusions The testimonial-based intervention’s efficacy appears promising, as it improved safety knowledge and simulated risk behaviors with water among rural Chinese children. PMID:26546476

Does Playworks Work? Findings from a Randomized Controlled Trial

ERIC Educational Resources Information Center

James-Burdumy, Susanne; Bleeker, Martha; Beyler, Nicholas; London, Rebecca A.; Westrich, Lisa; Stokes-Guinan, Katie; Castrechini, Sebastian

2013-01-01

Most school principals believe recess has a positive impact on the development of students' social skills and academic achievement. Research also suggests that physical activity and play during recess may be linked to improvements in both academic and prosocial behaviors (Centers for Disease Control and Prevention 2010). Recess, however, has been…

The Effect of a Text Messaging Based HIV Prevention Program on Sexual Minority Male Youths: A National Evaluation of Information, Motivation and Behavioral Skills in a Randomized Controlled Trial of Guy2Guy.

PubMed

Ybarra, Michele L; Liu, Weiwei; Prescott, Tonya L; Phillips, Gregory; Mustanski, Brian

2018-04-25

There is a paucity of literature documenting how the constructs of the Information-Motivation-Behavioral Skills (IMB) model are affected by exposure to technology-based HIV prevention programs. Guy2Guy, based on the IMB model, is the first comprehensive HIV prevention program delivered via text messaging and tested nationally among sexual minority adolescent males. Between June and November 2014, 302 14-18 year old gay, bisexual, and/or queer cisgender males were recruited across the US on Facebook and enrolled in a randomized controlled trial testing Guy2Guy versus an attention-matched control program. Among sexually inexperienced youth, those in the intervention were more than three times as likely to be in the "High motivation" group at follow-up as control youth (aOR = 3.13; P value = 0.04). The intervention effect was not significant when examined separately for those who were sexually active. HIV information did not significantly vary by experimental arm at 3 months post-intervention end, nor did behavioral skills for condom use or abstinence vary. The increase in motivation to engage in HIV preventive behavior for adolescent males with no prior sexual experience is promising, highlighting the need to tailor HIV prevention according to past sexual experience. The behavioral skills that were measured may not have reflected those most emphasized in the content (e.g., how to use lubrication to reduce risk and increase pleasure), which may explain the lack of detected intervention impact. ClinicalTrials.gov ID# NCT02113956.

One-Year Efficacy Testing of Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) Randomized Control Trial

ERIC Educational Resources Information Center

Knowlden, Adam; Sharma, Manoj

2016-01-01

Background: The purpose of this study was to evaluate the efficacy of the Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) intervention at 1-year, postintervention follow-up. Method: A mixed between-within subjects design was used to evaluate the trial. Independent variables included a…

Steady As You Go (SAYGO): A Falls-Prevention Program for Seniors Living in the Community.

ERIC Educational Resources Information Center

Robson, Ellie; Edwards, Joy; Gallagher, Elaine; Baker, Dorothy

2003-01-01

In a randomized trial of Steady as You Go, a falls-prevention program for the elderly, the treatment group (n=235) reduced eight of nine risk factors. Over a 4-month follow-up, the treatment group fell less than controls (n=236) and significantly fewer treatment group participants who had fallen before experienced falls (20%) compared to 35% of…

Preventive Intervention for Preschoolers at High Risk for Antisocial Behavior: Long-Term Effects on Child Physical Aggression and Parenting Practices

ERIC Educational Resources Information Center

Brotman, Laurie Miller; Gouley, Kathleen Kiely; Huang, Keng-Yen; Rosenfelt, Amanda; O'Neal, Colleen; Klein, Rachel G.; Shrout, Patrick

2008-01-01

This article presents long-term effects of a preventive intervention for young children at high risk for antisocial behavior. Ninety-two children (M age = 4 years) were randomly assigned to an 8-month family intervention or no-intervention control condition and assessed 4 times over a 24-month period. Intent-to-treat analyses revealed significant…

Project ORE: A Friendship-Based Intervention to Prevent HIV/STI in Urban African American Adolescent Females

ERIC Educational Resources Information Center

Dolcini, M. Margaret; Harper, Gary W.; Boyer, Cherrie B.; Pollack, Lance M.

2010-01-01

There is an urgent need for continued innovation in the design of HIV/STI prevention interventions for African American females, a group at high risk for STIs and HIV. In particular, attention to social development and to culture is needed. The present study reports on a group randomized controlled trial of a friendship-based HIV/STI prevention…

Pregnancy Rates Among Juvenile Justice Girls in Two RCTs of Multidimensional Treatment Foster Care

PubMed Central

Kerr, David C. R.; Leve, Leslie D.; Chamberlain, Patricia

2009-01-01

Preventing adolescent pregnancy is a national research priority that has had limited success. The present study examined whether Multidimensional Treatment Foster Care (MTFC) relative to intervention services as usual (group care [GC]) decreased pregnancy rates among juvenile justice girls mandated to out-of-home care. Girls (ages 13–17) with histories of criminal referrals (Mdn = 10) were randomly assigned to MTFC (n = 81) or GC (n = 85) as part of two randomized controlled trials. Pregnancy histories were assessed from baseline through 24 months. Fewer postbaseline pregnancies were reported for MTFC girls (26.9%) than for GC girls (46.9%), an effect that remained significant after controlling for baseline criminal referrals, pregnancy history, and sexual activity. MTFC has previously been shown to decrease arrest and lock-up rates. The present findings support the long-term preventive effects of MTFC on adolescent girls’ pregnancy rates. Findings are consistent with the notion that programs that target delinquency by impacting general risk behavior pathways and contexts may more successfully prevent teen pregnancy than those that directly target sexual behaviors. PMID:19485598

Stand-alone Emollient Treatment Reduces Flares After Discontinuation of Topical Steroid Treatment in Atopic Dermatitis: A Double-blind, Randomized, Vehicle-controlled, Left-right Comparison Study.

PubMed

Angelova-Fischer, Irena; Rippke, Frank; Richter, Daniel; Filbry, Alexander; Arrowitz, Craig; Weber, Teresa; Fischer, Tobias W; Zillikens, Detlef

2018-04-27

Prevention of the flares is a main goal in the long-term treatment of atopic dermatitis (AD). Therefore we investigated the efficacy of a water-in-oil emollient, containing licochalcone A, omega-6-fatty acids, ceramide 3 and glycerol, for prevention of the flares in adults with mild to moderately severe AD, treated with topical steroids, that led to clearing of the inflammatory lesions and had been discontinued prior to inclusion. The study was a 12-week, double-blind, randomized, vehicle-controlled, left-right comparison test with the number of relapses, defined as re-occurrence of erythema for at least 3 consecutive days, considered the primary outcome. Compared with the vehicle, the active formulation significantly reduced the number of relapses and maintained the barrier homeostasis of the respective arm. To the best of knowledge, this is the first study to show prevention of the AD flares by the use of stand-alone emollient treatment, based on comparison with the corresponding vehicle while excluding concomitant/rescue medications.

Household Obesity Prevention: Take Action—a Group-Randomized Trial

PubMed Central

French, Simone A.; Gerlach, Anne F.; Mitchell, Nathan R.; Hannan, Peter J.; Welsh, Ericka M.

2018-01-01

The purpose of the present study was to evaluate an intervention to prevent weight gain among households (HHs) in the community. Ninety HHs were randomized to intervention or control group for 1 year. Intervention consisted of six face-to-face group sessions, placement of a television (TV) locking device on all home TVs, and home-based intervention activities. Measures were collected in person at baseline and 1 year. Weight, height, eating behaviors, physical activity (PA), and TV viewing were measured among HH members ages ≥12 years. Follow-up rate at 1 year was 96%. No significant intervention effects were observed for change in HH BMI-z score. Intervention HHs significantly reduced TV viewing, snacks/sweets intake, and dollars per person spent eating out, and increased (adults only) PA and self-weighing frequency compared with control HHs. A 1 year obesity prevention intervention targeting entire HHs was effective in reducing TV viewing, snack/sweets intake and eating out purchases. Innovative methods are needed to strengthen the home food environment intervention component. Longer intervention durations also need to be evaluated. PMID:21212771

Household obesity prevention: Take Action--a group-randomized trial.

PubMed

French, Simone A; Gerlach, Anne F; Mitchell, Nathan R; Hannan, Peter J; Welsh, Ericka M

2011-10-01

The purpose of the present study was to evaluate an intervention to prevent weight gain among households (HHs) in the community. Ninety HHs were randomized to intervention or control group for 1 year. Intervention consisted of six face-to-face group sessions, placement of a television (TV) locking device on all home TVs, and home-based intervention activities. Measures were collected in person at baseline and 1 year. Weight, height, eating behaviors, physical activity (PA), and TV viewing were measured among HH members ages ≥ 12 years. Follow-up rate at 1 year was 96%. No significant intervention effects were observed for change in HH BMI-z score. Intervention HHs significantly reduced TV viewing, snacks/sweets intake, and dollars per person spent eating out, and increased (adults only) PA and self-weighing frequency compared with control HHs. A 1 year obesity prevention intervention targeting entire HHs was effective in reducing TV viewing, snack/sweets intake and eating out purchases. Innovative methods are needed to strengthen the home food environment intervention component. Longer intervention durations also need to be evaluated.

[Postpartum pelvic floor rehabilitation on prevention of female pelvic floor dysfunction: a multicenter prospective randomized controlled study].

PubMed

Sun, Zhijing; Zhu, Lan; Lang, Jinghe; Zhang, Yewu; Liu, Guizhi; Chen, Xiaochun; Feng, Songzhi; Zhang, Juxin; Yao, Yuhong; Zhang, Jie; Su, Yuanyuan; Fang, Guiying; Yang, Mei; Liu, Juan; Ma, Zhimin

2015-06-01

To study the postpartum pelvic floor rehabilitation on the improvement of pelvic floor electrical physiological indexes and the prevention of female pelvic floor dysfunction in China. A multicenter prospective randomized controlled study was carried out. From October 2011, postpartum women in five provinces were randomly assigned into treatment group and control group. The women in treatment group received electrical stimulation and biofeedback treatment. The women in control group performed pelvic floor muscle exercise at home. When 6 months and 12 months after delivery, comparing two groups of patients with pelvic floor electrical physiological indexes and pelvic organ prolapse quantitation measurements (POP-Q), to evaluate the effect of postpartum pelvic floor rehabilitation on the prevention of pelvic floor dysfunction. Pelvic floor impact questionnaire short form (PFIQ-7) and pelvic organ prolapse/incontinence sexual questionnaire-12 (PISQ-12) were used to evaluate the influence on quality of life and sexual life. Until June 2013, 324 women were participated, 124 in control group, 200 in treatment group. According to the baseline results, there was statistical significance in the results of pelvic floor electrical physiological indexes between the treatment and control groups in postpartum 6 months and 12 months; the proportion above level III of type I and type II muscle fibers strength in the treatment group, it was from 41.5% (83/200) and 40.5% (81/200) to 76.3% (145/190) and 79.5% (151/190) in postpartum 6 weeks and postpartum 6 months, increased to 80.6% (58/72) and 80.6% (58/72) in postpartum 12 months, improved significantly comparing with the control group (P < 0.01). According to Point Aa, treatment group and control group in the postpartum 6 weeks was (-2.2 ± 0.7) versus (-2.4 ± 0.6) cm, in postpartum 12 months (- 2.5 ± 1.1) versus (- 2.7 ± 0.6) cm, the improvement in treatment group was statistically significant (P < 0.01). And the other points were not significantly different (P > 0.05). There was no significant difference in the questionnaires in quality of life and quality of sexual life (P > 0.05). Neuromuscular electrical stimulation and biofeedback therapy in the early postpartum period could obviously improve pelvic floor electrical physiological indexes, and is beneficial to prevent the pelvic floor dysfunction.

The effectiveness of a construction worksite prevention program on work ability, health, and sick leave: results from a cluster randomized controlled trial.

PubMed

Oude Hengel, Karen M; Blatter, Brigitte M; van der Molen, Henk F; Bongers, Paulien M; van der Beek, Allard J

2013-09-01

This study aimed to investigate the effectiveness of a prevention program on work ability, health, and sick leave targeted at construction worksites. A total of 15 departments (N = 297 workers) from 6 construction companies participated in this cluster randomized controlled trial and were randomly allocated to the intervention (8 departments; N = 171 workers) or control (7 departments; N = 122 workers) group. The intervention consisted of two individual training sessions with a physical therapist aimed at lowering the physical workload, a rest-break tool to improve the balance between work and recovery, and two empowerment training sessions to increase the worker's influence at the worksite. Data on work ability, physical and mental health status, and musculoskeletal symptoms were collected at baseline, and at 3, 6, and 12 months follow-up. Sick leave data were obtained from the companies. Overall, no differences in work ability [β 0.02, 95% confidence interval (95% CI) -0.34-0.37] or physical and mental health status (β -0.04, 95% CI -1.43-1.35, and β 0.80 95% CI -0.51-2.11, respectively) were found between the intervention and control group. The intervention showed an overall decline in musculoskeletal symptoms (ranging from OR 0.68, 95% CI 0.34-1.33, to OR 0.86, 95% CI 0.47-1.57) and long-term sick leave (OR 0.44, 95% CI 0.13-1.26) among construction workers. Both reductions were not statistically significant. The prevention program seemed to result in a beneficial but not statistically significant decline in the prevalence of musculoskeletal symptoms and long-term sick leave among construction workers, but showed no effects with regard to work ability, physical health, and mental health.

Effects of intervention using a community-based walking program for prevention of mental decline: a randomized controlled trial.

PubMed

Maki, Yohko; Ura, Chiaki; Yamaguchi, Tomoharu; Murai, Tatsuhiko; Isahai, Mikie; Kaiho, Ayumi; Yamagami, Tetsuya; Tanaka, Satoshi; Miyamae, Fumiko; Sugiyama, Mika; Awata, Shuichi; Takahashi, Ryutaro; Yamaguchi, Haruyasu

2012-03-01

To evaluate the efficacy of a municipality-led walking program under the Japanese public Long-Term Care Insurance Act to prevent mental decline. Randomized controlled trial. The city of Takasaki. One hundred fifty community members aged 72.0 ± 4.0 were randomly divided into intervention (n = 75) and control (n = 75) groups. A walking program was conducted once a week for 90 minutes for 3 months. The program encouraged participants to walk on a regular basis and to increase their steps per day gradually. The intervention was conducted in small groups of approximately six, so combined benefits of exercise and social interaction were expected. Cognitive function was evaluated focusing on nine tests in five domains: memory, executive function, word fluency, visuospatial abilities, and sustained attention. Quality of life (QOL), depressive state, functional capacity, range of activities, and social network were assessed using questionnaires, and motor function was evaluated. Significant differences between the intervention and control groups were shown in word fluency related to frontal lobe function (F(1, 128) = 6.833, P = .01), QOL (F(1,128) = 9.751, P = .002), functional capacity including social interaction (F(1,128) = 13.055, P < .001), and motor function (Timed Up and Go Test: F(1,127) = 10.117, P = .002). No significant differences were observed in other cognitive tests. Walking programs may provide benefits in some aspects of cognition, QOL, and functional capacity including social interaction in elderly community members. This study could serve as the basis for implementation of a community-based intervention to prevent mental decline. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

Ankles back in randomized controlled trial (ABrCt): braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial.

PubMed

Janssen, Kasper W; van Mechelen, Willem; Verhagen, Evert Alm

2011-09-27

Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training) against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care. This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention. The ABrCt is the first randomized controlled trial to directly compare the secondary preventive effect of the combined use of braces and neuromuscular training, against the use of either braces or neuromuscular training as separate secondary preventive measures. This study expects to identify the most effective and cost-efficient secondary preventive measure for ankle sprains. The study results could lead to changes in the clinical guidelines on the prevention of ankle sprains, and they will become available in 2012. Netherlands Trial Register (NTR): NTR2157.

Stroke prevention by cilostazol in patients with atherothrombosis: meta-analysis of placebo-controlled randomized trials.

PubMed

Uchiyama, Shinichiro; Demaerschalk, Bart M; Goto, Shinya; Shinohara, Yukito; Gotoh, Fumio; Stone, William M; Money, Samuel R; Kwon, Sun Uck

2009-01-01

Cilostazol is an antiplatelet agent that inhibits phosphodiesterase III in platelets and vascular endothelium. Previous randomized controlled trials of cilostazol for prevention of cerebrovascular events have garnered mixed results. We performed a systematic review and meta-analysis of the randomized clinical trials in patients with atherothrombotic diseases to determine the effects of cilostazol on cerebrovascular, cardiac, and all vascular events, and on all major hemorrhagic events. Relevant trials were identified by searching MEDLINE, EMBASE, and the Cochrane Controlled Trial Registry for titles and abstracts. Data from 12 randomized controlled trials, involving 5674 patients, were analyzed for end points of cerebrovascular, cardiac, and major bleeding events. Searching, determination of eligibility, data extraction, and meta-analyses were conducted by multiple independent investigators. Data were available in 3782, 1187, and 705 patients with peripheral arterial disease, cerebrovascular disease, and coronary stenting, respectively. Incidence of total vascular events was significantly lower in the cilostazol group compared with the placebo group (relative risk [RR], 0.86; 95% confidence interval [CI], 0.74-0.99; P=.038). This was particularly influenced by a significant decrease of incidence of cerebrovascular events in the cilostazol group (RR, 0.58; 95% CI, 0.43-0.78; P < .001). There was no significant intergroup difference in incidence of cardiac events (RR, 0.99; 95% CI, 0.83-1.17; P=.908) and serious bleeding complications (RR, 1.00; 95% CI, 0.66-1.51; P=.996). This first meta-analysis of cilostazol in patients with atherothrombosis demonstrated a significant risk reduction for cerebrovascular events, with no associated increase of bleeding risk.

Long-term efficacy of a rural community-based integrated intervention for prevention and management of chronic obstructive pulmonary disease: a cluster randomized controlled trial in China's rural areas.

PubMed

Yuan, X; Tao, Y; Zhao, J P; Liu, X S; Xiong, W N; Xie, J G; Ni, W; Xu, Y J; Liu, H G

2015-11-01

This study aimed to assess the efficacy of a rural community-based integrated intervention for early prevention and management of chronic obstructive pulmonary disease (COPD) in China. This 18-year cluster-randomized controlled trial encompassing 15 villages included 1008 patients (454 men and 40 women in the intervention group [mean age, 54 ± 10 years]; 482 men and 32 women in the control group [mean age, 53 ± 10 years]) with confirmed COPD or at risk for COPD. Villages were randomly assigned to the intervention or the control group, and study participants residing within the villages received treatment accordingly. Intervention group patients took part in a program that included systematic health education, smoking cessation counseling, and education on management of COPD. Control group patients received usual care. The groups were compared after 18 years regarding the incidence of COPD, decline in lung function, and mortality of COPD. COPD incidence was lower in the intervention group than in the control group (10% vs 16%, <0.05). A decline in lung function was also significantly delayed in the intervention group compared to the control group of COPD and high-risk patients. The intervention group showed significant improvement in smoking cessation compared with the control group, and smokers in the intervention group had lower smoking indices than in the control group (350 vs 450, <0.05). The intervention group also had a significantly lower cumulative COPD-related death rate than the control group (37% vs 47%, <0.05). A rural community-based integrated intervention is effective in reducing the incidence of COPD among those at risk, delaying a decline in lung function in COPD patients and those at risk, and reducing mortality of COPD.

Does the therapy manual or the therapist matter most in treatment of obsessive-compulsive disorder? A randomized controlled trial of exposure with response or ritual prevention in 118 patients.

PubMed

van Oppen, Patricia; van Balkom, Anton J L M; Smit, Johannes H; Schuurmans, Josien; van Dyck, Richard; Emmelkamp, Paul M G

2010-09-01

The importance of the therapist's education and experience for the successful behavior treatment of obsessive-compulsive disorder (OCD) has not been investigated. Data on the relative effectiveness of self-controlled versus therapist-controlled in vivo exposure with response or ritual prevention (ERP) have yielded conflicting results. The present study compared the effectiveness of 4 different modes of delivery of ERP in a referred sample of OCD patients. Of the 146 eligible OCD outpatients, 118 patients enrolled in this randomized controlled trial and were randomly assigned to (1) therapist-controlled ERP performed by experienced behavior therapists; (2) therapist-controlled ERP performed by master's students of clinical psychology; (3) self-controlled ERP performed by experienced behavior therapists; and (4) self-controlled ERP performed by master's students of clinical psychology. This trial was performed from January 1999 to January 2005. Our analyses revealed no significant differences in clinical outcome between any of the different modes of delivery of ERP at posttreatment. The different ERP modes of delivery were associated with significant pretreatment to posttreatment improvement on all measurements, with large effect sizes on the primary outcome measure, the Yale-Brown Obsessive Compulsive Scale. Our results indicate that clinically inexperienced master's students with no postgraduate training can be as capable as experienced and certified behavior therapists in treating OCD patients, as long as therapists adhere to a standardized treatment manual and adequate training and supervision is provided. In contrast to other studies, we did not find a supposed benefit of therapist-controlled ERP versus self-controlled ERP in patients with OCD. www.trialregister.nl Identifier: NTR1444. © Copyright 2010 Physicians Postgraduate Press, Inc.

Hemodialysis Infection Prevention Protocols Ontario-Shower Technique (HIPPO-ST): A Pilot Randomized Trial.

PubMed

Kosa, S Daisy; Gafni, Amiram; House, Andrew A; Lawrence, JulieAnn; Moist, Louise; Nathoo, Bharat; Tam, Paul; Sarabia, Alicia; Thabane, Lehana; Wu, George; Lok, Charmaine E

2017-03-01

We developed the Hemodialysis Infection Prevention Protocols Ontario-Shower Technique (HIPPO-ST) to permit hemodialysis (HD) patients with central venous catheters (catheters) to shower without additional infection risk. Our primary objective was to determine the feasibility of conducting a parallel randomized controlled trial (RCT) to evaluate the impact of HIPPO-ST on catheter-related bacteremia (CRB) in adult HD patients. Adult HD patients using catheters were recruited from 11 HD units. Patients were randomized to receive HIPPO-ST or standard care and were followed up for 6 months. Only CRB-outcome assessors were blinded. For the study to be considered feasible, 4 of 5 feasibility outcomes, each with its own statistical threshold for success, must have been achieved. A total of 68 patients were randomized (33 HIPPO-ST and 35 control) and were followed up to 6 months. Of 5 measures of feasibility, 4 were achieved: (1) accurate CRB rate documented (threshold: κ level >0.80); (2) 97.8% (279/285) of satellite HD patients with catheters were screened (threshold: >95%); (3) 88% (23/26) in the HIPPO-ST arm were successfully educated by 6 months (threshold: >80%); and (4) 0% (0/29) patients in the control arm were "contaminated," that is, using HIPPO-ST (threshold: <5%). However, only 44.2% (72/163) of eligible patients consented to participate (threshold: >80%). The rate of CRB was similarly low in HIPPO-ST and control groups (0.68 vs. 0.88/1000 catheter days). This HIPPO-ST pilot study demonstrated the feasibility of the larger HIPPO-ST study, especially given the high levels of education success with the HIPPO-ST arm and the low levels of contamination in the control arm.

Efficacy of a short multidisciplinary falls prevention program for elderly persons with osteoporosis and a fall history: a randomized controlled trial.

PubMed

Smulders, Ellen; Weerdesteyn, Vivian; Groen, Brenda E; Duysens, Jacques; Eijsbouts, Agnes; Laan, Roland; van Lankveld, Wim

2010-11-01

To evaluate the efficacy of the Nijmegen Falls Prevention Program (NFPP) for persons with osteoporosis and a fall history in a randomized controlled trial. Persons with osteoporosis are at risk for fall-related fractures because of decreased bone strength. A decrease in the number of falls therefore is expected to be particularly beneficial for these persons. Randomized controlled trial. Hospital. Persons with osteoporosis and a fall history (N=96; mean ± SD age, 71.0±4.7y; 90 women). After baseline assessment, participants were randomly assigned to the exercise (n=50; participated in the NFPP for persons with osteoporosis [5.5wk]) or control group (n=46; usual care). Primary outcome measure was fall rate, measured by using monthly fall calendars for 1 year. Secondary outcomes were balance confidence (Activity-specific Balance Confidence Scale), quality of life (QOL; Quality of Life Questionnaire of the European Foundation for Osteoporosis), and activity level (LASA Physical Activity Questionnaire, pedometer), assessed posttreatment subsequent to the program and after 1 year of follow-up. The fall rate in the exercise group was 39% lower than for the control group (.72 vs 1.18 falls/person-year; risk ratio, .61; 95% confidence interval, .40-.94). Balance confidence in the exercise group increased by 13.9% (P=.001). No group differences were observed in QOL and activity levels. The NFPP for persons with osteoporosis was effective in decreasing the number of falls and improving balance confidence. Therefore, it is a valuable new tool to improve mobility and independence of persons with osteoporosis. Copyright © 2010 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Screening for asymptomatic bacteriuria in adults: evidence for the U.S. Preventive Services Task Force reaffirmation recommendation statement.

PubMed

Lin, Kenneth; Fajardo, Kevin

2008-07-01

Asymptomatic bacteriuria is common, and screening for this condition in pregnant women is a well-established, evidence-based standard of current medical practice. Screening other groups of adults has not been shown to improve outcomes. To review new and substantial evidence on screening for asymptomatic bacteriuria, to support the work of the U.S. Preventive Services Task Force. English-language studies of adults (age >18 years) indexed in PubMed and the Cochrane Library and published from 1 January 2002 through 30 April 2007. For benefits of screening or treatment for screened populations, systematic reviews; meta-analyses; and randomized, controlled trials were included. For harms of screening, systematic reviews; meta-analyses; randomized, controlled trials; cohort studies; case-control studies; and case series of large multisite databases were included. Two reviewers independently reviewed titles, abstracts, and full articles for inclusion. Two reviewers extracted data from studies on benefits of screening and treatment (including decreases in the incidence of adverse maternal and fetal outcomes, symptomatic urinary tract infections, hypertension, and renal function decline). An updated Cochrane systematic review of 14 randomized, controlled trials of treatment supports screening for asymptomatic bacteriuria in pregnant women. A randomized, controlled trial and a prospective cohort study show that screening nonpregnant women with diabetes for asymptomatic bacteriuria is unlikely to produce benefits. No new evidence on screening men for asymptomatic bacteriuria or on harms of screening was found. The focused search strategy may have missed some smaller studies on the benefits and harms of screening for asymptomatic bacteriuria. The available evidence continues to support screening for asymptomatic bacteriuria in pregnant women, but not in other groups of adults.

The role of critical self-reflection of assumptions in an online HIV intervention for men who have sex with men.

PubMed

Wilkerson, J Michael; Danilenko, Gene P; Smolenski, Derek J; Myer, Bryn B; Rosser, B R Simon

2011-02-01

The Men's INTernet Study II included a randomized controlled trial to develop and test an Internet-based HIV prevention intervention for U.S men who use the Internet to seek sex with men. In 2008, participants (n = 560) were randomized to an online, interactive, sexual risk-reduction intervention or to a wait list null control. After 3 months, participants in both conditions reported varying degrees of change in sexual beliefs or behaviors. Using content analysis and logistic regression, this mixed-methods study sought to understand why these changes occurred. Level of critical self-reflection of assumptions appeared to facilitate the labeling of sexual beliefs and behaviors as risky, which in turn encouraged men to commit to and enact change. New HIV prevention interventions should include activities in their curriculum that foster critical self-reflection on assumptions.

IMMEDIATE AND SHORT-TERM EFFECTS OF THE 5TH GRADE VERSION OF THE keepin’ it REAL SUBSTANCE USE PREVENTION INTERVENTION*

PubMed Central

Hecht, Michael L.; Elek, Elvira; Wagstaff, David A.; Kam, Jennifer A.; Marsiglia, Flavio; Dustman, Patricia; Reeves, Leslie; Harthun, Mary

2010-01-01

This study assessed the immediate and short-term outcomes of adapting a culturally-grounded middle school program, keepin’ it REAL, for elementary school students. After curriculum adaptation, 10 schools were randomly assigned to the intervention in 5th grade with follow-up boosters in 6th grade; 13 schools were randomly assigned to the control condition, implementing the school’s pre-existing substance use prevention programming. Students (n = 1,566) completed a questionnaire prior to curriculum implementation and follow-up questionnaires toward the end of 5th and 6th grade. The 5th grade kiR curriculum generally appeared no more effective than the control schools’ programming in changing students’ resistance or decision-making skills; substance use intentions, expectancies, or normative beliefs; or lifetime and recent substance use. Such findings have implications for the age appropriateness of school-based programs. PMID:19157042

Online training in sports concussion for youth sports coaches.

PubMed

Glang, Ann; Koester, Michael C; Beaver, Sherry Vondy; Clay, Janet E; McLaughlin, Karen A

2010-03-01

The purpose of this study was to evaluate ACTive: Athletic Concussion Training using Interactive Video Education, an interactive e-learning program designed to train community coaches of youth ages 10-18 in effective sports concussion prevention and management practices. Seventy-five youth sports coaches from across the country completed the study over the Internet. Results of a randomized control trial demonstrated significant differences between treatment and control participants on measures of (a) knowledge about sports concussion, management, and prevention; (b) attitudes about the importance of preventing sports concussion; and (c) intention and self-efficacy in sports concussion management and prevention. The results suggest that ACTive is an effective method of training youth sports coaches who are in an important position to reduce risks associated with sports concussion.

Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial.

PubMed

Leung, K S; Li, C Y; Tse, Y K; Choy, T K; Leung, P C; Hung, V W Y; Chan, S Y; Leung, A H C; Cheung, W H

2014-06-01

This study is a prospective cluster-randomized controlled clinical trial involving 710 elderly subjects to investigate the long-term effects of low-magnitude high-frequency vibration (LMHFV) on fall and fracture rates, muscle performance, and bone quality. The results confirmed that LMHFV is effective in reducing fall incidence and enhancing muscle performance in the elderly. Falls are direct causes of fragility fracture in the elderly. LMHFV has been shown to improve muscle function and bone quality. This study is to investigate the efficacy of LMHFV in preventing fall and fractures among the elderly in the community. A cluster-randomized controlled trial was conducted with 710 postmenopausal females over 60 years. A total of 364 participants received daily 20 min LMHFV (35 Hz, 0.3 g), 5 days/week for 18 months; 346 participants served as control. Fall or fracture rate was taken as the primary outcome. Also, quadriceps muscle strength, balancing abilities, bone mineral density (BMD), and quality of life (QoL) assessments were done at 0, 9, and 18 months. With an average of 66.0% compliance in the vibration group, 18.6% of 334 vibration group subjects reported fall or fracture incidences compared with 28.7% of 327 in the control (adjusted HR = 0.56, p = 0.001). The fracture rate of vibration and control groups were 1.1 and 2.3 % respectively (p = 0.171). Significant improvements were found in reaction time, movement velocity, and maximum excursion of balancing ability assessment, and also the quadriceps muscle strength (p < 0.001). No significant differences were found in the overall change of BMD. Minimal adverse effects were documented. LMHFV is effective in fall prevention with improved muscle strength and balancing ability in the elderly. We recommend its use in the community as an effective fall prevention program and to decrease related injuries.

Reducing and preventing internalizing and externalizing behavior problems in children with type 1 diabetes: a randomized controlled trial of the Triple P-Positive Parenting Program.

PubMed

Westrupp, E M; Northam, E; Lee, K J; Scratch, S E; Cameron, F

2015-11-01

Children with type 1 diabetes are at increased risk of mental health problems, which in turn are associated with poor glycemic control, diabetes-related complications, and long-term psychiatric morbidity. We tested the efficacy of the Triple P-Positive Parenting Program in reducing or preventing mental health problems and improving glycemic control in children with type 1 diabetes in a randomized controlled trial. Participants were recruited from the Diabetes Clinic, Royal Children's Hospital, Melbourne, Australia, and randomized to Triple P or standard diabetes care. The primary outcome was child internalizing and externalizing behavior problems 3 and 12 months postrandomization. Secondary outcomes were glycemic control, parent mental health, parenting skills, and family functioning at 3 and 12 months, and glycemic control at 24 months. A total of 76 participants were randomized (38 to intervention and 38 to control), 60 completed 3-month, and 57 completed 12-month assessments. Benefits of Triple P were evident at 3 months for parent mental health, parenting skills, and family functioning (p < 0.05), but not for child mental health or glycemic control, with little effect at 12 months. Prespecified subgroup analyses for children with pre-existing internalizing or externalizing behavior problems indicated greater improvements in child mental health, parent mental health, parenting skills, and diabetes family conflict (p < 0.05), but lower parenting self-efficacy at 3 months. Improvements in parent mental health and parenting competency associated with Triple P were sustained to 12 months for children with pre-existing mental health problems. This study provides some support for the efficacy of Triple P in improving parent and family outcomes, and reducing child internalizing and externalizing behavior problems primarily in children who have pre-existing mental health problems. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Adolescent Abstinence and Unprotected Sex in CyberSenga, an Internet-Based HIV Prevention Program: Randomized Clinical Trial of Efficacy

PubMed Central

Ybarra, Michele L.; Bull, Sheana S.; Prescott, Tonya L.; Korchmaros, Josephine D.; Bangsberg, David R.; Kiwanuka, Julius P.

2013-01-01

Context Cost-effective, scalable programs are urgently needed in countries deeply affected by HIV. Methods This parallel-group RCT was conducted in four secondary schools in Mbarara, Uganda. Participants were 12 years and older, reported past-year computer or Internet use, and provided informed caregiver permission and youth assent. The intervention, CyberSenga, was a five-hour online healthy sexuality program. Half of the intervention group was further randomized to receive a booster at four-months post-intervention. The control arm received ‘treatment as usual’ (i.e., school-delivered sexuality programming). The main outcome measures were: 1) condom use and 2) abstinence in the past three months at six-months' post-intervention. Secondary outcomes were: 1) condom use and 2) abstinence at three-month's post-intervention; and 6-month outcomes by booster exposure. Analyses were intention to treat. Results All 416 eligible youth were invited to participate, 88% (n = 366) of whom enrolled. Participants were randomized to the intervention (n = 183) or control (n = 183) arm; 91 intervention participants were further randomized to the booster. No statistically significant results were noted among the main outcomes. Among the secondary outcomes: At three-month follow-up, trends suggested that intervention participants (81%) were more likely to be abstinent than control participants (74%; p = 0.08), and this was particularly true among youth who were abstinent at baseline (88% vs. 77%; p = 0.02). At six-month follow-up, those in the booster group (80%) reported higher rates of abstinence than youth in the intervention, no booster (57%) and control (55%) groups (p = 0.15); they also reported lower rates of unprotected sex (5%) compared to youth in the intervention, no booster (24%) and control (21%) groups (p = 0.21) among youth sexually active at baseline. Conclusions The CyberSenga program may affect HIV preventive behavior among abstinent youth in the short term and, with the booster, may also promote HIV preventive behavior among sexually active youth in the longer term. Trial Registration NCT00906178. PMID:23967069

Louisiana (LA) Health: Design and Methods for a Childhood Obesity Prevention Program in Rural Schools

PubMed Central

Williamson, Donald A.; Champagne, Catherine M.; Harsha, David; Han, Hongmei; Martin, Corby K.; Newton, Robert; Stewart, Tiffany M.; Ryan, Donna H.

2008-01-01

There is a worldwide epidemic of obesity with far-reaching consequences for the health of our nation. Prevention of obesity, especially in children, has been deemed by public health policy makers to be one of the most important objectives for our country. This prevention project, called Louisiana (LA) Health, will test whether modification of environmental and behavioral factors can prevent inappropriate weight gain in children from rural parishes of Louisiana who are enrolled in the fourth to sixth grades during Year 1. The primary aim of the LA Health project is to test the efficacy of two school-based approaches for obesity prevention: primary prevention alone and a combination of primary and secondary prevention which will be compared to a no-intervention control group using a cluster randomization research design, with 17 school clusters randomly assigned to the three treatment arms. The study will span three years and will provide critical tests of strategies that: 1) modify the child’s environment as a primary prevention strategy and 2) provide health behavior modification via classroom instruction and internet counseling as a secondary prevention strategy. The study will also recruit a similar sample of students to measure changes in body weight relative to height, gender, and age over the same three-year period. PMID:18448393

A genotype-directed comparative effectiveness trial of Bucindolol and metoprolol succinate for prevention of symptomatic atrial fibrillation/atrial flutter in patients with heart failure: Rationale and design of the GENETIC-AF trial.

PubMed

Piccini, Jonathan P; Connolly, Stuart J; Abraham, William T; Healey, Jeff S; Steinberg, Benjamin A; Al-Khalidi, Hussein R; Dignacco, Patricia; van Veldhuisen, Dirk J; Sauer, William H; White, Michel; Wilton, Stephen B; Anand, Inder S; Dufton, Christopher; Marshall, Debra A; Aleong, Ryan G; Davis, Gordon W; Clark, Richard L; Emery, Laura L; Bristow, Michael R

2018-05-01

Few therapies are available for the safe and effective treatment of atrial fibrillation (AF) in patients with heart failure. Bucindolol is a non-selective beta-blocker with mild vasodilator activity previously found to have accentuated antiarrhythmic effects and increased efficacy for preventing heart failure events in patients homozygous for the major allele of the ADRB1 Arg389Gly polymorphism (ADRB1 Arg389Arg genotype). The safety and efficacy of bucindolol for the prevention of AF or atrial flutter (AFL) in these patients has not been proven in randomized trials. The Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Metoprolol Succinate for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure (GENETIC-AF) trial is a multicenter, randomized, double-blinded "seamless" phase 2B/3 trial of bucindolol hydrochloride versus metoprolol succinate, for the prevention of symptomatic AF/AFL in patients with reduced ejection fraction heart failure (HFrEF). Patients with pre-existing HFrEF and recent history of symptomatic AF are eligible for enrollment and genotype screening, and if they are ADRB1 Arg389Arg, eligible for randomization. A total of approximately 200 patients will comprise the phase 2B component and if pre-trial assumptions are met, 620 patients will be randomized at approximately 135 sites to form the Phase 3 population. The primary endpoint is the time to recurrence of symptomatic AF/AFL or mortality over a 24-week follow-up period, and the trial will continue until 330 primary endpoints have occurred. GENETIC-AF is the first randomized trial of pharmacogenetic guided rhythm control, and will test the safety and efficacy of bucindolol compared with metoprolol succinate for the prevention of recurrent symptomatic AF/AFL in patients with HFrEF and an ADRB1 Arg389Arg genotype. (ClinicalTrials.govNCT01970501). Copyright © 2017 Elsevier Inc. All rights reserved.

Parental emotional management benefits family relationships: A randomized controlled trial in Hong Kong, China.

PubMed

Fabrizio, Cecilia S; Lam, Tai Hing; Hirschmann, Malia R; Pang, Irene; Yu, Nancy Xiaonan; Wang, Xin; Stewart, Sunita M

2015-08-01

There is a shortage of culturally appropriate, brief, preventive interventions designed to be sustainable and acceptable for community participants in nonwestern cultures. Parents' ability to regulate their emotions is an important factor for psychological well-being of the family. In Chinese societies, emotional regulation may be more important in light of the cultural desirability of maintaining harmonious family relationships. The objectives of our randomized controlled trial were to test the effectiveness of our Effective Parenting Programme (EPP) to increase the use of emotional management strategies (primary outcome) and enhance the parent-child relationship (secondary outcome). We utilized design characteristics that promoted recruitment, retention, and intervention sustainability. We randomized a community sample of 412 Hong Kong middle- and low-income mothers of children aged 6-8 years to the EPP or attention control group. At 3, 6 and 12- month follow up, the Effective Parent Program group reported greater increases in the use of emotion management strategies during parent-child interactions, with small to medium effect size, and lower negative affect and greater positive affect, subjective happiness, satisfaction with the parent-child relationship, and family harmony, compared to the control group, with small to medium effect size. Our results provided evidence of effectiveness for a sustainable, preventive, culturally appropriate, cognitive behaviorally-based emotion management program, in a non-clinical setting for Chinese mothers. HKCTR-1190. Copyright © 2015 Elsevier Ltd. All rights reserved.

Implementing trials of complex interventions in community settings: The USC – Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS)

PubMed Central

Clark, Florence; Pyatak, Elizabeth A.; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B.; Garber, Susan L.; Diaz, Jesus; Florindez, Lucia I.; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

2014-01-01

Background Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)–Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to: (a) participant recruitment and retention, (b) intervention delivery and fidelity, (c) randomization and assessment, and (d) potential inadvertent treatment effects. Purpose We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Method Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. Results PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accord with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to: (a) determining pressure ulcer incidence/severity, (b) randomization imbalance, and (c) inadvertent potential control group contamination. Limitations We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings. Conclusions Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence as well as the ability to implement needed mid-course corrections. PMID:24577972

Impact of Probiotics on Necrotizing Enterocolitis

PubMed Central

Underwood, Mark A.

2016-01-01

A large number of randomized placebo-controlled clinical trials and cohort studies have demonstrated a decrease in the incidence of necrotizing enterocolitis with administration of probiotic microbes. These studies have prompted many neonatologists to adopt routine prophylactic administration of probiotics while others await more definitive studies and/or probiotic products with demonstrated purity and stable numbers of live organisms. Cross-contamination and inadequate sample size limit the value of further traditional placebo-controlled randomized controlled trials. Key areas for future research include mechanisms of protection, optimum probiotic species or strains (or combinations thereof) and duration of treatment, interactions between diet and the administered probiotic, and the influence of genetic polymorphisms in the mother and infant on probiotic response. Next generation probiotics selected based on bacterial genetics rather than ease of production and large cluster-randomized clinical trials hold great promise for NEC prevention. PMID:27836423

The role of vitamin D in the prevention of late-life depression.

PubMed

Okereke, Olivia I; Singh, Ankura

2016-07-01

In this article, we review current evidence regarding potential benefits of vitamin D for improving mood and reducing depression risk in older adults. We summarize gaps in knowledge and describe future efforts that may clarify the role of vitamin D in late-life depression prevention. MEDLINE and PsychINFO databases were searched for all articles on vitamin D and mood that had been published up to and including May 2015. Observational studies and randomized trials with 50 or more participants were included. We excluded studies that involved only younger adults and/or exclusively involved persons with current depression. Twenty observational (cross-sectional and prospective) studies and 10 randomized trials (nine were randomized placebo-controlled trials [RCTs]; one was a randomized blinded comparison trial) were reviewed. Inverse associations of vitamin D blood level or vitamin D intake with depression were found in 13 observational studies; three identified prospective relations. Results from all but one of the RCTs showed no statistically significant differences in depression outcomes between vitamin D and placebo groups. Observational studies were mostly cross-sectional and frequently lacked adequate control of confounding. RCTs often featured low treatment doses, suboptimal post-intervention changes in biochemical levels of vitamin D, and/or short trial durations. Vitamin D level-mood associations were observed in most, but not all, observational studies; results indicated that vitamin D deficiency may be a risk factor for late-life depression. However, additional data from well-designed RCTs are required to determine the impact of vitamin D in late-life depression prevention. Copyright © 2016 Elsevier B.V. All rights reserved.

Effectiveness of interactive discussion group in suicide risk assessment among general nurses in Taiwan: a randomized controlled trial.

PubMed

Wu, Chia-Yi; Lin, Yi-Yin; Yeh, Mei Chang; Huang, Lian-Hua; Chen, Shaw-Ji; Liao, Shih-Cheng; Lee, Ming-Been

2014-11-01

The evidence of suicide prevention training for nurses is scarce. Strategies to enhance general nurses' ability in suicide risk assessment are critical to develop effective training programs in general medical settings. This study was aimed to examine the effectiveness of an interactive discussion group in a suicide prevention training program for general nurses. In this randomized study with two groups of pre-post study design, the sample was recruited from the Medical, Surgical, and Emergency/Intensive Care Sectors of a 2000-bed general hospital via stratified randomization. Among the 111 nurses, 57 participants randomly assigned to the control group received a two-hour baseline suicide gatekeeper lecture, and 54 participants assigning to the experimental group received an additional five-hour group discussion about suicide risk assessment skills. Using a case vignette, the nurses discussed and assessed suicide risk factors specified in a 10-item Chinese SAD PERSONS Scale during a group discussion intervention. The findings revealed that the nurses achieved significant and consistent improvements of risk identification and assessment after the intervention without influencing their mental health status for assessing suicide risks. The result suggested an effective approach of interactive group discussion for facilitating critical thinking and learning suicide risk assessment skills among general nurses. Copyright © 2014 Elsevier Ltd. All rights reserved.

Comparative Effectiveness of Web-Based vs. Educator-Delivered HIV Prevention for Adolescent Substance Users: A Randomized, Controlled Trial.

PubMed

Marsch, Lisa A; Guarino, Honoria; Grabinski, Michael J; Syckes, Cassandra; Dillingham, Elaine T; Xie, Haiyi; Crosier, Benjamin S

2015-12-01

Young people who engage in substance use are at risk for becoming infected with HIV and diseases with similar transmission dynamics. Effective disease prevention programs delivered by prevention specialists exist but are rarely provided in systems of care due to staffing/resource constraints and operational barriers-and are thus of limited reach. Web-based prevention interventions could possibly offer an effective alternative to prevention specialist-delivered interventions and may enable widespread, cost-effective access to evidence-based prevention programming. Previous research has shown the HIV/disease prevention program within the Web-based therapeutic education system (TES) to be an effective adjunct to a prevention specialist-delivered intervention. The present study was the first randomized, clinical trial to evaluate the comparative effectiveness of this Web-based intervention as a standalone intervention relative to a traditional, prevention specialist-delivered intervention. Adolescents entering outpatient treatment for substance use participated in this multi-site trial. Participants were randomly assigned to either a traditional intervention delivered by a prevention specialist (n=72) or the Web-delivered TES intervention (n=69). Intervention effectiveness was assessed by evaluating changes in participants' knowledge about HIV, hepatitis, and sexually transmitted infections, intentions to engage in safer sex, sex-related risk behavior, self-efficacy to use condoms, and condom use skills. Participants in the TES intervention achieved significant and comparable increases in HIV/disease-related knowledge, condom use self-efficacy, and condom use skills and comparable decreases in HIV risk behavior relative to participants who received the intervention delivered by a prevention specialist. Participants rated TES as easier to understand. This study indicates that TES is as effective as HIV/disease prevention delivered by a prevention specialist. Because technology-based interventions such as TES have high fidelity, are inexpensive and scalable, and can be implemented in a wide variety of settings, they have the potential to greatly increase access to effective prevention programming. Copyright © 2015 Elsevier Inc. All rights reserved.

Does vitamin K2 play a role in the prevention and treatment of osteoporosis for postmenopausal women: a meta-analysis of randomized controlled trials.

PubMed

Huang, Z-B; Wan, S-L; Lu, Y-J; Ning, L; Liu, C; Fan, S-W

2015-03-01

To identify the role of vitamin K2 for the prevention and treatment of osteoporosis in postmenopausal women, we conducted this meta-analysis of 19 randomized controlled trials. Our results showed that vitamin K2 might play a role in maintaining the bone mineral density and in reducing the incidence of fractures for postmenopausal women with osteoporosis. Vitamin K2 has been revealed to be effective in the prevention and treatment of osteoporosis in Japan, which was not confirmed in western countries. Thus, we conduct this meta-analysis to verify the hypothesis that vitamin K2 plays a role in the prevention and treatment of osteoporosis for postmenopausal women. We searched the Cochrane Library, Pub Med, EMBASE, and ISI web of knowledge (until December 1, 2013) and reference lists of eligible articles. A meta-analysis of all-including randomized controlled trials was then performed. Nineteen randomized controlled trials encompassing 6759 participants have met the inclusion criteria. Subgroup analysis of postmenopausal women with osteoporosis revealed a significant improvement of vertebral BMD for both medium-term and long-term results favoring vitamin K2 group (p < 0.00001 and p = 0.0005). However, no significant difference in BMD changes was revealed for the non-osteoporosis subgroup analysis. As for the incidence of fractures, pooled analysis of the seven related studies demonstrated no significant difference in the incidence of fractures favoring vitamin K2 (RR = 0.63, p = 0.08). However, sensitivity analysis by rejecting the study inducing heterogeneity demonstrated a significant difference in the incidence of fractures favoring vitamin K2 (RR = 0.50, p = 0.0005). Significant differences were found in undercarboxylated osteocalcin reduction and osteocalcin increment. The result of adverse reaction analysis showed that vitamin K2 group seemed to have a higher adverse reaction rate (RR = 1.22, p = 0.06). This meta-analysis seemed to support the hypothesis that vitamin K2 plays kind of a role in the maintenance and improvement of vertebral BMD and the prevention of fractures in postmenopausal women with osteoporosis. The reduction of undercarboxylated osteocalcin and increment of osteocalcin may have some relation to the process of bone mineralization. However, the effect of vitamin K2 for postmenopausal women without osteoporosis had not been identified. Further high-quality RCTs with large sample size are needed to confirm the role of vitamin K2 in osteoporosis for postmenopausal women.

[Daily practice using the guidelines for prevention and treatment of osteoporosis. Effectiveness of exercise for preventing and treating osteoporosis].

PubMed

Miyakoshi, Naohisa

2008-08-01

There is increasing evidence that exercise is an effective strategy for the prevention and treatment of osteoporosis. The randomized controlled trials and their meta-analyses to date, evaluating the effects of exercise on osteoporosis reveal that the exercise is effective in preserving bone mass, preventing fractures and falls, and improving quality of life in patients with osteoporosis. Emphasis is also given to the importance of the specific protocols of exercises needed to achieve positive effects safely, keeping in view the age and general physical condition of the person.

Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

PubMed

Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

2015-10-01

Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication. (c) 2015 APA, all rights reserved).

Effect of motivational interviewing on rates of early childhood caries: a randomized trial.

PubMed

Harrison, Rosamund; Benton, Tonya; Everson-Stewart, Siobhan; Weinstein, Phil

2007-01-01

The purposes of this randomized controlled trial were to: (1) test motivational interviewing (MI) to prevent early childhood caries; and (2) use Poisson regression for data analysis. A total of 240 South Asian children 6 to 18 months old were enrolled and randomly assigned to either the MI or control condition. Children had a dental exam, and their mothers completed pretested instruments at baseline and 1 and 2 years postintervention. Other covariates that might explain outcomes over and above treatment differences were modeled using Poisson regression. Hazard ratios were produced. Analyses included all participants whenever possible. Poisson regression supported a protective effect of MI (hazard ratio [HR]=0.54 (95%CI=035-0.84)-that is, the M/ group had about a 46% lower rate of dmfs at 2 years than did control children. Similar treatment effect estimates were obtained from models that included, as alternative outcomes, ds, dms, and dmfs, including "white spot lesions." Exploratory analyses revealed that rates of dmfs were higher in children whose mothers had: (1) prechewed their food; (2) been raised in a rural environment; and (3) a higher family income (P<.05). A motivational interviewing-style intervention shows promise to promote preventive behaviors in mothers of young children at high risk for caries.

The history of hormone therapy use and recent controversy related to heart disease and breast cancer arising from prevention trial outcomes.

PubMed

Alexander, Ivy M

2012-01-01

The reasons for hormone therapy use have changed dramatically over time from being very popular for the purpose of preserving youth in women to menopause-related symptom management, disease prevention, and now back to menopause-related symptom management. Over time, several important risks associated with the use of hormone therapy have become evident, causing dramatic reductions in the use of hormone therapy for periods of time following identification of these risks. Most recently, randomized controlled prevention trials that evaluated hormone therapy for the purpose of reducing or preventing coronary heart disease among women have found that hormone therapy is associated with increased rather than decreased risks for coronary heart disease. The most recent of these trials again identified increased risks for breast cancer associated with estrogen plus progestogen therapy. The evolving evidence base from these randomized controlled prevention trials is complicated and in some cases contradictory. Specifically, the data suggest that the timing of when hormone therapy is initiated once a woman is postmenopausal may influence her risk for developing heart disease and breast cancer. In this article, contradictory evidence is carefully sifted so risks and benefits can be weighed by clinicians when partnering with women to individualize decisions about using hormone therapy. © 2012 by the American College of Nurse-Midwives.

Is a 6-week supervised pelvic floor muscle exercise program effective in preventing stress urinary incontinence in late pregnancy in primigravid women?: a randomized controlled trial.

PubMed

Sangsawang, Bussara; Sangsawang, Nucharee

2016-02-01

The study investigated the effect of a 6-week supervised pelvic floor muscle exercise (PFME) program to prevent stress urinary incontinence (SUI) at 38 weeks' gestation. We conducted a randomized controlled trial into two arms design: one intervention group and one control group, using the randomly computer-generated numbers. A research assistant, who was not involved with care of the participants, randomly drawn up and opened the envelope for each participant to allocate into the intervention group and the control group. The investigators could not be blinded to allocation. Seventy primigravid women who had continent with gestational ages of 20-30 weeks were randomly assigned to participate in the intervention (n=35) and control groups (n=35). The intervention was a supervised 6-week PFME program with verbal instruction and a handbook, three training sessions of 45 min with the main researcher (at 1st, 3rd and 5th week of the program) and self-daily training at home for an overall period of 6 weeks. The control condition was the PFME and the stop test had been trained by the main researcher to all of the participants in the intervention group. The primary outcome was self-reported of SUI, and the secondary outcome was the severity of SUI in pregnant women which comprises of frequency, volume of urine leakage and score of perceived severity of SUI in late pregnancy at 38th weeks of pregnancy. Statistical analysis was performed using Chi-square test, Independent-sample t-test, and Mann-Whitney U-test. Significance P-value was <0.05. At the end of the intervention, 2 of 35 women in the intervention group and 5 of 35 women in the control group dropped out of the study. Therefore, the total of the study participants consisted of 63 pregnant women (33 in the intervention group and 30 in the control group). Fewer women in the intervention group reported SUI than the control group: 9 of 33 (27.3%) versus 16 of 30 (53.3%) at 38 weeks' gestational age (OR 3.05, 95% CI 1.07-8.70, P=0.018). The 6-week supervised PFME program was effective in preventing SUI and decreasing the SUI severity in pregnant women who reported SUI at late pregnancy. The women who performed PFME program under the training sessions once every two weeks found that the program demands less time, incurs lower costs and possibly offers more motivation to exercise. This 6-week supervised PFME program may be suitable in real clinical situation. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Current role of sodium bicarbonate-based preprocedural hydration for the prevention of contrast-induced acute kidney injury: a meta-analysis.

PubMed

Hogan, Shea E; L'Allier, Phillipe; Chetcuti, Stanley; Grossman, P Michael; Nallamothu, Brahmajee K; Duvernoy, Claire; Bates, Eric; Moscucci, Mauro; Gurm, Hitinder S

2008-09-01

The optimal hydration strategy for prevention of contrast-induced acute kidney injury (AKI) remains unknown. The purpose of this meta-analysis is to compare the effectiveness of normal saline (NS) versus sodium bicarbonate hydration (NaHCO(3)) for prevention of contrast-induced AKI. We performed a meta-analysis of randomized controlled trials that compared saline-based hydration with sodium bicarbonate-based hydration regimen for prophylaxis of contrast-induced AKI. The literature search included MEDLINE, EMBASE, and Cochrane databases (2000 to October 2007); conference proceedings; and bibliographies of retrieved articles. Information was extracted on study design, sample characteristics, and interventions. Random-effects models were used to calculate summary risk ratios for contrast-induced AKI, need for hemodialysis, and death. Seven trials with 1,307 subjects were included. Preprocedural hydration with sodium bicarbonate was associated with a significant decrease in the rate of contrast-induced AKI (5.96% in the NaHCO(3) arm versus 17.23% in the NS arm, summary risk ratio 0.37, 95% CI 0.18-0.714, P = .005). There was no difference in the rates of postprocedure hemodialysis or death. Formal testing revealed moderate heterogeneity and a strong likelihood of publication bias. Although sodium bicarbonate hydration was found to be superior to NS in prevention of contrast-induced AKI, these results are in the context of study heterogeneity and, likely, publication bias. An adequately powered randomized controlled trial is warranted to define the optimal hydration strategy in patients at high risk of contrast-induced AKI who are scheduled to undergo contrast administration.

Efficacy of physical exercise in preventing falls in older adults with cognitive impairment: a systematic review and meta-analysis.

PubMed

Chan, Wai Chi; Yeung, Jerry Wing Fai; Wong, Corine Sau Man; Lam, Linda Chiu Wa; Chung, Ka Fai; Luk, James Ka Hay; Lee, Jenny Shun Wah; Law, Andrew Chi Kin

2015-02-01

Numerous studies have reported the prevention of falls through exercise among cognitively healthy older people. This study aimed to determine whether the current evidence supports that physical exercise is also efficacious in preventing falls in older adults with cognitive impairment. Two independent reviewers searched MEDLINE; EMBASE; PsycINFO; the Cumulative Index to Nursing & Allied Health Literature; the Cochrane Central Register of Controlled Trials; the Cochrane Bone, Joint, and Muscle Trauma Group Specialized Register; ClinicalTrials.gov; and the UK Clinical Research Network Study Portfolio up to July 2013 without language restriction. We included randomized controlled trials that examined the efficacy of physical exercise in older adults with cognitive impairment. The methodological qualities of the included trials were appraised according to the criteria developed for the Cochrane review of fall prevention trials. The primary outcome measure was the rate ratio of falls. A meta-analysis was performed to estimate the pooled rate ratio and summarize the results of the trials on fall prevention through physical exercise. Seven randomized controlled trials involving 781 participants were included, 4 of which examined solely older people with cognitive impairment. Subgroup data on persons with cognitive impairment were obtained from the other 3 trials that targeted older populations in general. The meta-analysis showed that physical exercise had a significant effect in preventing falls in older adults with cognitive impairment, with a pooled estimate of rate ratio of 0.68 (95% confidence interval 0.51-0.91). The present analysis suggests that physical exercise has a positive effect on preventing falls in older adults with cognitive impairment. Further studies will be required to determine the modality and frequency of exercise that are optimal for the prevention of falls in this population. Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review.

PubMed

Bus, S A; van Deursen, R W; Armstrong, D G; Lewis, J E A; Caravaggi, C F; Cavanagh, P R

2016-01-01

Footwear and offloading techniques are commonly used in clinical practice for preventing and healing of foot ulcers in persons with diabetes. The goal of this systematic review is to assess the medical scientific literature on this topic to better inform clinical practice about effective treatment. We searched the medical scientific literature indexed in PubMed, EMBASE, CINAHL, and the Cochrane database for original research studies published since 1 May 2006 related to four groups of interventions: (1) casting; (2) footwear; (3) surgical offloading; and (4) other offloading interventions. Primary outcomes were ulcer prevention, ulcer healing, and pressure reduction. We reviewed both controlled and non-controlled studies. Controlled studies were assessed for methodological quality, and extracted key data was presented in evidence and risk of bias tables. Uncontrolled studies were assessed and summarized on a narrative basis. Outcomes are presented and discussed in conjunction with data from our previous systematic review covering the literature from before 1 May 2006. We included two systematic reviews and meta-analyses, 32 randomized controlled trials, 15 other controlled studies, and another 127 non-controlled studies. Several randomized controlled trials with low risk of bias show the efficacy of therapeutic footwear that demonstrates to relief plantar pressure and is worn by the patient, in the prevention of plantar foot ulcer recurrence. Two meta-analyses show non-removable offloading to be more effective than removable offloading for healing plantar neuropathic forefoot ulcers. Due to the limited number of controlled studies, clear evidence on the efficacy of surgical offloading and felted foam is not yet available. Interestingly, surgical offloading seems more effective in preventing than in healing ulcers. A number of controlled and uncontrolled studies show that plantar pressure can be reduced by several conservative and surgical approaches. Sufficient evidence of good quality supports the use of non-removable offloading to heal plantar neuropathic forefoot ulcers and therapeutic footwear with demonstrated pressure relief that is worn by the patient to prevent plantar foot ulcer recurrence. The evidence base to support the use of other offloading interventions is still limited and of variable quality. The evidence for the use of interventions to prevent a first foot ulcer or heal ischemic, infected, non-plantar, or proximal foot ulcers is practically non-existent. High-quality controlled studies are needed in these areas. Copyright © 2015 John Wiley & Sons, Ltd.

How Do School-Based Prevention Programs Impact Teachers? Findings from a Randomized Trial of an Integrated Classroom Management and Social-Emotional Program.

PubMed

Domitrovich, Celene E; Bradshaw, Catherine P; Berg, Juliette K; Pas, Elise T; Becker, Kimberly D; Musci, Rashelle; Embry, Dennis D; Ialongo, Nicholas

2016-04-01

A number of classroom-based interventions have been developed to improve social and behavioral outcomes for students, yet few studies have examined how these programs impact the teachers who are implementing them. Impacts on teachers may affect students and therefore also serve as an important proximal outcome to examine. The current study draws upon data from a school-based randomized controlled trial testing the impact of two prevention programs. In one intervention condition, teachers were trained in the classroom behavior management program, PAX Good Behavior Game (PAX GBG). In a second intervention condition, teachers were trained to use an integrated program, referred to as PATHS to PAX, of the PAX GBG and a social and emotional learning curriculum called Promoting Alternative Thinking Strategies (PATHS©). This study aimed to determine whether both interventions positively impacted teachers, with a particular interest in the teachers' own beliefs and perceptions regarding self-efficacy, burnout, and social-emotional competence. The sample included 350 K-5 teachers across 27 schools (18 schools randomized to intervention, 9 to control). Multilevel latent growth curve analyses indicated that the PATHS to PAX condition generally demonstrated the most benefits to teachers, relative to both the control and PAX GBG conditions. These findings suggest that school-based preventive interventions can have a positive impact on teachers' beliefs and perceptions, particularly when the program includes a social-emotional component. Several possible mechanisms might account for the added benefit to teachers. Additional research is needed to better understand how these programs impact teachers, as well as students.

Moderators of intervention effects on parenting practices in a randomized controlled trial in early childhood.

PubMed

Theise, Rachelle; Huang, Keng-Yen; Kamboukos, Dimitra; Doctoroff, Greta L; Dawson-McClure, Spring; Palamar, Joseph J; Brotman, Laurie Miller

2014-01-01

The current study examined whether parent psychological resources (parenting stress, depression, and social support from friends and family) moderated the effects of early family preventive intervention on parenting among high-risk families. Ninety-two preschool-age children (M age = 3.94 years) at familial risk for conduct problems participated in a randomized controlled trial of a family intervention to prevent conduct problems. The majority of families were African American or Latino and experienced multiple stressors associated with poverty and familial antisocial behavior. Families were randomized to a 22-session group-based intervention or to a no-intervention, assessment-only control condition. Parents reported on their psychological resources (parenting stress, depression and social support from friends and family) at baseline. Parenting (responsive, harsh, stimulation for learning) was assessed through self-report and observational measures four times over 24 months. Previously-reported intervention effects on responsive parenting and stimulation for learning were moderated by depression and social support from friends, respectively, such that benefits were concentrated among those at greatest risk (i.e., depressed, limited support from friends). The intervention effect on harsh parenting was not moderated by any of the parent psychological resources examined, such that parents with high and low resources benefited comparably. Consideration of moderators of preventive intervention effects on parenting provides important information about intervention impact among families experiencing multiple barriers to engagement and effective parenting. Findings suggest that parents with diminished psychological resources are just as likely to benefit. Family-focused, group-based intervention is promising for strengthening parenting among the highest risk families.

The effectiveness of a suicide prevention app for indigenous Australian youths: study protocol for a randomized controlled trial.

PubMed

Shand, Fiona L; Ridani, Rebecca; Tighe, Joe; Christensen, Helen

2013-11-20

Indigenous Australian youth (aged 15 to 34) have up to four times the risk of suicide compared with their non-Indigenous counterparts. Barriers to help-seeking include shame, feared loss of autonomy and negative attitudes towards healthcare providers. The use of mobile devices and apps continues to rise amongst young people, thus presenting opportunities to utilize these aids in overcoming help-seeking barriers. Apps have been shown to assist in several health-related areas, including weight loss and smoking cessation, although no apps have as yet been evaluated for suicide prevention. Moreover, there is a lack of research that scientifically evaluates suicide prevention interventions within Indigenous communities. In this study, a recently developed self-help app will be evaluated in a randomized controlled trial. The intervention is based on acceptance and commitment therapy and mindfulness-based cognitive behavioural therapy. It is aimed at participants who have suicidal thoughts but who are not actively suicidal. In total, 150 participants will be randomly allocated to the intervention-condition (N = 75) or to the wait-list control condition (N = 75). Questionnaires will be completed at baseline, post-test and 6 weeks follow-up. The primary outcome measure is a reduction in frequency and intensity of suicidal thoughts. Secondary outcome measures are the reduction of depression, anxiety and impulsivity. This study is the first to evaluate the effectiveness of a self-help app for suicidal thoughts amongst young Indigenous people. Several limitations and strengths of the design are discussed. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000104752.

Moderators of Intervention Effects on Parenting Practices in a Randomized Controlled Trial in Early Childhood

PubMed Central

Theise, Rachelle; Huang, Keng-Yen; Kamboukos, Dimitra; Doctoroff, Greta L.; Dawson-McClure, Spring; Palamar, Joseph J.; Brotman, Laurie Miller

2013-01-01

Objective The current study examined whether parent psychological resources (parenting stress, depression, and social support from friends and family), moderated the effects of early family preventive intervention on parenting among high-risk families. Method Ninety-two preschool-age children (Mean age = 3.94 years) at familial risk for conduct problems participated in a randomized controlled trial of a family intervention to prevent conduct problems. The majority of families were African American or Latino and experienced multiple stressors associated with poverty and familial antisocial behavior. Families were randomized to a 22-session group-based intervention or to a no-intervention, assessment-only control condition. Parents reported on their psychological resources (parenting stress, depression and social support from friends and family) at baseline. Parenting (responsive, harsh, stimulation for learning) was assessed through self-report and observational measures four times over 24 months. Results Previously-reported intervention effects on responsive parenting and stimulation for learning were moderated by depression and social support from friends, respectively, such that benefits were concentrated among those at greatest risk (i.e., depressed, limited support from friends). The intervention effect on harsh parenting was not moderated by any of the parent psychological resources examined, such that parents with high and low resources benefited comparably. Conclusions Consideration of moderators of preventive intervention effects on parenting provides important information about intervention impact in families experiencing multiple barriers to engagement and effective parenting. Findings suggest that parents with diminished psychological resources are just as likely to benefit. Family-centered, group-based intervention is promising for strengthening parenting among the highest risk families. PMID:24063291

A randomized trial of effects of health risk appraisal combined with group sessions or home visits on preventive behaviors in older adults.

PubMed

Dapp, Ulrike; Anders, Jennifer A M; von Renteln-Kruse, Wolfgang; Minder, Christoph E; Meier-Baumgartner, Hans Peter; Swift, Cameron G; Gillmann, Gerhard; Egger, Matthias; Beck, John C; Stuck, Andreas E

2011-05-01

To explore effects of a health risk appraisal for older people (HRA-O) program with reinforcement, we conducted a randomized controlled trial in 21 general practices in Hamburg, Germany. Overall, 2,580 older patients of 14 general practitioners trained in reinforcing recommendations related to HRA-O-identified risk factors were randomized into intervention (n = 878) and control (n = 1,702) groups. Patients (n = 746) of seven additional matched general practitioners who did not receive this training served as a comparison group. Patients allocated to the intervention group, and their general practitioners, received computer-tailored written recommendations, and patients were offered the choice between interdisciplinary group sessions (geriatrician, physiotherapist, social worker, and nutritionist) and home visits (nurse). Among the intervention group, 580 (66%) persons made use of personal reinforcement (group sessions: 503 [87%], home visits: 77 [13%]). At 1-year follow-up, persons in the intervention group had higher use of preventive services (eg, influenza vaccinations, adjusted odds ratio 1.7; 95% confidence interval 1.4-2.1) and more favorable health behavior (eg, high fruit/fiber intake, odds ratio 2.0; 95% confidence interval 1.6-2.6), as compared with controls. Comparisons between intervention and comparison group data revealed similar effects, suggesting that physician training alone had no effect. Subgroup analyses indicated favorable effects for HRA-O with personal reinforcement, but not for HRA-O without reinforcement. HRA-O combined with physician training and personal reinforcement had favorable effects on preventive care use and health behavior.

Randomized Clinical Trial of Clinic-Integrated, Low-Intensity Treatment to Prevent Deterioration of Disease Care in Adolescents With Type 1 Diabetes

PubMed Central

Holmes, Clarissa S.; Chen, Rusan; Mackey, Eleanor; Grey, Margaret; Streisand, Randi

2014-01-01

OBJECTIVE To evaluate the efficacy of two office-based treatments designed to prevent deterioration in glycemic control in young adolescents with type 1 diabetes in a randomized clinical trial. An individualized, more intensive family teamwork Coping skills program was compared with a diabetes Education treatment. RESEARCH DESIGN AND METHODS A baseline assessment was followed by four brief treatment sessions and immediate posttesting over the course of 1.5 years. Families of 226 early adolescents (ages 11–14) were randomized to receive either individualized coping skills education or diabetes education as adjunctive treatment to quarterly medical appointments. Continued follow-up occurred at 3.5-month intervals for a long-term follow-up of up to 3 years. A post hoc Usual Care group facilitated comparisons of glycemic control. RESULTS Growth curve analysis showed that both treatment groups successfully prevented deterioration in adolescent disease care and simultaneously improved adolescent and parent quality of life that included indicators of more effective communication and reduced adherence barriers—without a concomitant increase in diabetes-related or general family conflict. However, contrary to expectation, the Education group was more efficacious than the Coping group in improvement of disease adherence and glycemic control over a 3-year follow-up. CONCLUSIONS Low-intensity office-based quarterly treatment can maintain or improve disease care adherence in early adolescence when provided to adolescent/parent dyads. Better outcomes are achieved when treatment goals and techniques match the needs of the targeted population. PMID:24623027

Online prevention of postpartum depression for Spanish- and English-speaking pregnant women: A pilot randomized controlled trial

PubMed Central

Barrera, Alinne Z.; Wickham, Robert E.; Muñoz, Ricardo F.

2015-01-01

Background Postpartum depression (PPD) is a maternal mental health problem that affects women from all regions of the world. Unfortunately, even in developed countries, half of the cases go undetected and, consequently, untreated. Individuals from low and middle income countries trend toward underutilization of mental health services, partly due to the limited number of available psychological resources. The primary aims of this pilot randomized controlled trial were to adapt to the Internet the Mothers and Babies Course/Curso Mamás y Bebés, a prevention of PPD intervention, to describe the characteristics of the pregnant women who engaged in the intervention site, and to obtain preliminary data on the efficacy of the Internet intervention to reduce the risk of PPD. Methods Pregnant women, 18 years or older who were interested in using the site for themselves were recruited and randomly assigned to a fully-automated self-help Internet intervention or to an information-only control condition. Randomized participants were invited to complete monthly depression assessments up to six months postpartum. To examine the prevention effects of the Internet intervention, pregnant women who did not meet current criteria for a major depressive episode, who engaged with the study website, and who provided depression data during the postpartum follow-up period were included in the study analyses. Results Participants were 111 predominantly Spanish-speaking (82.9%) and Latino/Hispanic (71.3%) pregnant women residing in 23 countries worldwide. The effect of the prevention intervention condition failed to reach significance at the a priori alpha-level. However, the observed coefficient trended in the hypothesized direction (b = −0.514, χ2 (1) = 3.43, p = .061; HR = 0.598). The benefits of receiving the e-MB Internet intervention was greater for pregnant women reporting high (vs. low) levels of prenatal depression symptoms (b = −0.605, χ2 (1) = 5.20, p =.023). Conclusions This study provides preliminary evidence that Internet interventions are a promising method toward expanding the reach of psychological resources to perinatal women at-risk for PPD. PMID:26273567

Text Messaging, Teen Outreach Program, and Sexual Health Behavior: A Cluster Randomized Trial.

PubMed

Bull, Sheana; Devine, Sharon; Schmiege, Sarah J; Pickard, Leslie; Campbell, Jon; Shlay, Judith C

2016-09-01

To consider whether Youth All Engaged! (a text message intervention) intensified the effects of the adolescent pregnancy prevention Teen Outreach Program (control) for youths. In this trial performed in Denver, Colorado, from 2011 to 2014, we randomized 8 Boys & Girls Clubs each of 4 years into 32 clubs per year combinations to ensure each club would serve as a treatment site for 2 years and a control site for 2 years. Control intervention consisted of the Teen Outreach Program only. We enrolled 852 youths (aged 14-18 years), and 632 were retained at follow-up, with analytic samples ranging from 50 to 624 across outcomes. We examined program costs, and whether the intervention increased condom and contraceptive use, access to care, and pregnancy prevention. Control program costs were $1184 per participant, and intervention costs were an additional $126 per participant (+10.6%). There were no statistically significant differences in primary outcomes for the full sample. Hispanic participants in the intervention condition had fewer pregnancies at follow-up (1.79%) than did those in the control group (6.72%; P = .02). Youth All Engaged is feasible, low cost, and could have potential benefits for Hispanic youths.

Breathing exercises in upper abdominal surgery: a systematic review and meta-analysis.

PubMed

Grams, Samantha T; Ono, Lariane M; Noronha, Marcos A; Schivinski, Camila I S; Paulin, Elaine

2012-01-01

There is currently no consensus on the indication and benefits of breathing exercises for the prevention of postoperative pulmonary complications PPCs and for the recovery of pulmonary mechanics. To undertake a systematic review of randomized and quasi-randomized studies that assessed the effects of breathing exercises on the recovery of pulmonary function and prevention of PCCs after upper abdominal surgery UAS. We searched the Physiotherapy Evidence Database PEDro, Scientific Electronic Library Online SciELO, MEDLINE, and Cochrane Central Register of Controlled Trials. We included randomized controlled trials and quasi-randomized controlled trials on pre- and postoperative UAS patients, in which the primary intervention was breathing exercises without the use of incentive inspirometers. The methodological quality of the studies was rated according to the PEDro scale. Data on maximal respiratory pressures MIP and MEP, spirometry, diaphragm mobility, and postoperative complications were extracted and analyzed. Data were pooled in fixed-effect meta-analysis whenever possible. Six studies were used for analysis. Two meta-analyses including 66 participants each showed that, on the first day post-operative, the breathing exercises were likely to have induced MEP and MIP improvement treatment effects of 11.44 mmH2O (95%CI 0.88 to 22) and 11.78 mmH2O (95%CI 2.47 to 21.09), respectively. Breathing exercises are likely to have a beneficial effect on respiratory muscle strength in patients submitted to UAS, however the lack of good quality studies hinders a clear conclusion on the subject.

A Web-Based Intervention to Reduce Indoor Tanning Motivations In Adolescents: A Randomized Controlled Trial

PubMed Central

Hillhouse, Joel; Turrisi, Rob; Scaglione, Nichole M.; Cleveland, Michael J.; Baker, Katie; Florence, L. Carter

2016-01-01

Youthful indoor tanning as few as ten sessions can increase the risk of melanoma by 2 to 4 times with each additional session adding another 2% to the risk. Recent research estimates that indoor tanning can be linked to approximately 450,000 cases of skin cancer annually in the United States, Europe, and Australia. Despite these risks, indoor tanning remains popular with adolescents. This study tested the efficacy of a web-based skin cancer prevention intervention designed to reduce indoor tanning motivations in adolescent females. A nationally representative sample of 443 female teens were enrolled from an online panel into a two-arm, parallel group design, randomized controlled trial. Treatment participants received an appearance-focused intervention grounded in established health behavior change models. Controls viewed a teen alcohol prevention website. Outcome variables included willingness and intentions to indoor tan, willingness to sunless tan and measures of indoor tanning attitudes and beliefs. The intervention decreased willingness and intentions to indoor tan and increased sunless tanning willingness relative to controls. We also examined indirect mechanisms of change through intervening variables (e.g., indoor tanning attitudes, norms, positive and negative expectancies) using the product of coefficients approach. The web-based intervention demonstrated efficacy in changing adolescent indoor tanning motivations and improving their orientation toward healthier alternatives. Results from the intervening variable analyses give guidance to future adolescent skin cancer prevention interventions. PMID:27549602

A Web-Based Intervention to Reduce Indoor Tanning Motivations in Adolescents: a Randomized Controlled Trial.

PubMed

Hillhouse, Joel; Turrisi, Rob; Scaglione, Nichole M; Cleveland, Michael J; Baker, Katie; Florence, L Carter

2017-02-01

Youthful indoor tanning as few as ten sessions can increase the risk of melanoma by two to four times with each additional session adding another 2 % to the risk. Recent research estimates that indoor tanning can be linked to approximately 450,000 cases of skin cancer annually in the USA, Europe, and Australia. Despite these risks, indoor tanning remains popular with adolescents. This study tested the efficacy of a web-based skin cancer prevention intervention designed to reduce indoor tanning motivations in adolescent females. A nationally representative sample of 443 female teens was enrolled from an online panel into a two-arm, parallel group design, randomized controlled trial. Treatment participants received an appearance-focused intervention grounded in established health behavior change models. Controls viewed a teen alcohol prevention website. Outcome variables included willingness and intentions to indoor tan, willingness to sunless tan, and measures of indoor tanning attitudes and beliefs. The intervention decreased willingness and intentions to indoor tan and increased sunless tanning willingness relative to controls. We also examined indirect mechanisms of change through intervening variables (e.g., indoor tanning attitudes, norms, positive and negative expectancies) using the product of coefficient approach. The web-based intervention demonstrated efficacy in changing adolescent indoor tanning motivations and improving their orientation toward healthier alternatives. Results from the intervening variable analyses give guidance to future adolescent skin cancer prevention interventions.

The effectiveness of a clinical and home-based physical activity program and simple lymphatic drainage in the prevention of breast cancer-related lymphedema: A prospective randomized controlled study.

PubMed

Dönmez, Ayşe Arıkan; Kapucu, Sevgisun

2017-12-01

To investigate the effectiveness of a clinical and home-based, nurse-led physical activity program (PAP) and simple lymphatic drainage (SLD) in the prevention of breast cancer-related lymphedema. A total of 52 breast cancer patients were randomized to either a PAP and SLD program (n = 25) or a control group (n = 27). Patients in both groups were also provided training for lymphedema. The PAP and SLD were administered through home visits by the investigators, twice a week for six weeks, in the intervention group. The control group did not undergo intervention. The circumference of the upper extremity, symptom severity, and physical function were measured in both groups. The upper extremity circumference increased by about two times from the baseline, in the control group, especially in the sixth week (p < 0.05). Lymphedema-related symptom severity scores were found to decrease significantly in the intervention group, compared to those at the baseline (p < 0.05). It was recommended that PAP and SLD, with a follow-up program, be used for patients who planned to undergo breast cancer surgery, starting from before surgery and continuing until after, to prevent breast cancer-related lymphedema. Copyright © 2017 Elsevier Ltd. All rights reserved.

Role of warm saline mouth rinse in prevention of alveolar osteitis: a randomized controlled trial.

PubMed

Osunde, Otasowie Daniel; Bassey, Godwin Obi

2015-01-01

The present study was aimed at determining the role warm saline rinse in the prevention of alveolar osteitis following dental extractions. Apparently patients aged 16 and above who were referred to the Oral Surgery Clinic of our institution, with an indication for non-surgical extraction of pathologic teeth were prospectively and uniformly randomized into warm saline group and control. The experimental group (n = 80) were instructed to gargle 6 times daily with warm saline and no such instructions were given to the second group (n = 80) to serve as controls. Information on demographic, indications for extraction, and development of alveolar osteitis were obtained and analyzed. Comparative statistics were done using Pearson's chi square or Fisher's exact test as appropriate. A p value of less than 0.05 was considered significant. The demographic and other baseline parameters such as indications for extractions were comparable among the study groups (p > 0.05). The overall prevalence of alveolar osteitis was 13.7%. There was a statistical significant difference between the study groups with respect to development of alveolar osteitis (X2 = 15.00, df = 1, p = 0.001).The risk of development of alveolar osteitis was 4 times higher in the control group (OR = 4.33, P = 0.001). Warm saline mouth rinse instruction is beneficial in the prevention of development of alveolar osteitis after dental extractions.

Computer-supported indirect-form lifestyle-modification support program using Lifestyle Intervention Support Software for Diabetes Prevention (LISS-DP) for people with a family history of type 2 diabetes in a medical checkup setting: a randomized controlled trial.

PubMed

Tokunaga-Nakawatase, Yuri; Nishigaki, Masakazu; Taru, Chiemi; Miyawaki, Ikuko; Nishida, Junko; Kosaka, Shiho; Sanada, Hiromi; Kazuma, Keiko

2014-10-01

To investigate the effect of a computer-supported indirect-form lifestyle-modification program using Lifestyle Intervention Support Software for Diabetes Prevention (LISS-DP), as a clinically feasible strategy for primary prevention, on diet and physical activity habits in adults with a family history of type 2 diabetes. This was a two-arm, randomized controlled trial: (1) lifestyle intervention (LI) group (n=70); (2) control (n=71). Healthy adults aged 30-60 years with a history of type 2 diabetes among their first-degree relatives were recruited. LI group received three times of lifestyle intervention using LISS-DP during six-month intervention period via mail. Lifestyle intervention group showed significantly greater decrease in energy intake six months after baseline, compared to control (-118.31 and -24.79 kcal/day, respectively, p=0.0099, Cohen's d=0.22), though the difference disappeared 1 year after from baseline. No difference was found in physical activity energy expenditure. A computer-based, non-face-to-face lifestyle intervention was effective on dietary habits, only during the intervention period. Further examination of the long-term effects of such intervention and physical activity is required. Copyright © 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Health and agricultural productivity: Evidence from Zambia.

PubMed

Fink, Günther; Masiye, Felix

2015-07-01

We evaluate the productivity effects of investment in preventive health technology through a randomized controlled trial in rural Zambia. In the experiment, access to subsidized bed nets was randomly assigned at the community level; 516 farmers were followed over a one-year farming period. We find large positive effects of preventative health investment on productivity: among farmers provided with access to free nets, harvest value increased by US$ 76, corresponding to about 14.7% of the average output value. While only limited information was collected on farming inputs, shifts in the extensive and the intensive margins of labor supply appear to be the most likely mechanism underlying the productivity improvements observed. Copyright © 2015 Elsevier B.V. All rights reserved.

[Effect of Visiting and a Smartphone Application Based Infection Prevention Education Program for Child Care Teachers: A Non-Randomized Controlled Trial].

PubMed

Yang, Yun Jeong; Kwon, In Soo

2017-12-01

This study was performed to develop an infection prevention education program for child care teachers and to verify its effects. The study was conducted using a nonequivalent control group with a pretest-posttest design. Four private daycare centers (2 centers per city) that were alike in terms of the number of children by age, number of child care teachers, and child care environment were chosen. Participants were assigned to the experimental group (n=20) or control group (n=20). As a part of the program, visiting education (90 min) was provided in the 1st week, and smartphone application education (10 min) was provided thrice a week, in the 2nd and 3rd weeks. Child care teachers' self-efficacy for infection prevention revealed a significant interaction effect between the group and time of measurement (F=21.62, p<.001). In terms of infection prevention behavior, a significant difference was observed between the experimental and control groups (z=-5.36, p<.001). The program implemented in this study was effective in improving the infection prevention self-efficacy and infection prevention behavior of child care teachers. Thus, this program may be effective in enhancing their infection control. © 2017 Korean Society of Nursing Science

Peer education for secondary stroke prevention in inner-city minorities: design and methods of the prevent recurrence of all inner-city strokes through education randomized controlled trial.

PubMed

Goldfinger, Judith Z; Kronish, Ian M; Fei, Kezhen; Graciani, Albert; Rosenfeld, Peri; Lorig, Kate; Horowitz, Carol R

2012-09-01

The highest risk for stroke is among survivors of strokes or transient ischemic attacks (TIA). However, use of proven-effective cardiovascular medications to control stroke risk is suboptimal, particularly among the Black and Latino populations disproportionately impacted by stroke. A partnership of Harlem and Bronx community representatives, stroke survivors, researchers, clinicians, outreach workers and patient educators used community-based participatory research to conceive and develop the Prevent Recurrence of All Inner-city Strokes through Education (PRAISE) trial. Using data from focus groups with stroke survivors, they tailored a peer-led, community-based chronic disease self-management program to address stroke risk factors. PRAISE will test, in a randomized controlled trial, whether this stroke education intervention improves blood pressure control and a composite outcome of blood pressure control, lipid control, and use of antithrombotic medications. Of the 582 survivors of stroke and TIA enrolled thus far, 81% are Black or Latino and 56% have an annual income less than $15,000. Many (33%) do not have blood pressures in the target range, and most (66%) do not have control of all three major stroke risk factors. Rates of stroke recurrence risk factors remain suboptimal in the high risk, urban, predominantly minority communities studied. With a community-partnered approach, PRAISE has recruited a large number of stroke and TIA survivors to date, and may prove successful in engaging those at highest risk for stroke and reducing disparities in stroke outcomes in inner-city communities. Copyright © 2012 Elsevier Inc. All rights reserved.

Mindfulness-based prevention for eating disorders: A school-based cluster randomized controlled study.

PubMed

Atkinson, Melissa J; Wade, Tracey D

2015-11-01

Successful prevention of eating disorders represents an important goal due to damaging long-term impacts on health and well-being, modest treatment outcomes, and low treatment seeking among individuals at risk. Mindfulness-based approaches have received early support in the treatment of eating disorders, but have not been evaluated as a prevention strategy. This study aimed to assess the feasibility, acceptability, and efficacy of a novel mindfulness-based intervention for reducing the risk of eating disorders among adolescent females, under both optimal (trained facilitator) and task-shifted (non-expert facilitator) conditions. A school-based cluster randomized controlled trial was conducted in which 19 classes of adolescent girls (N = 347) were allocated to a three-session mindfulness-based intervention, dissonance-based intervention, or classes as usual control. A subset of classes (N = 156) receiving expert facilitation were analyzed separately as a proxy for delivery under optimal conditions. Task-shifted facilitation showed no significant intervention effects across outcomes. Under optimal facilitation, students receiving mindfulness demonstrated significant reductions in weight and shape concern, dietary restraint, thin-ideal internalization, eating disorder symptoms, and psychosocial impairment relative to control by 6-month follow-up. Students receiving dissonance showed significant reductions in socio-cultural pressures. There were no statistically significant differences between the two interventions. Moderate intervention acceptability was reported by both students and teaching staff. Findings show promise for the application of mindfulness in the prevention of eating disorders; however, further work is required to increase both impact and acceptability, and to enable successful outcomes when delivered by less expert providers. © 2015 Wiley Periodicals, Inc.

Media Literacy Education for Elementary School Substance Use Prevention: Study of Media Detective

PubMed Central

Kupersmidt, Janis B.; Scull, Tracy M.; Austin, Erica Weintraub

2017-01-01

OBJECTIVES Media Detective is a 10-lesson elementary school substance use prevention program developed on the basis of the message interpretation processing model designed to increase children’s critical thinking skills about media messages and reduce intent to use tobacco and alcohol products. The purpose of this study was to conduct a short-term, randomized, controlled trial to evaluate the effectiveness of Media Detective for achieving these goals. METHODS Elementary schools were randomly assigned to conditions to either receive the Media Detective program (n = 344) or serve in a waiting list control group (n = 335). RESULTS Boys in the Media Detective group reported significantly less interest in alcohol-branded merchandise than boys in the control group. Also, students who were in the Media Detective group and had used alcohol or tobacco in the past reported significantly less intention to use and more self-efficacy to refuse substances than students who were in the control group and had previously used alcohol or tobacco. CONCLUSIONS This evaluation provides evidence that Media Detective can be effective for substance use prevention in elementary school–aged children. Notably, media-related cognitions about alcohol and tobacco products are malleable and relevant to the development and maintenance of substance use behaviors during late childhood. The findings from this study suggest that media literacy– based interventions may serve as both a universal and a targeted prevention program that has potential for assisting elementary school children in making healthier, more informed decisions about use of alcohol and tobacco products. PMID:20732940

Sodium Dichloroisocyanurate Tablets for Routine Treatment of Household Drinking Water in Periurban Ghana: A Randomized Controlled Trial

PubMed Central

Jain, Seema; Sahanoon, Osman K.; Blanton, Elizabeth; Schmitz, Ann; Wannemuehler, Kathleen A.; Hoekstra, Robert M.; Quick, Robert E.

2010-01-01

We conducted a randomized, placebo-controlled, triple-blinded trial to determine the health impact of daily use of sodium dichloroisocyanurate (NaDCC) tablets for household drinking water treatment in periurban Ghana. We randomized 240 households (3,240 individuals) to receive either NaDCC or placebo tablets. All households received a 20-liter safe water storage vvessel. Over 12 weeks, 446 diarrhea episodes (2.2%) occurred in intervention and 404 (2.0%) in control households (P = 0.38). Residual free chlorine levels indicated appropriate tablet use. Escherichia coli was found in stored water at baseline in 96% of intervention and 88% of control households and at final evaluation in 8% of intervention and 54% of control households (P = 0.002). NaDCC use did not prevent diarrhea but improved water quality. Diarrhea rates were low and water quality improved in both groups. Safe water storage vessels may have been protective. A follow-up health impact study of NaDCC tablets is warranted. PMID:20064989

PTH(1-34) for the Primary Prevention of Postthyroidectomy Hypocalcemia: The THYPOS Trial.

PubMed

Palermo, Andrea; Mangiameli, Giuseppe; Tabacco, Gaia; Longo, Filippo; Pedone, Claudio; Briganti, Silvia Irina; Maggi, Daria; Vescini, Fabio; Naciu, Anda; Lauria Pantano, Angelo; Napoli, Nicola; Angeletti, Silvia; Pozzilli, Paolo; Crucitti, Pierfilippo; Manfrini, Silvia

2016-11-01

There are no studies evaluating teriparatide for prevention of post-thyroidectomy hypocalcemia. Our objective was to evaluate whether teriparatide can prevent postsurgical hypocalcemia and shorten the hospitalization in subjects at high risk of hypocalcemia following thyroid surgery. This was a prospective phase II randomized open-label trial. This trial was set on a surgical ward. Twenty-six subjects (six males, 20 females) with intact PTH lower than10 pg/ml 4 hours after thyroidectomy were included. Subjects were randomized (1:1) to receive SC administration of 20 mcg of teriparatide every 12 hours until the discharge (treatment group) or to follow standard clinical care (control group). Adjusted serum calcium, duration of hospitalization, and calcium/calcitriol supplementation were measured. Overall, the incidence of hypocalcemia was 3/13 in treatment group and 11/13 in the control group (P = .006). Treated patients had a lower risk of hypocalcemia than controls (relative risk, 0.26 [95% confidence interval, 0.09-0.723)]). The median duration of hospitalization was 3 days (interquartile range, 1) in control subjects and 2 days (interquartile range, 0) in treated subjects (P = .012). One month after discharge, 10/13 subjects in the treatment group had stopped calcium carbonate supplements, while only 5/13 in the control group had discontinued calcium. The ANOVA for repeated measures showed a significant difference in calcium supplements between groups at 1-month visit (P = .04) as well as a significant difference between discharge and 1-month visit in the treatment group (P for interaction time group = .04) Conclusions: Teriparatide may prevent postsurgical hypocalcemia, shorten the duration of hospitalization, and reduce the need for calcium and vitamin D supplementation after discharge in high risk subjects after thyroid surgery.

Effectiveness of participatory training for prevention of musculoskeletal disorders: a randomized controlled trial.

PubMed

Yu, Wenzhou; Yu, Ignatius T S; Wang, Xiaorong; Li, Zhimin; Wan, Sabrina; Qiu, Hong; Lin, Hui; Xie, Shaohua; Sun, Trevor

2013-05-01

Health and safety training program has been applied to prevent work-related musculoskeletal disorders (MSDs) in workplace. We evaluated the effectiveness of participatory training and didactic training programs on MSD prevention among frontline workers in Shenzhen, China. The authors randomly assigned 918 workers from intervention factories to receive participatory training (intervention group), and 907 workers from intervention factories and 1,654 workers from control factories to receive didactic training (control_1 group, control_2 group, respectively) from June 1, 2008 to November 30, 2009. Participants were asked to report experience of ache, pain or discomfort in 10 body parts at baseline and 1 year after training. Data were analyzed to compare the MSD prevalence 1 year before and 1 year after training in different groups from 2009 to 2010. The follow-up rate was 61 % (2,120/3,479) at 1 year after training. In the year after training, there were no statistically significant changes in the proportion of workers who reported MSD in any body part. MSD prevalence rates in the intervention group reduced from 16.8 to 9.9 % for lower extremities (χ(2) = 13.102, p < 0.001) and from 12.9 to 8.3 % (χ(2) = 9.433, p = 0.002) for wrist and finger at 1 year after training. However, the rates did not change significantly for upper back, lower back, neck, shoulder and elbow in the intervention group and for all 10 body parts in two control groups. Overall, the training programs did not seem to prevent the occurrence of MSD among frontline workers. However, participatory training might be effective to reduce MSD in the lower extremities and wrist and finger.

A two-arm cluster randomized control trial to determine the effectiveness of a pressure ulcer prevention bundle for critically ill patients.

PubMed

Tayyib, Nahla; Coyer, Fiona; Lewis, Peter A

2015-05-01

This study tested the effectiveness of a pressure ulcer (PU) prevention bundle in reducing the incidence of PUs in critically ill patients in two Saudi intensive care units (ICUs). A two-arm cluster randomized experimental control trial. Participants in the intervention group received the PU prevention bundle, while the control group received standard skin care as per the local ICU policies. Data collected included demographic variables (age, diagnosis, comorbidities, admission trajectory, length of stay) and clinical variables (Braden Scale score, severity of organ function score, mechanical ventilation, PU presence, and staging). All patients were followed every two days from admission through to discharge, death, or up to a maximum of 28 days. Data were analyzed with descriptive correlation statistics, Kaplan-Meier survival analysis, and Poisson regression. The total number of participants recruited was 140: 70 control participants (with a total of 728 days of observation) and 70 intervention participants (784 days of observation). PU cumulative incidence was significantly lower in the intervention group (7.14%) compared to the control group (32.86%). Poisson regression revealed the likelihood of PU development was 70% lower in the intervention group. The intervention group had significantly less Stage I (p = .002) and Stage II PU development (p = .026). Significant improvements were observed in PU-related outcomes with the implementation of the PU prevention bundle in the ICU; PU incidence, severity, and total number of PUs per patient were reduced. Utilizing a bundle approach and standardized nursing language through skin assessment and translation of the knowledge to practice has the potential to impact positively on the quality of care and patient outcome. © 2015 Sigma Theta Tau International.

Effects of a multifactorial falls prevention program for people with stroke returning home after rehabilitation: a randomized controlled trial.

PubMed

Batchelor, Frances A; Hill, Keith D; Mackintosh, Shylie F; Said, Catherine M; Whitehead, Craig H

2012-09-01

To determine whether a multifactorial falls prevention program reduces falls in people with stroke at risk of recurrent falls and whether this program leads to improvements in gait, balance, strength, and fall-related efficacy. A single blind, multicenter, randomized controlled trial with 12-month follow-up. Participants were recruited after discharge from rehabilitation and followed up in the community. Participants (N=156) were people with stroke at risk of recurrent falls being discharged home from rehabilitation. Tailored multifactorial falls prevention program and usual care (n=71) or control (usual care, n=85). Primary outcomes were rate of falls and proportion of fallers. Secondary outcomes included injurious falls, falls risk, participation, activity, leg strength, gait speed, balance, and falls efficacy. There was no significant difference in fall rate (intervention: 1.89 falls/person-year, control: 1.76 falls/person-year, incidence rate ratio=1.10, P=.74) or the proportion of fallers between the groups (risk ratio=.83, 95% confidence interval=.60-1.14). There was no significant difference in injurious fall rate (intervention: .74 injurious falls/person-year, control: .49 injurious falls/person-year, incidence rate ratio=1.57, P=.25), and there were no significant differences between groups on any other secondary outcome. This multifactorial falls prevention program was not effective in reducing falls in people with stroke who are at risk of falls nor was it more effective than usual care in improving gait, balance, and strength in people with stroke. Further research is required to identify effective interventions for this high-risk group. Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Electronic Immunization Alerts and Spillover Effects on Other Preventive Care.

PubMed

Kim, Julia M; Rivera, Maria; Persing, Nichole; Bundy, David G; Psoter, Kevin J; Ghazarian, Sharon R; Miller, Marlene R; Solomon, Barry S

2017-08-01

The impact of electronic health record (EHR) immunization clinical alert systems on the delivery of other preventive services remains unknown. We assessed for spillover effects of an EHR immunization alert on delivery of 6 other preventive services, in children 18 to 30 months of age needing immunizations. We conducted a secondary data analysis, with additional primary data collection, of a randomized, historically controlled trial to improve immunization rates with EHR alerts, in an urban, primary care clinic. No significant differences were found in screening for anemia, lead, development, nutrition, and injury prevention counseling in children prompting EHR immunization alerts (n = 129), compared with controls (n = 135). Significant increases in oral health screening in patients prompting EHR alerts (odds ratio = 4.8, 95% CI = 1.8-13.0) were likely due to practice changes over time. An EHR clinical alert system targeting immunizations did not have a spillover effect on the delivery of other preventive services.

Impact of a school-based dating violence prevention program among Latino teens: randomized controlled effectiveness trial.

PubMed

Jaycox, Lisa H; McCaffrey, Daniel; Eiseman, Beth; Aronoff, Jessica; Shelley, Gene A; Collins, Rebecca L; Marshall, Grant N

2006-11-01

Given the high rate of dating violence between teens and associated deleterious outcomes, the need for effective prevention and early intervention programs is clear. Break the Cycle's Ending Violence curriculum, a three-class-session prevention program focused on legal issues, is evaluated here for its impact on Latino/a youth. Tracks within large urban high schools that had at least 80% Latino/a students were randomized to immediate or delayed curriculum. Classrooms were randomly selected within tracks and individual student outcomes were assessed pre- and postintervention and six months later. Students in intervention classrooms showed improved knowledge, less acceptance of female-on-male aggression, and enhanced perception of the helpfulness and likelihood of seeking assistance from a number of sources immediately after the program. Improved knowledge and perceived helpfulness of an attorney were maintained six months later. There were no differences in recent abusive/fearful dating experiences or violence victimization or perpetration. The Ending Violence curriculum has an impact on teen norms, knowledge, and help-seeking proclivities that may aid in early intervention for dating violence among Latino/a students.

A randomized controlled trial of eicosapentaenoic acid and/or aspirin for colorectal adenoma prevention during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme (The seAFOod Polyp Prevention Trial): study protocol for a randomized controlled trial.

PubMed

Hull, Mark A; Sandell, Anna C; Montgomery, Alan A; Logan, Richard F A; Clifford, Gayle M; Rees, Colin J; Loadman, Paul M; Whitham, Diane

2013-07-29

The naturally-occurring omega (ω)-3 polyunsaturated fatty acid (PUFA) eicosapentaenoic acid (EPA) reduces colorectal adenoma (polyp) number and size in patients with familial adenomatous polyposis. The safety profile and potential cardiovascular benefits associated with ω-3 PUFAs make EPA a strong candidate for colorectal cancer (CRC) chemoprevention, alone or in combination with aspirin, which itself has recognized anti-CRC activity. Colorectal adenoma number and size are recognized as biomarkers of future CRC risk and are established as surrogate end-points in CRC chemoprevention trials. The seAFOod Polyp Prevention Trial is a randomized, double-blind, placebo-controlled, 2×2 factorial 'efficacy' study, which will determine whether EPA prevents colorectal adenomas, either alone or in combination with aspirin. Participants are 55-73 year-old patients, who have been identified as 'high risk' (detection of ≥5 small adenomas or ≥3 adenomas with at least one being ≥10 mm in diameter) at screening colonoscopy in the English Bowel Cancer Screening Programme (BCSP). Exclusion criteria include the need for more than one repeat endoscopy within the three-month BCSP screening period, malignant change in an adenoma, regular use of aspirin or non-aspirin non-steroidal anti-inflammatory drugs, regular use of fish oil supplements and concomitant warfarin or anti-platelet agent therapy. Patients are randomized to either EPA-free fatty acid 1 g twice daily or identical placebo AND aspirin 300 mg once daily or identical placebo, for approximately 12 months. The primary end-point is the number of participants with one or more adenomas detected at routine one-year BCSP surveillance colonoscopy. Secondary end-points include the number of adenomas (total and 'advanced') per patient, the location (left versus right colon) of colorectal adenomas and the number of participants re-classified as 'intermediate risk' for future surveillance. Exploratory end-points include levels of bioactive lipid mediators such as ω-3 PUFAs, resolvin E1 and PGE-M in plasma, urine, erythrocytes and rectal mucosa in order to gain insights into the mechanism(s) of action of EPA and aspirin, alone and in combination, as well as to discover predictive biomarkers of chemopreventive efficacy. The recruitment target is 904 patients. Current Controlled Trials ISRCTN05926847.

The preventive effect of the nordic hamstring exercise on hamstring injuries in amateur soccer players: a randomized controlled trial.

PubMed

van der Horst, Nick; Smits, Dirk-Wouter; Petersen, Jesper; Goedhart, Edwin A; Backx, Frank J G

2015-06-01

Hamstring injuries are the most common muscle injuries in soccer, and they have a high rate of recurrence. Eccentric hamstrings strength is recognized as an important modifiable risk factor. This led to the development of prevention exercises such as the nordic hamstring exercise (NHE). The effectiveness of the NHE on hamstring injury prevention has never been investigated in amateur soccer. To investigate the preventive effect of the NHE on the incidence and severity of hamstring injuries in male amateur soccer players. Randomized controlled trial; Level of evidence, 1. Male amateur soccer players (age, mean ± SD, 24.5 ± 3.8 years) from 40 teams were randomly allocated to an intervention (n = 20 teams, 292 players) or control group (n = 20 teams, 287 players). The intervention group was instructed to perform 25 sessions of NHE in a 13-week period. Both the intervention and control groups performed regular soccer training and were followed for hamstring injury incidence and severity during the 2013 calendar year. At baseline, personal characteristics (eg, age, injury history, field position) were gathered from all participants via a questionnaire. Primary outcome was injury incidence. Secondary outcomes were injury severity and compliance with the intervention protocol. A total of 38 hamstring injuries were recorded, affecting 36 of 579 players (6.2%). The overall injury incidence rate was 0.7 (95% CI, 0.6-0.8) per 1000 player hours, 0.33 (95% CI, 0.25-0.46) in training, and 1.2 (95% CI, 0.82-1.94) in matches. Injury incidence rates were significantly different between the intervention (0.25; 95% CI, 0.19-0.35) and control groups (0.8; 95% CI, 0.61-1.15), χ(2)(1, n = 579) = 7.865; P = .005. The risk for hamstring injuries was reduced in the intervention group compared with the control group (odds ratio, 0.282; 95% CI, 0.110-0.721) and was statistically significant (P = .005). No statistically significant differences were identified between the intervention and control groups regarding injury severity. Compliance with the intervention protocol was 91%. Incorporating the NHE protocol in regular amateur training significantly reduces hamstring injury incidence, but it does not reduce hamstring injury severity. Compliance with the intervention was excellent. © 2015 The Author(s).

Universality properties of school-based preventive intervention targeted at cannabis use.

PubMed

Miovský, Michal; Voňková, Hana; Gabrhelík, Roman; Šťastná, Lenka

2015-02-01

This study aims to examine the effect of school-based preventive intervention on cannabis use in Czech adolescents with different levels of risk factors and provide evidence of its universality. A randomized controlled prevention trial with six waves was conducted over a period of 33 months. We used a two-level logistic random-intercept model for panel data; we first looked at the statistical significance of the effect of the intervention on cannabis use, controlling for the characteristics of the children and time dummies. Then we analyzed the effects of the interactions between the intervention and the characteristics of the children on cannabis use and related it to the definition of universal preventive interventions. The setting for the study was in basic schools in the Czech Republic in the years 2007-2010. A total of 1,874 sixth-graders (mean age 11.82 years) who completed the baseline testing. According to our results, the prevention intervention was effective. We found all the selected characteristics of the children to be relevant in relation to cannabis use, except their relationships with their friends. We showed empirically that the intervention is universal in two dimensions for the selected characteristics of the children. First, all adolescents who undergo the intervention are expected to benefit. Second, with respect to the effect of the intervention on cannabis use, the total level of individual risk of cannabis use is superior to the composition of the risk factors in the individual risk profile. We present indicative evidence that the drug prevention intervention may be considered a true universal preventive intervention.

[On-site quality control of acupuncture randomized controlled trial: design of content and checklist of quality control based on PICOST].

PubMed

Li, Hong-Jiao; He, Li-Yun; Liu, Zhi-Shun; Sun, Ya-Nan; Yan, Shi-Yan; Liu, Jia; Zhao, Ye; Liu, Bao-Yan

2014-02-01

To effectively guarantee quality of randomized controlld trial (RCT) of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall consideration. Based on content and checklist of on-site quality control in National 11th Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assessment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupuncture RCT should be conducted with PICOST (patient, intervention, comparison, out come, site and time) as core, especially on quality control of interveners' skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.

Evaluation of Visual Pedagogy in Dental Check-Ups and Preventive Practices among 6-12-Year-Old Children with Autism

ERIC Educational Resources Information Center

Nilchian, Firoozeh; Shakibaei, Fereshteh; Jarah, Zeinab Taghi

2017-01-01

This study was aimed to evaluate the impact of visual pedagogy in dental check-ups and preventive practices among children with autism aged 6-12. In this randomized double-blind clinical trial, the cooperation of 40 children with autism age 6-12. The selected children were equally divided into two groups of case and control (n = 20). The obtained…

Are Substance Use Prevention Programs More Effective in Schools Making Adequate Yearly Progress? A Study of Project ALERT

ERIC Educational Resources Information Center

Clark, Heddy Kovach; Ringwalt, Chris L.; Shamblen, Stephen R.; Hanley, Sean M.; Flewelling, Robert L.

2011-01-01

This exploratory study sought to determine if a popular school-based drug prevention program might be effective in schools that are making adequate yearly progress (AYP). Thirty-four schools with grades 6 through 8 in 11 states were randomly assigned either to receive Project ALERT (n = 17) or to a control group (n = 17); of these, 10 intervention…

Efficacy of a Preventive Counseling Program for Improving Psychological Hardiness and the Positive Use of Social Network Sites among Students at Risk

ERIC Educational Resources Information Center

Almahaireh, Abdallah Salem Farhan; Aldalaeen, Anas Saleh Rabi; Takhaineh, Suhib Khaled Ahmad

2018-01-01

The purpose of this study was to investigate the efficacy of a preventive counseling program for improving psychological hardiness (PsyH) and the positive use of social network sites (SNSs). The sample consisted of 30 students from Mu'tah University in Jordan who were randomly assigned into either an experimental group (15) or a control group…

Relapse Prevention in Pediatric Patients with ADHD Treated with Atomoxetine: A Randomized, Double-Blind, Placebo-Controlled Study

ERIC Educational Resources Information Center

Michelson, David; Buitelaar, Jan K.; Danckaerts, Marina; Gillberg, Christopher; Spencer, Thomas J.; Zuddas, Alessandro; Faries, Douglas E.; Zhang, Shuyu; Biederman, Joseph

2004-01-01

Objective: Attention-deficit/hyperactivity disorder (ADHD) is typically treated over extended periods; however, few placebo-controlled, long-term studies of efficacy have been reported. Method: In a global multicenter study, children and adolescents who responded to an initial 12-week, open-label period of treatment with atomoxetine, a…

Designing a Weight Gain Prevention Trial for Young Adults: The CHOICES Study

ERIC Educational Resources Information Center

Lytle, Leslie A.; Moe, Stacey G.; Nanney, M. Susie; Laska, Melissa N.; Linde, Jennifer A.; Petrich, Christine A.; Sevcik, Sarah M.

2014-01-01

Background: Young adults are at risk for weight gain. Little is known about how to design weight control programs to meet the needs of young adults and few theory-based interventions have been evaluated in a randomized control trial. The Choosing Healthy Options in College Environments and Settings (CHOICES) study was funded to create a…

Positive Outlook as a Moderator of the Effectiveness of an HIV/STI Intervention with Adolescents in Detention

ERIC Educational Resources Information Center

Schmiege, Sarah J.; Ewing, Sarah W. Feldstein; Hendershot, Christian S.; Bryan, Angela D.

2011-01-01

Justice-involved adolescents engage in high levels of risky sexual behavior, underscoring the need for targeted, effective, prevention interventions geared toward this population. In a randomized controlled trial, 484 detained adolescents received a theory-based intervention or an information-only control. We have previously demonstrated that the…

A randomized, placebo-controlled trial of patient education for acute low back pain (PREVENT Trial): statistical analysis plan.

PubMed

Traeger, Adrian C; Skinner, Ian W; Hübscher, Markus; Lee, Hopin; Moseley, G Lorimer; Nicholas, Michael K; Henschke, Nicholas; Refshauge, Kathryn M; Blyth, Fiona M; Main, Chris J; Hush, Julia M; Pearce, Garry; Lo, Serigne; McAuley, James H

Statistical analysis plans increase the transparency of decisions made in the analysis of clinical trial results. The purpose of this paper is to detail the planned analyses for the PREVENT trial, a randomized, placebo-controlled trial of patient education for acute low back pain. We report the pre-specified principles, methods, and procedures to be adhered to in the main analysis of the PREVENT trial data. The primary outcome analysis will be based on Mixed Models for Repeated Measures (MMRM), which can test treatment effects at specific time points, and the assumptions of this analysis are outlined. We also outline the treatment of secondary outcomes and planned sensitivity analyses. We provide decisions regarding the treatment of missing data, handling of descriptive and process measure data, and blinded review procedures. Making public the pre-specified statistical analysis plan for the PREVENT trial minimizes the potential for bias in the analysis of trial data, and in the interpretation and reporting of trial results. ACTRN12612001180808 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808). Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Do Technical Aids for Patient Handling Prevent Musculoskeletal Complaints in Health Care Workers?—A Systematic Review of Intervention Studies

PubMed Central

Hegewald, Janice; Berge, Wera; Heinrich, Philipp; Staudte, Ronny; Freiberg, Alice; Scharfe, Julia; Girbig, Maria; Nienhaus, Albert; Seidler, Andreas

2018-01-01

The physical load ensuing from the repositioning and moving of patients puts health care workers at risk of musculoskeletal complaints. Technical equipment developed to aid with patient handling should reduce physical strain and workload; however, the efficacy of these aids in preventing musculoskeletal disorders and complaints is still unclear. A systematic review of controlled intervention studies was conducted to examine if the risk of musculoskeletal complaints and disorders is reduced by technical patient handling equipment. MEDLINE®/PubMed®, EMBASE®, Allied and Complementary Medicine Database (AMED), and Cumulative Index of Nursing and Allied Health Literature (CINAHL®) were searched using terms for nursing, caregiving, technical aids, musculoskeletal injuries, and complaints. Randomized controlled trials and controlled before-after studies of interventions including technical patient handling equipment were included. The titles and abstracts of 9554 publications and 97 full-texts were screened by two reviewers. The qualitative synthesis included one randomized controlled trial (RCT) and ten controlled before-after studies. A meta-analysis of four studies resulted in a pooled risk ratio for musculoskeletal injury claims (post-intervention) of 0.78 (95% confidence interval 0.68–0.90). Overall, the methodological quality of the studies was poor and the results often based on administrative injury claim data, introducing potential selection bias. Interventions with technical patient handling aids appear to prevent musculoskeletal complaints, but the certainty of the evidence according to GRADE approach ranged from low to very low. PMID:29522440

The effectiveness of dry-cupping in preventing post-operative nausea and vomiting by P6 acupoint stimulation: A randomized controlled trial.

PubMed

Farhadi, Khosro; Choubsaz, Mansour; Setayeshi, Khosro; Kameli, Mohammad; Bazargan-Hejazi, Shahrzad; Heidari Zadie, Zahra; Ahmadi, Alireza

2016-09-01

Postoperative nausea and vomiting (PONV) is a common complication after general anesthesia, and the prevalence ranges between 25% and 30%. The aim of this study was to determine the preventive effects of dry cupping on PONV by stimulating point P6 in the wrist. This was a randomized controlled trial conducted at the Imam Reza Hospital in Kermanshah, Iran. The final study sample included 206 patients (107 experimental and 99 controls). Inclusion criteria included the following: female sex; age>18 years; ASA Class I-II; type of surgery: laparoscopic cholecystectomy; type of anesthesia: general anesthesia. Exclusion criteria included: change in the type of surgery, that is, from laparoscopic cholecystectomy to laparotomy, and ASA-classification III or more. Interventions are as follows: pre surgery, before the induction of anesthesia, the experimental group received dry cupping on point P6 of the dominant hand's wrist with activation of intermittent negative pressure. The sham group received cupping without activation of negative pressure at the same point. Main outcome was that the visual analogue scale was used to measure the severity of PONV. The experimental group who received dry cupping had significantly lower levels of PONV severity after surgery (P < 0.001) than the control group. The differences in measure were maintained after controlling for age and ASA in regression models (P < 0.01). Traditional dry cupping delivered in an operation room setting prevented PONV in laparoscopic cholecystectomy patients.

Do Technical Aids for Patient Handling Prevent Musculoskeletal Complaints in Health Care Workers?-A Systematic Review of Intervention Studies.

PubMed

Hegewald, Janice; Berge, Wera; Heinrich, Philipp; Staudte, Ronny; Freiberg, Alice; Scharfe, Julia; Girbig, Maria; Nienhaus, Albert; Seidler, Andreas

2018-03-09

The physical load ensuing from the repositioning and moving of patients puts health care workers at risk of musculoskeletal complaints. Technical equipment developed to aid with patient handling should reduce physical strain and workload; however, the efficacy of these aids in preventing musculoskeletal disorders and complaints is still unclear. A systematic review of controlled intervention studies was conducted to examine if the risk of musculoskeletal complaints and disorders is reduced by technical patient handling equipment. MEDLINE ® /PubMed ® , EMBASE ® , Allied and Complementary Medicine Database (AMED), and Cumulative Index of Nursing and Allied Health Literature (CINAHL ® ) were searched using terms for nursing, caregiving, technical aids, musculoskeletal injuries, and complaints. Randomized controlled trials and controlled before-after studies of interventions including technical patient handling equipment were included. The titles and abstracts of 9554 publications and 97 full-texts were screened by two reviewers. The qualitative synthesis included one randomized controlled trial (RCT) and ten controlled before-after studies. A meta-analysis of four studies resulted in a pooled risk ratio for musculoskeletal injury claims (post-intervention) of 0.78 (95% confidence interval 0.68-0.90). Overall, the methodological quality of the studies was poor and the results often based on administrative injury claim data, introducing potential selection bias. Interventions with technical patient handling aids appear to prevent musculoskeletal complaints, but the certainty of the evidence according to GRADE approach ranged from low to very low.

A randomized clinical trial aimed at preventing poor psychosocial and glycemic outcomes in teens with type 1 diabetes (T1D)

PubMed Central

Weissberg-Benchell, Jill; Rausch, Joseph; Iturralde, Esti; Jedraszko, Aneta; Hood, Korey

2016-01-01

Adolescents with type 1 diabetes have an increased risk for a variety of emotional and behavioral challenges as well as negative diabetes outcomes. This study was designed to compare the effectiveness of a depression-prevention, resilience promotion program with an advanced diabetes education program. Each program consisted of 9 group-based sessions. There were 264 adolescents enrolled in this multi-site randomized clinical trial. The primary outcomes were depressive symptoms and glycemic control; secondary outcomes included resilience skills, diabetes management and adherence, and diabetes-specific distress. The goal of the present paper is to describe the study design, the intervention, and the baseline characteristics of the sample. Preliminary data suggests that enrollment, randomization and retention were successful. Longitudinal follow-up and examination of mechanisms of action as they relate to psychosocial and glycemic outcomes will be explored in the future. PMID:27267154

A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

PubMed

Kuhlmann, Sophie Merle; Bürger, Arne; Esser, Günter; Hammerle, Florian

2015-02-08

Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind). This study protocol presents a prospective randomized controlled trial, involving four assessment time points: baseline, post-intervention, one-year follow-up and five-year follow-up. The aims include evaluating the effect on stress, coping, psychological morbidity and personality traits with validated measures. Participants are allocated randomly to one of three conditions: MediMind, Autogenic Training or control group. Eligible participants are medical or dental students in the second or eighth semester of a German university. They form a population of approximately 420 students in each academic term. A final total sample size of 126 (at five-year follow-up) is targeted. The trainings (MediMind and Autogenic Training) comprise five weekly sessions lasting 90 minutes each. MediMind will be offered to participants of the control group once the five-year follow-up is completed. The allotment is randomized with a stratified allocation ratio by course of studies, semester, and gender. After descriptive statistics have been evaluated, inferential statistical analysis will be carried out with a repeated measures ANOVA-design with interactions between time and group. Effect sizes will be calculated using partial η-square values. Potential limitations of this study are voluntary participation and the risk of attrition, especially concerning participants that are allocated to the control group. Strengths are the study design, namely random allocation, follow-up assessment, the use of control groups and inclusion of participants at different stages of medical training with the possibility of differential analysis. This trial is recorded at German Clinical Trials Register under the number DRKS00005354 (08 November 2013).

Lifestyle intervention for adults with spinal cord injury: Results of the USC-RLANRC Pressure Ulcer Prevention Study.

PubMed

Carlson, Mike; Vigen, Cheryl Lp; Rubayi, Salah; Blanche, Erna Imperatore; Blanchard, Jeanine; Atkins, Michal; Bates-Jensen, Barbara; Garber, Susan L; Pyatak, Elizabeth A; Diaz, Jesus; Florindez, Lucia I; Hay, Joel W; Mallinson, Trudy; Unger, Jennifer B; Azen, Stanley Paul; Scott, Michael; Cogan, Alison; Clark, Florence

2017-04-17

Medically serious pressure injuries (MSPrIs), a common complication of spinal cord injury (SCI), have devastating consequences on health and well-being and are extremely expensive to treat. We aimed to test the efficacy of a lifestyle-based intervention designed to reduce incidence of MSPrIs in adults with SCI. A randomized controlled trial (RCT), and a separate study wing involving a nonrandomized standard care control group. Rancho Los Amigos National Rehabilitation Center, a large facility serving ethnically diverse, low income residents of Los Angeles County. Adults with SCI, with history of one or more MSPrIs over the past 5 years: N=166 for RCT component, N=66 in nonrandomized control group. The Pressure Ulcer Prevention Program, a 12-month lifestyle-based treatment administered by healthcare professionals, largely via in-home visits and phone contacts. Blinded assessments of annualized MSPrI incidence rates at 12 and 24 months, based on: skin checks, quarterly phone interviews with participants, and review of medical charts and billing records. Secondary outcomes included number of surgeries and various quality-of-life measures. Annualized MSPrI rates did not differ significantly between study groups. At 12 months, rates were .56 for intervention recipients, .48 for randomized controls, and .65 for nonrandomized controls. At follow-up, rates were .44 and .39 respectively for randomized intervention and control participants. Evidence for intervention efficacy was inconclusive. The intractable nature of MSPrI threat in high-risk SCI populations, and lack of statistical power, may have contributed to this inability to detect an effect. ClinicalTrials.gov NCT01999816.

Prevention and Treatment of White Spot Lesions During and After Treatment with Fixed Orthodontic Appliances: a Systematic Literature Review

PubMed Central

Lopatiene, Kristina; Lapenaite, Egle

2016-01-01

ABSTRACT Objectives The aim of the systematic literature review is to update the evidence for the prevention of white spot lesions, using materials containing fluoride and/or casein phosphopeptide-amorphous calcium phosphate during and after treatment with fixed orthodontic appliances. Material and Methods Information search for controlled studies on humans published between January 2008 and February 2016 was performed in PubMed, ScienceDirect, Embase, The Cochrane Library. Inclusion criteria were: the English language, study on humans, patients undergoing orthodontic treatment with fixed appliances, randomized or quasi-randomized controlled clinical studies fluoride-containing product or casein derivates used throughout the appliance therapy or straightaway after debonding. Results 326 articles were reviewed (Embase 141, PubMed 129, ScienceDirect 41, Cochrane 15). Twelve clinical studies fulfilled all inclusion criteria. Use of fluoridated toothpaste had a remineralizing effect on white spot lesions (WSLs) (P < 0.05); fluoride varnish and casein supplements were effective in prevention and early treatment of WSLs (P < 0.05). Conclusions Early detection of white spot lesions during orthodontic treatment would allow implementing preventive measures to control the demineralization process before lesions progress. The systemic review has showed that the usage of fluoride and casein supplements in ameliorating white spot lesions during and after fixed orthodontic treatment is significantly effective. However the use of casein phosphopeptide-amorphous calcium phosphate can be more beneficial than fluoride rinse in the reduction of demineralization spots. PMID:27489605

Factors Influencing Prevention and Control of Malaria among Pregnant Women Resident in Urban Slums, Southern Ghana.

PubMed

Dako-Gyeke, Mavis; Kofie, Humphrey M

2015-03-01

Throughout Africa and particularly in Ghana, there are concerns about malaria infection during pregnancy. This study aimed to investigate factors that influence malaria prevention and control practices among pregnant women residing in Chorkor and Korle-Gonno in Accra, Ghana. One hundred and twenty pregnant women between ages 18-49 were randomly recruited during antenatal sessions at a maternity facility in Accra, as participants for the study. An interviewer-administered questionnaire was used to collect data, which were analysed using SPSS version16.0. It was found that in Chorkor and Korle-Gonno, 57.4% and 42.6% participants respectively reported having been infected with malaria during their current pregnancy. There was no significant relationship between religious beliefs of participants and their malaria prevention and control practices (X2 = 0.28, P = .53). However, there was a significant relationship between malaria prevention and control practices of participants and their income earning (X2 = 53.94, P = .00) and employment (X2 = 61.76, P = .00) statuses. With the exception of ethnicity (X2 = 35.62, P =.22), other socio-cultural conditions had a significant relationship with malaria prevention and control practices of the participants. The findings suggest the need to consider and integrate factors, such as poverty and poor living conditions in malaria prevention and control strategies.

The prevention of canine leishmaniasis and its impact on public health.

PubMed

Otranto, Domenico; Dantas-Torres, Filipe

2013-07-01

Canine leishmaniasis (CanL) caused by Leishmania infantum is a vector-borne disease of great veterinary and medical significance. Prevention of CanL requires a combined approach including measures focused on dogs and the environment where the vectors perpetuate. Over past decades, considerable effort has been put towards developing novel and cost-effective strategies against CanL. Vaccination is considered among the most promising tools for controlling CanL, and synthetic pyrethroids are useful and cost-effective in reducing risk of L. infantum infection in dogs. The effectiveness of the use of vaccines plus repellents in preventing L. infantum infection and subsequent disease development should be assessed by means of large-scale, randomized controlled field trials because this combined strategy may become the next frontier in the control of CanL. Copyright © 2013 Elsevier Ltd. All rights reserved.

A Medical Student-Delivered Smoking Prevention Program, Education Against Tobacco, for Secondary Schools in Germany: Randomized Controlled Trial

PubMed Central

Owczarek, Andreas Dawid; Seeger, Werner; Groneberg, David Alexander; Brieske, Christian Martin; Jansen, Philipp; Klode, Joachim; Stoffels, Ingo; Schadendorf, Dirk; Izar, Benjamin; Fries, Fabian Norbert; Hofmann, Felix Johannes

2017-01-01

Background More than 8.5 million Germans suffer from chronic diseases attributable to smoking. Education Against Tobacco (EAT) is a multinational network of medical students who volunteer for school-based prevention in the classroom setting, amongst other activities. EAT has been implemented in 28 medical schools in Germany and is present in 13 additional countries around the globe. A recent quasi-experimental study showed significant short-term smoking cessation effects on 11-to-15-year-old adolescents. Objective The aim of this study was to provide the first randomized long-term evaluation of the optimized 2014 EAT curriculum involving a photoaging software for its effectiveness in reducing the smoking prevalence among 11-to-15-year-old pupils in German secondary schools. Methods A randomized controlled trial was undertaken with 1504 adolescents from 9 German secondary schools, aged 11-15 years in grades 6-8, of which 718 (47.74%) were identifiable for the prospective sample at the 12-month follow-up. The experimental study design included measurements at baseline (t1), 6 months (t2), and 12 months postintervention (t3), via questionnaire. The study groups consisted of 40 randomized classes that received the standardized EAT intervention (two medical student-led interactive modules taking 120 minutes total) and 34 control classes within the same schools (no intervention). The primary endpoint was the difference in smoking prevalence from t1 to t3 in the control group versus the difference from t1 to t3 in the intervention group. The differences in smoking behavior (smoking onset, quitting) between the two groups, as well as gender-specific effects, were studied as secondary outcomes. Results None of the effects were significant due to a high loss-to-follow-up effect (52.26%, 786/1504). From baseline to the two follow-up time points, the prevalence of smoking increased from 3.1% to 5.2% to 7.2% in the control group and from 3.0% to 5.4% to 5.8% in the intervention group (number needed to treat [NNT]=68). Notable differences were observed between the groups for the female gender (4.2% to 9.5% for control vs 4.0% to 5.2% for intervention; NNT=24 for females vs NNT=207 for males), low educational background (7.3% to 12% for control vs 6.1% to 8.7% for intervention; NNT=30), and migrational background (students who claimed that at least one parent was not born in Germany) at the 12-month follow-up. The intervention appears to prevent smoking onset (NNT=63) but does not appear to initiate quitting. Conclusions The intervention appears to prevent smoking, especially in females and students with a low educational background. PMID:28588007

Relapse of Graves' disease after successful outcome of antithyroid drug therapy: results of a prospective randomized study on the use of levothyroxine.

PubMed

Hoermann, Rudolf; Quadbeck, Beate; Roggenbuck, Ulla; Szabolcs, István; Pfeilschifter, Johannes; Meng, Wieland; Reschke, Kirsten; Hackenberg, Klaus; Dettmann, Juergen; Prehn, Brigitte; Hirche, Herbert; Mann, Klaus

2002-12-01

Antithyroid drugs are effective in restoring euthyroidism in Graves' disease, but many patients experience relapse after withdrawal. Prevention of recurrence would therefore be a desirable goal. In a prospective study, patients with successful outcome of 12 to 15 months antithyroid drug therapy were stratified for risk factors and randomly assigned to receive levothyroxine in a variable thyrotropin (TSH)-suppressive dose for 2 years or no treatment. The levothyroxine group was randomized to continue or discontinue levothyroxine after 1 year. End points included relapse of overt hyperthyroidism. Of 346 patients with Graves' disease enrolled 225 were euthyroid 4 weeks after antithyroid drug withdrawal and were randomly assigned to receive levothyroxine (114 patients) or no treatment (controls, 111 patients). Of those not randomized, 39 patients showed early relapse within 4 weeks, 61 endogenous TSH suppression, 7 TSH elevation, and 14 had to be excluded. Dropout rate during the study were 13.3%. Kaplan-Meier analyses showed relapse rates to be similar in the levothyroxine group (20% after 1 year, 32% after 2 years) and the randomized controls (18%, 24%), whereas relapses were significantly more frequent in the follow-up group of patients with endogenously suppressed TSH (33%, 49%). Levothyroxine therapy did not influence TSH-receptor antibody, nor did it reduce goiter size. The best prognostic marker available was basal TSH determined 4 weeks after withdrawal of antithyroid drugs (posttreatment TSH). The study demonstrates that levothyroxine does not prevent relapse of hyperthyroidism after successful restoration of euthyroid function by antithyroid drugs and characterizes posttreatment TSH as a main prognostic marker.

Prone position as prevention of lung injury in comatose patients: a prospective, randomized, controlled study.

PubMed

Beuret, Pascal; Carton, Marie-Jose; Nourdine, Karim; Kaaki, Mahmoud; Tramoni, Gerard; Ducreux, Jean-Claude

2002-05-01

Comatose patients frequently exhibit pulmonary function worsening, especially in cases of pulmonary infection. It appears to have a deleterious effect on neurologic outcome. We therefore conducted a randomized trial to determine whether daily prone positioning would prevent lung worsening in these patients. Prospective, randomized, controlled study. Sixteen-bed intensive care unit. Fifty-one patients who required invasive mechanical ventilation because of coma with Glascow coma scores of 9 or less. In the prone position (PP) group: prone positioning for 4 h once daily until the patients could get up to sit in an armchair; in the supine position (SP) group: supine positioning. The primary end point was the incidence of lung worsening defined by an increase in the Lung Injury Score of at least 1 point since the time of randomization. The secondary end point was the incidence of ventilator-associated pneumonia (VAP). A total of 25 patients were randomly assigned to the PP group and 26 patients to the SP group. The characteristics of the patients from the two groups were similar at randomization. The incidence of lung worsening was lower in the PP group (12%) than in the SP group (50%) ( p=0.003). The incidence of VAP was 20% in the PP group and 38.4% in the SP group ( p=0.14). There was no serious complication attributable to prone positioning, however, there was a significant increase of intracranial pressure in the PP. In a selected population of comatose ventilated patients, daily prone positioning reduced the incidence of lung worsening.

Colorectal adenoma recurrence rates among post-polypectomy patients in the placebo-controlled groups of randomized clinical trials: a meta-analysis

PubMed Central

Shi, Xin; Yang, Zhiping; Wu, Qiong; Fan, Daiming

2017-01-01

Background Evidence regarding the benefit of therapy to prevent the post-polypectomy recurrence of colorectal adenoma is limited. Endoscopic recurrence is the main outcome according to an evaluation of trials involving recurrence prevention. Aim To estimate the recurrence rates of post-polypectomy colorectal adenoma in placebo-controlled arms of randomized clinical trials and to identify the prognostic factors influencing these rates. Methods We combined data from all randomized controlled trials evaluating therapies for colorectal adenoma using placebo from 1988 to 2016. The data were combined in a random-effects model. Primary outcomes were endoscopic adenoma and advanced adenoma recurrence of colorectal adenoma. Results The pooled estimates of the adenoma recurrence rates were 37% (95% confidence interval [CI], 33%-41%; range, 33%-52%) at 1 year, 47% (95% CI, 41%-54%; range, 46%-51%) at 2 years, 41% (95% CI, 33%-48%; range, 20%-61%) at 3 years, 48% (95% CI, 38%-57%; range, 37%-53%) at 4 years, and 60% (95% CI, 52%-68%; range, 48%-68%) at 5 years. The pooled estimates of the advanced adenoma recurrence rates were 10% (95% CI, 6%-15%; range, 7%-13%) at 1 year, 12% (95% CI, 8%-16%; range, 3%-19%) at 3 years, 14% (95% CI, 10%-18%; range, 13%-16%) at 4 years, and 14% (95% CI, 10%-19%; range, 9%-21%) at 5 years. Significant heterogeneity among the randomized clinical trials (P < 0.001) was observed for each recurrence rate. Conclusions This meta-analysis confirms the heterogeneity of recurrence rates among post-polypectomy colorectal adenoma patients who received placebo. No single design variable was identified that might explain the heterogeneity. PMID:28977952

Update on worldwide efforts to prevent type 1 diabetes.

PubMed

Skyler, Jay S

2008-12-01

This paper reviews worldwide efforts to interdict the type 1 diabetes (T1D) disease process, during the stage of evolution of the disease prior to the time of disease onset. The goal of intervention before disease onset is to arrest immune destruction and thus prevent or delay clinical disease. In this regard, there have been several large-scale multicenter randomized controlled clinical trials designed to prevent T1D. These have tested nicotinamide, parenteral insulin, oral insulin, nasal insulin, and the elimination of cow's milk from infant feeding.

Low vision depression prevention trial in age-related macular degeneration: a randomized clinical trial.

PubMed

Rovner, Barry W; Casten, Robin J; Hegel, Mark T; Massof, Robert W; Leiby, Benjamin E; Ho, Allen C; Tasman, William S

2014-11-01

To compare the efficacy of behavior activation (BA) + low vision rehabilitation (LVR) with supportive therapy (ST) + LVR to prevent depressive disorders in patients with age-related macular degeneration (AMD). Single-masked, attention-controlled, randomized, clinical trial with outcome assessment at 4 months. Patients with AMD and subsyndromal depressive symptoms attending retina practices (n = 188). Before randomization, all subjects had 2 outpatient LVR visits, and were then randomized to in-home BA+LVR or ST+LVR. Behavior activation is a structured behavioral treatment that aims to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention. The Diagnostic and Statistical Manual IV defined depressive disorder based on the Patient Health Questionnaire-9 (primary outcome), Activities Inventory, National Eye Institute Vision Function Questionnaire-25 plus Supplement (NEI-VFQ), and NEI-VFQ quality of life (secondary outcomes). At 4 months, 11 BA+LVR subjects (12.6%) and 18 ST+LVR subjects (23.4%) developed a depressive disorder (relative risk [RR], 0.54; 95% CI, 0.27-1.06; P = 0.067). In planned adjusted analyses the RR was 0.51 (95% CI, 0.27-0.98; P = 0.04). A mediational analysis suggested that BA+LVR prevented depression to the extent that it enabled subjects to remain socially engaged. In addition, BA+LVR was associated with greater improvements in functional vision than ST+LVR, although there was no significant between-group difference. There was no significant change or between-group difference in quality of life. An integrated mental health and low vision intervention halved the incidence of depressive disorders relative to standard outpatient LVR in patients with AMD. As the population ages, the number of persons with AMD and the adverse effects of comorbid depression will increase. Promoting interactions between ophthalmology, optometry, rehabilitation, psychiatry, and behavioral psychology may prevent depression in this population. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

HIV Prevention for Adults With Criminal Justice Involvement: A Systematic Review of HIV Risk-Reduction Interventions in Incarceration and Community Settings

PubMed Central

Dumont, Dora; Operario, Don

2014-01-01

We summarized and appraised evidence regarding HIV prevention interventions for adults with criminal justice involvement. We included randomized and quasi-randomized controlled trials that evaluated an HIV prevention intervention, enrolled participants with histories of criminal justice involvement, and reported biological or behavioral outcomes. We used Cochrane methods to screen 32 271 citations from 16 databases and gray literature. We included 37 trials enrolling n = 12 629 participants. Interventions were 27 psychosocial, 7 opioid substitution therapy, and 3 HIV-testing programs. Eleven programs significantly reduced sexual risk taking, 4 reduced injection drug risks, and 4 increased testing. Numerous interventions may reduce HIV-related risks among adults with criminal justice involvement. Future research should consider process evaluations, programs involving partners or families, and interventions integrating biomedical, psychosocial, and structural approaches. PMID:25211725

CPAP Treatment Supported by Telemedicine Does Not Improve Blood Pressure in High Cardiovascular Risk OSA Patients: A Randomized, Controlled Trial

PubMed Central

Mendelson, Monique; Vivodtzev, Isabelle; Tamisier, Renaud; Laplaud, David; Dias-Domingos, Sonia; Baguet, Jean-Philippe; Moreau, Laurent; Koltes, Christian; Chavez, Léonidas; De Lamberterie, Gilles; Herengt, Frédéric; Levy, Patrick; Flore, Patrice; Pépin, Jean-Louis

2014-01-01

Study Objectives: Obstructive sleep apnea (OSA) has been associated with hypertension, which is one of the intermediary mechanisms leading to increased cardiovascular morbidity. This study aimed at evaluating the effects of a combination of continuous positive airway pressure (CPAP) and telemedicine support on blood pressure (BP) reduction in high cardiovascular risk OSA patients. Design: A multi-center randomized controlled trial that compared standard CPAP care and CPAP care and a telemedicine intervention. Setting: Sleep clinics in France. Patients or Participants: 107 adult (18-65 years old) OSA patients (AHI > 15 events/h) with a high cardiovascular risk (cardiovascular SCORE > 5% or secondary prevention). Interventions: Patients were randomized to either standard care CPAP (n = 53) or CPAP and telemedicine (n = 54). Patients assigned to telemedicine were equipped with a smartphone for uploading BP measurements, CPAP adherence, sleepiness, and quality of life data; in return, they received pictograms containing health-related messages. Measurements: The main outcome was home self-measured BP and secondary outcomes were cardiovascular risk evolution, objective physical activity, CPAP adherence, sleepiness and quality of life. Results: Self-measured BP did not improve in either group (telemedicine or standard care). Patients in primary prevention showed greater BP reduction with CPAP treatment than those in secondary prevention. Conclusions: CPAP treatment supported by telemedicine alone did not improve blood pressure and cardiovascular risk in high cardiovascular risk OSA patients. This study emphasizes the need for diet and physical activity training programs in addition to CPAP when aiming at decreasing cardiometabolic risk factors in these patients. Clinical Trials Registration: ClinicalTrials.gov identifier: NCT01226641. Citation: Mendelson M, Vivodtzev I, Tamisier R, Laplaud D, Dias-Domingos S, Baguet JP, Moreau L, Koltes C, Chavez L, De Lamberterie G, Herengt F, Levy P, Flore P, Pépin JL. CPAP treatment supported by telemedicine does not improve blood pressure in high cardiovascular risk OSA patients: a randomized, controlled trial. SLEEP 2014;37(11):1863-1870. PMID:25364081

Vitamin D and type 2 diabetes.

PubMed

Lips, Paul; Eekhoff, Marelise; van Schoor, Natasja; Oosterwerff, Mirjam; de Jongh, Renate; Krul-Poel, Yvonne; Simsek, Suat

2017-10-01

Vitamin D deficiency is associated with a decreased insulin release, insulin resistance and type 2 diabetes in experimental and epidemiological studies. Animal studies show that 1α,25-dihydroxyvitamin D 3 (1,25(OH) 2 D 3 ) stimulates the pancreatic β-cell to secrete insulin. The relationship between vitamin D deficiency and insulin resistance could develop through inflammation, as vitamin D deficiency is associated with increased inflammatory markers. In addition, genetic polymorphisms of vitamin D -related genes may predispose to impaired glycemic control and type 2 diabetes. Epidemiologic studies showed an association between low serum 25-hydroxyvitamin D 3 (25(OH)D 3 ) concentration and an increased risk for the metabolic syndrome and type 2 diabetes. This may be partly explained by an increased fat mass. A possible causal relationship between vitamin D deficiency and type 2 diabetes should be proven by randomized clinical trials showing that either type 2 diabetes can be prevented or insulin release and insulin sensitivity can be improved by vitamin D supplements. The results of randomized clinical trials on the effect of vitamin D versus placebo, sometimes combined with calcium, in patients with impaired glucose tolerance ("prediabetes") or type 2 diabetes are inconsistent. Some studies showed a slight decrease of fasting plasma glucose or improvement of insulin resistance, but often only in posthoc analyses. These effects are mainly visible in patients with vitamin D deficiency and impaired glucose tolerance at baseline. Meta-analyses of randomized clinical trials in general did not show significant effects of vitamin D supplementation on glycemic control. Currently, several large scale randomized clinical trials with vitamin D supplementation in doses of 1600-4000IU/d are ongoing with glycemic control or incidence of diabetes mellitus as outcome. Vitamin D deficiency needs to be prevented or cured, but until the results of these trials are published, high-dose vitamin D supplementation cannot be recommended for prevention or amelioration of type 2 diabetes. Copyright © 2016 Elsevier Ltd. All rights reserved.

Exercise for the prevention of low back and pelvic girdle pain in pregnancy: A meta-analysis of randomized controlled trials.

PubMed

Shiri, R; Coggon, D; Falah-Hassani, K

2018-01-01

The effect of exercise in prevention of low back and pelvic girdle pain during pregnancy is uncertain. This study aimed to assess the effect of exercise on low back pain, pelvic girdle pain and associated sick leave. Literature searches were conducted in PubMed, EMBASE, Cochrane Library, Google Scholar, ResearchGate and ClinicalTrials.gov databases from their inception through May 2017. Randomized controlled trials (RCTs) were eligible for inclusion in the review if they compared an exercise intervention with usual daily activities and at least some of the participants were free from low back pain and/or pelvic girdle pain at baseline. Methodological quality of included studies was evaluated using the Cochrane Collaboration's tool. A random-effects meta-analysis was performed, and heterogeneity and publication bias were assessed. Eleven randomized controlled trials (2347 pregnant women) qualified for meta-analyses. Exercise reduced the risk of low back pain in pregnancy by 9% (pooled risk ratio (RR) = 0.91, 95% CI 0.83-0.99, I 2  = 0%, seven trials, N = 1175), whereas it had no protective effect on pelvic girdle pain (RR = 0.99, CI 0.81-1.21, I 2  = 0%, four RCTs, N = 565) or lumbopelvic pain (RR = 0.96, CI 0.90-1.02, I 2  = 0%, eight RCTs, N = 1737). Furthermore, exercise prevented new episodes of sick leave due to lumbopelvic pain (RR = 0.79, CI 0.64-0.99, I 2  = 0%, three RCTs, N = 1168). There was no evidence of publication bias. Exercise appears to reduce the risk of low back pain in pregnant women, and sick leave because of lumbopelvic pain, but there is no clear evidence for an effect on pelvic girdle pain. Exercise has a small protective effect against low back pain during pregnancy. © 2017 European Pain Federation - EFIC®.

A critical appraisal of the reporting quality of published randomized controlled trials in the fall injuries.

PubMed

Asghari Jafarabadi, Mohammad; Sadeghi-Bazrgani, Homayoun; Dianat, Iman

2018-06-01

To evaluate the quality of reporting in published randomized controlled trials (RTCs) in the field of fall injuries. The 188 RTCs published between 2001 and 2011, indexed in EMBASE and Medline databases were extracted through searching by appropriate keywords and EMTree classification terms. The evaluation trustworthiness was assured through parallel evaluations of two experts in epidemiology and biostatistics. About 40%-75% of papers had problems in reporting random allocation method, allocation concealment, random allocation implementation, blinding and similarity among groups, intention to treat and balancing benefits and harms. Moreover, at least 10% of papers inappropriately/not reported the design, protocol violations, sample size justification, subgroup/adjusted analyses, presenting flow diagram, drop outs, recruitment time, baseline data, suitable effect size on outcome, ancillary analyses, limitations and generalizability. Considering the shortcomings found and due to the importance of the RCTs for fall injury prevention programmes, their reporting quality should be improved.