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Sample records for 12-week randomized intervention-study

  1. Effect of a 12-Week Low vs. High Intensity Aerobic Exercise Training on Appetite-Regulating Hormones in Obese Adolescents: A Randomized Exercise Intervention Study.

    PubMed

    Prado, Wagner Luiz; Lofrano-Prado, Mara Cristina; Oyama, Lila Missae; Cardel, Michelle; Gomes, Priscyla Praxedes; Andrade, Maria Laura S S; Freitas, Camila R M; Balagopal, Prabhakaran; Hill, James O

    2015-11-01

    Little is known about how the intensity of aerobic training influences appetite-regulating hormones in obese adolescents. Our goal was to assess the effect of low and high intensity aerobic trainings on food intake and appetite-regulating hormones in obese adolescents. Forty three obese adolescents (age: 13-18y, BMI: 34.48 ± 3.94 kg/m2) were randomized into high intensity training (HIT; n = 20) or low intensity training (LIT; n = 23) groups for 12 weeks. All participants also received the same nutritional, psychological and clinical counseling. Pre- and postintervention energy intake (EI) and circulating levels of insulin, leptin, peptide YY3-36 (PYY3-36) and ghrelin were measured. Adolescents in the HIT showed a reduction in total EI and an increase in PYY3-36 (p < .05). Aerobic exercise training performed at ventilatory threshold 1 intensity, reduced EI and augmented PYY3-36 in obese adolescents, compared with LIT. The data suggest that HIT and LIT have differential effects in the regulation of appetite signals and subsequent EI in obese adolescents. PMID:26680421

  2. Exercise training versus diet-induced weight-loss on metabolic risk factors and inflammatory markers in obese subjects: a 12-week randomized intervention study.

    PubMed

    Christiansen, Tore; Paulsen, Søren K; Bruun, Jens M; Pedersen, Steen B; Richelsen, Bjørn

    2010-04-01

    The purpose of this study was to investigate the effect of exercise training and diet-induced weight loss alone or in combination on inflammatory markers in circulation, in adipose tissue (AT) and in skeletal muscle (SM) in obese subjects. Seventy-nine obese subjects were randomized into a 12-wk intervention: 1) exercise only (EXO), 2) diet-induced weight loss using a very low energy diet (DIO), and 3) exercise and diet-induced weight-loss combined (DEX). Blood samples (metabolic and inflammatory markers) and AT and SM biopsies (mRNA expression) were collected at baseline and after 12 wk. In the EXO group the weight loss was 3.5 kg and in the DIO and DEX groups it was 12 kg in both. Vo(2max) was increased by 14-18% in the EXO and DEX groups with no changes in the DIO group. In the DIO and DEX groups, circulating levels of MCP-1, MIP-1alpha, IL-15, and IL-18 were decreased, and adiponectin was increased (P < 0.05 for all). In the EXO group, MCP-1 was decreased with 10% (P = 0.06). By combining the weight loss in all three groups, we found a correlation between the degree of weight loss and improvement in several of the inflammatory markers (P < 0.05). In AT biopsies, subjects in the DIO and DEX groups achieved a general beneficial but nonsignificant effect on the gene expression of inflammatory markers. In the EXO group, no changes in AT adipokine mRNA were found except for an increment of adiponectin (P < 0.05). In SM, the only observed change was that the gene expression of IL-6 was increased in all three groups (P < 0.05). In conclusion, rather large weight losses (>5-7%) were found to have beneficial effects on circulating inflammatory markers in these obese subjects. Aerobic exercise for 12 wk, which increased Vo(2max), was found to have no effects on circulating inflammatory markers in these obese patients. It is suggested that more intensive exercise may be necessary to affect systemic inflammation. PMID:20086201

  3. Efficacy of Olibra: A 12-Week Randomized Controlled Trial and a Review of Earlier Studies

    PubMed Central

    Rebello, Candida J; Martin, Corby K; Johnson, William D; O'Neil, Carol E; Greenway, Frank L

    2012-01-01

    Background Intervention strategies that harness the body's appetite and satiety regulating signals provide a means of countering excessive energy intake. Methods Eighty-two subjects were enrolled (18–60 years, body mass index: 25–40 kg/m2) in a randomized, placebo-controlled, double-blind, parallel trial. During a 12-week period, the effects of Olibra™ fat emulsion (2.1 g twice daily) on food intake, appetite, satiety, weight, and body composition were compared with those of a twice daily administered placebo (1.95 g milk fat). On days -7, 0, and 28, Olibra or the placebo added to 200 g of yogurt was served at breakfast and lunch. Food intake, appetite, and satiety were assessed after lunch and dinner. Body weight was measured on days -7, 0, 14, 28, 56, and 84. Body fat, waist circumference, and waist-hip ratio were determined on days 0 and 84. The Eating Inventory was administered at screening and on day 28. Data relating to 71 subjects were analyzed using analysis of covariance. Results At 12 weeks, body weight was reduced in the test group (2.17 ± 0.46 kg standard error of the mean, p < .0001) and the control group (1.68 ± 0.42 kg, p < .0001). Waist circumference decreased by 2.93 ± 0.85 cm in the test group (p = .001) and by 1.78 ± 0.74 cm in the control group (p = .02). Differential weight and waist circumference reductions were not significant. Hunger scores (Eating Inventory) decreased more in the test group (p = .0082). Differential group effects were not significant for body fat, waist-hip ratio, food intake, appetite, and satiety. Conclusions At this dose, Olibra did not exert a consistent effect on food intake, appetite regulation, body weight, or body composition. PMID:22768902

  4. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial

    PubMed Central

    Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

    2016-01-01

    Objective Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Materials and Methods Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. Results The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Conclusion Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. Trial Registration CRiS KCT0001771 PMID:27253526

  5. Linagliptin monotherapy compared with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis: a 12-week randomized trial

    PubMed Central

    Mori, Katsuhito; Emoto, Masanori; Shoji, Tetsuo; Inaba, Masaaki

    2016-01-01

    Objective Focusing on efficacy and tolerability, we compared linagliptin monotherapy with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis (HD). Research design and methods In this multicenter, randomized, open-label, parallel-group, active-controlled study, 78 patients were randomized (1:1) to receive a 12-week treatment with 5 mg linagliptin once daily or 0.2 mg voglibose three times a day. To assess whether linagliptin was superior to voglibose, the primary efficacy end point was the change in glycated hemoglobin (HbA1c) level between baseline and week 12. Secondary efficacy end points included changes between baseline and week 12 in glycated albumin (GA) and casual plasma glucose (PG) levels. Results At week 12, the adjusted mean HbA1c levels had decreased by −0.60% after treatment with linagliptin and by −0.20% after treatment with voglibose (treatment difference: −0.40%, 95% CI −0.74% to −0.06%, p=0.022). A significant reduction in casual PG level was also observed after treatment with linagliptin compared with treatment with voglibose. Relative to voglibose, linagliptin tended to elicit reductions in GA, although without statistical significance. No hypoglycemic symptoms or severe hypoglycemia occurred during the study. Conclusions In patients with type 2 diabetes undergoing HD, linagliptin monotherapy provided significantly better glycemic control without severe hypoglycemia than voglibose monotherapy. Linagliptin represents a promising agent for glycemic management in patients with type 2 diabetes undergoing HD. Trial registration number UMIN000007635; results. PMID:27547421

  6. Magnesium Replacement Does Not Improve Insulin Resistance in Patients With Metabolic Syndrome: A 12-Week Randomized Double-Blind Study

    PubMed Central

    Lima de Souza e Silva, Maria de Lourdes; Cruz, Thomaz; Rodrigues, Luiz Erlon; Ladeia, Ana Marice; Bomfim, Olivia; Olivieri, Lucas; Melo, Juliana; Correia, Raquel; Porto, Mirna; Cedro, Alexandre

    2014-01-01

    Background To evaluate the effect of magnesium (Mg) replacement on insulin resistance and cardiovascular risk factors in women with metabolic syndrome (MS) without diabetes. Methods This 12-week clinical randomized double-blind study compared the effects of 400 mg/day of Mg with those of a placebo (n = 72) on fasting glucose, insulin, HOMA-IR, lipid profile and CRP. Mg was measured in serum (SMg) and in mononuclear cells (MMg). Results Hypomagnesemia (SMg < 1.7 mg/dL) was seen in 23.2% of patients and intracellular depletion in 36.1% of patients. The MMg means were lower in patients with obesity (0.94 ± 0.54 μg/mg vs. 1.19 ± 0.6 μg/mg, P = 0.04), and insulin resistance (0.84 ± 0.33 μg/mg vs. 1.14 ± 0.69 µg/mg, P < 0.05). Mg replacement did not alter SMg (1.82 ± 0.14 mg/dL vs. 1.81 ± 0.16 mg/dL, P = 0.877) and tended to increment MMg (0.90 ± 0.40 μg/mg vs. 1.21 ± 0.73 μg/mg, P = 0.089). HOMA-IR did not alter in interventions nor in placebo group (3.2 ± 2.0 to 2.8 ± 1.9, P = 0.368; 3.6 ± 1.9 to 3.2 ± 1.8, respectively), neither did other metabolic parameters. Conclusion Serum and intracellular Mg depletion is common in patients with MS; however, Mg replacement in recommended dosage did not increase significantly Mg levels, neither reduced insulin resistance or metabolic control. PMID:25247020

  7. Oral Microbiota Shift after 12-Week Supplementation with Lactobacillus reuteri DSM 17938 and PTA 5289; A Randomized Control Trial

    PubMed Central

    Romani Vestman, Nelly; Chen, Tsute; Lif Holgerson, Pernilla; Öhman, Carina; Johansson, Ingegerd

    2015-01-01

    Background Lactobacillus spp. potentially contribute to health by modulating bacterial biofilm formation, but their effects on the overall oral microbiota remain unclear. Methods and Findings Oral microbiota was characterized via 454-pyrosequencing of the 16S rDNA hypervariable region V3-V4 after 12 weeks of daily Lactobacillus reuteri DSM 17938 and PTA 5289 consumption. Forty-four adults were assigned to a test group (n = 22) that received lactobacilli lozenges (108 CFU of each strain/lozenge) or a control group that received placebo (n = 22). Presence of L. reuteri was confirmed by cultivation and species specific PCR. Tooth biofilm samples from 16 adults before, during, and after exposure were analyzed by pyrosequencing. A total of 1,310,292 sequences were quality filtered. After removing single reads, 257 species or phylotypes were identified at 98.5% identity in the Human Oral Microbiome Database. Firmicutes, Bacteroidetes, Fusobacteria, Proteobacteria, and Actinobacteria were the most abundant phyla. Streptococcus was the most common genus and the S. oralis/S. mitis/S. mitis bv2/S. infantis group comprised the dominant species. The number of observed species was unaffected by L. reuteri exposure. However, subjects who had consumed L. reuteri were clustered in a principal coordinates analysis relative to scattering at baseline, and multivariate modeling of pyrosequencing microbiota, and culture and PCR detected L. reuteri separated baseline from 12-week samples in test subjects. L. reuteri intake correlated with increased S. oralis/S. mitis/S. mitis bv2/S. infantis group and Campylobacter concisus, Granulicatella adiacens, Bergeyella sp. HOT322, Neisseria subflava, and SR1 [G-1] sp. HOT874 detection and reduced S. mutans, S. anginosus, N. mucosa, Fusobacterium periodicum, F. nucleatum ss vincentii, and Prevotella maculosa detection. This effect had disappeared 1 month after exposure was terminated. Conclusions L. reuteri consumption did not affect species

  8. Swahili 12 Weeks Course.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This 12-weeks course in basic Swahili comprises 55 lesson units in five volumes. The general course format consists of (1) perception drills for comprehension, oral production, and association using "situational picture" illustrations; (2) dialogs in English and Swahili, with cartoon guides; (3) sequenced pattern and recombination drills, and (4)…

  9. Evaluation of Immediate and 12-Week Effects of a Smartphone Sun-Safety Mobile Application: A Randomized Trial

    PubMed Central

    Buller, David B.; Berwick, Marianne; Lantz, Kathy; Buller, Mary Klein; Shane, James; Kane, Ilima; Liu, Xia

    2015-01-01

    Importance Mobile apps on smart phones can communicate a large amount of personalized, real-time health information, including advice on skin cancer prevention, but their effectiveness may be affected by whether Americans can be convinced to use them. Objective A smart phone mobile application delivering real-time sun protection advice was evaluated for a second time in a randomized trial. Design The trial conducted in 2013 utilized a randomized pretest-posttest controlled design. Screening procedures and a 3-week run-in period were added to increase use of the mobile app. Also, follow-ups at 3- and 8-weeks after randomization were conducted to examine immediate and longer-term effects. Setting Data was collected from participants recruited nationwide through online promotions. Participants A volunteer sample of adults aged 18 or older who owned an Android or iPhone smart phones. Intervention The mobile application gave feedback on sun protection (i.e., sun safety practices and sunburn risk) and alerted users to apply/reapply sunscreen and get out of the sun. Also, it displayed the hourly UV Index and vitamin D production based on the forecast UV Index, time, and location. Main Outcomes and Measures Percent of days using sun protection and days and minutes outdoors in the midday sun and number of sunburns in the past 3 months were assesed. Results Treatment group participants used wide-brimmed hats more at 7-weeks than controls. Women who used Solar Cell reported using all sun protection combined more than men but men and older individuals used sunscreen and hats less. Conclusions and Relevance The mobile application appeared to weakly improve sun protection initially. Use of the mobile application was higher than in a previous trial and associated with greater sun protection especially by women. Strategies to increase use are needed if the mobile app is to be effective deployed to the general adult population. PMID:25629819

  10. Low-dose memantine attenuated methadone dose in opioid-dependent patients: a 12-week double-blind randomized controlled trial

    PubMed Central

    Lee, Sheng-Yu; Chen, Shiou-Lan; Chang, Yun-Hsuan; Chen, Po See; Huang, San-Yuan; Tzeng, Nian-Sheng; Wang, Liang-Jen; Lee, I Hui; Wang, Tzu-Yun; Chen, Kao Chin; Yang, Yen Kuang; Hong, Jau-Shyong; Lu, Ru-Band

    2015-01-01

    Low-dose memantine might have anti-inflammatory and neurotrophic effects mechanistically remote from an NMDA receptor. We investigated whether add-on memantine reduced cytokine levels and benefitted patients with opioid dependence undergoing methadone maintenance therapy (MMT) in a randomized, double-blind, controlled 12-week study. Patients were randomly assigned to a group: Memantine (5 mg/day) (n = 53) or Placebo (n = 75). The methadone dose required and retention in treatment were monitored. Plasma tumor necrosis factor (TNF)-α, C-reactive protein (CRP), interleukin (IL)-6, IL-8, transforming growth factor (TGF)-β1, and brain-derived neurotrophic factor (BDNF) levels were examined during weeks 0, 1, 4, 8, and 12. General linear mixed models were used to examine therapeutic effect. After 12 weeks, Memantine-group required a somewhat lower methadone dose than did Placebo-group (P = 0.039). They also had significantly lower plasma TNF-α and significantly higher TGF-β1 levels. We provide evidence of the benefit of add-on memantine in opioid dependent patients undergoing MMT. PMID:25988317

  11. Comparative effect of 12 weeks of slow and fast pranayama training on pulmonary function in young, healthy volunteers: A randomized controlled trial

    PubMed Central

    Dinesh, T; Gaur, GS; Sharma, VK; Madanmohan, T; Harichandra Kumar, KT; Bhavanani, AB

    2015-01-01

    Context: Pranayamas are breathing techniques that exert profound physiological effects on pulmonary, cardiovascular, and mental functions. Previous studies demonstrate that different types of pranayamas produce divergent effects. Aim: The aim was to compare the effect of 12 weeks of slow and fast pranayama training on pulmonary function in young, healthy volunteers. Settings and Design: This study was carried out in Departments of Physiology and ACYTER, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry in 2011. Subjects and Methods: Ninety one healthy volunteers were randomized into slow pranayama group (SPG), n =29, fast pranayama group (FPG), n = 32 and control groups (CG) (n = 30). Supervised pranayama training (SPG: Nadisodhana, Pranav pranayama and Savitri pranayama; FPG: Kapalabhati, Bhastrika and Kukkriya pranayama) was given for 30 min/day, thrice/week for 12 weeks by certified yoga instructors. Pulmonary function parameters (PFT) such as forced vital capacity (FVC), forced expiratory volume in first second (FEV1), ratio between FEV1 and FVC (FEV1 /FVC), peak expiratory flow rate (PEFR), maximum voluntary ventilation (MVV), and forced expiratory flow25-75 (FEF25-75), were recorded at baseline and after 12 weeks of pranayama training using the computerized spirometer (Micro laboratory V1.32, England). Results: In SPG, PEFR, and FEF25-75 improved significantly (P < 0.05) while other parameters (FVC, FEV1, FEV1 /FVC, and MVV) showed only marginal improvements. In FPG, FEV1 /FVC, PEFR, and FEF25-75 parameters improved significantly (P < 0.05), while FVC, FEV1, and MVV did not show significant (P > 0.05) change. No significant change was observed in CG. Conclusion: Twelve weeks of pranayama training in young subjects showed improvement in the commonly measured PFT. This indicates that pranayama training improved pulmonary function and that this was more pronounced in the FPG. PMID:25558130

  12. Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials

    PubMed Central

    Myers, Jonathan S; Vold, Steven; Zaman, Fiaz; Williams, Julia M; Hollander, David A

    2014-01-01

    Background The purpose of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of bimatoprost 0.01% or 0.03% as monotherapy in patients treated with latanoprost 0.005% monotherapy who require additional IOP lowering for their ocular hypertension or open-angle glaucoma. Methods Two prospective, investigator-masked, randomized, parallel-group, multicenter studies enrolled patients with baseline IOP ≥20 mmHg after ≥30 days of latanoprost 0.005% monotherapy. Patients were randomized to 12 weeks of study treatment (study 1, bimatoprost 0.01% once daily or bimatoprost 0.01% once daily plus brimonidine 0.1% three times daily; study 2, bimatoprost 0.03% once daily or bimatoprost 0.03% once daily plus fixed-combination brimonidine 0.2%/timolol 0.5% twice daily). Patient evaluations at weeks 4 and 12 included IOP at 8 am, 10 am, and 4 pm and safety assessments. Results in the monotherapy study arms (bimatoprost 0.01% or 0.03%) are presented. Results Latanoprost-treated baseline mean diurnal IOP (± standard error of the mean) was 22.2±0.3 mmHg and 22.1±0.4 mmHg in the bimatoprost 0.01% and bimatoprost 0.03% treatment arms, respectively (P=0.957). In both treatment arms, mean (± standard error of the mean) reduction in IOP from latanoprost-treated baseline was statistically significant at each time point at both follow-up visits (P<0.001), ranging from 3.7±0.4 (17.0%) mmHg to 4.4±0.4 (19.9%) mmHg with bimatoprost 0.01% and from 2.8±0.5 (12.8%) mmHg to 3.9±0.5 (16.7%) mmHg with bimatoprost 0.03%. Mean percentage IOP reduction from latanoprost-treated baseline was numerically greater with bimatoprost 0.01% than with bimatoprost 0.03% throughout follow-up. The incidence of conjunctival hyperemia of mild or greater severity increased from latanoprost baseline after 12 weeks of treatment only in the bimatoprost 0.03% treatment arm. Conclusion Many patients who do not reach their target IOP on latanoprost can achieve additional IOP

  13. The effect of 12 weeks Anethum graveolens (dill) on metabolic markers in patients with metabolic syndrome; a randomized double blind controlled trial

    PubMed Central

    2012-01-01

    Background The clustering of metabolic abnormalities defined as metabolic syndrome is now both a public health and a clinical problem .While interest in herbal medicine has greatly increased, lack of human evidence to support efficacies shown in animals does exist. This clinical trial study designed to investigate whether herbal medicine, Anethum graveolens (dill) extract, could improve metabolic components in patients with metabolic syndrome. Methods A double-blind, randomized, placebo-controlled trial using a parallel design was conducted. 24 subjects who had metabolic syndrome diagnostic criteria (update of ATP III) were randomly assigned to either dill extract (n = 12) or placebo (n = 12) for 3 months. Results Across lipid component of metabolic syndrome, no significant differences in triglyceride (TG) concentration and high density lipoprotein cholesterol were seen between the two groups. However TG improved significantly from baseline (257.0 vs. 201.5p = 0.01) with dill treatment but such a significant effect was not observed in placebo group. Moreover, no significant differences in waist circumference, blood pressure and fasting blood sugar were seen between two groups after 3 months follow up period. Conclusion In this small clinical trial in patients with metabolic syndrome, 12 weeks of dill extract treatment had a beneficial effect in terms of reducing TG from baseline. However dill treatment was not associated with a significant improvement in metabolic syndrome related markers compared to control group. Larger studies might be required to prove the efficacy and safety of long-term administration of dill to resolve metabolic syndrome components. PMID:23351341

  14. Fluoxetine versus sertraline in the treatment of patients with undifferentiated somatoform disorder: a randomized, open-label, 12-week, parallel-group trial.

    PubMed

    Han, Changsu; Pae, Chi-Un; Lee, Bun Hee; Ko, Young-Hoon; Masand, Prakash S; Patkar, Ashwin A; Jung, In-Kwa

    2008-02-15

    The present study was conducted to compare the effectiveness and tolerability of fluoxetine and sertraline in the treatment of undifferentiated somatoform disorder (USD), using the Patient Health Questionnaire (PHQ-15), which was specifically designed for assessing the severity of somatic symptoms. A randomized, 12-week, open-label trial of fluoxetine (10-60 mg/d) and sertraline (25-350 mg/d) in patients with USD was conducted. Six visits, at baseline and weeks 1, 2, 4, 8, and 12, were scheduled. Assessments for effectiveness and tolerability were conducted at each visit. The primary effectiveness measure was the mean change in PHQ-15 total score, from baseline to the end of treatment. Secondary effectiveness measures were the mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire (GHQ-12), from baseline to the end of treatment. A total of 45 subjects were enrolled; of them, 28 were randomly assigned to receive fluoxetine and 17 to receive sertraline. The total score on the PHQ-15 from baseline to the end of treatment significantly decreased in the fluoxetine (-10.7, p<0.0001) and sertraline (-10.3, p<0.0001) treatment groups, with no between-group difference (F=0.0701, p=0.7924). Overall, both treatments were well tolerated and no serious adverse event was reported. This study suggests that both agents may have a potential role in the treatment of USD. A double-blind, placebo-controlled trial and/or head-to-head comparison study with larger samples are required to draw more definite conclusions. PMID:17950970

  15. Onion peel extract reduces the percentage of body fat in overweight and obese subjects: a 12-week, randomized, double-blind, placebo-controlled study

    PubMed Central

    Lee, Ji-Sook; Cha, Yong-Jun; Lee, Kyung-Hea

    2016-01-01

    BACKGROUND/OBJECTIVES The anti-obesity effect of quercetin-rich onion peel extract (OPE) was suggested in rats, but information from human studies is limited. This study aimed to investigate the effects of OPE on the body composition of overweight and obese subjects. MATERIALS/METHODS In this 12-week, randomized, double-blind, placebo-controlled study, parallel clinical trials were performed in overweight and obese Korean subjects. Randomly assigned subjects were instructed to take daily either the placebo (male, 6 and female, 30) or OPE capsules containing 100 mg of quercetin (male, 5 and female, 31). Body composition was measured by using bioimpedance and dual-energy X-ray absorptiometry (DXA). Resting energy expenditure (REE) and respiratory quotient (RQ) were evaluated by using indirect calorie measurement methods. Fasting blood levels of glucose, insulin, lipids, and leptin were determined. RESULTS Quercetin-rich OPE supplementation significantly reduced the weight and percentage of body fat as measured by DXA (P = 0.02). These effects were not shown in the control group. Levels of blood glucose (P = 0.04) and leptin (P = 0.001 for placebo, P = 0.002 for OPE) decreased in both groups. Significant increases in REE and RQ were observed in both groups (P = 0.003 for placebo, P = 0.006 for OPE) and in the OPE group alone (P = 0.02), respectively. CONCLUSIONS Quercetin-rich OPE supplementation changed the body composition of the overweight and obese subjects. This result suggests a beneficial role of the anti-obesity effect of OPE human subjects. PMID:27087901

  16. 12 Weeks of Combined Endurance and Resistance Training Reduces Innate Markers of Inflammation in a Randomized Controlled Clinical Trial in Patients with Multiple Sclerosis

    PubMed Central

    Wens, Inez; Nuyts, Amber H.; Hens, Niel; De Winter, Benedicte Y.; Koppen, Gudrun; Goossens, Herman; Van Damme, Pierre; Berneman, Zwi N.; Eijnde, Bert O.

    2016-01-01

    Previously, we reported that patients with multiple sclerosis (MS) demonstrate improved muscle strength, exercise tolerance, and lean tissue mass following a combined endurance and resistance exercise program. However, the effect of exercise on the underlying disease pathogenesis remains elusive. Since recent evidence supports a crucial role of dendritic cells (DC) in the pathogenesis of MS, we investigated the effect of a 12-week combined exercise program in MS patients on the number and function of DC. We demonstrate an increased number of plasmacytoid DC (pDC) following the exercise program. These pDC display an activated phenotype, as evidenced by increased numbers of circulating CD62L+ and CD80+ pDC. Interestingly, the number of CD80+ pDC positively correlates with the presence of IL-10-producing regulatory type 1 cells (Tr1), an important cell type for maintaining peripheral tolerance to self-antigens. In addition, decreased production of the inflammatory mediators, TNF-α and MMP-9, upon Toll-like receptor (TLR) stimulation was found at the end of the exercise program. Overall, our findings suggest that the 12-week exercise program reduces the secretion of inflammatory mediators upon TLR stimulation and promotes the immunoregulatory function of circulating pDC, suggestive for a favorable impact of exercise on the underlying immunopathogenesis of MS. PMID:26903712

  17. Portuguese Special Course: 12 Weeks.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This 12-week course in beginning Portuguese comprises four volumes of student text (Lessons 1-55) and a fifth volume of Portuguese-English/English-Portuguese vocabulary. Lesson materials consist of basic dialogs with English translation, recombination dialogs, readings and comprehension questions, oral exercises, and in later units, additional…

  18. Efficacy of the long-acting nitro vasodilator pentaerithrityl tetranitrate in patients with chronic stable angina pectoris receiving anti-anginal background therapy with beta-blockers: a 12-week, randomized, double-blind, placebo-controlled trial

    PubMed Central

    Münzel, Thomas; Meinertz, Thomas; Tebbe, Ulrich; Schneider, Heinrich Theodor; Stalleicken, Dirk; Wargenau, Manfred; Gori, Tommaso; Klingmann, Ingrid

    2014-01-01

    Background The organic nitrate pentaerithrityl tetranitrate (PETN) has been shown to have ancillary properties that prevent the development of tolerance and endothelial dysfunction. This randomized, double-blind, placebo-controlled, multicentre study (‘CLEOPATRA’ study) was designed to investigate the anti-ischaemic efficacy of PETN 80 mg b.i.d. (morning and mid-day) over placebo in patients with chronic stable angina pectoris. Methods and results A total of 655 patients were evaluated in the intention-to-treat population, randomized to PETN (80 mg b.i.d., n = 328) or placebo (n = 327) and completed the study. Patients underwent treadmill exercise tests at randomization, after 6 and 12 weeks of treatment. Treatment with PETN over 12 weeks did not modify the primary endpoint total exercise duration (TED, P = 0.423). In a pre-specified sub-analysis of patients with reduced exercise capacity (TED at baseline ≤9 min, n = 257), PETN appeared more effective than placebo treatment (P = 0.054). Superiority of PETN over placebo was evident in patients who were symptomatic at low exercise levels (n = 120; P = 0.017). Pentaerithrityl tetranitrate 80 mg b.i.d. was well tolerated, and the overall safety profile was comparable with placebo. Conclusion Although providing no additional benefit in unselected patients with known coronary artery disease, PETN therapy, administered in addition to modern anti-ischaemic therapy, could increase exercise tolerance in symptomatic patients with reduced exercise capacity. PMID:24071762

  19. Adjunctive α-lipoic acid reduces weight gain compared with placebo at 12 weeks in schizophrenic patients treated with atypical antipsychotics: a double-blind randomized placebo-controlled study.

    PubMed

    Kim, Nam Wook; Song, Yul-Mai; Kim, Eosu; Cho, Hyun-Sang; Cheon, Keun-Ah; Kim, Su Jin; Park, Jin Young

    2016-09-01

    α-Lipoic acid (ALA) has been reported to be effective in reducing body weight in rodents and obese patients. Our previous open trial showed that ALA may play a role in reducing weight gain in patients with schizophrenia on atypical antipsychotics. The present study evaluated the efficacy of ALA in reducing weight and BMI in patients with schizophrenia who had experienced significant weight gain since taking atypical antipsychotics. In a 12-week, double-blind randomized placebo-controlled study, 22 overweight and clinically stable patients with schizophrenia were randomly assigned to receive ALA or placebo. ALA was administered at 600-1800 mg, as tolerated. Weight, BMI, abdomen fat area measured by computed tomography, and metabolic values were determined. Adverse effects were also assessed to examine safety. Overall, 15 patients completed 12 weeks of treatment. There was significant weight loss and decreased visceral fat levels in the ALA group compared with the placebo group. There were no instances of psychopathologic aggravation or severe ALA-associated adverse effects. ALA was effective in reducing weight and abdominal obesity in patients with schizophrenia who had experienced significant weight gain since beginning an atypical antipsychotic regimen. Moreover, ALA was well tolerated throughout this study. ALA might play an important role as an adjunctive treatment in decreasing obesity in patients who take atypical antipsychotics. PMID:27276401

  20. Effect of an integrated community-based package for maternal and newborn care on feeding patterns during the first 12 weeks of life: a cluster-randomized trial in a South African township

    PubMed Central

    Ijumba, Petrida; Doherty, Tanya; Jackson, Debra; Tomlinson, Mark; Sanders, David; Swanevelder, Sonja; Persson, Lars-Åke

    2015-01-01

    Objective To analyse the effect of community-based counselling on feeding patterns during the first 12 weeks after birth, and to study whether the effect differs by maternal HIV status, educational level or household wealth. Design Cluster-randomized trial with fifteen clusters in each arm to evaluate an integrated package providing two pregnancy and five postnatal home visits delivered by community health workers. Infant feeding data were collected using 24 h recall of nineteen food and fluid items. Setting A township near Durban, South Africa. Subjects Pregnant women (1894 intervention and 2243 control) aged 17 yearsor more. Results Twelve weeks after birth, 1629 (intervention) and 1865 (control) mother–infant pairs were available for analysis. Socio-economic conditions differed slightly across intervention groups, which were considered in the analyses. There was no effect on early initiation of breast-feeding. At 12 weeks of age the intervention doubled exclusive breast-feeding (OR=2·29; 95 % CI 1·80, 2·92), increased exclusive formula-feeding (OR=1·70; 95 % CI 1·28, 2·27), increased predominant breast-feeding (OR=1·71; 95 % CI 1·34, 2·19), decreased mixed formula-feeding (OR=0·68; 95 % CI 0·55, 0·83) and decreased mixed breast-feeding (OR=0·54; 95 % CI 0·44, 0·67). The effect on exclusive breast-feeding at 12 weeks was stronger among HIV-negative mothers than HIV-positive mothers (P=0·01), while the effect on mixed formula feeding was significant only among HIV-positive mothers (P=0·03). The effect on exclusive feeding was not different by household wealth or maternal education levels. Conclusions A perinatal intervention package delivered by community health workers was effective in increasing exclusive breast-feeding, exclusive formula feeding and decreasing mixed feeding. PMID:25660465

  1. Reducing psychotropic pharmacotherapy in patients with severe mental illness: a cluster-randomized controlled intervention study

    PubMed Central

    Kilian, Reinhold; Sørensen, Helle Østermark; Eriksen, Susan Engelbrechsen; Davidsen, Annette Sofie; Jensen, Signe Olrik Wallenstein; Munk-Jørgensen, Povl

    2015-01-01

    Background: Many patients with mental illness receive psychotropic medicine in high dosages and from more than one drug. One of the consequences of this practice is obesity, which is a contributing factor to increased physical morbidity and premature death. Methods: Our study was a cluster-randomized intervention study involving 6 facilities and 174 patients diagnosed with severe mental illnesses (73% schizophrenia). The intervention period was 12 months and consisted of teaching sessions with the staff and evaluating the patients’ intake of psychotropic medication. At index, 44% met criteria for obesity and 76% met criteria for overweight. Waist circumferences were 108 cm for men and 108 cm for women. Olanzapine, clozapine and quetiapine were the most common prescribed antipsychotics. Mean values of daily doses of antipsychotic were 2.5. Results: The intervention showed no significant differences between the intervention and control group regarding psychotropic treatment. At follow up, independent of intervention, patients receiving antipsychotic polypharmacy had a larger waist circumference compared with patients receiving antipsychotic monotherapy of 9.8 cm (1.5–18.1) (p = 0.028). Discussion and conclusion: We found both a high prevalence of obesity and that the patients received treatment with antipsychotic polypharmaceutics in high dosages. Active awareness did not change practice and we must think of other ways to restrict treatment with psychotropics in this group of patients. PMID:26240746

  2. Effect of ginger powder supplementation on nitric oxide and C-reactive protein in elderly knee osteoarthritis patients: A 12-week double-blind randomized placebo-controlled clinical trial.

    PubMed

    Naderi, Zahra; Mozaffari-Khosravi, Hassan; Dehghan, Ali; Nadjarzadeh, Azadeh; Huseini, Hassan Fallah

    2016-07-01

    There is limited evidence that ginger ( shēng jiāng) powder consumption can relieve pain and inflammation because of its special phytochemical properties. This study is aimed at investigating the effect of ginger powder supplementation on some inflammatory markers in patients suffering from knee osteoarthritis. This is a double-blind randomized placebo-controlled clinical trial with a follow-up period of 3 months that was conducted on 120 outpatients with moderately painful knee osteoarthritis. Patients were randomly divided up into two groups: ginger group (GG) or placebo group (PG). Both groups received two identical capsules on a daily basis for 3 months. Each ginger capsule contained 500 mg of ginger powder; the placebo capsules had 500 mg of starch in them. Serum samples were collected prior to and after the intervention and were stored at -70 °C until the end of the study. Serum concentration of nitric oxide (NO) and hs-C reactive protein (hs-CRP) were measured using enzyme-linked immunosorbent assay kits. There was no significant difference between the two groups in terms of inflammatory markers (i.e., NO and hs-CRP) prior to the intervention. However, after 3 months of supplementation, serum concentration of NO and hs-CRP decreased in the GG. After 12 weeks, the concentration of these markers declined more in the GG than in the PG. Ginger powder supplementation at a dose of 1 g/d can reduce inflammatory markers in patients with knee osteoarthritis, and it thus can be recommended as a suitable supplement for these patients. PMID:27419081

  3. A 12-week randomized study of topical therapy with three dosages of ketoprofen in Transfersome® gel (IDEA-033) compared with the ketoprofen-free vehicle (TDT 064), in patients with osteoarthritis of the knee

    PubMed Central

    Kneer, Werner; Rother, Matthias; Mazgareanu, Stefan; Seidel, Egbert J

    2013-01-01

    Objective To evaluate the safety and efficacy of ketoprofen in Transfersome® gel (IDEA-033) in comparison with a ketoprofen-free vehicle (TDT 064) for the treatment of osteoarthritis (OA) of the knee. Methods Patients with knee OA (N = 866) were randomly assigned to receive topical IDEA-033 containing 100, 50, or 25 mg ketoprofen, or TDT 064 twice daily for 12 weeks, in a double-blind trial. The primary efficacy endpoint was the change in the Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index pain subscale score. The coprimary efficacy endpoints were the WOMAC function subscale score and the patient global assessment of response to therapy. The secondary endpoints included the numeric pain rating for the first 14 days of treatment and the Outcome Measures in Rheumatology (OMERACT)-Osteoarthritis Research Society International (OARSI) responder rates. Results The WOMAC pain scores were reduced by approximately 50% or more in all four groups. The 100 and 50 mg ketoprofen groups, but not the 25 mg group, showed a superior reduction in the WOMAC pain score versus the TDT 064 group (100 mg: −57.4% [P = 0.0383]; 50 mg: −57.1% [P = 0.0204]; and 25 mg: −53.4% [P = 0.3616] versus TDT 064: −49.5%). The superiority of the ketoprofen-containing formulations was not demonstrated for the WOMAC function subscale score, whereas the patient global assessment of 50 mg ketoprofen group, but not the 100 or 25 mg group, was superior to that of the TDT 064 group (P = 0.0283). Responder rates were significantly higher for all the IDEA-033 groups versus the TDT 064 group, but were high in all groups (100 mg: 88.6%; 50 mg: 86.8%; 25 mg: 88.6%; and TDT 064: 77.5%). Dermal reactions were the only relevant drug-related adverse events in all four groups. Conclusion The 50 and 100 mg ketoprofen doses of IDEA-033 were only marginally superior to TDT 064 for reducing pain associated with knee OA. The study indicates a high treatment response to the topical

  4. Testing Links between Childhood Positive Peer Relations and Externalizing Outcomes through a Randomized Controlled Intervention Study

    ERIC Educational Resources Information Center

    Witvliet, Miranda; van Lier, Pol A. C.; Cuijpers, Pim; Koot, Hans M.

    2009-01-01

    In this study, the authors used a randomized controlled trial to explore the link between having positive peer relations and externalizing outcomes in 758 children followed from kindergarten to the end of 2nd grade. Children were randomly assigned to the Good Behavior Game (GBG), a universal classroom-based preventive intervention, or a control…

  5. Comparison of curcumin with intralesional steroid injections in Oral Submucous Fibrosis – A randomized, open-label interventional study

    PubMed Central

    Yadav, Monu; Aravinda, K.; Saxena, Vasu S.; Srinivas, K.; Ratnakar, P.; Gupta, Jyothi; Sachdev, Arti Saluja; Shivhare, Peeyush

    2014-01-01

    Introduction Oral Submucous Fibrosis (OSMF) is precancerous condition caused by areca nut chewing characterized by restricted mouth opening, burning sensation and stiffness & blanching of oral mucosa. Complete regression of the condition had not been achieved in all cases with any of the present treatment regimens. Curcumin is (diferuloylmethane), a yellow pigment in curry powder, exhibits anti-oxidant, anti-inflammatory, and pro-apoptotic activities. Hence an interventional study was undertaken to establish the efficacy of curcumin in OSMF patients. Settings & design A randomized open label, interventional study was conducted in forty patients with clinically and histologically proven Oral Submucous Fibrosis. Materials & methods Forty patients with clinically and histologically proven Oral Submucous Fibrosis were selected for the study and were randomly divided into 2 groups. The first group was treated with weekly intralesional injection of 4 mg Dexamethasone & 1500 I.U Hyaluronidase and the second group by oral administration of two Curcumin tablets (Turmix 300 mg) per day for 3 months each. Improvement of burning sensation, interincisal distance and tongue protrusion was evaluated on a weekly basis. Results Burning sensation improved in both the groups from early to late stages. Complete resolution of burning sensation was noted with turmix. The mean increase in interincisal distance was 3.13 mm and 1.25 mm respectively in groups 1 &2. The interincisal distance improved in both the groups, with significant results at the end of first month. Tongue protrusion showed greater recovery at the end of 1st month in group 1 when compared with group 2. Conclusion Turmix is beneficial and effective in reducing burning sensation in early OSMF patients. PMID:25737939

  6. Attachment-Focused Integrative Reminiscence with Older African-Americans: A Randomized Controlled Intervention Study

    PubMed Central

    Henderson, Charles R.; Kang, Suk-Young; Pillemer, Karl

    2015-01-01

    Objectives Prior integrative reminiscence interventions have had a limited focus on attachment themes. The Attachment-Focused Integrative Reminiscence (AFIR) intervention differs from these in its central emphasis on attachment themes. The wide range of health benefits resulting from integrative reminiscence may be due in part to reminiscing about, mourning, and integrating unresolved attachment experiences. Method Participants were randomized into treatment and wait-list control conditions; completed a pre-test; met for 8 consecutive weekly 2-hour sessions of largely attachment-focused reminiscence; then completed post-tests immediately following the intervention and again 6 months later. Results Results show treatment effects for depression (p = .01 and .05 at 8 weeks and 6 months), perceived stress (p = .01 and .04), and emergency room (ER) visits at 6 months (p = .04), with the intervention group showing lower depression and stress and fewer ER visits. Conclusion Integrative reminiscence interventions are cost-effective, have rapid impact, and carry a certain appeal to older adults. Augmenting such interventions with a focus on attachment experiences may reduce perceived stress, an important health risk factor. Wider application of AFIRs may further reduce health disparities among U.S. older adults. PMID:25812080

  7. Improving Parental Stress Levels Among Mothers Living with HIV: A Randomized Control Group Intervention Study

    PubMed Central

    Johnson, Erica R.; Davies, Susan L.; Aban, Inmaculada; Mugavero, Michael J.; Shrestha, Sadeep

    2015-01-01

    Abstract Limited knowledge exists regarding parenting efficacy interventions for mothers living with HIV (MLH). This study evaluated the impact of a supportive group intervention on lowering parenting stress among MLH. Eighty MLH were randomized to a parenting (N=34) or health focused (control) (N=46) group intervention. Pre- and post-intervention stress levels were assessed using the Parental Stress Index-Short Form (PSI/SF). Differences in PSI/SF scores were examined using ANOVA, and predictors of PSI/SF scores were evaluated using multivariable linear regression. Findings indicate that both groups experienced significant decreases in parenting stress from baseline to post-intervention (p=0.0001), with no significant differences between interventions. At baseline, 41% of participants were identified as highly stressed and 30% as clinically stressed, with PSI/SF scores above the 85th and 90th percentile, respectively. Amongst the highly stressed subpopulation, significant improvements in PSI/SF scores for Parental Distress PSI/SF (p=0.039), Difficult Child PSI/SF (p=0.048), and total PSI/SF (p=0.036) were seen, with greater improvements in the parenting intervention. Among the clinically stressed subpopulation, significant improvements in total post-intervention PSI/SF scores were seen (p=0.049), with greater improvements in the parenting intervention. Results indicate that screening for high levels of stress should be considered in clinical practice to effectively implement stress-reducing interventions among MLH. PMID:25734870

  8. Use of a randomized multiple baseline design: rationale and design of the spirited life holistic health intervention study.

    PubMed

    Proeschold-Bell, Rae Jean; Swift, Robin; Moore, H Edgar; Bennett, Gary; Li, Xiang-Fang; Blouin, Rachel; Williams, Virginia P; Williams, Redford B; Toole, David

    2013-07-01

    Clergy suffer from high rates of obesity, chronic disease, and depression, and simultaneously underestimate the toll these take on their daily functioning. Health interventions are needed for clergy and may be tailored to their occupational context and theological beliefs. Few studies have sought to improve clergy health. No prior studies have utilized a randomized design. Spirited Life is a randomized, multiple baseline study that offered enrollment to nearly all United Methodist Church clergy in North Carolina in fall 2010. A total of 1114 clergy (response rate = 64%) enrolled. Using a multiple baseline design, we randomized participants to three cohorts. Each cohort began the health intervention in one of three consecutive years. The third cohort served as a randomized waitlist control cohort, allowing comparisons between the first and third cohorts. The two-year Spirited Life intervention consists of: 1) a theological underpinning for health stewardship based on incarnation, grace, and response and delivered during workshops; 2) the stress management program Williams LifeSkills; 3) Naturally Slim, an online weight loss program; 4) phone contact with a Wellness Advocate; and 5) $500 small grants for health goals. Metabolic syndrome is the primary endpoint. Stress and depressive severity are secondary endpoints. We measured each construct before, twice during, and at the end of the two-year intervention. Study outcomes, to be published after follow-up data are gathered, will provide evidence of the effectiveness of the combined intervention components of Spirited Life. If successful, the intervention may be considered for use with other clergy and faith populations. PMID:23685205

  9. Changes in Physical Activity and Sedentary Behavior in a Randomized Trial of an Internet-Based Versus Workbook-Based Family Intervention Study

    PubMed Central

    Catenacci, Victoria; Barrett, Christopher; Odgen, Lorraine; Browning, Ray; Schaefer, Christine Adele; Hill, James; Wyatt, Holly

    2015-01-01

    Background The America on the Move (AOM) Family Intervention Program has been shown to prevent excess weight gain in overweight children. Providing intervention materials via the internet would have the potential to reach more families but may increase sedentary behavior. The purpose was to evaluate whether delivering the AOM Family Intervention via the internet versus printed workbook would have a similar impact on sedentary behaviors in children. Methods 131 children (age 8–12) were randomized to receive the AOM Family Intervention via the internet or workbook for 12 weeks. Changes in objectively measured sedentary time and moderate-to vigorous physical activity (MVPA) as well as self-reported screen time were compared between groups. Results There were no significant differences between groups in screen time, sedentary time, or MVPA at the end of the 12 week intervention. Families receiving the intervention via the internet were more likely to remain in the study (98% vs. 82%, P = .016). Conclusions Using the internet to deliver the lifestyle intervention did not increase sedentary behavior in children. Attrition rates were lower when the program was delivered by internet versus via printed materials. These results provide support for using the internet to deliver healthy lifestyle programs for children. PMID:23364318

  10. A Randomized Intervention Study to Evaluate Whether Electronic Messaging Can Increase Human Papillomavirus Vaccine Completion and Knowledge among College Students

    ERIC Educational Resources Information Center

    Richman, Alice R.; Maddy, LaDonna; Torres, Essie; Goldberg, Ellen J.

    2016-01-01

    Objective: To evaluate an intervention aimed at increasing human papillomavirus (HPV) vaccine completion of the 3-dose series and knowledge. Participants: Two hundred sixty-four male and female US college students 18-26 years old who were receiving HPV vaccine dose 1. Methods: Students were randomly assigned to the intervention or control group.…

  11. Improving the Design of Science Intervention Studies: An Empirical Investigation of Design Parameters for Planning Group Randomized Trials

    ERIC Educational Resources Information Center

    Westine, Carl; Spybrook, Jessaca

    2013-01-01

    The capacity of the field to conduct power analyses for group randomized trials (GRTs) of educational interventions has improved over the past decade (Authors, 2009). However, a power analysis depends on estimates of design parameters. Hence it is critical to build the empirical base of design parameters for GRTs across a variety of outcomes and…

  12. Factors Associated with High Use of a Workplace Web-Based Stress Management Program in a Randomized Controlled Intervention Study

    ERIC Educational Resources Information Center

    Hasson, H.; Brown, C.; Hasson, D.

    2010-01-01

    In web-based health promotion programs, large variations in participant engagement are common. The aim was to investigate determinants of high use of a worksite self-help web-based program for stress management. Two versions of the program were offered to randomly selected departments in IT and media companies. A static version of the program…

  13. Effects of a 12-week strength training program on experimented fencers' movement time.

    PubMed

    Redondo, Juan C; Alonso, Cruz J; Sedano, Silvia; de Benito, Ana M

    2014-12-01

    The purpose of this study was to determine the effects of a 12-week strength training program on movement time (MT) on fencers of national level. Twelve male fencers were randomly divided into 2 groups: the control group (CG: N = 6; age, 22.3 ± 8.1 years) and the treatment group (TG: N = 6; age, 24.8 ± 7.2 years). The CG fencers followed the standard physical conditioning program, which was partially modified for the TG. The TG participated in a 12-week strength training program divided into 2 parts: maximal strength training, including weightlifting exercises (2 days a week for 6 weeks) and explosive strength training, with combined weights and plyometric exercises (2 days a week for 6 weeks). Body mass, body fat, muscle mass, jumping ability, maximal strength, reaction time, and MT were measured on 4 separate occasions. The TG demonstrated significant increases (p ≤ 0.05) in maximal strength and jumping ability after 6 weeks of training and in MT after 12 weeks. These improvements remained unaltered during the 4-week detraining period. It may be concluded that a 12-week strength training program can improve maximal and explosive strength, and these increases can be transferred to MT performance. However, fencers need time to transfer the gains. PMID:24942170

  14. Prevention of gestational diabetes through lifestyle intervention: study design and methods of a Finnish randomized controlled multicenter trial (RADIEL)

    PubMed Central

    2014-01-01

    Background Maternal overweight, obesity and consequently the incidence of gestational diabetes are increasing rapidly worldwide. The objective of the study was to assess the efficacy and cost-effectiveness of a combined diet and physical activity intervention implemented before, during and after pregnancy in a primary health care setting for preventing gestational diabetes, later type 2 diabetes and other metabolic consequences. Methods RADIEL is a randomized controlled multi-center intervention trial in women at high risk for diabetes (a previous history of gestational diabetes or prepregnancy BMI ≥30 kg/m2). Participants planning pregnancy or in the first half of pregnancy were parallel-group randomized into an intervention arm which received lifestyle counseling and a control arm which received usual care given at their local antenatal clinics. All participants visited a study nurse every three months before and during pregnancy, and at 6 weeks, 6 and 12 months postpartum. Measurements and laboratory tests were performed on all participants with special focus on dietary and exercise habits and metabolic markers. Of the 728 women [mean age 32.5 years (SD 4.7); median parity 1 (range 0-9)] considered to be eligible for the study 235 were non-pregnant and 493 pregnant [mean gestational age 13 (range 6 to 18) weeks] at the time of enrollment. The proportion of nulliparous women was 29.8% (n = 217). Out of all participants, 79.6% of the non-pregnant and 40.4% of the pregnant women had previous gestational diabetes and 20.4% of the non-pregnant and 59.6% of the pregnant women were recruited because of a prepregnancy BMI ≥30 kg/m2. Mean BMI at first visit was 30.1 kg/m2 (SD 6.2) in the non-pregnant and 32.7 kg/m2 (SD 5.6) in the pregnant group. Discussion To our knowledge, this is the first randomized lifestyle intervention trial, which includes, besides the pregnancy period, both the prepregnancy and the postpartum period. This study design also

  15. SPACE for physical activity - a multicomponent intervention study: study design and baseline findings from a cluster randomized controlled trial

    PubMed Central

    2011-01-01

    Background The aim of the School site, Play Spot, Active transport, Club fitness and Environment (SPACE) Study was to develop, document, and assess a comprehensive intervention in local school districts that promote everyday physical activity (PA) among 11-15-year-old adolescents. The study is based on a social ecological framework, and is designed to implement organizational and structural changes in the physical environment. Methods/design The SPACE Study used a cluster randomized controlled study design. Twenty-one eligible schools in the Region of Southern Denmark were matched and randomized in seven pairs according to eight matching variables summarized in an audit tool (crow-fly distance from residence to school for 5-6th graders; area household income; area education level; area ethnicity distribution; school district urbanity; condition and characteristics of school outdoor areas; school health policy; and active transport in the local area). Baseline measurements with accelerometers, questionnaires, diaries, and physical fitness tests were obtained in Spring 2010 in 5-6th grade in 7 intervention and 7 control schools, with follow-up measurements to be taken in Spring 2012 in 7-8th grade. The primary outcome measure is objective average daily physical activity and will be supported by analyses of time spent in moderate to vigorous activity and time spent sedentary. Other secondary outcome measures will be obtained, such as, overweight, physical fitness, active commuting to/from school and physical activity in recess periods. Discussion A total of 1348 adolescents in 5-6th grade in the Region of Southern Denmark participated at baseline (n = 14 schools). The response rate was high in all type of measurements (72.6-97.4%). There were no significant differences between intervention and control groups at baseline according to selected background variables and outcome measures: gender (p = .54), age (p = .17), BMI (p = .59), waist circumference (p = .17

  16. Efficacy of a Multicomponent Positive Psychology Self-Help Intervention: Study Protocol of a Randomized Controlled Trial

    PubMed Central

    Drossaert, Constance HC; Pieterse, Marcel E; Walburg, Jan A; Bohlmeijer, Ernst T

    2015-01-01

    Background Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A cost-effective approach could be a positive psychology-based self-help book with tailored email support to reach large target groups and to prevent dropout. Objective This study will evaluate the efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and will seek to determine the working mechanisms underlying the intervention. Methods In this 3-armed, parallel, randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3 months after baseline), and at 6 and 12 months after baseline. Results The primary outcomes are well-being and flourishing (ie, high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience, and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events, and client satisfaction. Conclusions This study will add knowledge to the efficacy and cost-effectiveness of a multicomponent positive psychology intervention. We will also explore who can benefit most from this intervention. If the intervention is found to be effective, our results will be especially relevant for public mental health services, governments, and primary care. Trial

  17. Effects of a Randomized Reading Intervention Study Aimed at 9-Year-Olds: A 5-Year Follow-up.

    PubMed

    Wolff, Ulrika

    2016-05-01

    The present paper reports on a 5-year follow-up of a randomized reading intervention in grade 3 in Sweden. An intervention group (n = 57) received daily training for 12 weeks in phoneme/grapheme mapping, reading comprehension and reading speed, whereas a control group (n = 55) participated in ordinary classroom activities. The main aim was to investigate if there were remaining effects of the intervention on reading-related skills. Previous analyses showed that the intervention group performed significantly better than the control group on spelling, reading speed, reading comprehension and phoneme awareness at the immediate post-test with sustained effects 1 year later. Results from the 5-year follow-up show that the only significant difference between the intervention (n = 47) and the control group (n = 37) was on word decoding. There was also a significant interaction effect of group assignment and initial word decoding, in the way that the lowest-performing students benefitted the most from the intervention. Another aim was to examine if the children identified in a screening (n = 2212) as poor readers in grade 2 still performed worse than typical readers. The analyses showed that the typically developing students (n = 66) outperformed the students identified as poor readers in grade 2 on working memory, spelling, reading comprehension and word decoding. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27146373

  18. Moderate alcohol consumption and changes in postprandial lipoproteins of premenopausal and postmenopausal women: a diet-controlled, randomized intervention study.

    PubMed

    van der Gaag, M S; Sierksma, A; Schaafsma, G; van Tol, A; Geelhoed-Mieras, T; Bakker, M; Hendriks, H F

    2000-01-01

    Moderate alcohol consumption is associated with a reduced risk of coronary heart disease. Earlier studies in men have shown that moderate alcohol consumption affects lipoprotein metabolism and hemostasis. In this diet-controlled, randomized, crossover trial, we investigated the effect on lipoprotein metabolism of moderate consumption of red wine or red grape juice with evening dinner for 3 weeks in premenopausal women using oral contraceptives and in postmenopausal women. After 3 weeks, blood samples were collected 1 hour before dinner up to 19 hours after starting dinner at 2-hour or 4-hour intervals. Plasma triglyceride concentrations and very low density lipoprotein (VLDL) triglyceride levels peaked 3 hours after dinner with wine in both premenopausal and postmenopausal women. After wine consumption, the overall high-density lipoprotein (HDL) cholesterol level was increased in postmenopausal women (mean increase 0.17 mmol/L, or 12%, p = 0.03), and the plasma low-density lipoprotein (LDL) cholesterol level was reduced in premenopausal women (mean reduction 0.35 mmol/L, or 12%, p = 0.01) as compared with grape juice consumption. The findings suggest that postprandial lipoprotein metabolism after moderate alcohol consumption differs between oral contraceptive-using premenopausal women and postmenopausal women. The response of postmenopausal women to alcohol resembled the response found in earlier studies in men. PMID:10957749

  19. The First Intervention Study in Elder Self-Neglect: A Randomized Clinical Trial to Improve Vitamin D Levels

    NASA Technical Reports Server (NTRS)

    Burnett, Jason; Hochschild, Ann; Smith, Scott M.; Diamond, Pam; Stotts, Angela; Dyer, Carmel

    2011-01-01

    Despite high mortality rates, elder self-neglect is characterized by refusal of medical and social interventions. To date there have been no tested clinical interventions in elders who self-neglect. Previous research from the TEAM Institute has shown significantly low vitamin D levels in this population. This study aimed to determine the feasibility of a clinical intervention. Replacement of vitamin D was chosen because of its ease of administration and favorable safety profile. Methods: A randomized clinical trial using directly observed therapy of vitamin D was conducted using 50 elders, >65 years of age, with Adult Protective Services (APS) validated self-neglect. A staggered intervention with waiting controls was used to maximize statistical power. One-third (n=17) of the group was administered 50,000 IU vitamin D2 (ergocalciferol) monthly and the remainder (n=33) were administered 400 IU monthly. Serum 25-OH vitamin D was assessed at baseline and 5-months. Results: 69% agreed to participate in the study and of those n=40 (80%) remained at 5-months. At baseline, 12% (n=7) were deficient in vitamin D (<30nmol/L) and approximately 38% (n=22) had inadequate vitamin D levels (<50nmol/L). The baseline 25-OH vitamin D level was 59 nmol/L +25 (mean SD), and increased significantly to 72nmol/L +21 nmol/L at 5-months. Conclusion: These data are the first to provide evidence that clinical interventions are feasible in elders who self-neglect. The increase in vitamin D levels confirmed that the study personnel were able to successfully intervene community-dwelling elders with self-neglect. This study sets the precedent for future intervention and prevention studies

  20. 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

  1. 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

    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

    2014-09-01

    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

  2. A Cluster-Randomized Controlled Intervention Study to Assess the Effect of a Contact Intervention in Reducing Leprosy-Related Stigma in Indonesia

    PubMed Central

    Peters, Ruth M. H.; Dadun; Zweekhorst, Marjolein B. M.; Bunders, Joske F. G.; Irwanto; van Brakel, Wim H.

    2015-01-01

    Background Can deliberate interaction between the public and persons affected by leprosy reduce stigmatization? The study described in this paper hypothesises that it can and assesses the effectiveness of a ‘contact intervention’. Methods/Principal Findings This cluster-randomized controlled intervention study is part of the Stigma Assessment and Reduction of Impact (SARI) project conducted in Cirebon District, Indonesia. Testimonies, participatory videos and comics given or made by people affected by leprosy were used as methods to facilitate a dialogue during so-called ‘contact events’. A mix of seven quantitative and qualitative methods, including two scales to assess aspects of stigma named the SDS and EMIC-CSS, were used to establish a baseline regarding stigma and knowledge of leprosy, monitor the implementation and assess the impact of the contact events. The study sample were community members selected using different sampling methods. The baseline shows a lack of knowledge about leprosy, a high level of stigma and contrasting examples of support. In total, 91 contact events were organised in 62 villages, directly reaching 4,443 community members (mean 49 per event). The interview data showed that knowledge about leprosy increased and that negative attitudes reduced. The adjusted mean total score of the EMIC-CSS reduced by 4.95 points among respondents who had attended a contact event (n = 58; p <0.001, effect size = 0.75) compared to the score at baseline (n = 213); for the SDS this was 3.56 (p <0.001, effect size = 0.81). About 75% of those attending a contact event said they shared the information with others (median 10 persons). Conclusions/Significance The contact intervention was effective in increasing knowledge and improving public attitudes regarding leprosy. It is relatively easy to replicate elsewhere and does not require expensive technology. More research is needed to improve scalability. The effectiveness of a contact intervention to

  3. Antioxidant intake, plasma antioxidants and oxidative stress in a randomized, controlled, parallel, Mediterranean dietary intervention study on patients with rheumatoid arthritis

    PubMed Central

    Hagfors, Linda; Leanderson, Per; Sköldstam, Lars; Andersson, Jan; Johansson, Gunnar

    2003-01-01

    Background Previously we have reported that patients with rheumatoid arthritis (RA) obtained a significant reduction in disease activity by adopting a Mediterranean-type diet. The present study was carried out to investigate the antioxidant intake, the plasma levels of antioxidants and a marker of oxidative stress (malondialdehyde) during the study presented earlier. Methods RA patients randomized to either a Mediterranean type diet (MD group; n = 26) or a control diet (CD group; n = 25) were compared during a three month dietary intervention study. Their antioxidant intake was assessed by means of diet history interviews and their intake of antioxidant-rich foods by a self-administered questionnaire. The plasma levels of retinol, antioxidants (α- and γ-tocopherol, β-carotene, lycopene, vitamin C and uric acid) and urinary malondialdehyde (MDA), a marker for oxidative stress, were determined using high performance liquid chromatography. The Student's t-test for independent samples and paired samples were used to test differences between and within groups. For variables with skewed distributions Mann-Whitney U-test and Wilcoxon signed ranks test were performed. To evaluate associations between dietary intake of antioxidants, as well as between disease activity, MDA and antioxidants we used Pearson's product moment correlation or Spearman's rank correlation. Results The MD group had significantly higher intake frequencies of antioxidant-rich foods, and also higher intakes of vitamin C (p = 0.014), vitamin E (p = 0.007) and selenium (p = 0.004), and a lower intake of retinol (p = 0.049), compared to the CD group. However, the difference between the groups regarding vitamin C intake was not significant when under- and over-repoters were excluded (p = 0.066). There were no changes in urine MDA or in the plasma levels of antioxidants (after p-lipid adjustments of the tocopherol results), from baseline to the end of the study. The levels of retinol, vitamin C and uric

  4. Intake of Novel Red Clover Supplementation for 12 Weeks Improves Bone Status in Healthy Menopausal Women

    PubMed Central

    Thorup, Anne Cathrine; Lambert, Max Norman; Kahr, Henriette Strøm; Bjerre, Mette; Jeppesen, Per Bendix

    2015-01-01

    Objective. To investigate the effect by which daily consumption of a novel red clover (RC) extract influences bone health, inflammatory status, and cardiovascular health in healthy menopausal women. Design. A 12-week randomized, double-blinded, placebo-controlled trial involving 60 menopausal women receiving a daily dose of 150 mL RC extract containing 37.1 mg isoflavones (33.8 mg as aglycones) or placebo. Methods. Bone parameters were changes in bone mineral density (BMD), bone mineral content (BMC), and T-score at the lumbar spine and femoral neck. Bone turnover (CTx) and inflammatory markers were measured in plasma and finally blood pressure (BP) was evaluated. Results. RC extract had positive effect on bone health, and only the women receiving the placebo experienced a decline in BMD (p < 0.01) at the lumbar spine. T-score at the lumbar spine only decreased in the placebo group (p < 0.01). CTx decreased in the RC group with −9.94 (±4.93)%, although not significant. Conclusion. Daily consumption of RC extract over a 12-week period was found to have a beneficial effect on bone health in menopausal women based on BMD and T-score at the lumbar spine and plasma CTx levels. No changes in BP or inflammation markers were found and no side effects were observed. PMID:26265926

  5. Clinical pharmacology study of cariprazine (MP-214) in patients with schizophrenia (12-week treatment)

    PubMed Central

    Nakamura, Tadakatsu; Kubota, Tomoko; Iwakaji, Atsushi; Imada, Masayoshi; Kapás, Margit; Morio, Yasunori

    2016-01-01

    Purpose Cariprazine is a potent dopamine D3-preferring D3/D2 receptor partial agonist in development for the treatment of schizophrenia, bipolar mania, and depression. Pharmacokinetics of cariprazine and the two clinically relevant metabolites (desmethyl- and didesmethyl-cariprazine) was evaluated in a clinical pharmacology study. Methods This was a multicenter, randomized, open-label, parallel-group, fixed-dose (3, 6, or 9 mg/day) study of 28-week duration (≤4-week observation, 12-week open-label treatment, and 12-week follow-up). Once-daily cariprazine was administered to 38 adult patients with schizophrenia. The pharmacokinetics of cariprazine, metabolites, and total active moieties (sum of cariprazine and two metabolites) was evaluated; efficacy and safety were also assessed. Results Steady state was reached within 1–2 weeks for cariprazine and desmethyl-cariprazine, 4 weeks for didesmethyl-cariprazine, and 3 weeks for total active moieties. Cariprazine and desmethyl-cariprazine levels decreased >90% within 1 week after the last dose, didesmethyl-cariprazine decreased ~50% at 1 week, and total active moieties decreased ~90% within 4 weeks. Terminal half-lives of cariprazine, desmethyl-cariprazine, and didesmethyl-cariprazine ranged from 31.6 to 68.4, 29.7 to 37.5, and 314 to 446 hours, respectively. Effective half-life (calculated from time to steady state) of total active moieties was ~1 week. Incidence of treatment-emergent adverse events was 97.4%; 15.8% of patients discontinued due to adverse events. No abnormal laboratory values or major differences from baseline in extrapyramidal symptoms were observed. Conclusion Cariprazine and its active metabolites reached steady state within 4 weeks, and exposure was dose proportional over the range of 3–9 mg/day. Once-daily cariprazine was generally well tolerated in adult patients with schizophrenia. PMID:26834462

  6. MONTEFIORE - ASTHMA INTERVENTION STUDY

    EPA Science Inventory

    Montefiore Medical Center is conducting an asthma intervention study using, in part, their Lead Safe House on the Montefiore campus, a low-allergen controlled setting. There are three groups of participants, all severe asthmatics. The first group is being moved temporarily into...

  7. Effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in type 2 diabetes mellitus patients.

    PubMed

    Kang, Seol-Jung; Ko, Kwang-Jun; Baek, Un-Hyo

    2016-07-01

    [Purpose] This study evaluated the effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in patients with Type 2 diabetes mellitus. [Subjects and Methods] The subjects were 16 female patients with Type 2 diabetes mellitus selected among the participants of a chronic disease management exercise class at C Region Public Health Center in South Korea. Subjects were randomly assigned to the exercise group (n=8; age, 55.97 ± 7.37) or the control group (n=8; age, 57.53 ± 4.63) The exercise group performed aerobic and resistance exercises for 60 minutes per day, 3 times per week for 12 weeks. Anthropometric measurements, biochemical markers, physical fitness, and heart rate variability were examined. [Results] After 12 weeks of exercise, weight, body fat percentage, waist circumference, blood glucose, insulin resistance, glycated hemoglobin level, systolic blood pressure, and diastolic blood pressure significantly decreased and cardiorespiratory fitness and muscular strength significantly increased in the exercise group. Although heart rate variability measures showed favorable changes with the exercise program, none were significant. [Conclusion] Although the exercise program did not show notable changes in heart rate variability in patients with Type 2 diabetes within the timeframe of the study, exercise may contribute to the prevention and control of cardiovascular autonomic neuropathy. PMID:27512271

  8. Effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in type 2 diabetes mellitus patients

    PubMed Central

    Kang, Seol-Jung; Ko, Kwang-Jun; Baek, Un-Hyo

    2016-01-01

    [Purpose] This study evaluated the effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in patients with Type 2 diabetes mellitus. [Subjects and Methods] The subjects were 16 female patients with Type 2 diabetes mellitus selected among the participants of a chronic disease management exercise class at C Region Public Health Center in South Korea. Subjects were randomly assigned to the exercise group (n=8; age, 55.97 ± 7.37) or the control group (n=8; age, 57.53 ± 4.63) The exercise group performed aerobic and resistance exercises for 60 minutes per day, 3 times per week for 12 weeks. Anthropometric measurements, biochemical markers, physical fitness, and heart rate variability were examined. [Results] After 12 weeks of exercise, weight, body fat percentage, waist circumference, blood glucose, insulin resistance, glycated hemoglobin level, systolic blood pressure, and diastolic blood pressure significantly decreased and cardiorespiratory fitness and muscular strength significantly increased in the exercise group. Although heart rate variability measures showed favorable changes with the exercise program, none were significant. [Conclusion] Although the exercise program did not show notable changes in heart rate variability in patients with Type 2 diabetes within the timeframe of the study, exercise may contribute to the prevention and control of cardiovascular autonomic neuropathy. PMID:27512271

  9. Evolution of the electrocardiogram in young dogs during the first 12 weeks of life.

    PubMed

    Trautvetter, E; Detweiler, D K; Patterson, D F

    1981-07-01

    In 36 normal pups the evolution of the ECG during the first 12 weeks was studied. Sixteen pups were randomly selected, healthy pups; 20 were normal littermates from dog families with congenital heart disease. The direction of P, QRS, and T vectors was determined, and the modal QRS axis (vector) was constructed from lead I and AVF in the frontal, from lead I and V10 in the transverse, and from lead AVF and V10 in the sagittal plane. Except for the T wave directly after birth, no marked difference in the ECG evolution between the two groups was found. After birth the modal QRS vector was almost exclusively directed to the right. The modal QRS vectors in the first, second, and third weeks were significantly different from each other. By the twelfth week all vectors were directed to the left and the majority was oriented leftward and caudally. In the serial ECG tracings the change from right ventricular to left ventricular dominance was seen to be progressive. The R/S ratio in the left chest leads increased from less than 1.0 at week 1 to a multiple of 1.0 after the sixth week. The changes occurring in scaler ECG's were mirrored in VCG's recorded in selected pups. PMID:7264504

  10. Effect of a 12-week aerobic training program on perceptual and affective responses in obese women

    PubMed Central

    Freitas, Luís Alberto Garcia; Ferreira, Sandro dos Santos; Freitas, Rosemari Queiroz; Henrique de Souza, Carlos; Garcia, Erick Doner Santos de Abreu; Gregorio da Silva, Sergio

    2015-01-01

    [Purpose] The aim of this study was to observe the effect of self-selected intensity or imposed intensity during aerobic training on perceptual and affective responses in obese women. [Subjects] The study included 26 obese women aged 30–60 years. [Methods] The subjects were randomly divided into two groups, with 13 subjects in each group: self-selected intensity and imposed intensity (10% above ventilatory threshold) groups. All subjects completed an intervention program that lasted 12 weeks, with three exercise sessions a week. The rating of perceived exertion and affective responses (Feeling Scale and Felt Arousal Scale) were monitored in the first, sixth, and twelfth weeks. [Results] Significant differences were observed between groups in heart rate and rating of perceived exertion. The affective responses during exercise were more negative in the imposed intensity group. [Conclusion] Use of a self-selected exercise intensity can promote smaller negative affective responses during exercise and provide a sufficient stimulus for improvement in cardiorespiratory fitness. PMID:26311958

  11. Swahili 12 Weeks Course. Volume VI, Vocabulary List: Swahili-English, English-Swahili.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This Swahili-English/English-Swahili vocabulary list accompanies the Defense Language Institute's 12-weeks course in Swahili. For a description of the first five volumes (55 lesson units), see ED 026 651. (AMM)

  12. Online self-administered training for post-traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study.

    PubMed

    Ruzek, Josef I; Rosen, Raymond C; Marceau, Lisa; Larson, Mary Jo; Garvert, Donn W; Smith, Lauren; Stoddard, Anne

    2012-01-01

    This paper presents the rationale and methods for a randomized controlled evaluation of web-based training in motivational interviewing, goal setting, and behavioral task assignment. Web-based training may be a practical and cost-effective way to address the need for large-scale mental health training in evidence-based practice; however, there is a dearth of well-controlled outcome studies of these approaches. For the current trial, 168 mental health providers treating post-traumatic stress disorder (PTSD) were assigned to web-based training plus supervision, web-based training, or training-as-usual (control). A novel standardized patient (SP) assessment was developed and implemented for objective measurement of changes in clinical skills, while on-line self-report measures were used for assessing changes in knowledge, perceived self-efficacy, and practice related to cognitive behavioral therapy (CBT) techniques. Eligible participants were all actively involved in mental health treatment of veterans with PTSD. Study methodology illustrates ways of developing training content, recruiting participants, and assessing knowledge, perceived self-efficacy, and competency-based outcomes, and demonstrates the feasibility of conducting prospective studies of training efficacy or effectiveness in large healthcare systems. PMID:22583520

  13. Online self-administered training for post-traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study

    PubMed Central

    2012-01-01

    This paper presents the rationale and methods for a randomized controlled evaluation of web-based training in motivational interviewing, goal setting, and behavioral task assignment. Web-based training may be a practical and cost-effective way to address the need for large-scale mental health training in evidence-based practice; however, there is a dearth of well-controlled outcome studies of these approaches. For the current trial, 168 mental health providers treating post-traumatic stress disorder (PTSD) were assigned to web-based training plus supervision, web-based training, or training-as-usual (control). A novel standardized patient (SP) assessment was developed and implemented for objective measurement of changes in clinical skills, while on-line self-report measures were used for assessing changes in knowledge, perceived self-efficacy, and practice related to cognitive behavioral therapy (CBT) techniques. Eligible participants were all actively involved in mental health treatment of veterans with PTSD. Study methodology illustrates ways of developing training content, recruiting participants, and assessing knowledge, perceived self-efficacy, and competency-based outcomes, and demonstrates the feasibility of conducting prospective studies of training efficacy or effectiveness in large healthcare systems. PMID:22583520

  14. Improving Outcomes in Cancer Patients on Oral Anti-Cancer Medications Using a Novel Mobile Phone-Based Intervention: Study Design of a Randomized Controlled Trial

    PubMed Central

    Flanagan, Clare; Searl, Meghan; Elfiky, Aymen; Kvedar, Joseph; Jethwani, Kamal

    2014-01-01

    Background The widespread and increasing use of oral anti-cancer medications has been ushered in by a rapidly increasing understanding of cancer pathophysiology. Furthermore, their popular ease of administration and potential cost savings has highlighted their central position in the health care system as a whole. These facts have heightened appreciation of the unique challenges associated with the use of oral anti-cancer medications; especially in the long-term use of these medications and the associated side effects that may impede optimal adherence to their use. Therefore, we developed ChemOtheRapy Assistant, CORA, a personalized mobile phone–based self-management application to help cancer patients on oral anti-cancer medications. Objective Our objective is to evaluate the effect of CORA on adherence to oral anti-cancer medications and other clinically relevant outcomes in the management of patients with renal and prostate cancer. Methods The study will be implemented as a 2-parallel group randomized controlled trial in 104 patients with renal or prostate cancer on oral anti-cancer medications over a 3-month study period. The intervention group will use CORA in addition to usual care for self-management while the control group will continue care as usual. Medication adherence will be measured objectively by a Medication Event Monitoring System device and is defined as the percentage of prescribed doses taken. We will also assess the effect of the intervention on cancer-related symptoms measured by the MD Anderson Symptom Inventory and unplanned hospital utilizations. Other outcomes that will be measured at study start, midpoint, and endpoint are health-related quality of life, cancer-related fatigue, and anxiety. Group differences in medication adherence will be examined by t tests or by non-parametric Mann-Whitney tests if the data are not normally distributed. Logistic regression will be used to identify potential predictors of adherence. Results We expect

  15. Increased masticatory activity and quality of life in elderly persons with dementia-a longitudinal matched cluster randomized single-blind multicenter intervention study

    PubMed Central

    2013-01-01

    Background Worldwide, millions of people are suffering from dementia and this number is rising. An index of quality of life (QoL) can describe the impact a disease or treatment has on a person’s wellbeing. QoL comprises many variables, including physical health and function, and mental health and function. QoL is related to masticatory ability and physical activity. Animal studies show that disruption of mastication due to loss of teeth or a soft diet leads to memory loss and learning problems. Since these are common complaints in dementia, it is hypothesized that improvement of masticatory function and normalization of diet consistency can increase QoL in elderly persons suffering from dementia. Therefore, the goal of the present study is to examine whether an increase in masticatory activity, achieved by increased food consistency and enhancement of masticatory function through improved oral health care has a positive effect on QoL, including cognition, mood, activities of daily living (ADL), and circadian rhythm in elderly persons with dementia. Methods and design The described study is a prospective longitudinal matched cluster randomized single-blind multicenter study. Participants are elderly persons living in the Netherlands, suffering from dementia and receiving psychogeriatric care. An intervention group will receive improved oral health care and a diet of increased consistency. A control group receives care as usual. Participants will be assessed four times; outcome variables besides QoL are cognition, mood, independence, rest-activity rhythm, blood pressure, and masticatory function. Discussion This research protocol investigates the effect of an intervention executed by daily caregivers. The intervention will increase masticatory activity, which is achieved by three different actions, (providing oral health care, increasing food consistency, or a combination of both). There is a certain amount of variety in the nature of the interventions due to local

  16. Serum levels of sex steroids and metabolites following 12 weeks of intravaginal 0.50% DHEA administration.

    PubMed

    Ke, Yuyong; Labrie, Fernand; Gonthier, Renaud; Simard, Jean-Nicolas; Bergeron, Danielle; Martel, Céline; Vaillancourt, Mario; Montesino, Marlene; Lavoie, Lyne; Archer, David F; Balser, John; Moyneur, Erick

    2015-11-01

    The objective of the present phase III, placebo-controlled, double-blind, prospective and randomized study was to confirm the efficacy of daily intravaginal administration of 0.50% dehydroepiandrosterone (DHEA; prasterone) ovules for 12 weeks on moderate to severe dyspareunia (or pain at sexual activity) as most bothersome symptom of vulvovaginal atrophy (VVA) while having serum steroid concentrations within normal postmenopausal values. To this end, serum levels of DHEA, DHEA-sulfate (DHEA-S), Androst-5-ene-diol-3β, 17β-diol (5-diol), testosterone, dihydrotestosterone (DHT), androstenedione (4-dione), estrone (E1), estradiol (E2), estrone sulfate (E1-S), androsterone glucuronide (ADT-G), and androstane-3α, 17β-diol 17-glucuronide (3α-diol-17G) were measured by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS). In agreement with the mechanisms of intracrinology, all serum sex steroids and metabolites concentrations after 12 weeks of daily intravaginal administration of 0.50% DHEA remain well within the limits of normal postmenopausal women. More specifically, the 12-week serum E2 concentration was measured at 22% below the average normal postmenopausal value (3.26 versus 4.17 pg/ml), thus eliminating any fear of E2 exposure outside the vagina. In addition, serum E1-S, a particularly reliable indicator of global estrogenic activity, shows serum levels practically superimposable to the value observed in normal postmenopausal women (219 versus 220 pg/ml). Similarly, serum ADT-G, the major metabolite of androgens, remains within normal postmenopausal values. The present data confirm the intracellular transformation of DHEA in the vagina resulting in local efficacy without any systemic exposure to sex steroids, observations which are in agreement with the physiological mechanisms of menopause. PMID:26291918

  17. Achondrogenesis type 2 diagnosed by transvaginal ultrasound at 12 weeks' gestation.

    PubMed

    Soothill, P W; Vuthiwong, C; Rees, H

    1993-06-01

    Ultrasound examination at 12 weeks' gestation revealed severe generalised subcutaneous oedema in a pregnancy at risk for achondrogenesis type II. Transvaginal scanning confirmed the oedema and suggested abnormal limb development. The prenatal diagnosis was confirmed by X-ray examination after transvaginal termination. PMID:8372079

  18. Japanese 12-Week Course. Volume I, Introduction and Lessons 1-15.

    ERIC Educational Resources Information Center

    Florida State Univ., Tallahassee. Educational Systems Development Center.

    This first volume in the Defense Language Institute's 12-week course in Japanese presents an introduction to Japanese phonology for the non-linguist beginning student, and a description of the format used throughout the DLI series (perception drills, dialogues with English equivalents, grammar notes, and exercises and conversations). This volume…

  19. The Treatment for Adolescents with Depression Study (TADS): Methods and Message at 12 Weeks

    ERIC Educational Resources Information Center

    March, John; Silva, Susan; Vitiello, Benedetto

    2006-01-01

    Funded by the National Institute of Mental Health, the Treatment for Adolescents With Depression Study (TADS) is intended to evaluate the short-term (12 weeks) and longer-term (36 weeks) effectiveness of four treatments for adolescents with DSM-IV major depressive disorder: clinical management with fluoxetine (FLX), cognitive-behavioral therapy…

  20. The Effects of a 12-Week Walking Program on Community-Dwelling Older Adults

    ERIC Educational Resources Information Center

    Cheng, Shun-Ping; Tsai, Tzu-I; Lii, Yun-Kung; Yu, Shu; Chou, Chen-Liang; Chen, I-Ju

    2009-01-01

    Walking is a popular and easily accessible form of physical activity. However, walking instruction for older adults is based on the evidence gathered from younger populations. This study evaluated walking conditions, strength, balance, and subjective health status after a 12-week walking-training program in community-dwelling adults greater than…

  1. Japanese 12-Week Course. Volume IV, Lessons 42-55. Volume V, Glossary.

    ERIC Educational Resources Information Center

    Florida State Univ., Tallahassee. Educational Systems Development Center.

    These two volumes comprise Lesson Units 42-55 (Volume IV), and a comprehensive Glossary (Volume V) which accompanies this 12-week Defense Language Institute course in beginning Japanese. (See AL 002 223 for Volume I--Introduction and Lesson Units 1-15, and AL 002 224 for Volumes II and III--Lesson Units 16-27 and 28-41.) (AMM)

  2. Japanese 12-Week Course. Volume II, Lessons 16-27. Volume III, Lessons 28-41.

    ERIC Educational Resources Information Center

    Florida State Univ., Tallahassee. Educational Systems Development Center.

    These two volumes contain Lesson Units 16-41 in the Defense Language Institute's 12-week course in Japanese. (See AL 002 223 for Volume I, Lessons Units 1-15 and AL 002 225 for Volume IV, Lesson Units 42-55 and Volume V, Glossary.) (AMM)

  3. 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens

    PubMed Central

    Luetkemeyer, Anne F.; McDonald, Cheryl; Ramgopal, Moti; Noviello, Stephanie; Bhore, Rafia; Ackerman, Peter

    2016-01-01

    Background. Highly effective hepatitis C virus (HCV) direct-acting antiviral therapies that do not require modification of human immunodeficiency virus (HIV) antiretroviral regimens are needed. We evaluated the efficacy and safety of daclatasvir + sofosbuvir (DCV + SOF) for 12 weeks by antiretroviral (ARV) regimen in HIV-HCV-coinfected patients. Methods. In the randomized, open-label ALLY-2 study, HIV-HCV-coinfected patients received 8 or 12 weeks of once-daily DCV 60 mg (dose-adjusted as-necessary for concomitant ARVs) + SOF 400 mg. Results were stratified by ARV class for the 151 patients who received 12 weeks of DCV + SOF. Results. Fifty-one patients were HCV treatment experienced, 100 were treatment naive, 89% male and 33% black. HCV genotypes were: genotype 1a (GT1a; 69%), GT1b (15%), GT2 (8%), GT3 (6%), and GT4 (2%). Sustained virologic response 12 weeks post-treatment (SVR12) was 97% and was similar across ARV regimens (P = .774): protease inhibitor-based, 97% (95% confidence interval [CI], 90%-99.7%); nonnucleoside reverse transcriptase inhibitor-based, 100% (95% CI, 91%-100%); and integrase inhibitor based, 95% (95% CI, 83%-99.4%). SVR12 among patients receiving either tenofovir disoproxil fumarate or abacavir as part of their antiretroviral therapy regimen was 98% (95% CI, 93%-99.5%) and 100% (95% CI, 85%-100%), respectively. Age, gender, race, cirrhosis, HCV treatment history, GT , and baseline HCV RNA did not affect SVR12. No discontinuations were attributed to treatment-related adverse events. Conclusions. DCV + SOF x12 weeks is a highly efficacious, all-oral, pan-GT HCV treatment for HIV-HCV coinfected patients across a broad range of ARV regimens. Clinical Trials Registration. NCT02032888. PMID:27025835

  4. Lateralization of infant holding by mothers: A longitudinal evaluation of variations over the first 12 weeks.

    PubMed

    Todd, Brenda K; Banerjee, Robin

    2016-01-01

    The maternal preference to hold infants on the left rather than right side of the body was examined longitudinally, with attention to 4 explanations: maternal monitoring of infant state, maternal handedness, infant proximity to the mother's heartbeat, and preferred infant head position. The side and site of holding were measured over the first 12 weeks of the lives of 24 infants. Information about group and individual consistency in holding side allowed novel evaluation of the theories. A strong bias to hold on the left dropped below significance when the infants were aged 12 weeks and was limited to specific holding positions. Findings were generally consistent with the monitoring hypothesis, and little support was found for the 3 alternative explanations. PMID:26314871

  5. The effect of 12-week Pilates exercises on wellness in the elderly

    PubMed Central

    Roh, Su Yeon

    2016-01-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, P<0.01), social (t=3.362, P<0.001), spiritual (t=2.307, P<0.05), and emotional wellness (t=2.489, P<0.05). Consequently, Pilates exercises helped improve wellness of the elderly. PMID:27162774

  6. The effect of 12-week Pilates exercises on wellness in the elderly.

    PubMed

    Roh, Su Yeon

    2016-04-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, P<0.01), social (t=3.362, P<0.001), spiritual (t=2.307, P<0.05), and emotional wellness (t=2.489, P<0.05). Consequently, Pilates exercises helped improve wellness of the elderly. PMID:27162774

  7. Immune Function Alterations during 12 Weeks of Abstinence in Heroin Users.

    PubMed

    Wang, Z; Yang, X-R; Song, H; Cao, B-R; Yin, F; An, Z-M; Kang, L; Li, J

    2015-01-01

    The intent of the study was to evaluate immune system changes during 12 weeks of abstinence in heroin users. We recruited men (N = 65) aged 18-45 years and collected demographic and heroin use pattern data. Serum blood levels of total interleukin 2 (IL-2), interferon γ (IFN-γ), immunoglobulin (Ig) A, IgG, and IgM were assessed at five time points. The IL-2 level was increased on day 84 as compared to that in healthy controls. The IFN-γ level was higher in heroin users than in healthy controls between days 0 and 28, and was decreased on day 84. IgG and IgM levels in heroin users were higher than those in healthy controls in our 12-week study, and were in positive correlation with the way of using the drug, duration of heroin dependence, and daily heroin intake. Our data revealed that the immune system was not restored during the 12 weeks of heroin withdrawal. PMID:26789146

  8. Kinematic Measurement of 12-week Head Control Correlates with 12-month Neurodevelopment in Preterm Infants

    PubMed Central

    Bentzley, Jessica P; Coker-Bolt, Patty; Moreau, Noelle; Hope, Kathryn; Ramakrishnan, Viswanathan; Brown, Truman; Mulvihill, Denise; Jenkins, Dorothea

    2015-01-01

    Background Although new interventions treating neonatal brain injury show great promise, our current ability to predict clinical functional outcomes is poor. Quantitative biomarkers of long-term neurodevelopmental outcome are critically needed to gauge treatment efficacy. Kinematic measures derived from commonly used developmental tasks may serve as early objective markers of future motor outcomes. Aim To develop reliable kinematic markers of head control at 12 weeks corrected gestational age (CGA) from two motor tasks: head lifting in prone and pull-to-sit Study design and subjects Prospective observational study of 22 preterm infants born between 24 and 34 weeks of gestation Outcome measures Bayley Scales of Infant Development III (Bayley) motor scores Results Intrarater and interrater reliability of prone head lift angles and pull-to-sit head angles were excellent. Prone head lift angles at 12 weeks CGA correlated with white matter NAA/Cho, concurrent Test of Infant Motor Performance (TIMP) scores, and 12-month Bayley motor scores. Head angles during pull-to-sit at 12-weeks CGA correlated with TIMP scores. Conclusions Poor ability to lift the head in prone and an inability to align the head with the trunk during the pull-to-sit task were associated with poorer future motor outcome scores. Kinematic measurements of head control in early infancy may serve as reliable objective quantitative markers of future motor impairment and neurodevelopmental outcome. PMID:25621433

  9. A Comparison of 12 Weeks of Pilates and Aquatic Training on the Dynamic Balance of Women with Mulitple Sclerosis

    PubMed Central

    Marandi, Sayyed Mohammad; Nejad, Vahid Shayegan; Shanazari, Zohreh; Zolaktaf, Vahid

    2013-01-01

    Background: Multiple Sclerosis (MS) is a disabling chronic disease of the nervous system in which the myelin system of the central nervous system is deteriorated. The objective of this study is to understand the effect of Pilates exercises and aquatic training for a 12 week period on the dynamic balance of MS patients. Methods: The research method is semi-experimental. As a result, among the female patients visiting the MS clinic of Kashani hospital in Esfahan, 57 patients with disease intensity levels between 0 and 4.5 were taken as samples. The average length of the disease was 8 ± 2 years, 20;40 years old, and they were randomly divided into three groups of Pilates exercise group, aquatic training group, and the control group. The exercise schedule for the experiment groups consisted of 12 weeks, three sessions per week, and 1 hour for each session. The dynamic balance of the patients, before and after the exercises was measured by Six Spot Step Test. Results: The adjusted mean differences of Timed Up and Go Test (TUGT) scores of the experimental groups are significantly different (P<0.05). Therefore, it can be said that Pilates exercise interventions and aquatic training can significantly increase the dynamic balance of the examinees in the post-experiment stage. Conclusions: Performing the Pilate exercises and aquatic training increases dynamic balance of the MS patients. Considering the role of dynamic balance on physical fitness and enabling the person in doing is daily chores and routines, and its direct effect on the quality of life, it leads the specialists in applying these exercises as a supplementary treatment along with the medicinal treatments for MS patients. PMID:23717760

  10. The impact of a 12-week resistance training program on strength, body composition, and self-concept of Hispanic adolescents.

    PubMed

    Velez, Amelia; Golem, Devon L; Arent, Shawn M

    2010-04-01

    Current evidence suggests that a resistance training program may be physically and psychologically beneficial for adolescents. The purpose of this study was to examine the effects of a structured resistance training program on strength, body composition, and self-concept in normal and overweight Hispanic adolescents. Male and female participants (n = 28; 16.1 +/- 0.2 y; 164.5 +/- 1.4 cm; 63.3 +/- 2.5 kg; 20.0 +/- 1.7% body fat [BF]) were recruited from a predominantly Hispanic high school. Prior to the 12-week program, strength, body composition, and self-concept were assessed. Subjects were randomly assigned to a control group (CON; n = 15) or to a resistance training group (RT; n = 13) that participated in supervised strength training 3 days/week. All measures were repeated at the end of the 12-week program. RT had significantly greater strength increases for bench press (p < 0.001), seated row (p = 0.002), shoulder press (p < 0.001), and squats (p = 0.002). RT had significant reductions in %BF (p = 0.001), whereas CON had slightly increased %BF. RT had an increase in condition/stamina competence (p = 0.008), attractive body adequacy (p = 0.017), and global self-worth (p = 0.013) from pretest to posttest, whereas no change was observed for CON. In conclusion, resistance training resulted in significant physiological and psychological improvements in Hispanic adolescents compared to typical school-based activities. These findings indicate that resistance training can be incorporated into the activities of Hispanic adolescents to promote improved health and fitness. PMID:20375719

  11. Initial response as a predictor of 12-week buprenorphine-naloxone treatment response in a prescription opioid dependent population

    PubMed Central

    McDermott, Katherine A.; Griffin, Margaret L.; Connery, Hilary S.; Hilario, E. Yvette; Fiellin, David A.; Fitzmaurice, Garrett M.; Weiss, Roger D.

    2015-01-01

    Objective Initial medication response has been shown to predict treatment outcome across a variety of substance use disorders, but no studies have examined the predictive power of initial response to buprenorphine-naloxone in the treatment of prescription opioid dependence. We therefore conducted a secondary analysis of data from the Prescription Opioid Addiction Treatment Study to determine whether initial response to buprenorphine-naloxone predicted 12-week treatment outcome in a prescription opioid-dependent population. Method Using data from a multi-site, randomized controlled trial of buprenorphine-naloxone plus counseling for DSM-IV prescription opioid dependence (June 2006–July 2009), we conducted a secondary analysis to investigate the relationship between initial medication response and 12-week treatment outcome to establish how soon the efficacy of buprenorphine-naloxone could be predicted. Outcomes were determined from the Substance Use Report, a self-report measure of substance use, and confirmatory urinalysis. Predictive values were calculated to determine the importance of abstinence vs. use at various time points within the first month of treatment (week 1, weeks 1–2, 1–3, or 1–4) in predicting successful vs. unsuccessful treatment outcome (based on abstinence or near-abstinence from opioids) in the last 4 weeks of buprenorphine-naloxone treatment (weeks 9–12). Results Outcome was best predicted by medication response after two weeks of treatment. Two weeks of initial abstinence was moderately predictive of treatment success (positive predictive value = 71%), while opioid use in both of the first two weeks was strongly predictive of unsuccessful treatment outcome (negative predictive value (NPV) = 84%), especially when successful outcome was defined as total abstinence from opioids in weeks 9–12 (NPV = 94%). Conclusion Evaluating prescription opioid-dependent patients after two weeks of buprenorphine-naloxone treatment may help determine

  12. Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study

    PubMed Central

    Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

    2015-01-01

    Background Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. Objective The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. Methods A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Results Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow

  13. Cognitive and mood effects in healthy children during 12 weeks' supplementation with multi-vitamin/minerals.

    PubMed

    Haskell, Crystal F; Scholey, Andrew B; Jackson, Philippa A; Elliott, Jade M; Defeyter, Margaret A; Greer, Joanna; Robertson, Bernadette C; Buchanan, Tom; Tiplady, Brian; Kennedy, David O

    2008-11-01

    Adequate levels of vitamins and minerals are essential for optimal neural functioning. A high proportion of individuals, including children, suffer from deficiencies in one or more vitamins or minerals. This study investigated whether daily supplementation with vitamins/minerals could modulate cognitive performance and mood in healthy children. In this randomised, double-blind, placebo-controlled, parallel groups investigation, eighty-one healthy children aged from 8 to 14 years underwent laboratory assessments of their cognitive performance and mood pre-dose and at 1 and 3 h post-dose on the first and last days of 12 weeks' supplementation with a commercially available vitamins/mineral product (Pharmaton Kiddi). Interim assessments were also completed at home after 4 and 8 weeks at 3 h post-dose. Each assessment comprised completion of a cognitive battery, delivered over the Internet, which included tasks assessing mood and the speed and accuracy of attention and aspects of memory (secondary, semantic and spatial working memory). The vitamin/mineral group performed more accurately on two attention tasks: 'Arrows' choice reaction time task at 4 and 8 weeks; 'Arrow Flankers' choice reaction time task at 4, 8 and 12 weeks. A single task outcome (Picture Recognition errors) evinced significant decrements at 12 weeks. Mood was not modulated in any interpretable manner. Whilst it is possible that the significant improvements following treatment were due to non-significant numerical differences in performance at baseline, these results would seem to suggest that vitamin/mineral supplementation has the potential to improve brain function in healthy children. This proposition requires further investigation. PMID:18507881

  14. Introduction of misoprostol for the treatment of incomplete abortion beyond 12 weeks of pregnancy in Benin.

    PubMed

    Adisso, Sosthène; Hounkpatin, Benjamin I B; Komongui, Gounnou D; Sambieni, Olivier; Perrin, René X

    2014-07-01

    Improving the care of women who have undergone a spontaneous or induced abortion is an important step in reducing abortion-related morbidity and mortality. Both the International Federation of Gynecology and Obstetrics (FIGO) and the World Health Organization recommend the use of manual vacuum aspiration (MVA) and misoprostol rather than sharp curettage to treat incomplete abortion. MVA was introduced into the public healthcare service in Benin in 2006 and since 2008 misoprostol has been available in 3 large maternity hospitals. The present study opted to use an oral dose of 800 μg and not to limit to pregnancies of up to 12 weeks, but to include women with second trimester abortions. After 5 years, results show that around three-quarters of the women treated with misoprostol at 13-18 weeks of pregnancy required MVA to complete uterine evacuation and approximately one-quarter had severe bleeding, confirming that the indication of misoprostol for incomplete abortion should be limited to pregnancies of up to 12 weeks. PMID:24800660

  15. A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Vilazodone in Generalized Social Anxiety Disorder

    PubMed Central

    Careri, Jason M.; Draine, Ann E.; Hanover, Rita; Liebowitz, Michael R.

    2015-01-01

    Objective: To examine the efficacy, safety, and tolerability of vilazodone for subjects (aged 18–75 years) with generalized social anxiety disorder. Method: Forty-four subjects with generalized social anxiety disorder (DSM-IV-TR criteria) were randomized to vilazodone or placebo in a 12-week double-blind, flexible-dose trial. Change from baseline to endpoint on the Liebowitz Social Anxiety Scale (LSAS) was the primary outcome measure. Secondary outcome measures included response and remission rates and changes in depression and anxiety. Data were collected between November 2012 and April 2014. The study was conducted at a private clinical trials facility in New York, New York. Results: The mean baseline LSAS score was 91.9 (SD = 17.5) and the mean Clinical Global Impressions–Severity scale score was 5.3 (SD = 0.56), indicating marked to severe illness. There were no significant baseline differences in severity of social anxiety between the treatment groups. At the end of treatment, in the intent-to-treat sample (n = 39), the vilazodone group had improved significantly more than the placebo group by 14.3 points on the LSAS (t = 1.80, P = .04, one-tail test) (Cohen d = 0.58). Conclusions: The findings suggest that vilazodone may be a promising treatment for social anxiety disorder. Further study is needed given the limited sample size. Trial Registration: ClinicalTrials.gov identifier: NCT01712321 PMID:27057414

  16. Variable effects of 12 weeks of omega-3 supplementation on resting skeletal muscle metabolism.

    PubMed

    Gerling, Christopher J; Whitfield, Jamie; Mukai, Kazutaka; Spriet, Lawrence L

    2014-09-01

    Omega-3 supplementation has been purported to improve the function of several organs in the body, including reports of increased resting metabolic rate (RMR) and reliance on fat oxidation. However, the potential for omega-3s to modulate human skeletal muscle metabolism has received little attention. This study examined the effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation on whole-body RMR and the content of proteins involved in fat metabolism in human skeletal muscle. Recreationally active males supplemented with 3.0 g/day of EPA and DHA (n = 21) or olive oil (n = 9) for 12 weeks. Resting muscle biopsies were sampled in a subset of 10 subjects before (pre) and after (post) omega-3 supplementation. RMR significantly increased (5.3%, p = 0.040) following omega-3 supplementation (Pre, 1.33 ±0.05; Post, 1.40 ±0.04 kcal/min) with variable individual responses. When normalizing for body mass, this effect was lost (5.2%, p = 0.058). Omega-3s did not affect whole-body fat oxidation, and olive oil did not alter any parameter assessed. Omega-3 supplementation did not affect whole muscle, sarcolemmal, or mitochondrial FAT/CD36, FABPpm, FATP1 or FATP4 contents or mitochondrial electron chain and PDH proteins, but did increase the long form of UCP3 by 11%. In conclusion, supplementation with a high dose of omega-3s for 12 weeks increased RMR in a small and variable manner in a group of healthy young men. Omega-3 supplementation also had no effect on several proteins involved in skeletal muscle fat metabolism and did not cause mitochondrial biogenesis. PMID:25054452

  17. Do 12-Week Yoga Program Influence Respiratory Function of Elderly Women?

    PubMed Central

    Bezerra, Lídia Aguiar; de Melo, Helton Fabrício; Garay, Ana Paula; Reis, Victor Machado; Aidar, Felipe José; Bodas, Ana Rita; Garrido, Nuno Domingos; de Oliveira, Ricardo Jacó

    2014-01-01

    Aging produces several respiratory limitations and reduces tolerance to physical efforts, sometimes leading to pulmonary diseases in the elderly. The literature draws attention to the possible benefits of Yoga practice among the elderly, presenting evidence for significant improvements in quality of life. It was hypothesized that yoga practice can improve respiratory function in the elderly. The effects of a yoga program on pulmonary volumes and respiratory muscle strength were verified in 36 elderly women divided into a yoga group [YG] (63.1 ± 13.3 years of age) and a control group (61.0 ± 6.9 years of age). Maximal inspiratory and expiratory pressure (MIP and MEP) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were measured by a ventilometer. The program comprised 65 min sessions, 3 times/week during 12 weeks. The heart rate and respiratory rate decreased significantly in the YG (76-39 ± 8-03 vs. 74-61±10.26 bpm and 18.61 ± 3.15 vs. 16.72 ± 3.12 resp/min, respectively). In the YG, VT and VE increased significantly (0.55 ± 0.22 vs. 0.64 ± 0.2 ml and 9.19 ± 2.39 vs. 10.05 ± 2.11 ml, respectively), as well as VC (1.48 ± 0.45 vs. 2.03 ± 0.72 ml). Improvements were also found in MIP and MEP in the YG (62.17 ± 14.77 vs. 73.06 ± 20.16 cmH2O and 80.56 ± 23.94 vs. 86.39 ± 20.16 cmH2O, respectively). It was concluded that a 12-week yoga program significantly improves pulmonary function of aged women. PMID:25713658

  18. Do soccer and Zumba exercise improve fitness and indicators of health among female hospital employees? A 12-week RCT.

    PubMed

    Barene, S; Krustrup, P; Jackman, S R; Brekke, O L; Holtermann, A

    2014-12-01

    This randomized controlled study investigated the effectiveness of soccer and Zumba on fitness and health indicators in female participants recruited from a workplace. One hundred seven hospital employees were cluster-randomized to either a soccer group (SG), Zumba group (ZG), or control group (CG). Intervention effects for the two training groups were compared with CG. The training was conducted outside working hours as 2-3 1-h sessions per week for 12 weeks. Peak oxygen uptake (VO2peak ), fat percentage, fat mass, bone mineral content, and plasma osteocalcin were measured before and after the intervention period. Based on intention-to-treat-analyses, SG significantly improved the VO2peak relative to body mass (5%; P = 0.02) and decreased heart rate during 100-W cycle exercise (-7 bpm; P = 0.01), total body fat percentage (-1.1%; P = 0.002), and total body fat mass (-1.0 kg; P = 0.001) compared with CG. ZG significantly improved the VO2peak relative to body mass (5%; P = 0.03) and decreased total fat mass (-0.6 kg; P < 0.05) compared with CG. Plasma osteocalcin increased in SG (21%; P < 0.001) and ZG (10%; P = 0.01) compared with CG. The present study indicates that workplace initiated short-term soccer training as well as Zumba outside working hours may result in fitness and modest health benefits among female hospital employees. PMID:24151956

  19. Effects of a 12-week resistance exercise program on physical self-perceptions in college students.

    PubMed

    Moore, Justin B; Mitchell, Nathanael G; Bibeau, Wendy S; Bartholomew, John B

    2011-06-01

    There is an increase in literature suggesting exercise can promote positive changes in physical self-perceptions that can manifest as an increase in global self-esteem. In the present study, we assessed self-esteem using the hierarchical framework of the Exercise and Self-Esteem Model (EXSEM) along with cognitive facets at the subdomain level (e.g., competence, certainty, importance, and ideal self-discrepancy). This allowed for an analysis of cognitive facets as possible contributors to changes in physical self-perceptions. We addressed these aims with a sample of 120 college-age adults who completed a 12-week resistance exercise program. Results indicated significant improvements in self-perception constructs at all levels of the EXSEM. The hierarchical structure of the EXSEM was partially supported, as we observed successively smaller improvements at each level of the model (e.g., self-esteem showed lesser improvements than physical self-worth). In addition, a path model developed to explain the impact of strength changes on self-esteem proved a good fit for the data. Results are discussed in terms of contemporary models of self-perception, potential mediators of exercise on self-esteem, and the need to consider cognitive facets of self-perception. PMID:21699109

  20. Metabolomics unveils urinary changes in subjects with metabolic syndrome following 12-week nut consumption.

    PubMed

    Tulipani, Sara; Llorach, Rafael; Jáuregui, Olga; López-Uriarte, Patricia; Garcia-Aloy, Mar; Bullo, Mònica; Salas-Salvadó, Jordi; Andrés-Lacueva, Cristina

    2011-11-01

    Through an HPLC-Q-TOF-MS-driven nontargeted metabolomics approach, we aimed to discriminate changes in the urinary metabolome of subjects with metabolic syndrome (MetS), following 12 weeks of mixed nuts consumption (30 g/day), compared to sex- and age-matched individuals given a control diet. The urinary metabolome corresponding to the nut-enriched diet clearly clustered in a distinct group, and the multivariate data analysis discriminated relevant mass features in this separation. Metabolites corresponding to the discriminating ions (MS features) were then subjected to multiple tandem mass spectrometry experiments using LC-ITD-FT-MS, to confirm their putative identification. The metabolomics approach revealed 20 potential markers of nut intake, including fatty acid conjugated metabolites, phase II and microbial-derived phenolic metabolites, and serotonin metabolites. An increased excretion of serotonin metabolites was associated for the first time with nut consumption. Additionally, the detection of urinary markers of gut microbial and phase II metabolism of nut polyphenols confirmed the understanding of their bioavailability and bioactivity as a priority area of research in the determination of the health effects derived from nut consumption. The results confirmed how a nontargeted metabolomics strategy may help to access unexplored metabolic pathways impacted by diet, thereby raising prospects for new intervention targets. PMID:21905751

  1. Sustained improvements in fitness and exercise tolerance in obese adolescents after a 12 week exercise intervention.

    PubMed

    Gow, Megan L; van Doorn, Nancy; Broderick, Carolyn R; Hardy, Louise L; Ho, Mandy; Baur, Louise A; Cowell, Chris T; Garnett, Sarah P

    2016-01-01

    A 12 week exercise program was evaluated for its effect on aerobic fitness, anaerobic threshold, physical activity and sedentary behavior levels in obese insulin resistant adolescents post intervention and at follow up. 111 obese insulin resistant 10-17 year olds were recruited to a 12 month lifestyle intervention, known as RESIST. From months 4 to 6, adolescents participated in supervised exercise sessions twice per week (45-60min/session). Aerobic fitness and anaerobic threshold were measured by gas analysis at baseline, 6 months (post intervention) and 12 months (follow up). Self-reported physical activity and sedentary behavior was measured using the CLASS questionnaire. At 6 months aerobic fitness and time to reach the anaerobic threshold had improved by 5.8% [95% CI: 0.8-11.3] and 19.7% [95% CI: 10.4-29.0], respectively compared with baseline. These improvements were maintained at 12 months. Compared to baseline, 6 month physical activity levels increased by 19min/day [95% CI: 5-33] and screen time decreased by 49min/day [95% CI: 23-74] but returned to baseline levels by 12 months. Improved fitness and anaerobic threshold can be sustained up to 6 months following completion of an exercise program possibly enhancing capacity to perform daily functional tasks. PMID:25959765

  2. Effects of a 12 Week SAQ Training Programme on Agility with and without the Ball among Young Soccer Players.

    PubMed

    Milanović, Zoran; Sporiš, Goran; Trajković, Nebojša; James, Nic; Samija, Krešimir

    2013-01-01

    The purpose of this study was to determine the effects of a 12 week conditioning programme involving speed, agility and quickness (SAQ) training and its effect on agility performance in young soccer players. Soccer players were randomly assigned to two groups: experimental group (EG; n = 66, body mass: 71.3 ± 5.9 kg; body height: 1.77 ± 0.07 m) and control group (CG; n = 66, body mass: 70.6 ± 4.9 kg; body height: 1.76 ± 0.06 m). Agility performance was assessed using field tests: Slalom; Slalom with ball; Sprint with 90° turns; Sprint with 90° turns with ball; Sprint with 180° turns; Sprint with backward and forward running; Sprint 4 x 5 m. Statistically significant improvements (p < 0.05) between pre and post training were evident for almost all measures of agility, with and without the ball, with the exception being the Sprint with backward and forward running. This suggests that SAQ training is an effective way of improving agility, with and without the ball, for young soccer players and can be included in physical conditioning programmes. Key pointsSAQ training appears to be an effective way of improving agility with and without the ball in young soccer playersSoccer coaches could use this training during pre-season and in-season trainingCompared with pre-training, there was a statistically significant improvement in all but one measure of agility, both with and without the ball after SAQ training. PMID:24149731

  3. Predictors of adherence to a 12-week exercise program among men treated for prostate cancer: ENGAGE study.

    PubMed

    Craike, Melinda; Gaskin, Cadeyrn J; Courneya, Kerry S; Fraser, Steve F; Salmon, Jo; Owen, Patrick J; Broadbent, Suzanne; Livingston, Patricia M

    2016-05-01

    Understanding the factors that influence adherence to exercise programs is necessary to develop effective interventions for people with cancer. We examined the predictors of adherence to a supervised exercise program for participants in the ENGAGE study - a cluster randomized controlled trial that assessed the efficacy of a clinician-referred 12-week exercise program among men treated for prostate cancer. Demographic, clinical, behavioral, and psychosocial data from 52 participants in the intervention group were collected at baseline through self-report and medical records. Adherence to the supervised exercise program was assessed through objective attendance records. Adherence to the supervised exercise program was 80.3%. In the univariate analyses, cancer-specific quality of life subscales (role functioning r = 0.37, P = 0.01; sexual activity r = 0.26, P = 0.06; fatigue r = -0.26, P = 0.06, and hormonal symptoms r = -0.31, P = 0.03) and education (d = -0.60, P = 0.011) were associated with adherence. In the subsequent multivariate analysis, role functioning (B = 0.309, P = 0.019) and hormonal symptoms (B = -0.483, P = 0.054) independently predicted adherence. Men who experienced more severe hormonal symptoms had lower levels of adherence to the exercise program. Those who experienced more positive perceptions of their ability to perform daily tasks and leisure activities had higher levels of adherence to the exercise program. Hormonal symptoms and role functioning need to be considered when conducting exercise programs for men who have been treated for prostate cancer. PMID:26872005

  4. Effects of a 12 Week SAQ Training Programme on Agility with and without the Ball among Young Soccer Players

    PubMed Central

    Milanović, Zoran; Sporiš, Goran; Trajković, Nebojša; James, Nic; Šamija, Krešimir

    2013-01-01

    The purpose of this study was to determine the effects of a 12 week conditioning programme involving speed, agility and quickness (SAQ) training and its effect on agility performance in young soccer players. Soccer players were randomly assigned to two groups: experimental group (EG; n = 66, body mass: 71.3 ± 5.9 kg; body height: 1.77 ± 0.07 m) and control group (CG; n = 66, body mass: 70.6 ± 4.9 kg; body height: 1.76 ± 0.06 m). Agility performance was assessed using field tests: Slalom; Slalom with ball; Sprint with 90° turns; Sprint with 90° turns with ball; Sprint with 180° turns; Sprint with backward and forward running; Sprint 4 x 5 m. Statistically significant improvements (p < 0.05) between pre and post training were evident for almost all measures of agility, with and without the ball, with the exception being the Sprint with backward and forward running. This suggests that SAQ training is an effective way of improving agility, with and without the ball, for young soccer players and can be included in physical conditioning programmes. Key points SAQ training appears to be an effective way of improving agility with and without the ball in young soccer players Soccer coaches could use this training during pre-season and in-season training Compared with pre-training, there was a statistically significant improvement in all but one measure of agility, both with and without the ball after SAQ training PMID:24149731

  5. A randomised placebo controlled 12 week trial of budesonide and prednisolone in rheumatoid arthritis

    PubMed Central

    Kirwan, J; Hallgren, R; Mielants, H; Wollheim, F; Bjorck, E; Persson, T; Book, C; Bowman, S; Byron, M; Cox, N; Field, M; Kanerud, L; Leirisalo-Repo, M; Malaise, M; Mohammad, A; Palmer, R; Petersson, I; Ringertz, B; Sheldon, P; Simonsson, M; Snowden, N; Van den Bosch, F

    2004-01-01

    Objectives: To compare budesonide, a locally acting glucocorticoid with minimal systemic exposure, with conventional glucocorticoid treatment and placebo in rheumatoid arthritis. Methods: A double blind, randomised, controlled trial over 12 weeks in 143 patients with active rheumatoid arthritis, comparing budesonide 3 mg daily, budesonide 9 mg daily, prednisolone 7.5 mg daily, and placebo. Particular attention was paid to the pattern of clinical response and to changes in the four week period following discontinuation of treatment. Results: There were improvements in tender joint count and swollen joint count on budesonide 9 mg compared with placebo (28% for tender and 34% for swollen joint counts, p<0.05). Prednisolone 7.5 mg gave similar results, while budesonide 3 mg was less effective. ACR20 response criteria were met by 25% of patients on placebo, 22% on budesonide 3 mg, 42% on budesonide 9 mg, and 56% on prednisolone 7.5 mg. A rapid and significant reduction in symptoms and signs in response to budesonide 9 mg and prednisolone 7.5 mg was evident by two weeks and maximal at eight weeks. There was no evidence that budesonide provided a different pattern of symptom control from prednisolone, or that symptoms became worse than placebo treatment levels after discontinuation of glucocorticoid treatment. Adverse effects attributable to glucocorticoids were equally common in all groups. Conclusions: The symptomatic benefits of budesonide 9 mg and prednisolone 7.5 mg are achieved within a short time of initiating treatment, are maintained for three months, and are not associated with any rebound in symptoms after stopping treatment. PMID:15140776

  6. The effect of 12 weeks Prop Pilates Exercise Program (PPEP) on body stability and pain for fruit farmers with MSDs.

    PubMed

    Kim, Hye-Jin; Nam, Sang-Nam; Bae, Ung Ryel; Hwang, Ryong; Lee, Jong-Bok; Kim, Jong-Hyuck

    2014-01-01

    The purpose of this study was to determine possible effects of 12-week Prop Pilates Exercise Program (PPEP) for the fruit farmers (grape, tomato, apple) with musculoskeletal disorders (MSD) on body stability and pain. 131 fruit farmers with MSD were selected and asked to join a 12-week Prop Pilates Exercise Program (PPEP) from 2009 to 2012. The subjects (female=74, male=57) aged 50 to 65 years old voluntarily participated. As a result, it was found that lateral-medial and anterior-posterior of body stability significantly improved in male and female fruit farmers. It was found that pain index (VAS) after 12-week Prop Pilates Exercise Program (PPEP) showed a significant decrease. PMID:24704650

  7. An analysis of the "Effect of Olibra: a 12-week randomized control trial and a review of earlier studies".

    PubMed

    Heer, Martina

    2012-05-01

    Nutrients affect hunger and satiety. However, food structure, in particular that of emulsions, may also affect the body's satiety mechanisms. Olibra™ is a fat emulsion, a mixture of fractionated palm oil and fractionated oat oil manufactured by Lipid Technologies Provider AB, Sweden, which affects hunger sensation. However, up to now, no data have shown convincingly that reduced appetite or hunger sensations induced by Olibra lead, in the long run, to a significant and clinically relevant reduction in body mass. To clearly demonstrate a cause-and-effect relationship of Olibra to weight loss, it seems that longer studies with strict control of energy intake and nutrient composition, as well as control of energy expenditure by exercise, are needed. PMID:22768903

  8. A Mixed Methods Evaluation of a 12-Week Insurance-Sponsored Weight Management Program Incorporating Cognitive-Behavioral Counseling

    ERIC Educational Resources Information Center

    Abildso, Christiaan; Zizzi, Sam; Gilleland, Diana; Thomas, James; Bonner, Daniel

    2010-01-01

    Physical activity is critical in healthy weight loss, yet there is still much to be learned about psychosocial mechanisms of physical activity behavior change in weight loss. A sequential mixed methods approach was used to assess the physical and psychosocial impact of a 12-week cognitive-behavioral weight management program and explore factors…

  9. Fasting plasma glucose 6–12 weeks after starting insulin glargine predicts likelihood of treatment success: a pooled analysis

    PubMed Central

    Karl, D; Zhou, R; Vlajnic, A; Riddle, M

    2012-01-01

    Aims To evaluate whether fasting plasma glucose values measured early during insulin therapy can identify patients with Type 2 diabetes who may not achieve adequate glycaemic control after 6 months and will require additional treatment. Methods Patient-level data from seven prospective, randomized, controlled studies using treat-to-target methods were pooled to evaluate the efficacy of insulin glargine. Fasting plasma glucose was measured at baseline, week 6 or 8 (6/8) and week 12. HbA1c was measured at week 24 to assess glycaemic control. Results One thousand and thirty-six patients (56% male, 81% white) were included in the analysis (mean age 56.3 years; duration of diabetes 8.4 years). Baseline mean fasting plasma glucose was 11.2 mmol/l and mean HbA1c was 73 mmol/mol (8.8%). After 24 weeks of treatment, mean HbA1c decreased to 53 mmol/mol (7.0%); 56% of patients reached a target HbA1c≤ 53 mmol/mol (7.0%). Significant correlations with week 24 HbA1c were obtained for fasting plasma glucose measured at week 6/8 and week 12 (r = 0.32; P < 0.0001 for both). Patients with fasting plasma glucose > 10 mmol/l at week 6/8 or week 12 were significantly less likely to achieve the HbA1c target at the end of treatment than patients with fasting plasma glucose < 8.9 mmol/l (P < 0.0001 for both). If fasting plasma glucose was > 10 mmol/l at week 6/8 or week 12, patients had only a 27% chance of reaching the HbA1c goal. Conclusions Fasting plasma glucose remaining > 10 mmol/l after 6–12 weeks of glargine therapy indicates that reaching target HbA1c≤ 53 mmol/mol (7.0%) is unlikely and calls for individualized attention to consider further therapeutic options. PMID:22413808

  10. Multi-component access to a community-based weight loss program: 12 week results

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The current study examined weight loss between a comprehensive lifestyle modification program (Weight Watchers PointsPlus program) that included three ways to access and a self-help (SH) condition. A total of 293 participants were randomized to either a Weight Watchers condition (WW) (n=148) or a SH...

  11. Right Breast Mastectomy and Reconstruction with Tissue Expander under Thoracic Paravertebral Blocks in a 12-Week Parturient

    PubMed Central

    Webb, Christopher Allen-John; Weyker, Paul David; Cohn, Shara; Wheeler, Amanda; Lee, Jennifer

    2015-01-01

    Paravertebral blocks are becoming increasingly utilized for breast surgery with studies showing improved postoperative pain control, decreased need for opioids, and less nausea and vomiting. We describe the anesthetic management of an otherwise healthy woman who was 12 weeks pregnant presenting for treatment of her breast cancer. For patients undergoing breast mastectomy and reconstruction with tissue expanders, paravertebral blocks offer an anesthetic alternative when general anesthesia is not desired. PMID:26229692

  12. Quality assurance in non-interventional studies.

    PubMed

    Theobald, Karlheinz; Capan, Müge; Herbold, Marlis; Schinzel, Stefan; Hundt, Ferdinand

    2009-01-01

    Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP) were published by the U.S. Food and Drug Administration (FDA) and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM) together with the Paul Ehrlich Institute (PEI) and the German Association of Research-Based Pharmaceutical Companies (VFA) have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF) and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV) should be performed in randomly selected centres - in between 2% and 5% of the centres depending on the number of participating centres. Before start of

  13. Effect of a 12-week complex training on the body composition and cardiorespiratory system of female college students

    PubMed Central

    Kim, Seungsuk; Han, Gunsoo

    2016-01-01

    [Purpose] The aim of this study was to examine the effects of a complex exercise program on the body composition and cardiorespiratory system of female college students. [Subjects and Methods] This study included 20 female college students who had not participated in any particular sports in the last 3 months. The complex exercise program consisted of two parts, aerobic exercise and weight training. First, aerobic exercise was implemented (30 min 5 times a week for 12 weeks) according to the participants’ exercise tolerance. Second, weight training was implemented (40 min 5 times a week for 12 weeks) with 60% of 1 repetition maximum (RM). [Results] The t-test results showed significant differences in body composition between the before and after the complex exercise program. The subjects’ body weights and body fat percentages were decreased, and their skeletal muscle masses were increased. Increased levels of maximal oxygen uptake (VO2max), maximal expiratory volume (VEmax), and maximal heart rate (HRmax) were also observed. [Conclusion] In conclusion, the 12-week complex exercise program, including aerobic and weight training, had positive effects on the body composition and cardiorespiratory system of the female college students.

  14. Clinical Application of Revised Laboratory Classification Criteria for Antiphospholipid Antibody Syndrome: Is the Follow-Up Interval of 12 Weeks Instead of 6 Weeks Significantly Useful?

    PubMed Central

    Park, Sang Hyuk; Park, Chan-Jeoung; Chi, Hyun-Sook

    2016-01-01

    Background. According to revised classification criteria of true antiphospholipid antibody syndrome, at least one of three antiphospholipid antibodies should be present on two or more occasions at least 12 weeks apart. However, it can be inconvenient to perform follow-up tests with interval of 12 weeks. We investigated clinical application of follow-up tests with interval of 12 weeks. Method. Totals of 67, 199, and 332 patients tested positive initially for the lupus anticoagulants confirm, the anti-β2 glycoprotein-I antibody, and the anti-cardiolipin antibody test, respectively, from Jan 2007 to Jul 2009. We investigated clinical symptoms of patients, follow-up interval, and results of each test. Results. Among patients with initial test positive, 1.5%–8.5% were subjected to follow-up tests at interval of more than 12 weeks. Among 25 patients with negative conversion in tests, patients with interval of more than 12 weeks showed clinical symptom positivity of 33.3%, which was higher than that of 12.5% with 6–12 weeks. Among 34 patients with persistent test positive, clinical symptoms positivity trended to be more evident in patients at interval of 6–12 weeks (47.4% versus 26.7%, P = 0.191) than more than 12 weeks. Conclusion. Less than 10% of patients with initial test positive had follow-up tests at interval of more than 12 weeks and the patients with persistent test positive at interval of more than 12 weeks showed trends toward having lower clinical symptoms than 6–12 weeks. More research is needed focused on the evidence that follow-up test at interval of more than 12 weeks should be performed instead of 6 weeks. PMID:27610369

  15. Clinical Application of Revised Laboratory Classification Criteria for Antiphospholipid Antibody Syndrome: Is the Follow-Up Interval of 12 Weeks Instead of 6 Weeks Significantly Useful?

    PubMed

    Park, Sang Hyuk; Jang, Seongsoo; Park, Chan-Jeoung; Chi, Hyun-Sook

    2016-01-01

    Background. According to revised classification criteria of true antiphospholipid antibody syndrome, at least one of three antiphospholipid antibodies should be present on two or more occasions at least 12 weeks apart. However, it can be inconvenient to perform follow-up tests with interval of 12 weeks. We investigated clinical application of follow-up tests with interval of 12 weeks. Method. Totals of 67, 199, and 332 patients tested positive initially for the lupus anticoagulants confirm, the anti-β 2 glycoprotein-I antibody, and the anti-cardiolipin antibody test, respectively, from Jan 2007 to Jul 2009. We investigated clinical symptoms of patients, follow-up interval, and results of each test. Results. Among patients with initial test positive, 1.5%-8.5% were subjected to follow-up tests at interval of more than 12 weeks. Among 25 patients with negative conversion in tests, patients with interval of more than 12 weeks showed clinical symptom positivity of 33.3%, which was higher than that of 12.5% with 6-12 weeks. Among 34 patients with persistent test positive, clinical symptoms positivity trended to be more evident in patients at interval of 6-12 weeks (47.4% versus 26.7%, P = 0.191) than more than 12 weeks. Conclusion. Less than 10% of patients with initial test positive had follow-up tests at interval of more than 12 weeks and the patients with persistent test positive at interval of more than 12 weeks showed trends toward having lower clinical symptoms than 6-12 weeks. More research is needed focused on the evidence that follow-up test at interval of more than 12 weeks should be performed instead of 6 weeks. PMID:27610369

  16. Mirabegron 50 mg once-daily for the treatment of symptoms of overactive bladder: an overview of efficacy and tolerability over 12 weeks and 1 year.

    PubMed

    Chapple, Christopher R; Kaplan, Steven A; Mitcheson, David; Blauwet, Mary Beth; Huang, Moses; Siddiqui, Emad; Khullar, Vik

    2014-10-01

    The aim of the present review article was to summarize the efficacy and tolerability for mirabegron 50 mg over 12 weeks and 1 year versus placebo (SCORPIO) or tolterodine ER 4 mg (SCORPIO and TAURUS). After a 2-week placebo run-in, adults with overactive bladder symptoms for ≥3 months were randomized if, during a 3-day micturition diary period before baseline, they had an average of ≥8 micturitions/24 h and ≥3 urgency episodes. Efficacy end-points were change from baseline to each study visit and final visit in incontinence, micturitions, volume voided/micturition, urgency incontinence, urgency (grades 3 or 4), level of urgency and nocturia. Additional secondary efficacy variables included patient-reported outcomes. Safety variables included changes in treatment-emergent adverse events and vital signs. For SCORPIO, statistically significant improvements from baseline in efficacy variables and patient-reported outcomes were seen with mirabegron versus placebo from week 4, and were maintained over time. For TAURUS, numerical improvements in efficacy were evident from month 1, and were maintained throughout 12 months. Treatment-emergent adverse events incidence was similar between groups, except for dry mouth, which was reported by fourfold (SCORPIO) and threefold (TAURUS) more patients taking tolterodine than mirabegron. Mirabegron 50 mg for 12 weeks was associated with statistically significant improvements in objective measures of efficacy and patient-reported outcomes. At final visit, improvements with mirabegron 50 mg were statistically greater versus placebo. The efficacy profile of mirabegron 50 mg appears to be maintained over 12 months. PMID:25092441

  17. Clinical Response within 12 Weeks as a Predictor of Future Low Disease Activity in Early RA Patients: Results from the TEAR Trial

    PubMed Central

    Curtis, Jeffrey R; McVie, Theresa; Mikuls, Ted R; Reynolds, Richard J.; Navarro-Millán, Iris; O’Dell, James; Moreland, Larry W; Bridges, S. Louis; Ranganath, Veena K.; Cofield, Stacey S

    2013-01-01

    Background Rapidly predicting future outcomes based upon short-term clinical response would be helpful to optimize RA management in early disease. Objective To derive and validate a clinical prediction rule to predict low disease activity (LDA) at 1 year among patients participating in the Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) trial escalating RA therapy by adding either etanercept (E) or sulfasalazine + hydroxychloroquine [triple therapy (TT)] after 6 months of methotrexate (MTX) therapy. Methods Eligible subjects included in the derivation cohort (used for model building, n=186) were participants with moderate or higher disease activity (DAS28ESR>3.2) despite 24 weeks of MTX monotherapy who added either etanercept or sulfasalazine+hydroxychloroquine. Clinical characteristics measured within the next 12 weeks were used to predict LDA 1 year later using multivariable logistic regression. Validation was performed in the cohort of TEAR patients randomized to initially receive either MTX+E or TT. Results The derivation cohort yielded three prediction models of varying complexity that included age, DAS28 at various time points, body mass index, and ESR (AUROC up to 0.83). Accuracy of the prediction models ranged between 80 and 95% in both derivation and validation cohorts, depending on the complexity of the model and the cutpoints chosen for response and non-response. Approximately 80% of patients could be predicted to be responders or non-responders at week 12. Conclusion Clinical data collected early after starting or escalating DMARD/biologic treatment could accurately predict LDA at 1 year in early RA patients. For patients predicted to be non-responders, treatment could be changed at 12 weeks to optimize outcomes. PMID:23588939

  18. Adding Memantine to Rivastigmine Therapy in Patients With Mild-to-Moderate Alzheimer's Disease: Results of a 12-Week, Open-Label Pilot Study

    PubMed Central

    Riepe, Matthias W.; Adler, Georg; Ibach, Bernd; Weinkauf, Birgit; Gunay, Ibrahim; Tracik, Ferenc

    2006-01-01

    Objective: At present, inhibition of cholines-terase is the treatment of choice for subjects with mild-to-moderate Alzheimer's disease (AD). Memantine, a noncompetitive antagonist at N-methyl-d-aspartate receptors, is currently used to treat subjects with moderate-to-severe AD. The goal of this multicenter, open-label pilot study was to investigate whether combination therapy with memantine added to rivastigmine is safe and beneficial in subjects with mild-to-moderate AD. Method: Patients with a DSM-IV diagnosis of dementia of the Alzheimer's type (N = 95), who were treated with rivastigmine (6–12 mg/day) for a maximum duration of 24 weeks prior to baseline, received memantine (5–20 mg/day) in combination with rivastigmine for 12 weeks. The primary efficacy variable was the change in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score at the end of 12 weeks compared with baseline. The study was conducted between September 15, 2003, and May 27, 2004. Results: There was a statistically significant difference between baseline and week 12 for the ADAS-cog total score, showing a positive effect of combination therapy. Combination therapy did not evidence any unexpected safety concerns and was well-tolerated by most patients. Conclusion: Memantine in combination with rivastigmine appears to be safe and beneficial in patients with mild-to-moderate AD. Our results need to be confirmed in a large, long-term, randomized, double-blind, placebo-controlled clinical trial. PMID:17235381

  19. The Effect of a 12-Week Omega-3 Supplementation on Body Composition, Muscle Strength and Physical Performance in Elderly Individuals with Decreased Muscle Mass.

    PubMed

    Krzymińska-Siemaszko, Roma; Czepulis, Natasza; Lewandowicz, Marta; Zasadzka, Ewa; Suwalska, Aleksandra; Witowski, Janusz; Wieczorowska-Tobis, Katarzyna

    2015-09-01

    The aim of the study was to assess the effect of a polyunsaturated omega-3 fatty acids (PUFA) supplementation on the parameters of body composition, muscle strength and physical performance in elderly people with decreased muscle mass (DMM). Fifty three elderly people with an ALM index (the ratio of appendicular lean mass to squared height) either below (-2SD: low muscle mass-LMM) or between (-1SD and -2SD: the risk of LMM-rLMM) the ALM index for the young Polish reference population were randomly assigned to PUFA-treated groups (LMM-PUFA, rLMM-PUFA) or control groups (LMM-control, rLMM-control). PUFA-treated groups received capsules containing 1.3 g of PUFA and 10 mg of vitamin E, while the control groups received 11 mg of vitamin E daily for 12 weeks. Body composition (BIA analysis), muscle strength (hand grip measured with dynamometer) and physical performance (Timed Up and Go test-TUG) were assessed before and after supplementation. No statistically significant differences were observed either in muscle mass or in the hand grip and TUG in any group. The post-pre difference (mean ± SD) in ALM index was as follows (kg/m²): LMM-PUFA: 0.00 ± 0.30, rLMM-PUFA: 0.00 ± 0.22, LMM-control: 0.03 ± 0.36, rLMM-control: -0.03 ± 0.20. In our study, a 12 week supplementation of PUFA did not affect the evaluated parameters in elderly individuals with DMM. PMID:26343698

  20. Consumption of cranberry polyphenols enhances human γδ-T cell proliferation and reduces the number of symptoms associated with colds and influenza: a randomized, placebo-controlled intervention study

    PubMed Central

    2013-01-01

    Background Our main objective was to evaluate the ability of cranberry phytochemicals to modify immunity, specifically γδ-T cell proliferation, after daily consumption of a cranberry beverage, and its effect on health outcomes related to cold and influenza symptoms. Methods The study was a randomized, double-blind, placebo-controlled, parallel intervention. Subjects drank a low calorie cranberry beverage (450 ml) made with a juice-derived, powdered cranberry fraction (n = 22) or a placebo beverage (n = 23), daily, for 10 wk. PBMC were cultured for six days with autologous serum and PHA-L stimulation. Cold and influenza symptoms were self-reported. Results The proliferation index of γδ-T cells in culture was almost five times higher after 10 wk of cranberry beverage consumption (p <0.001). In the cranberry beverage group, the incidence of illness was not reduced, however significantly fewer symptoms of illness were reported (p = 0.031). Conclusions Consumption of the cranberry beverage modified the ex vivo proliferation of γδ-T cells. As these cells are located in the epithelium and serve as a first line of defense, improving their function may be related to reducing the number of symptoms associated with a cold and flu. Trial registration ClinicalTrials.gov Identifier: NCT01398150. PMID:24330619

  1. Effects of supplementing n-3 fatty acid enriched eggs and walnuts on cardiovascular disease risk markers in healthy free-living lacto-ovo-vegetarians: a randomized, crossover, free-living intervention study

    PubMed Central

    2014-01-01

    Background Plant and marine n-3 fatty acids (FA) may favorably modify select markers of cardiovascular disease risk. Whether supplementing the habitual diet of lacto-ovo-vegetarians (LOV) with walnuts (containing α-linolenic acid, ALA) and n-3 FA enriched eggs (containing primarily docosahexaenoic acid, DHA and ALA) would have equivalent effects on CVD risk factors is explored in this study. Methods In this study, 20 healthy free-living LOVs following their habitual diet were randomly assigned in a crossover design to receive one of three supplements: n-3 FA enriched egg (6/week), walnuts (28.4 g, 6/week) or a standard egg, 6/week (control) for 8 weeks each with 4-wk washout between treatments. Erythrocyte membrane fatty acids, serum lipids and inflammatory markers were measured at the end of each treatment. Results Dietary compliance was observed by an expected increase in erythrocyte membrane ALA following the walnut treatment and in DHA following the n-3 FA enriched egg treatment. Walnut treatment lowered serum triacylglycerol, total cholesterol and Apo B (p < 0.05) compared to the standard egg but not the n-3 FA enriched egg treatment. However, walnut treatment significantly reduced total: HDL cholesterol ratio compared to both egg treatments. There were no differences between treatments for any of the inflammatory markers. Conclusions For LOV, a direct source of DHA such as n-3 FA enriched eggs seems necessary to increase membrane levels of DHA. However for producing an overall favorable blood lipid profile, daily consumption of a handful of walnuts rich in ALA may be a preferred option for lacto-ovo vegetarian. PMID:24673793

  2. The relation between anthropometric and physiological variables and bat velocity of high-school baseball players before and after 12 weeks of training.

    PubMed

    Szymanski, David J; Szymanski, Jessica M; Schade, Ryan L; Bradford, T Jason; McIntyre, Joseph S; DeRenne, Coop; Madsen, Nels H

    2010-11-01

    The purpose of this article was to investigate the relation between anthropometric and physiological variables to linear bat swing velocity (BV) of 2 groups of high-school baseball players before and after completing a 12-week periodized resistance exercise program. Participants were randomly assigned to 1 of 2 training groups using a stratified sampling technique. Group 1 (n = 24) and group 2 (n = 25) both performed a stepwise periodized resistance exercise program and took 100 swings a day, 3 d·wk-1, for 12 weeks with their normal game bat. Group 2 performed additional rotational and full-body medicine ball exercises 3 d·wk-1 for 12 weeks. Fourteen variables were measured or calculated before and after 12 weeks of training. Anthropometric and physiological variables tested were height, body mass, percent body fat, lean body mass (LBM), dominant torso rotational strength (DTRS) and nondominant torso rotational strength (NDTRS), sequential hip-torso-arm rotational strength measured by a medicine ball hitter's throw (MBHT), estimated 1 repetition maximum parallel squat (PS) and bench press (BP), vertical jump (VJ), estimated peak power, angular hip velocity (AHV), and angular shoulder velocity (ASV). The baseball-specific skill of linear BV was also measured. Statistical analysis indicated a significant moderately high positive relationship (p ≤ 0.05) between prelinear BV and pre-NDTRS for group 1, pre-LBM, DTRS, NDTRS, peak power, and ASV for group 2; moderate positive relationship between prelinear BV and preheight, LBM, DTRS, peak power, BP, PS, and ASV for group 1, preheight, body mass, MBHT, BP, and PS for group 2. Significantly high positive relationships were indicated between postlinear BV and post-NDTRS for group 1, post-DTRS and NDTRS for group 2; moderately high positive relationships between postlinear BV and post-LBM, DTRS, peak power, BP, and PS for group 1, postheight, LBM, VJ, peak power for group 2; moderate positive relationships between

  3. Does school-based physical activity decrease overweight and obesity in children aged 6–9 years? A two-year non-randomized longitudinal intervention study in the Czech Republic

    PubMed Central

    2012-01-01

    Background Globally, efforts aimed at the prevention of childhood obesity have led to the implementation of a range of school-based interventions. This study assessed whether augmenting physical activity (PA) within the school setting resulted in increased daily PA and decreased overweight/obesity levels in 6-9-year-old children. Methods Across the first to third primary school years, PA of 84 girls and 92 boys was objectively monitored five times (each for seven successive days) using Yamax pedometer (step counts) and Caltrac accelerometer (activity energy expenditure AEE - kcal/kg per day). Four schools were selected to participate in the research (2 intervention, 2 controls), comprising intervention (43 girls, 45 boys) and control children (41 girls, 47 boys). The study was non-randomized and the intervention schools were selected on the basis of existing PA-conducive environment. Analyses of variance (ANOVA) for repeated measures examined the PA programme and gender effects on the step counts and AEE. Logistic regression (Enter method) determined the obesity and overweight occurrence prospect over the course of implementation of the PA intervention. Results There was a significant increase of school-based PA during schooldays in intervention children (from ≈ 1718 to ≈ 3247 steps per day; and from 2.1 to ≈ 3.6 Kcal/Kg per day) in comparison with the control children. Increased school-based PA of intervention children during schooldays contributed to them achieving >10,500 steps and >10.5 Kcal/Kg per school day across the 2 years of the study, and resulted in a stop of the decline in PA levels that is known to be associated with the increasing age of children. Increased school-based PA had also positive impact on leisure time PA of schooldays and on PA at weekends of intervention children. One year after the start of the PA intervention, the odds of being overweight or obese in the intervention children was almost three times lower than that of

  4. A Double-Blind, 12-Week Study to Evaluate the Antiaging Efficacy of a Cream Containing the NFκB Inhibitor 4-Hexyl-1, 3-Phenylenediol and Ascorbic Acid-2 Glucoside in Adult Females.

    PubMed

    Roure, Romain; Nollent, Virginie; Dayan, Liliane; Camel, Etienne; Bertin, Christiane

    2016-06-01

    The 5 main physical manifestations of aged skin are wrinkles, uneven tone, brown spots, loss of elasticity, and dryness. One mechanism resulting in these physical manifestations is increased activity of the nuclear factor kappa B (NFκB) protein. This 12-week, double-blind, placebo-controlled, randomized split-face study compared the antiaging effect and safety of a face cream containing 4-Hexyl-1, 3-phenylenediol, an NFκB inhibitor, and ascorbic acid-2 glucoside versus placebo in adult females aged 45-70 years old. Subjects (n=42) applied active treatment or placebo to the same half face twice daily at home for 12 weeks. Clinical evaluation was carried out by a dermatologist. Subjects carried out similar self-grading assessments. Colorimetric measurements analyzed skin color, and biomechanical skin properties were evaluated. Clinical grading showed that most wrinkle parameters were significantly improved after 8 weeks of active treatment compared with baseline and placebo (P≤.05), with improvements maintained after 12 weeks. Only Marionette wrinkles did not show a significant improvement. Brown spots (color intensity/number), overall photodamage, and most complexion parameters improved significantly after 8 and 12 weeks compared with baseline and placebo (P≤.05). Self-grading yielded similar results compared with baseline. Self-grading did not demonstrate improvements with active treatment versus placebo, except for skin firmness at 8 and 12 weeks (P≤.05). A significant difference was seen with active treatment compared with placebo in all colorimetric parameters (L*, b*, and ITA°) after 8 weeks, and in spot coloration (b*) after 12 weeks (P<.05). Improvements in skin elasticity were not significantly different between treatments. Overall tolerability of active treatment was judged as good. In conclusion, a cream containing 4-Hexyl-1, 3-phenylenediol and ascorbic acid-2 glucoside improves the clinical appearance of aged

  5. Changes in selected cardiorespiratory responses to exercise and in body composition following a 12-week aerobic dance programme.

    PubMed

    Williams, L D; Morton, A R

    1986-01-01

    Cardiorespiratory and body composition changes were evaluated in 25 sedentary females, aged 18 to 30 years, following 12 weeks of aerobic dance training (3 days a week, 45 min a session). Fifteen subjects, from the same population, comprised a control group: they maintained their normal activity and dietary habits over the course of the study. Analysis of variance of the values for selected cardiorespiratory responses revealed that the aerobic dance programme produced training effects in the experimental group. These training effects were indicated by significant improvements in O2 pulse, VE, heart rate and perceived exertion during submaximal exercise. Significant improvements were also noted in VO2 max, maximal O2 pulse, VE max, maximal heart rate and maximal running time on the treadmill. Additionally, increases in lean body mass and body density, together with decreases in percentage body fat and the sum of four skinfold thicknesses were found to be significant for the experimental group. No significant improvements in any of these variables were found for the control group. It was concluded that this 12-week aerobic dance programme was successful in promoting beneficial changes in cardiorespiratory fitness and body composition. PMID:3586112

  6. Turkish 12 Week Course.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This audiolingual beginner's course has been prepared for the Defense Language Institute intensive program in modern spoken Turkish. The course, consisting of six volumes of basic text in 55 units begins with an introductory section which presents the linguistic background, phonology, and distinguishing features of Turkish. The lesson format…

  7. Outcomes of a Mobile Health Coaching Platform: 12-Week Results of a Single-Arm Longitudinal Study

    PubMed Central

    Walsh, James K

    2016-01-01

    Background The number of mobile health coaching applications is expanding at a rapid rate. An application that uses a guiding intelligence to deliver an individualized structured program has the potential to provide a significant benefit. However, there are few studies of this approach that examine multiple clinical outcomes in a longitudinal manner. Objective The objective of the study was to conduct a 12-week evaluation of participants using the YouPlus Health mobile coaching platform, specifically examining the effects on body weight, waist measurement, blood pressure, lipid profile, glycohemoglobin (A1C), and maximum volume of oxygen consumption (VO2 max). Methods A quasi-experimental research design was used. This included a single-arm pre and post intervention assessment of outcomes. Participants underwent a 12-week intervention in which they received the entirety of the mobile health coaching program via an application on their mobile phones and were evaluated in the same physician’s office setting every two weeks. Data regarding app usage was continuously collected and maintained in a database. Results 10 subjects were enrolled in and completed the pilot study. The mean weight loss was 13.5 lbs. which represented 7.3% of baseline (P=.005). Mean waist circumference was reduced by 7.2 cm or 6.6% of baseline (P=.005). Both systolic (SBP) and diastolic (DBP) blood pressure measures were significantly lower after 12 weeks of intervention. Mean SBP fell 18.6 mmHg (P=.005) and mean DBP declined 6.4 mmHg (P=.005). VO2 max increased by an average of 3.13 ml/kg/min from baseline to study end (P=.005). From baseline to end-of-study HDL levels increased significantly by 4.0 mg/dL (P=.04) Total cholesterol, LDL, triglycerides, and glycohemoglobin (A1C) trended in the desired direction but did not meet statistical significance. All of the participants in the study completed the necessary in-app tutorials and also completed the in-app questions and received feedback

  8. Lung function profiles and aerobic capacity of adult cigarette and hookah smokers after 12 weeks intermittent training

    PubMed Central

    Koubaa, Abdessalem; Triki, Moez; Trabelsi, Hajer; Masmoudi, Liwa; Zeghal, Khaled N.; Sahnoun, Zouhair; Hakim, Ahmed

    2015-01-01

    Introduction Pulmonary function is compromised in most smokers. Yet it is unknown whether exercise training improves pulmonary function and aerobic capacity in cigarette and hookah smokers and whether these smokers respond in a similar way as do non-smokers. Aim To evaluate the effects of an interval exercise training program on pulmonary function and aerobic capacity in cigarette and hookah smokers. Methods Twelve cigarette smokers, 10 hookah smokers, and 11 non-smokers participated in our exercise program. All subjects performed 30 min of interval exercise (2 min of work followed by 1 min of rest) three times a week for 12 weeks at an intensity estimated at 70% of the subject's maximum aerobic capacity (V.O2max). Pulmonary function was measured using spirometry, and maximum aerobic capacity was assessed by maximal exercise testing on a treadmill before the beginning and at the end of the exercise training program. Results As expected, prior to the exercise intervention, the cigarette and hookah smokers had significantly lower pulmonary function than the non-smokers. The 12-week exercise training program did not significantly affect lung function as assessed by spirometry in the non-smoker group. However, it significantly increased both forced expiratory volume in 1 second and peak expiratory flow (PEF) in the cigarette smoker group, and PEF in the hookah smoker group. Our training program had its most notable impact on the cardiopulmonary system of smokers. In the non-smoker and cigarette smoker groups, the training program significantly improved V.O2max (4.4 and 4.7%, respectively), v V.O2max (6.7 and 5.6%, respectively), and the recovery index (7.9 and 10.5%, respectively). Conclusions After 12 weeks of interval training program, the increase of V.O2max and the decrease of recovery index and resting heart rate in the smoking subjects indicated better exercise tolerance. Although the intermittent training program altered pulmonary function only partially, both

  9. The Outcomes of a 12-Week Internet Intervention Aimed at Improving Fitness and Health-Related Quality of Life in Overweight Adolescents: The Young & Active Controlled Trial

    PubMed Central

    Riiser, Kirsti; Løndal, Knut; Ommundsen, Yngvar; Småstuen, Milada Cvancarova; Misvær, Nina; Helseth, Sølvi

    2014-01-01

    Background Overweight and obesity among adolescents may have consequences, with potentially lasting effects on health and health-related quality of life (HRQoL). Excess weight is also associated with decreases in physical activity and cardiorespiratory fitness. The aim of the current study was to investigate the short-term effects of a 12-week Internet intervention in a primary care setting intended to increase cardiorespiratory fitness and HRQoL among overweight and obese adolescents. Methods In this controlled trial, participants (13–15 years) were non-randomly allocated to an intervention- or a control group. The intervention group received 12-weeks access to an online program providing tailored physical activity counseling based on principles from Self-determination Theory and Motivational Interviewing. The control group received standard follow-up by the school nurses. The primary outcome measure of cardiorespiratory fitness was determined using a shuttle run test. The secondary outcomes: HRQoL, leisure time exercise, body image and self-determined motivation for physical activity and exercise, were assessed by self-report measures. Age- and gender-adjusted body mass index (BMI) was calculated based on measurements of height and weight. To compare pre-to post intervention differences within groups, a paired samples t-test was used while crude differences between groups were analyzed with an independent samples t-test. Results Of the 120 participants, 108 completed the study, 75 in the intervention group and 33 in the control group. Exposure to the intervention had a small effect on cardiorespiratory fitness (0.14; 95% CI [0.01;0.28]; P = 0.04), and a moderate effect on HRQoL (5.22; 95% CI [0.90; 9.53]; P = 0.02). Moreover, the control group increased significantly in BMI, yielding a moderate preventive effect on BMI (−0.39; 95% CI [−0.74;−0.03]; P = 0.03) for the intervention group. Conclusion The results suggest that the Internet

  10. Malignant uveal schwannoma with peripheral nerve extension in a 12-week-old color-dilute Labrador Retriever.

    PubMed

    Duke, F D; Teixeira, L B C; Galle, L E; Green, N; Dubielzig, R R

    2015-01-01

    The formalin-fixed, amber-colored right globe from a 12-week-old female silver Labrador Retriever dog was submitted to the Comparative Ocular Pathology Laboratory of Wisconsin for light microscopic evaluation. The clinical history described a collapsed anterior chamber and multifocal nodular lesions in the peripheral iris. Histologically, immunohistochemically, and ultrastructurally, the uveal mass was consistent with a malignant schwannoma; there was extension along peripheral nerves within the sclera. The signalment and behavior of the neoplasm distinguish it from the uveal schwannoma of blue-eyed dogs and bear some resemblance to the ocular lesions in human neurofibromatosis. The dilute color mutation may contribute to the cause. Six weeks later, the dog did not develop any additional masses. PMID:24513800

  11. Changes of Heart Rate Variability during Methylphenidate Treatment in Attention-Deficit Hyperactivity Disorder Children: A 12-Week Prospective Study

    PubMed Central

    Kim, Hayeon Jennifer; Yang, Jaewon

    2015-01-01

    Purpose The aim of this study was to clarify the relationship between the autonomic nervous system and attention deficit hyperactivity disorder (ADHD) rating scales and to evaluate the usefulness of heart rate variability (HRV) as a psychophysiological biomarker for ADHD. Materials and Methods Subjects were recruited from outpatients in the Department of Child and Adolescent Psychiatry at the Korea University Medical Center from August 2007 to December 2010. Subjects received methylphenidate. Time- and frequency-domain analyses of HRV, the Korean ADHD rating scale (K-ARS), and computerized ADHD diagnostic system were evaluated before treatment. After a 12-week period of medication administration, we repeated the HRV measurements and K-ARS rating. Results Eighty-six subjects were initially enrolled and 37 participants completed the 12-week treatment and HRV measurements subsequent to the treatment. Significant correlations were found between the K-ARS inattention score and some HRV parameters. All of the HRV parameters, except the standard deviations of the normal-to-normal interval, very low frequency, and low frequency to high frequency, showed a significant positive correlation between baseline and endpoint measures in completers. High frequency (HF) and the square root of the mean squared differences of successive normal-to-normal intervals (RMSSD), which are related to parasympathetic vagal tone, showed significant decreases from baseline to endpoint. Conclusion The HRV test was shown to be reproducible. The decrease in HF and RMSSD suggests that parasympathetic dominance in ADHD can be altered by methylphenidate treatment. It also shows the possibility that HRV parameters can be used as psychophysiological markers in the treatment of ADHD. PMID:26256981

  12. Effects of 12-week supervised treadmill training on spatio-temporal gait parameters in patients with claudication.

    PubMed

    Konik, Anita; Kuklewicz, Stanisław; Rosłoniec, Ewelina; Zając, Marcin; Spannbauer, Anna; Nowobilski, Roman; Mika, Piotr

    2016-06-01

    The purpose of the study was to evaluate selected temporal and spatial gait parameters in patients with intermittent claudication after completion of 12-week supervised treadmill walking training. The study included 36 patients (26 males and 10 females) aged: mean 64 (SD 7.7) with intermittent claudication. All patients were tested on treadmill (Gait Trainer, Biodex). Before the programme and after its completion, the following gait biomechanical parameters were tested: step length (cm), step cycle (cycle/s), leg support time (%), coefficient of step variation (%) as well as pain-free walking time (PFWT) and maximal walking time (MWT) were measured. Training was conducted in accordance with the current TASC II guidelines. After 12 weeks of training, patients showed significant change in gait biomechanics consisting in decreased frequency of step cycle (p < 0.05) and extended step length (p < 0.05). PFWT increased by 96% (p < 0.05). MWT increased by 100% (p < 0.05). After completing the training, patients' gait was more regular, which was expressed via statistically significant decrease of coefficient of variation (p < 0.05) for both legs. No statistically significant relation between the post-training improvement of PFWT and MWT and step length increase and decreased frequency of step cycle was observed (p > 0.05). Implications for Rehabilitation Twelve-week treadmill walking training programme may lead to significant improvement of temporal and spatial gait parameters in patients with intermittent claudication. Twelve-week treadmill walking training programme may lead to significant improvement of pain-free walking time and maximum walking time in patients with intermittent claudication. PMID:26314413

  13. Child Support Grant access and receipt among 12-week-old infants in an urban township setting in South Africa

    PubMed Central

    Zembe-Mkabile, Wanga; Doherty, Tanya; Sanders, David; Jackson, Debra

    2014-01-01

    Background Cash transfers (CTs) are increasingly used as a strategy to alleviate poverty and improve child health outcomes in low- and middle-income countries. The Child Support Grant (CSG) is the largest CT programme in South Africa, and on the continent, targeting poor children from birth until the age of 18 with a monthly sum of R300 (USD30). Evidence on the CSG shows that early receipt of the grant is associated with improved child health outcomes. Since its implementation, one of the major concerns about the grant has been take-up rates, particularly for younger children. This paper reports results on take-up rates for 12-week-old infants residing in an urban township in South Africa. Methods This is a descriptive study utilising data from a community-based, cluster-randomised trial which evaluated a programme providing pregnancy and post-natal home visits by community health workers to 3,494 mothers in Umlazi township, South Africa. Results At the 12-week visit, half (52%) of the mothers who had enrolled in the study had applied for the CSG on behalf of their children, while 85% of the mothers who had not applied were still planning to apply. Only 38% (1,327) of all children had received the CSG. Conclusions In this study, many mothers had not applied for the CSG in the first few months after delivery, and only a third of children had accessed the grant. Further research is needed to understand what the current barriers are that prevent mothers from applying for this important form of social protection in the early months after delivery. PMID:25160516

  14. 12-Week, Placebo-Controlled Trial of Add-on Riluzole in the Treatment of Childhood-Onset Obsessive–Compulsive Disorder

    PubMed Central

    Grant, Paul J; Joseph, Lisa A; Farmer, Cristan A; Luckenbaugh, David A; Lougee, Lorraine C; Zarate, Carlos A; Swedo, Susan E

    2014-01-01

    Many children with childhood-onset obsessive–compulsive disorder (OCD) fail to respond adequately to standard therapies. Evidence from preclinical and clinical studies suggests that the glutamatergic neurotransmitter system might be an alternative treatment target. This study examined the efficacy of riluzole, a glutamatergic modulator, as an adjunctive therapy for children with treatment-resistant OCD. In a 12-week, double-blind, placebo-controlled study, 60 treatment-resistant children and adolescents (mean age=14.5±2.4 years), with moderate to severe OCD (mean Children's Yale-Brown Obsessive–Compulsive Scale (CY-BOCS)=28.2±3.7), 17 of whom also had concomitant autism spectrum disorder, were randomized to receive riluzole (final dose of 100 mg/day) or placebo in addition to the existing treatment regimen. Fifty-nine subjects completed the randomized trial. Primary outcome measures were changes on the CY-BOCS, the Clinical Global Impressions Scale, and the Children's Global Assessment Scale. Riluzole was fairly well tolerated, although it was associated with one case of pancreatitis and five instances of slight increases in transaminases. All subjects showed significant reductions in CY-BOCS scores during treatment; however, there was no significant difference between placebo and riluzole on any of the primary or secondary outcome measures. The study failed to demonstrate superiority of riluzole over placebo as an adjunctive treatment for children with childhood-onset OCD. However, future studies may show benefits for less treatment-refractory children with fewer concomitant medications. PMID:24356715

  15. Cutoff Designs for Community-Based Intervention Studies

    PubMed Central

    Pennell, Michael L.; Hade, Erinn M.; Murray, David M.; Rhoda, Dale A.

    2011-01-01

    Summary Public health interventions are often designed to target communities defined either geographically (e.g., cities, counties) or socially (e.g., schools or workplaces). The group randomized trial (GRT) is regarded as the gold standard for evaluating these interventions. However, community leaders may object to randomization as some groups may be denied a potentially beneficial intervention. Under a regression discontinuity design (RDD), individuals may be assigned to treatment based on the levels of a pretest measure, thereby allowing those most in need of the treatment to receive it. In this article, we consider analysis, power, and sample size issues in applying the RDD and related cutoff designs in community-based intervention studies. We examine the power of these designs as a function of intraclass correlation, number of groups, and number of members per group and compare results to the traditional GRT. PMID:21500240

  16. Effects of 12 weeks of aerobic training on autonomic modulation, mucociliary clearance, and aerobic parameters in patients with COPD

    PubMed Central

    Leite, Marceli Rocha; Ramos, Ercy Mara Cipulo; Kalva-Filho, Carlos Augusto; Freire, Ana Paula Coelho Figueira; de Alencar Silva, Bruna Spolador; Nicolino, Juliana; de Toledo-Arruda, Alessandra Choqueta; Papoti, Marcelo; Vanderlei, Luiz Carlos Marques; Ramos, Dionei

    2015-01-01

    Introduction Patients with chronic obstructive pulmonary disease (COPD) exhibit aerobic function, autonomic nervous system, and mucociliary clearance alterations. These parameters can be attenuated by aerobic training, which can be applied with continuous or interval efforts. However, the possible effects of aerobic training, using progressively both continuous and interval sessions (ie, linear periodization), require further investigation. Aim To analyze the effects of 12-week aerobic training using continuous and interval sessions on autonomic modulation, mucociliary clearance, and aerobic function in patients with COPD. Methods Sixteen patients with COPD were divided into an aerobic (continuous and interval) training group (AT) (n=10) and a control group (CG) (n=6). An incremental test (initial speed of 2.0 km·h−1, constant slope of 3%, and increments of 0.5 km·h−1 every 2 minutes) was performed. The training group underwent training for 4 weeks at 60% of the peak velocity reached in the incremental test (vVO2peak) (50 minutes of continuous effort), followed by 4 weeks of sessions at 75% of vVO2peak (30 minutes of continuous effort), and 4 weeks of interval training (5×3-minute effort at vVO2peak, separated by 1 minute of passive recovery). Intensities were adjusted through an incremental test performed at the end of each period. Results The AT presented an increase in the high frequency index (ms2) (P=0.04), peak oxygen uptake (VO2peak) (P=0.01), vVO2peak (P=0.04), and anaerobic threshold (P=0.02). No significant changes were observed in the CG (P>0.21) group. Neither of the groups presented changes in mucociliary clearance after 12 weeks (AT: P=0.94 and CG: P=0.69). Conclusion Twelve weeks of aerobic training (continuous and interval sessions) positively influenced the autonomic modulation and aerobic parameters in patients with COPD. However, mucociliary clearance was not affected by aerobic training. PMID:26648712

  17. Health markers in obese adolescents improved by a 12-week recreational soccer program: a randomised controlled trial.

    PubMed

    Vasconcellos, Fabrício; Seabra, Andre; Cunha, Felipe; Montenegro, Rafael; Penha, Jociene; Bouskela, Eliete; Nogueira Neto, José Firmino; Collett-Solberg, Paulo; Farinatti, Paulo

    2016-01-01

    The effects of a recreational soccer program (RSP) upon body composition, heart rate variability (HRV), biochemical markers, cardio-respiratory fitness, and endothelial function in obese adolescents were investigated. A randomised controlled clinical trial was conducted with 30 adolescents aged 12-17 years and body mass index (BMI) >2 standard deviations of WHO reference values, which were assigned to RSP (n = 10, 2 girls) and obese control (n = 10, 4 girls) groups. The 12-week RSP included 60-min sessions performed 3 times/week. BMI, waist circumference, blood pressure, blood glucose, lipid profile, insulin, C-reactive protein, HRV, and maximal oxygen consumption (VO2peak) were evaluated following standardised procedures. Body composition was determined by dual-energy X-ray absorptiometry and endothelial function by venous occlusion plethysmography. After intervention, RSP exhibited significant reductions in BMI (-0.7 ± 0.2 kg · m(-2)), waist circumference (-8.2 ± 1.4 cm), %body fat (-2.2 ± 0.4%), systolic blood pressure (-5.0 ± 2.3 mmHg), total cholesterol (-16.2 ± 5.8 mg · dL(-1)), triglycerides (-20.5 ± 12.9 mg · dL(-1)), C-reactive protein (-0.06 ± 0.01 mg · dL(-1)), insulin resistance (HOMA-IR, -1.4 ± 0.6), and sympathetic activity (LF, -13.9 ± 6.6 un) vs. controls (P < 0.05). Significant increase was observed in parasympathetic activity (HF, 13.9 ± 6.6 un), VO2peak (7.9 ± 2.8 ml · kg(-1) · min(-1)), and high-density lipoprotein cholesterol (11.0 ± 6.3 mg · dL(-1)) (P < 0.05). Vascular conductance (19.5 ± 8.1 ml · min(-1) · 100 ml, P = 0.005) increased and vascular resistance (-5.9 ± 2.4 ml · min(-1) · 100 ml, P = 0.041) decreased in RSP, but not in controls. A 12-week recreational soccer intervention was effective to improve biochemical, cardiovascular, and fitness health markers in obese adolescents. PMID:26208409

  18. Changes in serum enterolactone, genistein, and daidzein in a dietary intervention study in Finland.

    PubMed

    Stumpf, K; Pietinen, P; Puska, P; Adlercreutz, H

    2000-12-01

    Phytoestrogens are plant-derived compounds that may have cancer-protective properties. The purpose of the study was to see how enterolactone, daidzein, and genistein serum concentrations reflect major changes in the diet of Finnish subjects. Phytoestrogen concentrations were measured by time-resolved fluoroimmunoassay after hydrolysis and extraction in samples from 85 middle-aged subjects who were part of a 12-week dietary intervention study carried out in North Karelia, Finland. In the baseline and the switchback periods, the subjects consumed their habitual Finnish diet, which is high in saturated fat and low in polyunsaturated fat and vegetables. During the 12-week intervention period, the proportion of dietary energy derived from fat was reduced from approximately 39% to 23%, and the consumption of vegetables, fruit, and berries was markedly increased. Enterolactone concentrations were measured during the baseline, intervention, and switchback periods. The median concentration of enterolactone rose from 12.2 to 19.5 nmol/l (P = 0.002) during the low-fat, high-vegetable diet. Daidzein and genistein concentrations were very low and did not change during the intervention. At baseline, 65% of the population had a low serum enterolactone concentration of <15 nmol/l. During the intervention period, this proportion fell to 34%. These major differences in serum enterolactone concentrations suggest that enterolactone may be used as a biomarker of a healthy diet containing plenty of vegetables, fruit, and berries. PMID:11142423

  19. Knee Extension Range of Motion at 4 Weeks Is Related to Knee Extension Loss at 12 Weeks After Anterior Cruciate Ligament Reconstruction

    PubMed Central

    Noll, Sarah; Garrison, J. Craig; Bothwell, James; Conway, John E.

    2015-01-01

    Background: The anterior cruciate ligament (ACL) is commonly torn, and surgical reconstruction is often required to allow a patient to return to their prior level of activity. Avoiding range of motion (ROM) loss is a common goal, but little research has been done to identify when ROM loss becomes detrimental to a patient’s future function. Purpose: To determine whether there is a relationship between early knee side-to-side extension difference after ACL reconstruction and knee side-to-side extension difference at 12 weeks. The hypothesis was that early (within the first 8 weeks) knee side-to-side extension difference will be predictive of knee side-to-side extension difference seen at 12 weeks. Study Design: Cohort study; Level of evidence, 3. Methods: Knee side-to-side extension difference measures were taken on 74 patients undergoing ACL reconstruction rehabilitation at the initial visit and 4, 8, and 12 weeks postoperatively. Visual analog scores (VAS) and International Knee Documentation Committee (IKDC) scores were also recorded at these time frames. Results: There was a strong relationship between knee extension ROM at 4 and 12 weeks (r = 0.639, P < .001) and 8 and 12 weeks (r = 0.742, P < .001). When the variables of knee extension ROM at initial visit and 4 and 8 weeks were entered into a regression analysis, the predictor variable explained 61% (R2 = 0.611) of variance for knee extension ROM at 12 weeks, with 4 weeks (R2 = 0.259) explaining the majority of this variance. Conclusion: This study found that a patient’s knee extension at 4 weeks was strongly correlated with knee extension at 12 weeks. Clinical Relevance: This information may be useful for clinicians treating athletic patients who are anxious for return to sport by providing them an initial goal to work toward in hopes of ensuring successful rehabilitation of their knee. PMID:26675061

  20. Alcohol expectancy changes over a 12-week cognitive-behavioral therapy program are predictive of treatment success.

    PubMed

    Young, Ross McD; Connor, Jason P; Feeney, Gerald F X

    2011-01-01

    This study examines if outcome expectancies (perceived consequences of engaging in certain behavior) and self-efficacy expectancies (confidence in personal capacity to regulate behavior) contribute to treatment outcome for alcohol dependence. Few clinical studies have examined these constructs. The Drinking Expectancy Profile (DEP), a psychometric measure of alcohol expectancy and drinking refusal self-efficacy, was administered to 298 alcohol-dependent patients (207 males) at assessment and on completion of a 12-week cognitive-behavioral therapy alcohol abstinence program. Baseline measures of expectancy and self-efficacy were not strong predictors of outcome. However, for the 164 patients who completed treatment, all alcohol expectancy and self-efficacy factors of the DEP showed change over time. The DEP scores approximated community norms at the end of treatment. Discriminant analysis indicated that change in social pressure drinking refusal self-efficacy, sexual enhancement expectancies, and assertion expectancies successfully discriminated those who successfully completed treatment from those who did not. Future research should examine the basis of expectancies related to social functioning as a possible mechanism of treatment response and a means to enhance treatment outcome. PMID:20864294

  1. Treatment of feline lymphoma using a 12-week, maintenance-free combination chemotherapy protocol in 26 cats.

    PubMed

    Limmer, S; Eberle, N; Nerschbach, V; Nolte, I; Betz, D

    2016-08-01

    The aim of this prospective clinical trial was to investigate the efficacy and toxicity of a short-term, maintenance-free chemotherapy protocol in feline lymphoma. Twenty-six cats with confirmed diagnosis of high-/intermediate-grade lymphoma were treated with a 12-week protocol consisting of cyclic administration of l-asparaginase, vincristine, cyclophosphamide, doxorubicin and prednisolone. Complete (CR) and partial remission (PR) rates were 46 and 27%, respectively. Median duration of first CR was 394 days compared with a median PR duration of 41 days. No factor was identified to significantly influence the likelihood to reach CR. Overall survival amounted to 78 days (range: 9-2230 days). Median survival in CR cats was 454 days and in PR cats was 82 days. Toxicosis was mainly low grade with anorexia seen most frequently. In cats achieving CR, maintenance-free chemotherapy may be sufficient to attain long-term remission and survival. Factors aiding in prognosticating the likelihood for CR, strategies enhancing response and targeting chemotherapy-induced anorexia need to be identified in future. PMID:24548273

  2. Effect of 12 Weeks High Oleic Peanut Consumption on Cardio-Metabolic Risk Factors and Body Composition

    PubMed Central

    Barbour, Jayne A.; Howe, Peter R. C.; Buckley, Jonathan D.; Bryan, Janet; Coates, Alison M.

    2015-01-01

    Epidemiological evidence indicates an inverse association between nut consumption and obesity, inflammation, hyperlipidaemia and glucose intolerance. We investigated effects of high oleic peanut consumption vs. a nut free diet on adiposity and cardio-metabolic risk markers. In a randomised cross-over design, 61 healthy subjects (65 ± 7 years, body mass index (BMI) 31 ± 4 kg/m2) alternated either high oleic peanuts (15%–20% of energy) or a nut free diet for 12 weeks. Body composition and mass, waist circumference, C-reactive protein (CRP), lipids, glucose and insulin were assessed at baseline and after each phase. Repeated measures analysis of variance (ANOVA) compared the two diets. Consistent with other nut studies, there were no differences in lipids, CRP, glucose and insulin with peanut consumption. In contrast, some reports have demonstrated benefits, likely due to differences in the study cohort. Energy intake was 10% higher (853 kJ, p < 0.05), following peanut consumption vs. control, attributed to a 30% increase in fat intake (p < 0.001), predominantly monounsaturated (increase 22 g, p < 0.05). Despite greater energy intake during the peanut phase, there were no differences in body composition, and less than predicted increase (0.5 kg) in body weight for this additional energy intake, possibly due to incomplete nutrient absorption and energy utilisation. PMID:26404365

  3. Evaluating the effect of a haemoglobin spray on size reduction in chronic DFUs: clinical outcomes at 12 weeks.

    PubMed

    Dawn Hunt, Sharon; Haycocks, Samantha; McCardle, Joanne; Guttormsen, Karl

    2016-06-23

    A recent multi-centre observational evaluation investigated the effect of a topical haemoglobin spray (Granulox, Infirst), used as an adjunct to standard care, on wound size reduction in 17 patients (4 females/13 males) with 20 chronic diabetic foot ulcers (DFUs) over a 4-week period. In 14 of the 18 wounds that completed the evaluation (one patient dropped out due to an infection) there was a mean reduction of 53.8% (range: 11.9-100%). The product was acceptable to both patients and clinicians, who all found it easy to use. This article describes the outcomes for the remaining 13 patients (with 15 wounds) who continued using the spray after the 4-week evaluation ended. (Data are not available for two patients and the one patient who healed during the 4-week evaluation.) By 12 weeks, three wounds (20%) had healed, eight (53%) were progressing towards healing, three (20%) increased in size and one (7%) was slow healing. PMID:27345086

  4. Promoting healthful diets and exercise: efficacy of a 12-week after-school program in urban African Americans.

    PubMed

    Engels, Hermann-J; Gretebeck, Randall J; Gretebeck, Kimberlee A; Jiménez, Linda

    2005-03-01

    This study examined the effectiveness of a unique extracurricular after-school initiative designed to promote healthy diets and exercise in urban African Americans. The Students and Parents Actively Involved in Being Fit after-school program was offered for 12 weeks to students and their parents/guardians at an urban middle school. Specific aims of the intervention were to increase participants' vegetable and fruit intake by using established 5 A Day for Better Health educational resource materials/activities and to affect their health-related fitness through dance, games, and fitness activities. Fifty-six children and 25 parents/guardians completed a standard battery of evaluations before and after the program. Pre-post pairwise t test revealed that both children and their parents/guardians showed an increase in fruit consumption and a reduction in diastolic blood pressure (P <.05). Moreover, children showed improvements in systolic blood pressure and fruit juice, salad, and nonfried potato consumption while parents/guardians showed a decrease in body fat, body mass index, and endurance walk/run time (P <.05). Overall, findings indicate that children tended to gain more diet-related benefits while parents/guardians tended to derive more fitness-related benefits. After-school programs like the Students and Parents Actively Involved in Being Fit initiative can potentially contribute to improved health levels in urban African Americans. PMID:15746836

  5. 39-week toxicity and toxicokinetic study of ponezumab (PF-04360365) in cynomolgus monkeys with 12-week recovery period.

    PubMed

    Freeman, Gary B; Lin, John C; Pons, Jaume; Raha, Nancy M

    2012-01-01

    Ponezumab (PF-04360365) is a novel humanized IgG2Δa monoclonal antibody that binds to amyloid-β (Aβ). It is designed to have reduced immune effector function compared to other passive immunotherapies for Alzheimer's disease (AD). Toxicity was evaluated in cynomolgus monkeys treated intravenously with vehicle or 10, 30, or 100 mg/kg of ponezumab every 10th day for up to 39 weeks, and after a 12-week recovery phase. The Aβ peptide sequence of monkeys is identical to that of humans. No substantial difference in test article exposure between sexes was observed, and mean plasma Cmax and AUC0-n were approximately dose-proportional. Ponezumab was detectable approximately 9 weeks after cessation of dosing. All animals, except two males given 10 mg/kg, maintained exposure to test article. One of these males tested positive for anti-ponezumab antibodies. Ponezumab was detected in the cerebrospinal fluid (CSF) of animals given active treatment. The estimated CSF/plasma ponezumab concentration ratio was <0.008 after multiple doses. At the end of the dosing and recovery phases, plasma Aβ1-40 and Aβ1-x were increased in treated animals versus controls. No test article-related effects were seen after ophthalmogical, cardiovascular, physical examinations, and clinical and anatomic pathology evaluations. Plasma concentrations of ponezumab on day 261 at the no observed adverse effect level of 100 mg/kg were 22.4 and 5.3 times greater on a Cmax and AUC basis, respectively, than human exposures at the highest dose (10 mg/kg) in a single-dose Phase I trial. These data suggest an acceptable safety profile for ponezumab as an immunotherapy for AD. PMID:22045481

  6. Effect of 12 Weeks of Periodized Resistance Training Upon Total Plasma Adiponectin Concentration in Healthy Young Men.

    PubMed

    Davis, Greggory R; Stephens, Jacqueline M; Nelson, Arnold G

    2015-11-01

    The effects of resistance training on adiponectin have thus far yielded equivocal results. However, the effect of periodized resistance training on plasma adiponectin in offspring of type 2 diabetic and nondiabetic (ND) parents (first-degree family history) has yet to be determined. Untrained healthy young men with and without a first-degree family history of type 2 diabetes were assigned to an exercise intervention group (E) or an active control group (C). The E group performed a 12-week periodized resistance training program, whereas the C group did not participate in any structured exercise program. Fasting plasma samples were obtained pre- and posttraining. Total plasma adiponectin changed significantly in the E group (33.7 ± 14.7%, p = 0.025) but not in the C group (10.8 ± 19.2%). Offspring of type 2 diabetic parents subjects had significantly greater improvements in plasma adiponectin (69.3 ± 34.8%) compared with ND subjects (-3.2 ± 29.9%, p = 0.046). Regular aerobic exercise was significantly correlated with average plasma adiponectin (r = 0.32), whereas first-degree family history of type 2 diabetes (r = -0.58) and decreases in body fat percentage (r = -0.77) were inversely correlated with average plasma adiponectin. Periodized high-intensity resistance training seems to increase plasma adiponectin, particularly in individuals with a first-degree family history of type 2 diabetes or those who experience a significant loss of fat mass. The direct correlation between regular aerobic exercise and adiponectin further suggests that a combination of aerobic and resistance training yields greater improvements in plasma adiponectin compared with resistance training alone. PMID:26274372

  7. Combination therapy with nifedipine GITS 60 mg: subanalysis of a prospective, 12-week observational study (AdADOSE)

    PubMed Central

    Motaweih, Ahmed K.; Usova, Elena; Hussain, Wajid; Dello, Ziad; Petri, Thomas

    2016-01-01

    Abstract Background: AdADOSE was a 12-week, international, observational study conducted in the Middle East and Russia where patients received nifedipine gastrointestinal therapeutic system (GITS) at a daily dose of 30, 60, or 90 mg as part of an antihypertensive combination therapy. This subgroup analysis of the AdADOSE study assesses the efficacy and tolerability of nifedipine GITS combination therapy when used specifically at the 60-mg strength. Methods: Patients with hypertension who received a daily nifedipine GITS dose of 60 mg, either at constant dose (n = 686) or up-titrated from 30 mg (n = 392), were analyzed. Target blood pressure (BP) was <140/90 mmHg (or <130/80 mmHg for those at high/very high cardiovascular risk). Results: Following nifedipine GITS combination therapy, target BP was achieved by 33.7% patients in the 60 mg group (previously untreated, 42.5%; previously treated, 32.0%) and 32.4% patients in the 30–60 mg group (previously untreated, 45.2%; previously treated, 30.7%). Mean systolic BP/diastolic BP changes were −40.3/−20.7 mmHg and −35.6/−18.5 mmHg, respectively, and were similar regardless of previous antihypertensive treatment or the number of concomitant diseases. Incidences of drug-related adverse events (AEs) were low (3.2%, 60 mg; 2.0%, 30–60 mg group), few patients discontinued because of AEs (0.6% and 1.0%, respectively), and there were no serious AEs. Conclusion: Combination therapy with nifedipine GITS 60 mg in a real-life observational setting was effective and well tolerated in hypertensive patients, with low rates of treatment-related AEs. PMID:26331311

  8. Cloacal and surface temperatures of tom turkeys exposed to different rearing temperature regimes during the first 12 weeks of growth.

    PubMed

    Mayes, S L; Strawford, M L; Noble, S D; Classen, H L; Crowe, T G

    2015-06-01

    Years of genetic selection have caused an increase in growth rate and market body mass in agricultural poultry species compared to earlier genetic strains, potentially altering their physiological requirements. The objective of this study was to expose Hybrid Converter tom turkeys on a weekly basis to the recommended rearing temperature regime (TCON: control) or 4°C below the recommended standard (TTRT: treatment) to determine their thermal responses. Once per week for 12 weeks, 12 turkeys were individually exposed to either TCON or TTRT for a 2-h period. Surface temperatures of the breast (TBREAST), wing (TWING), drumstick (TDRUM), head (THEAD), and shank (TSHANK) were measured at 20-min intervals using an infrared camera, while a thermal data logger measured the skin surface temperature under the wing (TLOGGER) at 30-s intervals. The cloacal temperature (TCORE) was measured using a medical thermometer at the start and end of the exposure period. Regardless of exposure temperature, the TBREAST (TCON: P<0.001 and TTRT: P<0.001), TWING (TCON: P<0.001 and TTRT: P<0.001), and TDRUM (TCON: P<0.001 and TTRT: P<0.001) decreased from weeks 4 to 6 and remained constant from weeks 1 to 3 and 8 to 12. THEAD was elevated in week 2 (TCON: P<0.001) or week 3 (TTRT: P<0.001), TSHANK increased slightly during week 3 for both TCON (P<0.001) and TTRT (P<0.001), and TLOGGER (TCON: P<0.001 and TTRT: P=0.001) and TCORE (TCON: P<0.001 and TTRT: P<0.001) were lower during the first week. Thereafter, THEAD, TSHANK, TLOGGER, and TCORE remained constant. Exposure to TTRT resulted in lower TBREAST, TWING, and TDRUM compared to TCON. Generally, THEAD, TSHANK, TLOGGER, and TCORE were not affected by the different exposure temperatures. The data demonstrated that the degree of thermal response expressed is dependent on the location of measurement, age, and exposure temperature. PMID:25589083

  9. A 12-Week Exercise Program for Pregnant Women with Obesity to Improve Physical Activity Levels: An Open Randomised Preliminary Study

    PubMed Central

    Alméras, Natalie; Dufresne, Sébastien S.; Robitaille, Julie; Rhéaume, Caroline; Bujold, Emmanuel; Frenette, Jérôme; Tremblay, Angelo

    2015-01-01

    Objective To evaluate whether a 12-week supervised exercise program promotes an active lifestyle throughout pregnancy in pregnant women with obesity. Methods In this preliminary randomised trial, pregnant women (body mass index ≥ 30 kg/m2) were allocated to either standard care or supervised training, from 15 to 27 weeks of gestation. Physical activity was measured by accelerometry at 14, 28 and 36 weeks, while fitness (oxygen consumption (VO2) at the anaerobic threshold), nutrition (caloric intake and macronutrients percentage) and anthropometry were assessed at 14 and 28 weeks of gestation. Analyses were performed using repeated measures ANOVA. Results A total of fifty (50) women were randomised, 25 in each group. There was no time-group interaction for time spent at moderate and vigorous activity (pinteraction = 0.064), but the exercise group’s levels were higher than controls’ at all times (pgroup effect = 0.014). A significant time-group interaction was found for daily physical activity (p = 0.023); similar at baseline ((22.0 ± 6.7 vs 21.8 ± 7.3) x 104 counts/day) the exercise group had higher levels than the control group following the intervention ((22.8 ± 8.3 vs 19.2 ± 4.5) x 104 counts/day, p = 0.020) and at 36 weeks of gestation ((19.2 ± 1.5 vs 14.9 ± 1.5) x 104 counts/day, p = 0.034). Exercisers also gained less weight than controls during the intervention period despite similar nutritional intakes (difference in weight change = -0.1 kg/week, 95% CI -0.2; -0.02, p = 0.016) and improved cardiorespiratory fitness (difference in fitness change = 8.1%, 95% CI 0.7; 9.5, p = 0.041). Conclusions Compared with standard care, a supervised exercise program allows pregnant women with obesity to maintain fitness, limit weight gain and attenuate the decrease in physical activity levels observed in late pregnancy. Trial Registration ClinicalTrials.gov NCT01610323 PMID:26375471

  10. Cervical spine disc prosthesis: radiographic, biomechanical and morphological post mortal findings 12 weeks after implantation. A retrieval example.

    PubMed

    Pitzen, Tobias; Kettler, Annette; Drumm, Joerg; Nabhan, Abdullah; Steudel, Wolf Ingo; Claes, Lutz; Wilke, Hans Joachim

    2007-07-01

    implant contact is probably rare, and that debris may be found after 12 weeks. PMID:17242873

  11. Effects of a 12-week healthy-life exercise program on oxidized low-density lipoprotein cholesterol and carotid intima-media thickness in obese elderly women

    PubMed Central

    Park, Jong-Hwan; Park, Hyuntae; Lim, Seung-Taek; Park, Jin-Kee

    2015-01-01

    [Purpose] This study examined the effects of a 12-week exercise program on plasma level of oxidized low-density lipoprotein cholesterol in obese elderly women, who are at increased risk of heart disease morbidity. [Subjects and Methods] Twenty participants were assigned into either a control (n = 10) or a supervised exercise program (n = 10) group. The 12-week exercise intervention was performed 3 days per week and involved combined aerobic exercise, resistance exercise, and traditional Korean dance. [Results] Two-factor analysis of variance revealed significant group × time interactions for body mass, diastolic blood pressure, appendicular muscle mass. For high-density lipoprotein cholesterol, oxidized low-density lipoprotein cholesterol, and the ratio of oxidized low-/high-density lipoprotein cholesterol, two-factor analysis of variance revealed significant interactions (group × time), indicating responses differed significantly between the control and exercise groups after 12 weeks. [Conclusion] A 12-week low- to moderate-intensity exercise program appears to be beneficial for obese elderly women by improving risk factors for cardiovascular disease. PMID:26157235

  12. A 12 Week, Open Label, Phase I/IIa Study Using Apatone® for the Treatment of Prostate Cancer Patients Who Have Failed Standard Therapy

    PubMed Central

    Tareen, Basir; Summers, Jack L.; Jamison, James M.; Neal, Deborah R.; McGuire, Karen; Gerson, Lowell; Diokno, Ananias

    2008-01-01

    Purpose: To evaluate the safety and efficacy of oral Apatone® (Vitamin C and Vitamin K3) administration in the treatment of prostate cancer in patients who failed standard therapy. Materials and Methods: Seventeen patients with 2 successive rises in PSA after failure of standard local therapy were treated with (5,000 mg of VC and 50 mg of VK3 each day) for a period of 12 weeks. Prostate Specific Antigen (PSA) levels, PSA velocity (PSAV) and PSA doubling times (PSADT) were calculated before and during treatment at 6 week intervals. Following the initial 12 week trial, 15 of 17 patients opted to continue treatment for an additional period ranging from 6 to 24 months. PSA values were followed for these patients. Results: At the conclusion of the 12 week treatment period, PSAV decreased and PSADT increased in 13 of 17 patients (p ≤ 0.05). There were no dose-limiting adverse effects. Of the 15 patients who continued on Apatone after 12 weeks, only 1 death occurred after 14 months of treatment. Conclusion: Apatone showed promise in delaying biochemical progression in this group of end stage prostate cancer patients. PMID:18392145

  13. Effects of a 12-week healthy-life exercise program on oxidized low-density lipoprotein cholesterol and carotid intima-media thickness in obese elderly women.

    PubMed

    Park, Jong-Hwan; Park, Hyuntae; Lim, Seung-Taek; Park, Jin-Kee

    2015-05-01

    [Purpose] This study examined the effects of a 12-week exercise program on plasma level of oxidized low-density lipoprotein cholesterol in obese elderly women, who are at increased risk of heart disease morbidity. [Subjects and Methods] Twenty participants were assigned into either a control (n = 10) or a supervised exercise program (n = 10) group. The 12-week exercise intervention was performed 3 days per week and involved combined aerobic exercise, resistance exercise, and traditional Korean dance. [Results] Two-factor analysis of variance revealed significant group × time interactions for body mass, diastolic blood pressure, appendicular muscle mass. For high-density lipoprotein cholesterol, oxidized low-density lipoprotein cholesterol, and the ratio of oxidized low-/high-density lipoprotein cholesterol, two-factor analysis of variance revealed significant interactions (group × time), indicating responses differed significantly between the control and exercise groups after 12 weeks. [Conclusion] A 12-week low- to moderate-intensity exercise program appears to be beneficial for obese elderly women by improving risk factors for cardiovascular disease. PMID:26157235

  14. Effects of 12-week exercise training on osteocalcin, high-sensitivity C-reactive protein concentrations, and insulin resistance in elderly females with osteoporosis

    PubMed Central

    Ahn, Nayoung; Kim, Kijin

    2016-01-01

    [Purpose] This study examined the effects of exercise training on bone metabolism markers, inflammatory markers, and physical fitness in patients with osteoporosis from an osteoporosis-related immunological perspective. [Subjects and Methods] Twenty-nine elderly female subjects (age, 74.2 ± 3.2 years) were classified into normal, osteopenia, and osteoporosis groups based on the T-score measured using dual-energy X-ray absorptiometry. The exercise was performed voluntarily by the patients for 1 hour per day, three times per week, for 12 weeks. [Results] The differences between bone mineral content, bone mineral density, and osteocalcin concentrations increased significantly in the osteoporosis group after 12 weeks of exercise and were significantly higher than those in the normal and osteopenia groups. However, the homeostatic model assessment of insulin resistance score decreased significantly in the osteoporosis group after 12 weeks of exercise. High-sensitivity C-reactive protein concentrations tended to decrease in all groups after 12 weeks of exercise and showed an inverse correlation with osteocalcin concentration; however, no statistical significance was observed. [Conclusion] Our findings suggest that an exercise program in patients with osteopenia and osteoporosis effectively reduces the risk of osteoporotic fracture and related diseases since it improves bone density and physical fitness and reduces inflammatory marker levels.

  15. Analysis of inflammatory periimplant lesions during a 12-week period of undisturbed plaque accumulation--a comparison between flapless and flap surgery in the mini-pig.

    PubMed

    Mueller, Cornelia K; Thorwarth, Michael; Schultze-Mosgau, Stefan

    2012-04-01

    This study's aim was to clarify the influence of soft tissue management on the development of periimplant infection. Four weeks after removal of all maxillary premolars in 12 mini-pigs, four BEGO Semados RI implants were inserted in each maxillary quadrant. Employing a split-mouth design, one quadrant was randomized to flapless insertion while the contralateral side was chosen for flap surgery. Following 1, 2, 4 and 12 weeks of transmucosal implant, healing biopsies were retrieved from the periimplant soft tissue and subjected to further analysis. Histomorphometrically, a significant reduction of transmigration of polymorphonuclear neutrophils (week 1, p = 0.007; week 2, p = 0.021; week 4, p = 0.023; week 12, p = 0.013) as well as the density of the subepithelial inflammatory infiltrates (week 1, p = 0.007; week 2, p = 0.046; week 4, p = 0.003; week 12, p = 0.032) was verified following flapless surgery. Quantification of inducible nitric oxide synthase showed significantly reduced expression in the flapless group 2 (p = 0.027), 4 (p = 0.005) and 12 (p = 0.004) weeks post-insertion. Analysis of CD31 and collagen I immunostained sections revealed more regular capillary distribution as well as higher vessel and collagen density in the flapless group. The data of the present study indicate that flapless placement reduces the incidence of inflammatory periimplant soft tissue lesions during a 12-week period. Considering the beneficial effects of flapless placement on early soft tissue healing and stability, the technique might be preferred in case of an uncomplicated locoregional anatomy with sufficient hard and soft tissue. However, this positive effect might disappear after manipulation of the implant and soft tissue during impression taking or try in of the prosthodontic supraconstruction. PMID:22186942

  16. Statistical methodologies to pool across multiple intervention studies.

    PubMed

    Bangdiwala, Shrikant I; Bhargava, Alok; O'Connor, Daniel P; Robinson, Thomas N; Michie, Susan; Murray, David M; Stevens, June; Belle, Steven H; Templin, Thomas N; Pratt, Charlotte A

    2016-06-01

    Combining and analyzing data from heterogeneous randomized controlled trials of complex multiple-component intervention studies, or discussing them in a systematic review, is not straightforward. The present article describes certain issues to be considered when combining data across studies, based on discussions in an NIH-sponsored workshop on pooling issues across studies in consortia (see Belle et al. in Psychol Aging, 18(3):396-405, 2003). Several statistical methodologies are described and their advantages and limitations are explored. Whether weighting the different studies data differently, or via employing random effects, one must recognize that different pooling methodologies may yield different results. Pooling can be used for comprehensive exploratory analyses of data from RCTs and should not be viewed as replacing the standard analysis plan for each study. Pooling may help to identify intervention components that may be more effective especially for subsets of participants with certain behavioral characteristics. Pooling, when supported by statistical tests, can allow exploratory investigation of potential hypotheses and for the design of future interventions. PMID:27356993

  17. Cardiovascular, renal and gastrointestinal effects of incretin-based therapies: an acute and 12-week randomised, double-blind, placebo-controlled, mechanistic intervention trial in type 2 diabetes

    PubMed Central

    Smits, Mark M; Tonneijck, Lennart; Muskiet, Marcel H A; Hoekstra, Trynke; Kramer, Mark H H; Pieters, Indra C; Cahen, Djuna L; Diamant, Michaela; van Raalte, Daniël H

    2015-01-01

    Introduction Incretin-based therapies, that is, glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase (DPP)-4 inhibitors, are relatively novel antihyperglycaemic drugs that are frequently used in type 2 diabetes management. Apart from glucose-lowering, these agents exhibit pleiotropic actions that may have favourable and unfavourable clinical consequences. Incretin-based therapies have been associated with heart rate acceleration, heart failure, acute renal failure and acute pancreatitis. Conversely, these agents may reduce blood pressure, glomerular hyperfiltration, albuminuria and hepatic steatosis. While large-sized cardiovascular safety trials can potentially identify the clinical significance of some of these pleiotropic actions, small-sized mechanistic studies are important to understand the (patho)physiological rationale of these findings. The current protocol describes a mechanistic study to assess cardiovascular, renal and gastrointestinal effects, and mechanisms of incretin-based therapies in type 2 diabetes. Methods and analyses 60 patients with type 2 diabetes will undergo acute and prolonged randomised, double-blind, intervention studies. The acute intervention will consist of intravenous administration of the GLP-1 receptor agonist exenatide or placebo. For the prolonged intervention, patients will be randomised to 12-week treatment with the GLP-1 receptor agonist liraglutide, the DPP-4 inhibitor sitagliptin or matching placebos. For each examined organ system, a primary end point is defined. Primary cardiovascular end point is change in resting heart rate variability assessed by beat-to-beat heart rate monitor and spectral analyses software. Primary renal end point is change in glomerular filtration rate assessed by the classic inulin clearance methodology. Primary gastrointestinal end points are change in pancreatic exocrine function assessed by MRI-techniques (acute intervention) and faecal elastase-1 levels (12-week intervention

  18. Effects of a 12-Week Hatha Yoga Intervention on Metabolic Risk and Quality of Life in Hong Kong Chinese Adults with and without Metabolic Syndrome

    PubMed Central

    Lau, Caren; Yu, Ruby; Woo, Jean

    2015-01-01

    Objective To determine the efficacy of a 12-week Hatha yoga intervention to improve metabolic risk profiles and health-related quality of life (HRQoL) in Chinese adults with and without metabolic syndrome (MetS). Methods We conducted a controlled trial within an university-affiliated hospital. 173 Chinese men and women aged 18 or above were assigned to either the yoga intervention group (n = 87) or the control group (n = 86). Primary outcomes included 12-week change in metabolic risk factors and MetS z score. Secondary outcome was HRQoL (Medical Outcomes Short Form Survey at 12 weeks). Results The mean age of participants was 52.0 (SD 7.4, range 31-71) years. Analysis involving the entire study population revealed that the yoga group achieved greater decline in waist circumference (p<0.001), fasting glucose (p<0.01), triglycerides (p<0.05), and MetS z score (p<0.01). Yoga training also improved general health perceptions (p<0.01), physical component score (p<0.01), and social functioning (p<0.01) domains score of HRQoL. However, no significant differences between groups were observed in the mean change of systolic/diastolic blood pressures or high-density lipid protein cholesterol (all p>0.05). There were no significant differences in the intervention effects on waist circumference and MetS z score between the MetS subgroups (both p>0.05). Conclusion A 12-week Hatha yoga intervention improves metabolic risk profiles and HRQoL in Chinese adults with and without MetS. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12613000816752 PMID:26111165

  19. Effects of 12-week Vegetarian Diet on the Nutritional Status, Stress Status and Bowel Habits in Middle School Students and Teachers

    PubMed Central

    Lee, Bo Ra; Ko, Yu Mi; Cho, Mi Hee; Yoon, Young Ran

    2016-01-01

    This study investigated the effect of switching normal diet to vegetarian diet rich in vegetables and fruits for school foodservice and home meal on the nutritional status, bowel habit improvement and stress reduction of teachers and adolescents. A total of 40 research subjects (26 students, 14 teachers) from one middle school voluntarily participated in the research. Questionnaire surveys and blood analysis were conducted before and after a 12-week vegetarian diet period. The participants were asked on their dietary habit, bowel habit and stress measurement. After 12 weeks, reduction of BMI (kg/m2) in the students (p < 0.05) and reduction of TC (mg/dL) in both teachers and students (p < 0.05) were observed. Also reduction of LDL-C (mg/dL) was observed in the teachers (p < 0.05) whereas serum calcium and Vitamin B12 was increased in the students and teachers (p < 0.005). The teacher's stress level was reduced (p < 0.05) after the 12-week vegetarian diet. As for the changes in bowel habit, the number of the students and teachers classified as experiencing functional constipation was decreased respectively from 10 to 7, from 7 to 5. Based on the result, it is considered that the vegetarian diet rich in fruits and vegetables improved general health status of study subjects suggesting that such a dietary habit would substantially contribute to improving nutritional status and bowel habit. PMID:27152300

  20. Effects of 12-week Vegetarian Diet on the Nutritional Status, Stress Status and Bowel Habits in Middle School Students and Teachers.

    PubMed

    Lee, Bo Ra; Ko, Yu Mi; Cho, Mi Hee; Yoon, Young Ran; Kye, Seung Hee; Park, Yoo Kyoung

    2016-04-01

    This study investigated the effect of switching normal diet to vegetarian diet rich in vegetables and fruits for school foodservice and home meal on the nutritional status, bowel habit improvement and stress reduction of teachers and adolescents. A total of 40 research subjects (26 students, 14 teachers) from one middle school voluntarily participated in the research. Questionnaire surveys and blood analysis were conducted before and after a 12-week vegetarian diet period. The participants were asked on their dietary habit, bowel habit and stress measurement. After 12 weeks, reduction of BMI (kg/m(2)) in the students (p < 0.05) and reduction of TC (mg/dL) in both teachers and students (p < 0.05) were observed. Also reduction of LDL-C (mg/dL) was observed in the teachers (p < 0.05) whereas serum calcium and Vitamin B12 was increased in the students and teachers (p < 0.005). The teacher's stress level was reduced (p < 0.05) after the 12-week vegetarian diet. As for the changes in bowel habit, the number of the students and teachers classified as experiencing functional constipation was decreased respectively from 10 to 7, from 7 to 5. Based on the result, it is considered that the vegetarian diet rich in fruits and vegetables improved general health status of study subjects suggesting that such a dietary habit would substantially contribute to improving nutritional status and bowel habit. PMID:27152300

  1. The influence of a 12-week program of physical activity on changes in body composition and lipid and carbohydrate status in postmenopausal women

    PubMed Central

    Pilch, Wanda Barbara; Mucha, Dariusz Mikołaj; Pałka, Tomasz Adam; Suder, Agnieszka Ewa; Tyka, Anna Katarzyna; Tota, Łukasz Marcin; Ambroży, Tadeusz

    2015-01-01

    Introduction For years there have been studies on what kind of physical activity is optimal for maintaining proper health condition. Besides well known and approved endurance training of moderate intensity, an importance of interval exercise where short term, sudden intensification of work is performed at low endurance load is emphasized. The aim of the work was to assess the effects of a program of physical activity applied to postmenopausal women regarding improvement of their body composition and biochemical indices of lipid and carbohydrate status. Material and methods The program of physical activity contained 12-week trainings of Nordic walking (NW) and gymnastic-dance classes (G-D). The intensity of effort during the NW training was at the level of 60% HRmax, whereas intensity of G-D exercises was selected based on a subjective assessment of effort according to the scale of American College of Sports Medicine. Results The 12-week program of physical activity resulted in statistically significant lowering of total cholesterol and low density lipoprotein (LDL) fraction levels. An increase in high density lipoprotein (HDL) cholesterol level was observed, whereas the values of triacylglycerols (TG) did not change. The average fasting blood glucose level decreased significantly. Similar changes were noted for the insulin level. The analysed body biometrical-structural indices did not change significantly. Conclusions The applied 12-week program of physical activity without changes of dietary habits contributed to an improvement in plasma lipid profile and an increased insulin sensitivity, but it did not affect significantly body composition. PMID:26848294

  2. A cross-cultural comparison of the development of the social smile: a longitudinal study of maternal and infant imitation in 6- and 12-week-old infants.

    PubMed

    Wörmann, Viktoriya; Holodynski, Manfred; Kärtner, Joscha; Keller, Heidi

    2012-06-01

    Social smiling is universally regarded as being an infant's first facial expression of pleasure. Underlying co-constructivist emotion theories are the assumptions that the emergence of social smiling is bound to experiences of face-to-face interactions with caregivers and the impact of two developmental mechanisms--maternal and infant imitation. We analyzed mother-infant interactions from two different socio-cultural contexts and hypothesized that cross-cultural differences in face-to-face interactions determine the occurrence of both of these mechanisms and of the frequency of social smiling by 12-week-old infants. Twenty mother-infant dyads from a socio-cultural community with many face-to-face interactions (German families, Münster) were compared with 24 mother-infant dyads from a socio-cultural community with few such interactions (rural Nso families, Cameroon) when the infants were aged 6 and 12 weeks. When infants were 6 weeks old, mothers and their infants from both cultural communities smiled at each other for similar (albeit very short) amounts of time and used imitated each other's smiling similarly rarely. In contrast, when infants were 12 weeks old, mothers and their infants from Münster smiled at and imitated each other more often than did Nso mothers and their infants. PMID:22721734

  3. Optimized design and analysis of preclinical intervention studies in vivo

    PubMed Central

    Laajala, Teemu D.; Jumppanen, Mikael; Huhtaniemi, Riikka; Fey, Vidal; Kaur, Amanpreet; Knuuttila, Matias; Aho, Eija; Oksala, Riikka; Westermarck, Jukka; Mäkelä, Sari; Poutanen, Matti; Aittokallio, Tero

    2016-01-01

    Recent reports have called into question the reproducibility, validity and translatability of the preclinical animal studies due to limitations in their experimental design and statistical analysis. To this end, we implemented a matching-based modelling approach for optimal intervention group allocation, randomization and power calculations, which takes full account of the complex animal characteristics at baseline prior to interventions. In prostate cancer xenograft studies, the method effectively normalized the confounding baseline variability, and resulted in animal allocations which were supported by RNA-seq profiling of the individual tumours. The matching information increased the statistical power to detect true treatment effects at smaller sample sizes in two castration-resistant prostate cancer models, thereby leading to saving of both animal lives and research costs. The novel modelling approach and its open-source and web-based software implementations enable the researchers to conduct adequately-powered and fully-blinded preclinical intervention studies, with the aim to accelerate the discovery of new therapeutic interventions. PMID:27480578

  4. Optimized design and analysis of preclinical intervention studies in vivo.

    PubMed

    Laajala, Teemu D; Jumppanen, Mikael; Huhtaniemi, Riikka; Fey, Vidal; Kaur, Amanpreet; Knuuttila, Matias; Aho, Eija; Oksala, Riikka; Westermarck, Jukka; Mäkelä, Sari; Poutanen, Matti; Aittokallio, Tero

    2016-01-01

    Recent reports have called into question the reproducibility, validity and translatability of the preclinical animal studies due to limitations in their experimental design and statistical analysis. To this end, we implemented a matching-based modelling approach for optimal intervention group allocation, randomization and power calculations, which takes full account of the complex animal characteristics at baseline prior to interventions. In prostate cancer xenograft studies, the method effectively normalized the confounding baseline variability, and resulted in animal allocations which were supported by RNA-seq profiling of the individual tumours. The matching information increased the statistical power to detect true treatment effects at smaller sample sizes in two castration-resistant prostate cancer models, thereby leading to saving of both animal lives and research costs. The novel modelling approach and its open-source and web-based software implementations enable the researchers to conduct adequately-powered and fully-blinded preclinical intervention studies, with the aim to accelerate the discovery of new therapeutic interventions. PMID:27480578

  5. A 12-week rehabilitation program improves body composition, pain sensation, and internal/external torques of baseball pitchers with shoulder impingement symptom

    PubMed Central

    Cha, Jun-Youl; Kim, Jae-Hak; Hong, Ju; Choi, Young-Tae; Kim, Min-Ho; Cho, Ji-Hyun; Ko, Il-Gyu; Jee, Yong-Seok

    2014-01-01

    The aim of this study was to investigate the effects of a 12-week rehabilitation program on body composition, shoulder pain, and isokinetic internal/external torques of pitchers with impingement syndrome. A total of 30 pitchers were divided into 2 groups: experimental group (EG, n = 16) and control group (CG, n= 14). The rehabilitation program consisted of physical therapy, warm-up, work-out, and cool-down. As results, body weight and fat mass of EG were decreased whereas muscle mass of EG was significantly increased after the experiment. The pain degrees in resting, normal daily activity, and strenuous activity on the numeric pain rating scale were significantly decreased in the EG. The internal and external peak torques (PTs) of uninvolved and involved sides of EG were increased in EG after 12 weeks. Such results provide a deficit ratio of both sides in EG close to normal values. The ratios of internal/external PTs in EG were also close to the reference values. The internal and external total works of both sides in EG were similar to the values of PT. The fatigue indices of internal and external rotators of both sides in EG were decreased. As a conclusion, a 12-week rehabilitation program reduced the shoulder pain, improved the body composition and enhanced the isokinetic shoulder internal/external rotators in EG with impingement symptoms. Also the study suggested that the rehabilitation program evened out the ratio between internal and external rotators and lowered the fatigue level after the experiment. PMID:24678503

  6. Sofosbuvir with peginterferon-ribavirin for 12 weeks in previously treated patients with hepatitis C genotype 2 or 3 and cirrhosis

    PubMed Central

    Lawitz, Eric; Poordad, Fred; Brainard, Diana M; Hyland, Robert H; An, Di; Dvory-Sobol, Hadas; Symonds, William T; McHutchison, John G; Membreno, Fernando E

    2015-01-01

    Sofosbuvir (SOF) in combination with ribavirin (RBV) for 12 or 24 weeks is the current standard of care for patients infected with hepatitis C virus (HCV) genotypes 2 and 3, respectively. However, in clinical trials treatment-experienced patients, particularly those with cirrhosis, had suboptimal sustained virological response (SVR) rates. We assessed the efficacy and safety of sofosbuvir plus peginterferon and ribavirin (SOF+Peg-IFN+RBV) administered for 12 weeks to treatment-experienced patients with HCV genotypes 2 and 3, with and without cirrhosis. We enrolled 47 patients in this open-label, nonrandomized, uncontrolled phase 2 study. The primary endpoint was the proportion of patients with SVR at 12 weeks after cessation of study treatment (SVR12). The overall rate of SVR12 was 89% (95% confidence interval [CI]: 77-97). Rates of SVR12 were higher in patients with genotype 2 than in those with genotype 3, 96% (95% CI: 78-100) and 83% (95% CI: 62-95), respectively. Rates of SVR12 were similar in patients with and without cirrhosis: for genotype 2, 93% of patients with cirrhosis and 100% of patients without cirrhosis achieved SVR12, and for genotype 3, the SVR12 rate was 83% in patients both with and without cirrhosis. One patient discontinued study treatment because of an adverse event and four patients experienced serious adverse events. The most common adverse events were influenza-like illness, fatigue, anemia, and neutropenia. Conclusion: In treatment-experienced patients with HCV genotypes 2 and 3, 12-week administration of SOF+Peg-IFN+RBV provided high SVR rates, irrespective of cirrhosis status. No safety concerns were identified. (Hepatology 2015;61:769–775) PMID:25322962

  7. Decreasing cardiovascular risk factors in obese individuals using a combination of PGX® meal replacements and PGX® granules in a 12-week clinical weight modification program.

    PubMed

    Reichert, Ronald G; Lyon, Michael R; Kacinik, Veronica; Gahler, Roland J; Manjoo, Priya; Purnama, Monica; Wood, Simon

    2013-01-01

    In this open, clinically based, weight modification program, we determined in six sedentary obese adults (five women; one male; age range 30-62 years) that the combination of a modified calorie diet plus PGX® meal replacement and PGX® supplementation resulted in a significant reduction in several cardiovascular risk factors over a 12-week time period. This included a significant improvement in lipids (-0.98 mmol/l LDL-C), reduction in average weight (-9.2 kg), mean reduction in fat (-4.1%) and an increase in fat-free mass (2.8%). PMID:23652638

  8. Residual {sup 18}F-FDG-PET Uptake 12 Weeks After Stereotactic Ablative Radiotherapy for Stage I Non-Small-Cell Lung Cancer Predicts Local Control

    SciTech Connect

    Bollineni, Vikram Rao; Widder, Joachim; Pruim, Jan; Langendijk, Johannes A.; Wiegman, Erwin M.

    2012-07-15

    Purpose: To investigate the prognostic value of [{sup 18}F]fluorodeoxyglucose positron emission tomography (FDG-PET) uptake at 12 weeks after stereotactic ablative radiotherapy (SABR) for stage I non-small-cell lung cancer (NSCLC). Methods and Materials: From November 2006 to February 2010, 132 medically inoperable patients with proven Stage I NSCLC or FDG-PET-positive primary lung tumors were analyzed retrospectively. SABR consisted of 60 Gy delivered in 3 to 8 fractions. Maximum standardized uptake value (SUV{sub max}) of the treated lesion was assessed 12 weeks after SABR, using FDG-PET. Patients were subsequently followed at regular intervals using computed tomography (CT) scans. Association between post-SABR SUV{sub max} and local control (LC), mediastinal failure, distant failure, overall survival (OS), and disease-specific survival (DSS) was examined. Results: Median follow-up time was 17 months (range, 3-40 months). Median lesion size was 25 mm (range, 9-70 mm). There were 6 local failures: 15 mediastinal failures, 15 distant failures, 13 disease-related deaths, and 16 deaths from intercurrent diseases. Glucose corrected post-SABR median SUV{sub max} was 3.0 (range, 0.55-14.50). Using SUV{sub max} 5.0 as a cutoff, the 2-year LC was 80% versus 97.7% for high versus low SUV{sub max}, yielding an adjusted subhazard ratio (SHR) for high post-SABR SUV{sub max} of 7.3 (95% confidence interval [CI], 1.4-38.5; p = 0.019). Two-year DSS rates were 74% versus 91%, respectively, for high and low SUV{sub max} values (SHR, 2.2; 95% CI, 0.8-6.3; p = 0.113). Two-year OS was 62% versus 81% (hazard ratio [HR], 1.6; 95% CI, 0.7-3.7; p = 0.268). Conclusions: Residual FDG uptake (SUV{sub max} {>=}5.0) 12 weeks after SABR signifies increased risk of local failure. A single FDG-PET scan at 12 weeks could be used to tailor further follow-up according to the risk of failure, especially in patients potentially eligible for salvage surgery.

  9. Effects of a 12-week Rehabilitation Program with Music & Exercise Groups on Range of Motion in Young Children with Severe Burns

    PubMed Central

    Neugebauer, Christine Tuden; Serghiou, Michael; Herndon, David N.; Suman, Oscar E.

    2013-01-01

    Previous studies indicate that rehabilitation programs supplemented with a strength and endurance-based exercise program improve lean body mass, pulmonary function, endurance, strength, and functional outcomes in severely burned children over the age of 7-years when compared to standard of care. To date, supplemental exercise programming for severely burned children under the age of 7-years has not yet been explored. The purpose of this study was to determine if a 12-week rehabilitation program supplemented with music & exercise, was more effective in improving functional outcomes than the standard of care alone. METHODS This is a descriptive study that measured elbow and knee range of motion (ROM) in 24 severely burned children between ages two and six years. Groups were compared for demographics as well as active and passive ROM to bilateral elbows and knees. A total of 15 patients completed the rehabilitation with supplemental music and exercise, and data was compared to 9 patients who received standard of care. RESULTS Patients receiving the 12-week program significantly improved ROM in all joints assessed except for one. Patients receiving standard of care showed a significant improvement in only one of the joints assessed. CONCLUSION Providing a structured supplemental music and exercise program in conjunction with occupational and physical therapy seems to improve both passive and active ROM to a greater extent than the standard of care alone. PMID:18849852

  10. The relationship between stress, HPA axis functioning and brain structure in first episode psychosis over the first 12 weeks of treatment.

    PubMed

    Reniers, Renate L E P; Garner, Belinda; Phassouliotis, Christina; Phillips, Lisa J; Markulev, Connie; Pantelis, Christos; Bendall, Sarah; McGorry, Patrick D; Wood, Stephen J

    2015-02-28

    Stress and abnormal hypothalamic-pituitary-adrenal axis functioning have been implicated in the early phase of psychosis and may partly explain reported changes in brain structure. This study used magnetic resonance imaging to investigate whether biological measures of stress were related to brain structure at baseline and to structural changes over the first 12 weeks of treatment in first episode patients (n=22) compared with matched healthy controls (n=22). At baseline, no significant group differences in biological measures of stress, cortical thickness or hippocampal volume were observed, but a significantly stronger relationship between baseline levels of cortisol and smaller white matter volumes of the cuneus and anterior cingulate was found in patients compared with controls. Over the first 12 weeks of treatment, patients showed a significant reduction in thickness of the posterior cingulate compared with controls. Patients also showed a significant positive relationship between baseline cortisol and increases in hippocampal volume over time, suggestive of brain swelling in association with psychotic exacerbation, while no such relationship was observed in controls. The current findings provide some support for the involvement of stress mechanisms in the pathophysiology of early psychosis, but the changes are subtle and warrant further investigation. PMID:25492856

  11. Effects of a 12-Week Hatha Yoga Intervention on Cardiorespiratory Endurance, Muscular Strength and Endurance, and Flexibility in Hong Kong Chinese Adults: A Controlled Clinical Trial

    PubMed Central

    Lau, Caren; Yu, Ruby; Woo, Jean

    2015-01-01

    Objective. To examine the effects of a 12-week Hatha yoga intervention on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults. Methods. 173 adults (aged 52.0 ± 7.5 years) were assigned to either the yoga intervention group (n = 87) or the waitlist control group (n = 86). 19 dropped out from the study. Primary outcomes were changes in cardiorespiratory endurance (resting heart rate (HR) and maximal oxygen uptake (VO2max)), muscular strength and endurance (curl-up and push-up tests), and lower back and hamstring flexibility (the modified back-saver sit-and-reach (MBS) test). Results. Compared to controls, the yoga group achieved significant improvements in VO2max (P < 0.01), curl-up (P < 0.05) and push-up (P < 0.001) tests, and the MBS left and right leg tests (both P < 0.001) in both genders. Significant change was also found for resting HR between groups in women (P < 0.05) but not in men. Further analysis comparing participants between younger and older subgroups yielded similar findings, except that the older participants in the yoga group failed to improve resting HR or the curl-up test versus control. Adherence (89%) and attendance (94%) were high. No serious adverse events occurred. Conclusion. A 12-week Hatha yoga intervention has favorable effects on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults. PMID:26167196

  12. Effects of a 12-week rehabilitation program with music & exercise groups on range of motion in young children with severe burns.

    PubMed

    Neugebauer, Christine Tuden; Serghiou, Michael; Herndon, David N; Suman, Oscar E

    2008-01-01

    Previous studies indicate that rehabilitation programs supplemented with a strength and endurance-based exercise program improve lean body mass, pulmonary function, endurance, strength, and functional outcomes in severely burned children over the age of 7-years when compared with standard of care (SOC). To date, supplemental exercise programming for severely burned children under the age of 7-years has not yet been explored. The purpose of this study was to determine if a 12-week rehabilitation program supplemented with music & exercise, was more effective in improving functional outcomes than the SOC alone. This is a descriptive study that measured elbow and knee range of motion (ROM) in 24 severely burned children between ages 2 and 6 years. Groups were compared for demographics as well as active and passive ROM to bilateral elbows and knees. A total of 15 patients completed the rehabilitation with supplemental music and exercise, and data was compared with 9 patients who received SOC. Patients receiving the 12-week program significantly improved ROM in all joints assessed except for one. Patients receiving SOC showed a significant improvement in only one of the joints assessed. Providing a structured supplemental music and exercise program in conjunction with occupational and physical therapy seems to improve both passive and active ROM to a greater extent than the SOC alone. PMID:18849852

  13. School, Community, and Family Working Together to Address Childhood Obesity: Perceptions from the KOALA Lifestyle Intervention Study

    ERIC Educational Resources Information Center

    Smibert, Asa; Abbott, Rebecca; Macdonald, Doune; Hogan, Anna; Leong, Gary

    2010-01-01

    Epidemiological data on childhood obesity has prompted a significant response from both governments and academics seeking to recommend solutions to the reported "crisis". The "Kinder Overweight Active Living Action" (KOALA) healthy lifestyle programme is a randomized obesity prevention and intervention study designed to provide an understanding of…

  14. The Importance of Parenting in the Development of Disorganized Attachment: Evidence from a Preventive Intervention Study in Adoptive Families

    ERIC Educational Resources Information Center

    Juffer, Femmie; Bakermans-Kranenburg, Marian J.; van IJzendoorn, Marinus H.

    2005-01-01

    Background: As infant disorganized attachment is a serious risk factor for later child psychopathology, it is important to examine whether attachment disorganization can be prevented or reduced. Method: In a randomized intervention study involving 130 families with 6-month-old adopted infants, two attachment-based intervention programs were…

  15. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12weeks.

    PubMed

    Martel, Céline; Labrie, Fernand; Archer, David F; Ke, Yuyong; Gonthier, Renaud; Simard, Jean-Nicolas; Lavoie, Lyne; Vaillancourt, Mario; Montesino, Marlene; Balser, John; Moyneur, Érick

    2016-05-01

    This study integrates all data obtained in women aged 40-80years enrolled with moderate to severe symptoms of vulvovaginal atrophy (VVA) who received daily intravaginal administration of 0.50% (6.5mg) dehydroepiandrosterone (DHEA; prasterone) for 12weeks (n=723; ITT-S population) as compared with placebo (n=266; ITT-S population). To this end, serum steroid levels (DHEA, DHEA-sulfate (DHEA-S), androst-5-ene-3β, 17β-diol (5-diol), testosterone, dihydrotestosterone (DHT), androstenedione (4-dione), estrone (E1), estradiol (E2), estrone sulfate (E1-S), androsterone glucuronide (ADT-G), and androstane-3α, 17β-diol 17-glucuronide (3α-diol-17G)) were measured at Day 1 and Week 12 by liquid chromatography-tandem mass spectrometry (LC-MS/MS) following validation performed according to the FDA guidelines [1-6]. In agreement with the mechanisms of intracrinology where DHEA is exclusively transformed intracellularly into active sex steroids which act and are inactivated locally before being released as glucuronided or sulfated metabolites for elimination by the kidneys and liver, all sex steroids remained well within normal postmenopausal values following administration of intravaginal DHEA. Serum estradiol, the most relevant sex steroid, was measured after 12weeks of treatment at 3.36pg/ml (cITT-S population) or 19% below the normal postmenopausal value of 4.17pg/ml. On the other hand, serum E1-S, the best recognized marker of global estrogenic activity, shows an average value of 209pg/ml at 12 weeks compared to 220pg/ml in normal postmenopausal women. Moreover, serum ADT-G, the main metabolite of androgens, also remains well within normal postmenopausal values. The present data shows that a low daily intravaginal dose (6.5mg) of DHEA (prasterone) which is efficacious on the symptoms and signs of VVA, permits to achieve the desired local efficacy without systemic exposure, in agreement with the stringent mechanisms of menopause established after 500 million years of

  16. Effect of an herbal/botanical supplement on strength, balance, and muscle function following 12-weeks of resistance training: a placebo controlled study

    PubMed Central

    2014-01-01

    Background StemSport (SS; StemTech International, Inc. San Clemente, CA) contains a proprietary blend of the botanical Aphanizomenon flos-aquae and several herbal antioxidant and anti-inflammatory substances. SS has been purported to accelerate tissue repair and restore muscle function following resistance exercise. Here, we examine the effects of SS supplementation on strength adaptations resulting from a 12-week resistance training program in healthy young adults. Methods Twenty-four young adults (16 males, 8 females, mean age = 20.5 ± 1.9 years, mass = 70.9 ± 11.9 kg, stature = 176.6 ± 9.9 cm) completed the twelve week training program. The study design was a double-blind, placebo controlled parallel group trial. Subjects either received placebo or StemSport supplement (SS; mg/day) during the training. 1-RM bench press, 1-RM leg press, vertical jump height, balance (star excursion and center of mass excursion), isokinetic strength (elbow and knee flexion/extension) and perception of recovery were measured at baseline and following the 12-week training intervention. Results Resistance training increased 1-RM strength (p < 0.008), vertical jump height (p < 0.03), and isokinetic strength (p < 0.05) in both SS and placebo groups. No significant group-by-time interactions were observed (all p-values >0.10). Conclusions These data suggest that compared to placebo, the SS herbal/botanical supplement did not enhance training induced adaptations to strength, balance, and muscle function above strength training alone. PMID:24910543

  17. Exercise-training intervention studies in competitive swimming.

    PubMed

    Aspenes, Stian Thoresen; Karlsen, Trine

    2012-06-01

    Competitive swimming has a long history and is currently one of the largest Olympic sports, with 16 pool events. Several aspects separate swimming from most other sports such as (i) the prone position; (ii) simultaneous use of arms and legs for propulsion; (iii) water immersion (i.e. hydrostatic pressure on thorax and controlled respiration); (iv) propulsive forces that are applied against a fluctuant element; and (v) minimal influence of equipment on performance. Competitive swimmers are suggested to have specific anthropometrical features compared with other athletes, but are nevertheless dependent on physiological adaptations to enhance their performance. Swimmers thus engage in large volumes of training in the pool and on dry land. Strength training of various forms is widely used, and the energetic systems are addressed by aerobic and anaerobic swimming training. The aim of the current review was to report results from controlled exercise training trials within competitive swimming. From a structured literature search we found 17 controlled intervention studies that covered strength or resistance training, assisted sprint swimming, arms-only training, leg-kick training, respiratory muscle training, training the energy delivery systems and combined interventions across the aforementioned categories. Nine of the included studies were randomized controlled trials. Among the included studies we found indications that heavy strength training on dry land (one to five repetitions maximum with pull-downs for three sets with maximal effort in the concentric phase) or sprint swimming with resistance towards propulsion (maximal pushing with the arms against fixed points or pulling a perforated bowl) may be efficient for enhanced performance, and may also possibly have positive effects on stroke mechanics. The largest effect size (ES) on swimming performance was found in 50 m freestyle after a dry-land strength training regimen of maximum six repetitions across three

  18. The Importance of Risk and Subgroup Analysis of Nonparticipants in a Geriatric Intervention Study

    PubMed Central

    Poulsen, Ingrid; Hendriksen, Carsten

    2016-01-01

    Background. A major concern in intervention studies is the generalizability of the findings due to refusal of intended participants to actually take part. In studies including ill older people the number of those declining to participate may be large and the concern is therefore relevant. Objectives. To compare patients characteristics, rates of acute readmission, and mortality after one and six months among older persons who agreed and those who declined to participate in a randomized controlled trial and to describe subgroups of nonparticipants. Design. Comparative study based on a randomized controlled trial. Setting. University hospital in the Capital Region of Denmark. Participants. Patients ≥70 years discharged home after a short Emergency Department stay. 399 were requested to participate; 271 consented, whereas 128 refused. Results. Refusers were more likely to be readmitted (p < 0.001) or die (p = 0.006). The largest subgroup of refusers described as “too ill” had the highest risk of readmission (OR = 3.00, 95% CI = 1.61–5.47, p = 0.001) and of mortality within six months (OR = 3.50, 95% CI = 1.64–7.49, p = 0.002). However, this seems not to have affected the results of our randomized study. Conclusion. We recommend that intervention studies among older people or other fragile patient groups include analysis of relevant risk and subgroup analyses of refusers. PMID:27446634

  19. Academic Vocabulary and Middle School English Learners: An Intervention Study

    ERIC Educational Resources Information Center

    Townsend, Dianna; Collins, Penny

    2009-01-01

    The goal of this experimental intervention study was to determine if evidence-based instructional strategies for general vocabulary words are effective with middle school English learner (EL) students and academic vocabulary words. Participants showed significantly more growth in their knowledge of academic vocabulary during the treatment…

  20. Commentary: The Challenge of Nonexperimental Interventions Studies in Social Work

    ERIC Educational Resources Information Center

    Schilling, Robert

    2010-01-01

    The challenging context of social work interventions require that most intervention studies will be derived from nonexperimental research designs. Two evaluation studies in this special issue employed nonrandomized designs to examine the efficacy of two programs--a police crisis intervention team designed to enhance officers' responses to mental…

  1. Morphology in Malay-English Biliteracy Acquisition: An Intervention Study

    ERIC Educational Resources Information Center

    Zhang, Dongbo

    2016-01-01

    This intervention study examined the effect of English morphological instruction on the development of English as well as Malay morphological awareness and word reading abilities among Malay-English bilingual fourth graders in Singapore, where English is the medium of instruction. The intervention group experienced semester-long instruction in…

  2. Changes in Antioxidant Defense Capability and Lipid Profile after 12-Week Low- Intensity Continuous Training in Both Cigarette and Hookah Smokers: A Follow-Up Study

    PubMed Central

    Koubaa, Abdessalem; Triki, Moez; Trabelsi, Hajer; Masmoudi, Liwa; Sahnoun, Zouhair; Hakim, Ahmed

    2015-01-01

    To examine the impact of low-intensity continuous training program on antioxidant defense capability and lipid profile in male cigarette or hookah smokers. Forty-three male adults participated in a 12-week continuous training program at an intensity of 40% of VO2max. All subjects were subjected to anthropometric, physical and biochemical tests before and after the training program. The increase of Glutathione reductase (GR) and Superoxide dismutase (SOD) is significant only for cigarette smokers (CS) and hookah smokers (HS) groups. The Malondialdehyde (MDA) decrease and α-tocopherol increase are significant only for HS group. GPx was increased in NS, CS and HS by 2.6% (p< 0.01), 2% (p< 0.05) and 1.7% (p< 0.05) respectively. Likewise, significant improvements of high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and TC / HDL-C ratio were observed in three groups. En contrast no significant changes were recorded in triglycerides (TG). Also, significant reduction of total cholesterol (TC) for CS group (p< 0.01) and HS groups (p< 0.05). This continuous training program appears to have an important role in lipid levels improving and oxidative stress attenuation. PMID:26121249

  3. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial.

    PubMed

    Tong, Tomas K; Kong, Zhaowei; Lin, Hua; He, Yeheng; Lippi, Giuseppe; Shi, Qingde; Zhang, Haifeng; Nie, Jinlei

    2016-01-01

    This field study investigated the influences of exposure to natural low altitude on endurance training-induced alterations of redox homeostasis in professional adolescent runners undergoing 12-week off-season conditioning program at an altitude of 1700 m (Alt), by comparison with that of their counterparts completing the program at sea-level (SL). For age-, gender-, and Tanner-stage-matched comparison, 26 runners (n = 13 in each group) were selected and studied. Following the conditioning program, unaltered serum levels of thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (T-AOC), and superoxide dismutase accompanied with an increase in oxidized glutathione (GSSG) and decreases of xanthine oxidase, reduced glutathione (GSH), and GSH/GSSG ratio were observed in both Alt and SL groups. Serum glutathione peroxidase and catalase did not change in SL, whereas these enzymes, respectively, decreased and increased in Alt. Uric acid (UA) decreased in SL and increased in Alt. Moreover, the decreases in GSH and GSH/GSSG ratio in Alt were relatively lower compared to those in SL. Further, significant interindividual correlations were found between changes in catalase and TBARS, as well as between UA and T-AOC. These findings suggest that long-term training at natural low altitude is unlikely to cause retained oxidative stress in professional adolescent runners. PMID:26783415

  4. Effects of a 12-week Pilates course on lower limb muscle strength and trunk flexibility in women living in the community.

    PubMed

    Kao, Yu-Hsiu; Liou, Tsan-Hon; Huang, Yi-Ching; Tsai, Ya-Wen; Wang, Kuo-Ming

    2015-01-01

    Researchers in Taiwan studying regular adult physical activity found that among married women aged 26 to 55 years, 56% participated in physical activity, and that the convenience and safety of the activity were major factors contributing to their willingness to exercise. Muscle weakness and poor trunk flexibility are closely related to some chronic diseases in women. In this cross-sectional survey, we used the Polestar Pilates™ method to explore the effects of a 12-week Pilates course on the physical fitness of women living in the community. Fifty-three members of the experimental group (mean age: 42.30 ± 9.97) and 43 of the control group (mean age: 41.23 ± 9.83) were included. We confirm that a convenient Pilates exercise intervention can significantly improve muscle strength and trunk flexibility in women. Our findings serve as an important reference for health authorities in Taiwan and provide higher awareness of women's health and physical fitness, which can help prevent chronic and cardiovascular diseases. PMID:24611630

  5. The Effect of a 12-Week Moderate Intensity Interval Training Program on the Antioxidant Defense Capability and Lipid Profile in Men Smoking Cigarettes or Hookah: A Cohort Study

    PubMed Central

    Koubaa, Abdessalem; Triki, Moez; Trabelsi, Hajer; Baati, Hamza; Sahnoun, Zouhair; Hakim, Ahmed

    2015-01-01

    Aim. To examine the impact of interval training program on the antioxidant defense capability and lipid profile in men smoking cigarettes or hookah unable or unwilling to quit smoking. Methods. Thirty-five participants performed an interval training (2 : 1 work : rest ratio) 3 times a week for 12 weeks at an intensity of 70% of VO2max. All subjects were subjected to a biochemical test session before and after the training program. Results. The increase of total antioxidant status (TAS), glutathione peroxidase (GPx), and α-tocopherol, is significant only for cigarette smokers (CS) and hookah smokers (HS) groups. The decrease of malondialdehyde (MDA) and the increase of glutathione reductase (GR) are more pronounced in smokers groups compared to those of nonsmokers (NS). Superoxide dismutase (SOD) increases in NS, CS, and HS groups by 10.1%, 19.5%, and 13.3%, respectively (P < 0.001). Likewise, a significant improvement of high-density lipoprotein cholesterol (HDL-C) and TC/HDL-C ratio was observed in CS and HS groups (P < 0.05). Conclusion. Although the interval training program does not have a significant effect on blood lipid levels, it seems to be very beneficial in the defense and prevention programs of oxidative stress. PMID:25664340

  6. Changes in Antioxidant Defense Capability and Lipid Profile after 12-Week Low- Intensity Continuous Training in Both Cigarette and Hookah Smokers: A Follow-Up Study.

    PubMed

    Koubaa, Abdessalem; Triki, Moez; Trabelsi, Hajer; Masmoudi, Liwa; Sahnoun, Zouhair; Hakim, Ahmed

    2015-01-01

    To examine the impact of low-intensity continuous training program on antioxidant defense capability and lipid profile in male cigarette or hookah smokers. Forty-three male adults participated in a 12-week continuous training program at an intensity of 40% of VO2max. All subjects were subjected to anthropometric, physical and biochemical tests before and after the training program. The increase of Glutathione reductase (GR) and Superoxide dismutase (SOD) is significant only for cigarette smokers (CS) and hookah smokers (HS) groups. The Malondialdehyde (MDA) decrease and α-tocopherol increase are significant only for HS group. GPx was increased in NS, CS and HS by 2.6% (p< 0.01), 2% (p< 0.05) and 1.7% (p< 0.05) respectively. Likewise, significant improvements of high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and TC/HDL-C ratio were observed in three groups. En contrast no significant changes were recorded in triglycerides (TG). Also, significant reduction of total cholesterol (TC) for CS group (p< 0.01) and HS groups (p< 0.05). This continuous training program appears to have an important role in lipid levels improving and oxidative stress attenuation. PMID:26121249

  7. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial

    PubMed Central

    Tong, Tomas K.; Kong, Zhaowei; Lin, Hua; He, Yeheng; Lippi, Giuseppe; Shi, Qingde; Zhang, Haifeng

    2016-01-01

    This field study investigated the influences of exposure to natural low altitude on endurance training-induced alterations of redox homeostasis in professional adolescent runners undergoing 12-week off-season conditioning program at an altitude of 1700 m (Alt), by comparison with that of their counterparts completing the program at sea-level (SL). For age-, gender-, and Tanner-stage-matched comparison, 26 runners (n = 13 in each group) were selected and studied. Following the conditioning program, unaltered serum levels of thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (T-AOC), and superoxide dismutase accompanied with an increase in oxidized glutathione (GSSG) and decreases of xanthine oxidase, reduced glutathione (GSH), and GSH/GSSG ratio were observed in both Alt and SL groups. Serum glutathione peroxidase and catalase did not change in SL, whereas these enzymes, respectively, decreased and increased in Alt. Uric acid (UA) decreased in SL and increased in Alt. Moreover, the decreases in GSH and GSH/GSSG ratio in Alt were relatively lower compared to those in SL. Further, significant interindividual correlations were found between changes in catalase and TBARS, as well as between UA and T-AOC. These findings suggest that long-term training at natural low altitude is unlikely to cause retained oxidative stress in professional adolescent runners. PMID:26783415

  8. Effect of a fermented dietary supplement containing chromium and zinc on metabolic control in patients with type 2 diabetes: a randomized, placebo-controlled, double-blind cross-over study

    PubMed Central

    Lee, Yu-Mi; Wolf, Petra; Hauner, Hans; Skurk, Thomas

    2016-01-01

    Background For the increasing development of type 2 diabetes dietary habits play an important role. In this regard, dietary supplements are of growing interest to influence the progression of this disease. Objective The aim of this study was to investigate the effect of a cascade-fermented dietary supplement based on fruits, nuts, and vegetables fortified with chromium and zinc on metabolic control in patients with type 2 diabetes mellitus. Methods This was a randomized, placebo-controlled, double-blind, intervention study under free-living conditions using a cross-over design. Thirty-six patients with type 2 diabetes mellitus were enrolled and randomized either to receive a cascade-fermented dietary supplement enriched with chromium (100 µg/d) and zinc (15 mg/d) or a placebo similar in taste but without supplements, over a period of 12 weeks. After a wash-out period of 12 weeks, the patients received the other test product. The main outcome variable was the levels of glycated hemoglobin (HbA1c). Other outcome variables were fasting blood glucose, fructosamine, and lipid parameters. Results Thirty-one patients completed the study. HbA1c showed no relevant changes during both treatment periods, nor was there a relevant difference between the two treatments (HbA1c: p=0.48). The same results were found for fructosamine and fasting glucose (fructosamine: p=0.9; fasting glucose: p=0.31). In addition, there was no effect on lipid metabolism. Conclusion This intervention study does not provide evidence that a cascade-fermented plant-based dietary supplement enriched with a combination of chromium and zinc improves glucose metabolism in patients with type 2 diabetes mellitus under free-living conditions. PMID:27343205

  9. Effect of 12-week-long aerobic training programme on body composition, aerobic capacity, complete blood count and blood lipid profile among young women

    PubMed Central

    Nowak, Robert; Jastrzębski, Zbigniew; Zarębska, Aleksandra; Bichowska, Marta; Drobnik-Kozakiewicz, Izabela; Radzimiński, Łukasz; Leońska-Duniec, Agata; Ficek, Krzysztof; Cięszczyk, Paweł

    2015-01-01

    Background Numerous data suggest that aerobic-type exercise improves lipoprotein-lipid profiles, cardiorespiratory fitness and body composition in young women. The aim of this study was to evaluate the biological response to high-low impact aerobic fitness among young women. Materials and methods Thirty-four young women aged 22 (19-24) years were divided into three groups: underweight (N = 10), normal weight (N = 12) and overweight (N = 12). Aerobic capacity, anthropometry and body composition together with complete blood count and lipid profile were determined before and after completion of a 12-week-long training period. Results The training programme caused a significant decrease in weight (by 4.3 kg, P = 0.003), body mass index (by 1.3 kg/m2, P = 0.003), free fat mass (by 2.1 kg, P = 0.002), total body water (by 0.4 kg, P = 0.036), percentage of fat (by 3 percent points, P = 0.002), all analyzed skinfolds thicknesses, as well as the lipid profile in overweight group, and no changes in normal weight group. Significant changes in weight (by 4.2 kg, P = 0.005), body mass index (by 0.9 kg/m2, P = 0.005), crus skinfold thickness (by 3.3 mm, P = 0.028), and in maximum oxygen uptake (by 2.49 mL/kg/min; P = 0.047) were observed among underweight women. No change in total blood count was observed in all groups. Conclusion Twelve-week-long fitness training programme of two alternating styles (low and high impact) has a beneficial effect on overweight young women. PMID:25672474

  10. An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1)

    PubMed Central

    Asselah, Tarik; Moreno, Christophe; Sarrazin, Christoph; Gschwantler, Michael; Foster, Graham R.; Craxí, Antonio; Buggisch, Peter; Ryan, Robert; Lenz, Oliver; Scott, Jane; Van Dooren, Gino; Lonjon-Domanec, Isabelle; Schlag, Michael; Buti, Maria

    2016-01-01

    Background Shortening duration of peginterferon-based HCV treatment reduces associated burden for patients. Primary objectives of this study were to assess the efficacy against the minimally acceptable response rate 12 weeks post-treatment (SVR12) and safety of simeprevir plus PR in treatment-naïve HCV GT1 patients treated for 12 weeks. Additional objectives included the investigation of potential associations of rapid viral response and baseline factors with SVR12. Methods In this Phase III, open-label study in treatment-naïve HCV GT1 patients with F0–F2 fibrosis, patients with HCV-RNA <25 IU/mL (detectable/undetectable) at Week 2, and undetectable HCV-RNA at Weeks 4 and 8, stopped all treatment at Week 12. All other patients continued PR for a further 12 weeks. Baseline factors significantly associated with SVR12 were identified through logistic regression. Results Of 163 patients who participated in the study, 123 (75%) qualified for 12-week treatment; of these, 81 (66%) achieved SVR12. Baseline factors positively associated with SVR12 rates in patients receiving the 12-week regimen were: IL28B CC genotype: (94% SVR12); HCV RNA ≤800,000 IU/mL (82%); F0–F1 fibrosis (74%). Among all 163 patients, 94% experienced ≥1 adverse event (AE), 4% a serious AE, and 2.5% discontinued due to an AE. Reduced impairment in patient-reported outcomes was observed in the 12-week vs >12-week regimen. Conclusions Overall SVR12 rate (66%) was below the target of 80%, indicating that shortening of treatment with simeprevir plus PR to 12 weeks based on very early response is not effective. However, baseline factors associated with higher SVR12 rates were identified. Therefore, while Week 2 response alone is insufficient to predict efficacy, GT1 patients with favourable baseline factors may benefit from a shortened simeprevir plus PR regimen. Trial Registration ClinicalTrials.gov NCT01846832 PMID:27428331

  11. Effects of a 12-Week Physical Activity Protocol Delivered by YMCA After-School Counselors (Youth Fit for Life) on Fitness and Self-Efficacy Changes in 5-12-Year-Old Boys and Girls

    ERIC Educational Resources Information Center

    Annesi, James J.; Westcott, Wayne L.; Faigenbaum, Avery D.; Unruh, Jennifer L.

    2005-01-01

    To address reduced physical education (PE) in elementary schools, a 12-week physical activity protocol was tested on 5-12-year-old, primarily African American, girls (n = 226) and boys (n = 344) at 14 YMCA after-school care sites. The 3 times/week, 45-min session curriculum included cardiovascular, resistance, and flexibility training, in which…

  12. A 12-week double-blind study of the efficacy, safety and tolerance of pirazolac b.i.d. compared with indomethacin t.i.d. in patients with ankylosing spondylitis.

    PubMed

    Carcassi, C; La Nasa, G; Perpignano, G

    1990-01-01

    A 12-week trial was carried out to compare the efficacy of pirazolac (300-600 mg b.i.d.) with that of indomethacin (25-50 mg t.i.d.) in patients with ankylosing spondylitis. A total of 119 patients completed the treatment period, with 32 drop-outs. Both therapies showed significant improvements in clinical symptoms. PMID:2198157

  13. Development of opioid-induced constipation: post hoc analysis of data from a 12-week prospective, open-label, blinded-endpoint streamlined study in low-back pain patients treated with prolonged-release WHO step III opioids

    PubMed Central

    Ueberall, Michael A; Mueller-Schwefe, Gerhard HH

    2015-01-01

    OXN and was significantly superior to those seen with OXY (32.8% [98/300]) (odds ratio [OR]: 2.47, 95% confidence interval [CI]: 1.77–3.44; P<0.001) or MOR (29.7% [89/300]) (OR: 2.84, 95% CI: 2.03–3.97; P<0.001). Absolute BFI changes of ≥12mm 100 mm horizontal visual analog scale (VAS100) vs. baseline were seen for OXN in 41.4%, for OXY in 68.7%, and for MOR in 72.3%. Complete spontaneous bowel movements decreased at least by one per week in 10.3% with OXN vs 42.3% for OXY (OR: 6.39, 95% CI 4.13–9.89; P<0.001) and 42.0% for MOR (OR: 6.31, 95% CI: 4.08–9.76; P<0.001). Overall, 359 treatment emergent adverse events (78 [OXN], 134 [OXY], and 147 [MOR]) in 204 patients (41 [OXN], 80 [OXY], and 83 [MOR]) occurred, most affecting the gastrointestinal (49.3%) and the nervous system (39.3%). Treatment contrasts between randomized vs nonrandomized patients were insignificant. Conclusion In this post hoc analysis of data from a real-life 12-week study, OXN treatment was associated with a significantly lower risk of opioid-induced constipation, superior tolerability, and significantly better analgesic efficacy compared with OXY and MOR. PMID:26300655

  14. Effects of feeding transgenic corn with mCry1Ac or maroACC gene to laying hens for 12 weeks on growth, egg quality and organ health.

    PubMed

    Zhong, R Q; Chen, L; Gao, L X; Zhang, L L; Yao, B; Yang, X G; Zhang, H F

    2016-08-01

    The objective of the present study was to investigate the effect of feeding two transgenic corn lines containing the mCry1Ac gene from Bacillus thuringiensis strain (BT-799) and the maroACC gene from Agrobacterium tumefaciens strain (CC-2), respectively, on growth, egg quality and organ health indicators. Expression of the mCry1Ac gene confers resistance to Pyrausta nubilalis and the maroACC gene confers tolerance to herbicides. Healthy hens (n=96 placed in cages; 3 hens/cage) were randomly assigned to one of four corn-soybean meal dietary treatments (8 cages/treatment) formulated with the following corn: non-transgenic near-isoline control corn (control), BT-799 corn, CC-2 corn and commercially available non-transgenic reference corn (reference). The experiment was divided into three 4-week phases (week 1 to 4, week 5 to 8 and week 9 to 12), during which hens were fed mash diets. Performance (BW, feed intake and egg production) and egg quality were determined. Following slaughter at the end of 12 weeks of feeding (n=8/treatment), carcass yield and organ weights (heart, liver, spleen, lung, kidneys, stomach and ovary) were recorded; organs and intestines were sampled for histological analysis. Analysis of serum biochemistry parameters to assess the liver and kidney function were performed. No differences in BW, egg production and production efficiency were observed between hens consuming the control diet and hens consuming the BT-799 or CC-2 diet. Haugh unit measures and egg component weights were similar between the control and test groups. Carcass yield was not affected by the diet treatment. Similar organosomatic indices and serum parameters did not indicate the characteristics of organ dysfunction. All observed values of the BT-799 and CC-2 groups were within the calculated tolerance intervals. This research indicates that the performance, egg quality, organ health and carcass yield of laying hens fed diets containing the BT-799 or CC-2 corn line were similar

  15. Differences between men and women in dietary intakes and metabolic profile in response to a 12-week nutritional intervention promoting the Mediterranean diet.

    PubMed

    Leblanc, Vicky; Hudon, Anne-Marie; Royer, Marie-Michelle; Corneau, Louise; Dodin, Sylvie; Bégin, Catherine; Lemieux, Simone

    2015-01-01

    Few studies have compared men and women in response to nutritional interventions but none has assessed differences between men and women in the response to a nutritional intervention programme based on the self-determination theory (SDT) and using the Mediterranean diet (MedDiet) as a model of healthy eating, in a context of CVD prevention and within a non-Mediterranean population. The present study aimed to document differences between men and women in changes in dietary, anthropometric and metabolic variables, in response to a nutritional intervention programme promoting the adoption of the MedDiet and based on the SDT. A total of sixty-four men and fifty-nine premenopausal women presenting risk factors for CVD were recruited through different media advertisements in the Québec City Metropolitan area (Canada). The 12-week nutritional programme used a motivational interviewing approach and included individual and group sessions. A validated FFQ was administered to evaluate dietary intakes from which a Mediterranean score (Medscore) was derived. Both men and women significantly increased their Medscore in response to the intervention (P < 0·0001). Men showed a significantly greater decrease in red and processed meat (-0·4 (95 % CI -0·7, -0·1) portions per d) and a greater increase in fruit (0·9 (95 % CI 0·2, 1·6) portions per d) intakes than women. Significant decreases were observed for BMI and waist circumference in both men and women (P ≤ 0·04). Significant greater decreases were found for total cholesterol (total-C):HDL-cholesterol (HDL-C) (-0·2; 95 % CI -0·4, -0·03) and TAG:HDL-C (-0·2; 95 % CI -0·4, -0·04) ratios in men than in women. When adjusting for the baseline value of the response variable, differences between men and women became non-significant for red and processed meat and fruit intakes whereas significant differences between men and women (i.e. larger increases in men than women) were observed for legumes, nuts and seeds (0·6

  16. DNA damage as an intermediate biomarker in intervention studies.

    PubMed

    Santella, R M

    1997-11-01

    The development of sensitive assays for measurement of DNA damage in humans has great potential for enhancing intervention studies. Methods for DNA adduct measurement include immunoassays, [32p] postlabeling, high-performance liquid chromatography with fluorescence or electrochemical detection, and gas chromatography/mass spectroscopy. It is now well established that DNA adducts are a marker of exposure to various environmental, lifestyle, or occupational chemical carcinogens. Our own studies concentrate on immunologic detection of adducts by enzyme-linked immunosorbent assay (ELISA) of isolated DNA or quantitative immunohistochemical analysis of intact cells. Polycyclic aromatic hydrocarbon (PAH)-DNA adducts are elevated in blood cells of foundry and coke oven workers, individuals with high levels of exposure to environmental air pollution, and smokers. The study in smokers also found an inverse relationship between serum antioxidants and PAH-DNA, and is the basis for an ongoing antioxidant intervention. DNA adducts of PAH and 4-aminobiphenyl and oxidative DNA damage (8-oxo-deoxyguanosine) are being measured in blood mononuclear cells and exfoliated oral and bladder cells from subjects on antioxidants or placebo. Data on published intervention studies investigating oxidative damage and general aromatic DNA adducts measured by postlabeling are also summarized. These studies have already demonstrated that DNA adducts can be modulated by interventions and suggest that they can provide important mechanistic information in support of larger scale studies. PMID:9349685

  17. Adding Qualitative and Mixed Methods Research to Health Intervention Studies: Interacting With Differences.

    PubMed

    Johnson, R Burke; Schoonenboom, Judith

    2016-04-01

    The purpose of this article is to explain how to improve intervention designs, such as randomized controlled trials (RCTs), in health science research using a process philosophy and theory known as dialectical pluralism (DP). DP views reality as plural and uses dialectical, dialogical, and hermeneutical approaches to knowledge construction. Using DP and its "both/and" logic, and its attempt to produce new creative syntheses, researchers on heterogeneous teams can better dialogue with qualitative and mixed methods approaches, concepts, paradigms, methodologies, and methods to improve their intervention research studies. The concept of reflexivity is utilized but is expanded when it is a component of DP. Examples of strategies for identifying, inviting, and creating divergence and integrative strategies for producing strong mixed methods intervention studies are provided and illustrated using real-life examples. PMID:26657970

  18. Recruitment to a physical activity intervention study in women at increased risk of breast cancer

    PubMed Central

    2009-01-01

    Background Physical activity is being studied as a breast cancer prevention strategy. Women at risk of breast cancer report interest in lifestyle modification, but recruitment to randomized physical activity intervention studies is challenging. Methods We conducted an analysis of recruitment techniques used for a prospective, randomized pilot study of physical activity in women at risk of breast cancer. We evaluated differences in proportion of eligible patients, enrolled patients, and successful patients identified by each individual recruitment method. The Fisher-Freeman-Halton test (an extension of Fisher's exact test from 2 × 2 tables to general row by column tables) was used to compare the success of different recruitment strategies. Results We received 352 inquiries from women interested in participating, of whom 171 (54%) were eligible. Ninety-nine women completed a baseline activity evaluation, and 58 (34% of eligible; 16% of total inquiries) were randomized. Recruitment methods fell into three broad categories: media techniques, direct contact with potential participants, and contacts with health care providers. Recruitment strategies differed significantly in their ability to identify eligible women (p = 0.01), and women who subsequently enrolled in the study (p = 0.02). Conclusion Recruitment techniques had varying success. Our data illustrate the challenges in recruiting to behavior modification studies, and provide useful information for tailoring future recruitment efforts for lifestyle intervention trials. Trial Registration No(s) CDR0000393790, NCI-04-C-0276, NCI-NAVY-B05-001 PMID:19397816

  19. Impact of Individualized Diet Intervention on Body Composition and Respiratory Variables in Children with Respiratory Insufficiency- a Pilot Intervention Study

    PubMed Central

    Martinez, Enid E; Bechard, Lori J; Smallwood, Craig D; Duggan, Christopher P; Graham, Robert J; Mehta, Nilesh M

    2015-01-01

    Objective Diet modification may improve body composition and respiratory parameters in children with respiratory insufficiency. Our objective was to examine the effect of an individualized diet intervention on changes in weight, lean body mass (LBM), minute ventilation (MV) and carbon dioxide production (VCO2) in children on home mechanical ventilator support. Design Prospective, open-labeled interventional study. Setting Study subjects' homes Patients Children, ages 1 month to 17 years, dependent on at least 12 hours per day of transtracheal mechanical ventilator support. Intervention Twelve weeks of an individualized diet modified to deliver energy at 90-110% of measured energy expenditure (MEE) and protein intake per age-based guidelines. Measurements & Main Results During a multidisciplinary home visit we obtained baseline values of height and weight, LBM% by bioelectrical impedance analysis, actual energy and protein intake by food record, and MEE by indirect calorimetry. An individualized diet was then prescribed to optimize energy and protein intake. After 12 weeks on this interventional diet we evaluated changes in weight, height, LBM%, MV and VCO2. Sixteen subjects, mean age 9.3y (SD 4.9), 8 male, completed the study. For the diet intervention, a majority of subjects required a change in energy and protein prescription. The mean percentage of energy delivered as carbohydrate was significantly decreased, 51.7% at baseline vs. 48.2% at follow-up, p=0.009. Mean height and weight increased on the modified diet. Mean LBM% increased from 58.3% to 61.8%. MV was significantly lower (0.18 L/min/kg vs. 0.15 L/min/kg, p=0.04) and we observed a trend towards lower VCO2 (5.4 ml/min*kg vs. 5.3 ml/min*kg, p=0.06) after 12 weeks on the interventional diet. Conclusions Individualized diet modification is feasible and associated with a significant decrease in minute ventilation, a trend towards significant reduction in carbon dioxide production, and improved body

  20. Efficacy of Yoga for Vasomotor Symptoms: A Randomized Controlled Trial

    PubMed Central

    Newton, Katherine M.; Reed, Susan D.; Guthrie, Katherine A.; Sherman, Karen J.; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S.; Learman, Lee A.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Anderson, Garnet L.; Larson, Joseph C.; Hunt, Julie R.; Ensrud, Kristine E.; LaCroix, Andrea Z.

    2013-01-01

    Objective To determine the efficacy of yoga in alleviating VMS frequency and bother. Methods Three by two factorial design, randomized, controlled. Eligible women were randomized to yoga (n=107), exercise (n=106), or usual activity (n=142), and were simultaneously randomized to double-blind comparison of omega-3 fatty acid (n=177) or placebo (n=178) capsules. Yoga intervention was twelve, weekly, 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Results Among 249 randomized women, 237 (95%) completed 12-week assessments. Mean baseline VMS frequency was 7.4/day (95% CI 6.6, 8.1) in the yoga group and 8.0/day (95% CI 7.3, 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n=237). There was no difference between intervention groups in change in VMS frequency from baseline to 6 and 12 weeks (mean difference (yoga – usual activity) from baseline −0.3 (95% CI −1.1, 0.5) at 6 weeks and −0.3 (95% CI −1.2, 0.6) at 12 weeks (p=0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga-usual activity] in change –Insomnia Severity Index, 1.3 [95% CI −2.5, −0.1][p=0.007]). Conclusion Among healthy women, 12 weeks of yoga class plus home practice compared with usual activity did not improve VMS frequency or bother, but reduced insomnia symptoms. PMID:24045673

  1. Results of a quality control on non-interventional studies

    PubMed Central

    Wörz, Karl; Hundt, Ferdinand

    2011-01-01

    Non-interventional studies (NIS) have for decades been an established part of post-authorisation medicinal research. As early as the mid-nineties, there were at least rudimentary demands for controllable data quality. Beginning with the recommendations of the Federal Institute for Drugs and Medical Devices (BfArM) on the execution of non interventional (observational) studies of 1998 and finally with the guidelines and recommendations for ensuring Good Epidemiological Practice (GEP), with the VFA (Verband der forschenden Arzneimittelhersteller [German Association of Research-Based Pharmaceutical Companies]) – Recommendations for the Improvement of Quality and Transparency of NIS and the joint recommendations of BfArM and PEI (Paul-Ehrlich-Institut) on the execution of NIS, pharmaceutical companies are required to monitor and/or verify quality in the course of a project. According to a survey of pharmaceutical companies 2010, about one third of the companies surveyed to date carry out such quality controls on site, at participating study centres. This report deals with the results of such quality control measures in 4 completed projects. The control rates defined in the respective cohort study plans, the measures carried out on site and any consequent measures, such as adjustment of forms, reduction of consultation time and necessary organisational changes are described. A high level of agreement between the data collected and the original patient documents is found, comparable to that in clinical trials. PMID:21863135

  2. Results of a quality control on non-interventional studies.

    PubMed

    Wörz, Karl; Hundt, Ferdinand

    2011-01-01

    Non-interventional studies (NIS) have for decades been an established part of post-authorisation medicinal research. As early as the mid-nineties, there were at least rudimentary demands for controllable data quality. Beginning with the recommendations of the Federal Institute for Drugs and Medical Devices (BfArM) on the execution of non interventional (observational) studies of 1998 and finally with the guidelines and recommendations for ensuring Good Epidemiological Practice (GEP), with the VFA (Verband der forschenden Arzneimittelhersteller [German Association of Research-Based Pharmaceutical Companies]) - Recommendations for the Improvement of Quality and Transparency of NIS and the joint recommendations of BfArM and PEI (Paul-Ehrlich-Institut) on the execution of NIS, pharmaceutical companies are required to monitor and/or verify quality in the course of a project. According to a survey of pharmaceutical companies 2010, about one third of the companies surveyed to date carry out such quality controls on site, at participating study centres. This report deals with the results of such quality control measures in 4 completed projects. The control rates defined in the respective cohort study plans, the measures carried out on site and any consequent measures, such as adjustment of forms, reduction of consultation time and necessary organisational changes are described. A high level of agreement between the data collected and the original patient documents is found, comparable to that in clinical trials. PMID:21863135

  3. Intervention studies on Mediterranean diet and cardiovascular risk.

    PubMed

    Lairon, Denis

    2007-10-01

    The traditional Mediterranean diet, as studied in the 1950s to 1960s in the South of Europe, is characterized by moderate energy intake, low animal fat, high olive oil, high cereals, high legumes, nuts and vegetables, and regular and moderate wine. A Mediterranean-type diet is being developed to mimic the traditional one and fit with present life style. While numerous epidemiological studies have supported the concept that adherence to the traditional Mediterranean diet is beneficial for health and particularly protects against cardiovascular disease, the limited number of intervention studies in this field have not yet provided major support. Nevertheless, the dietary interventions performed until now have demonstrated that adoption of a Mediterranean-type diet reduces several cardiovascular risk factors in subjects at risk (primary prevention) and/or cardiovascular events or mortality in patients after a first cardiac event (secondary prevention). Among numerous foodstuffs characterizing the Mediterranean diet, virgin olive oil has been shown to display beneficial effects on a wide range of risk factors. PMID:17879996

  4. Liquid versus gel handrub formulation: a prospective intervention study

    PubMed Central

    Traore, Ousmane; Hugonnet, Stéphane; Lübbe, Jann; Griffiths, William; Pittet, Didier

    2007-01-01

    Introduction Hand hygiene is one of the cornerstones of the prevention of health care-associated infection, but health care worker (HCW) compliance with good practices remains low. Alcohol-based handrub is the new standard for hand hygiene action worldwide and usually requires a system change for its successful introduction in routine care. Product acceptability by HCWs is a crucial step in this process. Methods We conducted a prospective intervention study to compare the impact on HCW compliance of a liquid (study phase I) versus a gel (phase II) handrub formulation of the same product during daily patient care. All staff (102 HCWs) of the medical intensive care unit participated. Compliance with hand hygiene was monitored by a single observer. Skin tolerance and product acceptability were assessed using subjective and objective scoring systems, self-report questionnaires, and biometric measurements. Logistic regression was used to estimate the association between predictors and compliance with the handrub formulation as the main explanatory variable and to adjust for potential risk factors. Results Overall compliance (phases I and II) with hand hygiene practices among nurses, physicians, nursing assistants, and other HCWs was 39.1%, 27.1%, 31.1%, and 13.9%, respectively (p = 0.027). Easy access to handrub improved compliance (35.3% versus 50.6%, p = 0.035). Nurse status, working on morning shifts, use of the gel formulation, and availability of the alcohol-based handrub in the HCW's pocket were independently associated with higher compliance. Immediate accessibility was the strongest predictor. Based on self-assessment, observer assessment, and the measurement of epidermal water content, the gel performed significantly better than the liquid formulation. Conclusion Facilitated access to an alcohol-based gel formulation leads to improved compliance with hand hygiene and better skin condition in HCWs. PMID:17477858

  5. No effect of 12 weeks' supplementation with 1 g DHA-rich or EPA-rich fish oil on cognitive function or mood in healthy young adults aged 18-35 years.

    PubMed

    Jackson, Philippa A; Deary, Michael E; Reay, Jonathon L; Scholey, Andrew B; Kennedy, David O

    2012-04-01

    The n-3 PUFA are a unique class of fatty acids that cannot be manufactured by the body, and must be acquired via dietary sources. In the UK, as well as in other Western nations, these 'essential' fatty acids are consumed in quantities that fall below government guidelines. The present study explored the effects of 12 weeks' dietary supplementation with 1 g/d of two types of fish oil (FO; DHA-rich and EPA-rich) in 159 healthy young adults aged 18-35 years. An assessment of performance on a battery of computerised cognitive tasks and mood measures took place before and following the 12-week treatment regimen. Venous blood samples were also supplied by participants at both time points which were later analysed for serum fatty acid concentrations. Despite good adherence to the study protocol - as reflected in increased concentrations of n-3 serum fatty acids - compared with placebo, the observed effects of both active treatments were minimal. The only finding of note revealed that supplementation with EPA-rich FO may reduce subjective mental fatigue at times of high cognitive demand, although further investigation is required. These findings, taken together with other recent reports of null effects, suggest that dietary supplementation with n-3 PUFA in healthy, normally developing and impairment-free populations is unlikely to result in cognitive enhancement. PMID:21864417

  6. Dietary Antioxidants and Melanoma: Evidence from Cohort and Intervention Studies.

    PubMed

    Miura, Kyoko; Green, Adèle C

    2015-01-01

    Melanoma is the most serious form of skin cancer affecting mostly people of Caucasian origin and is associated with high exposure to solar ultraviolet (UV) radiation. Antioxidants in the diet are thought to prevent UV-induced DNA damage and oxidative stress and laboratory-based studies have shown that high antioxidant intakes inhibit melanoma development. Corresponding epidemiological evidence is inconsistent, however. We therefore reviewed results from prospective observational studies and randomized controlled trials (RCTs) to clarify whether consumption of antioxidant vitamin C, E (tocopherol), and A (retinol), carotenoids and selenium, as food, supplements, or both, or high fruit and vegetable intake, reduce the incidence of cutaneous melanoma. A total of 9 studies (2 cohort, 1 nested case-control, 6 RCTs) were included. Neither antioxidant nutrients, individually or combined, nor fruit and vegetable intake showed any strong and significant associations with melanoma, though the number of relevant studies was limited and several had methodological shortcomings. In particular, melanoma was not a primary disease outcome in any of the RCTs and therefore, none adequately accounted for potential confounding by sun exposure. In conclusion, available evidence is currently inadequate to assess possible beneficial effects of antioxidant intake on melanoma risk. PMID:26147450

  7. A 12-week worksite health promotion program reduces cardiovascular risk factors in male workers with the apolipoprotein E2 and apolipoprotein E3 genotypes, but not in apolipoprotein E4 genotype.

    PubMed

    Cho, Sang-Woon; Kang, Ji-Yeon; Park, Yoo-Kyoung; Paek, Yun-Mi; Choi, Tae-In

    2009-08-01

    Worksite health promotion programs focusing on diet and lifestyle modification have been shown to improve health outcomes in workers. The purpose of this study was to investigate whether a 12-week worksite health promotion program shows different response of cardiovascular risk factors in subjects according to apolipoprotein E (Apo E) genotype and obesity level in 141 male Korean industrial workers. We hypothesized that the health changes of a 12-week intervention may not be the same within Apo E genotypes in nonobese and obese subjects. They received 5 face-to-face meetings based on their health profiles. In obese group carrying Apo E3 genotype, body mass index, body fat (%), waist circumference, waist-hip ratio, and systolic blood pressure were decreased, as well as intakes of energy (P = .000) and carbohydrate (P = .005). High-density lipoprotein cholesterol (P = .004) level was improved in individuals with the Apo E2 genotype. These beneficial effects were only observed in individuals with the Apo E2 or Apo E3 genotype. Multiple linear regression revealed that obesity was strongly correlated with waist circumference (P = .002), plasma total cholesterol (P = .037), and changes in dietary cholesterol intake (P = .011) in individuals with the Apo E3 genotype, whereas only changes in dietary fat intake (P = .044) was correlated in those with the Apo E4 genotype. Overall, the results of this study suggest that a health promotion program can be a useful method of improving cardiovascular risk factors and dietary intake in industrial workers with certain genotypes only. Therefore, further research is needed to develop a tailored, long-term worksite health promotion program based on genetic background. PMID:19761888

  8. Taking a Low Glycemic Index Multi-Nutrient Supplement as Breakfast Improves Glycemic Control in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial

    PubMed Central

    Li, Di; Zhang, Peiwen; Guo, Honghui; Ling, Wenhua

    2014-01-01

    Dietary therapy is the mainstay of treatment for diabetes. This study examined the effect of a low glycemic index (GI) multi-nutrient supplement, consumed in place of breakfast, on glycemic control in patients with type 2 diabetes mellitus (T2DM). A total of 71 participants were randomized at a 2:1 ratio into either a breakfast replacement group or a normal breakfast group for a 12-week interventional study. The primary outcome measure was change in hemoglobin A1c (HbA1c). Nutrition status and somatometry were studied as secondary outcomes. The breakfast replacement group displayed a −0.2% absolute reduction in HbA1c (95% CI (confidence interval), −0.38% to −0.07%, p = 0.004), while the HbA1c of the control group increased 0.3% (95% CI, 0.1% to 0.5%, p = 0.005). The baseline Mini Nutritional Assessment score for both groups was 26.0 and no significant changes occurred following intervention. However, there was a statistically significant difference in body mass index between the treatment and control groups (p = 0.032) due to the weight gain in the control group (increased 0.5 kg, 95% CI was 0.2 to 0.9, p = 0.007). These data suggest that breakfast replacement with a low GI multi-nutrient supplement can improve glycemic and weight control in T2DM. PMID:25514391

  9. Taking a low glycemic index multi-nutrient supplement as breakfast improves glycemic control in patients with type 2 diabetes mellitus: a randomized controlled trial.

    PubMed

    Li, Di; Zhang, Peiwen; Guo, Honghui; Ling, Wenhua

    2014-12-01

    Dietary therapy is the mainstay of treatment for diabetes. This study examined the effect of a low glycemic index (GI) multi-nutrient supplement, consumed in place of breakfast, on glycemic control in patients with type 2 diabetes mellitus (T2DM). A total of 71 participants were randomized at a 2:1 ratio into either a breakfast replacement group or a normal breakfast group for a 12-week interventional study. The primary outcome measure was change in hemoglobin A1c (HbA1c). Nutrition status and somatometry were studied as secondary outcomes. The breakfast replacement group displayed a -0.2% absolute reduction in HbA1c (95% CI (confidence interval), -0.38% to -0.07%, p = 0.004), while the HbA1c of the control group increased 0.3% (95% CI, 0.1% to 0.5%, p = 0.005). The baseline Mini Nutritional Assessment score for both groups was 26.0 and no significant changes occurred following intervention. However, there was a statistically significant difference in body mass index between the treatment and control groups (p = 0.032) due to the weight gain in the control group (increased 0.5 kg, 95% CI was 0.2 to 0.9, p = 0.007). These data suggest that breakfast replacement with a low GI multi-nutrient supplement can improve glycemic and weight control in T2DM. PMID:25514391

  10. Dietary arginine and linear growth: the Copenhagen School Child Intervention Study.

    PubMed

    van Vught, Anneke J A H; Dagnelie, Pieter C; Arts, Ilja C W; Froberg, Karsten; Andersen, Lars B; El-Naaman, Bianca; Bugge, Anna; Nielsen, Birgit M; Heitman, Berit L

    2013-03-28

    The amino acid arginine is a well-known growth hormone (GH) stimulator and GH is an important modulator of linear growth. The aim of the present study was to investigate the effect of dietary arginine on growth velocity in children between 7 and 13 years of age. Data from the Copenhagen School Child Intervention Study during 2001-2 (baseline), and at 3-year and 7-year follow-up, were used. Arginine intake was estimated via a 7 d precoded food diary at baseline and 3-year follow-up. Data were analysed in a multilevel structure in which children were embedded within schools. Random intercept and slopes were defined to estimate the association between arginine intake and growth velocity, including the following covariates: sex; age; baseline height; energy intake; puberty stage at 7-year follow-up and intervention/control group. The association between arginine intake and growth velocity was significant for the third and fourth quintile of arginine intake (2.5-2.8 and 2.8-3.2 g/d, respectively) compared with the first quintile ( < 2.2 g/d) (P for trend = 0.04). Protein intake (excluding arginine) was significantly associated with growth velocity; however, the association was weaker than the association between arginine intake and growth velocity (P for trend = 0.14). The results of the present study suggest a dose-dependent physiological role of habitual protein intake, and specifically arginine intake, on linear growth in normally growing children. However, since the study was designed in healthy children, we cannot firmly conclude whether arginine supplementation represents a relevant clinical strategy. Further research is needed to investigate whether dietary arginine may represent a nutritional strategy potentially advantageous for the prevention and treatment of short stature. PMID:23046689

  11. Vestibular Stimulation for ADHD: Randomized Controlled Trial of Comprehensive Motion Apparatus

    ERIC Educational Resources Information Center

    Clark, David L.; Arnold, L. Eugene; Crowl, Lindsay; Bozzolo, Hernan; Peruggia, Mario; Ramadan, Yaser; Bornstein, Robert; Hollway, Jill A.; Thompson, Susan; Malone, Krista; Hall, Kristy L.; Shelton, Sara B.; Bozzolo, Dawn R.; Cook, Amy

    2008-01-01

    Objective: This research evaluates effects of vestibular stimulation by Comprehensive Motion Apparatus (CMA) in ADHD. Method: Children ages 6 to 12 (48 boys, 5 girls) with ADHD were randomized to thrice-weekly 30-min treatments for 12 weeks with CMA, stimulating otoliths and semicircular canals, or a single-blind control of equal duration and…

  12. Lower extremity power training in elderly subjects with moderate mobility limitations: A randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Fifty-seven community-dwelling older adults were randomized to either high-velocity high-power training (POW), slow-velocity progressive resistance training (STR) or a control group of lower extremity stretching (CON). Training was performed three times per week for 12 weeks and subjects completed t...

  13. Supervised Home Training of Dialogue Skills in Chronic Aphasia: A Randomized Parallel Group Study

    ERIC Educational Resources Information Center

    Nobis-Bosch, Ruth; Springer, Luise; Radermacher, Irmgard; Huber, Walter

    2011-01-01

    Purpose: The aim of this study was to prove the efficacy of supervised self-training for individuals with aphasia. Linguistic and communicative performance in structured dialogues represented the main study parameters. Method: In a cross-over design for randomized matched pairs, 18 individuals with chronic aphasia were examined during 12 weeks of…

  14. Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

    ERIC Educational Resources Information Center

    McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

    2008-01-01

    No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

  15. A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

    2011-01-01

    We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

  16. Parent Training for Young Children with Developmental Disabilities: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    McIntyre, Laura Lee

    2008-01-01

    A randomized controlled trial was used to evaluate a parent training intervention for caregivers with preschool-age children with developmental disabilities. The 21 families in the experimental group received usual care plus the 12-week Incredible Years Parent Training Program with developmental delay modifications. Families in the control group…

  17. Fluoxetine, Smoking, and History of Major Depression: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Spring, Bonnie; Doran, Neal; Pagoto, Sherry; McChargue, Dennis; Cook, Jessica Werth; Bailey, Katherine; Crayton, John; Hedeker, Donald

    2007-01-01

    The study was a randomized placebo-controlled trial testing whether fluoxetine selectively enhances cessation for smokers with a history of depression. Euthymic smokers with (H+, n = 109) or without (H-, n = 138) a history of major depression received 60 mg fluoxetine or placebo plus group behavioral quit-smoking treatment for 12 weeks. Fluoxetine…

  18. Depressor and Anti-Inflammatory Effects of Angiotensin II Receptor Blockers in Metabolic and/or Hypertensive Patients With Coronary Artery Disease: A Randomized, Prospective Study (DIAMOND Study)

    PubMed Central

    Adachi, Sen; Miura, Shin-ichiro; Shiga, Yuhei; Arimura, Tadaaki; Kuwano, Takashi; Kitajima, Ken; Ike, Amane; Sugihara, Makoto; Iwata, Atsushi; Nishikawa, Hiroaki; Morito, Natsumi; Saku, Keijiro

    2016-01-01

    Background We compared the efficacy and safety of azilsartan to those of olmesartan in a prospective, randomized clinical trial. Methods Forty-four hypertensive patients who had coronary artery disease (CAD) were enrolled. We randomly assigned patients to changeover from their prior angiotensin II receptor blockers (ARBs) to either azilsartan or olmesartan, and followed the patients for 12 weeks. Results Office systolic blood pressure (SBP) in the azilsartan group was significantly decreased after 12 weeks. SBP and diastolic blood pressure (DBP) after 12 weeks in the azilsartan group were significantly lower than those in the olmesartan group. The percentage of patients who reached the target BP at 12 weeks (78%) in the azilsartan group was significantly higher than that at 12 weeks (45%) in the olmesartan group. There were no significant changes in pentraxin-3, high-sensitively C-reactive protein or adiponectin in blood after 12 weeks in either group. Although serum levels of creatinine (Cr) in the azilsartan group significantly increased, these changes were within the respective normal range. Conclusion In conclusion, the ability of azilsartan to reduce BP may be superior to that of prior ARBs with equivalent safety in hypertensive patients with CAD.

  19. Children's physical activity levels during school recess: a quasi-experimental intervention study

    PubMed Central

    Ridgers, Nicola D; Stratton, Gareth; Fairclough, Stuart J; Twisk, Jos WR

    2007-01-01

    effect for younger children, and longer daily recess duration enabled children to engage in more MVPA following the intervention. This study concludes that the process of increasing recess physical activity is complex when school and pupil-level covariates are considered, though they should be taken into account when investigating the effects of playground intervention studies on children's physical activity during recess. PMID:17517136

  20. Invited review: Recommendations for reporting intervention studies on reproductive performance in dairy cattle: Improving design, analysis, and interpretation of research on reproduction.

    PubMed

    Lean, Ian J; Lucy, Matthew C; McNamara, John P; Bradford, Barry J; Block, Elliot; Thomson, Jennifer M; Morton, John M; Celi, Pietro; Rabiee, Ahmad R; Santos, José E P; Thatcher, William W; LeBlanc, Stephen J

    2016-01-01

    Abundant evidence from the medical, veterinary, and animal science literature demonstrates that there is substantial room for improvement of the clarity, completeness, and accuracy of reporting of intervention studies. More rigorous reporting guidelines are needed to improve the quality of data available for use in comparisons of outcomes (or meta-analyses) of multiple studies. Because of the diversity of factors that affect reproduction and the complexity of interactions between these, a systematic approach is required to design, conduct, and analyze basic and applied studies of dairy cattle reproduction. Greater consistency, clarity, completeness, and correctness of design and reporting will improve the value of each report and allow for greater depth of evaluation in meta-analyses. Each of these benefits will improve understanding and application of current knowledge and better identify questions that require additional modeling or primary research. The proposed guidelines and checklist will aid in the design, conduct, analysis, and reporting of intervention studies. We propose an adaptation of the REFLECT (Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety) statement to provide guidelines and a checklist specific to reporting intervention studies in dairy cattle reproduction. Furthermore, we provide recommendations that will assist investigators to produce studies with greater internal and external validity that can more often be included in systematic reviews and global meta-analyses. Such studies will also assist the development of models to describe the physiology of reproduction. PMID:26387020

  1. Outcome of Youth with Early-Phase Schizophrenia-Spectrum Disorders and Psychosis Not Otherwise Specified Treated with Second-Generation Antipsychotics: 12 Week Results from a Prospective, Naturalistic Cohort Study

    PubMed Central

    Vernal, Ditte L.; Kapoor, Sandeep; Al-Jadiri, Aseel; Sheridan, Eva M.; Borenstein, Yehonathan; Mormando, Charles; David, Lisa; Singh, Sukhbir; Seidman, Andrew J.; Carbon, Maren; Gerstenberg, Miriam; Saito, Ema; Kane, John M.; Steinhausen, Hans-Christoph

    2015-01-01

    Abstract Objectives: The purpose of this study was to assess differences in the outcomes of youth with schizophrenia-spectrum disorders (SCZ-S) and psychotic disorder not otherwise specified (PsyNOS) during early antipsychotic treatment. Methods: The study was a prospective, naturalistic, inception cohort study of youth ≤19 years old with SCZ-S (schizophrenia, schizoaffective disorder, schizophreniform disorder) or PsyNOS (PsyNOS, brief psychotic disorder) and ≤24 months of lifetime antipsychotic treatment receiving clinician's choice antipsychotic treatment. Baseline demographic, illness and treatment variables, and effectiveness outcomes were compared at 12 weeks last-observation-carried-forward across SCZ-S and PsyNOS patients, adjusting for significantly different baseline variables. Results: Altogether, 130 youth with SCZ-S (n=42) or PsyNOS (n=88), mostly antipsychotic naïve (76.9%), were prescribed risperidone (47.7%), olanzapine (19.2%), aripiprazole (14.6%), quetiapine (11.5%), or ziprasidone (6.9%). Compared with those with PsyNOS, SCZ-S youth were older (16.4±2.1 vs. 14.8±3.2, p=0.0040), and less likely to be Caucasian (19.1% vs. 42.5%, p=0.009). At baseline, SCZ-S patients had significantly higher Clinical Global Impressions-Severity (CGI-S) scores (6.0±0.9 vs. 5.5±0.8, p=0.0018) and lower Children's Global Assessment Scale (CGAS) scores (29.6±9.2 vs. 36.1±8.9, p=0.0002) and were more likely to be in the severely ill CGAS group (i.e., CGAS≤40). SCZ-S and PsyNOS patients did not differ regarding all-cause discontinuation (40.5 vs. 40.3%. p=0.49), discontinuation because of adverse effects (12.2% vs. 12.4%, p=0.97), or nonadherence (29.3% vs. 30.9%, p=0.88), but somewhat more SCZ-S patients discontinued treatment for inefficacy (19.5% vs. 7.4%, p=0.063). CGI-S and CGAS scores improved significantly in both diagnostic groups (p=0.0001, each). Adjusting for baseline differences, PsyNOS patients experienced significantly better CGI-I improvement

  2. FAST CP: protocol of a randomised controlled trial of the efficacy of a 12-week combined Functional Anaerobic and Strength Training programme on muscle properties and mechanical gait deficiencies in adolescents and young adults with spastic-type cerebral palsy

    PubMed Central

    Gillett, Jarred G; Lichtwark, Glen A; Boyd, Roslyn N; Barber, Lee A

    2015-01-01

    Introduction Individuals with cerebral palsy (CP) have muscles that are smaller, weaker and more resistant to stretch compared to typically developing people. Progressive resistance training leads to increases in muscle size and strength. In CP, the benefits of resistance training alone may not transfer to improve other activities such as walking; however, the transfer of strength improvements to improved mobility may be enhanced by performing training that involves specific functional tasks or motor skills. This study aims to determine the efficacy of combined functional anaerobic and strength training in (1) influencing muscle strength, structure and function and (2) to determine if any changes in muscle strength and structure following training impact on walking ability and gross motor functional capacity and performance in the short (following 3 months of training) and medium terms (a further 3 months post-training). Methods and analysis 40 adolescents and young adults with CP will be recruited to undertake a 12-week training programme. The training programme will consist of 3×75 min sessions per week, made up of 5 lower limb resistance exercises and 2–3 functional anaerobic exercises per session. The calf muscles will be specifically targeted, as they are the most commonly impacted muscles in CP and are a key muscle group involved in walking. If, as we believe, muscle properties change following combined strength and functional training, there may be long-term benefits of this type of training in slowing the deterioration of muscle function in people with spastic-type CP. Ethics and dissemination Ethical approval has been obtained from the ethics committees at The University of Queensland (2014000066) and Children's Health Queensland (HREC/15/QRCH/30). The findings will be disseminated by publications in peer-reviewed journals, conferences and local research organisations’ media. Trial registration number Australian and New Zealand Clinical Trials

  3. Efficacy and safety of the oral Janus kinase inhibitor peficitinib (ASP015K) monotherapy in patients with moderate to severe rheumatoid arthritis in Japan: a 12-week, randomised, double-blind, placebo-controlled phase IIb study

    PubMed Central

    Takeuchi, Tsutomu; Tanaka, Yoshiya; Iwasaki, Manabu; Ishikura, Hiroaki; Saeki, Satoshi; Kaneko, Yuichiro

    2016-01-01

    Objective To evaluate the efficacy, safety and dose response of a novel oral Janus kinase inhibitor, peficitinib (ASP015K), as monotherapy in Japanese patients with moderate to severe rheumatoid arthritis (RA). Methods In a 12-week, double-blind study, 281 adult patients with RA with active disease not on concomitant disease-modifying antirheumatic drug therapy were randomised equally to once-daily placebo or peficitinib 25, 50, 100 and 150 mg. The primary endpoint was American College of Rheumatology (ACR) 20 response in the peficitinib treatment groups versus placebo at week 12. Results Mean age was 53.0 years, 81.1% were female and 25.3% had previously used antitumour necrosis factor therapy. Peficitinib 50, 100 and 150 mg each showed statistically significantly higher ACR20 response rates compared with placebo, and response rates increased up to 150 mg with a statistically significant dose response. The total incidence of treatment-emergent adverse events (TEAEs) was similar between the placebo (64.3%) and peficitinib 25, 50, 100 and 150 mg groups (70.9%, 64.9%, 52.7% and 67.2%, respectively). TEAEs occurring more frequently in the peficitinib group compared with the placebo group included nasopharyngitis, increased blood creatine phosphokinase and diarrhoea. No cases of serious infections were reported. Herpes zoster occurred in four patients (two each in peficitinib 25 and 100 mg). Conclusions Treatment with peficitinib as monotherapy for 12 weeks in Japanese patients with moderate to severe RA is efficacious and showed acceptable safety profile. These findings support further developments of peficitinib for RA treatment. Trial registration number NCT01649999; Results. PMID:26672064

  4. Weight loss for women with and without polycystic ovary syndrome following a very low-calorie diet in a community-based setting with trained facilitators for 12 weeks

    PubMed Central

    Nikokavoura, Efsevia A; Johnston, Kelly L; Broom, John; Wrieden, Wendy L; Rolland, Catherine

    2015-01-01

    Background Polycystic ovary syndrome (PCOS) affects between 2% and 26% of reproductive-age women in the UK, and accounts for up to 75% of anovulatory infertility. The major symptoms include ovarian disruption, hyperandrogenism, insulin resistance, and polycystic ovaries. Interestingly, at least half of the women with PCOS are obese, with the excess weight playing a pathogenic role in the development and progress of the syndrome. The first-line treatment option for overweight/obese women with PCOS is diet and lifestyle interventions; however, optimal dietary guidelines are missing. Although many different dietary approaches have been investigated, data on the effectiveness of very low-calorie diets on PCOS are very limited. Materials and methods The aim of this paper was to investigate how overweight/obese women with PCOS responded to LighterLife Total, a commercial very low-calorie diet, in conjunction with group behavioral change sessions when compared to women without PCOS (non-PCOS). Results PCOS (n=508) and non-PCOS (n=508) participants were matched for age (age ±1 unit) and body mass index (body mass index ±1 unit). A 12-week completers analysis showed that the total weight loss did not differ significantly between PCOS (n=137) and non-PCOS participants (n=137) (−18.5±6.6 kg vs −19.4±5.7 kg, P=0.190). Similarly, the percentage of weight loss achieved by both groups was not significantly different (PCOS 17.1%±5.6% vs non-PCOS 18.2%±4.4%, P=0.08). Conclusion Overall, LighterLife Total could be an effective weight-loss strategy in overweight/obese women with PCOS. However, further investigations are needed to achieve a thorough way of understanding the physiology of weight loss in PCOS. PMID:26508882

  5. The Effect of Teacher Beliefs on Student Competence in Mathematical Modeling--An Intervention Study

    ERIC Educational Resources Information Center

    Mischo, Christoph; Maaß, Katja

    2013-01-01

    This paper presents an intervention study whose aim was to promote teacher beliefs about mathematics and learning mathematics and student competences in mathematical modeling. In the intervention, teachers received written curriculum materials about mathematical modeling. The concept underlying the materials was based on constructivist ideas and…

  6. A Replication by Any Other Name: A Systematic Review of Replicative Intervention Studies

    ERIC Educational Resources Information Center

    Cook, Bryan G.; Collins, Lauren W.; Cook, Sara C.; Cook, Lysandra

    2016-01-01

    Replication research is essential to scientific knowledge. Reviews of replication studies often electronically search for "replicat*" as a textword, which does not identify studies that replicate previous research but do not self-identify as such. We examined whether the 83 intervention studies published in six non-categorical research…

  7. Treatment Integrity: A Review of Intervention Studies Conducted with Children with Autism

    ERIC Educational Resources Information Center

    Wheeler, John J.; Baggett, Bob A.; Fox, James; Blevins, Leia

    2006-01-01

    The purpose of this study was to assess the degree to which behavioral intervention studies conducted with children diagnosed with autism operationally defined the independent variables (IVs) and evaluated treatment integrity (TI). The study replicated the criteria from Gresham, Gansle, and Noell (1993) and focused exclusively on research studies…

  8. Experimental Intervention Studies on Word Problem Solving and Math Disabilities: A Selective Analysis of the Literature

    ERIC Educational Resources Information Center

    Zheng, Xinhua; Flynn, Lindsay J.; Swanson, H. Lee

    2013-01-01

    This article provides a quantitative synthesis of the published literature on word problem solving intervention studies for children with math disabilities (MD). Seven group and eight single-subject design studies met inclusion criteria. Mean effect sizes ("ES"s) for solution accuracy for group design studies were 0.95 (SE = 0.19) for children…

  9. An Assessment of Treatment Integrity in Behavioral Intervention Studies Conducted with Persons with Mental Retardation

    ERIC Educational Resources Information Center

    Wheeler, John J.; Mayton, Michael R.; Carter, Stacy L.; Chitiyo, Morgan; Menendez, Anthony L.; Huang, Ann

    2009-01-01

    The purpose of this study was to assess the degree to which behavioral intervention studies conducted with persons with mental retardation operationally defined the independent variables and evaluated and reported measures of treatment integrity. The study expands the previous work in this area reported by Gresham, Gansle, and Noell (1993) and…

  10. Phonological and Articulation Treatment Approaches in Portuguese Children with Speech and Language Impairments: A Randomized Controlled Intervention Study

    ERIC Educational Resources Information Center

    Lousada, M.; Jesus, Luis M. T.; Capelas, S.; Margaca, C.; Simoes, D.; Valente, A.; Hall, A.; Joffe, V. L.

    2013-01-01

    Background: In Portugal, the routine clinical practice of speech and language therapists (SLTs) in treating children with all types of speech sound disorder (SSD) continues to be articulation therapy (AT). There is limited use of phonological therapy (PT) or phonological awareness training in Portugal. Additionally, at an international level there…

  11. Randomized Trial Comparing Two Treatment Strategies Using Prize-Based Reinforcement of Abstinence in Cocaine and Opiate Users

    ERIC Educational Resources Information Center

    Preston, Kenzie L.; Ghitza, Udi E.; Schmittner, John P.; Schroeder, Jennifer R.; Epstein, David H.

    2008-01-01

    We compared two strategies of prize-based contingency management (CM) in methadone-maintained outpatients. Urine was tested thrice weekly for 5 weeks pre-CM, 12 weeks CM, and 8 weeks post-CM. Participants were randomly assigned to a cocaine contingency (four prize draws for each cocaine-negative urine, N = 29) or an opiate-cocaine contingency (one…

  12. Anti-diabetic and antioxidant effect of cinnamon in poorly controlled type-2 diabetic Iraqi patients: A randomized, placebo-controlled clinical trial

    PubMed Central

    Sahib, Ahmed Salih

    2016-01-01

    Aim: To determine the effect of cinnamon on fasting blood glucose, hemoglobin (Hb) A1c, and oxidative stress markers in poorly controlled type 2 diabetes. Patients and Methods: A total of 25 type 2 diabetic patients of both sexes, aged 49.1 ± 6.0, treated only with hypoglycemic agent sulfonylurea (glibenclamide) were randomly assigned to receive either 1 g of cinnamon or placebo daily for 12 weeks. Results: A highly significant (P ≤ 0.001) reduction (10.12%) of fasting blood glucose level after 6 and 12 weeks of treatment 10.12% and 17.4%, respectively, compared to baseline value and to placebo group at corresponding duration. Meanwhile, the value of glycosylated Hb reduced in cinnamon treated group by (2.625%) and (8.25%) after 6 and 12 weeks, respectively, although this reduction was non-significant compared to baseline value. Concerning the oxidative stress markers, the level of serum glutathione showed highly significant (P ≤ 0.001) elevation after 12 weeks as compared to baseline value and placebo group at corresponding duration, malondialdehyde serum level decreased after treatment of diabetic patients with cinnamon resulted in highly significant (P ≤ 0.001) reduction after 6 and 12 weeks compared to placebo group, but when compared to baseline value, there is a (15%) reduction only after 12 weeks of treatment which was considered highly significant (P ≤ 0.001) change, Finally, administration of cinnamon to diabetic patients for 12 weeks resulted in significant (P ≤ 0.05) elevation of superoxide dismutase level. Conclusion: Intake of 1 g of cinnamon for 12 weeks reduces fasting blood glucose and glycosylated Hb among poorly controlled type 2 diabetes patients, as well as, there is improvement in the oxidative stress markers, indicating the beneficial effect of adjuvant cinnamon as anti-diabetic and antioxidant along with conventional medications to treat poorly controlled type 2 diabetes mellitus. PMID:27104030

  13. Social anxiety and self-concept in children with epilepsy: A pilot intervention study

    PubMed Central

    Jones, Jana E.; Blocher, Jacquelyn B.; Jackson, Daren C.; Sung, Connie; Fujikawa, Mayu

    2014-01-01

    Purpose The purpose of this study was to assess the impact of a cognitive behavioral therapy (CBT) anxiety intervention on social phobia, social skill development, and self-concept. Method Fifteen children with epilepsy and a primary anxiety disorder participated in a CBT intervention for 12 weeks plus a 3-month follow-up visit. Children were assessed at baseline, week 7, week 12, and 3 months post treatment to measure changes in social phobia using the Screen for Child Anxiety Related Emotional Disorders (SCARED). Self-concept was also assessed by using the Piers-Harris Children's Self-Concept Scale II (Piers-Harris 2). Results There was a significant reduction in symptoms of social phobia and improved self-concept at the end of the 12-week intervention and at the 3 month follow-up. Repeated measures ANOVA's of child ratings revealed significant change over time on the SCARED-Social Phobia/Social Anxiety subscale score (p = 0.024). In terms of self-concept, significant change over time was detected on the Piers-Harris 2-Total score (p = 0.015) and several subscale scores of Piers-Harris 2, including: Physical Appearance and Attributes (p = 0.016), Freedom from Anxiety (p = 0.005), and Popularity (p = 0.003). Conclusion This pilot investigation utilized an evidenced based CBT intervention to reduce symptoms of social phobia, which in turn provided a vehicle to address specific social skills improving self-concept in children with epilepsy. PMID:25053153

  14. Complementary health approach to quality of life in menopausal women: a community-based interventional study

    PubMed Central

    Jayabharathi, Baskaran; Judie, Arulappan

    2014-01-01

    Background Menopause is the stage when the menstrual period permanently stops, and is a part of every woman’s life. It usually occurs between the ages of 40 and 60 years, and is associated with hormonal, physical, and psychological changes. Estrogen and progesterone levels play the biggest part in menopause. In this stage, the ovaries make less estrogen and progesterone. When the body produces less of these hormones, the parts of the body that depend on estrogen to keep them healthy will react and this often causes discomfort for women. This study tested the impact of a complementary health approach to quality of life in menopausal women. Methods A community-based interventional study was conducted in selected areas in Kattankulathur Block, Kanchipuram District, Tamil Nadu, India. A simple random sampling technique was used to select menopausal women for the study. Of 260 menopausal women identified, 130 were allocated to a study group and 130 to a control group. The study group underwent yoga training for 1.5 hours per day on 5 consecutive days. After the 5-day intensive yoga training program, the menopausal women practiced yoga daily at home for 35–40 minutes a day. Along with daily yoga practice, they underwent group yoga practice for 2 days a week under the supervision of one of the investigators until 18 weeks. The yoga training program consisted of Yogasanas, Pranayama (breathing exercises), and meditation. The standardized World Health Organization QoL BREF scale was used to assess the women’s quality of life. We distributed an instruction manual on steps of selected yoga practice for the women’s self-reference at home after the 5 days of continuous yoga practice. A yoga practice diary was used to confirm regular performance of yoga. The women in the control group did not participate in the yoga program; however, on completion of the study, these women received intensive yoga training for 5 days. Results There was an extremely high statistically

  15. Evaluation of the effectiveness of testicular cancer and testicular self-examination training for patient care personnel: intervention study.

    PubMed

    Akar, Serife Zehra; Bebiş, Hatice

    2014-12-01

    Testicular cancer (TC) is the most common malignancy among men aged 15-35 years. Testicular self-examination (TSE) is an important tool for preventing late-stage TC diagnoses. This study aimed to assess health beliefs and knowledge related to TC and TSE and the effectiveness of TC and TSE training for patient care staff in a hospital. This was a prospective, randomized, controlled intervention study. The study included 96 patient care staff divided into two groups of 48 participants each: Group I, the interactive education group, and Group II, the pamphlet education group. The results demonstrated that TSE practice and TC knowledge significantly increased in both Group I and Group II. Significant differences were observed between the groups pre and post education. TSE and TC knowledge levels were higher for participants in Group I than those in Group II. There was a significant difference in the performance of TSEs between groups: the rates were 83.3% in Group I and 54.2% in Group II. Perceived confidence and perceived barriers increased significantly for both groups. Interactive education sessions should be used to train men at risk for TC to perform TSEs. PMID:25248831

  16. Who to target in sudden unexpected death in epilepsy prevention and how? Risk factors, biomarkers, and intervention study designs.

    PubMed

    Tomson, Torbjörn; Surges, Rainer; Delamont, Robert; Haywood, Serena; Hesdorffer, Dale C

    2016-01-01

    The risk of dying suddenly and unexpectedly is increased 24- to 28-fold among young people with epilepsy compared to the general population, but the incidence of sudden unexpected death in epilepsy (SUDEP) varies markedly depending on the epilepsy population. This article first reviews risk factors and biomarkers for SUDEP with the overall aim of enabling identification of epilepsy populations with different risk levels as a background for a discussion of possible intervention strategies. The by far most important clinical risk factor is frequency of generalized tonic-clonic seizures (GTCS), but nocturnal seizures, early age at onset, and long duration of epilepsy have been identified as additional risk factors. Lack of antiepileptic drug (AED) treatment or, in the context of clinical trials, adjunctive placebo versus active treatment is associated with increased risks. Despite considerable research, reliable electrophysiologic (electrocardiography [ECG] or electroencephalography [EEG]) biomarkers of SUDEP risk remain to be established. This is an important limitation for prevention strategies and intervention studies. There is a lack of biomarkers for SUDEP, and until validated biomarkers are found, the endpoint of interventions to prevent SUDEP must be SUDEP itself. These interventions, be they pharmacologic, seizure-detection devices, or nocturnal supervision, require large numbers. Possible methods for assessing prevention measures include public health community interventions, self-management, and more traditional (and much more expensive) randomized clinical trials. PMID:26749012

  17. Engaging adolescent mothers in a longitudinal mental health intervention study: challenges and lessons learned.

    PubMed

    Pinto-Foltz, Melissa Dawn; Logsdon, M Cynthia; Derrick, Ann

    2011-01-01

    Little is known about recruiting and retaining adolescent mothers in research studies. Investigators who study adolescent mothers have been guided by trial and error, clinical experience, qualitative inquiry, literature of special populations, or the advice of stakeholders. This paper describes the challenges and lessons learned in engaging adolescent mothers in a longitudinal community-based mental health intervention study. Audio-recorded data that describes the circumstances of five adolescent mothers lost to attrition were extracted from a longitudinal mental health intervention study. Adolescent mothers described a chaotic home environment with multiple demands, family conflict, health issues, limited access to a telephone, transportation, financial, and social support. Utilizing a multidisciplinary community advisory group, dedicated telephone, and free electronic media may assist in overcoming modifiable barriers to recruitment and retention of adolescent mothers. Exploring a waiver of informed consent and the engagement of mothers of adolescents in research are indicated. PMID:21355755

  18. Engaging Adolescent Mothers in a Longitudinal Mental Health Intervention Study: Challenges and Lessons Learned

    PubMed Central

    Pinto-Foltz, Melissa D.; Logsdon, M. Cynthia; Derrick, Ann

    2010-01-01

    Background Little is known about recruiting and retaining adolescent mothers in research studies. Investigators who study adolescent mothers have been guided by trial and error, clinical experience, qualitative inquiry, literature of special populations or advice of stakeholders. This paper describes the challenges and lessons learned in engaging adolescent mothers in a longitudinal community-based mental health intervention study. Methods Audio-recorded data that describes the circumstances of five adolescent mothers lost to attrition were extracted from a longitudinal mental health intervention study. Results Adolescent mothers described a chaotic home environment with multiple demands, family conflict, health issues, limited access to a telephone, transportation, financial, and social support. Discussion Utilizing a multidisciplinary community advisory group, dedicated telephone, and free electronic media may assist in overcoming modifiable barriers to recruitment and retention of adolescent mothers. Exploring a waiver of informed consent and the engagement of mothers of adolescents in research are indicated. PMID:21355755

  19. Cheek cell fatty acids reflect n-3 PUFA in blood fractions during linseed oil supplementation: a controlled human intervention study

    PubMed Central

    2013-01-01

    Background Adequate biomarkers for the dietary supply of fatty acids (FA) are FA of adipose tissue and blood fractions. In human studies, invasive sample collection is unpleasant for subjects. In contrast, cheek cell sampling can be considered as a non-invasive alternative to investigate FA status. The aim of this study was to analyze whether cheek cell FA composition reflect the supplementation of alpha-linolenic acid (ALA) using a linseed oil mixture compared to olive oil supplementation. Additionally, it was investigated if cheek cell FA composition correlates with the FA composition of plasma, red blood cells (RBC) and peripheral blood mononuclear cells (PBMC) before and during both interventions. Methods During a 10-week randomized, controlled, double-blind human intervention study, 38 subjects provided cheek cell and blood samples. After a two-week run-in period, the test group (n = 23) received 17 g/d of an ALA-rich linseed oil mixture, while the control group (n = 15) received 17 g/d of an omega-3 (n-3) polyunsaturated FA (PUFA)-free olive oil. Cheek cells and blood were collected on days 0, 7 and 56 of the 8-week intervention period. Results Compared to olive oil, the linseed oil intervention increased ALA and also the endogenously converted long-chain n-3 metabolites eicosatetraenoic-, eicosapentaenoic- and docosapentaenoic acid in cheek cells (P ≤ 0.05). Docosahexaenoic acid remained unchanged. Reflecting the treatment, the n-6/n-3 ratio decreased in the test group. In general, cheek cell FA reflected the changes of FA in blood fractions. Independent of treatment, significant correlations (P ≤ 0.05) of n-6 PUFA and n-3 PUFA between cheek cells and plasma, RBC and PBMC were found, except for linoleic acid and ALA. Conclusions The changes in FA composition of cheek cells confirmed that ALA from linseed oil increased endogenously derived n-3 PUFA in cheek cell lipids. These changes in cheek cells and their correlation to the respective

  20. Random Walks on Random Graphs

    NASA Astrophysics Data System (ADS)

    Cooper, Colin; Frieze, Alan

    The aim of this article is to discuss some of the notions and applications of random walks on finite graphs, especially as they apply to random graphs. In this section we give some basic definitions, in Section 2 we review applications of random walks in computer science, and in Section 3 we focus on walks in random graphs.

  1. The SYNCAN project: goals, set-up, first results and settings of the human intervention study.

    PubMed

    Van Loo, Jan; Clune, Yvonne; Bennett, Mary; Collins, John Kevin

    2005-04-01

    Experimental evidence on the anticancer properties of dietary prebiotics such as chicory inulin and oligofructose and dietary probiotics has accumulated in recent years. Various experimental models ranging from chemoprevention studies, tumour implantation models to genetically modified mice models, etc. have systematically shown the protective effects of these food ingredients. In some studies it appeared that synbiotics (combination of pre- and probiotics) exerted synergistic activity against processes of carcinogenesis. The logical next step in research was to find out if these observations also would be valid for human volunteers. This was the principal goal of the EU-sponsored SYNCAN project (QLK1-1999-346) which involved the integration of an in vitro study to select the most suitable synbiotic preparation, the application of this synbiotic in an in vivo rat model of chemically induced colon cancer, and, as the heart of the project, the investigation of the synbiotic effects in a human intervention study. The in vitro tests consisted of fermentation studies where the interaction of pre- and probiotics was studied. Cell-free supernatants were generated from various synbiotic combinations fermented by faecal slurry, which were then used to optimise a series of bioassays. In the rat study the anticarcinogenic effect of prebiotics and synbiotics but not of probiotics was demonstrated. Using tissue samples generated in this model, attempts were made to gain a better insight into the mechanisms underlying cancer development. The human intervention study consisted of two groups of volunteers. One group was composed of people at high risk (polypectomised subjects) for colon cancer and the other of volunteers (colon cancer subjects) who had previously undergone 'curative resection' for colon cancer but were not currently receiving treatment. The present paper describes the experimental design of the SYNCAN study, and demonstrates a functional effect of the synbiotic

  2. Ensuring Treatment Fidelity in a Multi-site Behavioral Intervention Study: Implementing NIH Behavior Change Consortium Recommendations in the SMART Trial

    PubMed Central

    Robb, Sheri L.; Burns, Debra S.; Docherty, Sharron L.; Haase, Joan E.

    2010-01-01

    The Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study (R01NR008583; U10CA098543; U10CA095861) is an ongoing multi-site Children’s Oncology Group randomized clinical trial testing the efficacy of a therapeutic music video intervention for adolescents/young adults (11–24 years of age) with cancer undergoing stem cell transplant. Treatment fidelity strategies from our trial are consistent with the NIH Behavior Change Consortium Treatment Fidelity Workgroup (BCC) recommendations and provide a successful working model for treatment fidelity implementation in a large, multi-site behavioral intervention study. In this paper we summarize 20 specific treatment fidelity strategies used in the SMART trial and how these strategies correspond with NIH BCC recommendations in 5 specific areas: 1) study design, 2) training providers, 3) delivery of treatment, 4) receipt of treatment, and 5) enactment of treatment skills. Increased use and reporting of treatment fidelity procedures is essential in advancing the reliability and validity of behavioral intervention research. The SMART trial provides a strong model for the application of fidelity strategies to improve scientific findings and addresses the absence of published literature illustrating the application of BCC recommendations in behavioral intervention studies. PMID:22012943

  3. The perceived quality of interprofessional teamwork in an intensive care unit: A single centre intervention study.

    PubMed

    Van den Bulcke, Bo; Vyt, Andre; Vanheule, Stijn; Hoste, Eric; Decruyenaere, Johan; Benoit, Dominique

    2016-05-01

    This article describes a study that evaluated the quality of teamwork in a surgical intensive care unit and assessed whether teamwork could be improved significantly through a tailor-made intervention. The quality of teamwork prior to and after the intervention was assessed using the Interprofessional Practice and Education Quality Scales (IPEQS) using the PROSE online diagnostics and documenting system, which assesses three domains of teamwork: organisational factors, care processes, and team members' attitudes and beliefs. Furthermore, team members evaluated strengths and weaknesses of the teamwork through open-ended questions. Information gathered by means of the open questions was used to design a tailor-made 12-week intervention consisting of (1) optimising the existing weekly interdisciplinary meetings with collaborative decision-making and clear communication of goal-oriented actions, including the psychosocial aspects of care; and (2) organising and supporting the effective exchange of information over time between all professions involved. It was found that the intervention had a significant impact on organisational factors and care processes related to interprofessional teamwork for the total group and within all subgroups, despite baseline differences between the subgroups in interprofessional teamwork. In conclusion, teamwork, and more particularly the organisational aspects of interprofessional collaboration and processes of care, can be improved by a tailor-made intervention that takes into account the professional needs of healthcare workers. PMID:27152533

  4. Effects of butter from mountain-pasture grazing cows on risk markers of the metabolic syndrome compared with conventional Danish butter: a randomized controlled study

    PubMed Central

    2013-01-01

    Background There is considerable interest in dairy products from low-input systems, such as mountain-pasture grazing cows, because these products are believed to be healthier than products from high-input conventional systems. This may be due to a higher content of bioactive components, such as phytanic acid, a PPAR-agonist derived from chlorophyll. However, the effects of such products on human health have been poorly investigated. Objective To compare the effect of milk-fat from mountain-pasture grazing cows (G) and conventionally fed cows (C) on risk markers of the metabolic syndrome. Design In a double-blind, randomized, 12-week, parallel intervention study, 38 healthy subjects replaced part of their habitual dietary fat intake with 39 g fat from test butter made from milk from mountain-pasture grazing cows or from cows fed conventional winter fodder. Glucose-tolerance and circulating risk markers were analysed before and after the intervention. Results No differences in blood lipids, lipoproteins, hsCRP, insulin, glucose or glucose-tolerance were observed. Interestingly, strong correlations between phytanic acid at baseline and total (P<0.0001) and LDL cholesterol (P=0.0001) were observed. Conclusions Lack of effects on blood lipids and inflammation indicates that dairy products from mountain-pasture grazing cows are not healthier than products from high-input conventional systems. Considering the strong correlation between LDL cholesterol and phytanic acid at baseline, it may be suggested that phytanic acid increases total and LDL cholesterol. Trial registration ClinicalTrials.gov, NCT01343589 PMID:23842081

  5. Community-centred eco-bio-social approach to control dengue vectors: an intervention study from Myanmar

    PubMed Central

    Wai, Khin Thet; Htun, Pe Than; Oo, Tin; Myint, Hla; Lin, Zaw; Kroeger, Axel; Sommerfeld, Johannes; Petzold, Max

    2012-01-01

    Objectives To build up and analyse the feasibility, process, and effectiveness of a partnership-driven ecosystem management intervention in reducing dengue vector breeding and constructing sustainable partnerships among multiple stakeholders. Methods A community-based intervention study was conducted from May 2009 to January 2010 in Yangon city. Six high-risk and six low-risk clusters were randomized and allocated as intervention and routine service areas, respectively. For each cluster, 100 households were covered. Bi-monthly entomological evaluations (i.e. larval and pupal surveys) and household acceptability surveys at the end of 6-month intervention period were conducted, supplemented by qualitative evaluations. Intervention description The strategies included eco-friendly multi-stakeholder partner groups (Thingaha) and ward-based volunteers, informed decision-making of householders, followed by integrated vector management approach. Findings Pupae per person index (PPI) decreased at the last evaluation by 5.7% (0.35–0.33) in high-risk clusters. But in low-risk clusters, PPI remarkably decreased by 63.6% (0.33–0.12). In routine service area, PPI also decreased due to availability of Temephos after Cyclone Nargis. As for total number of pupae in all containers, when compared to evaluation 1, there was a reduction of 18.6% in evaluation 2 and 44.1% in evaluation 3 in intervention area. However, in routine service area, more reduction was observed. All intervention tools were found as acceptable, being feasible to implement by multi-stakeholder partner groups. Conclusions The efficacy of community-controlled partnership-driven interventions was found to be superior to the vertical approach in terms of sustainability and community empowerment. PMID:23318238

  6. Community-based strategies for recruiting older, African Americans into a behavioral intervention study

    PubMed Central

    Ellish, Nancy J.; Scott, Deborah; Royak-Schaler, Renee; Higginbotham, Eve J.

    2012-01-01

    Purpose To describe community-based strategies that were effective in recruiting older, African-Americans into a behavioral intervention study designed to increase eye examination behavior. Methods Sites were identified that targeted older African-Americans, including senior centers, senior housing, and church groups. We conducted presentations at these sites, networked with community organizations, placed ads on the radio and in newspapers, and attended health fairs. Potential participants also called us in response to flyers and through word of mouth. Results We conducted 147 activities at 118 sites. A total of 688 potential participants were screened, with 330 (48%) enrolling, 33% ineligible, and 19% not interested. Highest enrollment rates were for word of mouth (69%), flyers (67%), and senior centers (66%). Barriers to participation included hesitancy of seniors to leave their apartments to attend presentations and competing health issues taking precedence over eye concerns. Conclusions A multi-faceted recruitment approach, incorporating both direct and indirect activities at a variety of sites, should be used to recruit older African Americans into a behavioral intervention study. Establishing relationships in the community, both prior to initiating recruitment activities and as an ongoing process, was important to the study’s success. PMID:19998638

  7. Motivation for physical activity and exercise in severe mental illness: A systematic review of intervention studies.

    PubMed

    Farholm, Anders; Sørensen, Marit

    2016-06-01

    There has been increasing interest for research on motivation for physical activity (PA) and exercise among individuals with severe mental illness (SMI). The aim of this systematic review is to summarize findings from all intervention studies on PA or exercise that either include empirical data on motivational constructs or apply motivational techniques/theories in their intervention. Systematic searches of seven databases were conducted from database inception to February 2015. Studies were eligible if they: (i) included participants with SMI, (ii) had PA as part of the intervention, and (iii) reported empirical data on motivational constructs related to PA or incorporated motivational techniques/theory in their intervention. Of the 79 studies that met the inclusion criteria only one had motivation for PA as its main outcome. Nine additional interventions reported empirical data on motivational constructs. Altogether these studies yielded mixed results with respect to change in motivational constructs. Only one of those examined the association between motivation and PA, but found none. Sixty-four studies reported using motivational techniques/theory in their intervention. Motivational interviewing and goal-setting were the most popular techniques. Due to the exploratory nature of most of these studies, findings from intervention studies do not so far give very clear directions for motivational work with the patients. There is an urgent need for a more systematic theory based approach when developing strategies that target to increase engagement in PA among people with SMI. PMID:26916699

  8. Coffee Consumption and Oxidative Stress: A Review of Human Intervention Studies.

    PubMed

    Martini, Daniela; Del Bo', Cristian; Tassotti, Michele; Riso, Patrizia; Del Rio, Daniele; Brighenti, Furio; Porrini, Marisa

    2016-01-01

    Research on the potential protective effects of coffee and its bioactives (caffeine, chlorogenic acids and diterpenes) against oxidative stress and related chronic disease risk has been increasing in the last years. The present review summarizes the main findings on the effect of coffee consumption on protection against lipid, protein and DNA damage, as well as on the modulation of antioxidant capacity and antioxidant enzymes in human studies. Twenty-six dietary intervention studies (involving acute and chronic coffee intake) have been considered. Overall, the results suggest that coffee consumption can increase glutathione levels and improve protection against DNA damage, especially following regular/repeated intake. On the contrary, the effects of coffee on plasma antioxidant capacity and antioxidant enzymes, as well as on protein and lipid damage, are unclear following both acute and chronic exposure. The high heterogeneity in terms of type of coffee, doses and duration of the studies, the lack of information on coffee and/or brew bioactive composition, as well as the choice of biomarkers and the methods used for their evaluation, may partially explain the variability observed among findings. More robust and well-controlled intervention studies are necessary for a thorough understanding of the effect of coffee on oxidative stress markers in humans. PMID:27483219

  9. Multilevel data analysis of a crossover designed human nutritional intervention study.

    PubMed

    van Velzen, Ewoud J J; Westerhuis, Johan A; van Duynhoven, John P M; van Dorsten, Ferdi A; Hoefsloot, Huub C J; Jacobs, Doris M; Smit, Suzanne; Draijer, Richard; Kroner, Christine I; Smilde, Age K

    2008-10-01

    A new method is introduced for the analysis of 'omics' data derived from crossover designed drug or nutritional intervention studies. The method aims at finding systematic variations in metabolic profiles after a drug or nutritional challenge and takes advantage of the crossover design in the data. The method, which can be considered as a multivariate extension of a paired t test, generates different multivariate submodels for the between- and the within-subject variation in the data. A major advantage of this variation splitting is that each submodel can be analyzed separately without being confounded with the other variation sources. The power of the multilevel approach is demonstrated in a human nutritional intervention study which used NMR-based metabolomics to assess the metabolic impact of grape/wine extract consumption. The variations in the urine metabolic profiles are studied between and within the human subjects using the multilevel analysis. After variation splitting, multilevel PCA is used to investigate the experimental and biological differences between the subjects, whereas a multilevel PLS-DA model is used to reveal the net treatment effect within the subjects. The observed treatment effect is validated with cross model validation and permutations. It is shown that the statistical significance of the multilevel classification model ( p < 0.0002) is a major improvement compared to a ordinary PLS-DA model ( p = 0.058) without variation splitting. Finally, rank products are used to determine which NMR signals are most important in the multilevel classification model. PMID:18754629

  10. N-Acetylcysteine in the Treatment of Pediatric Trichotillomania: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial

    ERIC Educational Resources Information Center

    Bloch, Michael H.; Panza, Kaitlyn E.; Grant, Jon E.; Pittenger, Christopher; Leckman, James F.

    2013-01-01

    Objective: To examine the efficacy of N-acetylcysteine (NAC) for the treatment of pediatric trichotillomania (TTM) in a double-blind, placebo-controlled, add-on study. Method: A total of 39 children and adolescents aged 8 to 17 years with pediatric trichotillomania were randomly assigned to receive NAC or matching placebo for 12 weeks. Our primary…

  11. Understanding Price Elasticities to Inform Public Health Research and Intervention Studies: Key Issues

    PubMed Central

    Nghiem, Nhung; Genç, Murat; Blakely, Tony

    2013-01-01

    Pricing policies such as taxes and subsidies are important tools in preventing and controlling a range of threats to public health. This is particularly so in tobacco and alcohol control efforts and efforts to change dietary patterns and physical activity levels as a means of addressing increases in noncommunicable diseases. To understand the potential impact of pricing policies, it is critical to understand the nature of price elasticities for consumer products. For example, price elasticities are key parameters in models of any food tax or subsidy that aims to quantify health impacts and cost-effectiveness. We detail relevant terms and discuss key issues surrounding price elasticities to inform public health research and intervention studies. PMID:24028228

  12. Public Health Under Attack: The American Stop Smoking Intervention Study (ASSIST) and the Tobacco Industry

    PubMed Central

    White, Jenny; Bero, Lisa A.

    2004-01-01

    We describe the tobacco industry’s response to the American Stop Smoking Intervention Study (ASSIST). Tobacco industry documents from the University of California, San Francisco/Legacy Tobacco Documents Library and industry Web sites were analyzed. LexisNexis and the Library of Congress’s Thomas Web site were searched for legislative history. We found that the tobacco industry considered ASSIST a major threat because of its emphasis on policy and creation of local tobacco control infrastructures. The industry mobilized resources for a well-coordinated attack on ASSIST. Although industry executives were sometimes frustrated in their efforts, they ultimately had a chilling effect on ASSIST. This evidence suggest that tobacco control advocates should expect a vigorous response from the tobacco industry to policy advocacy efforts, particularly at the local level. PMID:14759933

  13. Development of immune organs and functioning in humans and test animals: Implications for immune intervention studies.

    PubMed

    Kuper, C Frieke; van Bilsen, Jolanda; Cnossen, Hilde; Houben, Geert; Garthoff, Jossie; Wolterbeek, Andre

    2016-09-01

    A healthy immune status is mostly determined during early life stages and many immune-related diseases may find their origin in utero and the first years of life. Therefore, immune health optimization may be most effective during early life. This review is an inventory of immune organ maturation events in relation to developmental timeframes in minipig, rat, mouse and human. It is concluded that time windows of immune organ development in rodents can be translated to human, but minipig reflects the human timeframes better; however the lack of prenatal maternal-fetal immune interaction in minipig may cause less responsiveness to prenatal intervention. It is too early to conclude which immune parameters are most appropriate, because there are not enough comparative immune parameters. Filling these gaps will increase the predictability of results observed in experimental animals, and guide future intervention studies by assessing relevant parameters in the right corresponding developmental time frames. PMID:27282947

  14. Effectiveness of an education program to prevent nurses' low back pain: an interventional study in Turkey.

    PubMed

    Karahan, Azize; Bayraktar, Nurhan

    2013-02-01

    This study was undertaken to evaluate an education program to prevent low back pain among nurses. This interventional study used a one-group, pretest/posttest design and was conducted in four hospitals in Bolu, Turkey. Nurses' knowledge was assessed before and after training; 60 nurses were evaluated while performing five procedures that can lead to low back pain using an observation form. These forms were given to the nurses 3 months after the training to assess their knowledge and observations of the five specified behaviors were repeated. The mean knowledge and procedures scores of the nurses were higher just after and 3 months after the training compared to before training. PMID:23380640

  15. Reproducibility of erythrocyte polyamine measurements and correlation with plasma micronutrients in an antioxidant vitamin intervention study.

    PubMed

    Wang, W; Kucuk, O; Franke, A A; Liu, L Q; Custer, L J; Higuchi, C M

    1996-07-01

    Erythrocyte polyamine measurements have been previously investigated as candidate biomarkers for hyperproliferation and recently as a potential intermediate endpoint in clinical chemoprevention trials with difluoromethylornithine, an inhibitor of polyamine biosynthesis. This study was performed to determine the reproducibility of erythrocyte polyamine measurements and their possible correlation with plasma micronutrients in seven healthy adults in an antioxidant vitamin intervention study. As part of this cross-over intervention study, three subjects took beta-carotene (31.4 mg/day) plus D-alpha-tocopherol acetate (720 IU/day) supplements during the first 3 months and four subjects took the supplements during the second 3 months. Heparinized blood samples were collected at baseline and every month over total 6 months for simultaneous determination of erythrocyte polyamines and plasma micronutrients by the high-performance liquid chromatographic method. For all the measures of erythrocyte polyamines the intraindividual variation was smaller than that between subjects, and three or four measurements required to accurately characterize long-term erythrocyte polyamines for an individual. The intra-class correlations were moderately high for all erythrocyte polyamine measurements, indicating a good reproducibility for intra-individual erythrocyte polyamine measurements. Based on monthly values, significant inverse correlations were found between erythrocyte spermidine and the plasma levels of retinol (r = -0.50) and lutein (r = -0.52). There were also significant inverse associations between erythrocyte spermine and plasma levels of alpha-tocopherol (r = -0.29), lutein (r = -0.44), lycopene (r = -0.29), beta-cryptoxanthin (r = -0.30), and total carotenoids (r = -0.29). The effects of supplementation upon the associations between erythrocyte polyamines and plasma nutrient levels were additionally addressed. The results indicate an acceptable longitudinal reproducibility

  16. The effect of a school-based educational intervention on menstrual health: an intervention study among adolescent girls in Bangladesh

    PubMed Central

    Haque, Syed Emdadul; Rahman, Mosiur; Itsuko, Kawashima; Mutahara, Mahmuda; Sakisaka, Kayako

    2014-01-01

    Objectives To assess the impact of a school-based menstrual education programme on: (1) menstrual knowledge, beliefs and practices, (2) menstrual disorders experienced, and (3) restrictions on menstruating adolescents. Design Intervention study. Setting Araihazar area, Bangladesh. Participants 416 adolescent female students aged 11–16 years, in grade 6–8, and living with their parents. Interventions A school-based health education study conducted from April 2012 to April 2013. Primary and secondary outcome measures We randomly selected 3 of 26 high schools in the study area. We delivered 6 months of educational intervention by trained (by an obstetrician and gynaecologist) research assistants (RAs) on menstrual hygiene among school girls. RAs read the questionnaire and participants answered. The changes in knowledge, beliefs and practices regarding menstruation, menstrual disorders experienced, and the restrictions and behaviours practiced by menstruating adolescents were compared between the baseline and the follow-up assessments. Results After health education, participants reported a significant improvement (p<0.001) in ‘high knowledge and beliefs’ scores compared to baseline (51% vs 82.4%). Significant improvement was also observed in overall good menstrual practices (28.8% vs 88.9%), including improvements in using sanitary pads (22.4% change after the intervention), frequency of changing pads/cloths per day (68.8%), drying the used absorbent (77.6%), methods of disposing of the used absorbent (25.5%), and cleaning of genitalia (19.2%). During the follow-up, the participants reported significant improvements in the regularity of their menstrual cycle (94.5% vs 99.5%) and fewer complications during menstruation (78.6% vs 59.6%). Conclusions The programme produced significant changes in the knowledge, beliefs and practices of menstrual hygiene, complications from lack of hygiene, and the behaviour and restrictions of the menstruating adolescents

  17. Randomized Polypill Crossover Trial in People Aged 50 and Over

    PubMed Central

    Wald, David S.; Morris, Joan K.; Wald, Nicholas J.

    2012-01-01

    Background A Polypill is proposed for the primary prevention of cardiovascular disease in people judged to be at risk on account of their age alone. Its efficacy in reducing cholesterol and blood pressure is uncertain. Methods We conducted a randomized double-blind placebo-controlled crossover trial of a Polypill among individuals aged 50+ without a history of cardiovascular disease and compared the reductions with those predicted from published estimates of the effects of the individual drugs. Participants took the Polypill (amlodipine 2.5 mg, losartan 25 mg, hydrochlorothiazide 12.5 mg and simvastatin 40 mg) each evening for 12 weeks and a placebo each evening for 12 weeks in random sequence. The mean within-person differences in blood pressure and low density lipoprotein (LDL) cholesterol at the end of each 12 week period were determined. Results 84 out of 86 participants completed both treatment periods. The mean systolic blood pressure was reduced by 17.9 mmHg (95% CI, 15.7–20.1) on the Polypill, diastolic blood pressure by 9.8 mmHg (8.1–11.5), and LDL cholesterol by 1.4 mmol/L (1.2–1.6), reductions of 12%, 11%, and 39% respectively. The results were almost identical to those predicted; 18.4 mmHg, 9.7 mmHg, and 1.4 mmol/L respectively. Conclusion The Polypill resulted in the predicted reductions in blood pressure and LDL cholesterol. Long term reductions of this magnitude would have a substantial effect in preventing heart attacks and strokes. Trial Registration Controlled-Trials.com ISRCTN36672232 PMID:22815989

  18. Effectiveness of splinting and splinting plus local steroid injection in severe carpal tunnel syndrome: A Randomized control clinical trial

    PubMed Central

    Khosrawi, Saeid; Emadi, Masoud; Mahmoodian, Amir Ebrahim

    2016-01-01

    Background: The Study aimed to compare the effectiveness of two commonly used conservative treatments, splinting and local steroid injection in improving clinical and nerve conduction findings of the patients with severe carpal tunnel syndrome (CTS). Materials and Methods: In this randomized control clinical trial, the patients with severe CTS selected and randomized in two interventional groups. Group A was prescribed to use full time neutral wrist splint and group B was injected with 40 mg Depo-Medrol and prescribed to use the full time neutral wrist splint for 12 weeks. Clinical and nerve conduction findings of the patients was evaluated at baseline, 4 and 12 weeks after interventions. Results: Twenty-two and 21 patients were allocated in group A and B, respectively. Mean of clinical symptoms and functional status scores, nerve conduction variables and patients’ satisfaction score were not significant between group at baseline and 4 and 12 weeks after intervention. Within the group comparison, there was significant improvement in the patients’ satisfaction, clinical and nerve conduction items between the baseline level and 4 weeks after intervention and between the baseline and 12 weeks after intervention (P < 0.01). The difference was significant for functional status score between 4 and 12 weeks after intervention in group B (P = 0.02). Conclusion: considering some findings regarding the superior effect of splinting plus local steroid injection on functional status scale and median nerve distal motor latency, it seems that using combination therapy could be more effective for long-term period specially in the field of functional improvement of CTS. PMID:26962518

  19. Non-interventional study evaluating efficacy and tolerability of rifaximin for treatment of uncomplicated diverticular disease.

    PubMed

    Stallinger, Sylvia; Eller, Norbert; Högenauer, Christoph

    2014-01-01

    Patients with symptomatic uncomplicated diverticular disease represent a spectrum of patients who report recurrent abdominal symptoms, however are lacking substantial colonic inflammation in contrast to patients with acute diverticulitis. This non-interventional study investigated the efficacy and tolerability of rifaximin, a broad-spectrum poorly absorbable antibiotic, in cyclic treatment of these patients. Adult patients with uncomplicated diverticular disease in care of physicians in private practice intended to be treated with rifaximin were included. Patients with acute diverticulitis and symptoms suggestive of more severe intestinal inflammation were excluded. Data of 1,003 patients treated in cycles of 7-10 days per month over a period of 3 months were evaluated. In total, 75 % of patients had more than three episodes of symptoms in the last year before inclusion in the study. However, two-third of patients did not receive any treatment before. Over the 3-month treatment period with rifaximin, all assessed symptoms of diverticular disease, such as abdominal pain, diarrhoea and flatulence, improved significantly. There was an overall good compliance to the scheme of cyclic drug administration of rifaximin. During the study, 24 adverse events in 20 patients were recorded, of which 6 adverse events showed a causal relationship to the use of rifaximin (0.6 %). We conclude that cyclic rifaximin shows good clinical efficacy and tolerability in patients with symptomatic uncomplicated diverticular disease treated in a routine private practice outpatient setting. PMID:24240607

  20. Benefits of swimming pools in two remote Aboriginal communities in Western Australia: intervention study

    PubMed Central

    Lehmann, Deborah; Tennant, Mary T; Silva, Desiree T; McAullay, Daniel; Lannigan, Francis; Coates, Harvey; Stanley, Fiona J

    2003-01-01

    Objective To determine the health impact of swimming pools built with the aim of improving quality of life and reducing high rates of pyoderma and otitis media. Design Intervention study assessing prevalence of ear disease and skin infections before and at six monthly intervals after opening of swimming pools. Setting Two remote Aboriginal communities in Western Australia. Participants 84 boys and 78 girls aged < 17 years. Main outcome measures Changes in prevalence and severity of pyoderma and perforation of tympanic membranes with or without otorrhoea over 18 months after opening of pools. Results In community A, 61 children were seen before the pool was opened, and 41, 46, and 33 children were seen at the second, third, and fourth surveys. Equivalent figures for community B were 60, 35, 39, and 45. Prevalence of pyoderma declined significantly from 62% to 18% in community A and from 70% to 20% in community B during the 18 months after the pools opened. Over the same period, prevalence of severe pyoderma fell from 30% to 15% in community A and from 48% to 0% in community B. Prevalence of perforations of the tympanic membrane fell from 32% in both communities to 13% in community A and 18% in community B. School attendance improved in community A. Conclusion Swimming pools in remote communities were associated with reduction in prevalence of pyoderma and tympanic membrane perforations, which could result in long term benefits through reduction in chronic disease burden and improved educational and social outcomes. PMID:12933727

  1. A carnosine intervention study in overweight human volunteers: bioavailability and reactive carbonyl species sequestering effect

    NASA Astrophysics Data System (ADS)

    Regazzoni, Luca; de Courten, Barbora; Garzon, Davide; Altomare, Alessandra; Marinello, Cristina; Jakubova, Michaela; Vallova, Silvia; Krumpolec, Patrik; Carini, Marina; Ukropec, Jozef; Ukropcova, Barbara; Aldini, Giancarlo

    2016-06-01

    Carnosine is a natural dipeptide able to react with reactive carbonyl species, which have been recently associated with the onset and progression of several human diseases. Herein, we report an intervention study in overweight individuals. Carnosine (2 g/day) was orally administered for twelve weeks in order to evaluate its bioavailability and metabolic fate. Two carnosine adducts were detected in the urine samples of all subjects. Such adducts are generated from a reaction with acrolein, which is one of the most toxic and reactive compounds among reactive carbonyl species. However, neither carnosine nor adducts have been detected in plasma. Urinary excretion of adducts and carnosine showed a positive correlation although a high variability of individual response to carnosine supplementation was observed. Interestingly, treated subjects showed a significant decrease in the percentage of excreted adducts in reduced form, accompanied by a significant increase of the urinary excretion of both carnosine and carnosine-acrolein adducts. Altogether, data suggest that acrolein is entrapped in vivo by carnosine although the response to its supplementation is possibly influenced by individual diversities in terms of carnosine dietary intake, metabolism and basal production of reactive carbonyl species.

  2. The healthy building intervention study: Objectives, methods and results of selected environmental measurements

    SciTech Connect

    Fisk, W.J.; Faulkner, D.; Sullivan, D.

    1998-02-17

    To test proposed methods for reducing SBS symptoms and to learn about the causes of these symptoms, a double-blind controlled intervention study was designed and implemented. This study utilized two different interventions designed to reduce occupants` exposures to airborne particles: (1) high efficiency filters in the building`s HVAC systems; and (2) thorough cleaning of carpeted floors and fabric-covered chairs with an unusually powerful vacuum cleaner. The study population was the workers on the second and fourth floors of a large office building with mechanical ventilation, air conditioning, and sealed windows. Interventions were implemented on one floor while the occupants on the other floor served as a control group. For the enhanced-filtration intervention, a multiple crossover design was used (a crossover is a repeat of the experiment with the former experimental group as the control group and vice versa). Demographic and health symptom data were collected via an initial questionnaire on the first study week and health symptom data were obtained each week, for eight additional weeks, via weekly questionnaires. A large number of indoor environmental parameters were measured during the study including air temperatures and humidities, carbon dioxide concentrations, particle concentrations, concentrations of several airborne bioaerosols, and concentrations of several microbiologic compounds within the dust sampled from floors and chairs. This report describes the study methods and summarizes the results of selected environmental measurements.

  3. Effects of Light Intensity Activity on CVD Risk Factors: A Systematic Review of Intervention Studies

    PubMed Central

    Batacan, Romeo B.; Duncan, Mitch J.; Dalbo, Vincent J.; Tucker, Patrick S.; Fenning, Andrew S.

    2015-01-01

    The effects of light intensity physical activity (LIPA) on cardiovascular disease (CVD) risk factors remain to be established. This review summarizes the effects of LIPA on CVD risk factors and CVD-related markers in adults. A systematic search of four electronic databases (PubMed, Academic Search Complete, SPORTDiscus, and CINAHL) examining LIPA and CVD risk factors (body composition, blood pressure, glucose, insulin, glycosylated hemoglobin, and lipid profile) and CVD-related markers (maximal oxygen uptake, heart rate, C-reactive protein, interleukin-6, tumor necrosis factor-alpha, and tumor necrosis factor receptors 1 and 2) published between 1970 and 2015 was performed on 15 March 2015. A total of 33 intervention studies examining the effect of LIPA on CVD risk factors and markers were included in this review. Results indicated that LIPA did not improve CVD risk factors and CVD-related markers in healthy individuals. LIPA was found to improve systolic and diastolic blood pressure in physically inactive populations with a medical condition. Reviewed studies show little support for the role of LIPA to reduce CVD risk factors. Many of the included studies were of low to fair study quality and used low doses of LIPA. Further studies are needed to establish the value of LIPA in reducing CVD risk. PMID:26543862

  4. Effects of Light Intensity Activity on CVD Risk Factors: A Systematic Review of Intervention Studies.

    PubMed

    Batacan, Romeo B; Duncan, Mitch J; Dalbo, Vincent J; Tucker, Patrick S; Fenning, Andrew S

    2015-01-01

    The effects of light intensity physical activity (LIPA) on cardiovascular disease (CVD) risk factors remain to be established. This review summarizes the effects of LIPA on CVD risk factors and CVD-related markers in adults. A systematic search of four electronic databases (PubMed, Academic Search Complete, SPORTDiscus, and CINAHL) examining LIPA and CVD risk factors (body composition, blood pressure, glucose, insulin, glycosylated hemoglobin, and lipid profile) and CVD-related markers (maximal oxygen uptake, heart rate, C-reactive protein, interleukin-6, tumor necrosis factor-alpha, and tumor necrosis factor receptors 1 and 2) published between 1970 and 2015 was performed on 15 March 2015. A total of 33 intervention studies examining the effect of LIPA on CVD risk factors and markers were included in this review. Results indicated that LIPA did not improve CVD risk factors and CVD-related markers in healthy individuals. LIPA was found to improve systolic and diastolic blood pressure in physically inactive populations with a medical condition. Reviewed studies show little support for the role of LIPA to reduce CVD risk factors. Many of the included studies were of low to fair study quality and used low doses of LIPA. Further studies are needed to establish the value of LIPA in reducing CVD risk. PMID:26543862

  5. Burnout hazard in teachers results of a clinical-psychological intervention study

    PubMed Central

    2011-01-01

    Background The study investigates whether established in-patient therapy for teachers with burnout results in long-acting success and whether gender gaps and differences between teachers of different school levels exist. According to our knowledge, our study is the most extensive inpatient intervention study on the burnout of a defined occupational group, i.e., teachers. Methods 200 teachers participated, 150 took part in a later performed katamnestic survey. The Maslach Burnout Inventory (MBI) was used and work-related data were recorded. The days of incapacity for work and the percentage of teachers endangered by burnout decreased, which supports the long-term success of the treatment. Results Significant differences between males and females and between teacher levels were found. However, the differences between teacher levels only showed up before treatment. Because males only underwent treatment at a more severe stage, further efforts in persuading males to start therapy earlier are needed. Conclusions The proven and long-term success of the performed intervention could have greater effects if people, especially males, undergo treatment more frequently. Our results are based on selectively high proposition of teachers of advanced age. Thus it is possible that the long term effect of the intervention, particularly on retirement age, is greater when the intervention is started earlier. Regular burnout tests could help to identify risk cases among teachers at an early stage and to offer a therapeutic intervention. PMID:22192422

  6. Religious communities and HIV prevention: an intervention-study using a human rights-based approach

    PubMed Central

    Paiva, V.; Garcia, J.; Rios, L.F.; Santos, A.O.; Terto, V.; Munõz-Laboy, M.

    2011-01-01

    Religious communities have been a challenge to HIV prevention globally. Focusing on the acceptability component of the right to health, this intervention study examined how local Catholic, Evangelical and Afro-Brazilian religious communities can collaborate to foster young people’s sexual health and ensure their access to comprehensive HIV prevention in their communities in Brazil. This article describes the process of a three-stage sexual health promotion and HIV prevention initiative that used a multicultural human rights approach to intervention. Methods included 27 in-depth interviews with religious authorities on sexuality, AIDS prevention and human rights, and training 18 young people as research-agents, who surveyed 177 youth on the same issues using self-administered questionnaires. The results, analysed using a rights-based perspective on health and the vulnerability framework, were discussed in daylong interfaith workshops. Emblematic of the collaborative process, workshops are the focus of the analysis. Our findings suggest that this human rights framework is effective in increasing inter-religious tolerance and in providing a collective understanding of the sexuality and prevention needs of youth from different religious communities, and also serves as a platform for the expansion of state AIDS programmes based on laical principles. PMID:20373192

  7. Educating the clinical trainer: professional gain for the trainee? A controlled intervention study in general practice.

    PubMed

    Jochemsen-van der Leeuw, H G A Ria; van Dijk, Nynke; de Jong, Wilfried; Wieringa-de Waard, Margreet

    2014-12-01

    The aim of this study was to establish whether a 'teach-the-trainer' course leads to improvements in, firstly, the knowledge and attitude of clinical trainers and their trainees, and, secondly, the role model behaviour of the clinical trainers. A controlled intervention study was performed with GP trainers and GP trainees from four training institutes in the Netherlands. Clinical trainers in the two intervention institutes received two 3-h training sessions on weight management, focusing on knowledge and attitudes towards obesity, and on conveying the correct professional competency as a positive role model for trainees. This was measured using questionnaires on knowledge, attitude, and role model behaviour (the role model apperception tool; RoMAT). GP trainers showed an increase in knowledge and several characteristics could be identified as being related to positive role model behaviour. A small correlation was found between the trainer's score on the RoMAT and the attitude of the trainee. A teach-the-trainer course in which knowledge, attitudes, and role modelling are integrated proved to be a first step toward improving the knowledge of clinical trainers, but did not result in a measurably better professional outcome for the trainee, maybe due to a more objective level of assessment. PMID:25338922

  8. Use of Free-standing Filters in an Asthma Intervention Study

    PubMed Central

    Batterman, Stuart; Du, Liuliu; Parker, Edith; Robins, Thomas; Lewis, Toby; Mukherjee, Bhramar; Ramirez, Erminia; Rowe, Zachary; Brakefield-Caldwell, Wilma

    2014-01-01

    This study characterizes the use of HEPA air filters provided to 89 households participating in an intervention study investigating the respiratory health of children with asthma. Freestanding filters were placed in the child's bedroom and monitored continuously for nearly a year in each household. Filter use was significantly affected by study phase, season and monitoring week. During the “intensive” weeks when a community education worker and a field technician visited the household, the use rate averaged 70±33%. During season-long “non-intensive” periods between seasonal visits, use dropped to 34±30%. Filter use rapidly decreased during the 3 to 4 weeks following each intensive, was slightly higher in spring, summer, and in the evening and at night when the child was likely to be home, although households did not follow consistent diurnal patterns. While participants expressed an understanding of the benefits of filter use and reported good experiences with them, use rates were low, particularly during unobserved non-intensive periods. The provision of freestanding air filters to individuals or households must be considered an active intervention that requires monitoring and evaluation, otherwise unknown and unexpected patterns of filter use may alter and possibly bias results due to exposure misclassification. PMID:24436726

  9. Birth characteristics and age at menarche: results from the dietary intervention study in children (DISC)

    PubMed Central

    Ruder, Elizabeth H.; Hartman, Terryl J.; Rovine, Michael J.; Dorgan, Joanne F.

    2011-01-01

    Objective To examine whether birth weight, birth length, and gestational age are individually associated with age at menarche. Methods Analyses were conducted using data from n = 278 female participants in the Dietary Intervention Study in Children (DISC). Age at menarche was prospectively collected as part of the original DISC investigation. DISC participants self-reported birth weight, birth length, and gestational age with assistance from their mothers and other records as part of the DISC06 Follow-up Study at ages 25–29. Linear regression was used to estimate the association of birth characteristics and age at menarche. Results Birth weight was positively associated with age at menarche (p ≤ 0.01) in multiple regression analyses after controlling for BMI-for-age percentile, race and DISC treatment group. No statistically significant relationships were detected between either length or gestational age and age at menarche. Conclusions Higher birth weight may be associated with a modest delay in age at menarche. PMID:20495859

  10. A Narrative Review of Diabetes Intervention Studies to Explore Diabetes Care Opportunities for Pharmacists

    PubMed Central

    Ayadurai, Shamala; Hattingh, H. Laetitia; Tee, Lisa B. G.; Md Said, Siti Norlina

    2016-01-01

    Background. We conducted a review of current diabetes intervention studies in type 2 diabetes and identified opportunities for pharmacists to deliver quality diabetes care. Methods. A search on randomised controlled trials (RCT) on diabetes management by healthcare professionals including pharmacists published between 2010 and 2015 was conducted. Results and Discussion. Diabetes management includes multifactorial intervention which includes seven factors as outlined in diabetes guidelines, namely, glycaemic, cholesterol and blood pressure control, medication, lifestyle, education, and cardiovascular risk factors. Most studies do not provide evidence that the intervention methods used included all seven factors with exception of three RCT which indicated HbA1c (glycated hemoglobin) reduction range of 0.5% to 1.8%. The varied HbA1C reduction suggests a lack of standardised and consistent approach to diabetes care. Furthermore, the duration of most studies was from one month to two years; therefore long term outcomes could not be established. Conclusion. Although pharmacists' contribution towards improving clinical outcomes of diabetes patients was well documented, the methods used to deliver structured, consistent evidence-based care were not clearly stipulated. Therefore, approaches to achieving long term continuity of care are uncertain. An intervention strategy that encompass all seven evidence-based factors will be useful. PMID:27247949

  11. Sampling, Recruitment, and Retention in a Bereavement Intervention Study: Experiences from the Living After Loss Project

    PubMed Central

    Caserta, Michael; Utz, Rebecca; Lund, Dale; de Vries, Brian

    2010-01-01

    This paper reports on the sampling and recruitment challenges, as well as the strategies used to address them in the Living After Loss (LAL) project, a bereavement intervention study conducted in Salt Lake City and San Francisco comparing two 14-week group conditions with follow-up. We encountered three major challenges: 1) difficulty determining eligibility for some potential participants who were contacted, 2) locating and recruiting nonwhites, and 3) unavailable phone numbers for approximately one-third of those we attempted to contact. Despite these challenges, we achieved a 42% response rate with a sample size of 328 participants comprising 15% nonwhite. Eighty-five percent of the participants completed all of the follow-up data points. Leading factors in participants’ decisions to join and remain in the study were 1) opportunities to obtain help and support, 2) to potentially help other bereaved individuals, 3) to contribute to research, and 4) their on-going interactions with a professional, empathetic, and culturally sensitive project staff. Effectively focusing recruitment efforts and carefully and systematically training research staff were among the most effective strategies we employed and therefore suggest for those planning similar investigations. PMID:20873532

  12. Clinical diagnostic and intervention studies of children with semantic-pragmatic language disorder.

    PubMed

    Adams, C

    2001-01-01

    The diagnosis of semantic-pragmatic language disorder (SPLD) has been the subject of a number of research studies over the last two decades. Classification and diagnostic debates, while illuminating, have done little to develop tools to improve services to these children. In this paper, two children whose communication difficulties are suggestive of an SPLD diagnosis but who have differing profiles are studied. Using existing models of psycholinguistics and pragmatics to guide assessment and intervention, the diversity of language and social communicative behaviours that are covered by the label SPLD are exemplified. Consideration is given to whether the term SPLD is appropriate for both children or whether Bishop's revision of the diagnosis to 'pragmatic language impairment' might be more useful. Methods of intervention and evaluation for semantic and pragmatic deficits in these two cases are described. It is argued that existing tools can enable accurate explanation and modelling of the communication of children with SPLD and that there is a role for intervention studies in helping to refine those tools, to improve therapies and to understand the nature of the condition more fully. PMID:11491481

  13. A carnosine intervention study in overweight human volunteers: bioavailability and reactive carbonyl species sequestering effect.

    PubMed

    Regazzoni, Luca; de Courten, Barbora; Garzon, Davide; Altomare, Alessandra; Marinello, Cristina; Jakubova, Michaela; Vallova, Silvia; Krumpolec, Patrik; Carini, Marina; Ukropec, Jozef; Ukropcova, Barbara; Aldini, Giancarlo

    2016-01-01

    Carnosine is a natural dipeptide able to react with reactive carbonyl species, which have been recently associated with the onset and progression of several human diseases. Herein, we report an intervention study in overweight individuals. Carnosine (2 g/day) was orally administered for twelve weeks in order to evaluate its bioavailability and metabolic fate. Two carnosine adducts were detected in the urine samples of all subjects. Such adducts are generated from a reaction with acrolein, which is one of the most toxic and reactive compounds among reactive carbonyl species. However, neither carnosine nor adducts have been detected in plasma. Urinary excretion of adducts and carnosine showed a positive correlation although a high variability of individual response to carnosine supplementation was observed. Interestingly, treated subjects showed a significant decrease in the percentage of excreted adducts in reduced form, accompanied by a significant increase of the urinary excretion of both carnosine and carnosine-acrolein adducts. Altogether, data suggest that acrolein is entrapped in vivo by carnosine although the response to its supplementation is possibly influenced by individual diversities in terms of carnosine dietary intake, metabolism and basal production of reactive carbonyl species. PMID:27265207

  14. Intervention study on cardiac autonomic nervous effects of methylmercury from seafood.

    PubMed

    Yaginuma-Sakurai, Kozue; Murata, Katsuyuki; Shimada, Miyuki; Nakai, Kunihiko; Kurokawa, Naoyuki; Kameo, Satomi; Satoh, Hiroshi

    2010-01-01

    To scrutinize whether the provisional tolerable weekly intake (PTWI, 3.4 microg/kg body weight/week) of methylmercury in Japan is safe for adults, we conducted an intervention study using heart rate variability (HRV) that has been considered to reflect cardiac events. Fifty-four healthy volunteers were recruited and divided into experimental and control groups. The experimental group was exposed to methylmercury at the PTWI level through consumption of bigeye tuna and swordfish for 14 weeks, and HRV parameters were compared between the two groups. In the experimental group, mean hair mercury levels, determined before and after the dietary methylmercury exposure and after 15-week wash-out period following the cessation of exposure, were 2.30, 8.76 and 4.90 microg/g, respectively. The sympathovagal balance index of HRV was significantly elevated after the exposure, and decreased to the baseline level at the end of this study. Still, such changes in HRV parameters were not found in the control group with a mean hair mercury level of around 2.1 microg/g. In conclusion, the PTWI does not appear to be safe for adult health, because methylmercury exposure from fish consumption induced a temporary sympathodominant state. Rather, long-term exposure to methylmercury may pose a potential risk for cardiac events involving sympathovagal imbalance among fish-consuming populations. PMID:19732823

  15. A multicenter, non-interventional study to evaluate patient-reported experiences of living with psoriasis

    PubMed Central

    Pariser, David; Schenkel, Brad; Carter, Chureen; Farahi, Kamyar; Brown, T. Michelle; Ellis, Charles N.

    2016-01-01

    Abstract Background: Moderate to severe plaque psoriasis (with or without psoriatic arthritis) places significant burden on patients’ lives. Objective: Explore and document patients’ experiences of living with psoriasis, including symptoms, treatments, impact on daily lives and patient-reported functioning. Methods: In a US-based, non-interventional study, narrative interviews were conducted at baseline and again within 16 weeks. In interviews, patients with moderate to severe psoriasis indicated symptoms, ranked symptoms according to level of bother and indicated areas of their lives affected by psoriasis. Transcripts of interviews were coded for themes. Measurements of psoriasis severity including BSA, PGA and PASI were recorded. Results: Symptoms reported most frequently included flaking/scaling (non-scalp areas), itching/scratching and rash, while the most bothersome symptoms were itching/scratching, flaking/scaling (non-scalp areas) and skin pain. Frequently reported impact areas were social and emotional. Conclusion: Broad-reaching interviews with patients with psoriasis show that these patients suffer in many aspects of their lives and in ways not indicated by typical psoriasis severity measures. Patients with psoriatic arthritis reported symptoms and disease-related complications at higher rates than those without arthritis. Physicians’ explorations of the effect of psoriasis on patients’ life events could aid in managing these patients. PMID:26138406

  16. Workplace restructurings in intervention studies – a challenge for design, analysis and interpretation

    PubMed Central

    Olsen, Ole; Albertsen, Karen; Nielsen, Martin Lindhardt; Poulsen, Kjeld Børge; Gron, Sisse Malene Frydendal; Brunnberg, Hans Lennart

    2008-01-01

    Background Interventions in occupational health often target worksites rather than individuals. The objective of this paper is to describe the (lack of) stability in units of analysis in occupational health and safety intervention projects directed toward worksites. Methods A case study approach is used to describe naturally occurring organizational changes in four, large, Nordic intervention projects that ran 3–5 years, covered 3–52 worksites, cost 0.25 mill–2.2 mill €, and involved 3–7 researchers. Results In all four cases, high rates of closing, merging, moving, downsizing or restructuring was observed, and in all four cases at least one company/worksite experienced two or more re-organizations during the project period. If individual worksites remained, ownership or (for publicly owned) administrative or legal base often shifted. Forthcoming closure led employees and managers to seek employment at other worksites participating in the studies. Key employees involved in the intervention process often changed. Conclusion Major changes were the rule rather than the exception. Frequent fundamental changes at worksites need to be taken into account when planning intervention studies and raises serious questions concerning design, analyses and interpretation of results. The frequent changes may also have deleterious implications for the potential effectiveness of many real life interventions directed toward worksites. We urge researchers and editors to prioritize this subject in order to improve the quality of future intervention research and preventive action. PMID:18554380

  17. Involvement of informal caregivers in supporting patients with COPD: a review of intervention studies

    PubMed Central

    Bryant, Jamie; Mansfield, Elise; Boyes, Allison W; Waller, Amy; Sanson-Fisher, Rob; Regan, Timothy

    2016-01-01

    Caregivers of individuals with COPD have a key role in maintaining patient adherence and optimizing patient function. However, no systematic review has examined how the caregiver role has been operationalized in interventions to improve outcomes of individuals with COPD or the quality or effectiveness of these interventions. The aims of this review were to 1) determine whether caregivers have been involved as part of interventions to improve outcomes of individuals with COPD; 2) determine the risk of bias within included intervention studies; and 3) examine the effectiveness of interventions that have involved caregivers in improving outcomes of individuals with COPD. The electronic databases of Medline, Embase, PsycINFO, and Cochrane Library were searched from January 2000 to November 2015. Experimental studies testing interventions that involved a caregiver to improve COPD patient outcomes were eligible. Nine studies involving caregivers met inclusion criteria. No studies reported any intervention components targeted solely at caregivers, with most instead including caregivers in dyadic or group education sessions about COPD delivered by health care professionals. The risk of bias identified in included studies was mixed. Seven of the nine studies were effective in improving a broad range of outcomes. These findings highlight that there is an urgent need for methodologically rigorous interventions to examine the effectiveness of strategies to assist caregivers to provide direct care, encourage adherence to health care provider recommendations, act as a health care advocate, and provide emotional and psychosocial support to individuals with COPD. PMID:27478372

  18. Effects of the FTO gene on lifestyle intervention studies in children.

    PubMed

    Rendo, Tara; Moleres, Adriana; Marti Del Moral, Amelia

    2009-01-01

    The effects of FTO on body weight, body composition, and the risk of developing overweight and obesity in children, adolescents, and adults are analyzed in this review. Most trails have been conducted on the rs9939609 SNP of the FTO gene. The minor A-allele frequency ranged from 0.38 to 0.49 in different European populations. Briefly, it has been reported that overweight-obesity risk per A-allele ranged from 1.76 to 1.35, whereas z-score for BMI has a wider variation from 0.05 to 0.5 kg/m(2) in European children and adolescents. As for other adiposity indexes, a waist circumference increase from 0.60 to 0.95 cm per A-allele was found together with an increase in fat mass from 0.68 to 1.78 kg in European children and adoles-cents. In regard to food intake, AA carrier subjects were reported to have reduced satiety responsiveness scores and a higher total energy and fat intake. However, it is not clear whether energy expenditure did modify the role of the rs9939609 FTO gene variant in adiposity. Furthermore, few reports examined the influence of FTO gene variants using intervention studies. Overall, it seems that the A-allele (rs9939609 FTO) is associated with higher body weight gain. However, further studies into FTO gene variants in children and adults are needed. PMID:20090391

  19. Child development surveillance: intervention study with nurses of the Family Health Strategy1

    PubMed Central

    Reichert, Altamira Pereira da Silva; Collet, Neusa; Eickmann, Sophie Helena; Lima, Marília de Carvalho

    2015-01-01

    Objective: to evaluate the effectiveness of an educational action in child development surveillance performed by nurses working in primary health care. Methods: interventional study with a before-and-after type of design, carried out with 45 nurses and 450 mothers of children under 2 years of age. Initially, it was evaluated the practices and knowledge of nurses on child development surveillance and the mothers were interviewed about these practices. Subsequently, workshops were carried out with nurses and four months later, the knowledge of nurses and the maternal information were reevaluated. Results: after intervention there was significant increase in the frequency of the following aspects: from 73% to 100%, in relation to the practice of nurses of asking the opinion of mothers about their children's development; from 42% to 91%, regarding the use of the systematized instrument of evaluation; from 91% to 100% with respect to guidance to mothers on how to stimulate child development. Conclusions: the intervention contributed to the increase of knowledge of nurses and implementation of child development surveillance, showing the importance of this initiative to improve the quality of child health care. PMID:26487147

  20. A carnosine intervention study in overweight human volunteers: bioavailability and reactive carbonyl species sequestering effect

    PubMed Central

    Regazzoni, Luca; de Courten, Barbora; Garzon, Davide; Altomare, Alessandra; Marinello, Cristina; Jakubova, Michaela; Vallova, Silvia; Krumpolec, Patrik; Carini, Marina; Ukropec, Jozef; Ukropcova, Barbara; Aldini, Giancarlo

    2016-01-01

    Carnosine is a natural dipeptide able to react with reactive carbonyl species, which have been recently associated with the onset and progression of several human diseases. Herein, we report an intervention study in overweight individuals. Carnosine (2 g/day) was orally administered for twelve weeks in order to evaluate its bioavailability and metabolic fate. Two carnosine adducts were detected in the urine samples of all subjects. Such adducts are generated from a reaction with acrolein, which is one of the most toxic and reactive compounds among reactive carbonyl species. However, neither carnosine nor adducts have been detected in plasma. Urinary excretion of adducts and carnosine showed a positive correlation although a high variability of individual response to carnosine supplementation was observed. Interestingly, treated subjects showed a significant decrease in the percentage of excreted adducts in reduced form, accompanied by a significant increase of the urinary excretion of both carnosine and carnosine-acrolein adducts. Altogether, data suggest that acrolein is entrapped in vivo by carnosine although the response to its supplementation is possibly influenced by individual diversities in terms of carnosine dietary intake, metabolism and basal production of reactive carbonyl species. PMID:27265207

  1. Random thoughts

    NASA Astrophysics Data System (ADS)

    ajansen; kwhitefoot; panteltje1; edprochak; sudhakar, the

    2014-07-01

    In reply to the physicsworld.com news story “How to make a quantum random-number generator from a mobile phone” (16 May, http://ow.ly/xFiYc, see also p5), which describes a way of delivering random numbers by counting the number of photons that impinge on each of the individual pixels in the camera of a Nokia N9 smartphone.

  2. Impact of pedometer-based walking on menopausal women's sleep quality: a randomized controlled trial.

    PubMed

    Tadayon, M; Abedi, P; Farshadbakht, F

    2016-08-01

    Objective Sleep disturbances are one of the most common psycho-physiological issues among postmenopausal women. This study was designed to evaluate the impact of walking with a pedometer on the sleep quality of postmenopausal Iranian women. Methods This randomized, controlled trial was conducted on 112 women who were randomly assigned to two groups. The women in the intervention group (n = 56) were asked to walk with a pedometer each day for 12 weeks and to increase their walking distance by 500 steps per week. A sociodemographic instrument and the Pittsburgh Sleep Quality Index were used to collect data. Sleep quality was measured at baseline, 4, 8, and 12 weeks after intervention. The control group (n = 56) did not receive any intervention. Results After 12 weeks, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction improved to a significantly greater extent in the intervention group than in the control group (p < 0.05). The total sleep quality score was significantly higher in the intervention group than in the control group (0.64 vs. 0.98, p = 0.001). Conclusion This study showed that walking with a pedometer is an easy and cost-effective way to improve the quality of sleep among postmenopausal women. Use of this method in public health centers is recommended. PMID:26757356

  3. Treatment of bulimia nervosa with sertraline: a randomized controlled trial.

    PubMed

    Milano, W; Petrella, C; Sabatino, C; Capasso, A

    2004-01-01

    Bulimia nervosa (BN) is one of the most frequently encountered eating disorders in industrialized societies. It has been suggested that reduced serotonin activity may trigger some of the cognitive and mood disturbances associated with BN. Thus, pharmacologic treatment of BN is mainly based on the use of selective serotonin reuptake inhibitors, which have proved effective. At present, the biological basis of this disorder is not completely clear. The aim of this randomized, controlled trial was to verify the efficacy of sertraline, a selective serotonin reuptake inhibitor, in a group of patients with a diagnosis of BN. Twenty female outpatients, with an age range of 24 to 36 years and a diagnosis of purging type BN as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV), were assigned randomly to two treatment groups. The first group received sertraline 100 mg/day for 12 weeks; the second group received placebo. The study was conducted for 12 weeks, with weekly clinical assessments. At the end of the observation period, the group treated with sertraline had a statistically significant reduction in the number of binge eating crises and purging compared with the group who received placebo. In no case was treatment interrupted because of side effects. This study confirms that sertraline is well tolerated and effective in reducing binge-eating crises and purging in patients with BN. PMID:15605617

  4. The Role of Teacher Behavior Management in the Development of Disruptive Behaviors: An Intervention Study with the Good Behavior Game

    ERIC Educational Resources Information Center

    Leflot, Geertje; van Lier, Pol A. C.; Onghena, Patrick; Colpin, Hilde

    2010-01-01

    The role of teacher behavior management for children's disruptive behavior development (hyperactive and oppositional behavior) was investigated using a universal classroom preventive intervention study. Five-hundred seventy children were followed from second to third grade of elementary school. Observations of teacher behavior management and…

  5. A Systematic Investigation of Program Differentiation within a Kindergarten Reading Intervention Study: The Importance of Accounting for Implementation across Conditions

    ERIC Educational Resources Information Center

    Civetelli, Christina

    2012-01-01

    This study examined dimensions of treatment integrity, specifically program differentiation, within the context of a kindergarten reading intervention study. The study explored the relationship between program differentiation and student outcomes. The study was conducted within the context of Project Early Reading Intervention (ERI), a four-year…

  6. Effects of free leucine supplementation and resistance training on muscle strength and functional status in older adults: a randomized controlled trial

    PubMed Central

    Trabal, Joan; Forga, Maria; Leyes, Pere; Torres, Ferran; Rubio, Jordi; Prieto, Esther; Farran-Codina, Andreu

    2015-01-01

    Objective To assess the effect of free leucine supplementation combined with resistance training versus resistance training only on muscle strength and functional status in older adults. Methods This was a randomized, double-blind, placebo-controlled, parallel study with two intervention groups. Thirty older adults were randomly assigned to receive either 10 g leucine/day (leucine group [LG], n=15) or a placebo (control group [CG], n=15), plus resistance training over a 12-week period. Maximal overcoming isometric leg strength, functional status, nutritional status, body composition, health-related quality of life, depression, and dietary intake were assessed at 4 and 12 weeks. Missing data at 12 weeks were handled using mixed models for repeated measurements for data imputation. Results Twenty-four subjects completed the 4-week assessment and eleven completed the 12-week intervention. Clinically significant gains were found in isometric leg strength at both assessment time points. Analysis of the effect size also showed how participants in LG outperformed those in CG for chair stands and the timed up and go test. No significant changes were observed for the rest of the outcomes. Conclusion Our combined analysis showed moderate changes in isometric leg muscle strength and certain components of functional status. The magnitude of changes found on these outcomes should be qualified as a positive effect of the concomitant intervention. PMID:25926725

  7. Effect of Combining Therapy with Traditional Chinese Medicine-Based Psychotherapy and Herbal Medicines in Women with Menopausal Syndrome: A Randomized Controlled Clinical Trial

    PubMed Central

    Yang, Hongyan; Yang, Jing; Wen, Zehuai; Zha, Qinglin; Nie, Guangning; Huang, Xuchun; Zhang, Chunlin; Lu, Aiping; Jiang, Miao; Wang, Xiaoyun

    2012-01-01

    This multicenter, randomized, controlled clinical study was designed to address the effectiveness of combined traditional-Chinese-medicine- (TCM-) based psychotherapy and Chinese herbal medicine (CHM) in the treatment of menopausal syndrome. Altogether 424 eligible women diagnosed as menopausal syndrome and categorized as Kidney-Yin/Kidney-Yang deficiency pattern in TCM were randomly assigned into 4 groups and accepted TCM-based psychotherapy (PSY), CHM, PSY + CHM, or placebo therapies, respectively, for 12 weeks, and another 12 weeks were taken as the followup. Kupperman Index (KI) and the Menopause-Specific Quality of Life (MENQOL) with its four subscales (vasomotor, physical, psychosocial, and sexual) were employed for efficacy assessment. Results showed that 400 participants completed 12-week treatment, of which 380 finished the record of KI and MENQOF at week 24. The average adjusted number of KI score decreased between baseline and 12 weeks in all groups. Statistically significant differences were detected in the average adjusted change between the PSY + CHM group and placebo at overall time points (P < 0.05). No severe adverse events occurred in each group and no significant differences were indicated between any of the three groups and placebo in adverse event proportion. We concluded that TCM psychotherapy combined with CHM has a favorable outcome in treating menopausal syndrome. PMID:23304198

  8. The effects of surgical checklists on morbidity and mortality: a pre- and post-intervention study

    PubMed Central

    Rodrigo-Rincon, I; Martin-Vizcaino, MP; Tirapu-Leon, B; Zabalza-Lopez, P; Zaballos-Barcala, N; Villalgordo-Ortin, P; Abad-Vicente, FJ; Gost-Garde, J

    2015-01-01

    Background Surgical checklists (SCs) have been developed to enhance teamwork and facilitate handovers, thereby improving the safety of surgical patients in health care organisations. The aim of this study was to determine whether the implementation of a 39-item SC reduced mortality and surgical adverse events (AEs) in patients undergoing inpatient surgery. Methods A retrospective pre- and post-intervention study of two cohorts of surgical patients was conducted (n = 1602) in a tertiary teaching hospital. The patients' homogeneity was confirmed by studying 40 comorbidities, 13 analytical determinations and 14 patient- and intervention-related variables. A 39-item SC adapted from one by the World Health Organization was used. The primary endpoint was the occurrence of any AE, including death, within 30 days of the operation. Twenty-three types of AEs were analysed. Results Following implementation of the checklist, the rate of AEs per 100 patients decreased from 31.5% to 26.5% (P = 0.39), the rate of infectious AEs decreased from 13.9 to 9.6 (P = 0.037) and non-infectious AEs decreased from 17.5 to 16.8 (P = 0.82). For non-elective patients, total AEs decreased from 60.4 to 37.0 (P = 0.017). The proportion of patients with one or more AE decreased from 18.1% to 16.2% (P = 0.35), and the death rate at 30 days decreased from 1.5% to 0.9% (P = 0.35). Conclusion The overall AE rate did not decrease significantly between the two periods. However, the rate of infectious AEs and overall AEs in patients with non-elective admissions had statistically significant reductions. Further research is needed to determine how and in which patients SC introduction can work successfully. PMID:25476578

  9. The Effectiveness of Disaster Risk Communication: A Systematic Review of Intervention Studies

    PubMed Central

    Bradley, Declan T; McFarland, Marie; Clarke, Mike

    2014-01-01

    Introduction: A disaster is a serious disruption to the functioning of a community that exceeds its capacity to cope within its own resources. Risk communication in disasters aims to prevent and mitigate harm from disasters, prepare the population before a disaster, disseminate information during disasters and aid subsequent recovery. The aim of this systematic review is to identify, appraise and synthesise the findings of studies of the effects of risk communication interventions during four stages of the disaster cycle. Methods: We searched the Cochrane Central Register of Controlled Trials, Embase, MEDLINE, PsycInfo, Sociological Abstracts, Web of Science and grey literature sources for randomised trials, cluster randomised trials, controlled and uncontrolled before and after studies, interrupted time series studies and qualitative studies of any method of disaster risk communication to at-risk populations. Outcome criteria were disaster-related knowledge and behaviour, and health outcomes. Results: Searches yielded 5,224 unique articles, of which 100 were judged to be potentially relevant. Twenty-five studies met the inclusion criteria, and two additional studies were identified from other searching. The studies evaluated interventions in all four stages of the disaster cycle, included a variety of man-made, natural and infectious disease disasters, and were conducted in many disparate settings. Only one randomised trial and one cluster randomised trial were identified, with less robust designs used in the other studies. Several studies reported improvements in disaster-related knowledge and behaviour. Discussion: We identified and appraised intervention studies of disaster risk communication and present an overview of the contemporary literature. Most studies used non-randomised designs that make interpretation challenging. We do not make specific recommendations for practice but highlight the need for high-quality randomised trials and appropriately

  10. Peer Acceptance and the Development of Emotional and Behavioural Problems: Results from a Preventive Intervention Study

    ERIC Educational Resources Information Center

    Menting, Barbara; Koot, Hans; van Lier, Pol

    2015-01-01

    Difficulties in peer acceptance during elementary school have been associated with emotional and behavioural problems. This study used a randomized controlled intervention design to test whether improvements in peer acceptance mediated reduced rates of emotional and behavioural problems in intervention compared to control-group children. A total…

  11. Self-Regulation, Motivation and Teaching Styles in Physical Education Classes: An Intervention Study

    ERIC Educational Resources Information Center

    Chatzipanteli, Athanasia; Digelidis, Nikolaos; Papaioannou, Athanasios G.

    2015-01-01

    The aim of the study was to investigate the influence of student-activated teaching styles through a specific intervention program on students' self-regulation, lesson satisfaction, and motivation. Six hundred and one 7th grade students (318 boys and 283 girls), aged 13 years were randomly assigned to an experimental group and a comparison group.…

  12. Comprehension Strategy Instruction during Parent-Child Shared Reading: An Intervention Study

    ERIC Educational Resources Information Center

    Roberts, Kathryn L.

    2013-01-01

    This study examined the effectiveness of a series of workshops and at-home activities designed to teach parents to integrate comprehension strategy instruction into read-alouds with their pre-kindergarten-aged children. Twenty parent-child dyads were randomly assigned to condition and parents in the experimental (workshop) condition were taught to…

  13. Preservice Teachers' Beliefs and Attitude about Teaching and Learning Mathematics through Music: An Intervention Study

    ERIC Educational Resources Information Center

    An, Song A.; Ma, Tingting; Capraro, Mary Margaret

    2011-01-01

    This article presents exploratory research investigating the integration of music and a mathematics lesson as an intervention to promote preservice teachers' attitude and confidence and to extend their beliefs toward teaching mathematics integrated with music. Thirty students were randomly selected from 64 preservice teachers in a southern…

  14. A 12-week High School Course in Computer Use.

    ERIC Educational Resources Information Center

    Brown, Faith K.

    1982-01-01

    Using personal-sized microcomputers (8K), students learn to operate equipment and program in BASIC. They complete computer-assisted instruction lessons and select, design, operate, demonstrate, and document their own original programs in this one quarter, high school course. Course objectives, activities, materials, and evaluation are outlined.…

  15. [Split hand-foot: sonographic detection at 12 weeks].

    PubMed

    González-Ballano, Isabel; Savirón-Cornudella, Ricardo; Alastuey-Aisa, María; Garrido-Fernández, Pilar; Lerma-Puertas, Diego

    2014-07-01

    Split hand-foot malformation is a rare disorder inherited in an autosomal dominant pattern with variable expression. Inour case, it was detected early by ultrasound in the twelfth week of gestation. The sonographic findings were bilateral split hands and feet. No other alterations were observed in the rest of the systematic assessment of the foetal anatomy. The pathological findings were consistent with the sonographic diagnosis. Prenatal diagnosis by corionic villus sampling was performed and voluntary termination of gestation decided. PMID:25102675

  16. Effectiveness of a one-year multi-component day-camp intervention for overweight children: study protocol of the Odense overweight intervention study (OOIS)

    PubMed Central

    2014-01-01

    Background Childhood overweight has noticeable psychological and social consequences for the child and leads to an increased risk of mortality and morbidity later in life. With the high prevalence of overweight in children and adolescents, it is important to identify effective approaches for the prevention and treatment of overweight in children and young individuals. The primary aim of the study is to assess the effect of an intensive day-camp intervention on body mass index (BMI) in overweight children. Methods The Odense Overweight Intervention Study is a semi-blinded randomized controlled trial. Overweight children from the Municipality of Odense, Denmark, were invited to participate in the trial. Based on power calculations 98 participants were found to be sufficient to randomize in order to find an effect of minimum 1.5 BMI points. Gender-stratified concealed block randomization with a ratio of 1:1 and random block sizes of two, four, and six ensured balance between study arms. The intervention consisted of a six-week multi-component day camp including increased physical activity, healthy diet and health education followed by 46 weeks of family-based habitual intervention. The standard care arm was offered two weekly hours of physical activity training for six weeks. The outcomes were measured at baseline and at six-week and 52-week follow-ups. Furthermore, BMI will be assessed again at 48-month follow-up. Test personnel were kept blinded. The intervention effect will be evaluated using mixed model analyses. During 2012 and 2013, 115 children were enrolled in the study. Fifty-nine children were randomized to the day-camp intervention arm and 56 to the standard intervention arm. Discussion This study will provide novel information about the long-term health effects of an intense day-camp intervention program on overweight children, due to the design and the follow-up period. Moreover, it will add to the knowledge on designing and implementing feasible camp

  17. Random Vibrations

    NASA Technical Reports Server (NTRS)

    Messaro. Semma; Harrison, Phillip

    2010-01-01

    Ares I Zonal Random vibration environments due to acoustic impingement and combustion processes are develop for liftoff, ascent and reentry. Random Vibration test criteria for Ares I Upper Stage pyrotechnic components are developed by enveloping the applicable zonal environments where each component is located. Random vibration tests will be conducted to assure that these components will survive and function appropriately after exposure to the expected vibration environments. Methodology: Random Vibration test criteria for Ares I Upper Stage pyrotechnic components were desired that would envelope all the applicable environments where each component was located. Applicable Ares I Vehicle drawings and design information needed to be assessed to determine the location(s) for each component on the Ares I Upper Stage. Design and test criteria needed to be developed by plotting and enveloping the applicable environments using Microsoft Excel Spreadsheet Software and documenting them in a report Using Microsoft Word Processing Software. Conclusion: Random vibration liftoff, ascent, and green run design & test criteria for the Upper Stage Pyrotechnic Components were developed by using Microsoft Excel to envelope zonal environments applicable to each component. Results were transferred from Excel into a report using Microsoft Word. After the report is reviewed and edited by my mentor it will be submitted for publication as an attachment to a memorandum. Pyrotechnic component designers will extract criteria from my report for incorporation into the design and test specifications for components. Eventually the hardware will be tested to the environments I developed to assure that the components will survive and function appropriately after exposure to the expected vibration environments.

  18. Experimental Gingivitis Induces Systemic Inflammatory Markers in Young Healthy Individuals: A Single-Subject Interventional Study

    PubMed Central

    Luchtefeld, Maren; Heuer, Wieland; Schuett, Harald; Divchev, Dimitar; Scherer, Ralph; Schmitz-Streit, Ruth; Langfeldt, Daniela; Stumpp, Nico; Staufenbiel, Ingmar

    2013-01-01

    Objectives We here investigated whether experimental gingivitis enhances systemic markers of inflammation which are also known as surrogate markers of atherosclerotic plaque development. Background Gingivitis is a low-level oral infection induced by bacterial deposits with a high prevalence within Western populations. A potential link between the more severe oral disease periodontitis and cardiovascular disease has already been shown. Methods 37 non-smoking young volunteers with no inflammatory disease or any cardiovascular risk factors participated in this single-subject interventional study with an intra-individual control. Intentionally experimental oral inflammation was induced by the interruption of oral hygiene for 21 days, followed by a 21-days resolving phase after reinitiation of oral hygiene. Primary outcome measures at baseline, day 21 and 42 were concentrations of hsCRP, IL-6, and MCP-1, as well as adhesion capacity and oxLDL uptake of isolated blood monocytes. Results The partial cessation of oral hygiene procedures was followed by the significant increase of gingival bleeding (34.0%, P<0.0001). This local inflammation was associated with a systemic increase in hsCRP (0.24 mg/L, P = 0.038), IL-6 (12.52 ng/L, P = 0.0002) and MCP-1 (9.10 ng/l, P = 0.124) in peripheral blood samples between baseline and day 21, which decreased at day 42. Monocytes showed an enhanced adherence to endothelial cells and increased foam cell formation after oxLDL uptake (P<0.050) at day 21 of gingivitis. Conclusions Bacterial-induced gingival low-level inflammation induced a systemic increase in inflammatory markers. Dental hygiene almost completely reversed this experimental inflammatory process, suggesting that appropriate dental prophylaxis may also limit systemic markers of inflammation in subjects with natural gingivitis. International Clinical Trials Register Platform of the World Health Organization, registry number: DRKS00003366, URL: http

  19. A Facility Specialist Model for Improving Retention of Nursing Home Staff: Results from a Randomized, Controlled Study

    ERIC Educational Resources Information Center

    Pillemer, Karl; Meador, Rhoda; Henderson, Charles, Jr.; Robison, Julie; Hegeman, Carol; Graham, Edwin; Schultz, Leslie

    2008-01-01

    Purpose: This article reports on a randomized, controlled intervention study designed to reduce employee turnover by creating a retention specialist position in nursing homes. Design and Methods: We collected data three times over a 1-year period in 30 nursing homes, sampled in stratified random manner from facilities in New York State and…

  20. The Steps to Health Randomized Trial for Arthritis

    PubMed Central

    Wilcox, Sara; McClenaghan, Bruce; Sharpe, Patricia A.; Baruth, Meghan; Hootman, Jennifer M.; Leith, Katherine; Dowda, Marsha

    2015-01-01

    Background Despite the established benefits of exercise for adults with arthritis, participation is low. Safe, evidence-based, self-directed programs, which have the potential for high reach at a low cost, are needed. Purpose To test a 12-week, self-directed, multicomponent exercise program for adults with arthritis. Design Randomized controlled trial. Data were collected from 2010 to 2012. Data were analyzed in 2013 and 2014. Setting/participants Adults with arthritis (N=401, aged 56.3 [10.7] years, 85.8% women, 63.8% white, 35.2% African American, BMI of 33.0 [8.2]) completed measures at a university research center and participated in a self-directed exercise intervention (First Step to Active Health®) or nutrition control program (Steps to Healthy Eating). Intervention Intervention participants received a self-directed multicomponent exercise program and returned self-monitoring logs for 12 weeks. Main outcome measures Self-reported physical activity, functional performance measures, and disease-specific outcomes (arthritis symptoms and self-efficacy) assessed at baseline, 12 weeks, and 9 months. Results Participants in the exercise condition showed greater increases in physical activity than those in the nutrition control group (p=0.01). Significant improvements, irrespective of condition, were seen in lower body strength, functional exercise capacity, lower body flexibility, pain, fatigue, stiffness, and arthritis management self-efficacy (p values <0.0001). More adverse events occurred in the exercise than nutrition control condition, but only one was severe and most were expected with increased physical activity. Conclusions The exercise program improves physical activity, and both programs improve functional and psychosocial outcomes. Potential reasons for improvements in the nutrition control condition are discussed. These interventions have the potential for large-scale dissemination. This study is registered at Clinicaltrials.gov NCT01172327. PMID

  1. Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study

    NASA Astrophysics Data System (ADS)

    Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

    2016-06-01

    The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls (p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

  2. High Beta-palmitate formula and bone strength in term infants: a randomized, double-blind, controlled trial.

    PubMed

    Litmanovitz, Ita; Davidson, Keren; Eliakim, Alon; Regev, Rivka H; Dolfin, Tzipora; Arnon, Shmuel; Bar-Yoseph, Fabiana; Goren, Amit; Lifshitz, Yael; Nemet, Dan

    2013-01-01

    We aimed to compare the effect of 12-week feeding of commercially available infant formulas with different percentages of palmitic acid at sn-2 (beta-palmitate) on anthropometric measures and bone strength of term infants. It was hypothesized that feeding infants with high beta-palmitate (HBP) formula will enhance their bone speed of sound (SOS). Eighty-three infants appropriate for gestational age participated in the study; of these, 58 were formula-fed and 25 breast-fed infants, serving as a reference group. The formula-fed infants were randomly assigned to receive HBP formula (43 % of the palmitic acid is esterified to the middle position of the glycerol backbone, study group; n = 30) or regular formula with low-beta palmitate (LBP, 14 % of the palmitic acid is esterified to the middle position of the glycerol backbone, n = 28). Sixty-six infants completed the 12-week study. Anthropometric and quantitative ultrasound measurements of bone SOS for assessment of bone strength were performed at randomization and at 6 and 12 weeks postnatal age. At randomization, gestational age, birth weight, and bone SOS were comparable between the three groups. At 12 weeks postnatal age, the mean bone SOS of the HBP group was significantly higher than that of the LBP group (2,896 ± 133 vs. 2,825 ± 79 m/s respectively, P = 0.049) and comparable with that of the breast-fed group (2,875 ± 85 m/s). We concluded that infants consuming HBP formula had changes in bone SOS that were comparable to those of infants consuming breast milk and favorable compared to infants consuming LBP formula. PMID:23179103

  3. RANDOM LASSO.

    PubMed

    Wang, Sijian; Nan, Bin; Rosset, Saharon; Zhu, Ji

    2011-03-01

    We propose a computationally intensive method, the random lasso method, for variable selection in linear models. The method consists of two major steps. In step 1, the lasso method is applied to many bootstrap samples, each using a set of randomly selected covariates. A measure of importance is yielded from this step for each covariate. In step 2, a similar procedure to the first step is implemented with the exception that for each bootstrap sample, a subset of covariates is randomly selected with unequal selection probabilities determined by the covariates' importance. Adaptive lasso may be used in the second step with weights determined by the importance measures. The final set of covariates and their coefficients are determined by averaging bootstrap results obtained from step 2. The proposed method alleviates some of the limitations of lasso, elastic-net and related methods noted especially in the context of microarray data analysis: it tends to remove highly correlated variables altogether or select them all, and maintains maximal flexibility in estimating their coefficients, particularly with different signs; the number of selected variables is no longer limited by the sample size; and the resulting prediction accuracy is competitive or superior compared to the alternatives. We illustrate the proposed method by extensive simulation studies. The proposed method is also applied to a Glioblastoma microarray data analysis. PMID:22997542

  4. Cluster randomized trials for pharmacy practice research.

    PubMed

    Gums, Tyler; Carter, Barry; Foster, Eric

    2016-06-01

    Introduction Cluster randomized trials (CRTs) are now the gold standard in health services research, including pharmacy-based interventions. Studies of behaviour, epidemiology, lifestyle modifications, educational programs, and health care models are utilizing the strengths of cluster randomized analyses. Methodology The key property of CRTs is the unit of randomization (clusters), which may be different from the unit of analysis (individual). Subject sample size and, ideally, the number of clusters is determined by the relationship of between-cluster and within-cluster variability. The correlation among participants recruited from the same cluster is known as the intraclass correlation coefficient (ICC). Generally, having more clusters with smaller ICC values will lead to smaller sample sizes. When selecting clusters, stratification before randomization may be useful in decreasing imbalances between study arms. Participant recruitment methods can differ from other types of randomized trials, as blinding a behavioural intervention cannot always be done. When to use CRTs can yield results that are relevant for making "real world" decisions. CRTs are often used in non-therapeutic intervention studies (e.g. change in practice guidelines). The advantages of CRT design in pharmacy research have been avoiding contamination and the generalizability of the results. A large CRT that studied physician-pharmacist collaborative management of hypertension is used in this manuscript as a CRT example. The trial, entitled Collaboration Among Pharmacists and physicians To Improve Outcomes Now (CAPTION), was implemented in primary care offices in the United States for hypertensive patients. Limitations CRT design limitations include the need for a large number of clusters, high costs, increased training, increased monitoring, and statistical complexity. PMID:26715549

  5. The effects of fantastical pretend-play on the development of executive functions: An intervention study.

    PubMed

    Thibodeau, Rachel B; Gilpin, Ansley T; Brown, Melissa M; Meyer, Brooke A

    2016-05-01

    Although recent correlational studies have found a relationship between fantasy orientation (FO; i.e., a child's propensity to play in a fantastical realm) and higher order cognitive skills called executive functions (EFs), no work has addressed the causality and directionality of this relationship. The current study experimentally examined the directionality of the observed relationship between FO and EF development in preschool-aged children through an innovative play intervention employing a randomized controlled design. A sample of 110 children between the ages of 3 and 5years were randomly assigned to one of three conditions: fantastical pretend-play intervention, non-imaginative play intervention, or business-as-usual control. Results revealed that children who participated in a 5-week fantastical pretend-play intervention showed improvements in EFs, whereas children in the other two conditions did not. Within the fantastical pretend-play condition, children who were highly engaged in the play and those who were highly fantastical demonstrated the greatest gains in EFs. These data provide evidence for the equifinal relationship between fantasy-oriented play and EF development, such that engaging in fantasy-oriented play may be one of many ways to directly enhance EF development. PMID:26835841

  6. Carnosine Treatment for Gulf War Illness: A Randomized Controlled Trial

    PubMed Central

    Baraniuk, James N.; El-Amin, Suliman; Corey, Rebecca; Rayhan, Rakib U.; Timbol, Christian R.

    2013-01-01

    About 25% of 1990-1991 Persian Gulf War veterans experience disabling fatigue, widespread pain, and cognitive dysfunction termed Gulf War illness (GWI) or Chronic Multisymptom Illness (CMI). A leading theory proposes that wartime exposures initiated prolonged production of reactive oxygen species (ROS) and central nervous system injury. The endogenous antioxidant L-carnosine (β-alanyl-L-histidine) is a potential treatment since it is a free radical scavenger in nervous tissue. To determine if nutritional supplementation with L-carnosine would significantly improve pain, cognition and fatigue in GWI, a randomized double blind placebo controlled 12 week dose escalation study involving 25 GWI subjects was employed. L-carnosine was given as 500, 1000, and 1500 mg increasing at 4 week intervals. Outcomes included subjective fatigue, pain and psychosocial questionnaires, and instantaneous fatigue and activity levels recorded by ActiWatch Score devices. Cognitive function was evaluated by WAIS-R digit symbol substitution test. Carnosine had 2 potentially beneficial effects: WAIS-R scores increased significantly, and there was a decrease in diarrhea associated with irritable bowel syndrome. No other significant incremental changes were found. Therefore, 12 weeks of carnosine (1500 mg) may have beneficial cognitive effects in GWI. Fatigue, pain, hyperalgesia, activity and other outcomes were resistant to treatment. PMID:23618477

  7. Carnosine treatment for gulf war illness: a randomized controlled trial.

    PubMed

    Baraniuk, James Nicholas; El-Amin, Suliman; Corey, Rebecca; Rayhan, Rakib; Timbol, Christian

    2013-05-01

    About 25% of 1990-1991 Persian Gulf War veterans experience disabling fatigue, widespread pain, and cognitive dysfunction termed Gulf War illness (GWI) or Chronic Multisymptom Illness (CMI). A leading theory proposes that wartime exposures initiated prolonged production of reactive oxygen species (ROS) and central nervous system injury. The endogenous antioxidant L-carnosine (B-alanyl-L-histidine) is a potential treatment since it is a free radical scavenger in nervous tissue. To determine if nutritional supplementation with L-carnosine would significantly improve pain, cognition and fatigue in GWI, a randomized double blind placebo controlled 12 week dose escalation study involving 25 GWI subjects was employed. L-carnosine was given as 500, 1000, and 1500 mg increasing at 4 week intervals. Outcomes included subjective fatigue, pain and psychosocial questionnaires, and instantaneous fatigue and activity levels recorded by ActiWatch Score devices. Cognitive function was evaluated by WAIS-R digit symbol substitution test. Carnosine had 2 potentially beneficial effects: WAIS-R scores increased significantly, and there was a decrease in diarrhea associated with irritable bowel syndrome. No other significant incremental changes were found. Therefore, 12 weeks of carnosine (1500 mg) may have beneficial cognitive effects in GWI. Fatigue, pain, hyperalgesia, activity and other outcomes were resistant to treatment. PMID:23618477

  8. Community-based recruitment strategies for a longitudinal interventional study: the VECAT experience.

    PubMed

    Garrett, S K; Thomas, A P; Cicuttini, F; Silagy, C; Taylor, H R; McNeil, J J

    2000-05-01

    This article examines different recruitment strategies for the VECAT Study, a 4-year, double-masked, placebo-controlled, randomized clinical trial of vitamin E in the prevention of cataract and age-related maculopathy. Five recruitment methods were employed: newspaper advertising, radio advertising, approaches to community groups, approaches via general practices, and an electoral roll mail-out. Participants (1204) from the community in Melbourne, Australia were recruited and enrolled within 15 months (age range: 55-80 years, mean 66 years; gender ratio: 57% female, 43% male). The electoral roll mail-out and newspaper advertising were the most efficient methods of recruitment in terms of absolute numbers of participants recruited and cost per participant. Recruitment for the VECAT study was successfully completed within the planned period. Although the electoral roll mail-out and newspaper advertising were the most efficient for this study, other methods may be of value for studies with different subject selection criteria. PMID:10812328

  9. Weight management for overweight and obese men delivered through professional football clubs: a pilot randomized trial

    PubMed Central

    2013-01-01

    Background The prevalence of male obesity is increasing, but men are less likely than women to attend existing weight management programmes. We have taken a novel approach to reducing perceived barriers to weight loss for men by using professional football (soccer) clubs to encourage participation in a weight management group programme, gender-sensitised in content and style of delivery. Football Fans in Training (FFIT) provides 12 weeks of weight loss, physical activity and healthy eating advice at top professional football clubs in Scotland. This pilot randomized trial explored the feasibility of using these clubs as a setting for a randomized controlled trial of 12 month weight loss following men’s participation in FFIT. Methods A two-arm pilot trial at two Scottish Premier League football clubs (one large, one smaller), with 103 men (aged 35–65, body mass index (BMI) ≥27 kg/m2) individually randomized to the intervention (n=51, received the pilot programme (p-FFIT) immediately) and waitlist comparison (n=52, received p-FFIT after four months) groups. Feasibility of recruitment, randomization, data collection and retention were assessed. Objective physical measurements (weight, waist circumference, blood pressure, body composition) and questionnaires (self-reported physical activity, diet, alcohol consumption, psychological outcomes) were obtained from both groups by fieldworkers trained to standard protocols at baseline and 12 weeks, and from the intervention group at 6 and 12 months. Qualitative methods elicited men’s experiences of participation in the pilot trial. Results Following a short recruitment period, the recruitment target was achieved at the large, but not smaller, club. Participants’ mean age was 47.1±8.4 years; mean BMI 34.5±5.0 kg/m2. Retention through the trial was good (>80% at 12 weeks and 6 months; >75% at 12 months), and 76% attended at least 80% of available programme delivery sessions. At 12 weeks, the intervention group lost

  10. Effectiveness of a back care pillow as an adjuvant physical therapy for chronic non-specific low back pain treatment: a randomized controlled trial

    PubMed Central

    Prommanon, Bundit; Puntumetakul, Rungthip; Puengsuwan, Punnee; Chatchawan, Uraiwan; Kamolrat, Torkamol; Rittitod, Theera; Yamauchi, Junichiro

    2015-01-01

    [Purpose] The aim of this study was to investigate the effect of a back care pillow (BCP) on pain, lumbar range of motion (LROM) and functional disability of patients with chronic non-specific low back pain (LBP). [Subjects and Methods] Fifty-two subjects who were aged between 20–69 years old, who presented with LBP of more than 3 months duration with a numerical rating scale (NRS) value of at least 4 were randomly assigned to treatment (BCP) and control (CON) groups. Participants in each group received six sessions of the 30 minutes treatment for two weeks. The BCP group was asked to wear the BCP during the daytime during the study period. Pain, lumbar ROM and functional disability were assessed before and after the 2-week treatment, and at the end of a 12-week follow up. [Results] After the 2-week treatment and 12-week follow up, all outcomes had improved in both groups; the BCP group had maintained the decrease in pain intensity and improved lumbar ROM in the extension position after the 12-week follow up, and showed better improvements in all outcomes at 2 weeks and after the 12-week follow up. [Conclusion] BCP combined with physical therapy had better pain, lumbar ROM and functional disability outcomes than physical therapy alone. PMID:26311921

  11. Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.

    PubMed

    Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C; Milella, Luigi

    2015-01-01

    Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20-40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits. PMID:26421049

  12. Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

    PubMed Central

    Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C.; Milella, Luigi

    2015-01-01

    Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20–40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits. PMID:26421049

  13. Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial

    PubMed Central

    Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

    2014-01-01

    Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Results: Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Conclusion: Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia. PMID:25674110

  14. Single versus repetitive injection of lignocaine in the management of carpal tunnel syndrome--a randomized controlled trial.

    PubMed

    Akarsu, S; Karadaş, Ö; Tok, F; Levent Gül, H; Eroğlu, E

    2015-02-01

    The aim of this study was to determine the efficacy of single versus repetitive injection of lignocaine into the carpal tunnel for the management of carpal tunnel syndrome. The 42 patients included were randomly assigned to two Groups: group 1 was injected with 4 mL of 1% lignocaine once and Group 2 was injected with 4 mL of 1% lignocaine twice a week for 2 weeks. Clinical and electrophysiological evaluations were performed at the study onset, and at 6 and 12 weeks following the final injection. Initially, the groups were similar with respect to clinical and electrophysiological findings. All parameters in Group 2 improved 6 weeks post treatment (p < 0.05), and these improvements persisted at 12 weeks post treatment (p < 0.05). Repetitive local lignocaine injection was effective in reducing the symptoms of carpal tunnel syndrome and improving electrophysiological findings. PMID:25061062

  15. Minimally Invasive Total Knee Arthroplasty Improves Early Knee Strength but Not Functional Performance: A Randomized Controlled Trial

    PubMed Central

    Stevens-Lapsley, Jennifer E.; Bade, Michael J.; Shulman, Benjamin C.; Kohrt, Wendy M.; Dayton, Michael R.

    2012-01-01

    A prospective, randomized investigation compared early clinical outcomes of total knee arthroplasty (TKA) using conventional (CONTROL) or minimally invasive surgical (MIS) approaches (n=44). Outcome measures included isometric quadriceps and hamstrings strength, quadriceps activation, functional performance, knee pain, active knee range of motion (AROM), muscle mass, the SF-36, and WOMAC, assessed preoperatively and 4 and 12 weeks after TKA. Four weeks after TKA, the MIS group had greater hamstring strength (p=0.02) and quadriceps strength (p=0.07), which did not translate to differences in other outcomes. At 12 weeks, there were no clinically meaningful differences between groups on any measure. Although MIS may lead to faster recovery of strength in patients undergoing TKA, there was no benefit on longer-term recovery of strength or functional performance. PMID:22459124

  16. Preventing Acute Malnutrition among Young Children in Crises: A Prospective Intervention Study in Niger

    PubMed Central

    Langendorf, Céline; Roederer, Thomas; de Pee, Saskia; Brown, Denise; Doyon, Stéphane; Mamaty, Abdoul-Aziz; Touré, Lynda W.-M.; Manzo, Mahamane L.; Grais, Rebecca F.

    2014-01-01

    Background Finding the most appropriate strategy for the prevention of moderate acute malnutrition (MAM) and severe acute malnutrition (SAM) in young children is essential in countries like Niger with annual “hunger gaps.” Options for large-scale prevention include distribution of supplementary foods, such as fortified-blended foods or lipid-based nutrient supplements (LNSs) with or without household support (cash or food transfer). To date, there has been no direct controlled comparison between these strategies leading to debate concerning their effectiveness. We compared the effectiveness of seven preventive strategies—including distribution of nutritious supplementary foods, with or without additional household support (family food ration or cash transfer), and cash transfer only—on the incidence of SAM and MAM among children aged 6–23 months over a 5-month period, partly overlapping the hunger gap, in Maradi region, Niger. We hypothesized that distributions of supplementary foods would more effectively reduce the incidence of acute malnutrition than distributions of household support by cash transfer. Methods and Findings We conducted a prospective intervention study in 48 rural villages located within 15 km of a health center supported by Forum Santé Niger (FORSANI)/Médecins Sans Frontières in Madarounfa. Seven groups of villages (five to 11 villages) were allocated to different strategies of monthly distributions targeting households including at least one child measuring 60 cm–80 cm (at any time during the study period whatever their nutritional status): three groups received high-quantity LNS (HQ-LNS) or medium-quantity LNS (MQ-LNS) or Super Cereal Plus (SC+) with cash (€38/month [US$52/month]); one group received SC+ and family food ration; two groups received HQ-LNS or SC+ only; one group received cash only (€43/month [US$59/month]). Children 60 cm–80 cm of participating households were assessed at each monthly distribution from

  17. Is random access memory random?

    NASA Technical Reports Server (NTRS)

    Denning, P. J.

    1986-01-01

    Most software is contructed on the assumption that the programs and data are stored in random access memory (RAM). Physical limitations on the relative speeds of processor and memory elements lead to a variety of memory organizations that match processor addressing rate with memory service rate. These include interleaved and cached memory. A very high fraction of a processor's address requests can be satified from the cache without reference to the main memory. The cache requests information from main memory in blocks that can be transferred at the full memory speed. Programmers who organize algorithms for locality can realize the highest performance from these computers.

  18. LANGUAGE AND LITERACY OUTCOMES FROM A PILOT INTERVENTION STUDY FOR CHILDREN WITH FASD IN SOUTH AFRICA

    PubMed Central

    Adnams, Colleen M.; Sorour, Pharyn; Kalberg, Wendy O.; Kodituwakku, Piyadasa W.; Perold, Mariechen D.; Kotze, Anna; September, Sean; Castle, Bernice; Gossage, J. Philip; May, Philip A.

    2007-01-01

    This pilot study investigated the efficacy of a classroom language and literacy intervention in children with fetal alcohol spectrum disorders (FASD) in the Western Cape Province of South Africa. The study forms part of a larger, on-going study that includes metacognitive and family support interventions in addition to language and literacy training (LLT). For the LLT study, 65 nine year old children identified as either FASD or not prenatally exposed to alcohol, were recruited. Forty children with FASD were randomly assigned to either a Language and Literacy Training (LLT) intervention group or FASD control group (FASD-C). Twenty-five non alcohol-exposed children were randomly selected as non-exposed controls (NONEXP-C). Prior to intervention and after 9 school-term months of treatment, general scholastic tests, teacher and parent questionnaires, classroom observations and specific language and literacy tests were administered to the participants. The 9 months assessment reflects the mid-point and the first assessment stage of the overall study. At initial diagnosis and prior to commencement of the interventions, participants with FASD were significantly weaker than non-exposed control children in reading, spelling, addition, subtraction, phonological awareness and other tests of early literacy. Teachers rated a range of adaptive behaviors of children with FASD as significantly worse than non-exposed controls. Mean scholastic and language and literacy scores for all groups showed improvement over baseline scores after 9 months of intervention. The mean test scores of children with FASD remained lower than those of non-exposed controls. Comparison of mean baseline to post-intervention score changes between the LLT, FASD-C and NONEXP-C groups revealed that although there were no significant gains by the LLT intervention group over control groups on the general scholastic assessment battery, significantly greater improvements occurred in the LLT intervention group

  19. Evaluation of the PPAR-γ Agonist Pioglitazone in Mild Asthma: A Double-Blind Randomized Controlled Trial

    PubMed Central

    Anderson, J. R.; Pang, L.; Smith, K. M; Bailey, H.; Hodgson, D. B.; Shaw, D. E.; Knox, A. J.; Harrison, T. W.

    2016-01-01

    Background Peroxisome proliferator-activated receptor gamma (PPAR-γ) is a nuclear receptor that modulates inflammation in models of asthma. To determine whether pioglitazone improves measures of asthma control and airway inflammation, we performed a single-center randomized, double-blind, placebo-controlled, parallel-group trial. Methods Sixty-eight participants with mild asthma were randomized to 12 weeks pioglitazone (30 mg for 4 weeks, then 45 mg for 8 weeks) or placebo. The primary outcome was the adjusted mean forced expiratory volume in one second (FEV1) at 12 weeks. The secondary outcomes were mean peak expiratory flow (PEF), scores on the Juniper Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ), fractional exhaled nitric oxide (FeNO), bronchial hyperresponsiveness (PD20), induced sputum counts, and sputum supernatant interferon gamma-inducible protein-10 (IP-10), vascular endothelial growth factor (VEGF), monocyte chemotactic protein-1 (MCP-1), and eosinophil cationic protein (ECP) levels. Study recruitment was closed early after considering the European Medicines Agency’s reports of a potential increased risk of bladder cancer with pioglitazone treatment. Fifty-five cases were included in the full analysis (FA) and 52 in the per-protocol (PP) analysis. Results There was no difference in the adjusted FEV1 at 12 weeks (-0.014 L, 95% confidence interval [CI] -0.15 to 0.12, p = 0.84) or in any of the secondary outcomes in the FA. The PP analysis replicated the FA, with the exception of a lower evening PEF in the pioglitazone group (-21 L/min, 95% CI -39 to -4, p = 0.02). Conclusions We found no evidence that treatment with 12 weeks of pioglitazone improved asthma control or airway inflammation in mild asthma. Trial Registration ClinicalTrials.gov NCT01134835 PMID:27560168

  20. Yoga for veterans with chronic low back pain: Design and methods of a randomized clinical trial.

    PubMed

    Groessl, Erik J; Schmalzl, Laura; Maiya, Meghan; Liu, Lin; Goodman, Debora; Chang, Douglas G; Wetherell, Julie L; Bormann, Jill E; Atkinson, J Hamp; Baxi, Sunita

    2016-05-01

    Chronic low back pain (CLBP) afflicts millions of people worldwide, with particularly high prevalence in military veterans. Many treatment options exist for CLBP, but most have limited effectiveness and some have significant side effects. In general populations with CLBP, yoga has been shown to improve health outcomes with few side effects. However, yoga has not been adequately studied in military veteran populations. In the current paper we will describe the design and methods of a randomized clinical trial aimed at examining whether yoga can effectively reduce disability and pain in US military veterans with CLBP. A total of 144 US military veterans with CLBP will be randomized to either yoga or a delayed treatment comparison group. The yoga intervention will consist of 2× weekly yoga classes for 12weeks, complemented by regular home practice guided by a manual. The delayed treatment group will receive the same intervention after six months. The primary outcome is the change in back pain-related disability measured with the Roland-Morris Disability Questionnaire at baseline and 12-weeks. Secondary outcomes include pain intensity, pain interference, depression, anxiety, fatigue/energy, quality of life, self-efficacy, sleep quality, and medication usage. Additional process and/or mediational factors will be measured to examine dose response and effect mechanisms. Assessments will be conducted at baseline, 6-weeks, 12-weeks, and 6-months. All randomized participants will be included in intention-to-treat analyses. Study results will provide much needed evidence on the feasibility and effectiveness of yoga as a therapeutic modality for the treatment of CLBP in US military veterans. PMID:27103548

  1. mHealth Physical Activity Intervention: A Randomized Pilot Study in Physically Inactive Pregnant Women.

    PubMed

    Choi, JiWon; Lee, Ji Hyeon; Vittinghoff, Eric; Fukuoka, Yoshimi

    2016-05-01

    Introduction Physical inactivity is prevalent in pregnant women, and innovative strategies to promote physical activity are strongly needed. The purpose of the study was to test a 12-week mobile health (mHealth) physical activity intervention for feasibility and potential efficacy. Methods Participants were recruited between December 2012 and February 2014 using diverse recruitment methods. Thirty pregnant women between 10 and 20 weeks of gestation were randomized to an intervention (mobile phone app plus Fitbit) or a control (Fitbit) group. Both conditions targeted gradual increases in physical activity. The mHealth intervention included daily messages and a mobile phone activity diary with automated feedback and self-monitoring systems. Results On monthly average, 4 women were screened for initial eligibility by telephone and 2.5 were randomized. Intervention participants had a 1096 ± 1898 step increase in daily steps compared to an increase of 259 ± 1604 steps in control participants at 12 weeks. The change between groups in weekly mean steps per day during the 12-week study period was not statistically significant (p = 0.38). The intervention group reported lower perceived barrier to being active, lack of energy, than the control group at 12-week visit (p = 0.02). The rates of responding to daily messages and using the daily diary through the mobile app declined during the 12 week study period. Discussion It was difficult to recruit and randomize inactive women who wanted to increase physical activity during pregnancy. Pregnant women who were motivated to increase physical activity might find using mobile technologies in assessing and promoting PA acceptable. Possible reasons for the non-significant treatment effect of the mHealth intervention on physical activity are discussed. Public awareness of safety and benefits of physical activity during pregnancy should be promoted. Clinicaltrials.Gov Identifier NCT01461707. PMID:26649879

  2. Brief Online Training Enhances Competitive Performance: Findings of the BBC Lab UK Psychological Skills Intervention Study.

    PubMed

    Lane, Andrew M; Totterdell, Peter; MacDonald, Ian; Devonport, Tracey J; Friesen, Andrew P; Beedie, Christopher J; Stanley, Damian; Nevill, Alan

    2016-01-01

    In conjunction with BBC Lab UK, the present study developed 12 brief psychological skill interventions for online delivery. A protocol was designed that captured data via self-report measures, used video recordings to deliver interventions, involved a competitive concentration task against an individually matched computer opponent, and provided feedback on the effects of the interventions. Three psychological skills were used; imagery, self-talk, and if-then planning, with each skill directed to one of four different foci: outcome goal, process goal, instruction, or arousal-control. This resulted in 12 different intervention participant groups (randomly assigned) with a 13th group acting as a control. Participants (n = 44,742) completed a competitive task four times-practice, baseline, following an intervention, and again after repeating the intervention. Results revealed performance improved following practice with incremental effects for imagery-outcome, imagery-process, and self-talk-outcome and self-talk-process over the control group, with the same interventions increasing the intensity of effort invested, arousal and pleasant emotion. Arousal-control interventions associated with pleasant emotions, low arousal, and low effort invested in performance. Instructional interventions were not effective. Results offer support for the utility of online interventions in teaching psychological skills and suggest brief interventions that focus on increasing motivation, increased arousal, effort invested, and pleasant emotions were the most effective. PMID:27065904

  3. An intervention study to increase colorectal cancer knowledge and screening among community elders.

    PubMed

    Powe, Barbara D; Ntekop, Emmanuel; Barron, Mia

    2004-01-01

    This study evaluates the effectiveness of a culturally relevant intervention, delivered over 12 months on knowledge of colorectal cancer and participation in fecal occult blood testing. An experimental, repeated measures design was used. Free fecal occult blood testing was offered to the participants. Fifteen senior centers were randomly selected and assigned to the Cultural and Self-Empowerment Group, the Modified Cultural Group, or the Traditional Group. Their mean age was 73.83 years, and their average educational level was 8.8 years. The majority was African American, female, and reported annual incomes < or = 10,000 dollars. Data were collected at baseline, at 6 months, and at 12 months. Participants in the Cultural and Self-Empowerment Group had a significantly greater increase in their knowledge of colorectal cancer over time. Group membership and knowledge of colorectal cancer were significant predictors of participation in colorectal cancer screening. Participants in the Cultural and Self-Empowerment Group and those with greater knowledge of colorectal cancer were more likely to participate in fecal occult blood testing at the end of the 12-month period. Similar strategies may be implemented in community settings and health care agencies to inform elders about colorectal cancer. PMID:15363024

  4. The Keys to Healthy Family Child Care Homes intervention: Study design and rationale

    PubMed Central

    Østbye, Truls; Mann, Courtney M.; Vaughn, Amber E.; Namenek Brouwer, Rebecca J.; Benjamin Neelon, Sara E.; Hales, Derek; Bangdiwala, Shrikant I.; Ward, Dianne S.

    2014-01-01

    Background Obesity is a major public health problem for which early preventive interventions are needed. Large numbers of young children are enrolled in some form of child care program, making these facilities influential environments in children’s development. Family child care homes (FCCH) are a specific type of child care in which children are cared for within the provider’s own residence. FCCHs serve approximately 1.5 million children in the U.S.; however, research to date has overlooked FCCH providers and their potential to positively influence children’s health-related behaviors. Methods Keys to Healthy Family Child Care Homes (Keys) is a cluster-randomized controlled trial testing the efficacy of an intervention designed to help providers become healthy role models, provide quality food- and physical activity-supportive FCCH environments, and implement effective business practices. The intervention is delivered through workshops, home visits, tailored coaching calls, and educational toolkits. Primary outcomes are child physical activity measured via accelerometry data and dietary intake data collected using direct observation at the FCCH. Secondary outcomes include child body mass index, provider weight-related behaviors, and observed obesogenic environmental characteristics. Conclusion Keys is an innovative approach to promoting healthy eating and physical activity in young children. The intervention operates in a novel setting, targets children during a key developmental period, and addresses both provider and child behaviors to synergistically promote health. PMID:25460337

  5. Classroom ventilation and indoor air quality-results from the FRESH intervention study.

    PubMed

    Rosbach, J; Krop, E; Vonk, M; van Ginkel, J; Meliefste, C; de Wind, S; Gehring, U; Brunekreef, B

    2016-08-01

    Inadequate ventilation of classrooms may lead to increased concentrations of pollutants generated indoors in schools. The FRESH study, on the effects of increased classroom ventilation on indoor air quality, was performed in 18 naturally ventilated classrooms of 17 primary schools in the Netherlands during the heating seasons of 2010-2012. In 12 classrooms, ventilation was increased to targeted CO2 concentrations of 800 or 1200 ppm, using a temporary CO2 controlled mechanical ventilation system. Six classrooms were included as controls. In each classroom, data on endotoxin, β(1,3)-glucans, and particles with diameters of <10 μm (PM10 ) and <2.5 μm (PM2.5 ) and nitrogen dioxide (NO2 ) were collected during three consecutive weeks. Associations between the intervention and these measured indoor air pollution levels were assessed using mixed models, with random classroom effects. The intervention lowered endotoxin and β(1,3)-glucan levels and PM10 concentrations significantly. PM10 for instance was reduced by 25 μg/m³ (95% confidence interval 13-38 μg/m³) from 54 μg/m³ at maximum ventilation rate. No significant differences were found between the two ventilation settings. Concentrations of PM2.5 and NO2 were not affected by the intervention. Our results provide evidence that increasing classroom ventilation is effective in decreasing the concentrations of some indoor-generated pollutants. PMID:26171647

  6. Predictors of Sexual Risk Reduction Among Mexican Female Sex Workers Enrolled in a Behavioral Intervention Study

    PubMed Central

    Strathdee, Steffanie A.; Mausbach, Brent; Lozada, Remedios; Staines-Orozco, Hugo; Semple, Shirley J.; Abramovitz, Daniela; Fraga-Vallejo, Miguel; de la Torre, Adela; Amaro, Hortensia; Martínez-Mendizábal, Gustavo; Magis-Rodríguez, Carlos; Patterson, Thomas L.

    2009-01-01

    Objective We recently showed efficacy of an intervention to increase condom use among female sex workers (FSWs) in Tijuana and Ciudad Juarez, situated on the Mexico–United States border. We determined whether increases in condom use were predicted by social cognitive theory and injection drug user status among women randomized to this intervention. Methods Four hundred nine HIV-negative FSWs aged ≥18 years having unprotected sex with clients within the prior 2 months received a brief individual counseling session integrating motivational interviewing and principles of behavior change (ie, HIV knowledge, self-efficacy for using condoms, and outcome expectancies). Results Increases in self-efficacy scores were associated with increases in percent condom use (P = 0.008), whereas outcome expectancies were not. Female sex workers who inject drugs (FSW-IDUs) increased condom use with clients but not to the same extent as other FSWs (P = 0.09). Change in HIV knowledge was positively associated with change in percent condom use among FSW-IDUs (P = 0.03) but not noninjection drug users. Conclusions Increases in self-efficacy significantly predicted increased condom use among FSWs, consistent with social cognitive theory. Increased HIV knowledge was also important among FSW-IDUs, but their changes in condom use were modest. Enhanced interventions for FSW-IDUs are needed, taking into account realities of substance use during sexual transactions that can compromise safer sex negotiation. PMID:19384101

  7. Conducting systematic reviews of intervention questions III: Synthesizing data from intervention studies using meta-analysis.

    PubMed

    O'Connor, A M; Sargeant, J M; Wang, C

    2014-06-01

    This article is the sixth in a series of six articles describing systematic reviews of interventions in animal agriculture and veterinary medicine. The first article provided an overview of systematic reviews, followed by an article on building evidence across study designs, and an article describing criteria for validity in randomized controlled trials. The fourth article in this series overviewed the initial steps in conducting a systematic review: development of a review protocol, identification of the structured question to be addressed and conducting a comprehensive literature search to identify potentially relevant research to address the review question. The fifth article introduced relevance screening of literature to identify and include research that is relevant to the review question, the use of standardized checklists and procedures to assess the risk of bias in the relevant research, data extraction from primary research studies and summarizing the results of the body of research identified. Many systematic reviews of interventions aim to use a quantitative method to combine the results of multiple studies and provide a more precise estimate of the effect of the intervention on the outcome, that is, a summary effect measure. The objective of this article was to describe general approaches that are available for quantitative synthesis of data. Specific details of all meta-analysis statistical approaches are beyond the capacity of this article. PMID:24905996

  8. Brief Online Training Enhances Competitive Performance: Findings of the BBC Lab UK Psychological Skills Intervention Study

    PubMed Central

    Lane, Andrew M.; Totterdell, Peter; MacDonald, Ian; Devonport, Tracey J.; Friesen, Andrew P.; Beedie, Christopher J.; Stanley, Damian; Nevill, Alan

    2016-01-01

    In conjunction with BBC Lab UK, the present study developed 12 brief psychological skill interventions for online delivery. A protocol was designed that captured data via self-report measures, used video recordings to deliver interventions, involved a competitive concentration task against an individually matched computer opponent, and provided feedback on the effects of the interventions. Three psychological skills were used; imagery, self-talk, and if-then planning, with each skill directed to one of four different foci: outcome goal, process goal, instruction, or arousal-control. This resulted in 12 different intervention participant groups (randomly assigned) with a 13th group acting as a control. Participants (n = 44,742) completed a competitive task four times—practice, baseline, following an intervention, and again after repeating the intervention. Results revealed performance improved following practice with incremental effects for imagery-outcome, imagery-process, and self-talk-outcome and self-talk-process over the control group, with the same interventions increasing the intensity of effort invested, arousal and pleasant emotion. Arousal-control interventions associated with pleasant emotions, low arousal, and low effort invested in performance. Instructional interventions were not effective. Results offer support for the utility of online interventions in teaching psychological skills and suggest brief interventions that focus on increasing motivation, increased arousal, effort invested, and pleasant emotions were the most effective. PMID:27065904

  9. The Associations between Regional Gray Matter Structural Changes and Changes of Cognitive Performance in Control Groups of Intervention Studies

    PubMed Central

    Takeuchi, Hikaru; Taki, Yasuyuki; Sassa, Yuko; Sekiguchi, Atsushi; Nagase, Tomomi; Nouchi, Rui; Fukushima, Ai; Kawashima, Ryuta

    2015-01-01

    In intervention studies of cognitive training, the challenging cognitive tests, which were used as outcome measures, are generally completed in more than a few hours. Here, utilizing the control groups' data from three 1-week intervention studies in which young healthy adult subjects underwent a wide range of cognitive tests and T1-weighted magnetic resonance imaging (MRI) before and after the intervention period, we investigated how regional gray matter (GM) density (rGMD) of the subjects changed through voxel-based morphometry (VBM). Statistically significant increases in rGMD were observed in the anatomical cluster that mainly spread around the bilateral dorsal anterior cingulate cortex (dACC) and the right superior frontal gyrus (rSFG). Moreover, mean rGMD within this cluster changes were significantly and positively correlated with performance changes in the Stroop task, and tended to positively correlate with performance changes in a divergent thinking task. Affected regions are considered to be associated with performance monitoring (dACC) and manipulation of the maintained information including generating associations (rSFG), and both are relevant to the cognitive functions measured in the cognitive tests. Thus, the results suggest that even in the groups of the typical “control group” in intervention studies including those of the passive one, experimental or non-experimental factors can result in an increase in the regional GM structure and form the association between such neural changes and improvements related to these cognitive tests. These results suggest caution toward the experimental study designs without control groups. PMID:26733852

  10. Consumption of açai (Euterpe oleracea Mart.) functional beverage reduces muscle stress and improves effort tolerance in elite athletes: a randomized controlled intervention study.

    PubMed

    Carvalho-Peixoto, Jacqueline; Moura, Mirian Ribeiro Leite; Cunha, Felipe Amorim; Lollo, Pablo Christiano B; Monteiro, Walace David; Carvalho, Lucia Maria Jaeger de; Farinatti, Paulo de Tarso Veras

    2015-07-01

    The study analyzed the effect of an açai (Euterpe oleracea Mart.) functional beverage (AB) on muscle and oxidative stress markers, cardiorespiratory responses, perceived exertion, and time-to-exhaustion during maximal treadmill running. The beverage was developed as an ergogenic aid for athletes and contained 27.6 mg of anthocyanins per dose. Fourteen athletes performed 3 exercise tests: a ramp-incremental maximal exercise test and 2 maximal exercise bouts performed in 2 conditions (AB and without AB (control)) at 90% maximal oxygen uptake. Blood was collected at baseline and after maximal exercise in both conditions to determine biomarkers. AB increased time to exhaustion during short-term high-intensity exercise (mean difference: 69 s, 95% confidence interval = -296 s to 159 s, t = 2.2, p = 0.045), attenuating the metabolic stress induced by exercise (p < 0.05). AB also reduced perceived exertion and enhanced cardiorespiratory responses (p < 0.05). The AB may be a useful and practical ergogenic aid to enhance performance during high-intensity training. PMID:26140415

  11. Nasal cytology in southwest metropolitan Mexico City inhabitants: a pilot intervention study.

    PubMed Central

    Calderon-Garcidueñas, L; Roy-Ocotla, G

    1993-01-01

    Southwest metropolitan Mexico City (SWMMC) inhabitants have been exposed several hours per day for the last 6 years to photochemical smog, ozone being the most important oxidant pollutant. Subjects exposed to the SWMMC atmosphere develop several histopathological changes in their nasal mucosa: dysplasia is the most significant, affecting 78.72% of adult individuals within 60 or more days of residence in SWMMC. This study was originally designed to explore whether chemical intervention could modify nasal dysplasia, as determined by nasal cytology, in a defined adult population. In a placebo-controlled, randomized, double-blind trial, 177 healthy male subjects were divided into 5 groups to whom 5000 IU of vitamin A, 100 IU of vitamin E, a combination of vitamins A and E (5000 IU + 100 IU), 16 mg of beta-carotene, or placebo were administered daily for 4 months. Sixteen clinical and cytological variables were monitored. No effect on dysplasia was seen at the end of the 4-month trial; however, an apparent reversibility as well as progression of the dysplastic nasal lesions and high correlation coefficients between dysplasia and nasal cytology of polymorphonuclear leukocytes (PMNs; 0.85), squamous metaplasia (SM; 0.50), and nasal mucosa atrophy (NMA; 0.41) were found. A mathematical theoretical nasal dysplasia (tD) predictor equation for SWMMC adult male inhabitants is proposed (tD = 0.85 delta PMNs + 0.50 delta SM + 0.41 delta NMA + 0.98), in which PMNs are the best single dysplasia predictor, and all variables are independent.(ABSTRACT TRUNCATED AT 250 WORDS) Images p138-a Figure 1. Figure 2. Figure 3. Figure 4. PMID:8354200

  12. Supporting Well-Being in Retirement through Meaningful Social Roles: Systematic Review of Intervention Studies

    PubMed Central

    Heaven, Ben; Brown, Laura Je; White, Martin; Errington, Linda; Mathers, John C; Moffatt, Suzanne

    2013-01-01

    Context The marked demographic change toward greater proportions of older people in developed nations poses significant challenges for health and social care. Several studies have demonstrated an association between social roles in later life and positive health and well-being outcomes. After retiring from work, people may lose roles that provide purpose and social contacts. The outcomes of interventions to promote social roles in retirement have not been systematically reviewed. Methods We examined three research questions: (1) What kinds of intervention have been developed to promote social roles in retirement? (2) How much have they improved perceived roles? (3) Have these roles improved health or well-being? We included those studies that evaluated the provision of social roles; used a control or comparison group; targeted healthy retirement-transition adults who were living in the community; provided an abstract written in English; took place in a highly developed nation; and reported social role, health, or well-being outcomes. We searched eight electronic databases and combined the results with hand searches. Findings Through our searches, we identified 9,062 unique publications and eleven evaluative studies of acceptable quality, which reported seven interventions that met our inclusion criteria. These interventions varied in year of inception and scope, but only two were based outside North America. The studies rarely reported the quality or meaning of roles. Only three studies used random allocation, thus limiting inferences of causality from these studies. Interventions providing explicit roles and using supportive group structures were somewhat effective in improving one or more of the following: life satisfaction, social support and activity, physical health and activity, functional health, and cognition. Conclusions Social role interventions may improve health and well-being for people in retirement transition. Future research should improve the

  13. Effects of sodium and potassium supplementation on endothelial function: a fully controlled dietary intervention study.

    PubMed

    Gijsbers, Lieke; Dower, James I; Schalkwijk, Casper G; Kusters, Yvo H A M; Bakker, Stephan J L; Hollman, Peter C H; Geleijnse, Johanna M

    2015-11-14

    High Na and low K intakes have adverse effects on blood pressure, which increases the risk for CVD. The role of endothelial dysfunction and inflammation in this pathophysiological process is not yet clear. In a randomised placebo-controlled cross-over study in untreated (pre)hypertensives, we examined the effects of Na and K supplementation on endothelial function and inflammation. During the study period, subjects were provided with a diet that contained 2·4 g/d of Na and 2·3 g/d of K for a 10 460 kJ (2500 kcal) intake. After 1-week run-in, subjects received capsules with supplemental Na (3·0 g/d), supplemental K (2·8 g/d) or placebo, for 4 weeks each, in random order. After each intervention, circulating biomarkers of endothelial function and inflammation were measured. Brachial artery flow-mediated dilation (FMD) and skin microvascular vasomotion were assessed in sub-groups of twenty-two to twenty-four subjects. Of thirty-seven randomised subjects, thirty-six completed the study. Following Na supplementation, serum endothelin-1 was increased by 0·24 pg/ml (95 % CI 0·03, 0·45), but no change was seen in other endothelial or inflammatory biomarkers. FMD and microvascular vasomotion were unaffected by Na supplementation. K supplementation reduced IL-8 levels by 0·28 pg/ml (95 % CI 0·03, 0·53), without affecting other circulating biomarkers. FMD was 1·16 % (95% CI 0·37, 1·96) higher after K supplementation than after placebo. Microvascular vasomotion was unaffected. In conclusion, a 4-week increase in Na intake increased endothelin-1, but had no effect on other endothelial or inflammatory markers. Increased K intake had a beneficial effect on FMD and possibly IL-8, without affecting other circulating endothelial or inflammatory biomarkers. PMID:26343780

  14. Nasal cytology in southwest metropolitan Mexico City inhabitants: a pilot intervention study.

    PubMed

    Calderon-Garcidueñas, L; Roy-Ocotla, G

    1993-06-01

    Southwest metropolitan Mexico City (SWMMC) inhabitants have been exposed several hours per day for the last 6 years to photochemical smog, ozone being the most important oxidant pollutant. Subjects exposed to the SWMMC atmosphere develop several histopathological changes in their nasal mucosa: dysplasia is the most significant, affecting 78.72% of adult individuals within 60 or more days of residence in SWMMC. This study was originally designed to explore whether chemical intervention could modify nasal dysplasia, as determined by nasal cytology, in a defined adult population. In a placebo-controlled, randomized, double-blind trial, 177 healthy male subjects were divided into 5 groups to whom 5000 IU of vitamin A, 100 IU of vitamin E, a combination of vitamins A and E (5000 IU + 100 IU), 16 mg of beta-carotene, or placebo were administered daily for 4 months. Sixteen clinical and cytological variables were monitored. No effect on dysplasia was seen at the end of the 4-month trial; however, an apparent reversibility as well as progression of the dysplastic nasal lesions and high correlation coefficients between dysplasia and nasal cytology of polymorphonuclear leukocytes (PMNs; 0.85), squamous metaplasia (SM; 0.50), and nasal mucosa atrophy (NMA; 0.41) were found. A mathematical theoretical nasal dysplasia (tD) predictor equation for SWMMC adult male inhabitants is proposed (tD = 0.85 delta PMNs + 0.50 delta SM + 0.41 delta NMA + 0.98), in which PMNs are the best single dysplasia predictor, and all variables are independent.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:8354200

  15. Strategies to recruit and retain older adults in intervention studies: a quantitative comparative study.

    PubMed

    Michelet, Mona; Lund, Anne; Sveen, Unni

    2014-01-01

    Recruitment and retention of participants in randomized controlled trials (RCTs) drawn from the older population is challenging, and studies have shown that poor recruitment and retention may lead to biased samples and results. Several strategies to improve the participation of older adults in research are outlined in the literature. The objective was to identify factors associated with participation in an RCT aiming at preventing depressive symptoms and social isolation in a later phase following a stroke, in an older population living in their homes. Strategies to improve participation were applied in the RCT "Lifestyle intervention for older adults in rehabilitation after stroke: development, implementation and evaluation". Quantitative data collected on participants (n=99) and non-participants (n=56) in the trial were compared using statistical analyses. The findings are in line with earlier studies in that the participants were younger (p=0.01) and received less help in the home (p=0.01) than did non-participants. The results differ from earlier studies in that participants had a higher rate of depressive symptoms (participation rate was 57% with HAD depression scale score 0-2, 61% with score 3-4, 62% with score 5-6 and 79% with a score 7 or above). The findings also illustrate a poorer health-related quality of life among the participants in the role physical domain on Short Form-36 (p=0.01). The results indicate that the use of targeted strategies to enhance participation may lead to a less biased sample as well as the inclusion of more subjects who seem to meet the aims of the intervention. PMID:24698174

  16. Effects of physical activity on health status in older adults. II. Intervention studies.

    PubMed

    Buchner, D M; Beresford, S A; Larson, E B; LaCroix, A Z; Wagner, E H

    1992-01-01

    This review has focused on a specific part of the relationship of exercise to health. The overall evidence supporting the health benefits of exercise is substantial and has been critically reviewed recently (18, 94). Thus, the United States Preventive Services Task Force recommends that all adults exercise regularly (94). The conclusions summarized below regarding older adults do not affect this basic recommendation. There is solid evidence that exercise can improve measures of fitness in older adults, particularly strength and aerobic capacity. These exercise effects occur in chronically ill adults, as well as in healthy adults. Because physical fitness is a determinant of functional status, it is logical to ask whether exercise can prevent or improve impairments in functional status in older adults. The evidence that exercise improves functional status is promising, but inconclusive. Problems with existing studies include a lack of randomized controlled trials, a lack of evidence that effects of exercise can be sustained over long periods of time, inadequate statistical power, and failure to target physically unfit individuals. Existing studies suggest that exercise may produce improvements in gait and balance. Arthritis patients may experience long-term functional status benefits from exercise, including improved mobility and decreased pain symptoms. Nonrandomized trials suggest exercise promotes bone mineral density and thereby decreases fracture risk. Recent studies have generally concluded that short-term exercise does not improve cognitive function. Yet the limited statistical power of these studies does not preclude what may be a modest, but functionally meaningful, effect of exercise on cognition. Future research, beyond correcting methodologic deficiencies in existing studies, should systematically study how functional status effects of exercise vary with the type, intensity, and duration of exercise. It should address issues in recruiting functionally

  17. Protecting Adolescents From Self-Harm: A Critical Review of Intervention Studies

    PubMed Central

    Brent, David A.; McMakin, Dana L.; Kennard, Betsy D.; Goldstein, Tina R.; Mayes, Taryn L.; Douaihy, Antoine B.

    2013-01-01

    Objective To review the studies that test treatments targeting adolescent suicidal ideation, suicide attempts, or self-harm, and to make recommendations for future intervention development. Method The extant randomized clinical trials that aim to reduce the intensity of suicidal ideation or the recurrence of suicide attempts or self-harm were reviewed with respect to treatment components, comparison treatments, sample composition, and outcomes. Results The majority of studies that showed any effect on suicidal ideation, attempts, or self-harm had some focus on family interactions or non-familial sources of support. Two of the most efficacious interventions also provided the greatest number of sessions. Some other treatment elements associated with positive effects include addressing motivation for treatment and having explicit plans for integrating the experimental treatment with treatment as usual. In many studies, suicidal events tend to occur very early in the course of treatment prior to when an effective “dose” of treatment could be delivered. Important factors that might mitigate suicidal risk such as sobriety, healthy sleep, and promotion of positive affect were not addressed in most studies. Conclusion Interventions that can front-load treatment shortly after the suicidal crisis, e.g., while adolescent suicide attempters are hospitalized, may avert early suicidal events. Treatments that focus on the augmentation of protective factors, such as parent support and positive affect, as well as the promotion of sobriety and healthy sleep, may be beneficial with regard to the prevention of recurrent suicidal ideation, attempts, or self-harm in adolescents. PMID:24290459

  18. Nasal cytology in southwest metropolitan Mexico City inhabitants: A pilot intervention study

    SciTech Connect

    Calderon-Garciduenas, L.; Roy-Ocotla, G. )

    1993-06-01

    Southwest metropolitan Mexico City (SWMMC) inhabitants have been exposed several hours per day for the last 6 years to photochemical smog, ozone being the most important oxidant pollutant. Subjects exposed to the SWMMC atmosphere develop several histopathological changes in their nasal mucosa: dysplasia is the most significant, affecting 78.72% of adult individuals within 60 or more days of residence in SWMMC. This study was originally designed to explore whether chemical intervention could modify nasal dysplasia, as determined by nasal cytology, in a defined adult population. In a placebo-controlled, randomized, double-blind trial, 177 healthy male subjects were divided into 5 groups to whom 5000 IU of vitamin A, 100 IU of vitamin E, a combination of vitamins A and E (5000 IU + 100 IU), 16 mg of beta-carotene, or placebo were administered daily for 4 months. Sixteen clinical and cytological variables were monitored. No effect on dysplasia was seen at the end of the 4-month trial; however, an apparent reversibility as well as progression of the dysplastic nasal lesions and high correlation coefficients between dysplasia and nasal cytology of polymorphonuclear leukocytes (PMNs; 0.85), squamous metaplasia (SM; 0.50), and nasal mucosa atrophy (NMA; 0.41) were found. A mathematical theoretical nasal dysplasia (tD) predictor equation for SWMMC adult male inhabitants is proposed (tD = 0.85 delta PMNs + 0.50 delta SM + 0.41 delta NMA + 0.98), in which PMNs are the best single dysplasia predictor, and all variables are independent.

  19. Biofeedback-based training for stress management in daily hassles: an intervention study

    PubMed Central

    Kotozaki, Yuka; Takeuchi, Hikaru; Sekiguchi, Atsushi; Yamamoto, Yuki; Shinada, Takamitsu; Araki, Tsuyoshi; Takahashi, Kei; Taki, Yasuyuki; Ogino, Takeshi; Kiguchi, Masashi; Kawashima, Ryuta

    2014-01-01

    Background The day-to-day causes of stress are called daily hassles. Daily hassles are correlated with ill health. Biofeedback (BF) is one of the tools used for acquiring stress-coping skills. However, the anatomical correlates of the effects of BF with long training periods remain unclear. In this study, we aimed to investigate this. Methods Participants were assigned randomly to two groups: the intervention group and the control group. Participants in the intervention group performed a biofeedback training (BFT) task (a combination task for heart rate and cerebral blood flow control) every day, for about 5 min once a day. The study outcomes included MRI, psychological tests (e.g., Positive and Negative Affect Schedule, Center for Epidemiologic Studies Depression Scale, and Brief Job Stress Questionnaire), and a stress marker (salivary cortisol levels) before (day 0) and after (day 28) the intervention. Results We observed significant improvements in the psychological test scores and salivary cortisol levels in the intervention group compared to the control group. Furthermore, voxel-based morphometric analysis revealed that compared to the control group, the intervention group had significantly increased regional gray matter (GM) volume in the right lateral orbitofrontal cortex, which is an anatomical cluster that includes mainly the left hippocampus, and the left subgenual anterior cingulate cortex. The GM regions are associated with the stress response, and, in general, these regions seem to be the most sensitive to the detrimental effects of stress. Conclusions Our findings suggest that our BFT is effective against the GM structures vulnerable to stress. PMID:25161823

  20. The HOPE Social Media Intervention for Global HIV Prevention: A Cluster Randomized Controlled Trial in Peru

    PubMed Central

    Young, Sean D.; Cumberland, William G.; Nianogo, Roch; Menacho, Luis A.; Galea, Jerome T.; Coates, Thomas

    2015-01-01

    Background Social media technologies are newly emerging tools that can be used for HIV prevention and testing in low- and middle-income countries, such as Peru. This study examined the efficacy of using the Harnessing Online Peer Education (HOPE) social media intervention to increase HIV testing among men who have sex with men (MSM) in Peru. Methods In a cluster randomized controlled trial with concealed allocation, Peruvian MSM from Greater Lima/Callao (N = 556) were randomly assigned to join private intervention or control groups on Facebook for 12 weeks. In the intervention condition, forty-nine Peruvian MSM were trained and randomly assigned to be HIV prevention mentors to participants via Facebook groups over 12 weeks. Control participants received an enhanced standard of care, including standard offline HIV prevention available in Peru as well as participation in Facebook groups (without peer leaders) that provided study updates and HIV testing information. After accepting a request to join the groups, continued participation was voluntary. Participants could request a free HIV test at a local community clinic, and completed questionnaires on HIV risk behaviors and social media use at baseline and 12-week follow-up. Findings Between March 19, 2012, and June 11, 2012, and Sept 26, 2012, and Dec 19, 2012, 556 participants were randomly assigned to intervention groups (N=278) or control groups (N=278); we analyse data for 252 and 246. 43 participants (17%) in the intervention group and 16 (7%) in the control groups got tested for HIV (adjusted odds ratio 2.61, 95% CI 1.55–4.38). No adverse events were reported. Retention at 12-week follow-up was 90%. Across conditions, 7 (87.5%) of the 8 participants who tested positive were linked to care at a local clinic. Interpretation Development of peer-mentored social media communities seemed to be an effective method to increase HIV testing among high-risk populations in Peru.: Results suggest that the HOPE social

  1. Adolescent Diet and Subsequent Serum Hormones, Breast Density and Bone Mineral Density in Young Women: Results of the Dietary Intervention Study in Children (DISC) Follow-Up Study

    PubMed Central

    Dorgan, Joanne F.; Liu, Lea; Klifa, Catherine; Hylton, Nola; Shepherd, John A.; Stanczyk, Frank Z.; Snetselaar, Linda G.; Van Horn, Linda; Stevens, Victor J.; Robson, Alan; Kwiterovich, Peter O.; Lasser, Norman L.; Himes, John H.; Gabriel, Kelley Pettee; Kriska, Andrea; Ruder, Elizabeth H.; Fang, Carolyn Y.; Barton, Bruce A.

    2010-01-01

    Background Adolescent diet is hypothesized to influence breast cancer risk. We evaluated the long-term effects of an intervention to lower fat intake among adolescent girls on biomarkers that are related to breast cancer risk in adults. Methods A follow-up study was conducted of 230 girls who participated in the Dietary Intervention Study in Children (DISC), in which healthy, prepubertal 8-10 year olds were randomly assigned to usual care or to a behavioral intervention that promoted a reduced fat diet. Participants were 25-29 years old at follow-up visits. All tests of statistical significance are two-sided. Results In analyses that did not take account of diet at the time of the follow-up visit, the only statistically significant treatment group difference was higher bone mineral content (BMC) in intervention group participants compared to usual care group participants; their mean BMCs were 2,444g and 2,377g, respectively. After adjustment for current diet, the intervention group also had statistically significantly higher bone mineral density and luteal phase serum estradiol concentrations. Serum progesterone concentrations and breast density did not differ by treatment group in unadjusted or adjusted analyses. Conclusion Results do not support the hypothesis that consumption of a lower fat diet during adolescence reduces breast cancer risk via effects on subsequent serum estradiol and progesterone levels, breast density or BMD. Impact Additional research is needed to clarify the association of adolescent diet with breast cancer risk and to determine if the results reported here are specific to the DISC intervention or more broadly applicable. PMID:20501774

  2. Impact of palm date consumption on microbiota growth and large intestinal health: a randomised, controlled, cross-over, human intervention study.

    PubMed

    Eid, Noura; Osmanova, Hristina; Natchez, Cecile; Walton, Gemma; Costabile, Adele; Gibson, Glenn; Rowland, Ian; Spencer, Jeremy P E

    2015-10-28

    The reported inverse association between the intake of plant-based foods and a reduction in the prevalence of colorectal cancer may be partly mediated by interactions between insoluble fibre and (poly)phenols and the intestinal microbiota. In the present study, we assessed the impact of palm date consumption, rich in both polyphenols and fibre, on the growth of colonic microbiota and markers of colon cancer risk in a randomised, controlled, cross-over human intervention study. A total of twenty-two healthy human volunteers were randomly assigned to either a control group (maltodextrin-dextrose, 37·1 g) or an intervention group (seven dates, approximately 50 g). Each arm was of 21 d duration and was separated by a 14-d washout period in a cross-over manner. Changes in the growth of microbiota were assessed by fluorescence in situ hybridisation analysis, whereas SCFA levels were assessed using HPLC. Further, ammonia concentrations, faecal water genotoxicity and anti-proliferation ability were also assessed using different assays, which included cell work and the Comet assay. Accordingly, dietary intakes, anthropometric measurements and bowel movement assessment were also carried out. Although the consumption of dates did not induce significant changes in the growth of select bacterial groups or SCFA, there were significant increases in bowel movements and stool frequency (P<0·01; n 21) and significant reductions in stool ammonia concentration (P<0·05; n 21) after consumption of dates, relative to baseline. Furthermore, date fruit intake significantly reduced genotoxicity in human faecal water relative to control (P<0·01; n 21). Our data indicate that consumption of date fruit may reduce colon cancer risk without inducing changes in the microbiota. PMID:26428278

  3. Utility of a thematic network in primary health care: a controlled interventional study in a rural area

    PubMed Central

    Coma del Corral, Maria Jesús; Abaigar Luquín, Pedro; Cordero Guevara, José; Olea Movilla, Angel; Torres Torres, Gerardo; Lozano Garcia, Javier

    2005-01-01

    Background UniNet is an Internet-based thematic network for a virtual community of users (VCU). It supports a virtual multidisciplinary community for physicians, focused on the improvement of clinical practice. This is a study of the effects of a thematic network such as UniNet on primary care medicine in a rural area, specifically as a platform of communication between specialists at the hospital and doctors in the rural area. Methods In order to study the effects of a thematic network such as UniNet on primary care medicine in a rural area, we designed an interventional study that included a control group. The measurements included the number of patient displacements due to disease, number of patient hospital stays and the number of prescriptions of drugs of low therapeutic utility and generic drug prescriptions by doctors. These data were analysed and compared with those of the control center. Results Our study showed positive changes in medical practice, reflected in the improvement of the evaluated parameters in the rural health area where the interventional study was carried out, compared with the control area. We discuss the strengths and weaknesses of UniNet as a potential medium to improve the quality of medical care in rural areas. Conclusion The rural doctors had an effective, useful, user-friendly and cheap source of medical information that may have contributed to the improvement observed in the medical quality indices. PMID:16042778

  4. Trials and tribulations of conducting interventional studies in urban slums of a developing country: Experiences from Kolkata, India.

    PubMed

    Mahapatra, Tanmay; Mahapatra, Sanchita; Pal, Debottam; Saha, Jayanta; Lopez, AnnaLena; Ali, Mohammad; Bannerjee, Barnali; Manna, Byomkesh; Sur, Dipika; Bhattacharya, Sujit; Kanungo, Suman

    2016-01-01

    Experimental studies involving human subjects provide most internally valid evidences in epidemiological research due to their robust methodology. While conducting population-based interventional studies, to achieve external validity, inclusion of information from vulnerable groups like urban slum-dwellers of the developing world, in the epidemiological estimates is of paramount importance. The challenges faced while conducting 2 consecutive large-scale, community-based vaccine trials in urban slums of Kolkata, India are presented in this article. Interventions in these communities often get constrained by issues pertaining to human rights and benefits, socio-cultural factors, political environment, methodological shortcomings in addition to the challenges in ensuring community participation. While conducting these trials although we intermittently faced obstacles, by virtue of having a long term and robust surveillance system and developing a trusted relationship between the researchers, community leaders and residents we were able to come up with a commendable community participation which culminated into the success of the interventions. Bridging the gap between research and field operations by incorporating knowledge gathered from interventional studies and making strategies to improve health conditions of these informal settlers is a major unfulfilled agenda. We believe the lessons learnt during our research will help researchers while developing efficient interventions in similar setting. PMID:26224251

  5. A Randomized, Open-Label, Comparative Study of Efficacy and Safety of Tolterodine Combined with Tamsulosin or Doxazosin in Patients with Benign Prostatic Hyperplasia.

    PubMed

    Cao, Yanwei; Wang, Yonghua; Guo, Lei; Yang, Xuecheng; Chen, Tao; Niu, Haitao

    2016-01-01

    BACKGROUND Benign prostatic hyperplasia (BPH), a common disease in men over age 50 years, often causes bladder outlet obstruction and lower urinary tract symptoms (LUTS). Alpha blockers in combination with muscarinic receptor antagonists may have the potential to improve symptoms. This study aimed to assess the efficacy and safety of doxazosin or tamsulosin combined with tolterodine extend release (ER) in patients with BPH and LUTS. MATERIAL AND METHODS In a prospective, randomized, open-label study (ChiCTR-IPR-15005763), 220 consecutive men with BPH and LUTS were allocated to receive doxazosin 4 mg and tolterodine ER 4 mg per day (doxazosin group) or tamsulosin 0.2 mg and tolterodine ER 4 mg per day (tamsulosin group). Treatment lasted 12 weeks. The primary endpoint was the international prostatic symptom score (IPSS). Secondary endpoints were quality of life (QoL) and maximum flow rate (Qmax), which were evaluated at 0, 6, and 12 weeks, and urodynamic parameters assessed at 0 and 12 weeks. RESULTS A total of 192 patients completed the trial. Baseline measurements showed no differences between the groups. After 6 weeks, IPSS improved in both groups and QoL was significantly better in the doxazosin group (P=0.01). After 12 weeks, Qmax, IPSS, QoL, intravesical pressure (Pves), and bladder compliance (BC) in the doxazosin group were significantly better than in the tamsulosin group (P=0.03, P<0.001, P<0.001, P=0.027, and P=0.044, respectively). CONCLUSIONS Administration of alpha blockers combined with muscarinic receptor blocker for 12 weeks improved LUTS in men with BPH. PMID:27260129

  6. A Randomized, Open-Label, Comparative Study of Efficacy and Safety of Tolterodine Combined with Tamsulosin or Doxazosin in Patients with Benign Prostatic Hyperplasia

    PubMed Central

    Cao, Yanwei; Wang, Yonghua; Guo, Lei; Yang, Xuecheng; Chen, Tao; Niu, Haitao

    2016-01-01

    Background Benign prostatic hyperplasia (BPH), a common disease in men over age 50 years, often causes bladder outlet obstruction and lower urinary tract symptoms (LUTS). Alpha blockers in combination with muscarinic receptor antagonists may have the potential to improve symptoms. This study aimed to assess the efficacy and safety of doxazosin or tamsulosin combined with tolterodine extend release (ER) in patients with BPH and LUTS. Material/Methods In a prospective, randomized, open-label study (ChiCTR-IPR-15005763), 220 consecutive men with BPH and LUTS were allocated to receive doxazosin 4 mg and tolterodine ER 4 mg per day (doxazosin group) or tamsulosin 0.2 mg and tolterodine ER 4 mg per day (tamsulosin group). Treatment lasted 12 weeks. The primary endpoint was the international prostatic symptom score (IPSS). Secondary endpoints were quality of life (QoL) and maximum flow rate (Qmax), which were evaluated at 0, 6, and 12 weeks, and urodynamic parameters assessed at 0 and 12 weeks. Results A total of 192 patients completed the trial. Baseline measurements showed no differences between the groups. After 6 weeks, IPSS improved in both groups and QoL was significantly better in the doxazosin group (P=0.01). After 12 weeks, Qmax, IPSS, QoL, intravesical pressure (Pves), and bladder compliance (BC) in the doxazosin group were significantly better than in the tamsulosin group (P=0.03, P<0.001, P<0.001, P=0.027, and P=0.044, respectively). Conclusions Administration of alpha blockers combined with muscarinic receptor blocker for 12 weeks improved LUTS in men with BPH. PMID:27260129

  7. YOGA FOR CHRONIC LOW BACK PAIN IN A PREDOMINANTLY MINORITY POPULATION: A PILOT RANDOMIZED CONTROLLED TRIAL

    PubMed Central

    Saper, Robert B.; Sherman, Karen J.; Cullum-Dugan, Diana; Davis, Roger B.; Phillips, Russell S.; Culpepper, Larry

    2009-01-01

    Background Several studies suggest yoga may be effective for chronic low back pain; however, trials targeting minorities have not been conducted. Primary Study Objectives Assess the feasibility of studying yoga in a predominantly minority population with chronic low back pain. Collect preliminary data to plan a larger powered study. Study Design Pilot randomized controlled trial. Setting Two community health centers in a racially diverse neighborhood of Boston, Massachusetts. Participants Thirty English-speaking adults (mean age 44 years, 83% female, 83% racial/ethnic minorities; 48% with incomes ≤$30000) with moderate-to-severe chronic low back pain. Interventions Standardized series of weekly hatha yoga classes for 12 weeks compared to a waitlist usual care control. Outcome Measures Feasibility measured by time to complete enrollment, proportion of racial/ethnic minorities enrolled, retention rates, and adverse events. Primary efficacy outcomes were changes from baseline to 12 weeks in pain score (0=no pain to 10=worst possible pain) and back-related function using the modified Roland-Morris Disability Questionnaire (0–23 point scale, higher scores reflect poorer function). Secondary efficacy outcomes were analgesic use, global improvement, and quality of life (SF-36). Results Recruitment took 2 months. Retention rates were 97% at 12 weeks and 77% at 26 weeks. Mean pain scores for yoga decreased from baseline to 12 weeks (6.7 to 4.4) compared to usual care, which decreased from 7.5 to 7.1 (P=.02). Mean Roland scores for yoga decreased from 14.5 to 8.2 compared to usual care, which decreased from 16.1 to 12.5 (P=.28). At 12 weeks, yoga compared to usual care participants reported less analgesic use (13% vs 73%, P=.003), less opiate use (0% vs 33%, P=.04), and greater overall improvement (73% vs 27%, P=.03). There were no differences in SF-36 scores and no serious adverse events. Conclusion A yoga study intervention in a predominantly minority population with

  8. Peers Promoting Physical Activity among Breast Cancer Survivors: A Randomized Controlled Trial

    PubMed Central

    Pinto, Bernardine M.; Stein, Kevin; Dunsiger, Shira

    2015-01-01

    Objective Although studies have shown that physical activity (PA) can reduce some treatment-related side-effects of breast cancer, there is a need to offer PA programs outside of research settings to reach more cancer survivors. We partnered with the American Cancer Society's Reach to Recovery program (RTR) to train their volunteers (breast cancer survivors) to deliver a 12-week PA intervention to other breast cancer survivors. Methods We conducted a randomized controlled trial to compare the PA intervention delivered by RTR volunteers (PA plus RTR) with contact control (RTR Control). Eighteen RTR volunteers/coaches (mean age=54.9 years, mean years since diagnosis=7.0) delivered the contact control condition or the PA intervention. Seventy-six breast cancer survivors in New England (mean age=55.6 years, mean years since diagnosis=1.1) were randomized to one of the two groups. At baseline, 12 weeks (post-intervention) and at 24 weeks, participants wore an accelerometer for seven days, were interviewed about their PA and reported their motivational readiness for PA. Results Adjusted mixed effects longitudinal regression models showed significant group differences favoring the PA plus RTR group in minutes of moderate to vigorous PA at 12 weeks (mean difference=103 minutes/ week, p<.001) and 24 weeks (mean difference=34.7 minutes/week, p=.03). Results were corroborated with significant group differences in accelerometer data favoring the PA plus RTR group at both time-points. Conclusions Peer volunteers were able to significantly increase PA among cancer survivors relative to contact control. Partnerships with existing volunteer programs can help to widen the reach of behavioral interventions among cancer survivors. PMID:25110844

  9. Effects of combined exercise on physical fitness and neurotransmitters in children with ADHD: a pilot randomized controlled study.

    PubMed

    Lee, Sun-Kyoung; Lee, Chung-Moo; Park, Jong-Hwan

    2015-09-01

    [Purpose] The purpose of the present study was to determine the effect of a jump rope and ball combined exercise program on the physical fitness the neurotransmitter (epinephrine, serotonin) levels of children with attention-deficit hyperactivity disorder. [Subjects and Methods] The subjects were 12 boys attending elementary school, whose grade levels ranged from 1-4. The block randomization method was used to distribute the participants between the combined exercise group (n = 6) and control group (n = 6). The program consisted of a 60-min exercise (10-min warm-up, 40-min main exercise, and 10-min cool down) performed three times a week, for a total of 12 weeks. [Results] The exercise group showed a significant improvement in cardiorespiratory endurance, muscle strength, muscle endurance and flexibility after 12 weeks. A significant increase in the epinephrine level was observed in the exercise group. [Conclusion] The 12-week combined exercise program in the current study (jump rope and ball exercises) had a positive effect on overall fitness level, and neurotransmission in children with attention-deficit hyperactivity disorder. PMID:26504324

  10. Evaluation of Rhubarb Supplementation in Stages 3 and 4 of Chronic Kidney Disease: A Randomized Clinical Trial

    PubMed Central

    Khan, Irfan A.; Nasiruddin, Mohammad; Haque, Shahzad F.; Khan, Rahat A.

    2014-01-01

    Objective. To evaluate the efficacy and safety of Rhubarb supplementation in patients of chronic kidney disease. Material and Methods. This study was a prospective comparative study conducted in patients of chronic kidney disease (stages 3 & 4) attending Renal Clinic of Department of Medicine, JN Medical College & Hospital, AMU, Aligarh. Patients were randomly divided into two interventional groups. Group I (Control) was given conservative management while Group II (Rhubarb) received conservative management along with Rhubarb capsule (350 mg, thrice daily) for 12 weeks. Haemogram and renal function tests were measured at 0, 4, 8, and 12 weeks of treatment. Results. There was progressive improvement in clinical features in both the groups after 12 weeks of treatment but Rhubarb group showed more marked improvement as compared to control group. Both groups showed gradual improvement in the biochemical parameters as compared to their pretreated values which was more marked in Rhubarb supplemented group. There was reduction in blood glucose, blood urea, serum creatinine, and 24 hour total urine protein (TUP). There was increase in haemoglobin, 24 hour total urine volume (TUV), and glomerular filtration rate (GFR). There was no statistical difference in two groups with respect to side effects (P > 0.05). Conclusion. Rhubarb supplementation improved the therapeutic effect of conservative management in stage 3 and stage 4 patients of chronic kidney disease. PMID:26464863

  11. Effects of combined exercise on physical fitness and neurotransmitters in children with ADHD: a pilot randomized controlled study

    PubMed Central

    Lee, Sun-Kyoung; Lee, Chung-Moo; Park, Jong-Hwan

    2015-01-01

    [Purpose] The purpose of the present study was to determine the effect of a jump rope and ball combined exercise program on the physical fitness the neurotransmitter (epinephrine, serotonin) levels of children with attention-deficit hyperactivity disorder. [Subjects and Methods] The subjects were 12 boys attending elementary school, whose grade levels ranged from 1–4. The block randomization method was used to distribute the participants between the combined exercise group (n = 6) and control group (n = 6). The program consisted of a 60-min exercise (10-min warm-up, 40-min main exercise, and 10-min cool down) performed three times a week, for a total of 12 weeks. [Results] The exercise group showed a significant improvement in cardiorespiratory endurance, muscle strength, muscle endurance and flexibility after 12 weeks. A significant increase in the epinephrine level was observed in the exercise group. [Conclusion] The 12-week combined exercise program in the current study (jump rope and ball exercises) had a positive effect on overall fitness level, and neurotransmission in children with attention-deficit hyperactivity disorder. PMID:26504324

  12. High-dose Vitamin D Supplementation and Measures of Insulin Sensitivity in Polycystic Ovary Syndrome: a Randomized Controlled Pilot Trial

    PubMed Central

    Raja-Khan, Nazia; Shah, Julie; Stetter, Christy M.; Lott, Mary E.J.; Kunselman, Allen R.; Dodson, William C.; Legro, Richard S.

    2015-01-01

    Objective To determine the effects of high-dose vitamin D on insulin sensitivity in Polycystic Ovary Syndrome (PCOS). Design Randomized placebo-controlled trial. Setting Academic medical center. Patients 28 PCOS women. Interventions Vitamin D3 12,000 International Units or placebo daily for 12 weeks. Main Outcome Measures The primary outcome was quantitative insulin sensitivity check index (QUICKI). Secondary outcomes included glucose and insulin levels during a 75-gram oral glucose tolerance test and blood pressure. Results Twenty-two women completed the study. Compared to placebo, vitamin D significantly increased 25-hydroxyvitamin D (mean (95% confidence interval) in vitamin D group 20.1 (15.7 to 24.5) ng/ml at baseline and 65.7 (52.3 to 79.2) ng/ml at 12 weeks; placebo 22.5 (18.1 to 26.8) ng/ml at baseline and 23.8 (10.4 to 37.2) ng/ml at 12 weeks). There were no significant differences in QUICKI and other measures of insulin sensitivity, however we observed trends towards lower 2-hour insulin and lower 2-hour glucose. We also observed a protective effect of vitamin D on blood pressure. Conclusions In women with PCOS, insulin sensitivity was unchanged with high-dose vitamin D but there was a trend towards decreased 2-hour insulin and a protective effect on blood pressure. Clinical Trial registration number ClinicalTrials.gov Identifier: NCT00907153 PMID:24636395

  13. Glycolic Acid Peels/Azelaic Acid 20% Cream Combination and Low Potency Triple Combination Lead to Similar Reduction in Melasma Severity in Ethnic Skin: Results of a Randomized Controlled Study

    PubMed Central

    Mahajan, Rahul; Kanwar, Amrinder Jit; Parsad, Davinder; Kumaran, Muthu Sendhil; Sharma, Reena

    2015-01-01

    Background: Numerous therapeutic options have been tried in the management of melasma. Aims and Objectives: This prospective randomized study was planned to assess the efficacy of low potency triple combination (TC) cream (TC-hydroquinone 2%/tretinoin 0.05%/fluocinolone 0.01%) versus glycolic acid (GA) peels/azelaic acid (AA) 20% cream (GA/AA) combination in melasma. Materials and Methods: Forty patients with melasma were recruited into this study and randomized into two groups. Group A consisting 20 patients received TC cream once a day for night time application for 3 months. Group B comprising of 20 patients received GA/AA 20% cream combination for 3 months. The disease severity was monitored with digital photography, melasma area and severity index (MASI) score, which was calculated at baseline, 6 weeks and 12 weeks, and visual analog scale (VAS) score, which was calculated at baseline and 12 weeks. Results: Of 40 patients, 38 were completed the study. A significant reduction in MASI and VAS was recorded after 6 weeks and 12 weeks of treatment in both groups A and B (P = 0.001). However, there was no significant difference in the mean MASI scores between the two groups at baseline, 6 weeks and 12 weeks. Similarly, there was no difference in the mean VAS scores between the two groups at baseline and 12 weeks. Four patients in group A and 3 in group B experienced adverse effects such as irritation, dryness, and photosensitivity. Conclusion: Both low potency TC cream and GA/AA 20% cream combination are effective in treating melasma among Indian patients. PMID:25814702

  14. Health benefits of different sport disciplines for adults: systematic review of observational and intervention studies with meta-analysis.

    PubMed

    Oja, Pekka; Titze, Sylvia; Kokko, Sami; Kujala, Urho M; Heinonen, Ari; Kelly, Paul; Koski, Pasi; Foster, Charlie

    2015-04-01

    The aim was to assess the quality and strength of evidence for the health benefits of specific sport disciplines. Electronic search yielded 2194 records and the selection resulted in 69 eligible studies (47 cross-sectional, 9 cohort, 13 intervention studies). 105 comparisons between participation and non-participation groups in 26 different sport disciplines were reported. Moderately strong evidence showed that both running and football improve aerobic fitness and cardiovascular function at rest, and football reduces adiposity. Conditional evidence showed that running benefits metabolic fitness, adiposity and postural balance, and football improves metabolic fitness, muscular performance, postural balance, and cardiac function. Evidence for health benefits of other sport disciplines was either inconclusive or tenuous. The evidence base for the health benefits of specific sports disciplines is generally compromised by weak study design and quality. Future research should address the health effects of different sport disciplines using rigorous research designs. PMID:25568330

  15. Determining the Cost-Savings Threshold for HIV Adherence Intervention Studies for Persons with Serious Mental Illness and HIV.

    PubMed

    Wu, Evan S; Rothbard, Aileen; Holtgrave, David R; Blank, Michael B

    2016-05-01

    Persons with serious mental illnesses are at increased risk for contracting and transmitting HIV and often have poor adherence to medication regimens. Determining the economic feasibility of different HIV adherence interventions among individuals with HIV and serious mental illness is important for program planners who must make resource allocation decisions. The goal of this study was to provide a methodology to estimate potential cost savings from an HIV medication adherence intervention program for a new study population, using data from prior published studies. The novelty of this approach is the way CD4 count data was used as a biological marker to estimate costs averted by greater adherence to anti-retroviral treatment. Our approach is meant to be used in other adherence intervention studies requiring cost modeling. PMID:25535041

  16. Phonemes, rhymes, and intelligence as predictors of children's responsiveness to remedial reading instruction: evidence from a longitudinal intervention study.

    PubMed

    Hatcher, P J; Hulme, C

    1999-02-01

    We present an analysis of data from a longitudinal intervention study with 7-year-old poor readers (Hatcher, Hulme, & Ellis, 1994). A battery of cognitive and phonological tasks administered before the intervention began revealed five separate factors: Phoneme Manipulation, Rhyme, Verbal Ability, Nonverbal Ability and Phonological Memory. We assessed the extent to which these factors were predictive of children's responsiveness to the teaching interventions they received. For reading accuracy, Verbal Ability, Nonverbal Ability, Phonological Memory, and Rhyme made no significant contribution to predicting responsiveness to teaching, while Phoneme Manipulation was a very strong predictor. However for reading comprehension, Verbal ability (but not nonverbal ability) made an additional unique contribution to predicting responsiveness to teaching. The results are discussed in the context of current theories of the role of intelligence and phonological skills in learning to read. PMID:9927526

  17. Ancillary Benefits for Caregivers of Children with Asthma Participating in an Environmental Intervention Study to Alleviate Asthma Symptoms

    PubMed Central

    Kubzansky, Laura D.; Spengler, John D.; Levy, Jonathan I.

    2009-01-01

    Providing care for children with asthma can be demanding and time-intensive with far-reaching effects on caregivers’ lives. Studies have documented childhood asthma symptom reductions and improved asthma-related quality of life (AQOL) with indoor allergen-reducing environmental interventions. Few such studies, however, have considered ancillary benefits to caregivers or other family members. Ancillary benefits could be derived from child health improvements and reduced caregiving burden or from factors such as improved living environments or social support that often accompanies intensive residential intervention efforts. As part of the Boston Healthy Public Housing Initiative (HPHI), a longitudinal single-cohort intervention study of asthmatic children, we examined trends in caregivers’ quality of life related to their child’s asthma (caregiver AQOL) using monthly Juniper Caregiver Asthma Quality of Life Questionnaires (AQLQ) for 32 primary caregivers to 42 asthmatic children aged 4 to 17 years. Longitudinal analyses were used to examine caregiver AQOL trends and their relationship to the child’s AQOL, then to consider additional predictors of caregiver AQOL. Caregiver AQLQ improved significantly over the course of the study with overall improvements significantly correlated with child AQOL (p = 0.005). However, caregiver AQOL improved most in the months before environmental interventions, while children’s AQOL improved most in the months following. Time trends in caregiver AQOL, controlling for child AQOL, were not explained by available social support or caregiver stress measures. Our findings suggest potential participation effects not adequately captured by standard measures. Future environmental intervention studies should more formally consider social support and participation effects for both children and caregivers PMID:19184446

  18. Ancillary benefits for caregivers of children with asthma participating in an environmental intervention study to alleviate asthma symptoms.

    PubMed

    Clougherty, Jane E; Kubzansky, Laura D; Spengler, John D; Levy, Jonathan I

    2009-03-01

    Providing care for children with asthma can be demanding and time-intensive with far-reaching effects on caregivers' lives. Studies have documented childhood asthma symptom reductions and improved asthma-related quality of life (AQOL) with indoor allergen-reducing environmental interventions. Few such studies, however, have considered ancillary benefits to caregivers or other family members. Ancillary benefits could be derived from child health improvements and reduced caregiving burden or from factors such as improved living environments or social support that often accompanies intensive residential intervention efforts. As part of the Boston Healthy Public Housing Initiative (HPHI), a longitudinal single-cohort intervention study of asthmatic children, we examined trends in caregivers' quality of life related to their child's asthma (caregiver AQOL) using monthly Juniper Caregiver Asthma Quality of Life Questionnaires (AQLQ) for 32 primary caregivers to 42 asthmatic children aged 4 to 17 years. Longitudinal analyses were used to examine caregiver AQOL trends and their relationship to the child's AQOL, then to consider additional predictors of caregiver AQOL. Caregiver AQLQ improved significantly over the course of the study with overall improvements significantly correlated with child AQOL (p = 0.005). However, caregiver AQOL improved most in the months before environmental interventions, while children's AQOL improved most in the months following. Time trends in caregiver AQOL, controlling for child AQOL, were not explained by available social support or caregiver stress measures. Our findings suggest potential participation effects not adequately captured by standard measures. Future environmental intervention studies should more formally consider social support and participation effects for both children and caregivers. PMID:19184446

  19. The Effect of Green Tea Ingestion and Interval Sprinting Exercise on the Body Composition of Overweight Males: A Randomized Trial.

    PubMed

    Gahreman, Daniel; Heydari, Mehrdad; Boutcher, Yati; Freund, Judith; Boutcher, Stephen

    2016-01-01

    The combined effect of green tea ingestion and interval sprinting exercise on body and abdominal fat of overweight males was investigated. Participants were randomly assigned into control (C), green tea (GT), interval sprinting exercise (ISE), and green tea and ISE (GT + ISE) groups. The GT, GT + ISE, and C groups consumed three GT capsules daily. The ISE and GT + ISE groups completed 36 ISE sessions over 12 weeks. Forty eight overweight males with a mean BMI of 28.5 ± 0.92 kg/m² and age of 26 ± 0.7 years acted as participants. There was a significant reduction in total and abdominal fat mass for the ISE and GT + ISE groups, p < 0.05, however, total and abdominal fat mass did not significantly change in the GT and C groups. There was a significant increase in total lean mass, p < 0.05, after the intervention for the ISE and GT + ISE groups only. There was a significant increase in fat oxidation during submaximal aerobic exercise, p < 0.05, after the intervention for the ISE, GT + ISE, and GT groups with no change for the C group. Following the 12-week intervention the ISE and GT + ISE groups, compared to C, recorded a significantly greater decrease in body and abdominal fat, and a significant increase in total lean mass. Ingestion of green tea by itself, however, did not result in a significant decrease in body or abdominal fat, but increased fat utilization during submaximal exercise. The combination of 12 weeks of GT ingestion and ISE did not result in greater total and abdominal fat reduction compared to 12 weeks of ISE alone. PMID:27548216

  20. Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial.

    PubMed

    Sterling, Michele; Vicenzino, Bill; Souvlis, Tina; Connelly, Luke B

    2015-04-01

    This randomized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders (WAD). The setting was a single university centre and 4 physiotherapy practices in Queensland, Australia. Eighty patients with chronic WAD (>3 months) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013. The interventions were 6 weeks of dry-needling to posterior neck muscles (n = 40) and exercise or sham dry-needling and exercise (n = 40). The primary outcomes of the Neck Disability Index (NDI) and self-rated recovery were measured at baseline, 6 and 12 weeks, 6 and 12 months by a blinded assessor. Analysis was intention to treat. An economic evaluation was planned but missing data deemed further analysis unwarranted. Seventy-nine patients (99%) were followed up at 6 weeks, 78 (98%) at 12 weeks, 74 (93%) at 6 months, and 73 (91%) at 12 months. The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks. The treatment effects were small and not clinically worthwhile. At 6 weeks, the treatment effect on the 0-100 NDI was -0.3 (95% confidence interval -5.4 to 4.7), 12 weeks -0.3 (-5.2 to 4.9), 6 months -4.4 (-9.6 to -0.74), and 12 months -3.8 (-9.1 to -0.5). There was no effect for self-rated recovery. In patients with chronic WAD, dry-needling and exercise has no clinically worthwhile effects over sham dry-needling and exercise. PMID:25790454

  1. The Effect of Green Tea Ingestion and Interval Sprinting Exercise on the Body Composition of Overweight Males: A Randomized Trial

    PubMed Central

    Gahreman, Daniel; Heydari, Mehrdad; Boutcher, Yati; Freund, Judith; Boutcher, Stephen

    2016-01-01

    The combined effect of green tea ingestion and interval sprinting exercise on body and abdominal fat of overweight males was investigated. Participants were randomly assigned into control (C), green tea (GT), interval sprinting exercise (ISE), and green tea and ISE (GT + ISE) groups. The GT, GT + ISE, and C groups consumed three GT capsules daily. The ISE and GT + ISE groups completed 36 ISE sessions over 12 weeks. Forty eight overweight males with a mean BMI of 28.5 ± 0.92 kg/m2 and age of 26 ± 0.7 years acted as participants. There was a significant reduction in total and abdominal fat mass for the ISE and GT + ISE groups, p < 0.05, however, total and abdominal fat mass did not significantly change in the GT and C groups. There was a significant increase in total lean mass, p < 0.05, after the intervention for the ISE and GT + ISE groups only. There was a significant increase in fat oxidation during submaximal aerobic exercise, p < 0.05, after the intervention for the ISE, GT + ISE, and GT groups with no change for the C group. Following the 12-week intervention the ISE and GT + ISE groups, compared to C, recorded a significantly greater decrease in body and abdominal fat, and a significant increase in total lean mass. Ingestion of green tea by itself, however, did not result in a significant decrease in body or abdominal fat, but increased fat utilization during submaximal exercise. The combination of 12 weeks of GT ingestion and ISE did not result in greater total and abdominal fat reduction compared to 12 weeks of ISE alone. PMID:27548216

  2. Antimicrobial effect of a chlorhexidine-thymol varnish (Cervitec) in orthodontic patients. A prospective, randomized clinical trial.

    PubMed

    Ogaard, B; Larsson, E; Glans, R; Henriksson, T; Birkhed, D

    1997-01-01

    The aim of the present investigation was to study the effect of combined application of a fluoride varnish (Fluor Protector) and an antimicrobial varnish (Cervitec) on the oral microflora, caries and gingival condition in patients receiving treatment with fixed orthodontic appliances. A total of 198 individuals (12 to 15 years old), scheduled for fixed orthodontic treatment, were randomized into 2 groups. Prior to bonding, the Cervitec and the control group received one application with Cervitec or a placebo every week for 3 weeks, respectively. In the Cervitec group. Fluor Protector was applied at bonding and Cervitec at the next visit, 6 weeks later. Each varnish was then applied every 12 weeks for 24 weeks. In the control group, the fluoride varnish was applied only at bonding and every 12 weeks. The Visible Plaque Index (VPI), the Gingival Bleeding Index (GBI), the White Spot Lesion Index (WSL) and the level of mutans streptococci in plaque and saliva were recorded 3 weeks prior to bonding and after 24 weeks. At bonding and after 12 weeks, only VPI, GPI, plaque and salivary mutans streptococcus counts were recorded. During the 3-week prebonding period, the mean VPI, GBI and mutans streptococci in plaque decreased in both groups. At bonding, the mean level of mutans streptococci in plaque was significantly lower in the Cervitec group than in the control group. The mean level of mutans streptococci was significantly lower after 12 weeks' bonding in the Cervitec group than in the control group. No effects on the other parameters were found during the 24 weeks. PMID:9282547

  3. A (Pan-Canadian) Cluster Randomized Control Effectiveness Trial of the ABRACADABRA Web-Based Literacy Program

    ERIC Educational Resources Information Center

    Savage, Robert; Abrami, Philip C.; Piquette, Noella; Wood, Eileen; Deleveaux, Gia; Sanghera-Sidhu, Sukhbinder; Burgos, Giovani

    2013-01-01

    This report describes a cluster randomized control trial (RCT) intervention study of the effectiveness of the ABRACADABRA (ABRA) Web-based literacy system using a classroom-level RCT intervention with 1,067 children in 74 kindergarten and Grade 1 or Grade 1/2 classrooms across Canada. The authors closely followed the CONSORT criteria for executing…

  4. Random broadcast on random geometric graphs

    SciTech Connect

    Bradonjic, Milan; Elsasser, Robert; Friedrich, Tobias

    2009-01-01

    In this work, we consider the random broadcast time on random geometric graphs (RGGs). The classic random broadcast model, also known as push algorithm, is defined as: starting with one informed node, in each succeeding round every informed node chooses one of its neighbors uniformly at random and informs it. We consider the random broadcast time on RGGs, when with high probability: (i) RGG is connected, (ii) when there exists the giant component in RGG. We show that the random broadcast time is bounded by {Omicron}({radical} n + diam(component)), where diam(component) is a diameter of the entire graph, or the giant component, for the regimes (i), or (ii), respectively. In other words, for both regimes, we derive the broadcast time to be {Theta}(diam(G)), which is asymptotically optimal.

  5. Quantumness, Randomness and Computability

    NASA Astrophysics Data System (ADS)

    Solis, Aldo; Hirsch, Jorge G.

    2015-06-01

    Randomness plays a central role in the quantum mechanical description of our interactions. We review the relationship between the violation of Bell inequalities, non signaling and randomness. We discuss the challenge in defining a random string, and show that algorithmic information theory provides a necessary condition for randomness using Borel normality. We close with a view on incomputablity and its implications in physics.

  6. Antioxidant-rich coffee reduces DNA damage, elevates glutathione status and contributes to weight control: results from an intervention study.

    PubMed

    Bakuradze, Tamara; Boehm, Nadine; Janzowski, Christine; Lang, Roman; Hofmann, Thomas; Stockis, Jean-Pierre; Albert, Franz W; Stiebitz, Herbert; Bytof, Gerhard; Lantz, Ingo; Baum, Matthias; Eisenbrand, Gerhard

    2011-05-01

    Epidemiological and experimental evidence increasingly suggests coffee consumption to be correlated to prevention or delay of degenerative diseases connected with oxidative cellular stress. In an intervention study comprising 33 healthy volunteers, we examined DNA-protective and antioxidative effects exerted in vivo by daily ingestion of 750 mL of freshly brewed coffee rich in both green coffee bean constituents as well as roast products. The study design encompassed an initial 4 wk of wash-out, followed by 4 wk of coffee intake and 4 wk of second wash-out. At the start and after each study phase blood samples were taken to monitor biomarkers of oxidative stress response. In addition, body weight/composition and intake of energy/nutrients were recorded. In the coffee ingestion period, the primary endpoint, oxidative DNA damage as measured by the Comet assay (± FPG), was markedly reduced (p<0.001). Glutathione level (p<0.05) and GSR-activity (p<0.01) were elevated. Body weight (p<0.01)/body fat (p<0.05) and energy (p<0.001)/nutrient (p<0.001-0.05) intake were reduced. Our results allow to conclude that daily consumption of 3-4 cups of brew from a special Arabica coffee exerts health beneficial effects, as evidenced by reduced oxidative damage, body fat mass and energy/nutrient uptake. PMID:21462335

  7. Effects of a One Year Intensive Multidisciplinary Rehabilitation Program for Patients with Huntington’s Disease: a Prospective Intervention Study

    PubMed Central

    Piira, Anu; van Walsem, Marleen R.; Mikalsen, Geir; Nilsen, Kjell Haavik; Knutsen, Synnove; Frich, Jan C.

    2013-01-01

    Objective: To assess the effects of an intensive, multidisciplinary rehabilitation program for patients with early to mid-stage Huntington’s disease. Design: A prospective intervention study. Setting: Two Norwegian inpatient rehabilitation centers. Subjects: 37 patients, with early- to midstage Huntington’s disease Interventions: A one year rehabilitation program, consisting of three admissions of three weeks each, and a five-day evaluation stay approximately 3 months after the last rehabilitation admission. Focus was on physical exercise, social activities, and group/teaching sessions. There was also emphasis to implement of coordinated health care and social services for the patients. Main outcome measures: standard measures for motor function, including gait and balance, cognitive function, including MMSE and UHDRS cognitive assessment, anxiety and depression, activities of daily living (ADL), health related quality of life and Body Mass Index (BMI). Results: Significant improvements were observed in gait function, balance, in physical quality of life, anxiety and depression, as well as in BMI. ADL-function remained stable with no significant decline. Only one cognitive measure (SDMT) showed significant decline, while no decline was observed for the remaining cognitive measures. Conclusion: A multidisciplinary intensive rehabilitation program in patients with early and mid stage HD is associated with improved balance, gait function, physical quality of life and with reduced depressive and anxiety symptoms. Longer follow-up is needed to assess if these positive effects are sustained. There should be emphasis to establishment of long term and coordinated health care services for the HD patient PMID:24459605

  8. Perimetric progression using the Visual Field Index and the Advanced Glaucoma Intervention Study score and its clinical correlations

    PubMed Central

    Gros-Otero, Juan; Castejón, Miguel; Paz-Moreno, Javier; Mikropoulos, Dimitrios; Teus, Miguel

    2014-01-01

    Purpose To evaluate the association between clinical parameters and the diagnosis of progression using VFI (Visual Field Index) and AGIS (Advanced Glaucoma Intervention Study) score in primary open angle glaucoma. Methods Retrospective study of 517 visual fields of 78 eyes with primary open angle glaucoma analyzed with VFI and AGIS score. Clinical data registered included: age, sphere, pachimetry, basal intraocular pressure (IOP), and IOP during the follow up. Results Only the AGIS score diagnosis of progression was associated with the clinical parameters registered. Among the analyzed data, the mean IOP during follow up (p = 0.0005) and IOP at the third month of follow up (p = 0.004) were statistically associated with progression using the AGIS criteria. Conclusion The diagnosis of perimetric progression using the AGIS score in the current study was closer to the real functional progression than the diagnosis using the VFI, as the former was associated with known risk factors for progression in glaucoma. PMID:25182851

  9. Impact of vehicular strike on particulate matter air quality: results from a natural intervention study in Kathmandu valley.

    PubMed

    Fransen, Michelle; Pérodin, Joanne; Hada, Jayjeev; He, Xin; Sapkota, Amir

    2013-04-01

    In this natural intervention study, we evaluated the impact of vehicular shutdown during bandhas (general strikes) and meteorological parameters on ambient PM10 concentrations (particulate matter of aerodynamic diameter 10 μm or less) in the Kathmandu Valley, Nepal. Publicly available PM10 data (January 2003-February 2008) collected at six monitoring stations were combined with meteorological and bandh data. Linear mixed effects regression models were used to examine the effects of bandhas on PM10 concentrations. Lower PM10 concentrations were observed during the monsoon season compared to the winter, across all monitoring stations, with the largest reduction observed for the urban high traffic area (mean ± standard deviation: 290 ± 71 vs 143 ± 36 μg/m(3)). In the high traffic area, there was 36 μg/m(3) decrease in PM10 concentration during the bandh period compared to 2 days preceding the bandh, adjusting for season, rainfall, temperature, and windspeed. The improvements in air quality were short lived: PM10 concentration in the urban high traffic area increased by an average of 26 μg/m(3) within the first 2 days after the bandh. Our results suggest that controlling vehicular traffic can have an immediate impact in improving particulate matter air quality even among the most polluted cities in the world. PMID:23433338

  10. Birth characteristics and female sex hormone concentrations during adolescence: results from the Dietary Intervention Study in Children

    PubMed Central

    Hartman, Terryl J.; Rovine, Michael J.; Dorgan, Joanne F.

    2011-01-01

    Background Birth characteristics and adult hormone concentrations influence breast cancer risk, but little is known about the influence of birth characteristics on hormone concentrations, particularly during adolescence. Methods We evaluated the association of birth characteristics (birth weight, birth length, and gestational age) with serum sex hormone concentrations during late childhood and adolescence in 278 female participants of the Dietary Intervention Study in Children. Repeated measures analysis of variance models were used to assess the relationships of birth characteristics and serum estrogens and androgens at five different time points over a mean period of 7 years. Results In analyses that did not take into account time from blood draw until menarche, birth weight was inversely associated with pre-menarche concentrations of estradiol, estrone sulfate, androstenedione, testosterone, and dehydroepiandrosterone sulfate (DHEAS). In the post-menarche analyses, birth weight was not significantly associated with concentration of any of the hormones under investigation. Birth length and gestational age were not associated with hormone concentrations before or after menarche. Conclusion Birth weight is inversely associated with sex hormone concentrations before menarche in the model unadjusted for time from blood draw until menarche. Impact The in utero environment has long-term influences on the hormonal milieu, which could potentially contribute to breast cancer risk. PMID:21327460

  11. Anthocyanin/polyphenolic-rich fruit juice reduces oxidative cell damage in an intervention study with patients on hemodialysis.

    PubMed

    Spormann, Thomas M; Albert, Franz W; Rath, Thomas; Dietrich, Helmut; Will, Frank; Stockis, Jean-Pierre; Eisenbrand, Gerhard; Janzowski, Christine

    2008-12-01

    Hemodialysis patients face an elevated risk of cancer, arteriosclerosis, and other diseases, ascribed in part to increased oxidative stress. Red fruit juice with high anthocyanin/polyphenol content had been shown to reduce oxidative damage in healthy probands. To test its preventive potential in hemodialysis patients, 21 subjects in a pilot intervention study consumed 200 mL/day of red fruit juice (3-week run-in; 4-week juice uptake; 3-week wash-out). Weekly blood sampling was done to monitor DNA damage (comet assay +/- formamidopyrimidine-DNA glycosylase enzyme), glutathione, malondialdehyde, protein carbonyls, trolox equivalent antioxidant capacity, triglycerides, and DNA binding capacity of the transcription factor nuclear factor-kappaB. Results show a significant decrease of DNA oxidation damage (P < 0.0001), protein and lipid peroxidation (P < 0.0001 and P < 0.001, respectively), and nuclear factor-kappaB binding activity (P < 0.01), and an increase of glutathione level and status (both P < 0.0001) during juice uptake. We attribute this reduction in oxidative (cell) damage in hemodialysis patients to the especially high anthocyanin/polyphenol content of the juice. This provides promising perspectives into the prevention of chronic diseases such as cancer and cardiovascular disease in population subgroups exposed to enhanced oxidative stress like hemodialysis patients. PMID:19064553

  12. Experiences of home and institution in a secured nursing home ward in The Netherlands: A participatory intervention study.

    PubMed

    Klaassens, Mirjam; Meijering, Louise

    2015-08-01

    Nursing homes have been criticised for not providing a home for their residents. This article aims to provide insight into (1) the features of home and institution as experienced by residents and caregivers of a secured ward in a nursing home, and (2) how interventions implemented on the ward can contribute to a more home-like environment. For this purpose, a participatory intervention study, involving both caregivers and residents, was carried out. We collected data through qualitative research methods: observations, in-depth interviews and diaries to evaluate the interventions over time. We adopted an informed grounded theory approach, and used conceptualisations of total institutions and home as a theoretical lens. We found that the studied ward had strong characteristics of a total institution, such as batch living, block treatment and limited privacy. To increase the sense of home, interventions were formulated and implemented by the caregivers to increase the residents' autonomy, control and privacy. In this process, caregivers' perceptions and attitudes towards the provision of care shifted from task-oriented to person-centred care. We conclude that it is possible to increase the home-like character of a secured ward by introducing core values of home by means of interventions involving both caregivers and residents. PMID:26162729

  13. LA Sprouts Randomized Controlled Nutrition, Cooking and Gardening Program Reduces Obesity and Metabolic Risk in Latino Youth

    PubMed Central

    Gatto, Nicole M.; Martinez, Lauren C.; Spruijt-Metz, Donna; Davis, Jaimie N.

    2015-01-01

    Objective To assess the effects of a 12-week gardening, nutrition, and cooking intervention (“LA Sprouts”) on dietary intake, obesity parameters and metabolic disease risk among low-income, primarily Hispanic/Latino youth in Los Angeles. Methods Randomized control trial involving four elementary schools [2 schools randomized to intervention (172, 3rd–5th grade students); 2 schools randomized to control (147, 3rd–5th grade students)]. Classes were taught in 90-minute sessions once a week to each grade level for 12 weeks. Data collected at pre- and post-intervention included dietary intake via food frequency questionnaire (FFQ), anthropometric measures [BMI, waist circumference (WC)], body fat, and fasting blood samples. Results LA Sprouts participants had significantly greater reductions in BMI z-scores (0.1 versus 0.04 point decrease, respectively; p=0.01) and WC (−1.2 cm vs. no change; p<0.001). Fewer LA Sprouts participants had the metabolic syndrome (MetSyn) after the intervention than before, while the number of controls with MetSyn increased. LA Sprouts participants had improvements in dietary fiber intake (+3.5% vs. −15.5%; p=0.04) and less decreases in vegetable intake (−3.6% vs. −26.4%; p=0.04). Change in fruit intake before and after the intervention did not significantly differ between LAS and control subjects. Conclusions LA Sprouts was effective in reducing obesity and metabolic risk. PMID:25960146

  14. Pharmacologic treatment for urgency-predominant urinary incontinence in women diagnosed using a simplified algorithm: a randomized trial

    PubMed Central

    Huang, Alison J.; Hess, Rachel; Arya, Lily A.; Richter, Holly E.; Subak, Leslee L.; Bradley, Catherine S.; Rogers, Rebecca G.; Myers, Deborah L.; Johnson, Karen C.; Gregory, W. Thomas; Kraus, Stephen R.; Schembri, Michael; Brown, Jeanette S.

    2013-01-01

    Objective The purpose of this study was to evaluate clinical outcomes associated with the initiation of treatment for urgency-predominant incontinence in women diagnosed by a simple 3-item questionnaire. Study Design We conducted a multicenter, double-blinded, 12-week randomized trial of pharmacologic therapy for urgency-predominant incontinence in ambulatory women diagnosed by the simple 3-item questionnaire. Participants (N = 645) were assigned randomly to fesoterodine therapy (4-8 mg daily) or placebo. Urinary incontinence was assessed with the use of voiding diaries; postvoid residual volume was measured after treatment. Results After 12 weeks, women who had been assigned randomly to fesoterodine therapy reported 0.9 fewer urgency and 1.0 fewer total incontinence episodes/day, compared with placebo (P ≤ .001). Four serious adverse events occurred in each group, none of which was related to treatment. No participant had postvoid residual volume of ≥250 mL after treatment. Conclusion Among ambulatory women with urgency-predominant incontinence diagnosed with a simple 3-item questionnaire, pharmacologic therapy resulted in a moderate decrease in incontinence frequency without increasing significant urinary retention or serious adverse events, which provides support for a streamlined algorithm for diagnosis and treatment of female urgency-predominant incontinence. PMID:22542122

  15. The Management of Diabetic Foot Ulcers with Porcine Small Intestine Submucosa Tri-Layer Matrix: A Randomized Controlled Trial

    PubMed Central

    Cazzell, Shawn M.; Lange, Darrell L.; Dickerson, Jaime E.; Slade, Herbert B.

    2015-01-01

    Objective: This study demonstrates that superior outcomes are possible when diabetic foot ulcers (DFU) are managed with tri-layer porcine small intestine submucosa (SIS). Approach: Patients with DFU from 11 centers participated in this prospective randomized controlled trial. Qualified subjects were randomized (1:1) to either SIS or standard care (SC) selected at the discretion of the Investigator and followed for 12 weeks or complete ulcer closure. Results: Eighty-two subjects (41 in each group) were evaluable in the intent-to-treat analysis. Ulcers managed with SIS had a significantly greater proportion closed by 12 weeks than for the Control group (54% vs. 32%, p=0.021) and this proportion was numerically higher at all visits. Time to closure for ulcers achieving closure was 2 weeks earlier for the SIS group than for SC. Median reduction in ulcer area was significantly greater for SIS at each weekly visit (all p values<0.05). Review of reported adverse events found no safety concerns. Innovation: These data support the use of tri-layer SIS for the effective management of DFU. Conclusion: In this randomized controlled trial, SIS was found to be associated with more rapid improvement, and a higher likelihood of achieving complete ulcer closure than those ulcers treated with SC. PMID:26634183

  16. How random is a random vector?

    NASA Astrophysics Data System (ADS)

    Eliazar, Iddo

    2015-12-01

    Over 80 years ago Samuel Wilks proposed that the "generalized variance" of a random vector is the determinant of its covariance matrix. To date, the notion and use of the generalized variance is confined only to very specific niches in statistics. In this paper we establish that the "Wilks standard deviation" -the square root of the generalized variance-is indeed the standard deviation of a random vector. We further establish that the "uncorrelation index" -a derivative of the Wilks standard deviation-is a measure of the overall correlation between the components of a random vector. Both the Wilks standard deviation and the uncorrelation index are, respectively, special cases of two general notions that we introduce: "randomness measures" and "independence indices" of random vectors. In turn, these general notions give rise to "randomness diagrams"-tangible planar visualizations that answer the question: How random is a random vector? The notion of "independence indices" yields a novel measure of correlation for Lévy laws. In general, the concepts and results presented in this paper are applicable to any field of science and engineering with random-vectors empirical data.

  17. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    PubMed Central

    Shikiar, Richard; Bresnahan, Brian W; Stone, Stephen P; Thompson, Christine; Koo, John; Revicki, Dennis A

    2003-01-01

    Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome measures that were used in the trials – the Dermatology Life Quality Index (DLQI), the Psoriasis Symptom Assessment (PSA) Scale, and two itch measures, a Visual Analog Scale (VAS) and the National Psoriasis Foundation (NPF) itch measure. Methods Subjects aged 18 to 70 years with moderate to severe psoriasis for at least 6 months were recruited into the two clinical trials (n = 1095). Internal consistency reliability was evaluated for all patient reported outcomes at baseline and at 12 weeks. Construct validity was evaluated by relations among the different patient reported outcomes and between the patient reported outcomes and the clinical assessments (Psoriasis Area and Severity Index; Overall Lesion Severity Scale; Physician's Global Assessment of Change) assessed at baseline and at 12 weeks, as was the change over the course of the 12 week portion of the trial. Results Internal consistency reliability ranged from 0.86 to 0.95 for the patient reported outcome measures. The patient reported outcome measures were all shown to have significant construct validity with respect to each other and with respect to the clinical assessments. The four measures also demonstrated significant responsiveness to change in underlying clinical status of the patients over the course of the trial, as measured by the independently assessed clinical outcomes. Conclusions The DLQI, the PSA, VAS, and the NPF are considered useful tools for the measurement of dermatology-related limitations of functional

  18. Augmenting Psychoeducation with a Mobile Intervention for Bipolar Disorder: A Randomized Controlled Trial

    PubMed Central

    Depp, Colin A; Ceglowski, Jenni; Wang, Vicki C; Yaghouti, Faraz; Mausbach, Brent T; Thompson, Wesley K; Granholm, Eric L

    2014-01-01

    Background Psychosocial interventions for bipolar disorder are frequently unavailable and resource intensive. Mobile technology may improve access to evidence-based interventions and may increase their efficacy. We evaluated the feasibility, acceptability and efficacy of an augmentative mobile ecological momentary intervention targeting self-management of mood symptoms. Methods This was a randomized single-blind controlled trial with 82 consumers diagnosed with bipolar disorder who completed a four-session psychoeducational intervention and were assigned to 10 weeks of either: 1) mobile device delivered interactive intervention linking patient-reported mood states with personalized self-management strategies, or 2) paper-and-pencil mood monitoring. Participants were assessed at baseline, 6 weeks (mid-point), 12 weeks (post-treatment), and 24 weeks (follow up) with clinician-rated depression and mania scales and self-reported functioning. Results Retention at 12 weeks was 93% and both conditions were associated with high satisfaction. Compared to the paper-and-pencil condition, participants in the augmented mobile intervention condition showed significantly greater reductions in depressive symptoms at 6 and 12 weeks (Cohen's d for both were d=0.48). However, these effects were not maintained at 24-week follow up. Conditions did not differ significantly in the impact on manic symptoms or functional impairment. Limitations This was not a definitive trial and was not powered to detect moderators and mediators. Conclusions Automated mobile-phone intervention is feasible, acceptable, and may enhance the impact of brief psychoeducation on depressive symptoms in bipolar disorder. However, sustainment of gains from symptom self-management mobile interventions, once stopped, may be limited. PMID:25479050

  19. Randomized Trial of a Smartphone Mobile Application Compared to Text Messaging to Support Smoking Cessation

    PubMed Central

    Borland, Ron; Bettinghaus, Erwin P.; Shane, James H.; Zimmerman, Donald E.

    2014-01-01

    Abstract Background: Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Materials and Methods: Young adult smokers 18–30 years old (n=102) participated in a randomized pretest–posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and quitting behavior (quit attempts, point-prevalence, 30-day point-prevalence, and continued abstinence) were assessed in posttests. Results: Overall, 60% of smokers used mobile services (REQ-Mobile, 61%, mean of 128.5 messages received; onQ, 59%, mean of 107.8 messages), and 75% evaluated REQ-Mobile as user-friendly. A majority of smokers reported being abstinent at posttest (6 weeks, 53% of completers; 12 weeks, 66% of completers [44% of all cases]). Also, 37% (25%of all cases) reported 30-day point-prevalence abstinence, and 32% (22% of all cases) reported continuous abstinence at 12 weeks. OnQ produced more abstinence (p<0.05) than REQ-Mobile. Use of both services predicted increased 30-day abstinence at 12 weeks (used, 47%; not used, 20%; p=0.03). Conclusions: REQ-Mobile was feasible for delivering cessation support but appeared to not move smokers to quit as quickly as text messaging. Text messaging may work better because it is simple, well known, and delivered to a primary inbox. These advantages may disappear as smokers become more experienced with new handsets. Mobile phones may be promising delivery platforms for cessation services using either smartphone applications or text messaging. PMID:24350804

  20. A Randomized Controlled Pilot Trial of Oral N-Acetylcysteine in Children with Autism

    PubMed Central

    Hardan, Antonio Y.; Fung, Lawrence K.; Libove, Robin A.; Obukhanych, Tetyana V.; Nair, Surekha; Herzenberg, Leonore A.; Frazier, Thomas W.; Tirouvanziam, Rabindra

    2016-01-01

    Background An imbalance in the excitatory/inhibitory systems with abnormalities in the glutamatergic pathways has been implicated in the pathophysiology of autism. Furthermore, chronic redox imbalance was also recently linked to this disorder. The goal of this pilot study was to assess the feasibility of using oral N-acetylcysteine (NAC), a glutamatergic modulator and an antioxidant in the treatment of behavioral disturbance in children with autism. Methods This is a 12-week, double-blind, randomized, placebo-controlled study of NAC in children with autistic disorder. Subjects randomized to NAC were initiated at 900 mg daily for 4 weeks, then 900 mg twice-daily for 4 weeks and 900 mg three-times-daily for 4 weeks. The primary behavioral measure (Aberrant Behavior Checklist – Irritability subscale) and safety measures were performed at baseline, 4, 8, and 12 weeks. Secondary measures included the ABC-Stereotypy subscale, Repetitive Behavior Scale – Revised (RBS-R), and Social Responsiveness Scale (SRS). Results Thirty-three subjects (31 males, 2 females; aged 3.2–10.7 years) were randomized in the study. Follow-up data was available on fourteen subjects in the NAC group and fifteen in the placebo group. Oral NAC was well-tolerated with limited side effects. Compared to placebo, NAC resulted in significant improvements on ABC-Irritability subscale (F=6.80; p<.001; d=.96). Conclusions Data from this pilot investigation support the potential usefulness of NAC for treating irritability in children with autistic disorder. Large randomized controlled investigations are warranted. ClinicalTrials.gov Identifier NCT00627705 PMID:22342106

  1. Comparing MTI randomization procedures to blocked randomization.

    PubMed

    Berger, Vance W; Bejleri, Klejda; Agnor, Rebecca

    2016-02-28

    Randomization is one of the cornerstones of the randomized clinical trial, and there is no shortage of methods one can use to randomize patients to treatment groups. When deciding which one to use, researchers must bear in mind that not all randomization procedures are equally adept at achieving the objective of randomization, namely, balanced treatment groups. One threat is chronological bias, and permuted blocks randomization does such a good job at controlling chronological bias that it has become the standard randomization procedure in clinical trials. But permuted blocks randomization is especially vulnerable to selection bias, so as a result, the maximum tolerated imbalance (MTI) procedures were proposed as better alternatives. In comparing the procedures, we have somewhat of a false controversy, in that actual practice goes uniformly one way (permuted blocks), whereas scientific arguments go uniformly the other way (MTI procedures). There is no argument in the literature to suggest that the permuted block design is better than or even as good as the MTI procedures, but this dearth is matched by an equivalent one regarding actual trials using the MTI procedures. So the 'controversy', if we are to call it that, pits misguided precedent against sound advice that tends to be ignored in practice. We shall review the issues to determine scientifically which of the procedures is better and, therefore, should be used. PMID:26337607

  2. Promoting the Social and Communicative Behavior of Young Children with Autism Spectrum Disorders: A Review of Parent-Implemented Intervention Studies

    ERIC Educational Resources Information Center

    Meadan, Hedda; Ostrosky, Michaelene M.; Zaghlawan, Hasan Y.; Yu, SeonYeong

    2009-01-01

    The purpose of this article is to critically review the literature on parent-implemented interventions aimed at promoting and enhancing the social and communicative behavior of young children with autism spectrum disorders. Twelve parent-implemented intervention studies that were conducted, at least in part, in home environments and were published…

  3. Components of Fostering Self-Regulated Learning among Students. A Meta-Analysis on Intervention Studies at Primary and Secondary School Level

    ERIC Educational Resources Information Center

    Dignath, Charlotte; Buttner, Gerhard

    2008-01-01

    Due to new standards in fostering life-long learning at school, research has increasingly dealt with the promotion of self-regulated learning, resulting in a large number of intervention studies conducted at primary and secondary school. The current study aimed at investigating the impact of various training characteristics on the training…

  4. Comparison of the treatment of hydrocolloid and saline gauze for pressure ulcer: a meta-analysis of randomized controlled trials

    PubMed Central

    Zheng, Xuemei; Li, Jieqiong

    2015-01-01

    Purpose: To determine the hydrocolloid dressing versus saline gauze for the treatment of pressure ulcer. Methods: Pubmed and Web of Knowledge were searched for randomized controlled trials for the treatment of hydrocolloid and saline gauze for pressure ulcer. The random effect model was used. Sensitivity analysis and publication bias were conducted. Results: Seven randomized controlled trials involving a total of 329 participants were included in this meta-analysis. The combined results suggested that significant association in complete healing were detected among hydrocolloid dressings and saline gauze [Summary RR=2.20, 95% CI=1.21-4.02, I2=48.5%]. The associations were also significant when we only combine the results for ulcers healed and the treatment duration of 8-12 weeks. No publication bias was found. Conclusions: Our meta-analysis suggested that the use of hydrocolloid dressing increased the likelihood of complete healing by more than two-fold compared with saline gauze dressing. PMID:26885012

  5. Does social participation improve self-rated health in the older population? A quasi-experimental intervention study.

    PubMed

    Ichida, Yukinobu; Hirai, Hiroshi; Kondo, Katsunori; Kawachi, Ichiro; Takeda, Tokunori; Endo, Hideki

    2013-10-01

    Social participation has been linked to healthy aging and the maintenance of functional independence in older individuals. However, causality remains tenuous because of the strong possibility of reverse causation (healthy individuals selectively participate in social activities). We describe a quasi-experimental intervention in one municipality of Japan designed to boost social participation as a way of preventing long-term disability in senior citizens through the creation of 'salons' (or community centers). In this quasi-experimental intervention study, we compared 158 participants with 1391 non-participants in salon programs, and examined the effect of participation in the salon programs on self-rated health. We conducted surveys of community residents both before (in 2006) and after (in 2008) the opening of the salons. Even with a pre/post survey design, our study could be subject to reverse causation and confounding bias. We therefore utilized an instrumental variable estimation strategy, using the inverse of the distance between each resident's dwelling and the nearest salon as the instrument. After controlling for self-rated health, age, sex, equivalized income in 2006, and reverse causation, we observed significant correlations between participation in the salon programs and self-rated health in 2008. Our analyses suggest that participation in the newly-opened community salon was associated with a significant improvement in self-rated health over time. The odds ratio of participation in the salon programs for reporting excellent or good self-rated health in 2008 was 2.52 (95% CI 2.27-2.79). Our study provides novel empirical support for the notion that investing in community infrastructure to boost the social participation of communities may help promote healthy aging. PMID:23931949

  6. The Impact of E-Learning on Adherence to Guidelines for Acute Gastroenteritis: A Single-Arm Intervention Study

    PubMed Central

    Nicastro, Emanuele; Lo Vecchio, Andrea; Liguoro, Ilaria; Chmielewska, Anna; De Bruyn, Caroline; Dolinsek, Jernej; Doroshina, Elena; Fessatou, Smaragdi; Pop, Tudor Lucian; Prell, Christine; Tabbers, Merit Monique; Tavares, Marta; Urenden-Elicin, Pinar; Bruzzese, Dario; Zakharova, Irina; Sandhu, Bhupinder; Guarino, Alfredo

    2015-01-01

    Objective E-learning is a candidate tool for clinical practice guidelines (CPG) implementation due to its versatility, universal access and low costs. We aimed to assess the impact of a five-module e-learning course about CPG for acute gastroenteritis (AGE) on physicians’ knowledge and clinical practice. Study design This work was conceived as a pre/post single-arm intervention study. Physicians from 11 European countries registered for the online course. Personal data, pre- and post-course questionnaires and clinical data about 3 to 5 children with AGE managed by each physician before and after the course were collected. Primary outcome measures included the proportion of participants fully adherent to CPG and number of patients managed with full adherence. Results Among the 149 physicians who signed up for the e-learning course, 59 took the course and reported on their case management of 519 children <5 years of age who were referred to their practice because of AGE (281 and 264 children seen before and after the course, respectively). The course improved knowledge scores (pre-course 8.6 ± 2.7 versus post-course 12.8 ± 2.1, P < 0.001), average adherence (from 87.0 ± 7.7% to 90.6 ± 7.1%, P = 0.001) and the number of patients managed in full adherence with the guidelines (from 33.6 ± 31.7% to 43.9 ± 36.1%, P = 0.037). Conclusions E-learning is effective in increasing knowledge and improving clinical practice in paediatric AGE and is an effective tool for implementing clinical practice guidelines. PMID:26148301

  7. Implementation of a low-budget, lifestyle-improvement method in an ordinary primary healthcare setting: a stepwise intervention study

    PubMed Central

    Blomstrand, Ann; Ariai, Nashmil; Baar, Ann-Christine; Finbom-Forsgren, Britt-Marie; Thorn, Jörgen; Björkelund, Cecilia

    2012-01-01

    Objective To evaluate, in an ordinary primary healthcare setting, the effects of a screening questionnaire and a self-administered health profile dealing with special reference to the involvement of motivated individuals in need of lifestyle changes. Design Intervention study in a naturalistic context, using a screening questionnaire offered to consecutive patients, followed by a self-administered health profile and a health dialogue. Setting Hisingen primary healthcare area (130 033 inhabitants), Gothenburg, Sweden. Participants Men and women aged between 18 and 79, visiting any of the eight public primary healthcare centres (PCC) during an 8-month period, were presented with a screening questionnaire and, were offered, a health profile, a plasma glucose (p-glucose), blood pressure check and a health dialogue. Main outcome measures Motivation level, negative lifestyle factors in screening questionnaire and intraindividual changes in blood pressure, p-glucose, body mass index (BMI) and lifestyle factors between baseline and 1-year follow-up. Results Subjects with less favourable lifestyle and higher motivation chose to participate. A higher percentage of presumptive participants reported a less favourable lifestyle. The presumptive participants also indicated higher motivation. Participants showed more readiness to initiate lifestyle changes compared to non-participants (p<0.001). At 1-year follow-up significant reductions in BMI, waist circumference, waist–hip ratio (WHR), blood pressure and p-glucose were observed. Conclusions The results indicate that the method is on target and applicable to motivated individuals with a ‘risk profile’. A pedagogical model including a self-administered health-profile and a health dialogue, combined with emphasising the individual's own resources, seems to be a feasible method for effective preventive work in primary healthcare. PMID:22874629

  8. Ma-Pi 2 macrobiotic diet and type 2 diabetes mellitus: pooled analysis of short-term intervention studies.

    PubMed

    Porrata-Maury, C; Hernández-Triana, M; Ruiz-Álvarez, V; Díaz-Sánchez, M E; Fallucca, F; Bin, W; Baba-Abubakari, B; Pianesi, M

    2014-03-01

    The macrobiotic, Ma-Pi 2 diet (12% protein, 18% fat and 70% carbohydrate), has shown benefit in adults with type 2 diabetes mellitus (T2DM). This pooled analysis aims to confirm results from four, 21-day intervention studies with the Ma-Pi 2 diet, carried out in Cuba, China, Ghana and Italy. Baseline and end of study biochemical, body composition and blood pressure data, were compared using multivariate statistical methods and assessment of the Cohen effect size (d). Results showed that all measured indicators demonstrated significant changes (p < 0.001); most of them with a very high (d ≥ 1.30), or high (d = 0.80-1.29) effect size. The global effect size of the diet was Italy (1.96), China (1.79), Cuba (1.38) and Ghana (0.98). The magnitude of the individual effect on each variable by country, and the global effect by country, was independent of the sample size (p > 0.05). Similarly, glycemia and glycemic profiles in all four studies were independent of the sample size (p = 0.237). The Ma-Pi diet 2 significantly reduced glycemia, serum lipids, uremia and cardiovascular risk in adults with T2DM. These results suggest that the Ma-Pi 2 diet could be a valid alternative treatment for patients with T2DM and point to the need for further clinical studies. Mechanisms related to its benefits as a functional diet are discussed. PMID:24532293

  9. Navigating the maze of requirements for obtaining approval of non-interventional studies (NIS) in the European Union

    PubMed Central

    Ramirez, Isabelle

    2015-01-01

    Objective: The purpose of this article is to give an overview of the complexities and unexpected regulatory requirements for obtaining approval of multinational and multicentre non-interventional studies (NIS) in the European Union (EU). Methods: The websites of national competent authorities (CAs), ethics committees (ECs) and data protection (DP) authorities were consulted to find regulations and guidance information related to the authorisation of NIS in various member states of the EU. Results: Many additional hurdles, neither disclosed nor clear in the various regulations/guidances for NIS, were identified. Although approval from the CA is not needed for NIS, in many countries request of CA opinion is nevertheless recommended, prior to submission to the EC, to obtain confirmation that the planned NIS does not fall in the interventional trial category. Clinical trial insurance was required in some countries. In countries like Belgium and Italy, the multicentre NIS required the approval from a central EC and local ECs as a single central EC opinion was not considered sufficient. The EC document requirements for submission and the fees were extremely variable among all member states. Additional approvals from data protection authorities and insurance companies were required in some countries. Conclusions: The process of obtaining approval for multicentre and multinational NIS is time consuming due to lack of transparency and the different regulatory requirements among member states. The EU pharmacovigilance legislation and clinical trial regulation No 536/2014 is a step forward in providing a regulatory framework for PASS (post-authorisation safety studies) and low intervention clinical trials, but since regulation No 536/2014 excludes NIS, it will be difficult to enforce harmonization of requirements for approval of NIS among member states. PMID:26633964

  10. Prediction of fruit and vegetable intake from biomarkers using individual participant data of diet-controlled intervention studies.

    PubMed

    Souverein, Olga W; de Vries, Jeanne H M; Freese, Riitta; Watzl, Bernhard; Bub, Achim; Miller, Edgar R; Castenmiller, Jacqueline J M; Pasman, Wilrike J; van Het Hof, Karin; Chopra, Mridula; Karlsen, Anette; Dragsted, Lars O; Winkels, Renate; Itsiopoulos, Catherine; Brazionis, Laima; O'Dea, Kerin; van Loo-Bouwman, Carolien A; Naber, Ton H J; van der Voet, Hilko; Boshuizen, Hendriek C

    2015-05-14

    Fruit and vegetable consumption produces changes in several biomarkers in blood. The present study aimed to examine the dose-response curve between fruit and vegetable consumption and carotenoid (α-carotene, β-carotene, β-cryptoxanthin, lycopene, lutein and zeaxanthin), folate and vitamin C concentrations. Furthermore, a prediction model of fruit and vegetable intake based on these biomarkers and subject characteristics (i.e. age, sex, BMI and smoking status) was established. Data from twelve diet-controlled intervention studies were obtained to develop a prediction model for fruit and vegetable intake (including and excluding fruit and vegetable juices). The study population in the present individual participant data meta-analysis consisted of 526 men and women. Carotenoid, folate and vitamin C concentrations showed a positive relationship with fruit and vegetable intake. Measures of performance for the prediction model were calculated using cross-validation. For the prediction model of fruit, vegetable and juice intake, the root mean squared error (RMSE) was 258.0 g, the correlation between observed and predicted intake was 0.78 and the mean difference between observed and predicted intake was - 1.7 g (limits of agreement: - 466.3, 462.8 g). For the prediction of fruit and vegetable intake (excluding juices), the RMSE was 201.1 g, the correlation was 0.65 and the mean bias was 2.4 g (limits of agreement: -368.2, 373.0 g). The prediction models which include the biomarkers and subject characteristics may be used to estimate average intake at the group level and to investigate the ranking of individuals with regard to their intake of fruit and vegetables when validating questionnaires that measure intake. PMID:25850683

  11. The Role of Friends' Disruptive Behavior in the Development of Children's Tobacco Experimentation: Results from a Preventive Intervention Study

    ERIC Educational Resources Information Center

    van Lier, Pol A. C.; Huizink, Anja; Vuijk, Patricia

    2011-01-01

    Having friends who engage in disruptive behavior in childhood may be a risk factor for childhood tobacco experimentation. This study tested the role of friends' disruptive behavior as a mediator of the effects of a classroom based intervention on children's tobacco experimentation. 433 Children (52% males) were randomly assigned to the Good…

  12. Effects of an Automated Telephone Support System on Caregiver Burden and Anxiety: Findings from the REACH for TLC Intervention Study

    ERIC Educational Resources Information Center

    Mahoney, Diane Feeney; Tarlow, Barbara J.; Jones, Richard N.

    2003-01-01

    Purpose: We determine the main outcome effects of a 12-month computer-mediated automated interactive voice response (IVR) intervention designed to assist family caregivers managing persons with disruptive behaviors related to Alzheimer's disease (AD). Design and Methods: We conducted a randomized controlled study of 100 caregivers, 51 in the usual…

  13. Exogenous nitric oxide inhibits Rho-associated kinase activity in patients with angina pectoris: a randomized controlled trial

    PubMed Central

    Maruhashi, Tatsuya; Noma, Kensuke; Fujimura, Noritaka; Kajikawa, Masato; Matsumoto, Takeshi; Hidaka, Takayuki; Nakashima, Ayumu; Kihara, Yasuki; Liao, James K; Higashi, Yukihito

    2016-01-01

    The RhoA/Rho-associated kinase (ROCK) pathway has a key physiological role in the pathogenesis of atherosclerosis. Increased ROCK activity is associated with cardiovascular diseases. Endogenous nitric oxide (NO) has an anti-atherosclerotic effect, whereas the exogenous NO-mediated cardiovascular effect still remains controversial. The purpose of this study was to evaluate the effect of exogenous NO on ROCK activity in patients with angina pectoris. This is a prospective, open-label, randomized, controlled study. A total of 30 patients with angina pectoris were randomly assigned to receive 40 mg day−1 of isosorbide mononitrate (n = 15, 12 men and 3 women, mean age of 63 ± 12 years, isosorbide mononitrate group) or conventional treatment (n = 15, 13 men and 2 women, mean age of 64 ± 13 years, control group) for 12 weeks. ROCK activity in peripheral leukocytes was measured by western blot analysis. ROCK activities at 4 and 12 weeks after treatment were decreased in the isosorbide mononitrate group (0.82 ± 0.33 at 0 week, 0.62 ± 0.20 at 4 weeks, 0.61 ± 0.19 at 12 weeks, n = 15 in each group, P < 0.05, respectively) but not altered in the control group. ROCK1 and ROCK2 expression levels were similar in all treatment periods in the two groups. These findings suggest that the administration of exogenous NO can inhibit ROCK activity, indicating that the usage of exogenous NO could have a protective effect in patients with angina pectoris. PMID:25740292

  14. A Randomized Trial to Increase Acceptance of Childhood Vaccines by Vaccine-Hesitant Parents: A Pilot Study

    PubMed Central

    Williams, S. Elizabeth; Rothman, Russell L.; Offit, Paul A.; Schaffner, William; Sullivan, Molly; Edwards, Kathryn M.

    2013-01-01

    Objective A cluster-randomized trial was performed to evaluate an educational intervention to improve parental attitudes and vaccine uptake in vaccine-hesitant parents. Methods Two primary care sites were randomized to provide families with either usual care, or an intervention (video and written information) for vaccine-hesitant parents. Eligible parents included those presenting for their child’s 2 week well visit with performance on the Parent Attitudes about Childhood Vaccines (PACV) survey suggesting vaccine hesitancy (score ≥25). Enrollees completed PACV surveys at the 2 month well visit and vaccination status at 12 weeks of age was assessed. The primary outcome was the difference in PACV scores obtained at enrollment and 2 months between the two groups. The proportion of on-time vaccination was also compared at 12 weeks. Results 454 parents were approached and 369 (81.3%) participated; 132 had PACV scores ≥ 25 and were enrolled [67 in the control group (mean PACV score = 37) and 55 in the intervention group (mean PACV score = 40)]. Two month PACV surveys were completed by 108 (~90%) of enrollees. Parents in the intervention group had a significant decrease in PACV score at two months compared to control (median difference = 6.7, p=0.049); this remained significant after adjustment for baseline PACV score, race/ethnicity, and income (p=0.044). There was no difference in the on-time receipt of vaccines between groups at 12 weeks. Conclusions A brief educational intervention for vaccine-hesitant parents was associated with a modest but significant increase in measured parental attitudes towards vaccines. PMID:24011750

  15. Daily consumption of red grape cell powder in a dietary dose improves cardiovascular parameters: a double blind, placebo-controlled, randomized study.

    PubMed

    Vaisman, Nachum; Niv, Eva

    2015-05-01

    Consumption of polyphenol-rich food and food ingredient such as grape and grape products improved various cardiovascular parameters. In this study, we investigate the effect of dietary daily consumption of red grape cell powder (RGC) on blood pressure (BP) and flow-mediated dilatation (FMD) as well as on oxidative stress in 50 subjects with prehypertension and mild hypertension. The subjects were randomized into groups that consumed 200, 400 mg RGC or placebo daily for 12 weeks. RGC consumption was associated with an improvement of FMD (p = 0.013). There was a significant decrease in lipid peroxidation (p = 0.013) after 12 weeks in a combined RGC-treated group. The diastolic BP decreased significantly in the 200 mg RGC group compared to the placebo group (p = 0.032). Our results indicate that a daily supplementation, of red grape cell powder, for 12 weeks affects endothelial function, diastolic BP and oxidative stress without any adverse effects. PMID:25666417

  16. Effects of a resistance training program performed with an interocclusal splint for community-dwelling older adults: a randomized controlled trial

    PubMed Central

    Hirase, Tatsuya; Inokuchi, Shigeru; Matsusaka, Nobuou; Nakahara, Kazumi; Okita, Minoru

    2016-01-01

    [Purpose] To examine whether resistance training for elderly community-dwellers performed with an interocclusal splint resulted in greater lower extremity muscle strength and better balance than resistance training performed without an interocclusal splint. [Subjects and Methods] Eighty-eight elderly persons using Japanese community day centers were randomly divided into two groups: an intervention group (n=45), which performed resistance training with an interocclusal splint; and a control group (n=43), which performed resistance training without an interocclusal splint. The resistance training program comprised a 40-min session performed twice a week for 12 weeks. Outcome measures were the chair stand test (CST), timed up and go test (TUG), and one-leg standing test (OLST). Assessments were conducted before the intervention and every 2 weeks after the start of the intervention. [Results] There was a significant group × time interaction for the OLST, with the intervention group showing significant improvement from 8 to 12 weeks compared to the control group. For the CST and TUG, no significant differences were found between the two groups throughout the 12 weeks. [Conclusion] Resistance training with an interocclusal splint improved the balance ability of elderly community-dwellers more effectively than resistance training without an interocclusal splint. PMID:27313359

  17. Treatment of bulimia nervosa with fluvoxamine: a randomized controlled trial.

    PubMed

    Milano, W; Siano, C; Putrella, C; Capasso, A

    2005-01-01

    Bulimia nervosa (BN) is one of the most common eating disorders in industrialized societies. It has been suggested that reduced serotonin activity triggers some of the cognitive and mood disturbances associated with BN. For this reason, the pharmacologic treatment of BN consists mainly of selective serotonin reuptake inhibitors (SSRIs), which have been proven effective. At present, the physiologic bases of this disorder are not yet completely understood. We conducted a randomized controlled trial to verify the efficacy of the SSRI fluvoxamine in patients with a diagnosis of BN. Twelve female outpatients aged 21 to 34 years with a diagnosis of BN-binge purging (as defined by the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders [DSM IV]) were randomly assigned to 2 treatment groups: the fluvoxamine 200 mg/day group and the placebo group. The patients underwent weekly clinical assessments for 12 weeks. At the end of the observation period, there was a statistically significant reduction in the number of binge-eating crises and purging episodes in the fluvoxamine group compared with placebo. In no case was treatment interrupted because of emergent side effects. These findings support the hypothesis that fluvoxamine is well tolerated and effective in reducing binge-eating crises and purging episodes in patients with BN. PMID:16236688

  18. Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjögren’s Syndrome: a Double-Blind Randomized Control Study

    PubMed Central

    2016-01-01

    The effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined. This study aimed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren's syndrome (pSS). A double-blind, randomized control study was conducted in 39 pSS subjects from May 2011 through August 2013. pSS was diagnosed based on the classification criteria of the American-European Consensus Group. Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline, 6, and 12 weeks, with a re-visit at 16 weeks after drug discontinuance. The fluorescein staining score, Schirmer test score, tear film break-up time (TBUT), and ocular surface disease index (OSDI) were measured, and tears and blood were collected for ESR, IL-6, IL-17, B-cell activating factor (BAFF), and Th17 cell analysis. Color testing was performed and the fundus was examined to monitor HCQ complications. Twenty-six subjects completed the follow-up. The fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication in the HCQ group but was not significantly different between the groups. TBUT, serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group. HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS (ClinicalTrials.gov. NCT01601028). PMID:27366013

  19. Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjögren's Syndrome: a Double-Blind Randomized Control Study.

    PubMed

    Yoon, Chang Ho; Lee, Hyun Ju; Lee, Eun Young; Lee, Eun Bong; Lee, Won-Woo; Kim, Mee Kum; Wee, Won Ryang

    2016-07-01

    The effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined. This study aimed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren's syndrome (pSS). A double-blind, randomized control study was conducted in 39 pSS subjects from May 2011 through August 2013. pSS was diagnosed based on the classification criteria of the American-European Consensus Group. Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline, 6, and 12 weeks, with a re-visit at 16 weeks after drug discontinuance. The fluorescein staining score, Schirmer test score, tear film break-up time (TBUT), and ocular surface disease index (OSDI) were measured, and tears and blood were collected for ESR, IL-6, IL-17, B-cell activating factor (BAFF), and Th17 cell analysis. Color testing was performed and the fundus was examined to monitor HCQ complications. Twenty-six subjects completed the follow-up. The fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication in the HCQ group but was not significantly different between the groups. TBUT, serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group. HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS (ClinicalTrials.gov. NCT01601028). PMID:27366013

  20. Reduced viscosity Barley β-Glucan versus placebo: a randomized controlled trial of the effects on insulin sensitivity for individuals at risk for diabetes mellitus

    PubMed Central

    2011-01-01

    Background Prior studies suggest soluble fibers may favorably affect glucose/insulin metabolism. Methods This prospective, randomized, placebo controlled, double blind, parallel group trial evaluated 50 generally healthy subjects without prior diagnosis of diabetes mellitus (44 completers), who were administered beverages containing placebo (control), lower dose (3 g/d), or higher dose (6 g/d) reduced viscosity barley β-glucan (BBG) extract. Subjects (68% women) mean age 56 years, Body Mass Index (BMI) 32 kg/m2 and baseline fasting plasma glucose 102 mg/dl were instructed to follow a weight-maintaining Therapeutic Lifestyle Changes (TLC) diet and consumed three 11 oz study beverages daily with meals for 12 weeks. The four primary study endpoint measures were plasma glucose and insulin [each fasting and post-Oral Glucose Tolerance Testing (OGTT)]. Results Compared to placebo, administration of 3 g/d BBG over 12 weeks significantly reduced glucose incremental Area Under the Curve (iAUC) measures during OGTT and 6 g/d BBG over 12 weeks significantly reduced fasting insulin as well as the related homeostasis model assessment of insulin resistance (HOMA-IR). Beverages were generally well tolerated with no serious adverse experiences and no significant differences between groups for adverse experiences. Per protocol instruction, subjects maintained body weight. Conclusions These findings suggest 6 g/d BBG consumed in a beverage over 12 weeks may improve insulin sensitivity among hyperglycemic individuals with no prior diagnosis of diabetes mellitus, and who experience no change in body weight. Trial Registration ClinicalTrials.gov Identifier: NCT01375803. PMID:21846371

  1. Fixed combination of cinnarizine and dimenhydrinate versus betahistine dimesylate in the treatment of Ménière's disease: a randomized, double-blind, parallel group clinical study.

    PubMed

    Novotný, Miroslav; Kostrica, Rom

    2002-01-01

    In a randomized, double-blind clinical study, we evaluated the efficacy and tolerability of the fixed combination of cinnarizine, 20 mg, and dimenhydrinate, 40 mg (Arlevert [ARL]) in comparison to betahistine dimesylate (12 mg) in 82 patients suffering from Ménière's disease for at least 3 months and showing the characteristic triad of symptoms (paroxysmal vertigo attacks, cochlear hearing loss, and tinnitus). The treatment (one tablet three times daily) extended to 12 weeks, with control visits at 1, 3, 6, and 12 weeks after drug intake. The study demonstrated for both the fixed-combination ARL and for betahistine a highly efficient reduction of vertigo symptoms in the course of the 12 weeks of treatment; however, no statistically significant difference between the two treatment groups could be established. Similar results were found for tinnitus (approximately 60% reduction) and for the associated vegetative symptoms (almost complete disappearance). Vestibulospinal reactions, recorded by means of craniocorpography, also improved distinctly, with a statistically significant superiority of ARL versus betahistine (p < .042) for the parameter of lateral sway (Unterberger's test). The caloric tests (electronystagmography) showed only minor changes for both treatment groups in the course of the study. A statistically significant improvement of hearing function of the affected ear (p = .042) was found for the combination preparation after 12 weeks of treatment. The tolerability was judged by the vast majority of patients (97.5%) in both groups to be very good. Only one patient (betahistine group) reported a nonserious adverse event, and two betahistine patients did not complete the study. In conclusion, the combination preparation proved to be a highly efficient and safe treatment option for Ménière's disease and may be used both in the management of acute episodes and in long-term treatment. Efficacy and safety were found to be similar to the widely used standard

  2. Superior border versus inferior border fixation in displaced mandibular angle fractures: prospective randomized comparative study.

    PubMed

    Singh, V; Khatana, S; Bhagol, A

    2014-07-01

    A prospective randomized comparative study was conducted to compare open reduction and internal fixation of displaced fractures (>2mm) via intraoral approach with application of a single monocortical miniplate according to Champy's ideal line of osteosynthesis (group A) versus an extraoral approach with application of an inferior border plate with at least two holes (bicortical screws) on either side of the fracture line (group B). Clinical and radiographic assessment was done preoperatively, immediately postoperative, and at 1, 4, and 12 weeks of follow-up. Parametric and non-parametric data were evaluated by independent samples t-test and χ(2) analysis, respectively; P<0.05 was considered statistically significant. There was no significant difference between the two groups with regard to complication rates, although functional outcomes including pain (visual analogue scale score) at the 1-week follow-up and inter-incisal mouth opening at the 12-week follow-up were found to be better in group B. On radiographic assessment, the inferior border was better aligned in group B than in group A, with no superior border distraction in group B. The duration of surgery was shorter in group B, and this was considered to be the easier approach for fixation of the device as assessed by the surgeons. PMID:24636170

  3. Fractional Carbon Dioxide Laser for Keratosis Pilaris: A Single-Blind, Randomized, Comparative Study

    PubMed Central

    Vachiramon, Vasanop; Anusaksathien, Pattarin; Kanokrungsee, Silada; Chanprapaph, Kumutnart

    2016-01-01

    Objective. Keratosis pilaris (KP) is a common condition which can frequently be cosmetically disturbing. Topical treatments can be used with limited efficacy. The objective of this study is to evaluate the effectiveness and safety of fractional carbon dioxide (CO2) laser for the treatment of KP. Patients and Methods. A prospective, randomized, single-blinded, intraindividual comparative study was conducted on adult patients with KP. A single session of fractional CO2 laser was performed to one side of arm whereas the contralateral side served as control. Patients were scheduled for follow-up at 4 and 12 weeks after treatment. Clinical improvement was graded subjectively by blinded dermatologists. Patients rated treatment satisfaction at the end of the study. Results. Twenty patients completed the study. All patients stated that the laser treatment improved KP lesions. At 12-week follow-up, 30% of lesions on the laser-treated side had moderate to good improvement according to physicians' global assessment (p = 0.02). Keratotic papules and hyperpigmentation appeared to respond better than the erythematous component. Four patients with Fitzpatrick skin type V developed transient pigmentary alteration. Conclusions. Fractional CO2 laser treatment may be offered to patients with KP. Dark-skinned patients should be treated with special caution. PMID:27247936

  4. The Use of Text Messaging to Promote Physical Activity in Working Women: A Randomized Controlled Trial

    PubMed Central

    Gell, Nancy M.; Wadsworth, Danielle D.

    2014-01-01

    Background The study evaluated the effects of a text message intervention on physical activity in adult working women. Methods Eighty-seven participants were randomized to an intervention (n=41) or control group (n=46). Pedometer step counts and measures of self-efficacy were collected at baseline, 12 and 24 weeks. Intervention participants received approximately three text messages per week that were motivational, informational, and specific to performing physical activity. Results ANCOVA results showed a significant difference between groups for mean steps/day at 12 weeks (6540.0 vs. 5685.0, p=.01) and no significant difference at 24 weeks (6867.7 vs. 6189.0, p= .06). There was no change in mean step counts during or after the intervention compared to baseline. There was a significant difference between groups for mean self-efficacy scores at 12 weeks (68.5, vs. 60.3, p=.02) and at 24 weeks (67.3 vs. 59.0, p=.03). Conclusions Intervention participants had higher step counts after 12 and 24 weeks compared to a control group; however, the difference was significant only at the midpoint of the intervention and was attributable to a decrease in steps for the control group. Text messaging did not increase step counts but may be a cost effective tool for maintenance of physical activity behavior. PMID:25110303

  5. A Randomized Clinical Trial of Treatments for Symptomatic Convergence Insufficiency in Children

    PubMed Central

    2009-01-01

    Objective To compare home-based pencil push-ups (HBPP), home-based computer vergence/accommodative therapy and pencil push-ups (HBCVAT+), office-based vergence/accommodative therapy with home reinforcement (OBVAT), and office-based placebo therapy with home reinforcement (OBPT) as treatments for symptomatic convergence insufficiency (CI). Methods In a randomized clinical trial, 221 children 9 to 17 years with symptomatic CI were assigned to one of four treatments. Main Outcome Measures Convergence Insufficiency Symptom Survey (CISS) score after 12 weeks of treatment. Secondary outcomes were near point of convergence (NPC) and positive fusional vergence at near (PFV). Results After 12 weeks of treatment the OBVAT group’s CISS score (15.1) was statistically significantly lower than the HBCVAT+, HBPP, and OBPT groups’ scores of 21.3, 24.7, and 21.9, respectively (P < 0.001). The OBVAT group also demonstrated a significantly improved NPC and PFV compared with the other groups (P <= 0.005). A successful or improved outcome for the OBVAT, HBPP, HBCVAT+, and OBPT groups was found in 73%, 43%, 33%, and 35%, respectively. Conclusion Twelve weeks of OBVAT results in a significantly greater improvement in symptoms and clinical measures of NPC and PFV and a greater percentage of patients reaching pre-determined criteria of success when compared with HBPP, HBCVAT+, or OBPT. PMID:18852411

  6. Efficacy and safety of a dieckol-rich extract (AG-dieckol) of brown algae, Ecklonia cava, in pre-diabetic individuals: a double-blind, randomized, placebo-controlled clinical trial.

    PubMed

    Lee, Seung-Hong; Jeon, You-Jin

    2015-03-01

    The effects of 12 weeks of supplementation with a dieckol-rich extract (AG-dieckol) from brown algae, Ecklonia cava, on glycemic parameters, serum biochemistry, and hematology were investigated in this study. Eighty pre-diabetic male and female adults were enrolled in a randomized, double-blind, placebo-controlled trial with parallel-group design. Subjects were randomly allocated into two groups designated as placebo and AG-dieckol (1500 mg per day). Compared with the placebo group, the AG-dieckol group showed a significant decrease in postprandial glucose levels after 12 weeks. The AG-dieckol group also showed a significant decrease in insulin and C-peptide levels after 12 weeks, but there was no significant difference between the AG-dieckol and placebo groups. There were no significant adverse events related to the consumption of AG-dieckol, and biochemical and hematological parameters were maintained within the normal range during the intervention period. In conclusion, these results demonstrate that AG-dieckol supplementation significantly contributes to lowering postprandial hyperglycemia and in reducing insulin resistance. Furthermore, we believe that based on these results the consumption of phlorotannin-rich foods such as marine algae may be useful for the treatment of diabetes. PMID:25608849

  7. Random Item IRT Models

    ERIC Educational Resources Information Center

    De Boeck, Paul

    2008-01-01

    It is common practice in IRT to consider items as fixed and persons as random. Both, continuous and categorical person parameters are most often random variables, whereas for items only continuous parameters are used and they are commonly of the fixed type, although exceptions occur. It is shown in the present article that random item parameters…

  8. Randomization in robot tasks

    NASA Technical Reports Server (NTRS)

    Erdmann, Michael

    1992-01-01

    This paper investigates the role of randomization in the solution of robot manipulation tasks. One example of randomization is shown by the strategy of shaking a bin holding a part in order to orient the part in a desired stable state with some high probability. Randomization can be useful for mobile robot navigation and as a means of guiding the design process.

  9. Targeting condom distribution at high risk places increases condom utilization-evidence from an intervention study in Livingstone, Zambia

    PubMed Central

    2012-01-01

    Background The PLACE-method presumes that targeting HIV preventive activities at high risk places is effective in settings with major epidemics. Livingstone, Zambia, has a major HIV epidemic despite many preventive efforts in the city. A baseline survey conducted in 2005 in places where people meet new sexual partners found high partner turnover and unprotected sex to be common among guests. In addition, there were major gaps in on-site condom availability. This study aimed to assess the impact of a condom distribution and peer education intervention targeting places where people meet new sexual partners on condom use and sexual risk taking among people socializing there. Methods The 2005 baseline survey assessed the presence of HIV preventive activities and sexual risk taking in places where people meet new sexual partners in Livingstone. One township was selected for a non-randomised intervention study on condom distribution and peer education in high risk venues in 2009. The presence of HIV preventive activities in the venues during the intervention was monitored by an external person. The intervention was evaluated after one year with a follow-up survey in the intervention township and a comparison township. In addition, qualitative interviews and focus group discussions were conducted. Results Young people between 17-32 years of age were recruited as peer educators, and 40% were females. Out of 72 persons trained before the intervention, 38 quit, and another 11 had to be recruited. The percentage of venues where condoms were reported to always be available at least doubled in both townships, but was significantly higher in the intervention vs. the control venues in both surveys (84% vs. 33% in the follow-up). There was a reduction in reported sexual risk taking among guests socializing in the venues in both areas, but reporting of recent condom use increased more among people interviewed in the intervention (57% to 84%) than in the control community (55% to 68

  10. An intervention study demonstrates effects of MC4R genotype on boar taint and performances of growing-finishing pigs.

    PubMed

    Van den Broeke, A; Aluwé, M; Tuyttens, F A M; Ampe, B; Vanhaecke, L; Wauters, J; Janssens, S; Coussé, A; Buys, N; Millet, S

    2015-03-01

    The Asp298Asn polymorphism of the melanocortin-4 receptor (MC4R) in pigs is known to affect economically important traits such as growth rate and backfat thickness. We have assessed the possible use of this polymorphism as a molecular marker to perform genetic selection toward lower boar taint levels without compromising growth performance and carcass and meat quality in commercial boars and gilts. Homozygous boars and gilts of the AA genotype and GG genotype were compared in an intervention study with a 2 × 2 design to assess main effects and possible interactions between sex and genotype. The concentrations of the 3 boar taint compounds androstenone ( = 0.044), skatole ( = 0.049), and indole ( = 0.006) were significantly higher in fat of AA boars compared to GG boars. However, no effect on the sensory analysis of the fat samples could be observed. Between 20 and 115 kg BW, AA pigs showed higher ADFI than GG pigs ( < 0.001). An interaction between genotype and sex was observed for ADG ( = 0.044): AA boars had a significantly higher ADG than GG boars but there was no significant difference between the gilts. Daily lean meat gain tended to be higher in boars compared to gilts ( = 0.051), independent of genotype. Similarly, boars showed higher G:F compared to gilts ( < 0.001), without effect of genotype. Genotype and sex affected several carcass quality parameters but there was no interaction. Pigs of the AA genotype displayed a lower dressing percentage ( = 0.005), lower ham width ( = 0.024), lower muscle thickness ( = 0.011), and higher fat thickness ( < 0.001), resulting in a lower lean meat percentage ( < 0.001) in comparison with GG pigs. Gilts had a significantly higher dressing percentage ( < 0.001), higher muscle thickness ( < 0.001), higher ham width ( < 0.001), and lower ham angle ( < 0.001) compared to boars. Other than the boar taint compounds, meat quality was not affected by genotype. Pork of gilts was darker ( = 0.014) and less exudative during

  11. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials.

    PubMed

    Berry-Kravis, Elizabeth; Des Portes, Vincent; Hagerman, Randi; Jacquemont, Sébastien; Charles, Perrine; Visootsak, Jeannie; Brinkman, Marc; Rerat, Karin; Koumaras, Barbara; Zhu, Liansheng; Barth, Gottfried Maria; Jaecklin, Thomas; Apostol, George; von Raison, Florian

    2016-01-13

    Fragile X syndrome (FXS), the most common cause of inherited intellectual disability and autistic spectrum disorder, is typically caused by transcriptional silencing of the X-linked FMR1 gene. Work in animal models has described altered synaptic plasticity, a result of the up-regulation of metabotropic glutamate receptor 5 (mGluR5)-mediated signaling, as a putative downstream effect. Post hoc analysis of a randomized, placebo-controlled, crossover phase 2 trial suggested that the selective mGluR5 antagonist mavoglurant improved behavioral symptoms in FXS patients with completely methylated FMR1 genes. We present the results of two phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of mavoglurant in FXS, designed to confirm this result in adults (n = 175, aged 18 to 45 years) and adolescents (n = 139, aged 12 to 17 years). In both trials, participants were stratified by methylation status and randomized to receive mavoglurant (25, 50, or 100 mg twice daily) or placebo over 12 weeks. Neither of the studies achieved the primary efficacy end point of improvement on behavioral symptoms measured by the Aberrant Behavior Checklist-Community Edition using the FXS-specific algorithm (ABC-C(FX)) after 12 weeks of treatment with mavoglurant. The safety and tolerability profile of mavoglurant was as previously described, with few adverse events. Therefore, under the conditions of our study, we could not confirm the mGluR theory of FXS nor the ability of the methylation state of the FMR1 promoter to predict mavoglurant efficacy. Preclinical results suggest that future clinical trials might profitably explore initiating treatment in a younger population with longer treatment duration and longer placebo run-ins and identifying new markers to better assess behavioral and cognitive benefits. PMID:26764156

  12. Evaluation of a crataegus-based multiherb formula for dyslipidemia: a randomized, double-blind, placebo-controlled clinical trial.

    PubMed

    Hu, Miao; Zeng, Weiwei; Tomlinson, Brian

    2014-01-01

    Background. We for the first time examined the effects of a multiherb formula containing Crataegus pinnatifida (1 g daily), Alisma orientalis, Stigma maydis, Ganoderma lucidum, Polygonum multiflorum, and Morus alba on plasma lipid and glucose levels in Chinese patients with dyslipidemia. Methods. In this randomized, double-blind, placebo-controlled study, 42 patients were randomized at a ratio of 1 : 1 to receive the herbal formula or placebo for 12 weeks and 40 patients completed the study. Lipid profiles, glucose, glycated haemoglobin (HbA1c), and laboratory safety parameters were performed before and after treatment. Results. The difference in the changes in low-density lipoprotein cholesterol (LDL-C) levels between placebo and active treatment (-9%) was significantly (P < 0.05) better with active treatment. HbA1c levels significantly decreased by -3.9% in the active treatment group, but the change was not significantly different from that with placebo (-1.1%) (P = 0.098). There were no apparent adverse effects or changes in laboratory safety parameters with either treatment. Conclusions. The multiherb formula had mild beneficial effects on plasma LDL-C after 12-weeks treatment in subjects with dyslipidemia without any noticeable adverse effects. PMID:24834096

  13. Progressive Change in Joint Degeneration in Patients with Knee or Hip Osteoarthritis Treated with Fentanyl in a Randomized Trial

    PubMed Central

    Fujii, Tatsuya; Takana, Koshi; Orita, Sumihisa; Inoue, Gen; Ochiai, Nobuyasu; Kuniyoshi, Kazuki; Aoki, Yasuchika; Ishikawa, Tetsuhiro; Miyagi, Masayuki; Kamoda, Hiroto; Suzuki, Miyako; Sakuma, Yoshihiro; Kubota, Gou; Oikawa, Yasuhiro; Inage, Kazuhide; Sainoh, Takeshi; Sato, Jun; Yamauchi, Kazuyo; Toyone, Tomoaki; Nakamura, Junichi; Kishida, Shunji; Takahashi, Kazuhisa

    2014-01-01

    Purpose Opioids improve pain from knee and hip osteoarthritis (OA) and decrease the functional impairment of patients. However, there is a possibility that opioids induce analgesia and suppress the physiological pain of OA in patients, thereby inducing the progression of OA changes in these patients. The purpose of the current study was to investigate the possibility of progressive changes in OA among patients using opioids. Materials and Methods Two hundred knee or hip OA patients were evaluated in the current prospective, randomized, active-controlled study. Patients were randomized 1:1:1 into three parallel treatment groups: loxoprofen, tramadol/acetaminophen, and transdermal fentanyl groups. Medication was administered for 12 weeks. Pain scores and progressive OA changes on X-ray films were evaluated. Results Overall, pain relief was obtained by all three groups. Most patients did not show progressive OA changes; however, 3 patients in the transdermal fentanyl group showed progressive OA changes during the 12 weeks of treatment. These 3 patients used significantly higher doses than others in the transdermal fentanyl group. Additionally, the average pain score for these 3 patients was significantly lower than the average pain score for the other patients in the transdermal fentanyl group. Conclusion Fentanyl may induce progressive changes in knee or hip OA during a relatively short period, compared with oral Non-Steroidal Anti-Inflammatory Drugs or tramadol. PMID:25048500

  14. Mangiferin supplementation improves serum lipid profiles in overweight patients with hyperlipidemia: a double-blind randomized controlled trial

    PubMed Central

    Na, Lixin; Zhang, Qiao; Jiang, Shuo; Du, Shanshan; Zhang, Wei; Li, Ying; Sun, Changhao; Niu, Yucun

    2015-01-01

    Our previous studies have shown that mangiferin decreased serum triglycerides and free fatty acids (FFAs) by increasing FFAs oxidation in both animal and cell experiments. This study sought to evaluate the effects of mangiferin on serum lipid profiles in overweight patients with hyperlipidemia. Overweight patients with hyperlipidemia (serum triglyceride ≥ 1.70 mmol/L, and total cholesterol ≥ 5.2 mmol/L) were included in this double-blind randomized controlled trial. Participants were randomly allocated to groups, either receiving mangiferin (150 mg/day) or identical placebo for 12 weeks. The lipid profile and serum levels of mangiferin, glucose, L-carnitine, β-hydroxybutyrate, and acetoacetate were determined at baseline and 12 weeks. A total of 97 participants completed the trial. Compared with the placebo control, mangiferin supplementation significantly decreased the serum levels of triglycerides and FFAs, and insulin resistance index. Mangiferin supplementation also significantly increased the serum levels of mangiferin, high-density lipoprotein cholesterol, L-carnitine, β-hydroxybutyrate, and acetoacetate, and increased lipoprotein lipase activity. However, there were no differences in the serum levels of total cholesterol, low-density lipoprotein cholesterol, serum glucose, and insulin between groups. Mangiferin supplementation could improve serum lipid profiles by reducing serum triglycerides and FFAs in overweight patients with hyperlipidemia, partly due to the promotion of FFAs oxidation. PMID:25989216

  15. Comparative Effectivenesses of Pulsed Radiofrequency and Transforaminal Steroid Injection for Radicular Pain due to Disc Herniation: a Prospective Randomized Trial

    PubMed Central

    2016-01-01

    Transforaminal Epidural steroid injections (TFESI) have been widely adopted to alleviate and control radicular pain in accord with current guidelines. However, sometimes repeated steroid injections have adverse effects, and thus, this prospective randomized trial was undertaken to compare the effectivenesses of pulsed radiofrequency (PRF) administered to a targeted dorsal root ganglion (DRG) and TFESI for the treatment of radicular pain due to disc herniation. Subjects were recruited when first proved unsuccessful (defined as a score of > 4 on a visual analogue scale (VAS; 0-10 mm) and of > 30% according to the Oswestry Disability Index (ODI) or the Neck Disability Index (NDI)). Forty-four patients that met the inclusion criteria were enrolled. The 38 subjects were randomly assigned to receive either PRF (PRF group; n = 19) or additional TFESI (TFESI group; n = 19) and were then followed for 2, 4, 8, and 12 weeks. To evaluate pain intensity were assessed by VAS. ODI and NDI were applied to evaluate functional disability. Mean VAS scores for cervical and lumbar radicular pain were significantly lower 12 weeks after treatment in both study groups. NDI and ODI scores also declined after treatment. However, no statistically significant difference was observed between the PRF and TFESI groups in terms of VAS, ODI, or NDI scores at any time during follow-up. PRF administered to a DRG might be as effective as TFESI in terms of attenuating radicular pain caused by disc herniation, and its use would avoid the adverse effects of steroid. PMID:27478346

  16. Comparative Effectivenesses of Pulsed Radiofrequency and Transforaminal Steroid Injection for Radicular Pain due to Disc Herniation: a Prospective Randomized Trial.

    PubMed

    Lee, Dong Gyu; Ahn, Sang-Ho; Lee, Jungwon

    2016-08-01

    Transforaminal Epidural steroid injections (TFESI) have been widely adopted to alleviate and control radicular pain in accord with current guidelines. However, sometimes repeated steroid injections have adverse effects, and thus, this prospective randomized trial was undertaken to compare the effectivenesses of pulsed radiofrequency (PRF) administered to a targeted dorsal root ganglion (DRG) and TFESI for the treatment of radicular pain due to disc herniation. Subjects were recruited when first proved unsuccessful (defined as a score of > 4 on a visual analogue scale (VAS; 0-10 mm) and of > 30% according to the Oswestry Disability Index (ODI) or the Neck Disability Index (NDI)). Forty-four patients that met the inclusion criteria were enrolled. The 38 subjects were randomly assigned to receive either PRF (PRF group; n = 19) or additional TFESI (TFESI group; n = 19) and were then followed for 2, 4, 8, and 12 weeks. To evaluate pain intensity were assessed by VAS. ODI and NDI were applied to evaluate functional disability. Mean VAS scores for cervical and lumbar radicular pain were significantly lower 12 weeks after treatment in both study groups. NDI and ODI scores also declined after treatment. However, no statistically significant difference was observed between the PRF and TFESI groups in terms of VAS, ODI, or NDI scores at any time during follow-up. PRF administered to a DRG might be as effective as TFESI in terms of attenuating radicular pain caused by disc herniation, and its use would avoid the adverse effects of steroid. PMID:27478346

  17. Medical yoga for patients with stress-related symptoms and diagnoses in primary health care: a randomized controlled trial.

    PubMed

    Köhn, Monica; Persson Lundholm, Ulla; Bryngelsson, Ing-Liss; Anderzén-Carlsson, Agneta; Westerdahl, Elisabeth

    2013-01-01

    An increasing number of patients are suffering from stress-related symptoms and diagnoses. The purpose of this study was to evaluate the medical yoga treatment in patients with stress-related symptoms and diagnoses in primary health care. A randomized controlled study was performed at a primary health care centre in Sweden from March to June, 2011. Patients were randomly allocated to a control group receiving standard care or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age of 53 ± 12 years were included. General stress level (measured using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)), and overall health status (Euro Quality of Life VAS (EQ-VAS)) were measured before and after 12 weeks. Patients assigned to the Yoga group showed significantly greater improvements on measures of general stress level (P < 0.000), anxiety (P < 0.019), and overall health status (P < 0.018) compared to controls. Treatment with medical yoga is effective in reducing levels of stress and anxiety in patients with stress-related symptoms in primary health care. PMID:23533465

  18. Quantum random number generation

    SciTech Connect

    Ma, Xiongfeng; Yuan, Xiao; Cao, Zhu; Zhang, Zhen; Qi, Bing

    2016-01-01

    Here, quantum physics can be exploited to generate true random numbers, which play important roles in many applications, especially in cryptography. Genuine randomness from the measurement of a quantum system reveals the inherent nature of quantumness — coherence, an important feature that differentiates quantum mechanics from classical physics. The generation of genuine randomness is generally considered impossible with only classical means. Based on the degree of trustworthiness on devices, quantum random number generators (QRNGs) can be grouped into three categories. The first category, practical QRNG, is built on fully trusted and calibrated devices and typically can generate randomness at a high speed by properly modeling the devices. The second category is self-testing QRNG, where verifiable randomness can be generated without trusting the actual implementation. The third category, semi-self-testing QRNG, is an intermediate category which provides a tradeoff between the trustworthiness on the device and the random number generation speed.

  19. Quantum random number generation

    DOE PAGESBeta

    Ma, Xiongfeng; Yuan, Xiao; Cao, Zhu; Zhang, Zhen; Qi, Bing

    2016-06-28

    Here, quantum physics can be exploited to generate true random numbers, which play important roles in many applications, especially in cryptography. Genuine randomness from the measurement of a quantum system reveals the inherent nature of quantumness -- coherence, an important feature that differentiates quantum mechanics from classical physics. The generation of genuine randomness is generally considered impossible with only classical means. Based on the degree of trustworthiness on devices, quantum random number generators (QRNGs) can be grouped into three categories. The first category, practical QRNG, is built on fully trusted and calibrated devices and typically can generate randomness at amore » high speed by properly modeling the devices. The second category is self-testing QRNG, where verifiable randomness can be generated without trusting the actual implementation. The third category, semi-self-testing QRNG, is an intermediate category which provides a tradeoff between the trustworthiness on the device and the random number generation speed.« less

  20. Efficacy and effectiveness of infant vaccination against chronic hepatitis B in the Gambia Hepatitis Intervention Study (1986–90) and in the nationwide immunisation program

    PubMed Central

    2014-01-01

    Background Gambian infants were not routinely vaccinated against hepatitis B virus (HBV) before 1986. During 1986–90 the Gambia Hepatitis Intervention Study (GHIS) allocated 125,000 infants, by area, to vaccination or not and thereafter all infants were offered the vaccine through the nationwide immunisation programme. We report HBV serology from samples of GHIS vaccinees and unvaccinated controls, and from children born later. Methods During 2007–08, 2670 young adults born during the GHIS (1986-90) were recruited from 80 randomly selected villages and four townships. Only 28% (753/2670) could be definitively linked to their infant HBV vaccination records (255 fully vaccinated, 23 partially vaccinated [1–2 doses], 475 not vaccinated). All were tested for current HBV infection (HBV surface antigen [HBsAg]) and, if HBsAg-negative, evidence of past infection (HBV core-protein antibody [anti-HBc]). HBsAg-positive samples (each with two age- and sex-matched HBsAg-negative samples) underwent liver function tests. In addition, 4613 children born since nationwide vaccination (in 1990-2007) were tested for HBsAg. Statistical analyses ignore clustering. Results Comparing fully vaccinated vs unvaccinated GHIS participants, current HBV infection was 0.8% (2/255) vs 12.4% (59/475), p < 0.0001, suggesting 94% (95% CI 77-99%) vaccine efficacy. Among unvaccinated individuals, the prevalence was higher in males (p = 0.015) and in rural areas (p = 0.009), but adjustment for this did not affect estimated vaccine efficacy. Comparing fully vaccinated vs unvaccinated participants, anti-HBc was 27.4% (70/255) vs 56.0% (267/475), p < 0.00001. Chronic active hepatitis was not common: the proportion of HBsAg-positive subjects with abnormal liver function tests (ALT > 2 ULN) was 4.1%, compared with 0.2% in those HBsAg-negative. The prevalence of antibodies to hepatitis C virus was low (0.5%, 13/2592). In children born after the end of GHIS, HBsAg prevalence has

  1. Special Issue on "Analytical Methods for Oxidized Biomolecules and Antioxidants" The use of isoprostanoids as biomarkers of oxidative damage, and their role in human dietary intervention studies.

    PubMed

    Galano, J-M; Lee, Y Y; Durand, T; Lee, J C-Y

    2015-05-01

    Isoprostanoids are a group of non-enzymatic oxidized lipids from polyunsaturated fatty acids. They are commonly used as biomarkers for oxidative damage, to assess in vivo lipid peroxidation in diseases related to the vascular system and neurodegeneration. Currently, there is a mismatch with the outcome in the use of these biomarkers in intervention studies, particularly when testing the effect of antioxidants such as vitamins C and E, or zinc, or a cocktail of these, with other food components. Much of this is because the biomarkers, the method of measurement, and the duration of supplementation are unsuitable. In this review, we will highlight the formation of isoprostanoids from their respective fatty acids, and their application as biomarkers for oxidative damage in vivo, considering human dietary intervention studies evaluating plasma and urine, using mass spectrometry techniques. PMID:25734631

  2. Progesterone Reduces Cocaine Use in Postpartum Women with a Cocaine Use Disorder: A Randomized,Double-Blind Study

    PubMed Central

    Yonkers, Kimberly Ann; Forray, Ariadna; Nich, Charla; Carroll, Kathleen M.; Hine, Cristine; Merry, Brian C.; Shaw, Howard; Shaw, Julia; Sofuoglu, Mehmet

    2014-01-01

    Background Progesterone modulates multiple brain functions implicated in the pathogenesis ofdrug addiction. During high endogenous progesterone states, women reduce use of cocaine. We sought to test whether progesterone replacement reduces cocaine use in postpartum women with a cocaine use disorder (CUD). Methods A 12-week, double-blind, parallel, randomized, placebo-controlled pilot trial with a 3-month post trial follow-up. 25 women within 12 weeks of deliverywere randomized to placeboand 25 to100 mgs of oral micronized progesterone, administered twice daily. Participants were recruited from obstetrical clinics. Randomization and allocation were performed by the study biostatistician. Attrition was 18% and the analysis included all50participants. Outcomes were self-reported days of cocaine use and positive urine toxicology assays for cocaine metabolites. Findings Participants randomized to placebo compared to progesterone had increased likelihood of cocaine use per week (RR=1·19; 95% confidence interval (CI)=1·05 to 1·36; p<0·01). At the three-month post trial visit the difference between groups was not significant (Likelihood RatioΧ2 =5·16; P=·08). There were no group differences in rates of submission of a positive urine test. A post hoc analysis showed a higher rate of relapse for participants randomized to placebo (HR=4·71; 95% CI= 1·09 to 20·5). We did not observe groups differences in the rate of adverse events. Interpretation These preliminary findings support the promise of progesterone treatment in postpartum women with a CUD and could constitute a therapeutic break through. Funding US National Institute on Drug Abuse; Veterans Administration PMID:25328863

  3. Aerobic endurance training versus relaxation training in patients with migraine (ARMIG): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Migraine is one of the most frequent headache diseases and impairs patients’ quality of life. Up to now, many randomized studies reported efficacy of prophylactic therapy with medications such as beta-blockers or anti-epileptic drugs. Non-medical treatment, like aerobic endurance training, is considered to be an encouraging alternative in migraine prophylaxis. However, there is still a lack of prospective, high-quality randomized trials. We therefore designed a randomized controlled trial to evaluate the efficacy of aerobic endurance training versus relaxation training in patients with migraine (ARMIG). Methods This is a single-center, open-label, prospective, randomized trial. Sixty participants with migraine are randomly allocated to either endurance training or a relaxation group. After baseline headache diary documentation over at least 4 weeks, participants in the exercise group will start moderate aerobic endurance training under a sport therapist’s supervision at least 3 times a week over a 12-week period. The second group will perform Jacobson’s progressive muscle relaxation training guided by a trained relaxation therapist, also at least 3 times a week over a 12-week period. Both study arms will train in groups of up to 10 participants. More frequent individual training is possible. The follow-up period will be 12 weeks after the training period. The general state of health, possible state of anxiety or depression, impairments due to the headache disorder, pain-related disabilities, the headache-specific locus of control, and the motor fitness status are measured with standardized questionnaires. Discussion The study design is adequate to generate meaningful results. The trial will be helpful in gaining important data on exercise training for non-medical migraine prophylaxis. Trial registration The trial is registered at ClinicalTrials.gov: NCT01407861. PMID:22540391

  4. Comparison of efficacy and safety of choline fenofibrate (fenofibric acid) to micronized fenofibrate in patients of mixed dyslipidemia: A randomized, open-label, multicenter clinical trial in Indian population

    PubMed Central

    Patel, Piyush; Barkate, Hanmant

    2016-01-01

    Introduction: Choline fenofibrate is a newly developed choline salt of fenofibric acid, which is more hydrophilic than fenofibrate. This study was initiated to evaluate the safety and efficacy of choline fenofibrate in comparison to micronized fenofibrate among Indian patients of mixed dyslipidemia. Methods: A multicenter, open-label, randomized, active controlled, comparative, parallel group study was conducted at around 10 centers spread all across the country. Mixed dyslipidemia patients (serum triglycerides [TG] levels between 150 and 500 mg/dl), aged 18–70 years and taking stable statin dose for 8 weeks were randomized to choline fenofibrate 135 mg delayed release tablets and micronized fenofibrate 160 mg tablets once daily for 12 weeks. The primary endpoint of the study was percentage change in serum TG level at the end of 12 weeks. Results: A total of 226 patients were enrolled in this study, of which 116 patients were administered choline fenofibrate and 110 patients were administered micronized fenofibrate. At the end of 12 weeks, there was a significant reduction in TG level (34.24% in choline fenofibrate group and 38.13% reduction in micronized fenofibrate group). However, the difference between group was not statistically different (P = 0.471). Similarly, there was a significant increase in high-density lipoprotein cholesterol at the end of 12 weeks (10% increase in choline fenofibrate group and 9% increase in micronized fenofibrate group); but the difference between the group was not statistically significant (P = 0.598). Both the treatment was safe and well tolerated. Conclusion: Choline fenofibrate delayed release 135 mg is as safe and effective as 160 mg of micronized fenofibrate in Indian patients with mixed dyslipidemia. PMID:26904471

  5. Blocked randomization with randomly selected block sizes.

    PubMed

    Efird, Jimmy

    2011-01-01

    When planning a randomized clinical trial, careful consideration must be given to how participants are selected for various arms of a study. Selection and accidental bias may occur when participants are not assigned to study groups with equal probability. A simple random allocation scheme is a process by which each participant has equal likelihood of being assigned to treatment versus referent groups. However, by chance an unequal number of individuals may be assigned to each arm of the study and thus decrease the power to detect statistically significant differences between groups. Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block. Yet still, the allocation process may be predictable, for example, when the investigator is not blind and the block size is fixed. This paper provides an overview of blocked randomization and illustrates how to avoid selection bias by using random block sizes. PMID:21318011

  6. A Mobile Health Lifestyle Program for Prevention of Weight Gain in Young Adults (TXT2BFiT): Nine-Month Outcomes of a Randomized Controlled Trial

    PubMed Central

    Partridge, Stephanie Ruth; McGeechan, Kevin; Balestracci, Kate; Hebden, Lana; Wong, Annette; Phongsavan, Philayrath; Denney-Wilson, Elizabeth; Harris, Mark F; Bauman, Adrian

    2016-01-01

    Background The unprecedented rise in obesity among young adults, who have limited interaction with health services, has not been successfully abated. Objective The objective of this study was to assess the maintenance outcomes of a 12-week mHealth intervention on prevention of weight gain in young adults and lifestyle behaviors at 9 months from baseline. Methods A two-arm, parallel, randomized controlled trial (RCT) with subjects allocated to intervention or control 1:1 was conducted in a community setting in Greater Sydney, Australia. From November 2012 to July 2014, 18- to 35-year-old overweight individuals with a body mass index (BMI) of 25-31.99 kg/m2 and those with a BMI ≥ 23 kg/m2 and a self-reported weight gain of ≥ 2 kg in the past 12 months were recruited. A 12-week mHealth program “TXT2BFiT” was administered to the intervention arm. This included 5 coaching calls, 96 text messages, 12 emails, apps, and downloadable resources from the study website. Lifestyle behaviors addressed were intake of fruits, vegetables, sugar-sweetened beverages (SSBs), take-out meals, and physical activity. The control group received 1 phone call to introduce them to study procedures and 4 text messages over 12 weeks. After 12 weeks, the intervention arm received 2 further coaching calls, 6 text messages, and 6 emails with continued access to the study website during 6-month follow-up. Control arm received no further contact. The primary outcome was weight change (kg) with weight measured at baseline and at 12 weeks and self-report at baseline, 12 weeks, and 9 months. Secondary outcomes were change in physical activity (metabolic equivalent of task, MET-mins) and categories of intake for fruits, vegetables, SSBs, and take-out meals. These were assessed via Web-based surveys. Results Two hundred and fifty young adults enrolled in the RCT. Intervention participants weighed less at 12 weeks compared with controls (model β=−3.7, 95% CI −6.1 to −1.3) and after 9 months

  7. Methylation patterns in sentinel genes in peripheral blood cells of heavy smokers: Influence of cruciferous vegetables in an intervention study.

    PubMed

    Scoccianti, Chiara; Ricceri, Fulvio; Ferrari, Pietro; Cuenin, Cyrille; Sacerdote, Carlotta; Polidoro, Silvia; Jenab, Mazda; Hainaut, Pierre; Vineis, Paolo; Herceg, Zdenko

    2011-09-01

    Changes in DNA methylation patterns are a hallmark of tobacco-induced carcinogenesis. We have conducted a randomized 4-week intervention trial to investigate the effects of three dietary regimens to modify DNA methylation patterns in peripheral white blood cells of heavy smokers. A group of 88 smokers were randomly assigned to and distributed among three diets, including (1) normal isocaloric diet (balanced in fruits and vegetables), according to international guidelines; (2) a diet enriched in flavonoids and isothiocyanates (particularly cruciferous vegetables); (3) a regimen consisting of diet 1 supplemented with flavonoids (green tea and soy products). Methylation patterns were analyzed by pyrosequencing in LINE1 (Long Interspersed DNA Elements), RASSF1A, ARF and CDKN2a (tumor suppressor genes), MLH1 (mismatch DNA repair) and MTHFR (folate metabolism). Three distinct patterns of methylation were observed. In LINE1, methylation showed a small but reproducible increase with all three regimens. MTHFR was constitutively methylated with no significant modulation by diets. The four other loci showed low basal levels of methylation with no substantial change after intervention. These data suggest that the isocaloric diet may stabilize global epigenetic (LINE1 DNA methylation) patterns in peripheral white blood cells but does not provide evidence for methylation changes in specific genes associated with this short-term dietary intervention. PMID:21822058

  8. Predictors of remission in depression to individual and combined treatments (PReDICT): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Limited controlled data exist to guide treatment choices for clinicians caring for patients with major depressive disorder (MDD). Although many putative predictors of treatment response have been reported, most were identified through retrospective analyses of existing datasets and very few have been replicated in a manner that can impact clinical practice. One major confound in previous studies examining predictors of treatment response is the patient’s treatment history, which may affect both the predictor of interest and treatment outcomes. Moreover, prior treatment history provides an important source of selection bias, thereby limiting generalizability. Consequently, we initiated a randomized clinical trial designed to identify factors that moderate response to three treatments for MDD among patients never treated previously for the condition. Methods/design Treatment-naïve adults aged 18 to 65 years with moderate-to-severe, non-psychotic MDD are randomized equally to one of three 12-week treatment arms: (1) cognitive behavior therapy (CBT, 16 sessions); (2) duloxetine (30–60 mg/d); or (3) escitalopram (10–20 mg/d). Prior to randomization, patients undergo multiple assessments, including resting state functional magnetic resonance imaging (fMRI), immune markers, DNA and gene expression products, and dexamethasone-corticotropin-releasing hormone (Dex/CRH) testing. Prior to or shortly after randomization, patients also complete a comprehensive personality assessment. Repeat assessment of the biological measures (fMRI, immune markers, and gene expression products) occurs at an early time-point in treatment, and upon completion of 12-week treatment, when a second Dex/CRH test is also conducted. Patients remitting by the end of this acute treatment phase are then eligible to enter a 21-month follow-up phase, with quarterly visits to monitor for recurrence. Non-remitters are offered augmentation treatment for a second 12-week course of

  9. Executive function in adults with attention-deficit/hyperactivity disorder during treatment with atomoxetine in a randomized, placebo-controlled, withdrawal study.

    PubMed

    Adler, Lenard; Tanaka, Yoko; Williams, David; Trzepacz, Paula T; Goto, Taro; Allen, Albert J; Escobar, Rodrigo; Upadhyaya, Himanshu P

    2014-08-01

    We assessed the executive function in adults with attention-deficit/hyperactivity disorder (ADHD) during atomoxetine treatment in a randomized withdrawal trial. Responders (Conners' ADHD Rating Scale-Investigator Rated: Screening Version [adult prompts] ≥30% reduction from baseline and Clinical Global Impression Scale-ADHD Severity score ≤3) to open-label atomoxetine (40-100 mg/d, 12 weeks) entered a 37-week double-blind maintenance period. Patients who maintained response (double-blind atomoxetine for 12 weeks) were randomized 1:1 to atomoxetine (80-100 mg/d, n = 266) or placebo (n = 258) for 25 weeks (total duration, 1 year). Patients and investigators were blinded to response criteria and randomization timing. Change in executive function was assessed with the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Self-Report and Informant T scores from the randomization to the last-observation-carried-forward postrandomization week 25 (after week 17). Of the enrolled patients (n = 2017; mean age, 33.2 years; male, 58.7%), 524 responders were randomized. During open-label atomoxetine, subscales and individual items on both BRIEF-A questionnaires showed significant improvement (P < 0.001). After randomization, the following T scores improved significantly (P ≤ 0.05) with patients in the atomoxetine group versus those in the placebo group: global executive composite, behavioral regulation, and metacognition indices; plan/organize, working memory, inhibit, task monitor and shift (both BRIEF-A questionnaires), emotional control and organization of materials (BRIEF-A Informant), and initiate (BRIEF-A Self-Report). Atomoxetine significantly improved the executive function compared with placebo, which was maintained for 25 weeks or more; the executive function of patients in the placebo group worsened but did not return to baseline levels after randomization. PMID:24977716

  10. Creating a representative sample of small manufacturing businesses for an integrated workplace safety and smoking cessation intervention study

    PubMed Central

    Egelhoff, Claudia; Katz, Marc; Brosseau, Lisa M; Hennrikus, Deborah

    2015-01-01

    Objectives We aimed to recruit a representative sample of small manufacturing businesses (20-150 employees) for a group-randomized trial of an integrated workplace safety and smoking cessation program. Methods An initial sample was drawn from commercial databases, screened for duplicates or ineligibility and contacted. Participating and non-participating businesses were compared on size, location and type. Employee demographics of participating businesses were compared to a U.S. Census Bureau database of similar businesses. Results From an initial sample of 2716 businesses, 328 were eligible and 47 (9%) agreed to participate. Participating companies tended to be larger. Employees were similar to employees in the Census Bureau dataset. Conclusions Considerable resources were required to identify eligible businesses; commercial databases are the best resource but may not be comprehensive or current. The sample appeared to be representative of small manufacturing businesses in the study region. PMID:26147544

  11. Effect of Kaempferia parviflora Extract on Physical Fitness of Soccer Players: A Randomized Double-Blind Placebo-Controlled Trial

    PubMed Central

    Promthep, Kreeta; Eungpinichpong, Wichai; Sripanidkulchai, Bungorn; Chatchawan, Uraiwan

    2015-01-01

    Background Physical fitness is a fundamental prerequisite for soccer players. Kaempferia parviflora is an herbal plant that has been used in some Asian athletes with the belief that it might prevent fatigue and improve physical fitness. This study aimed to determine the effects of Kaempferia parviflora on the physical fitness of soccer players. Material/Methods Sixty soccer players who routinely trained at a sports school participated in a double-blind placebo-controlled trial and were randomly allocated to the treatment group or the placebo group. The participants in both groups were given either 180 mg of Kaempferia parviflora extract in capsules or a placebo once daily for 12 weeks. Baseline data were collected using the following 6 tests of physical performance: a sit-and-reach test, a hand grip strength test, a back-and-leg strength test, a 40-yard technical test, a 50-metre sprint test, and a cardiorespiratory fitness test. All of the tests were performed every 4 weeks throughout the 12-week study period. Results The study showed that after treatment with Kaempferia parviflora, the right-hand grip strength was significantly increased at weeks 4, 8, and 12. The left-hand grip strength was significantly increased at week 8. However, the back-and-leg strength, the 40-yard technical test, the sit-and-reach test, the 50-metre sprint test, and the cardiorespiratory fitness test results of the treatment group were not significantly different from those of the placebo group. Conclusions Taking Kaempferia parviflora supplements for 12 weeks may significantly enhance some physical fitness components in soccer players. PMID:25957542

  12. Effects of Cardiovascular Disease Risk Communication for Patients With Type 2 Diabetes on Risk Perception in a Randomized Controlled Trial

    PubMed Central

    Welschen, Laura M.C.; Bot, Sandra D.M.; Kostense, Piet J.; Dekker, Jacqueline M.; Timmermans, Daniëlle R.M.; van der Weijden, Trudy; Nijpels, Giel

    2012-01-01

    OBJECTIVE Patients with type 2 diabetes mellitus (T2DM) underestimate their risk of developing severe complications, and they do not always understand the risk communication by their caregivers. The aim of this study was to investigate the effects of an intervention focused on the communication of the absolute 10-year risk of developing cardiovascular disease (CVD) in patients with T2DM. RESEARCH DESIGN AND METHODS A randomized controlled trial was performed in T2DM patients newly referred to the Diabetes Care System (DCS) West-Friesland, a managed-care system in the Netherlands. The intervention group (n = 131) received a six-step CVD risk communication. Control subjects (n = 130) received standard managed care. The primary outcome measure was appropriateness of risk perception (difference between actual CVD risk calculated by the UK Prospective Diabetes Study risk engine and risk perception). Secondary outcome measures were illness perceptions, attitude and intention to change behavior, satisfaction with the communication, and anxiety and worry about CVD risk. Patients completed questionnaires at baseline, at 2 weeks (immediately after the intervention), and at 12 weeks. RESULTS Appropriateness of risk perception improved between the intervention and control groups at 2 weeks. This effect disappeared at 12 weeks. No effects were found on illness perceptions, attitude and intention to change behavior, or anxiety and worry about CVD risk. Patients in the intervention group were significantly more satisfied with the communication. CONCLUSIONS This risk communication method improved patients’ risk perception at 2 weeks but not at 12 weeks. Negative effects were not found, as patients did not become anxious or worried after the CVD risk communication. PMID:22923669

  13. Effects of sodium and potassium supplementation on blood pressure and arterial stiffness: a fully controlled dietary intervention study.

    PubMed

    Gijsbers, L; Dower, J I; Mensink, M; Siebelink, E; Bakker, S J L; Geleijnse, J M

    2015-10-01

    We performed a randomised, placebo-controlled, crossover study to examine the effects of sodium and potassium supplementation on blood pressure (BP) and arterial stiffness in untreated (pre)hypertensive individuals. During the study, subjects were on a fully controlled diet that was relatively low in sodium and potassium. After a 1-week run-in period, subjects received capsules with supplemental sodium (3 g d(-1), equals 7.6 g d(-1) of salt), supplemental potassium (3 g d(-1)) or placebo, for 4 weeks each, in random order. Fasting office BP, 24-h ambulatory BP and measures of arterial stiffness were assessed at baseline and every 4 weeks. Of 37 randomized subjects, 36 completed the study. They had a mean pre-treatment BP of 145/81 mm Hg and 69% had systolic BP ⩾140 mm Hg. Sodium excretion was increased by 98 mmol per 24 h and potassium excretion by 63 mmol per 24 h during active interventions, compared with placebo. During sodium supplementation, office BP was significantly increased by 7.5/3.3 mm Hg, 24-h BP by 7.5/2.7 mm Hg and central BP by 8.5/3.6 mm Hg. During potassium supplementation, 24-h BP was significantly reduced by 3.9/1.6 mm Hg and central pulse pressure by 2.9 mm Hg. Pulse wave velocity and augmentation index were not significantly affected by sodium or potassium supplementation. In conclusion, increasing the intake of sodium caused a substantial increase in BP in subjects with untreated elevated BP. Increased potassium intake, on top of a relatively low-sodium diet, had a beneficial effect on BP. Arterial stiffness did not materially change during 4-week interventions with sodium or potassium. PMID:25673113

  14. Review: Assessment of completeness of reporting in intervention studies using livestock: an example from pain mitigation interventions in neonatal piglets.

    PubMed

    O'Connor, A; Anthony, R; Bergamasco, L; Coetzee, J F; Dzikamunhenga, R S; Johnson, A K; Karriker, L A; Marchant-Forde, J N; Martineau, G P; Millman, S T; Pajor, E A; Rutherford, K; Sprague, M; Sutherland, M A; von Borell, E; Webb, S R

    2016-04-01

    Accurate and complete reporting of study methods, results and interpretation are essential components for any scientific process, allowing end-users to evaluate the internal and external validity of a study. When animals are used in research, excellence in reporting is expected as a matter of continued ethical acceptability of animal use in the sciences. Our primary objective was to assess completeness of reporting for a series of studies relevant to mitigation of pain in neonatal piglets undergoing routine management procedures. Our second objective was to illustrate how authors can report the items in the Reporting guidElines For randomized controLled trials for livEstoCk and food safety (REFLECT) statement using examples from the animal welfare science literature. A total of 52 studies from 40 articles were evaluated using a modified REFLECT statement. No single study reported all REFLECT checklist items. Seven studies reported specific objectives with testable hypotheses. Six studies identified primary or secondary outcomes. Randomization and blinding were considered to be partially reported in 21 and 18 studies, respectively. No studies reported the rationale for sample sizes. Several studies failed to report key design features such as units for measurement, means, standard deviations, standard errors for continuous outcomes or comparative characteristics for categorical outcomes expressed as either rates or proportions. In the discipline of animal welfare science, authors, reviewers and editors are encouraged to use available reporting guidelines to ensure that scientific methods and results are adequately described and free of misrepresentations and inaccuracies. Complete and accurate reporting increases the ability to apply the results of studies to the decision-making process and prevent wastage of financial and animal resources. PMID:26556522

  15. [Homeopathic treatment of adenoid vegetations. Results of a prospective, randomized double-blind study].

    PubMed

    Friese, K H; Feuchter, U; Moeller, H

    1997-08-01

    In a monocenter prospective randomized double-blind clinical trial the efficacy of homeopathic treatment was investigated on children with adenoid vegetations justifying an operation. Patients were treated with either homeopathic remedies such as Nux vomica D200, Okoubaka D3, Tuberculinum D200, Barium jodatum D4 and Barium jodatum D6 or with placebo. The duration of the study for each patient was 3 months. Examination of the ears using a microscope, rhinoscopy, stomatoscopy and pharyngoscopy, as well as tympanometry and audiometry were performed after 4, 8 and 12 weeks. Out of a total of 97 children studied between the ages of 4 to 10 years 82 could be analyzed. At the end of the study no operation was required in 70.7% of the placebo-treated children and in 78.1% of the children treated with homeopathic preparations. These results show no statistical significance. PMID:9378668

  16. A randomized trial comparing two approaches to weight loss: Differences in weight loss maintenance

    PubMed Central

    Carels, Robert A; Burmeister, Jacob M; Koball, Afton M; Oehlhof, Marissa W; Hinman, Nova; LeRoy, Michelle; Bannon, Erin; Ashrafioun, Lee; Storfer-Isser, Amy; Darby, Lynn A; Gumble, Amanda

    2013-01-01

    This study compared treatment outcomes for a new weight loss program that emphasized reducing unhealthy relationships with food, body image dissatisfaction, and internalized weight bias (New Perspectives) to a weight loss program that emphasizes environmental modification and habit formation and disruption (Transforming Your Life). Fifty-nine overweight and obese adults (body mass index ≥ 27 kg/m2) were randomly assigned to either a 12-week New Perspectives or Transforming Your Life intervention. Despite equivalent outcomes at the end of treatment, the Transforming Your Life participants were significantly more effective at maintaining their weight loss than New Perspectives participants during the 6-month no-treatment follow-up period. PMID:23349402

  17. Effectiveness of papain gel in venous ulcer treatment: randomized clinical trial1

    PubMed Central

    Rodrigues, Ana Luiza Soares; de Oliveira, Beatriz Guitton Renaud Baptista; Futuro, Débora Omena; Secoli, Silvia Regina

    2015-01-01

    OBJECTIVE: to assess the effectiveness of 2% papain gel compared to 2% carboxymethyl cellulose in the treatment of chronic venous ulcer patients. METHOD: randomized controlled clinical trial with 12-week follow-up. The sample consisted of 18 volunteers and 28 venous ulcers. In the trial group, 2% papain gel was used and, in the control group, 2% carboxymethyl cellulose gel. RESULTS: the trial group showed a significant reduction in the lesion area, especially between the fifth and twelfth week of treatment, with two healed ulcers and a considerable increase in the amount of epithelial tissue in the wound bed. CONCLUSION: 2% papain gel demonstrated greater effectiveness in the reduction of the lesion area, but was similar to 2% carboxymethyl cellulose gel regarding the reduction in the amount of exudate and devitalized tissue. Multicenter research is suggested to evidence the effectiveness of 2% papain gel in the healing of venous ulcers. UTN number: U1111-1157-2998 PMID:26155004

  18. Parent Training for Young Children With Developmental Disabilities: Randomized Controlled Trial

    PubMed Central

    McIntyre, Laura Lee

    2009-01-01

    A randomized controlled trial was used to evaluate a parent training intervention for caregivers with preschool-age children with developmental disabilities. The 21 families in the experimental group received usual care plus the 12-week Incredible Years Parent Training Program with developmental delay modifications. Families in the control group (n = 23) received usual care, including early childhood education and related services. Results suggest that this parent training intervention was superior to usual care for young children with developmental delays or disabilities in reducing negative parent–child interactions and child behavior problems. Participants in the experimental group indicated high satisfaction with treatment. Additional research is necessary to document maintenance and generalization of treatment outcomes. PMID:18702556

  19. A Randomized Controlled Trial of Innovative Postpartum Care Model for Mother-Baby Dyads

    PubMed Central

    Laliberté, Corinne; Dunn, Sandra; Pound, Catherine; Sourial, Nadia; Yasseen, Abdool S.; Millar, David; Rennicks White, Ruth; Walker, Mark; Lacaze-Masmonteil, Thierry

    2016-01-01

    Objective To evaluate the efficacy, safety, and maternal satisfaction of a newly established integrative postpartum community-based clinic providing comprehensive support for mothers during the first month after discharge from the hospital. Our primary interests were breastfeeding rates, readmission and patient satisfaction. Methods A randomized controlled trial was conducted in Ottawa, Canada, where 472 mothers were randomized via a 1:2 ratio to either receive standard of care (n = 157) or to attend the postpartum breastfeeding clinic (n = 315). Outcome data were captured through questionnaires completed by the participants at 2, 4, 12 and 24 weeks postpartum. Unadjusted and adjusted logistic regression models were conducted to determine the effect of the intervention on exclusive breastfeeding at 12 weeks (primary outcome). Secondary outcomes included breastfeeding rate at 2, 4 and 24 weeks, breastfeeding self-efficacy scale, readmission rate, and satisfaction score. Results More mothers in the intervention group (n = 195, 66.1%) were exclusively breastfeeding at 12 weeks compared to mothers in the control group (n = 81, 60.5%), however no statistically significant difference was observed (OR = 1.28; 95% CI:0.84–1.95)). The rate of emergency room visits at 2 weeks for the intervention group was 11.4% compared to the standard of care group (15.2%) (OR = 0.69; 95% CI: 0.39–1.23). The intervention group was significantly more satisfied with the overall care they received for breastfeeding compared to the control group (OR = 1.96; 95% CI: 3.50–6.88)). Conclusion This new model of care did not significantly increase exclusive breastfeeding at 12 weeks. However, there were clinically meaningful improvements in the rate of postnatal problems and satisfaction that support this new service delivery model for postpartum care. A community-based multidisciplinary postpartum clinic is feasible to implement and can provide appropriate and highly satisfactory care to

  20. Slimming World in Stop Smoking Services (SWISSS): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Quitting smokers gain weight. This deters some from trying to stop smoking and may explain the increased incidence of type 2 diabetes after cessation. Dieting when stopping smoking may be counterproductive. Hunger increases cravings for smoking and tackling two behaviours together may undermine quitting success. A meta-analysis of randomized controlled trials (RCTs) showed individualized dietary support may prevent weight gain, although there is insufficient evidence whether it undermines smoking cessation. Commercial weight management providers (CWMPs), such as Slimming World, provide individualized dietary support for National Health Service (NHS) patients; however, there is no evidence that they can prevent cessation-related weight gain. Our objective is to determine whether attending Slimming World from quit date, through referral from NHS Stop Smoking Services, is more effective than usual care at preventing cessation-related weight gain. Methods This RCT will examine the effectiveness of usual cessation support plus referral to Slimming World compared to usual cessation support alone. Healthy weight, overweight and obese adult smokers attending Stop Smoking Services will be included. The primary outcome is weight change in quitters 12 weeks post-randomization. Multivariable linear regression analysis will compare weight change between trial arms and adjust for known predictors of cessation-related weight gain. We will recruit 320 participants, with 160 participants in each arm. An alpha error rate of 5% and 90% power will detect a 2 kg (SD = 2.5) difference in weight gain at 12 weeks, assuming 20% remain abstinent by then. Discussion This trial will establish whether referral to the 12-week Slimming World programme plus usual care is an effective intervention to prevent cessation-related weight gain. If so, we will seek to establish whether weight control comes at the expense of a successful quit attempt in a further non-inferiority trial. Positive

  1. Albendazole treatment of HIV-1 and helminth co-infection: A randomized, double blind, placebo-controlled trial

    PubMed Central

    Walson, Judd L.; Otieno, Phelgona A.; Mbuchi, Margaret; Richardson, Barbra A.; Lohman-Payne, Barbara; Macharia, Steve Wanyee; Overbaugh, Julie; Berkley, James; Sanders, Eduard J.; Chung, Michael; John-Stewart, Grace C.

    2009-01-01

    OBJECTIVE Several co-infections have been shown to impact the progression of HIV-1 infection. We sought to determine if treatment of helminth co-infection in HIV-1 infected adults impacted markers of HIV-1 disease progression. DESIGN To date there have been no randomized trials to examine the effects of soil-transmitted helminth eradication on markers of HIV-1 progression. METHODS A randomized, double-blind, placebo-controlled trial of albendazole (400mg daily for three days) in antiretroviral-naïve HIV-1 infected adults (CD4 >200 cells/mm3) with soil-transmitted helminth infection was conducted at ten sites in Kenya (Clinical Trials.gov NCT00130910). CD4 and plasma HIV-1 RNA levels at 12 weeks following randomization were compared in the trial arms using linear regression, adjusting for baseline values. RESULTS Of 1,551 HIV-1 infected individuals screened for helminth-infection, 299 were helminth-infected. 234 adults were enrolled and underwent randomization and 208 individuals were included in intent-to-treat analyses. Mean CD4 count was 557 cells/mm3 and mean plasma viral load was 4.75 log10 copies/mL at enrolment. Albendazole therapy resulted in significantly higher CD4 counts among individuals with Ascaris lumbricoides infection after 12 weeks of follow up (+109 cells/mm3; 95% CI +38.9 to +179.0, p=0.003) and a trend for 0.54 log10 lower HIV-1 RNA levels (p=0.09). These effects were not seen with treatment of other species of soil-transmitted helminths. CONCLUSIONS Treatment of A. lumbricoides with albendazole in HIV-1 co-infected adults resulted in significantly increased CD4 counts during 3-month follow-up. Given the high prevalence of A. lumbricoides infection worldwide, deworming may be an important potential strategy to delay HIV-1 progression. PMID:18670219

  2. 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.

  3. Reflecting Random Flights

    NASA Astrophysics Data System (ADS)

    De Gregorio, Alessandro; Orsingher, Enzo

    2015-09-01

    We consider random flights in reflecting on the surface of a sphere with center at the origin and with radius R, where reflection is performed by means of circular inversion. Random flights studied in this paper are motions where the orientation of the deviations are uniformly distributed on the unit-radius sphere . We obtain the explicit probability distributions of the position of the moving particle when the number of changes of direction is fixed and equal to . We show that these distributions involve functions which are solutions of the Euler-Poisson-Darboux equation. The unconditional probability distributions of the reflecting random flights are obtained by suitably randomizing n by means of a fractional-type Poisson process. Random flights reflecting on hyperplanes according to the optical reflection form are considered and the related distributional properties derived.

  4. Quantum random number generator

    DOEpatents

    Pooser, Raphael C.

    2016-05-10

    A quantum random number generator (QRNG) and a photon generator for a QRNG are provided. The photon generator may be operated in a spontaneous mode below a lasing threshold to emit photons. Photons emitted from the photon generator may have at least one random characteristic, which may be monitored by the QRNG to generate a random number. In one embodiment, the photon generator may include a photon emitter and an amplifier coupled to the photon emitter. The amplifier may enable the photon generator to be used in the QRNG without introducing significant bias in the random number and may enable multiplexing of multiple random numbers. The amplifier may also desensitize the photon generator to fluctuations in power supplied thereto while operating in the spontaneous mode. In one embodiment, the photon emitter and amplifier may be a tapered diode amplifier.

  5. Feasibility and Acceptability of a Tai Chi Chih Randomized Controlled Trial in Senior Female Cancer Survivors

    PubMed Central

    Campo, Rebecca A.; O’Connor, Kathleen; Light, Kathleen C.; Nakamura, Yoshio; Lipschitz, David; LaStayo, Paul C.; Pappas, Lisa; Boucher, Kenneth; Irwin, Michael R.; Agarwal, Neeraj; Kinney, Anita Y.

    2013-01-01

    Objective Tai Chi Chih (TCC) is associated with improved physical functioning and psychological benefits in breast cancer survivors and healthy older adults; thus, may also be beneficial for senior cancer survivors with physical functioning declines. The purpose of this randomized controlled trial (RCT) was to examine the feasibility and acceptability of a Tai Chi Chih (TCC) intervention in senior female cancer survivors, with physical functioning limitations, as well as, its effects on QOL. Design This was a two-armed, parallel group, RCT with 12-weeks of Tai Chi Chih or Health Education Control. Methods Sixty-three senior (M age=67 years, SD=7.15) female cancer survivors (83% breast cancer, stages I–III) with physical functioning limitations (SF-12 Health Survey role physical & physical functioning subscales) were randomized to 12-weeks of TCC or Health Education control (HEC). Primary outcomes were feasibility and acceptability. Secondary outcomes included quality of life (SF-36 Health Survey), and participants’ qualitative feedback on intervention. Results Retention (TCC = 91%; HEC = 81%) and class attendance (TCC =79%; HEC = 83%) rates, and satisfaction levels for both study arms were high, but did not significantly differ from one another. At one-week post-intervention, none of the SF-36 scores differed between the TCC and HEC arms. Within-group analyses revealed significant improvements in the mental component summary score in TCC (p = 0.01), but not in HEC. Qualitative analyses indicated that the TCC group felt they received mental and physical benefits, whereas HEC group reported on social support benefits and information received. Conclusion A TCC intervention was found to be a feasible and acceptable modality for senior female cancer survivors. Future, larger definitive trials are needed to clarify TCC dosage effects on QOL in this vulnerable population. PMID:23620504

  6. Varenicline efficacy and safety among methadone maintained smokers: A randomized placebo-controlled trial

    PubMed Central

    Nahvi, Shadi; Ning, Yuming; Segal, Kate S.; Richter, Kimber P.; Arnsten, Julia H.

    2015-01-01

    Aims To test the efficacy and safety of varenicline as an aid to smoking cessation in methadone maintained smokers. Design Multicenter, randomized, double-blind, placebo-controlled trial with random assignment to 12 weeks of varenicline 1 mg twice daily (n=57) or matched placebo (n=55), with in-person and telephone counseling. Setting Urban methadone programmes in the Bronx, New York City, New York, USA. Participants: Methadone maintenance patients, smoking ≥5 cigarettes/day, interested in quitting, stable in methadone treatment, without current axis I psychiatric disorders, suicidal ideation, or recent suicide attempts. Measurements Seven-day point prevalence abstinence verified by expired carbon monoxide (CO) < 8 p.p.m at week 12 (primary outcome); CO-verified abstinence, cigarettes/day, incident axis I psychiatric illness, suicidal ideation or serious adverse events (SAEs) at weeks 2, 4, 8, 12 or 24 (secondary outcomes). Findings Baseline demographic, smoking and clinical factors were similar between groups. Retention at 24 weeks was 90%. Subjects receiving varenicline were more likely than those receiving placebo to achieve abstinence (10.5% v 0%, p = .03; effect size 10.5%, 95% CI 4.4 – 19.3%) and to reduce smoking (median 5 v 2 cigarettes/day, p<.001) at 12 weeks. These effects were not maintained after drug treatment ceased. Incident psychiatric illness (OR = 0.84, 95% CI 0.16, 4.4) and suicidality (OR = 0.88, 95% CI 0.2, 3.9) were not different between groups. There were no psychiatric or cardiac SAEs. Conclusions Varenicline can aid short-term smoking abstinence in methadone maintained smokers. PMID:24862167

  7. Pelvic Static Magnetic Stimulation to Control Urinary Incontinence in Older Women: A Randomized Controlled Trial

    PubMed Central

    Wallis, Marianne C.; Davies, Elizabeth A.; Thalib, Lukman; Griffiths, Susan

    2012-01-01

    Objectives To determine the efficacy of non-invasive static magnetic stimulation (SMS) of the pelvic floor compared to placebo in the treatment of women aged 60 years and over with urinary incontinence for 6 months or more. Subjects and Methods A single-blinded randomized, placebo-controlled, parallel-group trial. Subjects were excluded if they had an implanted electronic device, had experienced a symptomatic urinary tract infection, or had commenced pharmacotherapy for the same in the previous 4 weeks, or if they were booked for pelvic floor or gynecological surgery within the next 3 months. Once written consent was obtained, subjects were randomly assigned to the active SMS group (n=50) or the placebo group (n=51). Treatment was an undergarment incorporating 15 static magnets of 800–1200 Gauss anterior, posterior, and inferior to the pelvis for at least 12 hours a day for 3 months. Placebo was the same protocol with inert metal disks replacing the magnets. Primary outcome measure was cessation of incontinence as measured by a 24-hour pad test. Secondary outcomes were frequency and severity of symptoms as measured by the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTS-SF), the Incontinence Severity Index, a Bothersomeness Visual Analog scale, and a 24-hour bladder diary. Data were collected at baseline and 12 weeks later. Results There were no statistically significant differences between groups in any of the outcome measures from baseline to 12 weeks. Initial evidence of subjective improvement in the treatment group compared to the placebo group was not sustained with sensitivity analysis. Conclusion This study found no evidence that static magnets cure or decrease the symptoms of urinary incontinence. Additional work into the basic physics of the product and garment design is recommended prior to further clinical trials research. PMID:21817123

  8. Flunarizine in the prophylaxis of migrainous vertigo: a randomized controlled trial.

    PubMed

    Lepcha, Anjali; Amalanathan, Sophia; Augustine, Ann Mary; Tyagi, Amit Kumar; Balraj, Achamma

    2014-11-01

    Migrainous vertigo is a common cause of dizziness presenting to an otorhinolaryngology/otoneurology clinic. Although it causes a substantial burden to the individual and society there are no randomized controlled trails on prophylactic medication for this condition. Flunarizine, a calcium channel blocker has been used effectively in both migraine and vestibular conditions. This randomized control trial was undertaken in a tertiary academic referral center to evaluate the efficacy of flunarizine in patients with migrainous vertigo when compared to non-specific vestibular treatment of betahistine and vestibular exercises. The effect of flunarizine on two particularly disabling symptoms of vertigo and headache was studied. A total of 48 patients who were diagnosed with definitive migrainous vertigo completed the study of 12 weeks duration. Patients in arm A received 10-mg flunarizine daily along with betahistine 16 mg and paracetamol 1 gm during episodes, and arm B received only betahistine and paracetamol during episodes. Symptom scores were noted at the start of the study and at the end of 12 weeks. Analysis of the frequency of vertiginous episodes showed a significant difference between arm A and arm B (p = 0.010) and improvement in severity of vertigo between the two groups (p = 0.046). Headache frequency and severity did not improve to a significant degree in arm A as compared to arm B. The main side effects were weight gain and somnolence and this was not significantly different between the two groups. Flunarizine (10 mg) is effective in patients with migrainous vertigo who suffer from considerable vestibular symptoms. PMID:24166742

  9. Weight loss improves reproductive outcomes in obese women undergoing fertility treatment: a randomized controlled trial.

    PubMed

    Sim, K A; Dezarnaulds, G M; Denyer, G S; Skilton, M R; Caterson, I D

    2014-04-01

    For women attempting pregnancy, obesity reduces fertility and is an independent risk factor for obstetric and neonatal complications. The aim of this evaluator-blinded, randomized controlled trial was to evaluate a weight loss intervention on pregnancy rates in obese women undertaking fertility treatment. Forty-nine obese women, aged ≤ 37 years, presenting for fertility treatment were randomized to either a 12-week intervention (n = 27) consisting of a very-low-energy diet for the initial 6 weeks followed by a hypocaloric diet, combined with a weekly group multidisciplinary programme; or a control group (n = 22) who received recommendations for weight loss and the same printed material as the intervention. Anthropometric and reproductive parameters were measured at baseline and at 12 weeks. The 22 women who completed the intervention had greater anthropometric changes (-6.6 ± 4.6 kg and -8.7 ± 5.6 cm vs. -1.6 ± 3.6 kg and -0.6 ± 6.3 cm) compared with the control group (n = 17; P < 0.001). The intervention group achieved a pregnancy rate of 48% compared with 14% (P = 0.007), took a mean two fertility treatment cycles to achieve each pregnancy compared with four in the control group (P = 0.002), and had a marked increase in the number of live births (44% vs. 14%; P = 0.02). A group weight loss programme, incorporating dietary, exercise and behavioural components, is associated with a significant improvement in pregnancy rates and live births in a group of obese women undergoing fertility treatment. PMID:25826729

  10. Autonomous Byte Stream Randomizer

    NASA Technical Reports Server (NTRS)

    Paloulian, George K.; Woo, Simon S.; Chow, Edward T.

    2013-01-01

    Net-centric networking environments are often faced with limited resources and must utilize bandwidth as efficiently as possible. In networking environments that span wide areas, the data transmission has to be efficient without any redundant or exuberant metadata. The Autonomous Byte Stream Randomizer software provides an extra level of security on top of existing data encryption methods. Randomizing the data s byte stream adds an extra layer to existing data protection methods, thus making it harder for an attacker to decrypt protected data. Based on a generated crypto-graphically secure random seed, a random sequence of numbers is used to intelligently and efficiently swap the organization of bytes in data using the unbiased and memory-efficient in-place Fisher-Yates shuffle method. Swapping bytes and reorganizing the crucial structure of the byte data renders the data file unreadable and leaves the data in a deconstructed state. This deconstruction adds an extra level of security requiring the byte stream to be reconstructed with the random seed in order to be readable. Once the data byte stream has been randomized, the software enables the data to be distributed to N nodes in an environment. Each piece of the data in randomized and distributed form is a separate entity unreadable on its own right, but when combined with all N pieces, is able to be reconstructed back to one. Reconstruction requires possession of the key used for randomizing the bytes, leading to the generation of the same cryptographically secure random sequence of numbers used to randomize the data. This software is a cornerstone capability possessing the ability to generate the same cryptographically secure sequence on different machines and time intervals, thus allowing this software to be used more heavily in net-centric environments where data transfer bandwidth is limited.

  11. Language and literacy outcomes from a pilot intervention study for children with fetal alcohol spectrum disorders in South Africa.

    PubMed

    Adnams, Colleen M; Sorour, Pharyn; Kalberg, Wendy O; Kodituwakku, Piyadasa; Perold, Mariechen D; Kotze, Anna; September, Sean; Castle, Bernice; Gossage, J; May, Philip A

    2007-09-01

    This pilot study investigated the efficacy of a classroom language and literacy intervention in children with fetal alcohol spectrum disorders (FASD) in the Western Cape Province of South Africa. The study forms part of a larger, ongoing study that includes metacognitive and family support interventions in addition to language and literacy training (LLT). For the LLT study, 65 nine-year-old children identified as either FASD or not prenatally exposed to alcohol, were recruited. Forty children with FASD were randomly assigned to either a LLT intervention group or FASD control group (FASD-C). Twenty-five nonalcohol-exposed children were randomly selected as nonexposed controls (NONEXP-C). Prior to intervention and after nine school-term months of treatment, general scholastic tests, teacher and parent questionnaires, classroom observations and specific language and literacy tests were administered to the participants. The nine months assessment reflects the midpoint and the first assessment stage of the overall study. At initial diagnosis and prior to commencement of the interventions, participants with FASD were significantly weaker than NONEXP-C children in reading, spelling, addition, subtraction, phonological awareness, and other tests of early literacy. Teachers rated a range of adaptive behaviors of children with FASD as significantly worse than NONEXP-C. Mean scholastic and language and literacy scores for all groups showed improvement over baseline scores after 9 months of intervention. The mean test scores of children with FASD remained lower than those of NONEXP-C. Comparison of mean baseline to postintervention score changes between the LLT, FASD-C, and NONEXP-C groups revealed that although there were no significant gains by the LLT intervention group over control groups on the general scholastic assessment battery, significantly greater improvements occurred in the LLT intervention group compared to the FASD-C group in specific categories of language and

  12. Unexpected benefit of sorbitol placebo in Mg intervention study of premenstrual symptoms: implications for choice of placebo in RCTs.

    PubMed

    Walker, Ann F; De Souza, M C; Marakis, G; Robinson, P A; Morris, A P; Bolland, K M

    2002-03-01

    We carried out a randomized, double-blind, crossover study of 85 women, designed to investigate the dose-response of daily Mg supplementation on premenstrual symptoms. Each woman took one of four treatments: Mg (200, 350 or 500 mg/day) or sorbitol (placebo) for 2 months. This was followed by a washout of 1 month, and then each woman received one of the three remaining treatments for a further 2 months. Unexpectedly, sorbitol (1305 mg) reduced anxiety-related and total premenstrual symptoms after 2 months compared with Mg treatments (P<0.001 and P<0.001, respectively). We conclude that low-dose sorbitol reduces premenstrual symptoms beyond that expected of a placebo. After 2 months of treatment, sorbitol also reduced urinary Mg excretion compared to baseline (no intervention) and Mg treatments (P=0.005). A follow-up study on 17 healthy volunteers confirmed lack of effect on urinary Mg output of a similar sorbitol intervention regime compared with either baseline or cellulose placebo. It appears that sorbitol may influence Mg homeostasis in women suffering premenstrual symptoms, but not in healthy individuals. Implications for placebo choice in RCTs are discussed. PMID:12018972

  13. Can Word Puzzles be Tailored to Improve Different Dimensions of Verbal Fluency? A Report of an Intervention Study.

    PubMed

    Murphy, Mike; Spillane, Katie; Cully, James; Navarro-Pardo, Esperanza; Moret-Tatay, Carmen

    2016-08-17

    Verbal fluency is commonly used as a proxy measure of executive functioning, as it involves cognitive flexibility, working memory, and inhibitory control. Previous research has demonstrated that crosswords can be a useful means of improving verbal fluency, results consistent with the cognitive reserve hypothesis; the form of verbal fluency affected has, however, differed across studies. The present study sought to assess the extent to which it was possible to target phonemic (PVF) and semantic verbal fluency (SVF) separately through word puzzles designed to focus on semantic/thematic and structural clues respectively. Fifty-three university students were randomly assigned to one of three groups: semantic/thematic, structural, or a daily diary control group. They were assessed on PVF and SVF at baseline, and immediately following a four-week intervention. Age, sex, and depression scores were controlled for. A 2 × 3 mixed ANCOVA showed that the structural group improved significantly more in PVF during the intervention period than did the semantic/thematic or control groups, with the improvement linked to improved switching performance. The effect size was large. No significant difference in improvement in SVF emerged, although the effect size was moderate. The findings support the notion that it is possible to improve specific forms of verbal fluency through tailored brief word-puzzle interventions. PMID:27224052

  14. Sono-Electro-Magnetic Therapy for Treating Chronic Pelvic Pain Syndrome in Men: A Randomized, Placebo-Controlled, Double-Blind Trial

    PubMed Central

    Kessler, Thomas M.; Mordasini, Livio; Weisstanner, Christian; Jüni, Peter; da Costa, Bruno R.; Wiest, Roland; Thalmann, George N.

    2014-01-01

    Objective To assess the efficacy and safety of sono-electro-magnetic therapy compared to placebo in men with refractory CPPS. Patients and Methods In a randomized, placebo-controlled, double-blind single center trial, we assessed the effect of sono-electro-magnetic therapy in men with treatment refractory CPPS. Sixty male patients were randomly assigned to treatment with either sono-electro-magnetic (n = 30) or placebo therapy (n = 30) for 12 weeks. The primary outcome was a change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) from baseline to 12 weeks. Results The 12-week difference between sono-electro-magnetic and placebo therapy in changes of the NIH-CPSI total score was −3.1 points (95% CI −6.8 to 0.6, p = 0.11). In secondary comparisons of NIH-CPSI sub-scores, we found differences between groups most pronounced for the quality-of-life sub-score (difference at 12 weeks −1.6, 95% CI −2.8 to −0.4, p = 0.015). In stratified analyses, the benefit of sono-electro-magnetic therapy appeared more pronounced among patients who had a symptom duration of 12 months or less (difference in NIH-CPSI total score −8.3, 95% CI −14.5 to 2.6) than in patients with a longer symptom duration (−0.8, 95% CI −4.6 to 3.1; p for interaction = 0.023). Conclusions Sono-electro-magnetic therapy did not result in a significant improvement of symptoms in the overall cohort of treatment refractory CPPS patients compared to placebo treatment. Subgroup analysis indicates, however, that patients with a symptom-duration of 12 months or less may benefit from sono-electro-magnetic therapy, warranting larger randomized controlled trials in this subpopulation. Trial Registration ClinicalTrials.gov NCT00688506 PMID:25546177

  15. Effectiveness of diclofenac versus acetaminophen in primary care patients with knee osteoarthritis: [NTR1485], DIPA-Trial: design of a randomized clinical trial

    PubMed Central

    2010-01-01

    Background Osteoarthritis is the most frequent chronic joint disease which causes pain and disability of especially hip and knee. According to international guidelines and the Dutch general practitioners guidelines for non-traumatic knee symptoms, acetaminophen should be the pain medication of first choice for osteoarthritis. However, of all prescribed pain medication in general practice, 90% consists of non-steroidal anti-inflammatory drugs compared to 10% of acetaminophen. Because general practitioners may lack evidence showing a similar efficacy of acetaminophen and non-steroidal anti-inflammatory drugs, we present the design of a randomized open-label trial to investigate the efficacy of a non-steroidal anti-inflammatory drug (diclofenac) compared with acetaminophen in new consulters with knee osteoarthritis in general practice. Methods/Design Patients aged 45 years or older consulting their general practitioner with non-traumatic knee pain, meeting the clinical American College of Rheumatology criteria, and with a pain severity score of 2 or higher (on a 0-10 scale), will be randomly allocated to either diclofenac (maximum daily dose of 150 mg) or acetaminophen (maximum daily dose of 3000 mg) for 2 weeks and, if required, an additional 1-2 weeks, with a total follow-up period of 12 weeks. The primary outcomes are knee pain measured with a daily diary, and pain and function measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, and at 3, 6, 9, and 12-weeks follow-up. Secondary outcomes are patients' perceived recovery, quality of life, medical, patient, and productivity costs, compliance to therapy, co-interventions, and adverse reactions. Discussion The successful completion of this trial would lead to a better understanding of which medication should be used in the treatment of primary care patients with mild knee osteoarthritis. Trial registration Dutch trial registry NTR1485. PMID:20067607

  16. A randomized study on pharmacodynamic effects of vaginal rings delivering the progesterone receptor modulator, Ulipristal acetate. Research for a novel estrogen-free, method of contraception

    PubMed Central

    Huang, YongMei; Jensen, Jeffrey T.; Brache, Vivian; Cochon, Leila; Williams, Alistair; Miranda, Maria-José; Croxatto, Horacio; Kumar, Narender; Sussman, Heather; Hoskin, Elena; Plagianos, Marlena; Roberts, Kevin; Merkatz, Ruth; Blithe, Diana; Sitruk-Ware, Regine

    2014-01-01

    Objective To determine whether a 3-month contraceptive vaginal ring (CVR) delivering ulipristal acetate (UPA) can inhibit ovulation in 90% of cycles. Study Design This was a randomized dose-finding parallel group clinical trial. Fifty-five healthy women with normal ovulation at baseline were randomized to receive a low-dose (1500μg/day) or a high-dose (2500μg/d) UPA-CVR for two consecutive 12-week treatment periods, followed by a recovery cycle. A subgroup of women received levonorgestrel (LNG) 1.5 mg orally twice (at the end of both 12-week ring periods) or once (at the end of the 24-week treatment). The primary outcome was ovulation suppression assessed by transvaginal ultrasound and hormone levels. Secondary outcomes included endometrial safety and bleeding patterns. Results All subjects showed normal ovulation at baseline and recovery. Ovulation suppression was seen in 81.8% (95% CI: 73.3%, 88.5%) and 86.1% (95% CI: 78.1%, 92%) of treatment cycles with low and high-dose, respectively. Benign progesterone receptor modulator associated endometrial changes (PAEC) were seen during treatment; 78.8% at week 24, but resolved at recovery cycle. A few cases of heavy bleeding occurred near the end of the 24-week treatment, but a single dose of LNG every 12weeks reduced the increase in endometrial thickness during the second treatment period and prevented excessive bleeding. Conclusion The 3-month UPA-CVR may become an effective long-acting, user-controlled estrogen-free contraceptive. The greatest suppression of ovulation was seen with the 2500 μg/d ring. PMID:25193534

  17. Randomness for Free

    NASA Astrophysics Data System (ADS)

    Chatterjee, Krishnendu; Doyen, Laurent; Gimbert, Hugo; Henzinger, Thomas A.

    We consider two-player zero-sum games on graphs. These games can be classified on the basis of the information of the players and on the mode of interaction between them. On the basis of information the classification is as follows: (a) partial-observation (both players have partial view of the game); (b) one-sided complete-observation (one player has complete observation); and (c) complete-observation (both players have complete view of the game). On the basis of mode of interaction we have the following classification: (a) concurrent (players interact simultaneously); and (b) turn-based (players interact in turn). The two sources of randomness in these games are randomness in transition function and randomness in strategies. In general, randomized strategies are more powerful than deterministic strategies, and randomness in transitions gives more general classes of games. We present a complete characterization for the classes of games where randomness is not helpful in: (a) the transition function (probabilistic transition can be simulated by deterministic transition); and (b) strategies (pure strategies are as powerful as randomized strategies). As consequence of our characterization we obtain new undecidability results for these games.

  18. Regular consumption of Fiit-ns, a polyphenol extract from fruit and vegetables frequently consumed within the Mediterranean diet, improves metabolic ageing of obese volunteers: a randomized, double-blind, parallel trial.

    PubMed

    Cases, Julien; Romain, Cindy; Dallas, Constantin; Gerbi, Alain; Cloarec, Maurice

    2015-02-01

    Epidemiological studies suggest that metabolic ageing process of overweight and obese populations is associated with an increased risk of developing non-communicable diseases (NCDs). Inflammation, hyper-glycaemia, dyslipidemia and oxidative stress have been associated with early stages of NCDs development whereas cohort surveys have demonstrated health benefits of dietary polyphenols from various dietary sources to reverse such progress. Obese volunteers were included in a double-blind, randomized, parallel pilot trial where they received daily for a 12-week period 900 mg of a polyphenol-rich treatment extracted from fruit and vegetables frequently consumed within the Mediterranean diet. Anthropometric and blood parameters were assessed before and at the end of the intervention period. After 12 weeks, while the silhouette slimmed down, metabolic parameters were significantly improved and general satisfaction considerably ameliorated. These data suggest that over a 12-week period, the synergistic action of bioactives within the treatment improves metabolic ageing process and quality of life in obese volunteers. PMID:25358490

  19. Gabapentin Treatment for Alcohol Dependence: A Randomized Controlled Trial

    PubMed Central

    Mason, Barbara J.; Quello, Susan; Goodell, Vivian; Shadan, Farhad; Kyle, Mark; Begovic, Adnan

    2013-01-01

    Importance Approved medications for alcohol dependence are prescribed for fewer than 9% of US alcoholics. Objective To determine if gabapentin, a widely-prescribed generic calcium channel/GABA modulating medication, increases rates of sustained abstinence and no heavy drinking, and decreases alcohol-related insomnia, dysphoria and craving, in a dose-dependent manner. Design, Participants and Setting A 12-week, double-blind, placebo-controlled, randomized dose-ranging trial of 150 men and women over 18 years of age with current alcohol dependence, conducted 2004–2010 at a single-site outpatient clinical research facility adjoining a general medical hospital. Interventions Oral gabapentin (0, 900, 1800 mg/d) and concomitant manual-guided counseling. Main Outcome Measures Rates of complete abstinence and no heavy drinking (co-primary) and changes in mood, sleep and craving (secondary) over the 12-week study. Results Gabapentin significantly improved the rates of abstinence and no heavy drinking. The abstinence rate was 4.1% (95% CI, 1.1 to 13.7) in the placebo group, 11.1% (95% CI, 5.2 to 22.2) in the 900 mg group, and 17.0% (95% CI, 8.9 to 30.1) in the 1800 mg group (p = 0.04 for linear dose effect, NNT = 8 for 1800 mg). The no heavy drinking rate was 22.5% (95% CI, 13.6 to 37.2) in the placebo group, 29.6% (95% CI, 19.1 to 42.8) in the 900 mg group, and 44.7% (95% CI, 31.4 to 58.8) in the 1800 mg group (p = 0.02 for linear dose effect, NNT = 5 for 1800 mg). Similar linear dose effects were obtained with measures of mood (F=7.37, df=2, p=0.001), sleep (F=136, df=2, p<0.001), and craving (F=3.56, df=2, p=0.029). There were no serious drug-related adverse events, and terminations from adverse-events (9 of 150 participants), time on study (9.1 [3.8] weeks) and rate of study completion (85 of 150 participants) did not differ between groups. Conclusions and Relevance Gabapentin (particularly the 1800 mg dosage) was effective in treating alcohol dependence and relapse

  20. Optofluidic random laser

    NASA Astrophysics Data System (ADS)

    Shivakiran Bhaktha, B. N.; Bachelard, Nicolas; Noblin, Xavier; Sebbah, Patrick

    2012-10-01

    Random lasing is reported in a dye-circulated structured polymeric microfluidic channel. The role of disorder, which results from limited accuracy of photolithographic process, is demonstrated by the variation of the emission spectrum with local-pump position and by the extreme sensitivity to a local perturbation of the structure. Thresholds comparable to those of conventional microfluidic lasers are achieved, without the hurdle of state-of-the-art cavity fabrication. Potential applications of optofluidic random lasers for on-chip sensors are discussed. Introduction of random lasers in the field of optofluidics is a promising alternative to on-chip laser integration with light and fluidic functionalities.

  1. Effects of Pistachio Nut Supplementation on Blood Glucose in Patients with Type 2 Diabetes: A Randomized Crossover Trial

    PubMed Central

    Parham, Mahmoud; Heidari, Saeide; Khorramirad, Ashraf; Hozoori, Mohammad; Hosseinzadeh, Fatemeh; Bakhtyari, Lida; Vafaeimanesh, Jamshid

    2014-01-01

    BACKGROUND: Diabetes is a chronic, potentially debilitating, and often fatal disease. Dietary strategies to reduce postprandial glycemia are important in the prevention and treatment of diabetes. Nuts are rich in mono- and polyunsaturated fatty acids, which may reduce hyperglycemia and improve metabolism. OBJECTIVES: To evaluate the effectiveness of pistachio nut supplementation on glycemic and inflammatory measures in patients with type 2 diabetes. METHODS: In this double-blind, randomized, placebo-controlled, crossover trial, 48 diabetic patients were equally assigned to groups A and B. Patients in group A received a snack of 25 g pistachio nuts twice a day for 12 weeks and group B received a control meal without nuts. After 12 weeks of intervention, the patients had an 8-week washout. Then the groups were displaced, and group B received the same amount of pistachios for 12 weeks. RESULTS: With respect to the total change in variables over both phases, there was a marked decrease in HbA1c (-0.4%) and fasting blood glucose (FBG) concentrations (-16 mg/dl) in the pistachio group compared with the control group (p ≤ 0.001 for both). There was no overall significant change in BMI, blood pressure, HOMA-IR, and C-reactive protein (CRP) concentrations. Analysis of the two phases separately showed a decrease in FBG by 14 mg/dl and in HbA1c by 0.45% in the treatment group (A) after 12 weeks, while no significant differences were seen in group B (control group). In the second phase, FBG decreased from 151.36 ± 39.22 to 137.28 ± 28.65 mg/dl (-14 mg/dl) and HbA1c decreased from 7.42 ± 0.97 to 7.15 ± 0.68 mg/dl (-0.28%, p = 0.013 and p = 0.033, respectively) in the pistachio group (B). Pistachio consumption reduced systolic blood pressure (p = 0.007), BMI (p = 0.011), and CRP (p = 0.002) in patients from the treatment groups, but not insulin resistance. CONCLUSIONS: Dietary consumption of pistachio nuts as a snack has beneficial effects on glycemic control, blood

  2. Interaction of fatty acid genotype and diet on changes in colonic fatty acids in a Mediterranean diet intervention study.

    PubMed

    Porenta, Shannon R; Ko, Yi-An; Gruber, Stephen B; Mukherjee, Bhramar; Baylin, Ana; Ren, Jianwei; Djuric, Zora

    2013-11-01

    A Mediterranean diet increases intakes of n-3 and n-9 fatty acids and lowers intake of n-6 fatty acids. This can impact colon cancer risk as n-6 fatty acids are metabolized to proinflammatory eicosanoids. The purpose of this study was to evaluate interactions of polymorphisms in the fatty acid desaturase (FADS) genes, FADS1 and FADS2, and changes in diet on fatty acid concentrations in serum and colon. A total of 108 individuals at increased risk of colon cancer were randomized to either a Mediterranean or a Healthy Eating diet. Fatty acids were measured in both serum and colonic mucosa at baseline and after six months. Each individual was genotyped for four single-nucleotide polymorphisms in the FADS gene cluster. Linear regression was used to evaluate the effects of diet, genotype, and the diet by genotype interaction on fatty acid concentrations in serum and colon. Genetic variation in the FADS genes was strongly associated with baseline serum arachidonic acid (n-6) but serum eicosapentaenoic acid (n-3) and colonic fatty acid concentrations were not significantly associated with genotype. After intervention, there was a significant diet by genotype interaction for arachidonic acid concentrations in colon. Subjects who had all major alleles for FADS1/2 and were following a Mediterranean diet had 16% lower arachidonic acid concentrations in the colon after six months of intervention than subjects following the Healthy Eating diet. These results indicate that FADS genotype could modify the effects of changes in dietary fat intakes on arachidonic acid concentrations in the colon. PMID:24022589

  3. Effects of a family centered program on perceived social support in patients with congestive heart failure: An interventional study

    PubMed Central

    Shahriari, Mohsen; Alimohammadi, Nasrollah; Ahmadi, Maryam

    2016-01-01

    Background and Objectives: Congestive heart failure is one of the most common cardiovascular diseases that have a progressive and chronic trend and influences individuals’ and their families’ various dimensions. Social support is one of the psychosocial factors that can have a positive effect on individuals’ physical, mental and social status. Despite the existence of evidences, revealing the importance of family's support on patients’ condition, family centered supportive interventions with goal of clinical outcomes improvement have been less conducted among these patients. Therefore, the present study aimed to investigate the effect of family supportive intervention on the level of the support, received among heart failure patients. Materials and Methods: This is a two-group two-stage clinical trial, conducted on 64 patients with cardiac failure, referring to selected educational centers and meeting the inclusion criteria, who were selected through convenient sampling. They were assigned to study (n = 32) and control (n = 32) groups through random allocation. Data were collected by questioning through a two-section medical records questionnaire and were analyzed by SPSS. Results: Results of the study showed that mean scores of received support score were 13.7 (3.8) in the study and 0.8 (2.4) in the control group. Independent t-test showed a significant difference in mean changes of perceived support scores after the intervention between study and control groups (P < 0.001). Conclusions: Based on familial dimension in social support have a positive effect on patients’ perceived support. Nurses, as professional members of health care team, and with an important role in education and care of cardiac failure patients, can support, educate and guide these patients through designing appropriate care plans and educating their family members. PMID:27512698

  4. Poor Sleep Quality in Patients after Coronary Artery Bypass Graft Surgery: An Intervention Study Using the PRECEDE-PROCEED Model

    PubMed Central

    Ranjbaran, Soheila; Dehdari, Tahereh; Sadeghniiat-Haghighi, Khosro; Majdabadi, Mahmood Mahmoodi

    2015-01-01

    Abstract Background: Poor sleep quality (SQ) is common among patients after coronary artery bypass graft surgery (CABG). This study attempted to determine the status of SQ following an intervention based on the PRECEDE-PROCEED model in patients with poor SQ after CABG. Methods: This study was a randomized clinical trial. The study sample, including 100 patients referred to the Cardiac Rehabilitation Clinic of Tehran Heart Center, was assigned either to the intervention (recipient of exercise and lifestyle training plus designed intervention based on the PRECEDE-PROCEED model) or to the control group (recipient of exercise and lifestyle training). Eight training sessions over 8 weeks were conducted for the intervention group. Predisposing, enabling, and reinforcing factors as well as social support and SQ were measured in the intervention group before and one month after the intervention and compared to those in the control group at the same time points. Results: The mean age of the patients in the intervention (24% women) and control (24% women) groups was 59.3 ± 7.3 and 59.5 ± 9.3 years, respectively. The results showed that the mean scores of SQ (p value < 0.001), knowledge (p value < 0.001), beliefs (p value < 0.001), sleep self-efficacy (p value < 0.001), enabling factors (p value < 0.001), reinforcing factors (p value < 0.001), and social support (p value < 0.001) were significantly different between the intervention and control groups after the intervention. Conclusion: Adding an intervention based on the PRECEDE-PROCEED model to the cardiac rehabilitation program may further improve the SQ of patients. PMID:26157457

  5. Clarification of the link between polyunsaturated fatty acids and Helicobacter pylori-associated duodenal ulcer disease: a dietary intervention study.

    PubMed

    Duggan, A E; Atherton, J C; Cockayne, A; Balsitis, M; Evison, S; Hale, T; Hawkey, C J; Spiller, R C

    1997-10-01

    Epidemiological evidence has suggested that the declining prevalence of duodenal ulcer disease may be attributable to rising consumption of polyunsaturated fatty acids, a hypothesis supported by in vitro evidence of toxicity of such substances to Helicobacter pylori. The objective of the present study was to establish whether this association is causal. Forty patients with proven infection with H. pylori and endoscopic evidence of past or present duodenal ulcer disease were randomized to receive either polyunsaturated fatty acids (PUFA group), in the form of capsules and margarine, or a placebo (control). Both groups received concurrent H2 antagonist therapy. Efficacy of therapy was determined endoscopically by assessment of ulcer healing while H. pylori status was determined by antral biopsy, urease (EC 3.5.1.5) culture and histological assessment of the severity of H. pylori infection. Antral levels of prostaglandin E2 (PGE2) and leukotriene B4 (LTB4) were quantified. Compliance was monitored. Before treatment, both groups were comparable for severity of H. pylori infection, smoking status and levels of LTB4 and PGE2. Despite a significant difference in consumption of linoleic acid (19.9 (SE 1.6) g for PUFA group v. 6.7 (SE 0.8) g for controls (P < 0.01) and linolenic acid (2.6 (SE 0.2) g v. 0.6 (SE 0.03) g (P < 0.01) there was no significant change in either the severity of H. pylori infection or prostaglandin levels in either group at 6 weeks. Consumption of a considerable amount of PUFA does not inhibit the colonization of the stomach by H. pylori nor does this alter the inflammatory changes characteristic of H. pylori gastritis. We conclude that the association between duodenal ulceration and a low level of dietary PUFA is likely to be spurious, probably reflecting the effect of confounding factors such as affluence, social class or smoking. PMID:9389880

  6. Cost-effectiveness of reducing salt intake in the Pacific Islands: protocol for a before and after intervention study

    PubMed Central

    2014-01-01

    Background There is broad consensus that diets high in salt are bad for health and that reducing salt intake is a cost-effective strategy for preventing chronic diseases. The World Health Organization has been supporting the development of salt reduction strategies in the Pacific Islands where salt intakes are thought to be high. However, there are no accurate measures of salt intake in these countries. The aims of this project are to establish baseline levels of salt intake in two Pacific Island countries, implement multi-pronged, cross-sectoral salt reduction programs in both, and determine the effects and cost-effectiveness of the intervention strategies. Methods/Design Intervention effectiveness will be assessed from cross-sectional surveys before and after population-based salt reduction interventions in Fiji and Samoa. Baseline surveys began in July 2012 and follow-up surveys will be completed by July 2015 after a 2-year intervention period. A three-stage stratified cluster random sampling strategy will be used for the population surveys, building on existing government surveys in each country. Data on salt intake, salt levels in foods and sources of dietary salt measured at baseline will be combined with an in-depth qualitative analysis of stakeholder views to develop and implement targeted interventions to reduce salt intake. Discussion Salt reduction is a global priority and all Member States of the World Health Organization have agreed on a target to reduce salt intake by 30% by 2025, as part of the global action plan to reduce the burden of non-communicable diseases. The study described by this protocol will be the first to provide a robust assessment of salt intake and the impact of salt reduction interventions in the Pacific Islands. As such, it will inform the development of strategies for other Pacific Island countries and comparable low and middle-income settings around the world. PMID:24495646

  7. Effectiveness and cost-effectiveness of telephone-based support versus usual care for treatment of pressure ulcers in people with spinal cord injury in low-income and middle-income countries: study protocol for a 12-week randomised controlled trial

    PubMed Central

    Arora, Mohit; Harvey, Lisa Anne; Hayes, Alison Joy; Chhabra, Harvinder Singh; Glinsky, Joanne Valentina; Cameron, Ian Douglas; Lavrencic, Lucija; Arumugam, Narkeesh; Hossain, Sohrab; Bedi, Parneet Kaur

    2015-01-01

    Introduction Pressure ulcers are a common and severe complication of spinal cord injury, particularly in low-income and middle-income countries where people often need to manage pressure ulcers alone and at home. Telephone-based support may help people in these situations to manage their pressure ulcers. The aim of this study is to determine the effectiveness and cost-effectiveness of telephone-based support to help people with spinal cord injury manage pressure ulcers at home in India and Bangladesh. Methods and analysis A multicentre (3 sites), prospective, assessor-blinded, parallel, randomised controlled trial will be undertaken. 120 participants with pressure ulcers on the sacrum, ischial tuberosity or greater trochanter of the femur secondary to spinal cord injury will be randomly assigned to a Control or Intervention group. Participants in the Control group will receive usual community care. That is, they will manage their pressure ulcers on their own at home but will be free to access whatever healthcare support they can. Participants in the Intervention group will also manage their pressure ulcers at home and will also be free to access whatever healthcare support they can, but in addition they will receive weekly telephone-based support and advice for 12 weeks (15–25 min/week). The primary outcome is the size of the pressure ulcer at 12 weeks. 13 secondary outcomes will be measured reflecting other aspects of pressure ulcer resolution, depression, quality of life, participation and satisfaction with healthcare provision. An economic evaluation will be run in parallel and will include a cost-effectiveness and a cost-utility analysis. Ethics and dissemination Ethical approval was obtained from the Institutional Ethics Committee at each site. The results of this study will be disseminated through publications and presented at national and international conferences. Trial registration number ACTRN12613001225707. PMID:26220871

  8. Diabetes NetPLAY: A physical activity website and linked email counselling randomized intervention for individuals with type 2 diabetes.

    PubMed

    Liebreich, Tanis; Plotnikoff, Ronald C; Courneya, Kerry S; Boulé, Normand

    2009-01-01

    BACKGROUND -: This pilot study evaluated the feasibility (recruitment, retention, adherence and satisfaction) and preliminary efficacy of a 12-week website and email-linked counselling intervention on physical activity behaviour change in individuals with type 2 diabetes. METHODS -: A total of 49 individuals with type 2 diabetes (59% female, average age 54.1 years) were randomized to the Diabetes NetPLAY intervention or control condition. The intervention condition received information grounded in the Social Cognitive Theory (SCT), personalized weekly emails, an on-line logbook and message board. Key outcomes included physical activity behaviour and related cognition changes. The control condition was provided links to the Canadian Diabetes Association's Clinical Practice Guidelines for Physical Activity and Canada's Guide to Physical Activity. RESULTS -: Intervention participants indicated high levels of satisfaction for this mode of delivery and study results demonstrated the feasibility of web-based mediums for the delivery of physical activity information in this population. The intervention group demonstrated a significant improvement in total vigorous and moderate minutes of physical activity (p = 0.05) compared to the control group over the 12-week study. Among the SCT variables, behavioural capacity, showed a significant increase (p < 0.001) among intervention participants. CONCLUSION -: Web-based interventions for individuals with type 2 diabetes are feasible and show promise for improving positive physical activity outcomes. PMID:19327141

  9. Transdiagnostic versus Diagnosis-Specific CBT for Anxiety Disorders: A Preliminary Randomized Controlled Non-inferiority Trial

    PubMed Central

    Norton, Peter J.; Barrera, Terri L.

    2012-01-01

    BACKGROUND Transdiagnostic cognitive-behavioral treatments for anxiety disorders have been gaining increased attention and empirical study in recent years. Despite this, research on transdiagnostic anxiety treatments has, to date, relied on open trials, or comparisons to waitlist conditions, published benchmarks, or relaxation-based interventions. METHODS The current study was a randomized clinical trial examining the efficacy of a 12-week transdiagnostic cognitive-behavioral group treatment in comparison to 12-week diagnosis-specific group CBT protocols for panic disorder, social anxiety disorder and generalized anxiety disorder. RESULTS Results from 46 treatment initiators suggested significant improvement during treatment, strong evidence for treatment equivalence across transdiagnostic and diagnosis-specific CBT conditions, and no differences in treatment credibility. CONCLUSIONS This study provides evidence supporting the efficacy of transdiagnostic CBT by comparison to current gold-standard diagnosis-specific CBT for social anxiety disorder, generalized anxiety disorder, and panic disorder. Transdiagnostic group CBT has the benefit of potentially easing dissemination and increasing access to evidence based treatments for anxiety without sacrificing efficacy. PMID:22767410

  10. Ginger Supplementation in Nonalcoholic Fatty Liver Disease: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

    PubMed Central

    Rahimlou, Mehran; Yari, Zahra; Hekmatdoost, Azita; Alavian, Seyed Moayed; Keshavarz, Seyed Ali

    2016-01-01

    Background: Nonalcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. The pathogenesis of this disease is closely associated with obesity and insulin resistance. Ginger can have hypolipidemic and antioxidant effects, and act as an insulinsensitizer. Objectives: The aim of this study was to evaluate the effects of ginger supplementation in NAFLD management. Patients and Methods: In a randomized, double-blind, placebo-controlled clinical trial, 44 patients with NAFLD were assigned to take either two grams per day of a ginger supplement or the identical placebo, for 12 weeks. In both groups, patients were advised to follow a modified diet and physical activity program. The metabolic parameters and indicators of liver damage were measured at study baseline and after the 12 week intervention. Results: Ginger supplementation resulted in a significant reduction in alanine aminotransferase, γ-glutamyl transferase, inflammatory cytokines, as well as the insulin resistance index and hepatic steatosis grade in comparison to the placebo. We did not find any significant effect of taking ginger supplements on hepatic fibrosis and aspartate aminotransferase. Conclusions: Twelve weeks of two grams of ginger supplementation showed beneficial effects on some NAFLD characteristics. Further studies are recommended to assess the long-term supplementation effects. PMID:27110262

  11. Religious vs. conventional cognitive behavioral therapy for major depression in persons with chronic medical illness: a pilot randomized trial.

    PubMed

    Koenig, Harold G; Pearce, Michelle J; Nelson, Bruce; Shaw, Sally F; Robins, Clive J; Daher, Noha S; Cohen, Harvey Jay; Berk, Lee S; Bellinger, Denise L; Pargament, Kenneth I; Rosmarin, David H; Vasegh, Sasan; Kristeller, Jean; Juthani, Nalini; Nies, Douglas; King, Michael B

    2015-04-01

    We examine the efficacy of conventional cognitive behavioral therapy (CCBT) versus religiously integrated CBT (RCBT) in persons with major depression and chronic medical illness. Participants were randomized to either CCBT (n = 67) or RCBT (n = 65). The intervention in both groups consisted of ten 50-minute sessions delivered remotely during 12 weeks (94% by telephone). Adherence to treatment was similar, except in more religious participants in whom adherence to RCBT was slightly greater (85.7% vs. 65.9%, p = 0.10). The intention-to-treat analysis at 12 weeks indicated no significant difference in outcome between the two groups (B = 0.33; SE, 1.80; p = 0.86). Response rates and remission rates were also similar. Overall religiosity interacted with treatment group (B = -0.10; SE, 0.05; p = 0.048), suggesting that RCBT was slightly more efficacious in the more religious participants. These preliminary findings suggest that CCBT and RCBT are equivalent treatments of major depression in persons with chronic medical illness. Efficacy, as well as adherence, may be affected by client religiosity. PMID:25816046

  12. Effects of Pilates on muscle strength, postural balance and quality of life of older adults: a randomized, controlled, clinical trial

    PubMed Central

    Campos de Oliveira, Laís; Gonçalves de Oliveira, Raphael; Pires-Oliveira, Deise Aparecida de Almeida

    2015-01-01

    [Purpose] The aim of the present study was to determine the effects of Pilates on lower leg strength, postural balance and the health-related quality of life (HRQoL) of older adults. [Subjects and Methods] Thirty-two older adults were randomly allocated either to the experimental group (EG, n = 16; mean age, 63.62 ± 1.02 years), which performed two sessions of Pilates per week for 12 weeks, or to the control group (CG, n = 16; mean age, 64.21 ± 0.80), which performed two sessions of static stretching per week for 12 weeks. The following evaluations were performed before and after the interventions: isokinetic torque of knee extensors and flexors at 300°/s, the Timed Up and Go (TUG) test, the Berg Balance Scale, and the Health Survey assessment (SF-36). [Results] In the intra-group analysis, the EG demonstrated significant improvement in all variables. In the inter-group analysis, the EG demonstrated significant improvement in most variables. [Conclusion] Pilates exercises led to significant improvement in isokinetic torque of the knee extensors and flexors, postural balance and aspects of the health-related quality of life of older adults. PMID:25931749

  13. Psychosocial treatment for methamphetamine use disorders: a preliminary randomized controlled trial of cognitive behavior therapy and Acceptance and Commitment Therapy.

    PubMed

    Smout, Matthew F; Longo, Marie; Harrison, Sonia; Minniti, Rinaldo; Wickes, Wendy; White, Jason M

    2010-04-01

    Acceptance and Commitment Therapy (ACT) incorporates developments in behavior therapy, holds promise but has not been evaluated for methamphetamine use disorders. The objective of this study was to test whether ACT would increase treatment attendance and reduce methamphetamine use and related harms compared to cognitive behavior therapy (CBT). One hundred and four treatment-seeking adults with methamphetamine abuse or dependence were randomly assigned to receive 12 weekly 60-minute individual sessions of ACT or CBT. Attrition was 70% at 12 weeks and 86% at 24 weeks postentry. Per intention-to-treat analysis, there were no significant differences between the treatment groups in treatment attendance (median 3 sessions), and methamphetamine-related outcomes; however, methamphetamine use (toxicology-assessed and self-reported), negative consequences, and dependence severity significantly improved over time in both groups. Although ACT did not improve treatment outcomes or attendance compared to CBT, it may be a viable alternative to CBT for methamphetamine use disorders. Future rigorous research in this area seems warranted. PMID:20408061

  14. Effects of Pilates on muscle strength, postural balance and quality of life of older adults: a randomized, controlled, clinical trial.

    PubMed

    Campos de Oliveira, Laís; Gonçalves de Oliveira, Raphael; Pires-Oliveira, Deise Aparecida de Almeida

    2015-03-01

    [Purpose] The aim of the present study was to determine the effects of Pilates on lower leg strength, postural balance and the health-related quality of life (HRQoL) of older adults. [Subjects and Methods] Thirty-two older adults were randomly allocated either to the experimental group (EG, n = 16; mean age, 63.62 ± 1.02 years), which performed two sessions of Pilates per week for 12 weeks, or to the control group (CG, n = 16; mean age, 64.21 ± 0.80), which performed two sessions of static stretching per week for 12 weeks. The following evaluations were performed before and after the interventions: isokinetic torque of knee extensors and flexors at 300°/s, the Timed Up and Go (TUG) test, the Berg Balance Scale, and the Health Survey assessment (SF-36). [Results] In the intra-group analysis, the EG demonstrated significant improvement in all variables. In the inter-group analysis, the EG demonstrated significant improvement in most variables. [Conclusion] Pilates exercises led to significant improvement in isokinetic torque of the knee extensors and flexors, postural balance and aspects of the health-related quality of life of older adults. PMID:25931749

  15. Random array grid collimator

    DOEpatents

    Fenimore, E.E.

    1980-08-22

    A hexagonally shaped quasi-random no-two-holes touching grid collimator. The quasi-random array grid collimator eliminates contamination from small angle off-axis rays by using a no-two-holes-touching pattern which simultaneously provides for a self-supporting array increasng throughput by elimination of a substrate. The presentation invention also provides maximum throughput using hexagonally shaped holes in a hexagonal lattice pattern for diffraction limited applications. Mosaicking is also disclosed for reducing fabrication effort.

  16. Exposure to nature versus relaxation during lunch breaks and recovery from work: development and design of an intervention study to improve workers’ health, well-being, work performance and creativity

    PubMed Central

    2014-01-01

    Background The objective of this research project is to understand and to improve workers’ recovery from work stress. Although recovery during lunch breaks is the most common within-workday break, it has received only minor research attention. Therefore, we will study whether lunch breaks including a relaxation session or exposure to nature have more favorable outcomes than usually spent lunch breaks concerning: a) recovery processes, b) health, c) well-being, d) job performance and e) creativity. We approach recovery by combining the theoretical frameworks of work and environmental psychology. Methods/Design We conduct an intervention study in a sample of 268 knowledge-workers who engage in different lunch break activities for 15-minutes per day, two weeks in a row. We randomly assign participants to three experimental conditions: 1) exposure to nature, 2) relaxation and 3) control group (lunch break spent as usual). Online questionnaires before and after the intervention assess long term changes regarding recovery processes and the major outcome variables. Before, during and after the intervention, SMS and paper-pencil questionnaires measure the same constructs four times a day with fewer items. We also measure blood pressure and collect saliva samples to map cortisol excretion across the intervention period. A timed experimental task (i.e., the Alternative Uses Task) is used to examine differences in creativity between the three groups after the intervention period. Discussion By combining the knowledge of work and environmental psychology about recovery and restorative experiences, by merging three recovery perspectives (settings, processes, and outcomes) and by using data triangulation, we produce valid results that broaden our view on mechanisms underlying recovery and enhance our understanding about their links to psychological, behavioural and physiological outcomes, resulting in a more comprehensive picture of work stress recovery in general. Trial

  17. A new delirium phenotype with rapid high amplitude onset and nearly as rapid reversal: Central Coast Australia Delirium Intervention Study

    PubMed Central

    Regal, Paul J

    2015-01-01

    Background Traditional models for delirium based on the Diagnostic and Statistical Manual for Mental Disorders and its 1990 offspring, the Confusion Assessment Method (CAM), were not designed to distinguish behavioral and psychological symptoms of dementia from rapid cognitive decline. We examined a new diagnostic criterion for delirium plus exclusion of behavioral and psychological symptoms of dementia and recent inattention with a 25% decline in digit span forward (DSF). Methods This was a prospective, randomized controlled trial comparing management of prevalent delirium in general medical with that in geriatric medical wards in a 370-bed hospital north of Sydney. Inclusion criteria were age ≥65 years and prevalent delirium in the emergency department based on: CAM; proof that CAM elements were not better explained by behavioral and psychological symptoms of dementia; proof of recent inattention on DSF; evidence of cognitive decline not due to sedatives or antipsychotics in the emergency department. Measurements included the Instrumental Activities of Daily Living (IADL, 22-item), Selective IADL (8-item), Mini-Mental State Examination, DSF daily, Delirium Index daily, and Apathy Evaluation Scale. Pre-delirium scores from past cognitive tests and best scores were imputed after admission. Relative change (RC) was calculated as absolute change/test range and RC/MPC ratio was calculated as RC after admission/maximal possible change. Results A total of 130 subjects were recruited but 14 with subsyndromal delirium were excluded, leaving 116 subjects (mean age 83.6 years). Forty-eight percent had prior dementia. RC from pre-delirium to admission was 42% for the Mini-Mental State Examination, 41% for Selective IADL, 34% for 5-DSF, 54% for 6-DSF, and 37% for the Apathy Evaluation Scale. Improvements after admission (RC and RC/MPC ratios) were 32%/98% for 5-DSF, 54%/82% for 6-DSF, and 45%/80% for the Delirium Index. General medicine and geriatric medicine groups had

  18. An empirical investigation of the potential impact of selective inclusion of results in systematic reviews of interventions: study protocol

    PubMed Central

    2013-01-01

    Background Systematic reviewers may encounter a multiplicity of outcome data in the reports of randomised controlled trials included in the review (for example, multiple measurement instruments measuring the same outcome, multiple time points, and final and change from baseline values). The primary objectives of this study are to investigate in a cohort of systematic reviews of randomised controlled trials of interventions for rheumatoid arthritis, osteoarthritis, depressive disorders and anxiety disorders: (i) how often there is multiplicity of outcome data in trial reports; (ii) the association between selection of trial outcome data included in a meta-analysis and the magnitude and statistical significance of the trial result, and; (iii) the impact of the selection of outcome data on meta-analytic results. Methods/Design Forty systematic reviews (20 Cochrane, 20 non-Cochrane) of RCTs published from January 2010 to January 2012 and indexed in the Cochrane Database of Systematic Reviews (CDSR) or PubMed will be randomly sampled. The first meta-analysis of a continuous outcome within each review will be included. From each review protocol (where available) and published review we will extract information regarding which types of outcome data were eligible for inclusion in the meta-analysis (for example, measurement instruments, time points, analyses). From the trial reports we will extract all outcome data that are compatible with the meta-analysis outcome as it is defined in the review and with the outcome data eligibility criteria and hierarchies in the review protocol. The association between selection of trial outcome data included in a meta-analysis and the magnitude and statistical significance of the trial result will be investigated. We will also investigate the impact of the selected trial result on the magnitude of the resulting meta-analytic effect estimates. Discussion The strengths of this empirical study are that our objectives and methods are pre