WorldWideScience

Sample records for loss randomized controlled

  1. Effects of manipulating eating frequency during a behavioral weight loss intervention: a pilot randomized controlled trial.

    Science.gov (United States)

    Bachman, Jessica L; Raynor, Hollie A

    2012-05-01

    Eating frequency has been inversely related to BMI but the impact of eating frequency on weight loss is unclear. This randomized controlled trial pilot study examined the effect of eating frequency on hunger, energy intake, and weight loss during a 6-month behavioral weight loss intervention. Participants (age: 51.0 ± 9.9 years, BMI: 35.5 ± 4.8 kg/m(2), 57.8% female, 94.1% white) were randomized to one of two eating frequency prescriptions: Three meal (n = 25): three eating bouts/day; or grazing (n = 26): eat at least 100 kcals every 2-3 h. Both groups attended 20 sessions and had identical dietary (1,200-1,500 kcals/day, frequency than three meal at 6 months (5.8 ± 1.1 eating bouts/day vs. 3.2 ± 0.6 eating bouts/day, P weight loss intervention.

  2. A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pellegrini Christine A

    2012-11-01

    Full Text Available Abstract Background Obesity remains a major public health challenge, demanding cost-effective and scalable weight management programs. Delivering key treatment components via mobile technology offers a potential way to reduce expensive in-person contact, thereby lowering the cost and burden of intensive weight loss programs. The ENGAGED study is a theory-guided, randomized controlled trial designed to examine the feasibility and efficacy of an abbreviated smartphone-supported weight loss program. Methods/design Ninety-six obese adults (BMI 30–39.9 kg/m2 will be randomized to one of three treatment conditions: (1 standard behavioral weight loss (STND, (2 technology-supported behavioral weight loss (TECH; or (3 self-guided behavioral weight loss (SELF. All groups will aim to achieve a 7% weight loss goal by reducing calorie and fat intake and progressively increasing moderate intensity physical activity to 175 minutes/week. STND and TECH will attend 8 group sessions and receive regular coaching calls during the first 6 months of the intervention; SELF will receive the Group Lifestyle Balance Program DVD’s and will not receive coaching calls. During months 1–6, TECH will use a specially designed smartphone application to monitor dietary intake, body weight, and objectively measured physical activity (obtained from a Blue-tooth enabled accelerometer. STND and SELF will self-monitor on paper diaries. Linear mixed modeling will be used to examine group differences on weight loss at months 3, 6, and 12. Self-monitoring adherence and diet and activity goal attainment will be tested as mediators. Discussion ENGAGED is an innovative weight loss intervention that integrates theory with emerging mobile technologies. We hypothesize that TECH, as compared to STND and SELF, will result in greater weight loss by virtue of improved behavioral adherence and goal achievement. Trial registration NCT01051713

  3. Who responds to financial incentives for weight loss? Evidence from a randomized controlled trial.

    Science.gov (United States)

    Paloyo, Alfredo R; Reichert, Arndt R; Reuss-Borst, Monika; Tauchmann, Harald

    2015-11-01

    There is a paucity of evidence on the heterogeneous impacts of financial incentives on weight loss. Between March 2010 and January 2012, in a randomized controlled trial, we assigned 700 obese persons to three experimental arms. We test whether particular subgroups react differently to financial incentives for weight loss. Two treatment groups obtained a cash reward (€150 and €300 with 237 and 229 participants, respectively) for achieving an individually-assigned target weight within four months; the control group (234 participants) was not incentivized. Participants and administrators were not blinded to the intervention. We find that monetary rewards effectively induced obese individuals to reduce weight across all subgroups. However, there is no evidence for treatment-effect heterogeneity for those groups that were incentivized. Among those who were in the €300 group, statistically significant and large weight losses were observed for women, singles, and those who are not working (all above 4 kg in four months). In addition, the magnitude of the reward matters only for women and migrants. The effectiveness of financial incentives to reduce weight nevertheless raises sensitive ethical issues that should be taken into consideration by policymakers. Copyright © 2015 Elsevier Ltd. All rights reserved.

  4. Weight loss with a modified Mediterranean-type diet using fat modification: a randomized controlled trial.

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    Austel, A; Ranke, C; Wagner, N; Görge, J; Ellrott, T

    2015-08-01

    There is evidence that Mediterranean diets with a high proportion of olive oil and nuts can be effective for weight management and prevention of cardiovascular disease. It might be difficult for populations with other eating habits to follow such diets. Therefore, a modified Mediterranean-type diet using fat modification through neutral and butter-flavored canola oil, walnuts and walnut oil with two portion-controlled sweet daily snacks was tested in Germany. Randomized waiting-list control study with overweight/grade 1 obese subjects: 12-week self-help modified Mediterranean-type diet, 6 weeks of diet plans and 6 weeks of weight loss maintenance training. Trial duration was 12 months. Intervention group (IG) included 100 participants (average age of 52.4 years, weight 85.1 kg and body mass index (BMI) 30.1 kg/m(2)), waiting-list control group (CG) included 112 participants (52.6 years, 84.1 kg and 30.1 kg/m(2)). Per-protocol weight loss after 12 weeks was 5.2 kg in IG vs 0.4 kg in CG (P ⩽ 0.0001), BMI -1.8 vs -0.1 kg/m(2) (P ⩽ 0.0001), waist circumference -4.7 vs -0.9 cm (P ⩽ 0.0001). Triglycerides, total cholesterol and LDL cholesterol improved significantly in IG but not in CG. One-year dropouts: 44% in IG and 53% in CG. Weight loss after 12 months: 4.2 kg (pooled data). A five-meal modified Mediterranean-type diet with two daily portion-controlled sweet snacks was effective for weight management in a self-help setting for overweight and grade 1 obese subjects. Fat modification through canola oil, walnuts and walnut oil improved blood lipids even at 12 months.

  5. The Breathe Easier through Weight Loss Lifestyle (BE WELL Intervention: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Buist A

    2010-03-01

    Full Text Available Abstract Background Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals. Methods/Design BE WELL is a 2-arm parallel randomized clinical trial (RCT of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324 are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke. The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical

  6. Smartphone Technology and Text Messaging for Weight Loss in Young Adults: A Randomized Controlled Trial.

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    Stephens, Janna D; Yager, Allison M; Allen, Jerilyn

    Using smartphone technology and text messaging for health is a growing field. This type of technology is well integrated into the lives of young adults. However, few studies have tested the effect of this type of technology to promote weight loss in young adults OBJECTIVE:: The purpose of this study is to test the effectiveness of a behaviorally based smartphone application for weight loss combined with text messaging from a health coach on weight, body mass index (BMI), and waist circumference in young adults as compared with a control condition. Sixty-two young adults, aged 18 to 25 years, were randomized to receive (1) a smartphone application + health coach intervention and counseling sessions or (2) control condition with a counseling session. All outcome measures were tested at baseline and 3 months. These included weight, BMI, waist circumference, dietary habits, physical activity habits, and self-efficacy for healthy eating and physical activity. The sample was 71% female and 39% white, with an average age of 20 years and average BMI of 28.5 kg/m. Participants in the smartphone + health coach group lost significantly more weight (P = .026) and had a significant reduction in both BMI (P = .024) and waist circumference (P technology and feedback from a health coach on improving weight in a group of diverse young adults.

  7. A randomized controlled trial testing an Internet delivered cost-benefit approach to weight loss maintenance.

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    Leahey, Tricia M; Fava, Joseph L; Seiden, Andrew; Fernandes, Denise; Doyle, Caroline; Kent, Kimberly; La Rue, Molly; Mitchell, Marc; Wing, Rena R

    2016-11-01

    Weight loss maintenance is a significant challenge in obesity treatment. During maintenance the "costs" of adhering to weight management behaviors may outweigh the "benefits." This study examined the efficacy of a novel approach to weight loss maintenance based on modifying the cost-benefit ratio. Individuals who achieved a 5% weight loss (N=75) were randomized to one of three, 10-month maintenance interventions. All interventions were delivered primarily via the Internet. The Standard arm received traditional weight maintenance strategies. To increase benefits, or rewards, for maintenance behaviors, the two cost-benefit intervention conditions received weekly monetary rewards for self-monitoring and social reinforcement via e-coaching. To decrease behavioral costs (boredom) and increase novelty, participants in the cost-benefit conditions also monitored different evidence-based behaviors every two weeks (e.g., Weeks 1 & 2: steps; Week 3 & 4: red foods). The primary difference between the cost-benefit interventions was type of e-coach providing social reinforcement: Professional (CB Pro) or Peer (CB Peer). Study procedures took place in Providence, RI from 2013 to 2014. Retention was 99%. There were significant group differences in weight regain (p=.01). The Standard arm gained 3.5±5.7kg. In contrast, participants in CB Pro and CB Peer lost an additional 1.8±7.0kg and 0.5±6.4kg, respectively. These results suggest that an Internet delivered cost-benefit approach to weight loss maintenance may be effective for long-term weight control. In addition, using peer coaches to provide reinforcement may be a particularly economic alternative to professionals. These data are promising and provide support for a larger, longer trial. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Screen-Time Weight-loss Intervention Targeting Children at Home (SWITCH): a randomized controlled trial.

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    Maddison, Ralph; Marsh, Samantha; Foley, Louise; Epstein, Leonard H; Olds, Timothy; Dewes, Ofa; Heke, Ihirangi; Carter, Karen; Jiang, Yannan; Mhurchu, Cliona Ni

    2014-09-10

    Screen-based activities, such as watching television (TV), playing video games, and using computers, are common sedentary behaviors among young people and have been linked with increased energy intake and overweight. Previous home-based sedentary behaviour interventions have been limited by focusing primarily on the child, small sample sizes, and short follow-up periods. The SWITCH (Screen-Time Weight-loss Intervention Targeting Children at Home) study aimed to determine the effect of a home-based, family-delivered intervention to reduce screen-based sedentary behaviour on body composition, sedentary behaviour, physical activity, and diet over 24 weeks in overweight and obese children. A two-arm, parallel, randomized controlled trial was conducted. Children and their primary caregiver living in Auckland, New Zealand were recruited via schools, community centres, and word of mouth. The intervention, delivered over 20 weeks, consisted of a face-to-face meeting with the parent/caregiver and the child to deliver intervention content, which focused on training and educating them to use a wide range of strategies designed to reduce their child's screen time. Families were given Time Machine TV monitoring devices to assist with allocating screen time, activity packages to promote alternative activities, online support via a website, and monthly newsletters. Control participants were given the intervention material on completion of follow-up. The primary outcome was change in children's BMI z-score from baseline to 24 weeks. Children (n = 251) aged 9-12 years and their primary caregiver were randomized to receive the SWITCH intervention (n = 127) or no intervention (controls; n = 124). There was no significant difference in change of zBMI between the intervention and control groups, although a favorable trend was observed (-0.016; 95% CI: -0.084, 0.051; p = 0.64). There were also no significant differences on secondary outcomes, except for a trend towards

  9. Behavioral self-regulation for weight loss in young adults: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wing Rena R

    2009-02-01

    Full Text Available Abstract Objective To determine the feasibility of recruiting and retaining young adults in a brief behavioral weight loss intervention tailored for this age group, and to assess the preliminary efficacy of an intervention that emphasizes daily self-weighing within the context of a self-regulation model. Methods Forty young adults (29.1 ± 3.9 years, range 21–35, average BMI of 33.36 ± 3.4 were randomized to one of two brief behavioral weight loss interventions: behavioral self-regulation (BSR or adapted standard behavioral treatment (SBT. Assessments were conducted at baseline, post-treatment (10 weeks, and follow-up (20 weeks. Intent to treat analyses were conducted using general linear modeling in SPSS version 14.0. Results Participants in both groups attended an average of 8.7 out of 10 group meetings, and retention rates were 93% and 88% for post-treatment and follow-up assessments, respectively. Both groups achieved significant weight losses at post-treatment (BSR = -6.4 kg (4.0; SBT = -6.2 kg (4.5 and follow-up (BSR = -6.6 kg (5.5; SBT = -5.8 kg (5.2, p p = .84. Across groups, there was a positive association between frequency of weighing at follow-up and overall weight change at follow-up (p = .01. Daily weighing was not associated with any adverse changes in psychological symptoms. Conclusion Young adults can be recruited and retained in a behavioral weight loss program tailored to their needs, and significant weight losses can be achieved and maintained through this brief intervention. Future research on the longer-term efficacy of a self-regulation approach using daily self-weighing for weight loss in this age group is warranted. Clinical Trials Registration # NCT00488228

  10. The relationship between weight loss and time and risk preference parameters: a randomized controlled trial.

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    Takada, Akemi; Nakamura, Ryota; Furukawa, Masakazu; Takahashi, Yoshimitsu; Nishimura, Shuzo; Kosugi, Shinji

    2011-07-01

    This study aimed to assess the effectiveness of intervention (specifically, intervention by telephone and mails, known as 'tele-care') relative to self-help as a weight-loss method. The question of whether there is a correlation between changes in two preference parameters--time discounting (i.e. impatience) and risk aversion--and the level of commitment was examined. The study, spanning a period of 24 weeks in 2006-2007, comprised 118 participants, each of whom was randomly assigned to either the tele-care or the self-help group. A public-health nurse provided support through telephone and mail communications to the tele-care group, aiming to reduce their calorie intake and increase exercise via this intervention. There was a significant decrease in the body weight of the participants of the tele-care group from the baseline; however, there were no significant differences in the weight loss, median time discounting or risk aversion between the two groups. The subsequent analysis for weight loss with changes in time and risk parameters revealed a significant difference in the weight loss in the time-discounting-loss and risk-aversion-gain groups. From the results of the multiple regression analysis, the time discounting was noted to be associated with age, initial BMI and marital status among men, and risk aversion was associated with age and job status among women. There is a possibility that a decrease in time discounting and increase in risk aversion might correlate with the weight loss or effectiveness of commitment in this trial. This study suggests that time discounting and risk aversion may be useful in anti-obesity efforts, since they are accurate criteria of behavioural patterns associated with weight problems. © Cambridge University Press, 2011

  11. Applying economic incentives to increase effectiveness of an outpatient weight loss program (TRIO) - A randomized controlled trial.

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    Finkelstein, Eric A; Tham, Kwang-Wei; Haaland, Benjamin A; Sahasranaman, Aarti

    2017-07-01

    The prevalence of overweight and obesity has more than doubled in the past three decades, leading to rising rates of non-communicable diseases. This study tests whether adding a payment/rewards (term reward) program to an existing evidence-based weight loss program can increase weight loss and weight loss maintenance. We conducted a parallel-group randomized controlled trial from October 2012 to October 2015 with 161 overweight or obese individuals randomized to either control or reward arm in a 1:2 ratio. Control and reward arm participants received a four month weight loss program at the LIFE (Lifestyle Improvement and Fitness Enhancement) Centre at Singapore General Hospital. Those in the reward arm paid a fee of S$165.00 (1US$ = 1.35S$) to access a program that provided rewards of up to S$660 for meeting weight loss and physical activity goals. Participants could choose to receive rewards as guaranteed cash payments or a lottery ticket with a 1 in 10 chance of winning but with the same expected value. The primary outcome was weight loss at months 4, 8, and 12. 161 participants were randomized to control (n = 54) or reward (n = 107) arms. Average weight loss was more than twice as great in the reward arm compared to the control arm at month 4 when the program concluded (3.4 kg vs 1.4 kg, p rewards concluded (3.3 kg vs 1.8 kg, p rewards program can be used to improve weight loss and weight loss maintenance when combined with an evidence-based weight loss program. Future efforts should attempt to replicate this approach and identify how to cost effectively expand these programs to maximize their reach. This study is registered at www.clinicaltrials.gov (Identifier: NCT01533454). Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Efficacy of polyglucosamine for weight loss?confirmed in a randomized double-blind, placebo-controlled clinical investigation

    OpenAIRE

    Pokhis, Karina; Bitterlich, Norman; Cornelli, Umberto; Cassano, Giuseppina

    2015-01-01

    Background The purpose of this clinical study was to ascertain whether low molecular weight chitosan polyglucosamine is able to produce significantly better weight loss than placebo. Method 115 participants were included in the study. We used a two-center randomized, double blind, placebo-controlled design. The participants followed a standard treatment (ST), which included the combination of a low-calorie diet achieved through creating a daily calorie deficit (500 cal) and an increased daily...

  13. An overview of the Families Improving Together (FIT) for weight loss randomized controlled trial in African American families.

    Science.gov (United States)

    Wilson, Dawn K; Kitzman-Ulrich, Heather; Resnicow, Ken; Van Horn, M Lee; St George, Sara M; Siceloff, E Rebekah; Alia, Kassandra A; McDaniel, Tyler; Heatley, VaShawn; Huffman, Lauren; Coulon, Sandra; Prinz, Ron

    2015-05-01

    The Families Improving Together (FIT) randomized controlled trial tests the efficacy of integrating cultural tailoring, positive parenting, and motivational strategies into a comprehensive curriculum for weight loss in African American adolescents. The overall goal of the FIT trial is to test the effects of an integrated intervention curriculum and the added effects of a tailored web-based intervention on reducing z-BMI in overweight African American adolescents. The FIT trial is a randomized group cohort design the will involve 520 African American families with an overweight adolescent between the ages of 11-16 years. The trial tests the efficacy of an 8-week face-to-face group randomized program comparing M + FWL (Motivational Plus Family Weight Loss) to a comprehensive health education program (CHE) and re-randomizes participants to either an 8-week on-line tailored intervention or control on-line program resulting in a 2 (M + FWL vs. CHE group) × 2 (on-line intervention vs. control on-line program) factorial design to test the effects of the intervention on reducing z-BMI at post-treatment and at 6-month follow-up. The interventions for this trial are based on a theoretical framework that is novel and integrates elements from cultural tailoring, Family Systems Theory, Self-Determination Theory and Social Cognitive Theory. The intervention targets positive parenting skills (parenting style, monitoring, communication); cultural values; teaching parents to increase youth motivation by encouraging youth to have input and choice (autonomy-support); and provides a framework for building skills and self-efficacy through developing weight loss action plans that target goal setting, monitoring, and positive feedback. Copyright © 2015. Published by Elsevier Inc.

  14. Low-Dose Epinephrine Plus Tranexamic Acid Reduces Early Postoperative Blood Loss and Inflammatory Response: A Randomized Controlled Trial.

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    Zeng, Wei-Nan; Liu, Jun-Li; Wang, Fu-You; Chen, Cheng; Zhou, Qiang; Yang, Liu

    2018-02-21

    The reductions of perioperative blood loss and inflammatory response are important in total knee arthroplasty. Tranexamic acid reduced blood loss and the inflammatory response in several studies. However, the effect of epinephrine administration plus tranexamic acid has not been intensively investigated, to our knowledge. In this study, we evaluated whether the combined administration of low-dose epinephrine plus tranexamic acid reduced perioperative blood loss or inflammatory response further compared with tranexamic acid alone. This randomized placebo-controlled trial consisted of 179 consecutive patients who underwent primary total knee arthroplasty. Patients were randomized into 3 interventions: Group IV received intravenous low-dose epinephrine plus tranexamic acid, Group TP received topical diluted epinephrine plus tranexamic acid, and Group CT received tranexamic acid alone. The primary outcome was perioperative blood loss on postoperative day 1. Secondary outcomes included perioperative blood loss on postoperative day 3, coagulation and fibrinolysis parameters (measured by thromboelastography), inflammatory cytokine levels, transfusion values (rate and volume), thromboembolic complications, length of hospital stay, wound score, range of motion, and Hospital for Special Surgery (HSS) score. The mean calculated total blood loss (and standard deviation) in Group IV was 348.1 ± 158.2 mL on postoperative day 1 and 458.0 ± 183.4 mL on postoperative day 3, which were significantly reduced (p 0.05). The combined administration of low-dose epinephrine and tranexamic acid demonstrated an increased effect in reducing perioperative blood loss and the inflammatory response compared with tranexamic acid alone, with no apparent increased incidence of thromboembolic and other complications. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  15. Active Mothers Postpartum: a randomized controlled weight-loss intervention trial.

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    Østbye, Truls; Krause, Katrina M; Lovelady, Cheryl A; Morey, Miriam C; Bastian, Lori A; Peterson, Bercedis L; Swamy, Geeta K; Brouwer, Rebecca J N; McBride, Colleen M

    2009-09-01

    Pregnancy may contribute to overweight and obesity. The primary objective of Active Mothers Postpartum was to promote a reduction in BMI through 24-months postpartum via sustainable lifestyle changes. Behavioral intervention RCT to enhance postpartum weight loss. A total of 450 overweight or obese women, enrolled 6-weeks postpartum, were recruited through obstetrics clinics and community posters in the Durham NC area. Intervention participants were offered eight healthy-eating classes, ten physical-activity classes, and six telephone-counseling sessions over 9 months. Changes from baseline (6-weeks postpartum) to 1-month post-intervention (12-months postpartum) in: (1) diet (caloric intake, calories from fat, intake of certain foods); (2) physical activity (self-reported physical activity, television time); and (3) weight (collected 2004-2007, analyzed 2007-2008). Mean weight loss was 0.90 kg (+/-5.1 kg) in the intervention group and 0.36 kg (+/-4.9 kg) in the control group; this difference was not significant. There were also no significant group differences in improvement of diet or increased physical activity. In secondary analyses, there was a positive bivariate relationship between classes attended and weight loss (p=0.01). There were no significant differences among the arms in diet, physical activity, or weight change. Home-based interventions via mail, telephone, or Internet/e-mail may be more feasible and successful in this population. The postpartum period is an important phase in women's lives with regard to weight retention, but engaging them during this busy period remains a challenge. NCT00212251.

  16. Habit-based interventions for weight loss maintenance in adults with overweight and obesity: a randomized controlled trial.

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    Cleo, Gina; Glasziou, Paul; Beller, Elaine; Isenring, Elisabeth; Thomas, Rae

    2018-04-23

    The objective of this study was to determine whether habit-based interventions are clinically beneficial in achieving long-term (12-month) weight loss maintenance and explore whether making new habits or breaking old habits is more effective. Volunteer community members aged 18-75 years who had overweight or obesity (BMI ≥ 25 kg/m 2 ) were randomized in a single-blind, three-arm, randomized controlled trial. Ten Top Tips (TTT), Do Something Different (DSD), and the attention-only waitlist (WL) control groups were conducted for 12 weeks from July to October 2015. Participants were followed up post-intervention (all groups) and at 6 and 12-month post-intervention (Ten Top Tips and Do Something Different only). The primary outcome was weight-loss maintenance at 12-month follow-up. Secondary outcomes included weight loss at all time points, fruit and vegetable consumption, exercise, wellbeing, depression, anxiety, habit strength, and openness to change. Of the 130 participants assessed for eligibility, 75 adults (mean BMI 34.5 kg/m 2 [SD 6.2]), with a mean age of 51 years were recruited. Assessments were completed post-intervention by 66/75 (88%) of participants and by 43/50 (86%) at 12 months. At post-intervention, participants in the Ten Top Tips (-3.3 kg; 95% CI -5.2, -1.4) and Do Something Different (-2.9 kg; 95% CI -4.3, -1.4) interventions lost significantly more weight (P = Habit-based weight-loss interventions-forming new habits (TTT) and breaking old habits (DSD), resulted in clinically important weight-loss maintenance at 12-month follow-up.

  17. Tranexamic acid reduces blood loss during and after cesarean section: A double blinded, randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Amr H. Yehia

    2014-03-01

    Conclusions: Tranexamic acid can be used safely to reduce blood loss during cesarean section. Reduced blood loss after tranexamic acid was associated with improvement of post-operative hemoglobin, hematocrit and with reduction of post-partum need for iron replacement.

  18. Whey Protein Supplementation Enhances Body Fat and Weight Loss in Women Long After Bariatric Surgery: a Randomized Controlled Trial.

    Science.gov (United States)

    Lopes Gomes, Daniela; Moehlecke, Milene; Lopes da Silva, Fernanda Bassan; Dutra, Eliane Said; D'Agord Schaan, Beatriz; Baiocchi de Carvalho, Kenia Mara

    2017-02-01

    The ideal nutritional approach for weight regain after bariatric surgery remains unclear. The objective of this study is to assess the effect of whey protein supplementation on weight loss and body composition of women who regained weight 24 or more months after bariatric surgery. This is a 16-week open-label, parallel-group, randomized controlled trial of women who regained at least 5 % of their lowest postoperative weight after a Roux-en-Y gastric bypass (RYGB). A total of 34 participants were treated with hypocaloric diet and randomized (1:1) to receive or not supplementation with whey protein, 0.5 g/kg of the ideal body weight. The primary outcomes were changes in body weight, fat free mass (FFM), and fat mass (FM), evaluated by tetrapolar bioelectrical impedance analysis (BIA). Secondary outcomes included resting energy expenditure, blood glucose, lipids, adiponectin, interleukin 6 (IL-6), and cholecystokinin levels. Statistical analyses included generalized estimating equations adjusted for age and physical activity. Fifteen patients in each group were evaluated: mean age was 45 ± 11 years, body mass index (BMI) was 35.7 ± 5.2 kg/m 2 , and time since surgery was 69 ± 23 months. Protein intake during follow-up increased by approximately 75 % in the intervention group (p = 0.01). The intervention group presented more body weight loss (1.86 kg, p = 0.017), accounted for FM loss (2.78, p = 0.021) and no change in FFM, as compared to controls (gain of 0.42 kg of body weight and 0.6 kg of FM). No differences in secondary outcomes were observed between groups. Whey protein supplementation promoted body weight and FM loss in women with long-term weight regain following RYGB.

  19. Effects of a weight loss plus exercise program on physical function in overweight, older women: a randomized controlled trial.

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    Anton, Stephen D; Manini, Todd M; Milsom, Vanessa A; Dubyak, Pamela; Cesari, Matteo; Cheng, Jing; Daniels, Michael J; Marsiske, Michael; Pahor, Marco; Leeuwenburgh, Christiaan; Perri, Michael G

    2011-01-01

    Obesity and a sedentary lifestyle are associated with physical impairments and biologic changes in older adults. Weight loss combined with exercise may reduce inflammation and improve physical functioning in overweight, sedentary, older adults. This study tested whether a weight loss program combined with moderate exercise could improve physical function in obese, older adult women. Participants (N = 34) were generally healthy, obese, older adult women (age range 55-79 years) with mild to moderate physical impairments (ie, functional limitations). Participants were randomly assigned to one of two groups for 24 weeks: (i) weight loss plus exercise (WL+E; n = 17; mean age = 63.7 years [4.5]) or (ii) educational control (n = 17; mean age = 63.7 [6.7]). In the WL+E group, participants attended a group-based weight management session plus three supervised exercise sessions within their community each week. During exercise sessions, participants engaged in brisk walking and lower-body resistance training of moderate intensity. Participants in the educational control group attended monthly health education lectures on topics relevant to older adults. Outcomes were: (i) body weight, (ii) walking speed (assessed by 400-meter walk test), (iii) the Short Physical Performance Battery (SPPB), and (iv) knee extension isokinetic strength. Participants randomized to the WL+E group lost significantly more weight than participants in the educational control group (5.95 [0.992] vs 0.23 [0.99] kg; P meter walk test = 44 seconds; P < 0.05). Scores on the SPPB improved in both the intervention and educational control groups from pre- to post-test (P < 0.05), with significant differences between groups (P = 0.02). Knee extension strength was maintained in both groups. Our findings suggest that a lifestyle-based weight loss program consisting of moderate caloric restriction plus moderate exercise can produce significant weight loss and improve physical function while maintaining muscle

  20. Comparative effectiveness of plant-based diets for weight loss: a randomized controlled trial of five different diets.

    Science.gov (United States)

    Turner-McGrievy, Gabrielle M; Davidson, Charis R; Wingard, Ellen E; Wilcox, Sara; Frongillo, Edward A

    2015-02-01

    The aim of this study was to determine the effect of plant-based diets on weight loss. Participants were enrolled in a 6-mo, five-arm, randomized controlled trial in 2013 in South Carolina. Participants attended weekly group meetings, with the exception of the omnivorous group, which served as the control and attended monthly meetings augmented with weekly e-mail lessons. All groups attended monthly meetings for the last 4 mo of the study. Diets did not emphasize caloric restriction. Overweight adults (body mass index 25-49.9 kg/m(2); age 18-65 y, 19% non-white, and 27% men) were randomized to a low-fat, low-glycemic index diet: vegan (n = 12), vegetarian (n = 13), pesco-vegetarian (n = 13), semi-vegetarian (n = 13), or omnivorous (n = 12). Fifty (79%) participants completed the study. In intention-to-treat analysis, the linear trend for weight loss across the five groups was significant at both 2 (P vegan group (-7.5% ± 4.5%) was significantly different from the omnivorous (-3.1% ± 3.6%; P = 0.03), semi-vegetarian (-3.2% ± 3.8%; P = 0.03), and pesco-vegetarian (-3.2% ± 3.4%; P = 0.03) groups. Vegan participants decreased their fat and saturated fat more than the pesco-vegetarian, semi-vegetarian, and omnivorous groups at both 2 and 6 mo (P Vegan diets may result in greater weight loss than more modest recommendations. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation.

    Science.gov (United States)

    Pokhis, Karina; Bitterlich, Norman; Cornelli, Umberto; Cassano, Giuseppina

    2015-01-01

    The purpose of this clinical study was to ascertain whether low molecular weight chitosan polyglucosamine is able to produce significantly better weight loss than placebo. 115 participants were included in the study. We used a two-center randomized, double blind, placebo-controlled design. The participants followed a standard treatment (ST), which included the combination of a low-calorie diet achieved through creating a daily calorie deficit (500 cal) and an increased daily physical activity (7 MET-h/week). They were randomized to receive standard treatment plus placebo (ST + PL) or standard treatment plus polyglucosamine (ST + PG), respectively. Participants were instructed to take 2 × 2 tablets before the two meals containing the highest fat content for at least 24 weeks. Body weight, BMI, waist circumference and the time needed for a 5 % body weight reduction (5R) were taken as main variables. The average weight loss over a period of 25 weeks in the ITT population was 5.8 ± 4.09 kg in the ST + PG group versus 4.0 ± 2.94 kg in the ST + PL (pU = 0.023; pt = 0.010). After 25 weeks, 34 participants achieved 5R in the ST + PG group (64.1 %) compared to only 23 participants in the ST + PL group (42.6 %) (ITT) (p Fisher = 0.033). Weight loss through hypo-caloric diets have been found to be effective. The additional effect of PG in combination with standard treatment is able to produce significantly better weight loss than placebo. Participants treated with ST + PG showed a significant amount of weight loss, an additional 1.8 kg, compared to controls treated with ST + PL. Trial Registration at ClinicalTrials.gov: NCT02410785 Registered 07 April 2015.

  2. Vitamin D Supplementation in Elderly Black Women Does Not Prevent Bone Loss, a Randomized Controlled Trial.

    Science.gov (United States)

    Aloia, John F; Fazzari, Melissa; Islam, Shahidul; Mikhail, Mageda; Katumuluwa, Subhashini; Dhaliwal, Ruban; Stolberg, Alexandra; Usera, Gianina; Ragolia, Louis

    2018-06-15

    Black Americans have lower levels of serum 25(OH)D but superior bone health compared to white Americans. There is controversy over whether they should be screened for vitamin D deficiency and have higher vitamin D requirements than recommended by the Institute of Medicine (IOM). The purpose of this trial was to determine whether Vitamin D supplementation in elderly black women prevents bone loss. 260 healthy black American women, 60 years of age and older were recruited to take part in a two arm, double-dummy 3 year RCT of vitamin D 3 vs. placebo. The study was conducted in an ambulatory clinical research center. Vitamin D 3 dose was adjusted to maintain serum 25(OH)D above 75 nmol/L. Bone mineral density (BMD) and serum were measured for [parathyroid hormone (PTH), C-terminal crosslink telopeptide (CTX) and bone specific alkaline phosphatase (BSAP) every 6 months. Baseline serum 25(OH)D 3 was 54.8 ± 16.8 nmol/L. There was no group xtime interaction effect for any BMD measurement. For all BMD measurements, except for total body and spine, there was a statistically significant negative effect of time (P D above 75 nmol/L is comparable to the rate of loss with serum 25(OH)D at the RDA of 50 nmol/L. Black Americans should have the same exposure to vitamin D as white Americans. The trial was registered at clinical trials.gov: NCT01153568. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  3. Effects of a weight loss plus exercise program on physical function in overweight, older women: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Anton SD

    2011-06-01

    Full Text Available Stephen D Anton1,2, Todd M Manini1, Vanessa A Milsom2, Pamela Dubyak2, Matteo Cesari3, Jing Cheng4, Michael J Daniels5, Michael Marsiske2, Marco Pahor1, Christiaan Leeuwenburgh1, Michael G Perri21Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA; 2Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA; 3Area di Geriatria, Università Campus Bio-Medico, Rome, Italy; 4Division of Oral Epidemiology and Dental Public Health, San Francisco, CA, USA; 5Department of Statistics, University of Florida, Gainesville, FL, USABackground: Obesity and a sedentary lifestyle are associated with physical impairments and biologic changes in older adults. Weight loss combined with exercise may reduce inflammation and improve physical functioning in overweight, sedentary, older adults. This study tested whether a weight loss program combined with moderate exercise could improve physical function in obese, older adult women.Methods: Participants (n = 34 were generally healthy, obese, older adult women (age range 55–79 years with mild to moderate physical impairments (ie, functional limitations. Participants were randomly assigned to one of two groups for 24 weeks: (i weight loss plus exercise (WL+E; n = 17; mean age = 63.7 years [4.5] or (ii educational control (n = 17; mean age = 63.7 [6.7]. In the WL+E group, participants attended a group-based weight management session plus three supervised exercise sessions within their community each week. During exercise sessions, participants engaged in brisk walking and lower-body resistance training of moderate intensity. Participants in the educational control group attended monthly health education lectures on topics relevant to older adults. Outcomes were: (i body weight, (ii walking speed (assessed by 400-meter walk test, (iii the Short Physical Performance Battery (SPPB, and (iv knee extension isokinetic strength.Results: Participants randomized

  4. Can local application of Tranexamic acid reduce post-coronary bypass surgery blood loss? A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Latter David

    2009-06-01

    Full Text Available Abstract Background Diffuse microvascular bleeding remains a common problem after cardiac procedures. Systemic use of antifibrinolytic reduces the postoperative blood loss. The purpose of this study was to examine the effectiveness of local application of tranexamic acid to reduce blood loss after coronary artery bypass grafting (CABG. Methods Thirty eight patients scheduled for primary isolated coronary artery bypass grafting were included in this double blind, prospective, randomized, placebo controlled study. Tranexamic acid (TA group (19 patients received 1 gram of TA diluted in 100 ml normal saline. Placebo group (19 patients received 100 ml of normal saline only. The solution was purred in the pericardial and mediastinal cavities. Results Both groups were comparable in their baseline demographic and surgical characteristics. During the first 24 hours post-operatively, cumulative blood loss was significantly less in TA group (median of 626 ml compared to Placebo group (median of 1040 ml (P = 0.04. There was no significant difference in the post-op Packed RBCs transfusion between both groups (median of one unit in each (P = 0.82. Significant less platelets transfusion required in TA group (median zero unit than in placebo group (median 2 units (P = 0.03. Apart from re-exploration for excessive surgical bleeding in one patient in TA group, no difference was found in morbidity or mortality between both groups. Conclusion Topical application of tranexamic acid in patients undergoing primary coronary artery bypass grafting led to a significant reduction in postoperative blood loss without adding extra risk to the patient.

  5. Differences in Weight Loss Between Persons on Standard Balanced vs Nutrigenetic Diets in a Randomized Controlled Trial.

    Science.gov (United States)

    Frankwich, Karen A; Egnatios, Jeremy; Kenyon, Mandy L; Rutledge, Thomas R; Liao, Patricia S; Gupta, Samir; Herbst, Karen L; Zarrinpar, Amir

    2015-09-01

    Many companies provide genetic tests for obesity-related polymorphisms (nutrigenetics) and make dietary recommendations for weight loss that are based on the results. We performed a randomized controlled trial to determine whether more participants who followed a nutrigenetic-guided diet lost ≥5% of their body weight than participants on a standard balanced diet for 8 and 24 weeks. We performed a prospective study of 51 obese or overweight U.S. veterans on an established weight management program at the Veterans Administration San Diego Healthcare System (the MOVE! program). Participants were randomly assigned to groups placed on a nutrigenetic-guided diet (balanced, low-carbohydrate, low-fat, or Mediterranean; n = 30) or a standard balanced diet (n = 21). Nutrigenetic diets were selected on the basis of results from the Pathway FIT test. There was no significant difference in the percentage of participants on the balanced diet vs the nutrigenetic-guided diet who lost 5% of their body weight at 8 weeks (35.0% ± 20.9% vs 26.9% ± 17.1%, respectively; P = .28) or at 24 weeks. Both groups had difficulty adhering to the diets. However, adherence to the nutrigenetic-guided diet correlated with weight loss (r = 0.74; P = 4.0 × 10(-5)), but not adherence to standard therapy (r = 0.34; P = .23). Participants who had low-risk polymorphisms for obesity lost more weight than all other participants at 8 weeks (5.0% vs 2.9%, respectively; P = .02) and had significantly greater reductions in body mass index (6.4% vs 3.6%, respectively; P = .03) and waist circumference (6.5% vs 2.6%, respectively; P = .02) at 24 weeks. In a prospective study, a nutrigenetic-based diet did not increase weight loss compared with a standard balanced diet. However, genetic features can identify individuals most likely to benefit from a balanced diet weight loss strategy; these findings require further investigation. ClinicalTrials.gov number: NCT01859403. Copyright © 2015 AGA

  6. Adherence and success in long-term weight loss diets: the dietary intervention randomized controlled trial (DIRECT).

    Science.gov (United States)

    Greenberg, Ilana; Stampfer, Meir J; Schwarzfuchs, Dan; Shai, Iris

    2009-04-01

    Data are limited as to whether participants in diet trials truly adhere to their assigned diet and the factors that affect their adherence. We evaluated success and adherence in a two-year dietary intervention randomized controlled trial (DIRECT) in which 322 moderately obese participants (mean age 52 yrs, mean body-mass-index (BMI) 31 kg/m(2), 86% men) were randomized to one of three groups: low-fat, Mediterranean, or low-carbohydrate diets. Overall compliance at month-24 was 85%, with 90% in low-fat, 85% in Mediterranean, and 78% in low-carbohydrate diet (p = .042 between groups). Attrition was higher in women (29% vs. 14% men, p = .001) and current smokers (25% vs. 14% among maintainers, p = 0.04). In a multivariate model, independent predictors of dropping-out were: higher baseline BMI (OR = 1.11; CI: 1.03-1.21) and less weight loss at month-6 (OR = 1.20; CI: 1.1-1.3). In a multivariate model, greater weight loss achieved at month-6 was the main predictor associated with success in weight loss (> 5%) over 2 years (OR = 1.5; CI: 1.35-1.67). Self-reported complete adherence score to diet was greater on low-carbohydrate diet (p low-fat) until month-6, but dropped overall from 81% at month-1 to 57% at month-24. Holidays were a trigger to a significant decrease in adherence followed by a partial rebound. Changes in diet composition from month-1 to month-12 were more pronounced in the multi-stage low-carbohydrate diet-group (p < .05). Generally, the most irresistible restricted food items were cookies (45% of dieters) and fruits (30%). Among the physically active (n = 107), 44% reported a tendency to eat less after exercising compared to 10% who tended to eat more. Initial 6-month reduction in weight is the main predictor of both long-term retention and success in weight loss. Special attention is needed for women, current smokers, and during holidays. Physical activity is associated with subsequent reduction in energy intake.

  7. Differences in Weight Loss Between Persons on Standard Balanced vs Nutrigenetic Diets in a Randomized Controlled Trial

    Science.gov (United States)

    Kenyon, Mandy L.; Rutledge, Thomas R.; Liao, Patricia S.; Gupta, Samir; Herbst, Karen L.; Zarrinpar, Amir

    2015-01-01

    Background & Aims Many companies provide genetic tests for obesity-related polymorphisms (nutrigenetics) and make dietary recommendations for weight loss based on the results. We performed a randomized controlled trial to determine whether more participants who followed a nutrigenetic-guided diet lost ≥5% of their body weight than participants on a standard balanced diet, for 8 and 24 weeks. Methods We performed a prospective study of 51 obese or overweight US veterans on an established weight management program at the Veterans Administration San Diego Healthcare System (the MOVE! Program). Participants were randomly assigned to groups placed on a nutrigenetic-guided diet (balanced, low-carbohydrate, low-fat, or Mediterranean; n=30) or a standard balanced diet (n=21). Nutrigenetic diets were selected based on results from the Pathway FIT test (Pathway Genomics; San Diego, CA). Results There was no significant difference in the percentage of participants on the balanced diet vs the nutrigenetic-guided diet who lost 5% of their body weight at 8 weeks (35.0%±20.9% vs 26.9%±17.1%, respectively; P=.28) or at 24 weeks. Both groups had difficulty adhering to the diets. However, adherence to the nutrigenetic-guided diet correlated with weight loss (r=0.74; P= 4.0 × 10−5), but not adherence to standard therapy (r=0.34; P=.23). Participants who had low-risk polymorphisms for obesity lost more weight than all other participants at 8 weeks (5.0% vs 2.9%, respectively; P=.02), and had significantly greater reductions in body mass index (6.4% vs 3.6% respectively; P=.03) and waist circumference (6.5% vs 2.6% respectively; P=.02) at 24 weeks. Conclusions In a prospective study, a nutrigenetic-based diet did not increase weight loss compared with a standard balanced diet. However, genetic features can identify individuals most likely to benefit from a balanced diet weight loss strategy; these findings require further investigation. ClincialTrials.gov number: NCT01859403

  8. Effect of tranexamic acid irrigation on perioperative blood loss during orthognathic surgery: a double-blind, randomized controlled clinical trial.

    Science.gov (United States)

    Eftekharian, Hamidreza; Vahedi, Ruhollah; Karagah, Tuba; Tabrizi, Reza

    2015-01-01

    Perioperative hemorrhage is an important concern during orthognathic surgery. The purpose of this study was to assess the effect of tranexamic acid (TXA) irrigation on perioperative hemorrhage during orthognathic surgery. In this double-blind, randomized controlled clinical trial, 56 participants who underwent orthognathic surgery were divided into 2 groups. The patients in the first group received TXA irrigation with normal saline (1 mg/mL), and the patients in the second group had normal saline for irrigation during orthognathic surgery. Age, gender, operation duration, the amount of irrigation solution used, and preoperative hemoglobin, hematocrit, and weight were the variables that were studied. The use of TXA solution for irrigation was the predictive factor of the study. Each group consisted of 28 patients. Group 1 consisted of 15 male patients (53.6%) and 13 female patients (46.4%) and group 2 consisted of 14 male patients (50%) and 14 female patients (50%). There was no difference in the distributions of the variables between the 2 groups, except for the duration of the operation. The mean duration of the operation was 3.94 ± 0.61 hours in group 1 and 4.17 ± 0.98 hours in group 2, and the difference in this respect between the 2 groups was statistically significant (P .05). TXA is effective in reducing intraoperative blood loss in patients for whom substantial blood loss is anticipated. Copyright © 2015 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  9. Effectiveness of web-based self-disclosure peer-to-peer support for weight loss: randomized controlled trial.

    Science.gov (United States)

    Imanaka, Mie; Ando, Masahiko; Kitamura, Tetsuhisa; Kawamura, Takashi

    2013-07-09

    Obesity is one of the most common public health problems in the industrialized world as a cause of noncommunicable diseases. Although primarily used for one-on-one communication, email is available for uninterrupted support for weight loss, but little is known about the effects of dietitian group counseling for weight control via the Internet. We developed a Web-based self-disclosure health support (WSHS) system for weight loss. This study aims to compare the effect of weight change between those using the WSHS and those using the email health support (EHS). This study was designed as an open prospective individual randomized controlled trial. Eligible participants were aged 35 to 65 years with a body mass index (BMI) of ≥25.0 in their latest health examination. Participants were randomly assigned to either the WSHS group or the EHS group. Thirteen registered dietitians under the direction of a principal dietitian each instructed 6 to 8 participants from the respective groups. All participants in the WSHS group could receive nutritional advice and calculate their nutritive intake from a photograph of a meal on their computer screen from the Internet sent to them by their dietitian, receive supervision from the registered dietitian, and view fellow participants' weight changes and lifestyle modifications. In the EHS group, a participant could receive one-on-one nutritional advice and calculate his/her nutritive intake from the photograph of a meal on computer screen sent by email from his/her dietitian, without being able to view fellow participants' status. The follow-up period was 12 weeks for both groups. The primary outcome measure was change in body weight. The secondary outcome measure included changes in BMI and waist circumference. The intergroup comparison of the changes before and after intervention was evaluated using analysis of covariance. A total of 193 participants were randomly assigned to either the WSHS group (n=97) or the EHS group (n=96). Ten

  10. Effects of medium-chain triglycerides on weight loss and body composition: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Mumme, Karen; Stonehouse, Welma

    2015-02-01

    Medium-chain triglycerides (MCTs) may result in negative energy balance and weight loss through increased energy expenditure and lipid oxidation. However, results from human intervention studies investigating the weight reducing potential of MCTs, have been mixed. To conduct a systematic review and meta-analysis of randomized controlled trials comparing the effects of MCTs, specifically C8:0 and C10:0, to long-chain triglycerides (LCTs) on weight loss and body composition in adults. Changes in blood lipid levels were secondary outcomes. Randomized controlled trials >3 weeks' duration conducted in healthy adults were identified searching Web of Knowledge, Discover, PubMed, Scopus, New Zealand Science, and Cochrane CENTRAL until March 2014 with no language restriction. Identified trials were assessed for bias. Mean differences were pooled and analyzed using inverse variance models with fixed effects. Heterogeneity between studies was calculated using I(2) statistic. An I(2)>50% or P<0.10 indicated heterogeneity. Thirteen trials (n=749) were identified. Compared with LCTs, MCTs decreased body weight (-0.51 kg [95% CI-0.80 to -0.23 kg]; P<0.001; I(2)=35%); waist circumference (-1.46 cm [95% CI -2.04 to -0.87 cm]; P<0.001; I(2)=0%), hip circumference (-0.79 cm [95% CI -1.27 to -0.30 cm]; P=0.002; I(2)=0%), total body fat (standard mean difference -0.39 [95% CI -0.57 to -0.22]; P<0.001; I(2)=0%), total subcutaneous fat (standard mean difference -0.46 [95% CI -0.64 to -0.27]; P<0.001; I(2)=20%), and visceral fat (standard mean difference -0.55 [95% CI -0.75 to -0.34]; P<0.001; I(2)=0%). No differences were seen in blood lipid levels. Many trials lacked sufficient information for a complete quality assessment, and commercial bias was detected. Although heterogeneity was absent, study designs varied with regard to duration, dose, and control of energy intake. Replacement of LCTs with MCTs in the diet could potentially induce modest reductions in body weight and composition

  11. Does the incorporation of portion-control strategies in a behavioral program improve weight loss in a 1-year randomized controlled trial?

    Science.gov (United States)

    Rolls, B J; Roe, L S; James, B L; Sanchez, C E

    2017-03-01

    Controlling food portion sizes can help reduce energy intake, but the effect of different portion-control methods on weight management is not known. In a 1-year randomized trial, we tested whether the efficacy of a behavioral weight-loss program was improved by incorporating either of the two portion-control strategies instead of standard advice about eating less. The Portion-Control Strategies Trial included 186 women with obesity (81%) or overweight (19%). Participants were randomly assigned to one of three equally intensive behavioral programs, consisting of 19 individual sessions over 12 months. The Standard Advice Group was instructed to eat less food while making healthy choices, the Portion Selection Group was instructed to choose portions based on the energy density using tools such as food scales and the Pre-portioned Foods Group was instructed to structure meals around pre-portioned foods such as single-serving main dishes, for which some vouchers were provided. In an intention-to-treat analysis, a mixed-effects model compared weight loss trajectories across 23 measurements; at month 12, weight was measured for 151 participants (81%). The trajectories showed that the Pre-portioned Foods Group initially lost weight at a greater rate than the other two groups (P=0.021), but subsequently regained weight at a greater rate (P=0.0005). As a result, weight loss did not differ significantly across groups at month 6 (mean±s.e. 5.2±0.4 kg) or month 12 (4.5±0.5 kg). After 1 year, measured weight loss averaged 6% of baseline weight. The frequency of using portion-control strategies initially differed across groups, then declined over time and converged at months 6 and 12. Incorporating instruction on portion-control strategies within a 1-year behavioral program did not lead to a greater weight loss than standard advice. Using pre-portioned foods enhanced early weight loss, but this was not sustained over time. Long-term maintenance of behavioral strategies to

  12. Design and implementation of a randomized controlled social and mobile weight loss trial for young adults (project SMART).

    Science.gov (United States)

    Patrick, K; Marshall, S J; Davila, E P; Kolodziejczyk, J K; Fowler, J H; Calfas, K J; Huang, J S; Rock, C L; Griswold, W G; Gupta, A; Merchant, G; Norman, G J; Raab, F; Donohue, M C; Fogg, B J; Robinson, T N

    2014-01-01

    To describe the theoretical rationale, intervention design, and clinical trial of a two-year weight control intervention for young adults deployed via social and mobile media. A total of 404 overweight or obese college students from three Southern California universities (M(age) = 22( ± 4) years; M(BMI) = 29( ± 2.8); 70% female) were randomized to participate in the intervention or to receive an informational web-based weight loss program. The intervention is based on behavioral theory and integrates intervention elements across multiple touch points, including Facebook, text messaging, smartphone applications, blogs, and e-mail. Participants are encouraged to seek social support among their friends, self-monitor their weight weekly, post their health behaviors on Facebook, and e-mail their weight loss questions/concerns to a health coach. The intervention is adaptive because new theory-driven and iteratively tailored intervention elements are developed and released over the course of the two-year intervention in response to patterns of use and user feedback. Measures of body mass index, waist circumference, diet, physical activity, sedentary behavior, weight management practices, smoking, alcohol, sleep, body image, self-esteem, and depression occur at 6, 12, 18, and 24 months. Currently, all participants have been recruited, and all are in the final year of the trial. Theory-driven, evidence-based strategies for physical activity, sedentary behavior, and dietary intake can be embedded in an intervention using social and mobile technologies to promote healthy weight-related behaviors in young adults. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Randomized Controlled Trial on the Effects of CCTV Training on Quality of Life, Depression, and Adaptation to Vision Loss

    NARCIS (Netherlands)

    Burggraaff, M.C.; van Nispen, R.M.A.; Knol, D.L.; Ringens, P.J.; van Rens, G.H.M.B.

    2012-01-01

    PURPOSE. In addition to performance-based measures, visionrelated quality of life (QOL) and other subjective measures of psychosocial functioning are considered important outcomes of training in the visually impaired. In a multicenter, masked, randomized controlled trial, subjective effects of

  14. A randomized controlled trial of behavioral weight loss treatment versus combined weight loss/depression treatment among women with comorbid obesity and depression.

    Science.gov (United States)

    Linde, Jennifer A; Simon, Gregory E; Ludman, Evette J; Ichikawa, Laura E; Operskalski, Belinda H; Arterburn, David; Rohde, Paul; Finch, Emily A; Jeffery, Robert W

    2011-02-01

    Obesity is associated with clinical depression among women. However, depressed women are often excluded from weight loss trials. This study examined treatment outcomes among women with comorbid obesity and depression. Two hundred three (203) women were randomized to behavioral weight loss (n = 102) or behavioral weight loss combined with cognitive-behavioral depression management (n = 101). Average participant age was 52 years; mean baseline body mass index was 39 kg/m(2). Mean Patient Health Questionnaire and Hopkins Symptom Checklist (SCL-20) scores indicated moderate to severe baseline depression. Weight loss and SCL-20 changes did not differ between groups at 6 or 12 months in intent-to-treat analyses (p = 0.26 and 0.55 for weight, p = 0.70 and 0.25 for depressive symptoms). Depressed obese women lost weight and demonstrated improved mood in both treatment programs. Future weight loss trials are encouraged to enroll depressed women.

  15. Effect of weight loss with or without exercise on inflammatory markers and adipokines in postmenopausal women : The SHAPE-2 Trial, a randomized controlled trial

    NARCIS (Netherlands)

    Van Gemert, Willemijn A.; May, Anne M.; Schuit, Albertine J.; Oosterhof, Blanche Y M; Peeters, Petra H.; Monninkhof, Evelyn M.

    2016-01-01

    Background: We investigated the effect of equivalent weight loss, by a hypocaloric diet or mainly exercise, on inflammatory markers and adipokines in overweight postmenopausal women. Methods: Women were randomized to a diet (n = 97), mainly exercise (n = 98), or control group (n = 48). Goal of both

  16. Effect of Weight Loss with or without Exercise on Inflammatory Markers and Adipokines in Postmenopausal Women : The SHAPE-2 Trial, A Randomized Controlled Trial

    NARCIS (Netherlands)

    van Gemert, Willemijn A; May, Anne M; Schuit, Albertine J; Oosterhof, Blanche Y M; Peeters, Petra H M; Monninkhof, Evelyn M.

    BACKGROUND: We investigated the effect of equivalent weight loss, by a hypocaloric diet or mainly exercise, on inflammatory markers and adipokines in overweight postmenopausal women. METHODS: Women were randomized to a diet (n = 97), mainly exercise (n = 98), or control group (n = 48). Goal of both

  17. Renal function following three distinct weight loss dietary strategies during 2 years of a randomized controlled trial.

    Science.gov (United States)

    Tirosh, Amir; Golan, Rachel; Harman-Boehm, Ilana; Henkin, Yaakov; Schwarzfuchs, Dan; Rudich, Assaf; Kovsan, Julia; Fiedler, Georg M; Blüher, Matthias; Stumvoll, Michael; Thiery, Joachim; Stampfer, Meir J; Shai, Iris

    2013-08-01

    This study addressed the long-term effect of various diets, particularly low-carbohydrate high-protein, on renal function on participants with or without type 2 diabetes. In the 2-year Dietary Intervention Randomized Controlled Trial (DIRECT), 318 participants (age, 51 years; 86% men; BMI, 31 kg/m(2); mean estimated glomerular filtration rate [eGFR], 70.5 mL/min/1.73 m(2); mean urine microalbumin-to-creatinine ratio, 12:12) with serum creatinine low-fat, Mediterranean, or low-carbohydrate diets. The 2-year compliance was 85%, and the proportion of protein intake significantly increased to 22% of energy only in the low-carbohydrate diet (P vs. low-fat and Mediterranean). We examined changes in urinary microalbumin and eGFR, estimated by Modification of Diet in Renal Disease and Chronic Kidney Disease Epidemiology Collaboration formulas. Significant (P low-carbohydrate (+5.3% [95% CI 2.1-8.5]), Mediterranean (+5.2% [3.0-7.4]), and low-fat diets (+4.0% [0.9-7.1]) with similar magnitude (P > 0.05) across diet groups. The increased eGFR was at least as prominent in participants with (+6.7%) or without (+4.5%) type 2 diabetes or those with lower baseline renal function of eGFR low-carbohydrate diet is as safe as Mediterranean or low-fat diets in preserving/improving renal function among moderately obese participants with or without type 2 diabetes, with baseline serum creatinine <176 μmol/L. Potential improvement is likely to be mediated by weight loss-induced improvements in insulin sensitivity and blood pressure.

  18. A 1-year randomized, double-blind, placebo-controlled study of intravenous ibandronate on bone loss following renal transplantation.

    Science.gov (United States)

    Smerud, K T; Dolgos, S; Olsen, I C; Åsberg, A; Sagedal, S; Reisæter, A V; Midtvedt, K; Pfeffer, P; Ueland, T; Godang, K; Bollerslev, J; Hartmann, A

    2012-12-01

    The clinical profile of ibandronate as add-on to calcitriol and calcium was studied in this double-blind, placebo-controlled trial of 129 renal transplant recipients with early stable renal function (≤ 28 days posttransplantation, GFR ≥ 30 mL/min). Patients were randomized to receive i.v. ibandronate 3 mg or i.v. placebo every 3 months for 12 months on top of oral calcitriol 0.25 mcg/day and calcium 500 mg b.i.d. At baseline, 10 weeks and 12 months bone mineral density (BMD) and biochemical markers of bone turnover were measured. The primary endpoint, relative change in BMD for the lumbar spine from baseline to 12 months was not different, +1.5% for ibandronate versus +0.5% for placebo (p = 0.28). Ibandronate demonstrated a significant improvement of BMD in total femur, +1.3% versus -0.5% (p = 0.01) and in the ultradistal radius, +0.6% versus -1.9% (p = 0.039). Bone formation markers were reduced by ibandronate, whereas the bone resorption marker, NTX, was reduced in both groups. Calcium and calcitriol supplementation alone showed an excellent efficacy and safety profile, virtually maintaining BMD without any loss over 12 months after renal transplantation, whereas adding ibandronate significantly improved BMD in total femur and ultradistal radius, and also suppressed biomarkers of bone turnover. Ibandronate was also well tolerated. © Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.

  19. Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.

    Science.gov (United States)

    Svetkey, Laura P; Batch, Bryan C; Lin, Pao-Hwa; Intille, Stephen S; Corsino, Leonor; Tyson, Crystal C; Bosworth, Hayden B; Grambow, Steven C; Voils, Corrine; Loria, Catherine; Gallis, John A; Schwager, Jenifer; Bennett, Gary G; Bennett, Gary B

    2015-11-01

    To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults. Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control. The 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P = 0.003), but not at 12 and 24 months. Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design. © 2015 The Obesity Society.

  20. Acupuncture therapy for sudden sensorineural hearing loss: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhang, Xin-chang; Xu, Xiu-ping; Xu, Wen-tao; Hou, Wen-zhen; Cheng, Ying-ying; Li, Chang-xi; Ni, Guang-xia

    2015-01-01

    Acupuncture has commonly been used in China, either alone or in combination with Western medicine, to treat sudden sensorineural hearing loss (SSHL). The purpose of this systematic review is to assess the efficacy and safety of acupuncture therapy for patients with SSHL. We searched PubMed, the Cochrane Library, Embase, China National Knowledge Internet (CNKI), Database for Chinese Technical Periodicals (VIP), and Chinese Biomedical literature service system (SinoMed) to collect randomized controlled trials of acupuncture for SSHL published before July 2014. A meta-analysis was conducted according to the Cochrane systematic review method using RevMan 5.2 software. The evidence level for each outcome was assessed using the GRADE methodology. Twelve trials involving 863 patients were included. A meta-analysis showed that the effect of manual acupuncture combined with Western medicine comprehensive treatment (WMCT) was better than WMCT alone (RR 1.33, 95%CI 1.19-1.49) and the same as the effect of electroacupuncture combined with WMCT (RR 1.33, 95%CI 1.19-1.50). One study showed a better effect of electroacupuncture than of WMCT (RR 1.34, 95%CI 1.24-1.45). For mean changes in hearing over all frequencies, the meta-analysis showed a better effect with the combination of acupuncture and WMCT than with WMCT alone (MD 10.85, 95%CI 6.84-14.86). However, the evidence levels for these interventions were low or very low due to a high risk of bias and small sample sizes in the included studies. There was not sufficient evidence showing that acupuncture therapy alone was beneficial for treating SSHL. However, interventions combining acupuncture with WMCT had more efficacious results in the treatment of SSHL than WMCT alone. Electroacupuncture alone might be a viable alternative treatment besides WMCT for SSHL. However, given that there were fewer eligible RCTs and limitations in the included trials, such as methodological drawbacks and small sample sizes, large-scale RCTs are

  1. Acupuncture therapy for sudden sensorineural hearing loss: a systematic review and meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Xin-chang Zhang

    Full Text Available Acupuncture has commonly been used in China, either alone or in combination with Western medicine, to treat sudden sensorineural hearing loss (SSHL. The purpose of this systematic review is to assess the efficacy and safety of acupuncture therapy for patients with SSHL.We searched PubMed, the Cochrane Library, Embase, China National Knowledge Internet (CNKI, Database for Chinese Technical Periodicals (VIP, and Chinese Biomedical literature service system (SinoMed to collect randomized controlled trials of acupuncture for SSHL published before July 2014. A meta-analysis was conducted according to the Cochrane systematic review method using RevMan 5.2 software. The evidence level for each outcome was assessed using the GRADE methodology.Twelve trials involving 863 patients were included. A meta-analysis showed that the effect of manual acupuncture combined with Western medicine comprehensive treatment (WMCT was better than WMCT alone (RR 1.33, 95%CI 1.19-1.49 and the same as the effect of electroacupuncture combined with WMCT (RR 1.33, 95%CI 1.19-1.50. One study showed a better effect of electroacupuncture than of WMCT (RR 1.34, 95%CI 1.24-1.45. For mean changes in hearing over all frequencies, the meta-analysis showed a better effect with the combination of acupuncture and WMCT than with WMCT alone (MD 10.85, 95%CI 6.84-14.86. However, the evidence levels for these interventions were low or very low due to a high risk of bias and small sample sizes in the included studies.There was not sufficient evidence showing that acupuncture therapy alone was beneficial for treating SSHL. However, interventions combining acupuncture with WMCT had more efficacious results in the treatment of SSHL than WMCT alone. Electroacupuncture alone might be a viable alternative treatment besides WMCT for SSHL. However, given that there were fewer eligible RCTs and limitations in the included trials, such as methodological drawbacks and small sample sizes, large

  2. Reduced reward-driven eating accounts for the impact of a mindfulness-based diet and exercise intervention on weight loss: Data from the SHINE randomized controlled trial.

    Science.gov (United States)

    Mason, Ashley E; Epel, Elissa S; Aschbacher, Kirstin; Lustig, Robert H; Acree, Michael; Kristeller, Jean; Cohn, Michael; Dallman, Mary; Moran, Patricia J; Bacchetti, Peter; Laraia, Barbara; Hecht, Frederick M; Daubenmier, Jennifer

    2016-05-01

    Many individuals with obesity report over eating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12- and 18-months post-baseline among 194 adults with obesity (BMI: 30-45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [β = -0.06, SE(β) = 0.03, p = .030, 95% CI (-0.12, -0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p = .396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414). Published by Elsevier Ltd.

  3. Efficacy of cognitive behavioral internet-based therapy in parents after the loss of a child during pregnancy: pilot data from a randomized controlled trial.

    Science.gov (United States)

    Kersting, Anette; Kroker, Kristin; Schlicht, Sarah; Baust, Katja; Wagner, Birgit

    2011-12-01

    The loss of a child during pregnancy can be a traumatic event associated with long-lasting grief and psychological distress. This study examined the efficacy of an internet-based cognitive behavioral therapy program for mothers after pregnancy loss. In a randomized controlled trial with a waiting list control group, 83 participants who had lost a child during pregnancy were randomly allocated either to 5 weeks of internet therapy or to a 5-week waiting condition. Within a manualized cognitive behavioral treatment program, participants wrote ten essays on loss-specific topics. Posttraumatic stress, grief, and general psychopathology, especially depression, were assessed pretreatment, posttreatment, and at 3-month follow-up. Intention-to-treat analyses and completer analyses were performed. Relative to controls, participants in the treatment group showed significant improvements in posttraumatic stress, grief, depression, and overall mental health, but not in anxiety or somatization. Medium to large effect sizes were observed, and the improvement was maintained at 3-month follow-up. This internet-based cognitive behavioral therapy program represents an effective treatment approach with stable effects for women after pregnancy loss. Implementation of the program can thus help to improve the health care provision for mothers in this traumatic loss situation.

  4. Protocol and Recruitment Results from a Randomized Controlled Trial Comparing Group Phone-Based versus Newsletter Interventions for Weight Loss Maintenance among Rural Breast Cancer Survivors

    OpenAIRE

    Befort, Christie A.; Klemp, Jennifer R.; Fabian, Carol; Perri, Michael G.; Sullivan, Debra K.; Schmitz, Kathryn H.; Diaz, Francisco J.; Shireman, Theresa

    2014-01-01

    Obesity is a risk factor for breast cancer recurrence and death. Women who reside in rural areas have higher obesity prevalence and suffer from breast cancer treatment-related disparities compared to urban women. The objective of this 5-year randomized controlled trial is to compare methods for delivering extended care for weight loss maintenance among rural breast cancer survivors. Group phone-based counseling via conference calls addresses access barriers, is more cost-effective than indivi...

  5. Using a technology-based intervention to promote weight loss in sedentary overweight or obese adults: a randomized controlled trial study design

    Directory of Open Access Journals (Sweden)

    Vaughn W Barry

    2011-02-01

    Full Text Available Vaughn W Barry1, Amanda C McClain1, Sara Shuger1, Xuemei Sui1, James W Hardin2, Gregory A Hand1, Sara Wilcox1, Steven N Blair1,21Department of Exercise Science; 2Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, SC, USAPurpose: The SenseWear™ Armband is an activity monitor developed to improve lifestyle self-monitoring. Currently, few studies assess electronic self-monitoring and weight loss with a lifestyle intervention program. To our knowledge, only one study has used the SenseWear Armband in combination with a lifestyle intervention to improve weight loss, and no studies have evaluated whether a self-monitoring intervention based solely on the armband can promote weight loss. Consequently, the aims of the study were to assess weight loss from electronic self-monitoring, to compare these values to the lifestyle intervention and standard care groups, and to compare weight loss with lifestyle intervention with and without the armband.Patients and methods: We recruited 197 sedentary overweight or obese adults (age, 46.8 ± 10.8 years; BMI, 33.3 ± 5.2 kg/m2 to participate in the 9-month study. Participants were randomized into one of four weight loss groups: 1 the standard care group received a self-directed weight loss program, complete with an evidence-based weight loss manual (standard care, n = 50; 2 a 14-week group-based behavioral weight loss program followed by weekly, biweekly, and monthly telephone counseling calls (GWL, n = 49; 3 the use of the armband to help improve lifestyle self-monitoring (SWA alone, n = 49; or (4 the group-based behavioral weight loss program and follow-up telephone counseling calls plus the armband (GWL + SWA, n = 49. All participants received the evidence-based weight loss manual at baseline. All measures were performed at baseline and months 4 and 9. The primary outcomes were weight loss and waist circumference reduction.Results: This study is a well-designed randomized

  6. Renal Function Following Three Distinct Weight Loss Dietary Strategies During 2 Years of a Randomized Controlled Trial

    OpenAIRE

    Tirosh, Amir; Golan, Rachel; Harman-Boehm, Ilana; Henkin, Yaakov; Schwarzfuchs, Dan; Rudich, Assaf; Kovsan, Julia; Fiedler, Georg M.; Blüher, Matthias; Stumvoll, Michael; Thiery, Joachim; Stampfer, Meir J.; Shai, Iris

    2013-01-01

    OBJECTIVE This study addressed the long-term effect of various diets, particularly low-carbohydrate high-protein, on renal function on participants with or without type 2 diabetes. RESEARCH DESIGN AND METHODS In the 2-year Dietary Intervention Randomized Controlled Trial (DIRECT), 318 participants (age, 51 years; 86% men; BMI, 31 kg/m2; mean estimated glomerular filtration rate [eGFR], 70.5 mL/min/1.73 m2; mean urine microalbumin-to-creatinine ratio, 12:12) with serum creatinine 0.05) across...

  7. Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).

    Science.gov (United States)

    Batch, Bryan C; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P

    2014-03-01

    The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to 3) a usual care, advice-only control condition. A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364. Published by Elsevier Inc.

  8. Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

    Science.gov (United States)

    Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.

    2014-01-01

    Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

  9. Preventing Excessive Blood Loss During Percutaneous Nephrolithotomy by Using Tranexamic Acid: A Double Blinded Prospective Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Adnan Siddiq

    2017-12-01

    Full Text Available Objective: Percutaneous nephrolithotomy (PCNL is most frequently performed procedure for renal stones 2 cm and larger. Perioperative hemorrhage being most common complication, warrants as important predicting factor of adverse outcomes. Prevention with inexpensive and safe drug like tranexamic acid (TA would ultimately turn out to be cornerstone for establishing future guidelines. Aim of this study is to evaluate whether TA is efficacious in preventing blood loss during PCNL. Materials and Methods: Ethical review board approval taken. Sample size calculation yielded 240 patients, comprising 120 in each group. Group A receiving TA and group B receiving placebo. Age, gender, body mass index (BMI, stone size, volume and location, preoperative blood count, creatinine, urine analysis, coagulation profile and necessary radiological investigations done. Randomization through lottery method. Both patient and investigator were blinded. Hemoglobin (Hb and hematocrit (Hct levels done at 24 hours postoperatively and fall in values recorded. Results: Both groups were equal in characteristics like age, gender, BMI, stone size, volume and location (p>0.05. Operative variables like calyx punctured, position of puncture and operative time were also found to be similar in both groups. Median change in Hb in placebo group was 1.6 interquartile range (IQR 4, while in TA group was 1.3 (IQR 7.8 (p=0.001. Similarly, median change in Hct level in placebo group was 3.6 (IQR 11.8 and in TA group was 2.4 (IQR 13 (p<0.001. Sixteen patients were transfused after surgery; 12 (75% belonged to placebo group while 4 (25% belonged to TA group (p=0.038. Hospital stay was not significantly different in both groups (p=0.177 with median of 4.0 and IQR of 0 in both groups. Conclusion: TA during PCNL reduces blood loss and minimizes blood transfusion rate.

  10. Screen-time Weight-loss Intervention Targeting Children at Home (SWITCH: A randomized controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Tsai Midi

    2011-06-01

    Full Text Available Abstract Background Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33% do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family oriented intervention to reduce sedentary screen time on children's body composition, sedentary behavior, physical activity, and diet. Methods/Design The study design is a pragmatic two-arm parallel randomized controlled trial. Two hundred and seventy overweight children aged 9-12 years and primary caregivers are being recruited. Participants are randomized to intervention (family-based screen time intervention or control (no change. At the end of the study, the control group is offered the intervention content. Data collection is undertaken at baseline and 24 weeks. The primary trial outcome is child body mass index (BMI and standardized body mass index (zBMI. Secondary outcomes are change from baseline to 24 weeks in child percentage body fat; waist circumference; self-reported average daily time spent in physical and sedentary activities; dietary intake; and enjoyment of physical activity and sedentary behavior. Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity. Discussion This study provides an excellent example of a theory-based, pragmatic, community-based trial targeting sedentary behavior in overweight children. The study has been specifically designed to allow for estimation of the consistency of effects on body composition for Māori (indigenous, Pacific and non-Māori/non-Pacific ethnic groups. If effective, this intervention is imminently scalable and could be integrated within existing weight

  11. Body fat loss and compensatory mechanisms in response to different doses of aerobic exercise - a randomized controlled trial in overweight sedentary males

    DEFF Research Database (Denmark)

    Larsen, Mads Rosenkilde; Auerbach, Pernille Landrock; Reichkendler, Michala Holm

    2012-01-01

    The amount of weight loss induced by exercise is often disappointing. A diet-induced negative energy balance triggers compensatory mechanisms, e.g. lower metabolic rate and increased appetite. However, knowledge about potential compensatory mechanisms triggered by increased aerobic exercise...... is limited. A randomized controlled trial was performed in healthy sedentary moderately overweight young men to examine the effects of increasing doses of aerobic exercise on body composition, accumulated energy balance, and the degree of compensation. Eighteen participants were randomized to a continuous...... sedentary control group, 21 to a moderate (MOD; 300 kcal/day) and 22 to a high dose (HIGH; 600 kcal/day) exercise group for 13 weeks, corresponding to approximately 30 and 60 minutes of daily aerobic exercise, respectively. Body weight (MOD: -3.6kg, P...

  12. A 12-week commercial web-based weight-loss program for overweight and obese adults: randomized controlled trial comparing basic versus enhanced features.

    Science.gov (United States)

    Collins, Clare E; Morgan, Philip J; Jones, Penelope; Fletcher, Kate; Martin, Julia; Aguiar, Elroy J; Lucas, Ashlee; Neve, Melinda J; Callister, Robin

    2012-04-25

    The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m(2)) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: -0.72, SD 1.1 kg/m(2), enhanced: -1.0, SD 1.4, control: 0.15, SD 0.82; P 3.0, SD 4.1, control: 0.4, SD 2.3; P 3.0; P Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks, the impact of superior participant retention on longer-term outcomes requires further study. Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time. Australian New Zealand Clinical Trials Registry (ANZCTR): 12610000197033.

  13. Effects of an Oral Elemental Nutritional Supplement on Post-gastrectomy Body Weight Loss in Gastric Cancer Patients: A Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Imamura, Hiroshi; Nishikawa, Kazuhiro; Kishi, Kentaro; Inoue, Kentaro; Matsuyama, Jin; Akamaru, Yusuke; Kimura, Yutaka; Tamura, Shigeyuki; Kawabata, Ryohei; Kawada, Junji; Fujiwara, Yoshiyuki; Kawase, Tomono; Fukui, Junichi; Takagi, Mari; Takeno, Atsushi; Shimokawa, Toshio

    2016-09-01

    Post-gastrectomy weight loss is associated with deterioration in quality of life, and influences the long-term prognosis of gastric cancer patients. We conducted a prospective, randomized controlled, open-label study to examine whether an oral elemental diet (Elental(®), Ajinomoto Pharmaceuticals, Tokyo, Japan; hereafter referred to as ED) prevents postoperative weight loss in post-gastrectomy patients. Patients were randomly divided to receive the ED or control diet. The ED group received 300 kcal of ED plus their regular diet for 6-8 weeks after surgery, starting from the day the patient started a soft rice or equivalent diet after surgery, while the control group received the regular diet alone. The primary endpoint was the percentage of body weight loss (%BWL) from the presurgical body weight to that at 6-8 weeks after surgery. Secondary endpoints were dietary adherence, nutrition-related blood parameters, and adverse events. This study included 112 patients in eight hospitals. The mean treatment compliance rate in the ED group was 68.7 ± 30.4 % (median 81.2 %). The %BWL was significantly different between the ED and control groups (4.86 ± 3.72 vs. 6.60 ± 4.90 %, respectively; p = 0.047). In patients who underwent total gastrectomy, the %BWL was significantly different between the two groups (5.03 ± 3.65 vs. 9.13 ± 5.43 %, respectively; p = 0.012). In multivariate analysis, ED treatment, surgery type, and preoperative performance status were independently associated with %BWL. No significant differences were observed in the other clinical variables. ED supplementation reduced postoperative weight loss in gastric cancer patients undergoing gastrectomy.

  14. Web-based interventions for weight loss and weight maintenance among rural midlife and older women: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Boeckner Linda S

    2011-06-01

    Full Text Available Abstract Background Weight loss is challenging and maintenance of weight loss is problematic among midlife and older rural women. Finding effective interventions using innovative delivery methods that can reach underserved and vulnerable populations of overweight and obese rural women is a public health challenge. Methods/Design This Women Weigh-In for Wellness (The WWW study randomized-controlled trial is designed to compare the effectiveness of theory-based behavior-change interventions using (1 website only, (2 website with peer-led support, or (3 website with professional email-counseling to facilitate initial weight loss (baseline to 6 months, guided continuing weight loss and maintenance (7-18 months and self-directed weight maintenance (19-30 months among rural women ages 45-69 with a BMI of 28-45. Recruitment efforts using local media will target 306 rural women who live within driving distance of a community college site where assessments will be conducted at baseline, 3, 6, 12, 18, 24 and 30 months by research nurses blinded to group assignments. Primary outcomes include changes in body weight, % weight loss, and eating and activity behavioral and biomarkers from baseline to each subsequent assessment. Secondary outcomes will be percentage of women achieving at least 5% and 10% weight loss without regain from baseline to 6, 18, and 30 months and achieving healthy eating and activity targets. Data analysis will use generalized estimating equations to analyze average change across groups and group differences in proportion of participants achieving target weight loss levels. Discussion The Women Weigh-In for Wellness study compares innovative web-based alternatives for providing lifestyle behavior-change interventions for promoting weight loss and weight maintenance among rural women. If effective, such interventions would offer potential for reducing overweight and obesity among a vulnerable, hard-to-reach, population of rural women

  15. Genetic Predisposition to Weight Loss and Regain With Lifestyle Intervention: Analyses From the Diabetes Prevention Program and the Look AHEAD Randomized Controlled Trials.

    Science.gov (United States)

    Papandonatos, George D; Pan, Qing; Pajewski, Nicholas M; Delahanty, Linda M; Peter, Inga; Erar, Bahar; Ahmad, Shafqat; Harden, Maegan; Chen, Ling; Fontanillas, Pierre; Wagenknecht, Lynne E; Kahn, Steven E; Wing, Rena R; Jablonski, Kathleen A; Huggins, Gordon S; Knowler, William C; Florez, Jose C; McCaffery, Jeanne M; Franks, Paul W

    2015-12-01

    Clinically relevant weight loss is achievable through lifestyle modification, but unintentional weight regain is common. We investigated whether recently discovered genetic variants affect weight loss and/or weight regain during behavioral intervention. Participants at high-risk of type 2 diabetes (Diabetes Prevention Program [DPP]; N = 917/907 intervention/comparison) or with type 2 diabetes (Look AHEAD [Action for Health in Diabetes]; N = 2,014/1,892 intervention/comparison) were from two parallel arm (lifestyle vs. comparison) randomized controlled trials. The associations of 91 established obesity-predisposing loci with weight loss across 4 years and with weight regain across years 2-4 after a minimum of 3% weight loss were tested. Each copy of the minor G allele of MTIF3 rs1885988 was consistently associated with greater weight loss following lifestyle intervention over 4 years across the DPP and Look AHEAD. No such effect was observed across comparison arms, leading to a nominally significant single nucleotide polymorphism×treatment interaction (P = 4.3 × 10(-3)). However, this effect was not significant at a study-wise significance level (Bonferroni threshold P lifestyle. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  16. Circumferential bone loss around splinted and nonsplinted immediately loaded implants retaining mandibular overdentures: A randomized controlled clinical trial using cone beam computed tomography.

    Science.gov (United States)

    Elsyad, Moustafa Abdou; Khirallah, Ahmed Samir

    2016-11-01

    Circumferential marginal bone around 2 splinted and nonsplinted immediately loaded implants in the edentulous mandible has not been previously investigated. The purpose of this randomized controlled clinical trial was to assess circumferential bone loss around splinted and nonsplinted immediately loaded implants retaining mandibular overdentures, using cone beam computed tomography (CBCT). Thirty participants with complete edentulism were allocated to 2 groups and received 2 implants in the canine region of the mandible. Implants were either left nonsplinted (with ball attachment [BA]) or splinted (with bar attachment [RA]). Mandibular overdentures were connected to the implants 1 week later. CBCT was used to evaluate vertical bone loss (VBL) and horizontal bone loss (HBLo) bone loss at the distal (D), buccal (B), mesial (M), and lingual (L) sites of each implant upon overdenture insertion (baseline, T0), 1 year (T1) and 3 years (T3) after insertion. Repeated measures ANOVA was used for statistical analysis (α=.05). No significant difference in the survival rate (93.3% for BA and 100% for RA) was found between groups (P=.156). VBL and HBLo increased significantly at T3 compared with T1 for both groups (Poverdentures were associated with significantly higher vertical and horizontal circumferential bone loss than those associated with splinted implants after a follow-up of 3 years. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  17. Long-term Impact of Weight Loss Intervention on Changes in Cognitive Function: Exploratory Analyses from the Action for Health in Diabetes Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Espeland, Mark A; Carmichael, Owen; Hayden, Kathleen; Neiberg, Rebecca H; Newman, Anne B; Keller, Jeffery N; Wadden, Thomas A; Rapp, Stephen R; Hill, James O; Horton, Edward S; Johnson, Karen C; Wagenknecht, Lynne; Wing, Rena R

    2018-03-14

    Diabetes adversely impacts cognition. Lifestyle change can improve diabetes control and potentially improve cognition. We examined whether weight loss through reduced caloric intake and increased physical activity was associated with slower cognitive aging in older adults with type 2 diabetes mellitus. The Look AHEAD randomized controlled clinical trial delivered 10 years of intensive lifestyle intervention (ILI) that yielded long-term weight losses. During 5 years spanning the end of intervention and postintervention follow-up, repeated cognitive assessments were obtained in 1,091 individuals who had been assigned to ILI or a control condition of diabetes support and education (DSE). We compared the means and slopes of scores on cognitive testing over these repeated assessments. Compared with DSE, assignment to ILI was associated with a -0.082 SD deficit in mean global cognitive function across repeated assessments (p = .010). However, overweight (body mass index [BMI] memory. The behavioral weight loss intervention was associated with small relative deficits in cognitive function among individuals who were obese and marginally greater cognitive decline overall compared to control. ClinicalTrials.gov Identifier: NCT00017953.

  18. Project TEAMS (Talking about Eating, Activity, and Mutual Support: a randomized controlled trial of a theory-based weight loss program for couples

    Directory of Open Access Journals (Sweden)

    Amy A. Gorin

    2017-09-01

    Full Text Available Abstract Background Obesity risk is shared between spouses, yet existing weight loss programs focus on individuals and not the marital dyad. Given the interdependence of weight in couples, weight management outcomes might be improved by targeting joint weight loss and the creation of an interpersonal milieu that supports long-term behavior change. According to Self-Determination Theory (SDT, greater autonomous self-regulation of behaviors, and subsequently better treatment outcomes, are observed in needs supportive environments in which personally meaningful choice is supported and criticism and control are minimized. Correlational analyses confirm these pathways in weight management, with needs support from one’s spouse or partner emerging as a distinct predictor of weight loss success. Research is now needed to establish causal links and to develop and test weight loss interventions designed to facilitate the needs supportive behavior of spouses. Methods Project TEAMS (Talking about Eating, Activity, and Mutual Support is a randomized controlled trial testing a couples-based intervention, grounded in SDT, designed to change the social context of weight loss by training spouses to provide needs support for each other’s eating and physical activity behavior. Sixty-four couples will be randomized to either 6 months of behavioral weight loss treatment informed by SDT (SDT-WL or to 6 months of standard behavioral weight loss treatment (BWL. Couples will attend weekly sessions for 6 months and will be assessed at 0, 3, 6, and 12 months. By bolstering needs support, SDT-WL is predicted to increase autonomous self-regulation and perceived competence and produce greater weight loss and maintenance than standard behavioral treatment. Exploratory analyses will examine the SDT process model prediction that the influence of needs support on treatment outcomes will be mediated by autonomous self-regulation and perceived competence. Discussion This

  19. Project TEAMS (Talking about Eating, Activity, and Mutual Support): a randomized controlled trial of a theory-based weight loss program for couples.

    Science.gov (United States)

    Gorin, Amy A; Powers, Theodore A; Gettens, Katelyn; Cornelius, Talea; Koestner, Richard; Mobley, Amy R; Pescatello, Linda; Medina, Tania Huedo

    2017-09-29

    Obesity risk is shared between spouses, yet existing weight loss programs focus on individuals and not the marital dyad. Given the interdependence of weight in couples, weight management outcomes might be improved by targeting joint weight loss and the creation of an interpersonal milieu that supports long-term behavior change. According to Self-Determination Theory (SDT), greater autonomous self-regulation of behaviors, and subsequently better treatment outcomes, are observed in needs supportive environments in which personally meaningful choice is supported and criticism and control are minimized. Correlational analyses confirm these pathways in weight management, with needs support from one's spouse or partner emerging as a distinct predictor of weight loss success. Research is now needed to establish causal links and to develop and test weight loss interventions designed to facilitate the needs supportive behavior of spouses. Project TEAMS (Talking about Eating, Activity, and Mutual Support) is a randomized controlled trial testing a couples-based intervention, grounded in SDT, designed to change the social context of weight loss by training spouses to provide needs support for each other's eating and physical activity behavior. Sixty-four couples will be randomized to either 6 months of behavioral weight loss treatment informed by SDT (SDT-WL) or to 6 months of standard behavioral weight loss treatment (BWL). Couples will attend weekly sessions for 6 months and will be assessed at 0, 3, 6, and 12 months. By bolstering needs support, SDT-WL is predicted to increase autonomous self-regulation and perceived competence and produce greater weight loss and maintenance than standard behavioral treatment. Exploratory analyses will examine the SDT process model prediction that the influence of needs support on treatment outcomes will be mediated by autonomous self-regulation and perceived competence. This study addresses the fundamental importance of interpersonal

  20. A randomized controlled trial to determine the efficacy of a high carbohydrate and high protein ready-to-eat food product for weight loss.

    Science.gov (United States)

    Fuller, N R; Fong, M; Gerofi, J; Leung, L; Leung, C; Denyer, G; Caterson, I D

    2016-04-01

    Incorporating meal replacements has been shown to produce a significantly greater weight loss than a conventional reduced calorie diet. Ready-to-eat conventional foods may also be effective in this role and provide additional benefit because of their palatability, acceptance and enjoyment and thus increase dietary compliance. This trial investigated the efficacy of a ready-to-eat food product (Vita-Weat biscuit) that is both high in carbohydrate and high in protein as part of a diet prescription for weight loss in an overweight and obese population group. A total of 76 participants were randomized to a 6-week weight loss intervention including the ready-to-eat food product (intervention group) or advice on the 'Australian Guide to Healthy Eating' (control group). Both groups lost approximately 2 kg weight which equated to a reduction in body mass index of 0.70 kg m(-2) . There was no significant difference in percentage weight loss from screening to 6 weeks between the two groups; mean difference for the intervention vs. -0.20% (95% confidence interval: -0.96, 1.36); P = 0.73. Both diets were nutritionally matched and well-accepted over the 6-week period. This study shows that the inclusion of a ready-to-eat food product can be included as part of a dietary programme to achieve a clinically significant weight loss over a short period. This may have benefit when incorporated into an individual's meal plan intermittently to assist weight control. It also provides support for current public health nutritional guidelines as the participants in this study following such advice were also successful in achieving a clinically meaningful weight loss. © 2016 World Obesity.

  1. Synergistic effects of intravenous and intra-articular tranexamic acid on reducing hemoglobin loss in revision total knee arthroplasty: a prospective, randomized, controlled study.

    Science.gov (United States)

    Yuan, Xiangwei; Wang, Jiaxing; Wang, Qiaojie; Zhang, Xianlong

    2018-04-01

    Tranexamic acid decreases blood loss in primary total knee arthroplasty, and no related prospective randomized clinical trials have been conducted to evaluate the effectiveness and safety of tranexamic acid in revision total knee arthroplasty. Thus, we conducted this work to evaluate the synergistic effects of intravenous plus intra-articular tranexamic acid on reducing hemoglobin loss compared with intra-articular tranexamic acid alone in revision total knee arthroplasty. This prospective, controlled study randomized 96 patients undergoing revision total knee arthroplasty into two groups: an intravenous plus intra-articular tranexamic acid group (48 patients who received 20 mg/kg intravenous tranexamic acid and 3.0 g intra-articular tranexamic acid); and an intra-articular tranexamic acid alone group (48 patients who received the same intravenous volume of normal saline and 3.0 g intra-articular tranexamic acid). The primary outcome was hemoglobin loss. Secondary outcomes included the volume of drain output, the percentage of patients who received transfusions, the number of units transfused, and thromboembolic events. The baseline data, preoperative hemoglobin, and tourniquet time were similar in both groups. There was significantly less hemoglobin loss in the intravenous plus intra-articular tranexamic acid group compared with the intra-articular tranexamic acid alone group (2.7 ± 0.6 g/dL and 3.7 ± 0.7 g/dL; p tranexamic acid alone group, the intravenous plus intra-articular tranexamic acid group also had significantly less drain output, fewer patients who received transfusions, and fewer units transfused (all p tranexamic acid alone, combined intravenous plus intra-articular tranexamic acid significantly reduced hemoglobin loss and the need for transfusion without an apparent increase in thromboembolic events in patients who underwent revision total knee arthroplasty. © 2018 AABB.

  2. Meal replacement based on Human Ration modulates metabolic risk factors during body weight loss: a randomized controlled trial.

    Science.gov (United States)

    Alves, Natalia Elizabeth Galdino; Enes, Bárbara Nery; Martino, Hércia Stampini Duarte; Alfenas, Rita de Cássia Gonçalves; Ribeiro, Sônia Machado Rocha

    2014-04-01

    A meal replacement may be an effective strategy in the management of obesity to increase antioxidant intake, attenuating oxidative stress and inflammation. In the present study, we investigated the efficacy of a new nutritional supplement to reduce metabolic risk parameters in obese women. In a randomized controlled crossover study (2 × 2), 22 women (percentage body fat 40.52 ± 3.75%; body mass index-BMI 28.72 ± 2.87 kg/m²; 35.04 ± 5.6 years old) were allocated into two treatments: hypocaloric diet and drink containing "Human Ration" (HR) consumption (CRHR), and hypocaloric diet and control drink consumption (CR). The study consisted of 2 periods of 5 weeks with 1 week of washout in two orders (CR → CRHR and CRHR → CR). Caloric restriction was 15%, based on estimated energy requirement. Anthropometric, clinical and metabolic risk parameters were assessed at baseline and at the end of each period. Some metabolic risk factors were favorably modulated in both interventions: reduction in body weight (CR -0.74 ± 1.27 kg; p = 0.01; CRHR -0.77 ± 1.3 kg; p = 0.02), body mass index (BMI) (CR -0.27 ± 0.51 kg/m²; p = 0.02; CRHR -0.30 ± 0.52 kg/m²; p = 0.01) and HOMA-IR (CR -0.35 ± 0.82; p = 0.02, CRHR -0.41 ± 0.83; p = 0.03). However, CRHR reduced waist circumference (-2.54 ± 2.74 cm; p < 0.01) and gynoid fat (-0.264 ± 0.28 g; p < 0.01), and increased HDL-c levels (0.08 ± 0.15 mmol/l; p = 0.04). Associated with hypocaloric diet, the intake of a nutritional supplement rich in phytochemicals as a breakfast substitute for 5 weeks had no additional effect on weight reduction than caloric restriction alone, but increased central lipolysis and improved the lipoprotein profile.

  3. Effects of Greenselect Phytosome? on weight maintenance after weight loss in obese women: a randomized placebo-controlled study

    OpenAIRE

    Gilardini, Luisa; Pasqualinotto, Lucia; Di Pierro, Francesco; Risso, Paolo; Invitti, Cecilia

    2016-01-01

    Background Most subjects regain weight after weight loss due to compensatory adaptations finalized to maintain stable body energy stores. Green tea (GT) preparations, which help maintain energy expenditure while dieting could be a useful strategy to facilitate weight maintenance. The usefulness of GT preparations in weight maintenance has been poorly studied so far with conflicting results. This study evaluated if a supplement of GSP and piperine helps obese women to maintain the weight loss ...

  4. Study protocol for Log2Lose: A feasibility randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity.

    Science.gov (United States)

    Voils, Corrine I; Levine, Erica; Gierisch, Jennifer M; Pendergast, Jane; Hale, Sarah L; McVay, Megan A; Reed, Shelby D; Yancy, William S; Bennett, Gary; Strawbridge, Elizabeth M; White, Allison C; Shaw, Ryan J

    2018-02-01

    The obesity epidemic has negative physical, psychological, and financial consequences. Despite the existence of effective behavioral weight loss interventions, many individuals do not achieve adequate weight loss, and most regain lost weight in the year following intervention. We report the rationale and design for a 2×2 factorial study that involves financial incentives for dietary self-monitoring (yes vs. no) and/or interim weight loss (yes vs. no). Outpatients with obesity participate in a 24-week, group-based weight loss intervention. All participants are asked to record their daily dietary and liquid intake on a smartphone application (app) and to weigh themselves daily at home on a study-provided cellular scale. An innovative information technology (IT) solution collates dietary data from the app and weight from the scale. Using these data, an algorithm classifies participants weekly according to whether they met their group's criteria to receive a cash reward ranging from $0 to $30 for dietary self-monitoring and/or interim weight loss. Notice of the reward is provided via text message, and credit is uploaded to a gift card. This pilot study will provide information on the feasibility of using this novel IT solution to provide variable-ratio financial incentives in real time via its effects on recruitment, intervention adherence, retention, and cost. This study will provide the foundation for a comprehensive, adequately-powered, randomized controlled trial to promote short-term weight loss and long-term weight maintenance. If efficacious, this approach could reduce the prevalence, adverse outcomes, and costs of obesity for millions of Americans. Clinicaltrials.gov registration: NCT02691260. Published by Elsevier Inc.

  5. Effects of a combined dietary, exercise and behavioral intervention and sympathetic system on body weight maintenance after intended weight loss: results of a randomized controlled trial.

    Science.gov (United States)

    Mai, Knut; Brachs, Maria; Leupelt, Verena; Schwartzenberg, Reiner Jumpertz-von; Maurer, Lukas; Grüters-Kieslich, Annette; Ernert, Andrea; Bobbert, Thomas; Krude, Heiko; Spranger, Joachim

    2018-01-19

    Lifestyle based weight loss interventions are hampered by long-term inefficacy. Prediction of individuals successfully reducing body weight would be highly desirable. Although sympathetic activity is known to contribute to energy homeostasis, its predictive role in body weight maintenance has not yet been addressed. We investigated, whether weight regain could be modified by a weight maintenance intervention and analyzed the predictive role of weight loss-induced changes of the sympathetic system on long-term weight regain. 156 subjects (age > 18; BMI ≥ 27 kg/m 2 ) participated in a 12-week weight reduction program. After weight loss (T0), 143 subjects (weight loss >8%) were randomized to a 12-month lifestyle intervention or a control group. After 12 months (T12) no further intervention was performed until month 18 (T18). Weight regain at T18 (regain BMI ) was the primary outcome. Evaluation of systemic and tissue specific estimates of sympathetic system was a pre-defined secondary outcome. BMI was reduced by 4.67 ± 1.47 kg/m 2 during the initial weight loss period. BMI maintained low in subjects of the intervention group until T12 (+0.07 ± 2.98 kg/m 2 ; p = 0.58 compared to T0), while control subjects regained +0.98 ± 1.93 kg/m 2 (p predicted regain BMI (R 2  = 0.138; p Predictive sympathetic activity was not persistently modified by the intervention, which may partially explain the lack of long-term success of such interventions. Copyright © 2018. Published by Elsevier Inc.

  6. Effects of a caloric restriction weight loss diet and exercise on inflammatory biomarkers in overweight/obese postmenopausal women: a randomized controlled trial.

    Science.gov (United States)

    Imayama, Ikuyo; Ulrich, Cornelia M; Alfano, Catherine M; Wang, Chiachi; Xiao, Liren; Wener, Mark H; Campbell, Kristin L; Duggan, Catherine; Foster-Schubert, Karen E; Kong, Angela; Mason, Caitlin E; Wang, Ching-Yun; Blackburn, George L; Bain, Carolyn E; Thompson, Henry J; McTiernan, Anne

    2012-05-01

    Obese and sedentary persons have increased risk for cancer; inflammation is a hypothesized mechanism. We examined the effects of a caloric restriction weight loss diet and exercise on inflammatory biomarkers in 439 women. Overweight and obese postmenopausal women were randomized to 1-year: caloric restriction diet (goal of 10% weight loss, N = 118), aerobic exercise (225 min/wk of moderate-to-vigorous activity, N = 117), combined diet + exercise (N = 117), or control (N = 87). Baseline and 1-year high-sensitivity C-reactive protein (hs-CRP), serum amyloid A (SAA), interleukin-6 (IL-6), leukocyte, and neutrophil levels were measured by investigators blind to group. Inflammatory biomarker changes were compared using generalized estimating equations. Models were adjusted for baseline body mass index (BMI), race/ethnicity, and age. Four hundred and thirty-eight (N = 1 in diet + exercise group was excluded) were analyzed. Relative to controls, hs-CRP decreased by geometric mean (95% confidence interval, P value): 0.92 mg/L (0.53-1.31, P restriction weight loss diet with or without exercise reduces biomarkers of inflammation in postmenopausal women, with potential clinical significance for cancer risk reduction. ©2012 AACR

  7. A three-component cognitive behavioural lifestyle program for preconceptional weight-loss in women with polycystic ovary syndrome (PCOS): a protocol for a randomized controlled trial.

    Science.gov (United States)

    Jiskoot, G; Benneheij, S H; Beerthuizen, A; de Niet, J E; de Klerk, C; Timman, R; Busschbach, J J; Laven, J S E

    2017-03-06

    Obesity in women with polycystic ovary syndrome (PCOS) negatively affects all clinical features, and a 5 to 10% weight loss has shown promising results on reproductive, metabolic and psychological level. Incorporating a healthy diet, increasing physical activity and changing dysfunctional thought patterns in women with PCOS are key points in losing weight. The biggest challenge in weight management programs is to achieve a reasonable and sustainable weight loss. The aim of this study is to explore whether Cognitive Behavioural Therapy (CBT) by a mental health professional, working in a multidisciplinary team with a dietician and a physical therapist (a three-component intervention), is more effective for weight loss in the long term, within 12 months. We will also explore whether mobile phone applications are effective in supporting behavioural change and sustainable weight loss. The present study is a longitudinal randomized controlled trial (RCT) to study the effectiveness of a three-component 1-year cognitive-behavioural lifestyle intervention in overweight/obese women with PCOS. A total of 210 participants are randomly assigned to three groups: 1) CBT provided by the multidisciplinary team or; 2) CBT provided by the multidisciplinary team and Short Message Service (SMS) or; 3) usual care: encourage weight loss through publicly available services (control group). The primary aim of the 12-month intervention is to explore whether a three-component 1-year cognitive-behavioural lifestyle intervention is effective to decrease weight, when compared to usual care. Secondary outcomes include: the effect of the intervention on the PCOS phenotype, waist circumference, waist to hip ratio, ovulation rates, total testosterone, SHBG, free androgen index (FAI), AMH, hirsutism, acne, fasting glucose, blood pressure and all psychological parameters. Additionally, we assessed time to pregnancy, ongoing pregnancies, clinical pregnancies, miscarriages and birth weight. All

  8. Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors.

    Science.gov (United States)

    Befort, Christie A; Klemp, Jennifer R; Fabian, Carol; Perri, Michael G; Sullivan, Debra K; Schmitz, Kathryn H; Diaz, Francisco J; Shireman, Theresa

    2014-03-01

    Obesity is a risk factor for breast cancer recurrence and death. Women who reside in rural areas have higher obesity prevalence and suffer from breast cancer treatment-related disparities compared to urban women. The objective of this 5-year randomized controlled trial is to compare methods for delivering extended care for weight loss maintenance among rural breast cancer survivors. Group phone-based counseling via conference calls addresses access barriers, is more cost-effective than individual phone counseling, and provides group support which may be ideal for rural breast cancer survivors who are more likely to have unmet support needs. Women (n=210) diagnosed with Stage 0 to III breast cancer in the past 10 years who are ≥ 3 months out from initial cancer treatments, have a BMI 27-45 kg/m(2), and have physician clearance were enrolled from multiple cancer centers. During Phase I (months 0 to 6), all women receive a behavioral weight loss intervention delivered through group phone sessions. Women who successfully lose 5% of weight enter Phase II (months 6 to 18) and are randomized to one of two extended care arms: continued group phone-based treatment or a mail-based newsletter. During Phase III, no contact is made (months 18 to 24). The primary outcome is weight loss maintenance from 6 to 18 months. Secondary outcomes include quality of life, serum biomarkers, and cost-effectiveness. This study will provide essential information on how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. Efficacy of a meal replacement diet plan compared to a food-based diet plan after a period of weight loss and weight maintenance: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hutchisen Tammy

    2010-03-01

    Full Text Available Abstract Background Obesity has reached epidemic proportions in the United States. It is implicated in the development of a variety of chronic disease states and is associated with increased levels of inflammation and oxidative stress. The objective of this study is to examine the effect of Medifast's meal replacement program (MD on body weight, body composition, and biomarkers of inflammation and oxidative stress among obese individuals following a period of weight loss and weight maintenance compared to a an isocaloric, food-based diet (FB. Methods This 40-week randomized, controlled clinical trial included 90 obese adults with a body mass index (BMI between 30 and 50 kg/m2, randomly assigned to one of two weight loss programs for 16 weeks and then followed for a 24-week period of weight maintenance. The dietary interventions consisted of Medifast's meal replacement program for weight loss and weight maintenance, or a self-selected, isocaloric, food-based meal plan. Results Weight loss at 16 weeks was significantly better in the Medifast group (MD versus the food-based group (FB (12.3% vs. 6.9%, and while significantly more weight was regained during weight maintenance on MD versus FB, overall greater weight loss was achieved on MD versus FB. Significantly more of the MD participants lost ≥ 5% of their initial weight at week 16 (93% vs. 55% and week 40 (62% vs. 30%. There was no difference in satiety observed between the two groups during the weight loss phase. Significant improvements in body composition were also observed in MD participants compared to FB at week 16 and week 40. At week 40, both groups experienced improvements in biochemical outcomes and other clinical indicators. Conclusions Our data suggest that the meal replacement diet plan evaluated was an effective strategy for producing robust initial weight loss and for achieving improvements in a number of health-related parameters during weight maintenance, including inflammation

  10. Stress Management-Augmented Behavioral Weight Loss Intervention for African American Women: A Pilot, Randomized Controlled Trial

    Science.gov (United States)

    Cox, Tiffany L.; Krukowski, Rebecca; Love, ShaRhonda J.; Eddings, Kenya; DiCarlo, Marisha; Chang, Jason Y.; Prewitt, T. Elaine; West, Delia Smith

    2013-01-01

    The relationship between chronic stress and weight management efforts may be a concern for African American (AA) women, who have a high prevalence of obesity, high stress levels, and modest response to obesity treatment. This pilot study randomly assigned 44 overweight/obese AA women with moderate to high stress levels to either a 12-week…

  11. Effects of Tai Chi and Walking Exercises on Weight Loss, Metabolic Syndrome Parameters, and Bone Mineral Density: A Cluster Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Stanley Sai-Chuen Hui

    2015-01-01

    Full Text Available Tai Chi and walking are both moderate-intensity physical activity (PA that can be easily practiced in daily life. The objective of the study was to determine the effects of these two PAs on weight loss, metabolic syndrome parameters, and bone mineral density (BMD in Chinese adults. We randomized 374 middle-aged subjects (45.8 ± 5.3 years into 12-week training (45 minutes per day, 5 days per week of Tai Chi (n=124 or self-paced walking (n=121 or control group (n=129. On average, Tai Chi and walking groups lost 0.50 and 0.76 kg of body weight and 0.47 and 0.59 kg of fat mass after intervention, respectively. The between-group difference of waist circumference (WC and fasting blood glucose (FBG was −3.7 cm and −0.18 mmol/L for Tai Chi versus control and −4.1 cm and −0.22 mmol/L for walking versus control. No significant differences were observed regarding lean mass, blood pressure, triglycerides, total cholesterol, high-density and low-density lipoprotein cholesterol, and BMD compared to control. Change in lean mass, not fat mass or total weight loss, was significantly correlated to the change in BMD. Our results suggest that both of these two PAs can produce moderate weight loss and significantly improve the WC and FBG in Hong Kong Chinese adults, with no additional effects on BMD.

  12. The effect of different dosage regimens of tranexamic acid on blood loss in bimaxillary osteotomy: a randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Apipan, B; Rummasak, D; Narainthonsaenee, T

    2018-05-01

    The purpose of this study was to compare the effects of three dosage regimens of intravenous tranexamic acid and normal saline placebo on blood loss and the requirement for transfusion during bimaxillary osteotomy. A prospective, randomized, double-blind, placebo-controlled study was performed. Eighty patients scheduled for elective bimaxillary osteotomy were divided into four groups: a placebo group and three groups receiving a single dose of tranexamic acid 10, 15, or 20mg/kg body weight after the induction of anaesthesia. Demographic data, the anaesthetic time, the operative time, and the experience of the surgical team were similar in the four groups. Patients receiving placebo had increased blood loss compared to those receiving tranexamic acid. No significant difference in blood loss was found among those who received 10, 15, or 20mg/kg body weight of tranexamic acid. There was no significant difference in transfusion requirement, amount of 24-h postoperative vacuum drainage, length of hospital stay, or complications among the four groups. Prophylactic tranexamic acid decreased bleeding during bimaxillary osteotomy. Of the three dosages of tranexamic acid studied, the most efficacious and cost-effective dose to reduce bleeding was 10mg/kg body weight. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  13. Dietary weight loss and exercise interventions effects on quality of life in overweight/obese postmenopausal women: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wang Ching-Yun

    2011-10-01

    Full Text Available Abstract Background Although lifestyle interventions targeting multiple lifestyle behaviors are more effective in preventing unhealthy weight gain and chronic diseases than intervening on a single behavior, few studies have compared individual and combined effects of diet and/or exercise interventions on health-related quality of life (HRQOL. In addition, the mechanisms of how these lifestyle interventions affect HRQOL are unknown. The primary aim of this study was to examine the individual and combined effects of dietary weight loss and/or exercise interventions on HRQOL and psychosocial factors (depression, anxiety, stress, social support. The secondary aim was to investigate predictors of changes in HRQOL. Methods This study was a randomized controlled trial. Overweight/obese postmenopausal women were randomly assigned to 12 months of dietary weight loss (n = 118, moderate-to-vigorous aerobic exercise (225 minutes/week, n = 117, combined diet and exercise (n = 117, or control (n = 87. Demographic, health and anthropometric information, aerobic fitness, HRQOL (SF-36, stress (Perceived Stress Scale, depression [Brief Symptom Inventory (BSI-18], anxiety (BSI-18 and social support (Medical Outcome Study Social Support Survey were assessed at baseline and 12 months. The 12-month changes in HRQOL and psychosocial factors were compared using analysis of covariance, adjusting for baseline scores. Multiple regression was used to assess predictors of changes in HRQOL. Results Twelve-month changes in HRQOL and psychosocial factors differed by intervention group. The combined diet + exercise group improved 4 aspects of HRQOL (physical functioning, role-physical, vitality, and mental health, and stress (p ≤ 0.01 vs. controls. The diet group increased vitality score (p Conclusions A combined diet and exercise intervention has positive effects on HRQOL and psychological health, which may be greater than that from exercise or diet alone. Improvements in

  14. Efficacy of gamification-based smartphone application for weight loss in overweight and obese adolescents: study protocol for a phase II randomized controlled trial.

    Science.gov (United States)

    Timpel, Patrick; Cesena, Fernando Henpin Yue; da Silva Costa, Christiane; Soldatelli, Matheus Dorigatti; Gois, Emanuel; Castrillon, Eduardo; Díaz, Lina Johana Jaime; Repetto, Gabriela M; Hagos, Fanah; Castillo Yermenos, Raul E; Pacheco-Barrios, Kevin; Musallam, Wafaa; Braid, Zilda; Khidir, Nesreen; Romo Guardado, Marcela; Roepke, Roberta Muriel Longo

    2018-06-01

    Overweight and obesity are significant public health concerns that are prevalent in younger age cohorts. Preventive or therapeutic interventions are difficult to implement and maintain over time. On the other hand, the majority of adolescents in the United States have a smartphone, representing a huge potential for innovative digitized interventions, such as weight loss programs delivered via smartphone applications. Although the number of available smartphone applications is increasing, evidence for their effectiveness in weight loss is insufficient. Therefore, the proposed study aims to assess the efficacy of a gamification-based smartphone application for weight loss in overweight and obese adolescents. The trial is designed to be a phase II, single-centre, two-arm, triple-blinded, randomized controlled trial (RCT) with a duration of 6 months. The intervention consists of a smartphone application that provides both tracking and gamification elements, while the control arm consists of an identically designed application solely with tracking features of health information. The proposed trial will be conducted in an urban primary care clinic of an academic centre in the United States of America, with expertise in the management of overweight and obese adolescents. Eligible adolescents will be followed for 6 months. Changes in body mass index z score from baseline to 6 months will be the primary outcome. Secondary objectives will explore the effects of the gamification-based application on adherence, as well as anthropometric, metabolic and behavioural changes. A required sample size of 108 participants (54 participants per group) was calculated. The benefits of the proposed study include mid-term effects in weight reduction for overweight and obese adolescents. The current proposal will contribute to fill a gap in the literature on the mid-term effects of gamification-based interventions to control weight in adolescents. This trial is a well-designed RCT that is in

  15. Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer.

    Science.gov (United States)

    Reeves, Marina M; Terranova, Caroline O; Erickson, Jane M; Job, Jennifer R; Brookes, Denise S K; McCarthy, Nicole; Hickman, Ingrid J; Lawler, Sheleigh P; Fjeldsoe, Brianna S; Healy, Genevieve N; Winkler, Elisabeth A H; Janda, Monika; Veerman, J Lennert; Ware, Robert S; Prins, Johannes B; Vos, Theo; Demark-Wahnefried, Wendy; Eakin, Elizabeth G

    2016-10-28

    Obesity, physical inactivity and poor diet quality have been associated with increased risk of breast cancer-specific and all-cause mortality as well as treatment-related side-effects in breast cancer survivors. Weight loss intervention trials in breast cancer survivors have shown that weight loss is safe and achievable; however, few studies have examined the benefits of such interventions on a broad range of outcomes and few have examined factors important to translation (e.g. feasible delivery method for scaling up, assessment of sustained changes, cost-effectiveness). The Living Well after Breast Cancer randomized controlled trial aims to evaluate a 12-month telephone-delivered weight loss intervention (versus usual care) on weight change and a range of secondary outcomes including cost-effectiveness. Women (18-75 years; body mass index 25-45 kg/m 2 ) diagnosed with stage I-III breast cancer in the previous 2 years are recruited from public and private hospitals and through the state-based cancer registry (target n = 156). Following baseline assessment, participants are randomized 1:1 to either a 12-month telephone-delivered weight loss intervention (targeting diet and physical activity) or usual care. Data are collected at baseline, 6-months (mid-intervention), 12-months (end-of-intervention) and 18-months (maintenance). The primary outcome is change in weight at 12-months. Secondary outcomes are changes in body composition, bone mineral density, cardio-metabolic and cancer-related biomarkers, metabolic health and chronic disease risk, physical function, patient-reported outcomes (quality of life, fatigue, menopausal symptoms, body image, fear of cancer recurrence) and behaviors (dietary intake, physical activity, sitting time). Data collected at 18-months will be used to assess whether outcomes achieved at end-of-intervention are sustained six months after intervention completion. Cost-effectiveness will be assessed, as will mediators and moderators of

  16. A Targeted and Tailored eHealth Weight Loss Program for Young Women: The Be Positive Be Healthe Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Melinda J. Hutchesson

    2018-05-01

    Full Text Available Young women are gaining weight rapidly. Evidence for effective weight loss interventions targeting young women is lacking. This randomized controlled trial assessed the efficacy and acceptability of a six-month targeted and tailored eHealth weight loss program for young women (Be Positive Be Healthe (BPBH. Women aged 18–35 years were randomized to BPBH (n = 29 or control (n = 28. BPBH supported participants to modify diet and physical activity behaviours using evidenced-based strategies (e.g., self-monitoring tailored for young women and delivered using e-health (website, social media, smartphone application, email, text messages. The primary outcome was a change in weight (kg at six months. Acceptability was assessed via a process evaluation survey and usage of intervention components. No significant between-group differences were observed for weight, with significant mean differences favouring the intervention group observed for body fat (kg (−3.10 (−5.69, 0.52, p = 0.019 and intakes of alcohol (g (−0.69 (−1.33, 0.04, p = 0.037, vegetables (% energy/day (4.71 (−2.20, 7.22, p < 0.001 and energy-dense, nutrient-poor foods (% energy/day (−9.23 (−16.94, 1.52, p = 0.018. Retention, intervention usage and satisfaction were moderate. BPBH facilitated positive improvements in body fat and dietary intake, but not weight. Intervention acceptability findings support the use of some intervention components (e.g., Facebook, Smartphone app with young women.

  17. Effects of low-carbohydrate vs low-fat diets on weight loss and cardiovascular risk factors: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Nordmann, Alain J; Nordmann, Abigail; Briel, Matthias; Keller, Ulrich; Yancy, William S; Brehm, Bonnie J; Bucher, Heiner C

    2006-02-13

    Low-carbohydrate diets have become increasingly popular for weight loss. However, evidence from individual trials about benefits and risks of these diets to achieve weight loss and modify cardiovascular risk factors is preliminary. We used the Cochrane Collaboration search strategy to identify trials comparing the effects of low-carbohydrate diets without restriction of energy intake vs low-fat diets in individuals with a body mass index (calculated as weight in kilograms divided by the square of height in meters) of at least 25. Included trials had to report changes in body weight in intention-to-treat analysis and to have a follow-up of at least 6 months. Two reviewers independently assessed trial eligibility and quality of randomized controlled trials. Five trials including a total of 447 individuals fulfilled our inclusion criteria. After 6 months, individuals assigned to low-carbohydrate diets had lost more weight than individuals randomized to low-fat diets (weighted mean difference, -3.3 kg; 95% confidence interval [CI], -5.3 to -1.4 kg). This difference was no longer obvious after 12 months (weighted mean difference, -1.0 kg; 95% CI, -3.5 to 1.5 kg). There were no differences in blood pressure. Triglyceride and high-density lipoprotein cholesterol values changed more favorably in individuals assigned to low-carbohydrate diets (after 6 months, for triglycerides, weighted mean difference, -22.1 mg/dL [-0.25 mmol/L]; 95% CI, -38.1 to -5.3 mg/dL [-0.43 to -0.06 mmol/L]; and for high-density lipoprotein cholesterol, weighted mean difference, 4.6 mg/dL [0.12 mmol/L]; 95% CI, 1.5-8.1 mg/dL [0.04-0.21 mmol/L]), but total cholesterol and low-density lipoprotein cholesterol values changed more favorably in individuals assigned to low-fat diets (weighted mean difference in low-density lipoprotein cholesterol after 6 months, 5.4 mg/dL [0.14 mmol/L]; 95% CI, 1.2-10.1 mg/dL [0.03-0.26 mmol/L]). Low-carbohydrate, non-energy-restricted diets appear to be at least as

  18. Low-fat versus low-carbohydrate weight reduction diets: effects on weight loss, insulin resistance, and cardiovascular risk: a randomized control trial.

    Science.gov (United States)

    Bradley, Una; Spence, Michelle; Courtney, C Hamish; McKinley, Michelle C; Ennis, Cieran N; McCance, David R; McEneny, Jane; Bell, Patrick M; Young, Ian S; Hunter, Steven J

    2009-12-01

    Low-fat hypocaloric diets reduce insulin resistance and prevent type 2 diabetes in those at risk. Low-carbohydrate, high-fat diets are advocated as an alternative, but reciprocal increases in dietary fat may have detrimental effects on insulin resistance and offset the benefits of weight reduction. We investigated a low-fat (20% fat, 60% carbohydrate) versus a low-carbohydrate (60% fat, 20% carbohydrate) weight reduction diet in 24 overweight/obese subjects ([mean +/- SD] BMI 33.6 +/- 3.7 kg/m(2), aged 39 +/- 10 years) in an 8-week randomized controlled trial. All food was weighed and distributed, and intake was calculated to produce a 500 kcal/day energy deficit. Insulin action was assessed by the euglycemic clamp and insulin secretion by meal tolerance test. Body composition, adipokine levels, and vascular compliance by pulse-wave analysis were also measured. Significant weight loss occurred in both groups (P loss with no difference between groups (P = 0.71). The change in overall systemic arterial stiffness was, however, significantly different between diets (P = 0.04); this reflected a significant decrease in augmentation index following the low-fat diet, compared with a nonsignificant increase within the low-carbohydrate group. This study demonstrates comparable effects on insulin resistance of low-fat and low-carbohydrate diets independent of macronutrient content. The difference in augmentation index may imply a negative effect of low-carbohydrate diets on vascular risk.

  19. A comparison of lower canine retraction and loss of anchorage between conventional and self-ligating brackets: a single-center randomized split-mouth controlled trial.

    Science.gov (United States)

    da Costa Monini, André; Júnior, Luiz Gonzaga Gandini; Vianna, Alexandre Protásio; Martins, Renato Parsekian

    2017-05-01

    To evaluate the rate of lower canine retraction, anchorage loss, and changes on lower canines and first molars axial inclination using self-ligating and conventional brackets. Twenty-five adult patients with a treatment plan involving extractions of four first premolars were selected for this split-mouth trial and had either conventional or self-ligating brackets bonded to lower canines in a block randomization. Retraction was accomplished using 100-g nickel titanium closed-coil springs, which were reactivated each 4 weeks. Oblique radiographs were taken before and after total canine retraction and the cephalograms were superimposed on stable structures of the mandible. Cephalometric points were digitized twice by a single-blinded operator for error control and the average of the points were used to determine the following variables: canine cusp horizontal changes, molar cusp horizontal changes, and angulation changes in canines and molars. Paired t tests were used to analyze the blinded data for group differences. All patients reached final phase without bracket debonds. No differences were found between the two groups for all variables tested. No serious harm was observed. Both brackets showed the same rate of canine retraction and loss of anteroposterior anchorage of the molars. No changes were found between brackets regarding the inclination of canines and first molars. Using self-ligating brackets to retract lower canines will not increase the velocity of tooth movement, does not increase anchorage, and does not decrease tipping.

  20. Effect of Twice-Yearly Denosumab on Prevention of Bone Mineral Density Loss in De Novo Kidney Transplant Recipients: A Randomized Controlled Trial.

    Science.gov (United States)

    Bonani, M; Frey, D; Brockmann, J; Fehr, T; Mueller, T F; Saleh, L; von Eckardstein, A; Graf, N; Wüthrich, R P

    2016-06-01

    We conducted an open-label, prospective, randomized trial to assess the efficacy and safety of RANKL inhibition with denosumab to prevent the loss of bone mineral density (BMD) in the first year after kidney transplantation. Ninety kidney transplant recipients were randomized 1:1 2 weeks after surgery to receive denosumab (60 mg at baseline and 6 months) or no treatment. After 12 months, total lumbar spine areal BMD (aBMD) increased by 4.6% (95% confidence interval [CI] 3.3-5.9%) in 46 patients in the denosumab group and decreased by -0.5% (95% CI -1.8% to 0.9%) in 44 patients in the control group (between-group difference 5.1% [95% CI 3.1-7.0%], p bone turnover (C-terminal telopeptide of type I collagen, procollagen type I N-terminal propeptide) markedly decreased with denosumab (all p transplantation but was associated with more frequent episodes of urinary tract infection. © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.

  1. Effects of a caloric restriction weight loss diet and exercise on inflammatory biomarkers in overweight/obese postmenopausal women: a randomized controlled trial

    Science.gov (United States)

    Imayama, Ikuyo; Ulrich, Cornelia M.; Alfano, Catherine M.; Wang, Chiachi; Xiao, Liren; Wener, Mark H.; Campbell, Kristin L.; Duggan, Catherine; Foster-Schubert, Karen E.; Kong, Angela; Mason, Caitlin E.; Wang, Ching-Yun; Blackburn, George L.; Bain, Carolyn E.; Thompson, Henry J.; McTiernan, Anne

    2012-01-01

    Obese and sedentary persons have increased risk for cancer; inflammation is a hypothesized mechanism. We examined the effects of a caloric restriction weight loss diet and exercise on inflammatory biomarkers in 439 women. Overweight and obese postmenopausal women were randomized to 1-year: caloric restriction diet (goal of 10% weight loss, N=118), aerobic exercise (225 minutes/week of moderate-to-vigorous activity, N=117), combined diet+exercise (N=117) or control (N=87). Baseline and 1-year high-sensitivity C-reactive protein (hs-CRP), serum amyloid A (SAA), interleukin-6 (IL-6), leukocyte and neutrophil levels were measured by investigators blind to group. Inflammatory biomarker changes were compared using generalized estimating equations. Models were adjusted for baseline body mass index (BMI), race/ethnicity and age. 438 (N=1 in diet+exercise group was excluded) were analyzed. Relative to controls, hs-CRP decreased by geometric mean (95% confidence interval, p-value) 0.92mg/L (0.53–1.31, Pdiet and 0.87mg/L (0.51–1.23, Pdiet+exercise groups. IL-6 decreased by 0.34pg/ml (0.13–0.55, P=0.001) in the diet and 0.32pg/ml (0.15–0.49, Pdiet+exercise groups. Neutrophil counts decreased by 0.31×109/L (0.09–0.54, P=0.006) in the diet and 0.30×109/L (0.09–0.50, P=0.005) in the diet+exercise groups. Diet and diet+exercise participants with ≥5% weight loss reduced inflammatory biomarkers (hs-CRP, SAA, and IL-6) compared to controls. The diet and diet+exercise groups reduced hs-CRP in all subgroups of baseline BMI, waist circumference, CRP level, and fasting glucose. Our findings indicate that a caloric restriction weight loss diet with or without exercise reduces biomarkers of inflammation in postmenopausal women, with potential clinical significance for cancer risk reduction. PMID:22549948

  2. Comparison of 3 ad libitum diets for weight-loss maintenance, risk of cardiovascular disease, and diabetes: A 6-mo randomized, controlled trial

    DEFF Research Database (Denmark)

    Due, Anette; Larsen, Thomas M; Mu, Huiling

    2008-01-01

    BACKGROUND: The optimal dietary content and type of fat and carbohydrate for weight management has been debated for decades. OBJECTIVE: The objective was to compare the effects of 3 ad libitum diets on the maintenance of an initial weight loss of >or=8% and risk factors for CVD and diabetes during...... a 6-mo controlled dietary intervention. DESIGN: Nondiabetic overweight or obese [mean +/- SD body mass index (in kg/m(2)): 31.5 +/- 2.6] men (n = 55) and women (n = 76) aged 28.2 +/- 4.8 y were randomly assigned to a diet providing a moderate amount of fat (35-45% of energy) and >20% of fat...... as monounsaturated fatty acids (MUFA diet; n = 54), to a low-fat (20-30% of energy) diet (LF diet; n = 51), or to a control diet (35% of energy as fat; n = 26). Protein constituted 10-20% of energy in all 3 diets. All foods were provided free of charge from a purpose-built supermarket. RESULTS: More subjects dropped...

  3. Whole-body protein turnover response to short-term high-protein diets during weight loss: a randomized controlled trial

    Science.gov (United States)

    Objective: Determine whole-body protein turnover responses to high protein diets during weight loss. Design: Thirty-nine adults (age, 21 ± 1 yr; VO2peak, 48 ± 1 ml'kg-1'min-1; body mass index, 25 ± 1 kg•m2) were randomized to diets providing protein at the recommend dietary allowance (RDA), 2X-RD...

  4. Impact of a Mindfulness-Based Weight-Loss Intervention on Sleep Quality Among Adults with Obesity: Data from the SHINE Randomized Controlled Trial.

    Science.gov (United States)

    Adler, Elizabeth; Dhruva, Anand; Moran, Patricia J; Daubenmier, Jennifer; Acree, Michael; Epel, Elissa S; Bacchetti, Peter; Prather, Aric A; Mason, Ashley; Hecht, Frederick M

    2017-03-01

    Sleep disturbance is a common problem among adults with obesity. Mindfulness interventions have been shown to improve sleep quality in various populations but have not been investigated in adults with obesity. The aim of this study was to compare the effects of a mindfulness-based weight-loss intervention with an active control on self-reported sleep quality among adults with obesity. This study was a secondary analysis of a randomized controlled trial and included 194 adults with a body mass index in the range 30-45 kg/m 2 . The treatment intervention included mindfulness-based eating and stress-management practices, and the active control intervention included training in progressive muscle relaxation (PMR). Both groups received identical diet and exercise guidelines in 17 group sessions conducted over 5.5 months that were matched for time, attention, and social support. The primary outcome of this analysis was between-group change in self-reported sleep quality, which was assessed using the Pittsburgh Sleep Quality Index (PSQI) global score at baseline and at 6, 12, and 18 months. Between-group differences in mean PSQI change scores in the mindfulness group (n = 100) compared to the control group (n = 94) were -0.27 (-0.68, 1.22; p = 0.58) at 6 months, -0.57 (-0.35, 1.50; p = 0.22) at 12 months, and -0.50 (-0.53, 1.53; p = 0.34) at 18 months, all in the direction of more sleep improvement in the mindfulness group but none reaching statistical significance. In the mindfulness group, average weekly minutes of meditation practice time was associated with improved sleep quality from baseline to 6 months. No statistically significant evidence was found that a weight-loss program that incorporates mindfulness improves self-reported sleep quality compared to a control diet/exercise intervention that included PMR. Within the mindfulness group, average weekly minutes of mindfulness practice was associated with improved sleep quality.

  5. A randomized controlled trial on the effect of incomplete milking during early lactation on ketonemia and body condition loss in Holstein dairy cows.

    Science.gov (United States)

    Morin, P-A; Krug, C; Chorfi, Y; Dubuc, J; Lacasse, P; Roy, J-P; Santschi, D E; Dufour, S

    2018-05-01

    Limiting milk production for a short period of time in early lactation could be a relevant strategy to prevent hyperketonemia (HYK). From December 2013 to March 2015, 838 multiparous Holstein cows from 13 herds were enrolled in a randomized controlled trial evaluating the effect of incomplete milking in early lactation on ketonemia and its effect on body condition score (BCS) loss. Cows were randomly assigned 4 wk before expected calving date to 1 of 2 treatment groups, (1) a conventional milking protocol (CON) for which cows were completely milked or (2) an incomplete milking protocol (INC) for which a maximum of 10 to 14 kg of milk/d were withdrawn during the first 5 d in milk (DIM). β-Hydroxybutyrate (BHB) concentrations were measured from blood samples collected on each cow 3 times at weekly intervals. Hyperketonemia was defined as BHB ≥1.4 mmol/L. Body condition score variation in the postcalving period was calculated by subtracting BCS assessed at wk 7 from BCS assessed at first week after calving. Effect of treatment on ketonemia and prevalence of HYK were evaluated for 4 specific time periods: 1 to 3, 4 to 7, 8 to 17, and 18 to 26 DIM. Effect of treatment on ketonemia was investigated using linear mixed models with natural logarithm of BHB measurements as outcome and treatment groups as fixed effect. Generalized linear mixed models with HYK as outcome, using logit link, and treatment groups as fixed effect were used to investigate effect of treatment on odds of HYK. A logistic regression model with BCS loss (effects was used to study effect of INC on odds of having BCS loss ≥0.75. A total of 813 lactations had complete data and were used for statistical analysis of ketonemia and HYK. A total of 709 lactations had complete data and were used for analysis of BCS loss. Geometric means of blood BHB concentrations during the 1 to 3, 4 to 7, 8 to 17, and 18 to 26 DIM periods were, respectively, 0.72 (95% confidence interval = 0.66, 0.80), 0.66 (0.60, 0

  6. A double-blind, placebo-controlled randomized trial of creatine for the cancer anorexia/weight loss syndrome (N02C4): an Alliance trial.

    Science.gov (United States)

    Jatoi, A; Steen, P D; Atherton, P J; Moore, D F; Rowland, K M; Le-Lindqwister, N A; Adonizio, C S; Jaslowski, A J; Sloan, J; Loprinzi, C

    2017-08-01

    Multiple pilot studies, including one in colorectal cancer patients, suggest that creatine, an amino acid derivative, augments muscle, improves strength, and thereby could palliate the cancer anorexia/weight loss syndrome. In this randomized, double-blind, placebo-controlled trial, incurable patients with this syndrome were assigned creatine (20 g/day load×5 days followed by 2 g/day orally) versus identical placebo. Patients were weighed once a week for 1 month and then monthly. Patients were also assessed over 1 month for appetite and quality of life (validated questionnaires), fist grip strength, body composition (bioelectrical impedance), and adverse events. The primary endpoint was 10% or greater weight gain from baseline during the first month. Within this combined cohort of 263 evaluable patients (134 received creatine and 129 placebo), only 3 gained ≥10% of their baseline weight by 1 month: two creatine-treated and the other placebo-exposed (P = 1.00). Questionnaire data on appetite, quality of life, and activities of daily living showed no statistically significant differences between groups. Similarly, no statistically significant differences between groups were observed for fist-grip strength or body composition. Rates and severity of adverse events were comparable between groups. Finally, a median survival of 230 and 239 days were observed in the creatine and placebo groups, respectively (P = 0.70). Creatine, as prescribed in this trial, had no effect on the cancer anorexia/weight loss syndrome. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  7. A randomized controlled trial to prevent excessive gestational weight gain and promote postpartum weight loss in overweight and obese women: Health In Pregnancy and Postpartum (HIPP).

    Science.gov (United States)

    Wilcox, Sara; Liu, Jihong; Addy, Cheryl L; Turner-McGrievy, Gabrielle; Burgis, Judith T; Wingard, Ellen; Dahl, Alicia A; Whitaker, Kara M; Schneider, Lara; Boutté, Alycia K

    2018-03-01

    Interventions to prevent excessive gestational weight gain and promote postpartum weight loss have yielded modest results, particularly in overweight and obese women. To examine the impact of a theory-based lifestyle intervention on gestational weight gain, postpartum weight loss, and related maternal and child outcomes and to examine race differences in these outcomes. A randomized controlled trial (target N=400; 200 intervention, 200 standard care; 200 African American, 200 white). Overweight and obese African American and white women ≤16weeks gestation are recruited from obstetrics and gynecology clinics in South Carolina. Intervention participants receive two in-depth counseling sessions (early pregnancy and postpartum), telephone counseling, behavioral podcasts, and social media support that target weight self-monitoring and increasing physical activity and healthy dietary behavior practices, guided by Social Cognitive Theory. Standard care participants receive monthly mailings and a matched number of podcasts on non-weight related topics. All intervention activities last from ≤18weeks gestation to 6months after delivery. Gestational weight gain is the primary outcome. Secondary outcomes are meeting gestational weight gain guidelines (inadequate, adequate, excessive), weekly rate of gestational weight gain, postpartum weight retention, physical activity and dietary behaviors, health-related quality of life, and offspring adiposity. Participants are assessed at baseline (≤16weeks gestation), 32weeks gestation, and 6 and 12months postpartum, and offspring are assessed at 6 and 12months. HIPP is an innovative study that addresses significant gaps in the literature. Primary outcome results are expected in 2019. Copyright © 2018 Elsevier Inc. All rights reserved.

  8. A Multi-Component Day-Camp Weight-Loss Program Is Effective in Reducing BMI in Children after One Year: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Kristian Traberg Larsen

    Full Text Available The objective of the present study was to evaluate the effectiveness of a one-year multi-component immersive day-camp weight-loss intervention for children with overweight and obesity. The study design was a parallel-group randomized controlled trial. One hundred fifteen 11-13-year-old children with overweight and obesity were randomized into either: A six-week day-camp intervention arm focusing on increased physical activity, and healthy diet followed by a subsequent one-year family-based intervention, or a standard intervention arm consisting of one weekly exercise session for six weeks. Body mass index (BMI was the primary outcome. BMI z-score, clustered cardiovascular risk z-score, and body composition were secondary outcomes. All outcomes were measured at baseline, six week-, and 52 week follow-up. After six weeks, children from the day-camp intervention arm had improved their BMI (-2.2 kg/m2 (95% CI -2.6 to -1.7, P<0.001 and all secondary outcomes when compared to the children from the standard intervention arm. After 52 weeks, the day-camp intervention arm had a lower BMI (-1.2 kg/m2 (95% CI -1.8 to -0.5, P = 0.001, and BMI z-score (-0.20 (95% CI -0.35 to -0.05, P = 0.008, and clustered cardiovascular risk z-score (-0.23 (95% CI -0.37 to -0.08, P = 0.002 compared to the standard intervention arm. No group differences were detected in body composition after 52 weeks. This study shows that the day-camp intervention arm is effective in reducing BMI and improving the metabolic health of children with overweight and obesity. However, the effects seem to be diminishing over time.

  9. A Sound Therapy-Based Intervention to Expand the Auditory Dynamic Range for Loudness among Persons with Sensorineural Hearing Losses: A Randomized Placebo-Controlled Clinical Trial

    Science.gov (United States)

    Formby, Craig; Hawley, Monica L.; Sherlock, LaGuinn P.; Gold, Susan; Payne, JoAnne; Brooks, Rebecca; Parton, Jason M.; Juneau, Roger; Desporte, Edward J.; Siegle, Gregory R.

    2015-01-01

    The primary aim of this research was to evaluate the validity, efficacy, and generalization of principles underlying a sound therapy–based treatment for promoting expansion of the auditory dynamic range (DR) for loudness. The basic sound therapy principles, originally devised for treatment of hyperacusis among patients with tinnitus, were evaluated in this study in a target sample of unsuccessfully fit and/or problematic prospective hearing aid users with diminished DRs (owing to their elevated audiometric thresholds and reduced sound tolerance). Secondary aims included: (1) delineation of the treatment contributions from the counseling and sound therapy components to the full-treatment protocol and, in turn, the isolated treatment effects from each of these individual components to intervention success; and (2) characterization of the respective dynamics for full, partial, and control treatments. Thirty-six participants with bilateral sensorineural hearing losses and reduced DRs, which affected their actual or perceived ability to use hearing aids, were enrolled in and completed a placebo-controlled (for sound therapy) randomized clinical trial. The 2 × 2 factorial trial design was implemented with or without various assignments of counseling and sound therapy. Specifically, participants were assigned randomly to one of four treatment groups (nine participants per group), including: (1) group 1—full treatment achieved with scripted counseling plus sound therapy implemented with binaural sound generators; (2) group 2—partial treatment achieved with counseling and placebo sound generators (PSGs); (3) group 3—partial treatment achieved with binaural sound generators alone; and (4) group 4—a neutral control treatment implemented with the PSGs alone. Repeated measurements of categorical loudness judgments served as the primary outcome measure. The full-treatment categorical-loudness judgments for group 1, measured at treatment termination, were

  10. Effectiveness of conventional versus virtual reality-based balance exercises in vestibular rehabilitation for unilateral peripheral vestibular loss: results of a randomized controlled trial.

    Science.gov (United States)

    Meldrum, Dara; Herdman, Susan; Vance, Roisin; Murray, Deirdre; Malone, Kareena; Duffy, Douglas; Glennon, Aine; McConn-Walsh, Rory

    2015-07-01

    To compare the effectiveness of virtual reality-based balance exercises to conventional balance exercises during vestibular rehabilitation in patients with unilateral peripheral vestibular loss (UVL). Assessor-blind, randomized controlled trial. Two acute care university teaching hospitals. Patients with UVL (N=71) who had dizziness/vertigo, and gait and balance impairment. Patients with UVL were randomly assigned to receive 6 weeks of either conventional (n=36) or virtual reality-based (n=35) balance exercises during vestibular rehabilitation. The virtual reality-based group received an off-the-shelf virtual reality gaming system for home exercise, and the conventional group received a foam balance mat. Treatment comprised weekly visits to a physiotherapist and a daily home exercise program. The primary outcome was self-preferred gait speed. Secondary outcomes included other gait parameters and tasks, Sensory Organization Test (SOT), dynamic visual acuity, Hospital Anxiety and Depression Scale, Vestibular Rehabilitation Benefits Questionnaire, and Activities Balance Confidence Questionnaire. The subjective experience of vestibular rehabilitation was measured with a questionnaire. Both groups improved, but there were no significant differences in gait speed between the groups postintervention (mean difference, -.03m/s; 95% confidence interval [CI], -.09 to .02m/s). There were also no significant differences between the groups in SOT scores (mean difference, .82%; 95% CI, -5.00% to 6.63%) or on any of the other secondary outcomes (P>.05). In both groups, adherence to exercise was high (∼77%), but the virtual reality-based group reported significantly more enjoyment (P=.001), less difficulty with (P=.009) and less tiredness after (P=.03) balance exercises. At 6 months, there were no significant between-group differences in physical outcomes. Virtual reality-based balance exercises performed during vestibular rehabilitation were not superior to conventional balance

  11. Probiotic supplementation and the effects on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Ahmadi, Shahnaz; Jamilian, Mehri; Karamali, Maryam; Tajabadi-Ebrahimi, Maryam; Jafari, Parvaneh; Taghizadeh, Mohsen; Memarzadeh, Mohammad Reza; Asemi, Zatollah

    2017-12-01

    The aim of the current study was to assess the effects of probiotic supplementation on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome (PCOS). In a randomized, double-blind, placebo-controlled trial, 60 women with PCOS were randomized to receive probiotic capsule (n = 30) or placebo (n = 30) for 12 weeks. Consumption of probiotic supplements resulted in a significant reduction in weight (-0.5 ± 0.4 vs. +0.1 ± 1.0 kg, p = 0.004) and BMI (-0.2 ± 0.2 vs. +0.03 ± 0.4 kg/m 2 , p = 0.004) compared with the placebo. In addition, compared with the placebo, probiotic administration was associated with a significant decrease in fasting plasma glucose (-2.4 ± 8.4 vs. +2.1 ± 7.0 mg/dL, p = 0.02), serum insulin concentrations (-2.0 ± 5.8 vs. +1.6 ± 5.0 μIU/mL, p = 0.01), homoeostasis model of assessment-insulin resistance (-0.5 ± 1.4 vs. +0.3 ± 1.1, p = 0.01), homoeostatic model assessment-beta cell function (-7.5 ± 22.3 vs. +6.3 ± 21.7, p = 0.01), serum triglycerides (-13.3 ± 51.3 vs. +13.6 ± 37.1 mg/dL, p= 0.02) and a significant increase in quantitative insulin sensitivity check index (QUICKI) (+0.006 ± 0.01 vs. -0.005 ± 0.02, p = 0.01). When we adjusted the analysis for baseline values of biochemical parameters, age and baseline BMI, except for QUICKI (p = 0.08), other findings did not alter. We found that probiotic supplementation among PCOS women for 12 weeks had favourable effects on weight loss, markers of insulin resistance, triglycerides and VLDL-cholesterol concentrations.

  12. Orange juice allied to a reduced-calorie diet results in weight loss and ameliorates obesity-related biomarkers: A randomized controlled trial.

    Science.gov (United States)

    Ribeiro, Carolina; Dourado, Grace; Cesar, Thais

    2017-06-01

    Assumptions have linked orange juice (OJ) consumption with weight gain and adverse effects on health due to its sugar content; however, epidemiologic studies have not shown increased risk for overweight or obesity with the consumption of 100% OJ. The aim of this study was to verify whether the combination of a reduced-calorie diet (RCD) and 100% OJ contribute to weight loss, promote changes in glucose and lipid metabolism, and improve diet quality in obese individuals. A randomized controlled trial with 78 obese patients (age 36 ± 1 y, body mass index [BMI] 33 ± 3 kg/m 2 ) were enrolled in two groups: Individuals in the OJ group submitted to an RCD that included OJ (500 mL/d), and individuals in the control group submitted to an RCD without OJ. Body composition, biochemical biomarkers, and dietary intake were analyzed over a 12-wk period. Both treatments had similar outcomes regarding body weight (-6.5 kg; P = 0.363), BMI (-2.5 kg/m 2 ; P = 0.34), lean mass (-1 kg; P = 0.29), fat mass (-5 kg; P = 0.58), body fat (-3%; P = 0.15), and waist-to-hip ratio (-0.1; P = 0.79). Insulin levels in the OJ group decreased by 18% (P = 0.05), homeostasis model assessment-insulin resistance by 33% (P = 0.04), total cholesterol by 24% (P = 0.004), low-density lipoprotein cholesterol by 24% (P ≤ 0.001), and high-sensitivity C-reactive protein levels by 33% (P = 0.001) compared with the control group. Consumption of energy and nutrients was similar between the two groups, but vitamin C and folate increased by 62% (P ≤ 0.015) and 39% (P = 0.033), respectively, after OJ intervention. When consumed concomitantly with an RCD, OJ does not inhibit weight loss; ameliorate the insulin sensitivity, lipid profile, or inflammatory status, or contribute nutritionally to the quality of the diet. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  13. Effects of Greenselect Phytosome® on weight maintenance after weight loss in obese women: a randomized placebo-controlled study.

    Science.gov (United States)

    Gilardini, Luisa; Pasqualinotto, Lucia; Di Pierro, Francesco; Risso, Paolo; Invitti, Cecilia

    2016-07-22

    Most subjects regain weight after weight loss due to compensatory adaptations finalized to maintain stable body energy stores. Green tea (GT) preparations, which help maintain energy expenditure while dieting could be a useful strategy to facilitate weight maintenance. The usefulness of GT preparations in weight maintenance has been poorly studied so far with conflicting results. This study evaluated if a supplement of GSP and piperine helps obese women to maintain the weight loss obtained with a 3-month lifestyle intervention. In a randomized placebo-controlled study, we examined whether a highly bioavailable GT extract may counteract weight regain after weight loss. Forty obese women (age 50.1 ± 10.1 years, Body Mass Index (BMI) 36.3 ± 2.7 kg/m(2)) underwent a 3-month lifestyle intervention. At the end of the intervention, the women were randomized in two groups for the weight-maintenance phase: 20 of them were prescribed twice a day, for 3 months, with a formula containing 150 mg/dose of Greenselect Phytosome® and 15 mg/dose of pure piperine (GSP group), and 20 were given placebo (P group). Anthropometric measures and body composition were measured before (V-3) and after lifestyle intervention (V0), 1 (V1), 2 (V2), and 3 (V3) months after prescribing supplements and 3 months following the discontinuation of supplements (V6). Lifestyle intervention induced a significant weight reduction in both groups with similar weight change (-6.2 ± 2.6 in GSP group vs. -4.8 ± 3.1 % in P group). In the GSP group, V1 in comparison to V0, had further reduction in weight and fat mass, which remained stable at V2 and V3 and increased at V6. In the P group, weight and fat mass increased from V2 onwards. Weight changes in GSP group and P group from V0 to V3 were -1.0 kg (95 % CI -2.5 to +0.5) and + 0.3 kg (95 % CI -0.9 to +1.6), respectively. The proportion of women with weight loss ≥ 5 % was greater in the GSP group than in the P group (75

  14. Weight loss in individuals with metabolic syndrome given DASH diet counseling when provided a low sodium vegetable juice: a randomized controlled trial.

    Science.gov (United States)

    Shenoy, Sonia F; Poston, Walker Sc; Reeves, Rebecca S; Kazaks, Alexandra G; Holt, Roberta R; Keen, Carl L; Chen, Hsin Ju; Haddock, C Keith; Winters, Barbara L; Khoo, Chor San H; Foreyt, John P

    2010-02-23

    Metabolic syndrome, a constellation of metabolic risk factors for type 2 diabetes and cardiovascular disease, is one of the fastest growing disease entities in the world. Weight loss is thought to be a key to improving all aspects of metabolic syndrome. Research studies have suggested benefits from diets rich in vegetables and fruits in helping individuals reach and achieve healthy weights. To evaluate the effects of a ready to serve vegetable juice as part of a calorie-appropriate Dietary Approaches to Stop Hypertension (DASH) diet in an ethnically diverse population of people with Metabolic Syndrome on weight loss and their ability to meet vegetable intake recommendations, and on their clinical characteristics of metabolic syndrome (waist circumference, triglycerides, HDL, fasting blood glucose and blood pressure).A secondary goal was to examine the impact of the vegetable juice on associated parameters, including leptin, vascular adhesion markers, and markers of the oxidative defense system and of oxidative stress. A prospective 12 week, 3 group (0, 8, or 16 fluid ounces of low sodium vegetable juice) parallel arm randomized controlled trial. Participants were requested to limit their calorie intake to 1600 kcals for women and 1800 kcals for men and were educated on the DASH diet. A total of 81 (22 men & 59 women) participants with Metabolic Syndrome were enrolled into the study. Dietary nutrient and vegetable intake, weight, height, leptin, metabolic syndrome clinical characteristics and related markers of endothelial and cardiovascular health were measured at baseline, 6-, and 12-weeks. There were significant group by time interactions when aggregating both groups consuming vegetable juice (8 or 16 fluid ounces daily). Those consuming juice lost more weight, consumed more Vitamin C, potassium, and dietary vegetables than individuals who were in the group that only received diet counseling (p juice into the daily diet can be a simple and effective way to

  15. Weight loss in individuals with metabolic syndrome given DASH diet counseling when provided a low sodium vegetable juice: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Hsin

    2010-02-01

    Full Text Available Abstract Background Metabolic syndrome, a constellation of metabolic risk factors for type 2 diabetes and cardiovascular disease, is one of the fastest growing disease entities in the world. Weight loss is thought to be a key to improving all aspects of metabolic syndrome. Research studies have suggested benefits from diets rich in vegetables and fruits in helping individuals reach and achieve healthy weights. Objective To evaluate the effects of a ready to serve vegetable juice as part of a calorie-appropriate Dietary Approaches to Stop Hypertension (DASH diet in an ethnically diverse population of people with Metabolic Syndrome on weight loss and their ability to meet vegetable intake recommendations, and on their clinical characteristics of metabolic syndrome (waist circumference, triglycerides, HDL, fasting blood glucose and blood pressure. A secondary goal was to examine the impact of the vegetable juice on associated parameters, including leptin, vascular adhesion markers, and markers of the oxidative defense system and of oxidative stress. Methods A prospective 12 week, 3 group (0, 8, or 16 fluid ounces of low sodium vegetable juice parallel arm randomized controlled trial. Participants were requested to limit their calorie intake to 1600 kcals for women and 1800 kcals for men and were educated on the DASH diet. A total of 81 (22 men & 59 women participants with Metabolic Syndrome were enrolled into the study. Dietary nutrient and vegetable intake, weight, height, leptin, metabolic syndrome clinical characteristics and related markers of endothelial and cardiovascular health were measured at baseline, 6-, and 12-weeks. Results There were significant group by time interactions when aggregating both groups consuming vegetable juice (8 or 16 fluid ounces daily. Those consuming juice lost more weight, consumed more Vitamin C, potassium, and dietary vegetables than individuals who were in the group that only received diet counseling (p

  16. Benefits of phoneme discrimination training in a randomized controlled trial of 50- to 74-year-olds with mild hearing loss.

    Science.gov (United States)

    Ferguson, Melanie A; Henshaw, Helen; Clark, Daniel P A; Moore, David R

    2014-01-01

    The aims of this study were to (i) evaluate the efficacy of phoneme discrimination training for hearing and cognitive abilities of adults aged 50 to 74 years with mild sensorineural hearing loss who were not users of hearing aids, and to (ii) determine participant compliance with a self-administered, computer-delivered, home- and game-based auditory training program. This study was a randomized controlled trial with repeated measures and crossover design. Participants were trained and tested over an 8- to 12-week period. One group (Immediate Training) trained during weeks 1 and 4. A second waitlist group (Delayed Training) did no training during weeks 1 and 4, but then trained during weeks 5 and 8. On-task (phoneme discrimination) and transferable outcome measures (speech perception, cognition, self-report of hearing disability) for both groups were obtained during weeks 0, 4, and 8, and for the Delayed Training group only at week 12. Robust phoneme discrimination learning was found for both groups, with the largest improvements in threshold shown for those with the poorest initial thresholds. Between weeks 1 and 4, the Immediate Training group showed moderate, significant improvements on self-report of hearing disability, divided attention, and working memory, specifically for conditions or situations that were more complex and therefore more challenging. Training did not result in consistent improvements in speech perception in noise. There was no evidence of any test-retest effects between weeks 1 and 4 for the Delayed Training group. Retention of benefit at 4 weeks post-training was shown for phoneme discrimination, divided attention, working memory, and self-report of hearing disability. Improved divided attention and reduced self-reported hearing difficulties were highly correlated. It was observed that phoneme discrimination training benefits some but not all people with mild hearing loss. Evidence presented here, together with that of other studies that

  17. The effect of autologous activated platelet-rich plasma injection on female pattern hair loss: A randomized placebo-controlled study.

    Science.gov (United States)

    Tawfik, Abeer Attia; Osman, Mai Abdel Raouf

    2018-02-01

    Hair is an essential part of a woman's appearance and attractiveness. This is reflected in the predominantly psychological morbidity that can be associated with female pattern hair loss. Platelet-rich plasma(PRP) has been used in numerous fields of medicine. Recently, PRP has received growing attention as a potential therapeutic tool for hair loss. To evaluate the efficacy and safety of autologous platelet-rich plasma in the treatment of female pattern hair loss. Thirty female patients with female pattern hair loss were randomly assigned to receive autologous PRP injection into a selected area, and another area was injected with normal saline as a placebo. Sessions were performed weekly for a maximum total of four sessions. Patients were followed up 6 months after the end of last session. The outcome was assessed both subjectively and objectively. There was a statistical significant difference between PRP and placebo areas (Phair density and hair thickness as measured by a folliscope. The hair pull test became negative in PRP-injected areas in 25 patients (83%) with average number of three hairs. Global pictures showed a significant improvement in hair volume and quality together with a high overall patient satisfaction in PRP-injected sites, and these results were maintained during the 6-month follow- up. Platelet-rich plasma injections can be regarded as an alternative for the treatment of female pattern hair loss with minimal morbidity and a low cost-to-benefit ratio. © 2017 Wiley Periodicals, Inc.

  18. Long-Term Weight Maintenance after a 17-Week Weight Loss Intervention with or without a One-Year Maintenance Program: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Tuula Pekkarinen

    2015-01-01

    Full Text Available Background. Weight lost by obese patients is almost always regained over time. Extended treatment may improve maintenance, but solid evidence is lacking. Purpose. We determined effectiveness of maintenance therapy after a weight loss program. Methods. Together 201 patients (mean age 47 years and BMI 42 kg/m2, 71% women were randomly assigned to either a 17-week weight loss program followed by a one-year maintenance program or to a weight loss program without subsequent maintenance intervention. The weight loss program included behavior modification and a very-low-calorie diet, and maintenance program behavior modification. The primary outcome measure was percentage of patients with 5% or more weight loss at the end of maintenance (week 69 and one year later (week 121. Secondary outcomes were weight related changes in lifestyle and quality of life. Results. At week 69, 52% of the patients with and 44% of those without maintenance program had lost weight ≥5%, P=0.40, and, at week 121, 33% and 34%, P=0.77, respectively. At week 121 secondary outcomes did not differ between the groups among those successfully followed up. Conclusions. This one-year maintenance program was not effective in preventing weight regain in severely obese patients. Trial Registration. This trial is registered under clinicaltrials.gov Identifier: NCT00590655.

  19. Low glycemic index vegan or low-calorie weight loss diets for women with polycystic ovary syndrome: a randomized controlled feasibility study.

    Science.gov (United States)

    Turner-McGrievy, Gabrielle M; Davidson, Charis R; Wingard, Ellen E; Billings, Deborah L

    2014-06-01

    The aim of this randomized pilot was to assess the feasibility of a dietary intervention among women with polycystic ovary syndrome (PCOS) comparing a vegan to a low-calorie (low-cal) diet. Overweight (body mass index, 39.9 ± 6.1 kg/m(2)) women with PCOS (n = 18; age, 27.8 ± 4.5 years; 39% black) who were experiencing infertility were recruited to participate in a 6-month randomized weight loss study delivered through nutrition counseling, e-mail, and Facebook. Body weight and dietary intake were assessed at 0, 3, and 6 months. We hypothesized that weight loss would be greater in the vegan group. Attrition was high at 3 (39%) and 6 months (67%). All analyses were conducted as intention-to-treat and presented as median (interquartile range). Vegan participants lost significantly more weight at 3 months (-1.8% [-5.0%, -0.9%] vegan, 0.0 [-1.2%, 0.3%] low-cal; P = .04), but there was no difference between groups at 6 months (P = .39). Use of Facebook groups was significantly related to percent weight loss at 3 (P Vegan participants had a greater decrease in energy (-265 [-439, 0] kcal/d) and fat intake (-7.4% [-9.2%, 0] energy) at 6 months compared with low-cal participants (0 [0, 112] kcal/d, P = .02; 0 [0, 3.0%] energy, P = .02). These preliminary results suggest that engagement with social media and adoption of a vegan diet may be effective for promoting short-term weight loss among women with PCOS; however, a larger trial that addresses potential high attrition rates is needed to confirm these results. Copyright © 2014 Elsevier Inc. All rights reserved.

  20. Effects of Hypotensive Anesthesia on Reducing Intraoperative Blood Loss, Duration of Operation, and Quality of Surgical Field During Orthognathic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Lin, Susie; McKenna, Samuel J; Yao, Chuan-Fong; Chen, Yu-Ray; Chen, Chit

    2017-01-01

    The objective of this study was to evaluate the efficacy of hypotensive anesthesia in reducing intraoperative blood loss, decreasing operation time, and improving the quality of the surgical field during orthognathic surgery. A systematic review and meta-analysis of randomized controlled trials addressing these issues were carried out. An electronic database search was performed. The risk of bias was evaluated with the Jadad Scale and Delphi List. The inverse variance statistical method and a random-effects model were used. Ten randomized controlled trials were included for analysis. Our meta-analysis indicated that hypotensive anesthesia reduced intraoperative blood loss by a mean of about 169 mL. Hypotensive anesthesia was not shown to reduce the operation time for orthognathic surgery, but it did improve the quality of the surgical field. Subgroup analysis indicated that for blood loss in double-jaw surgery, the weighted mean difference favored the hypotensive group, with a reduction in blood loss of 175 mL, but no statistically significant reduction in blood loss was found for anterior maxillary osteotomy. If local anesthesia with epinephrine was used in conjunction with hypotensive anesthesia, the reduction in intraoperative blood loss was increased to 254.93 mL. Hypotensive anesthesia was effective in reducing blood loss and improving the quality of the surgical field, but it did not reduce the operation time for orthognathic surgery. The use of local anesthesia in conjunction with hypotensive general anesthesia further reduced the amount of intraoperative blood loss for orthognathic surgery. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  1. Long-Term Effect of Interactive Online Dietician Weight Loss Advice in General Practice (LIVA) Protocol for a Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Brandt, Carl J; Brandt, Vibeke; Pedersen, Mathilde

    2014-01-01

    Background. Internet-based complex interventions aiming to promote weight loss and optimize healthy behaviors have attracted much attention. However, evidence for effect is lacking. Obesity is a growing problem, resulting in an increasing demand for cost efficient weight loss programs suitable...... for use on a large scale, for example, as part of standard primary care. In a previous pilot project by Brandt et al. (2011) without a control group, we examined the effects of online dietician counseling and found an average weight loss of 7.0 kg (95% CI: 4.6 to 9.3 kg) after 20 months. Aims and Methods....... To analyze the effects of a complex intervention using trained dieticians in a general practice setting combined with internet-based interactive and personalized weight management support compared with conventional advice with a noninteractive internet support as placebo treatment in 340 overweight patients...

  2. Weight loss among female health care workers- a 1-year workplace based randomized controlled trial in the FINALE-health study

    Directory of Open Access Journals (Sweden)

    Christensen Jeanette R

    2012-08-01

    Full Text Available Abstract Background Weight management constitutes a substantial problem particularly among groups of low socio-economic status. Interventions at work places may be a solution, but high quality worksite interventions documenting prolonged weight loss are lacking. This paper presents results of an intervention aimed to achieve a 12 months weight loss among overweight health care workers. Methods Ninety-eight overweight female health care workers were randomized into an intervention or a reference group. The intervention consisted of diet, physical exercise and cognitive behavioral training during working hours 1 hour/week. The reference group was offered monthly oral presentations. Several anthropometric measures, blood pressure, cardiorespiratory fitness, maximal muscle strength, and musculoskeletal pain were measured before and after the 12-months intervention period. Data were analyzed by intention-to-treat analysis. Results The intervention group significantly reduced body weight by 6 kg (p  Conclusions The intervention generated substantial reductions in body weight, BMI and body fat percentage among overweight female health care workers over 12 months. The positive results support the workplace as an efficient arena for weight loss among overweight females. Trial registration NCT01015716.

  3. A randomized controlled trial on the efficacy of carbohydrate-reduced or fat-reduced diets in patients attending a telemedically guided weight loss program.

    Science.gov (United States)

    Frisch, Sabine; Zittermann, Armin; Berthold, Heiner K; Götting, Christian; Kuhn, Joachim; Kleesiek, Knut; Stehle, Peter; Körtke, Heinrich

    2009-07-18

    We investigated whether macronutrient composition of energy-restricted diets influences the efficacy of a telemedically guided weight loss program. Two hundred overweight subjects were randomly assigned to a conventional low-fat diet and a low-carbohydrate diet group (target carbohydrate content: >55% energy and Bluetooth technology by mobile phone. Various fatness and fat distribution parameters, energy and macronutrient intake, and various biochemical risk markers were measured at baseline and after 6, and 12 months. In both groups, energy intake decreased by 400 kcal/d compared to baseline values within the first 6 months and slightly increased again within the second 6 months. Macronutrient composition differed significantly between the groups from the beginning to month 12. At study termination, weight loss was 5.8 kg (SD: 6.1 kg) in the low-carbohydrate group and 4.3 kg (SD: 5.1 kg) in the low-fat group (p = 0.065). In the low-carbohydrate group, triglyceride and HDL-cholesterol levels were lower at month 6 and waist circumference and systolic blood pressure were lower at month 12 compared with the low-fat group (P = 0.005-0.037). Other risk markers improved to a similar extent in both groups. Despite favourable effects of both diets on weight loss, the carbohydrate-reduced diet was more beneficial with respect to cardiovascular risk factors compared to the fat-reduced diet. Nevertheless, compliance with a weight loss program appears to be even a more important factor for success in prevention and treatment of obesity than the composition of the diet. Clinicaltrials.gov as NCT00868387.

  4. A randomized controlled trial on the efficacy of carbohydrate-reduced or fat-reduced diets in patients attending a telemedically guided weight loss program

    Directory of Open Access Journals (Sweden)

    Stehle Peter

    2009-07-01

    Full Text Available Abstract Background We investigated whether macronutrient composition of energy-restricted diets influences the efficacy of a telemedically guided weight loss program. Methods Two hundred overweight subjects were randomly assigned to a conventional low-fat diet and a low-carbohydrate diet group (target carbohydrate content: >55% energy and ® technology by mobile phone. Various fatness and fat distribution parameters, energy and macronutrient intake, and various biochemical risk markers were measured at baseline and after 6, and 12 months. Results In both groups, energy intake decreased by 400 kcal/d compared to baseline values within the first 6 months and slightly increased again within the second 6 months. Macronutrient composition differed significantly between the groups from the beginning to month 12. At study termination, weight loss was 5.8 kg (SD: 6.1 kg in the low-carbohydrate group and 4.3 kg (SD: 5.1 kg in the low-fat group (p = 0.065. In the low-carbohydrate group, triglyceride and HDL-cholesterol levels were lower at month 6 and waist circumference and systolic blood pressure were lower at month 12 compared with the low-fat group (P = 0.005–0.037. Other risk markers improved to a similar extent in both groups. Conclusion Despite favourable effects of both diets on weight loss, the carbohydrate-reduced diet was more beneficial with respect to cardiovascular risk factors compared to the fat-reduced diet. Nevertheless, compliance with a weight loss program appears to be even a more important factor for success in prevention and treatment of obesity than the composition of the diet. Trial registration Clinicaltrials.gov as NCT00868387

  5. A Randomized Controlled Trial of Two Different Macronutrient Profiles on Weight, Body Composition and Metabolic Parameters in Obese Adolescents Seeking Weight Loss.

    Directory of Open Access Journals (Sweden)

    Helen Truby

    Full Text Available Adolescent obesity is difficult to treat and the optimal dietary pattern, particularly in relation to macronutrient composition, remains controversial. This study tested the effect of two structured diets with differing macronutrient composition versus control, on weight, body composition and metabolic parameters in obese adolescents.A randomized controlled trial conducted in a children's hospital.Eighty seven obese youth (means: age 13.6 years, BMI z-score 2.2, waist: height ratio 0.65, 69% female completed a psychological preparedness program and were then randomized to a short term 'structured modified carbohydrate' (SMC, 35% carbohydrate; 30% protein; 35% fat, n = 37 or a 'structured low fat' (SLF, 55% carbohydrate; 20% protein; 25% fat, n = 36 or a wait listed control group (n = 14. Anthropometric, body composition and biochemical parameters were measured at randomization and after 12 weeks, and analyzed under the intention to treat principle using analysis of variance models.After 12 weeks, data was collected from 79 (91% participants. BMI z-scores were significantly lower in both intervention groups compared to control after adjusting for baseline values, SLF vs. control, mean difference = -0.13 (95%CI = -0.18, -0.07, P<0.001; SMC vs. control, -0.14 (-0.19, -0.09, P<0.001, but there was no difference between the two intervention diet groups: SLF vs. SMC, 0.00 (-0.05, 0.04, P = 0.83.Both dietary patterns resulted in similar changes in weight, body composition and metabolic improvements compared to control. The use of a structured eating system which allows flexibility but limited choices can assist in weight change and the rigid application of a low fat eating pattern is not exclusive in its efficacy.International Clinical Trials Registry ISRCTN49438757.

  6. Finding all sorting tandem duplication random loss operations

    DEFF Research Database (Denmark)

    Bernt, Matthias; Chen, Kuan Yu; Chen, Ming Chiang

    2011-01-01

    A tandem duplication random loss (TDRL) operation duplicates a contiguous segment of genes, followed by the random loss of one copy of each of the duplicated genes. Although the importance of this operation is founded by several recent biological studies, it has been investigated only rarely from...

  7. Effect of mindfulness meditation on short-term weight loss and eating behaviors in overweight and obese adults: A randomized controlled trial.

    Science.gov (United States)

    Spadaro, Kathleen C; Davis, Kelliann K; Sereika, Susan M; Gibbs, Bethany B; Jakicic, John M; Cohen, Susan M

    2017-12-05

    Background There is a significant health crisis with rates of obesity continuing to increase despite research and clinical standard behavioral weight loss programs (SBWP). Mindfulness meditation (MM), with demonstrated benefits on physical, psychological health, and self-regulation behaviors was explored with SBWP. Methods Forty-six adults (BMI=32.5±3.7 kg/m2; age=45.2±8.2 years, 87 % female, 21.7 % African American) were randomly assigned to a 6-month SBWP only (n=24) or SBWP+MM (n=22) at a university-based physical activity and weight management research center in a northeastern US city. Participants were instructed to decrease intake (1200-1500 kcal/day), increase physical activity (300 min/wk), and attend weekly SBWP or SBWP+MM sessions. SBWP+MM had the same SBWP lessons with addition of focused MM training. Outcome measures collected at 0, 3, and 6 months included: weight, Block Food Frequency Questionnaire, Eating Behavior Inventory, Eating Inventory and Paffenbarger Physical Activity Questionnaire. Data were analyzed using linear mixed modeling for efficacy analysis of weight (primary) and eating, exercise and mindfulness (secondary outcomes). Results Retention rate was 76.1 % (n=35). A significant group by time interaction (p=0.03) was found for weight, with weight loss favoring SBWP+MM (-6.9 kg+2.9) over SBWP (-4.1 kg+2.8). Eating behaviors (p=0.02) and dietary restraint (p=0.02) improved significantly in SBWP+MM, compared to SBWP. MM enhanced weight loss by 2.8 kg potentially through greater improvements in eating behaviors and dietary restraint. Conclusions These findings support further study into the use of MM strategies with overweight and obese adults. The use of this low-cost, portable strategy with standard behavioral interventions could improve weight management outcomes.

  8. A Commercially Available Portion-Controlled Diet Program Is More Effective for Weight Loss than a Self-Directed Diet: Results from a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Chad M. Cook

    2017-11-01

    Full Text Available ObjectiveTo examine changes in weight and related outcomes in response to a commercial weight loss program compared to a self-directed diet in adults with overweight or obesity.DesignParticipants were randomly assigned [stratified by body mass index (BMI and age] to a commercial weight loss program (n = 38 or to a self-directed Dietary Approaches to Stop Hypertension (DASH diet (n = 40 for a 16-week period. Daily energy intake goals were 1,500 kcal/d for men and 1,200 kcal/d for women, except for the first week of the commercial program (1,000 kcal/d. This study was registered at http://ClinicalTrials.gov (NCT03017443.ParticipantsPrimarily Caucasian (71% women (n = 61 and men (n = 17 from the greater metropolitan area of the city of Chicago, IL, USA. with a mean baseline BMI of 34.4 kg/m2, body weight of 95.7 kg, and age of 50.4 years.ResultsData = mean (95% CI. At week 16, the commercial program group lost significantly more body weight [−5.9 (−7.5, −4.3 kg vs. −1.8 (−2.9, −0.8 kg; or −6.4 vs. −1.8% of initial body weight, respectively], fat mass [−4.4 (−5.7, −3.1 kg vs. −1.2 (−2.1, −0.4 kg] and total body circumference (chest + waist + hip + upper arm + thigh [−16.9 (−21.5, −12.3 cm vs. −5.8 (−9.0, −2.6 cm] (p < 0.01 for all. Additionally, more participants in the commercial program group lost a clinically meaningful amount of weight, defined as ≥5% of initial body weight, at week 16 (58% vs. 13%, p < 0.001.ConclusionThe commercial program resulted in greater weight loss and improvements in body composition/anthropometric parameters compared to a self-directed DASH diet over a 16-week period. Some important limitations were that no objective measurements of dietary intake or physical activity were collected to potentially ascertain the independent or combined effects of these components on weight loss (or lack thereof. Additionally, future

  9. Effect of zoledronic acid on reducing femoral bone mineral density loss following total hip arthroplasty: A meta-analysis from randomized controlled trails.

    Science.gov (United States)

    Gao, Jian; Gao, Chong; Li, Hui; Wang, Guo-Sheng; Xu, Chang; Ran, Jian

    2017-11-01

    This meta-analysis aimed to assess the efficiency of intravenous administration of zoledronic acid on reducing femoral periprosthetic bone mineral density loss in patients undergoing primary total hip arthroplasty (THA). A systematic search was performed in Medline (1966-2017.07.31), PubMed (1966-2017.07.31), Embase (1980-2017.07.31), ScienceDirect (1985-2017.07.31) and the Cochrane Library (1966-2017.07.31). Fixed/random effect model was used according to the heterogeneity tested by I 2 statistic. Sensitivity analysis was conducted and publication bias was assessed. Meta-analysis was performed using Stata 11.0 software. Four studies including 185 patients met the inclusion criteria. The present meta-analysis indicated that there were significant differences between groups in terms of periprosthetic bone mineral density in Gruen zone 1 (SMD = 0.752, 95% CI: 0.454 to 1.051, P = 0.000), 2 (SMD = 0.524, 95% CI: 0.230 to 0.819, P = 0.000), 4 (SMD = 0.400, 95% CI: 0.107 to 0.693, P = 0.008), 6 (SMD = 0.893, 95% CI: 0.588 to 1.198, P = 0.000) and 7 (SMD = 0.988, 95% CI: 0.677 to 1.300, P = 0.000). Intravenous administration of zoledronic acid could significantly reduce periprosthetic bone mineral density loss (Gruen zone 1, 2, 4, 6 and 7) after THA. In addition, no severe adverse events were identified. High-quality RCTs with large sample size were still required. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  10. Effect of Mechanical Ventilation Mode Type on Intra- and Postoperative Blood Loss in Patients Undergoing Posterior Lumbar Interbody Fusion Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Kang, Woon-Seok; Oh, Chung-Sik; Kwon, Won-Kyoung; Rhee, Ka Young; Lee, Yun Gu; Kim, Tae-Hoon; Lee, Suk Ha; Kim, Seong-Hyop

    2016-07-01

    The aim of study was to evaluate the effect of mechanical ventilation mode type, pressure-controlled ventilation (PCV), or volume-controlled ventilation (VCV) on intra- and postoperative surgical bleeding in patients undergoing posterior lumbar interbody fusion (PLIF) surgery. This was a prospective, randomized, single-blinded, and parallel study that included 56 patients undergoing PLIF and who were mechanically ventilated using PCV or VCV. A permuted block randomization was used with a computer-generated list. The hemodynamic and respiratory parameters were measured after anesthesia induction in supine position, 5 min after patients were changed from supine to prone position, at the time of skin closure, and 5 min after the patients were changed from prone to supine position. The amount of intraoperative surgical bleeding, fluid administration, urine output, and transfusion requirement were measured at the end of surgery. The amount of postoperative bleeding and transfusion requirement were recorded every 24 h for 72 h. The primary outcome was the amount of intraoperative surgical bleeding, and 56 patients were analyzed. The amount of intraoperative surgical bleeding was significantly less in the PCV group than that in the VCV group (median, 253.0 [interquartile range, 179.0 to 316.5] ml in PCV group vs. 382.5 [328.0 to 489.5] ml in VCV group; P patients undergoing PLIF, which may be related to lower intraoperative peak inspiratory pressure.

  11. Does a thrombin-based topical haemostatic agent reduce blood loss and transfusion requirements after total knee revision surgery? A randomized, controlled trial.

    Science.gov (United States)

    Romanò, Carlo L; Monti, Lorenzo; Logoluso, Nicola; Romanò, Delia; Drago, Lorenzo

    2015-11-01

    The aim of the present study was to assess the efficacy of a thrombin-based topical haemostatic in reducing blood requirements after total knee replacement (TKR) revision surgery. This prospective, randomized, controlled study was designed to evaluate the haemostatic efficacy and safety of a thrombin-based topical haemostatic (Floseal) versus standard treatment in patients receiving total knee revision arthroplasty. The decrease in haemoglobin values postsurgery and the blood units transfused were recorded. The decision to transfuse was made by a surgeon blinded to the patient's group allocation. Forty-eight patients were enroled in the study; twenty-four patients each were randomized to the treatment and control groups, respectively. The median decrease in haemoglobin concentration on the first postoperative day was 2.2 g/dL in the treatment group and 2.7 g/dL in the control group. A significant reduction in units of blood transfused was also observed in the treatment group compared with the control group [1.1 ± 1.13 (range 0-4) vs. 1.9 ± 1.41 (range 0-5) blood units; P = 0.04]. No major treatment-related adverse events were recorded in the study. This study shows that a thrombin-based topical haemostatic reduces the need for blood transfusion in TKR revision surgery. A thrombin-based topical haemostatic agent can be an appropriate solution to enhance haemostasis and vessel sealing at the operative site in TKR revision surgery, in order to reduce the need for blood transfusion after surgery. II.

  12. Cognitive and Self-regulatory Mechanisms of Obesity Study (COSMOS): Study protocol for a randomized controlled weight loss trial examining change in biomarkers, cognition, and self-regulation across two behavioral treatments.

    Science.gov (United States)

    Hawkins, M A W; Colaizzi, Janna; Gunstad, John; Hughes, Joel W; Mullins, Larry L; Betts, Nancy; Smith, Caitlin E; Keirns, Natalie G; Vohs, Kathleen D; Moore, Shirley M; Forman, Evan M; Lovallo, William R

    2018-03-01

    Obesity is a global epidemic, yet successful interventions are rare. Up to 60% of people fail to achieve clinically meaningful, short-term weight loss (5-10% of start weight), whereas up to 72% are unsuccessful at achieving long-term weight loss (5-10% loss for ≥5years). Understanding how biological, cognitive, and self-regulatory factors work together to promote or to impede weight loss is clearly needed to optimize obesity treatment. This paper describes the methodology of the Cognitive and Self-regulatory Mechanisms of Obesity Study (the COSMOS trial). COSMOS is the first randomized controlled trial to investigate how changes in multiple biopsychosocial and cognitive factors relate to weight loss and one another across two weight loss treatments. The specific aims are to: 1) Confirm that baseline obesity-related physiological dysregulation is linked to cognitive deficits and poorer self-regulation, 2) Evaluate pre- to post-treatment change across time to assess individual differences in biomarkers, cognition, and self-regulation, and 3) Evaluate whether the acceptance-based treatment (ABT) group has greater improvements in outcomes (e.g., greater weight loss and less weight regain, improvements in biomarkers, cognition, and self-regulation), than the standard behavioral treatment group (SBT) from pre- to post-treatment and 1-year follow-up. The results of COSMOS will provide critical information about how dysregulation in biomarkers, cognition, and/or self-regulation is related to weight loss and whether weight loss treatments are differentially associated with these factors. This information will be used to identify promising treatment targets that are informed by biological, cognitive, and self-regulatory factors in order to advance obesity treatment. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Effect of a vegetable-oil emulsion on body composition; a 12-week study in overweight women on a meal replacement therapy after an initial weight loss: a randomized controlled trial.

    Science.gov (United States)

    Olsson, Johan; Sundberg, Birgitta; Viberg, Annika; Haenni, Arvo

    2011-06-01

    The maintenance of an obtained lower weight level is often found to be difficult. The aim of this study was to determine weight maintenance after an initial weight loss by consumption of a meal replacement with a vegetable-oil emulsion associated with prolonged satiety. After a 6-week weight loss period with very low calorie diet (VLCD), subjects with >5% body weight (BW) loss were randomized to a 12-week weight maintenance follow-up period, comparing a partial meal replacement diet containing a vegetable-oil emulsion (test) or dairy fat (control). Anthropometric data and safety variables were collected at baseline and after 4, 8 and 12 weeks. A significant weight loss was observed during the 12-week weight maintenance diet in the test and control group, respectively; 1.0 ± 2.1 kg (p Body fat mass (BFM) decreased significantly (p initial weight loss using VLCD was associated with decreased BFM by 0.9% without any change in BW between the two groups.

  14. Effects of Meditation versus Music Listening on Perceived Stress, Mood, Sleep, and Quality of Life in Adults with Early Memory Loss: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Innes, Kim E; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

    2016-04-08

    Older adults with subjective cognitive decline (SCD) are at increased risk not only for Alzheimer's disease, but for poor mental health, impaired sleep, and diminished quality of life (QOL), which in turn, contribute to further cognitive decline, highlighting the need for early intervention. In this randomized controlled trial, we assessed the effects of two 12-week relaxation programs, Kirtan Kriya Meditation (KK) and music listening (ML), on perceived stress, sleep, mood, and health-related QOL in older adults with SCD. Sixty community-dwelling older adults with SCD were randomized to a KK or ML program and asked to practice 12 minutes daily for 12 weeks, then at their discretion for the following 3 months. At baseline, 12 weeks, and 26 weeks, perceived stress, mood, psychological well-being, sleep quality, and health-related QOL were measured using well-validated instruments. Fifty-three participants (88%) completed the 6-month study. Participants in both groups showed significant improvement at 12 weeks in psychological well-being and in multiple domains of mood and sleep quality (p's≤0.05). Relative to ML, those assigned to KK showed greater gains in perceived stress, mood, psychological well-being, and QOL-Mental Health (p's≤0.09). Observed gains were sustained or improved at 6 months, with both groups showing marked and significant improvement in all outcomes. Changes were unrelated to treatment expectancies. Findings suggest that practice of a simple meditation or ML program may improve stress, mood, well-being, sleep, and QOL in adults with SCD, with benefits sustained at 6 months and gains that were particularly pronounced in the KK group.

  15. Low energy density diet, weight loss maintenance, and risk of cardiovascular disease following a recent weight reduction program: A randomized control trial

    Directory of Open Access Journals (Sweden)

    Golgis Karimi

    2016-01-01

    Full Text Available Background: Little is known about the effects of a low energy dense diet on weight maintenance and cardiovascular risks following a recent weight reduction. Therefore, we assessed if weight maintenance, lipid profiles, and glycemic control differ between low energy density (LED diet and usual diet consumers following a recent weight reduction. Materials and Methods: In this randomized controlled clinical trial study in a parallel design, we recruited 70 patients with the history of weight reduction in the recent 1 year. LED diet contained 30% fat, 15% protein, and 55% carbohydrate was administered to the test group, and a usual diet including 35% fat, 15% protein, and 50% carbohydrate was prescribed to the control group for 7 months. Dietary intake was assessed by using 3 days food records. Biochemical markers and anthropometric measures were done according to the standard protocol. Results: Weight reduced in LED diet consumers compared to usual diet consumers (−0.3 ± 0.2 vs. 1.3 ± 0.4%, P = 0.002. The results was the same regarding waist circumference (−0.4 ± 0.2 vs. 0.3 ± 0.1%, P = 0.004. Fasting blood sugar also decreased in LED diet group (−9.5 ± 0.8 vs. 0.4 ± 1.0%, P = 0.0001. LED diet group had a drop in percent change of their total cholesterol (−0.4 ± 0.5 vs. 2.05 ± 0.4%, P = 0.04 and low-density lipoprotein-cholesterol (4.8 ± 0.9 vs. −0.3 ± 0.9%, P = 0.002. Conclusion: Our findings confirmed beneficial effects of LED diet on attenuating weight regain in subjects with history of recent weight reduction. It might be derived from higher consumption of fruits, vegetables, and fiber among LED diet than usual diet consumers.

  16. Cognitive-Behavioral Therapy, Behavioral Weight Loss, and Sequential Treatment for Obese Patients with Binge-Eating Disorder: A Randomized Controlled Trial

    Science.gov (United States)

    Grilo, Carlos M.; Masheb, Robin M.; Wilson, G. Terence; Gueorguieva, Ralitza; White, Marney A.

    2011-01-01

    Objective: Cognitive-behavioral therapy (CBT) is the best established treatment for binge-eating disorder (BED) but does not produce weight loss. The efficacy of behavioral weight loss (BWL) in obese patients with BED is uncertain. This study compared CBT, BWL, and a sequential approach in which CBT is delivered first, followed by BWL (CBT + BWL).…

  17. An internet-based self-administered intervention for promoting healthy habits and weight loss in hypertensive people who are overweight or obese: a randomized controlled trial.

    Science.gov (United States)

    Banos, Rosa M; Mensorio, Marinna S; Cebolla, Ausias; Rodilla, Enrique; Palomar, Gonzalo; Lisón, JuanFrancisco; Botella, Cristina

    2015-08-04

    The prevalence of overweight and obesity is on the rise worldwide with severe physical and psychosocial consequences. One of the most dangerous is hypertension. Lifestyle changes related to eating behaviour and physical activity are the critical components in the prevention and treatment of hypertension and obesity. Data indicates that the usual procedures to promote these healthy habits in health services are either insufficient or not efficient enough. Internet has been shown to be an effective tool for the implementation of lifestyle interventions based on this type of problem. This study aims to assess the efficacy of a totally self-administered online intervention programme versus the usual medical care for obese and overweight participants with hypertension (from the Spanish public health care system) to promote healthy lifestyles (eating behaviour and physical activity). A randomized controlled trial will be conducted with 100 patients recruited from the hypertension unit of a public hospital. Participants will be randomly assigned to one of two conditions: a) SII: a self-administered Internet-based intervention protocol; and b) MUC-medical usual care. The online intervention is an Internet-delivered, multimedia, interactive, self-administered programme, composed of nine modules designed to promote healthy eating habits and increase physical activity. The first five modules will be activated at a rate of one per week, and access for modules 5 to 9 will open every two weeks. Patients will be assessed at four points: before the intervention, after the intervention (3 months), and at 6 and 12 months (follow-up). The outcome variables will include blood pressure, and Body Mass Index, as primary outcome measures, and quality of life and other lifestyle and anthropometrical variables as secondary outcome measures. The literature highlights the need for more studies on the benefits of using the Internet to promote lifestyle interventions. This study aims to

  18. Does Glycine max leaves or Garcinia Cambogia promote weight-loss or lower plasma cholesterol in overweight individuals: a randomized control trial

    OpenAIRE

    Kim, Ji-Eun; Jeon, Seon-Min; Park, Ki Hun; Lee, Woo Song; Jeong, Tae-Sook; McGregor, Robin A; Choi, Myung-Sook

    2011-01-01

    Abstract Background Natural food supplements with high flavonoid content are often claimed to promote weight-loss and lower plasma cholesterol in animal studies, but human studies have been more equivocal. The aim of this study was firstly to determine the effectiveness of natural food supplements containing Glycine max leaves extract (EGML) or Garcinia cambogia extract (GCE) to promote weight-loss and lower plasma cholesterol. Secondly to examine whether these supplements have any beneficial...

  19. A three-component cognitive behavioural lifestyle program for preconceptional weight-loss in women with polycystic ovary syndrome (PCOS): A protocol for a randomized controlled trial

    OpenAIRE

    Jiskoot, Geranne; Benneheij, Sofie; Beerthuizen, Annemerle; Niet, J.E.; Klerk, Cora; Timman, Reinier; Busschbach, Jan; Laven, Joop

    2017-01-01

    textabstractBackground: Obesity in women with polycystic ovary syndrome (PCOS) negatively affects all clinical features, and a 5 to 10% weight loss has shown promising results on reproductive, metabolic and psychological level. Incorporating a healthy diet, increasing physical activity and changing dysfunctional thought patterns in women with PCOS are key points in losing weight. The biggest challenge in weight management programs is to achieve a reasonable and sustainable weight loss. The ai...

  20. a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MS Yıldırım

    2016-02-01

    Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.

  1. Sustainable weight loss among overweight and obese lactating women is achieved with an energy-reduced diet in line with dietary recommendations: results from the LEVA randomized controlled trial.

    Science.gov (United States)

    Bertz, Fredrik; Winkvist, Anna; Brekke, Hilde K

    2015-01-01

    The aim of this study was to evaluate dietary changes during and after a dietary treatment shown to result in significant and sustained weight loss among lactating overweight and obese women. This is crucial before clinical implementation. Data were collected from the LEVA (in Swedish: Livsstil för Effektiv Viktminskning under Amning [Lifestyle for Effective Weight Loss During Lactation]) randomized controlled factorial trial with a 12-week intervention and a 1-year follow up. At 10 to 14 weeks postpartum, 68 lactating Swedish women with a prepregnancy body mass index (calculated as kg/m(2)) of 25 to 35 were randomized to structured dietary treatment, physical exercise treatment, combined treatment, or usual care (controls) for a 12-week intervention, with a 1-year follow-up. Dietary intake was assessed with 4-day weighed dietary records. Recruitment took place between 2007 and 2010. The main outcome measures were changes in macro- and micronutrient intake from baseline to 12 weeks and 1 year. Main and interaction effects of the treatments were analyzed by a 2×2 factorial approach using a General Linear Model adjusted for relevant covariates (baseline intake and estimated underreporting). It was found that at baseline, the women had an intake of fat and sucrose above, and an intake of total carbohydrates and fiber below, recommended levels. At 12 weeks and 1 year, the dietary treatment led to reduced intake of energy (Pfat (both P values carbohydrates were reduced (Pfat and carbohydrates. Diet composition changed to decreased proportions of fat and sucrose, and increased proportions of complex carbohydrates, protein and fiber. Weight loss through dietary treatment was achieved with a diet in line with macronutrient recommendations. Copyright © 2015 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  2. Does Glycine max leaves or Garcinia Cambogia promote weight-loss or lower plasma cholesterol in overweight individuals: a randomized control trial.

    Science.gov (United States)

    Kim, Ji-Eun; Jeon, Seon-Min; Park, Ki Hun; Lee, Woo Song; Jeong, Tae-Sook; McGregor, Robin A; Choi, Myung-Sook

    2011-09-21

    Natural food supplements with high flavonoid content are often claimed to promote weight-loss and lower plasma cholesterol in animal studies, but human studies have been more equivocal. The aim of this study was firstly to determine the effectiveness of natural food supplements containing Glycine max leaves extract (EGML) or Garcinia cambogia extract (GCE) to promote weight-loss and lower plasma cholesterol. Secondly to examine whether these supplements have any beneficial effect on lipid, adipocytokine or antioxidant profiles. Eighty-six overweight subjects (Male:Female = 46:40, age: 20~50 yr, BMI > 23 GCE (2 g/day) or placebo (starch, 2 g/day) for 10 weeks. At baseline and after 10 weeks, body composition, plasma cholesterol and diet were assessed. Blood analysis was also conducted to examine plasma lipoproteins, triglycerides, adipocytokines and antioxidants. EGML and GCE supplementation failed to promote weight-loss or any clinically significant change in %body fat. The EGML group had lower total cholesterol after 10 weeks compared to the placebo group (p GCE had no effect on triglycerides, non-HDL-C, adipocytokines or antioxidants when compared to placebo supplementation. However, HDL-C was higher in the EGML group (p GCE supplementation did not promote weight-loss or lower total cholesterol in overweight individuals consuming their habitual diet. Although, EGML did increase plasma HDL-C levels which is associated with a lower risk of atherosclerosis.

  3. Does Glycine max leaves or Garcinia Cambogia promote weight-loss or lower plasma cholesterol in overweight individuals: a randomized control trial

    Directory of Open Access Journals (Sweden)

    Jeong Tae-Sook

    2011-09-01

    Full Text Available Abstract Background Natural food supplements with high flavonoid content are often claimed to promote weight-loss and lower plasma cholesterol in animal studies, but human studies have been more equivocal. The aim of this study was firstly to determine the effectiveness of natural food supplements containing Glycine max leaves extract (EGML or Garcinia cambogia extract (GCE to promote weight-loss and lower plasma cholesterol. Secondly to examine whether these supplements have any beneficial effect on lipid, adipocytokine or antioxidant profiles. Methods Eighty-six overweight subjects (Male:Female = 46:40, age: 20~50 yr, BMI > 23 Results EGML and GCE supplementation failed to promote weight-loss or any clinically significant change in %body fat. The EGML group had lower total cholesterol after 10 weeks compared to the placebo group (p Conclusions Ten weeks of EGML or GCE supplementation did not promote weight-loss or lower total cholesterol in overweight individuals consuming their habitual diet. Although, EGML did increase plasma HDL-C levels which is associated with a lower risk of atherosclerosis.

  4. Effects of high protein diets on fat-free mass and muscle protein synthesis following weight loss: a randomized controlled trial

    Science.gov (United States)

    Context: The benefits of high protein diets for sparing lean body mass and sustaining skeletal muscle protein metabolism during short-term weight loss in normal-weight adults are not well described. Objective: Determine the effects of varying levels of dietary protein intake on body compos...

  5. A three-component cognitive behavioural lifestyle program for preconceptional weight-loss in women with polycystic ovary syndrome (PCOS): A protocol for a randomized controlled trial

    NARCIS (Netherlands)

    L.G. Jiskoot (Geranne); S.H. Benneheij (Sofie); A. Beerthuizen (Annemerle); J.E. de Niet; C. de Klerk (Cora); R. Timman (Reinier); J.J. van Busschbach (Jan); J.S.E. Laven (Joop)

    2017-01-01

    textabstractBackground: Obesity in women with polycystic ovary syndrome (PCOS) negatively affects all clinical features, and a 5 to 10% weight loss has shown promising results on reproductive, metabolic and psychological level. Incorporating a healthy diet, increasing physical activity and changing

  6. Kefir drink leads to a similar weight loss, compared with milk, in a dairy-rich non-energy-restricted diet in overweight or obese premenopausal women: a randomized controlled trial.

    Science.gov (United States)

    Fathi, Yasamin; Faghih, Shiva; Zibaeenezhad, Mohammad Javad; Tabatabaei, Sayed Hamid Reza

    2016-02-01

    Controversy exists regarding whether increasing dairy intake without energy restriction would lead to weight loss. We aimed to compare the potential weight-reducing effects of kefir drink (a probiotic dairy product) and milk in a dairy-rich non-energy-restricted diet in overweight or obese premenopausal women. One hundred and forty-four subjects were assessed for eligibility in this single-center, multi-arm, parallel-group, randomized controlled trial. Of these, seventy-five eligible women aged 25-45 years were randomly assigned to three groups, labeled as control, milk, and kefir, to receive an outpatient dietary regimen for 8 weeks. Subjects in the control group received a diet providing a maintenance level of energy intake, containing 2 servings/day of low-fat dairy products, while those in the milk and kefir groups received a weight maintenance diet, containing 2 additional servings/day (a total of 4 servings/day) of dairy products from low-fat milk or commercial kefir drink, respectively. Anthropometric outcomes including weight, body mass index (BMI), and waist circumference (WC) were measured every 2 weeks. Fifty-eight subjects completed the study. Using analysis of covariance models in the intention-to-treat population (n = 75), we found that at 8 weeks, subjects in the kefir and milk groups had significantly greater reductions in weight, BMI, and WC compared to those in the control group (all p < 0.01). However, no such significant differences were found between the kefir and milk groups. Kefir drink leads to a similar weight loss, compared with milk, in a dairy-rich non-energy-restricted diet in overweight or obese premenopausal women. However, further studies are warranted.

  7. A randomized, double-blind, placebo-controlled clinical trial of megestrol acetate as an appetite stimulant in children with weight loss due to cancer and/or cancer therapy.

    Science.gov (United States)

    Cuvelier, Geoff D E; Baker, Tina J; Peddie, Elaine F; Casey, Linda M; Lambert, Pascal J; Distefano, Dianne S; Wardle, Marlene G; Mychajlunow, Beth A; Romanick, Marcel A; Dix, David B; Wilson, Beverly A

    2014-04-01

    Megestrol acetate (MA) is an appetite stimulant with efficacy in promoting weight gain in adults with cancer-associated anorexia-cachexia. Studies documenting MA efficacy in children, however, are limited. We present the first randomized, double-blind, placebo-controlled clinical trial of MA versus placebo in children with cancer and weight loss. Subjects nutrition, and toxicities. Twenty-six patients were randomly assigned (13 MA, 13 placebo). The MA group experienced a mean weight gain of +19.7% compared to a mean weight loss of -1.2% in the placebo group, for a difference of +20.9% (95%CI: +11.3% to +30.5%, P = 0.003) in favor of MA over placebo. MA subjects experienced significant increases in weight for age z-scores, body mass index z-scores, and mid upper arm circumference compared to placebo. DXA scanning suggested disproportionate increases in fat accrual. Adrenal suppression was the main toxicity of MA. In children with high-risk malignancies, MA resulted in significant increases in mean percent weight change compared to placebo. Further studies of MA should be pursued to better delineate the effect on nutritional status. © 2013 Wiley Periodicals, Inc.

  8. Pre-treatment microbial Prevotella-to-Bacteroides ratio, determines body fat loss success during a 6-month randomized controlled diet intervention

    DEFF Research Database (Denmark)

    Hjorth, M F; Roager, Henrik Munch; Larsen, T. M.

    2017-01-01

    Based on the abundance of specific bacterial genera, the human gut microbiota can be divided into two relatively stable groups that might play a role in personalized nutrition. We studied these simplified enterotypes as prognostic markers for successful body fat loss on two different diets. A total....... divided by Bacteroides spp. (P/B ratio) obtained by quantitative PCR analysis. Modifications of dietary effects of pre-treatment P/B group were examined by linear mixed models. Among individuals with high P/B the NND resulted in a 3.15 kg (95%CI 1.55;4.76, Pfat loss compared to ADD...... to lose body fat on diets high in fiber and wholegrain than subjects with a low P/B-ratio....

  9. Weight loss among female health care workers- a 1-year workplace based randomized controlled trial in the FINALE-health study

    DEFF Research Database (Denmark)

    Christensen, Jeanette R; Overgaard, Kristian; Carneiro, Isabella G

    2012-01-01

    working hours 1 hour/week. The reference group was offered monthly oral presentations. Several anthropometric measures, blood pressure, cardiorespiratory fitness, maximal muscle strength, and musculoskeletal pain were measured before and after the 12-months intervention period. Data were analyzed......ABSTRACT: Background Weight management constitutes a substantial problem particularly among groups of low socio-economic status. Interventions at work places may be a solution, but high quality worksite interventions documenting prolonged weight loss are lacking. This paper presents results...... by intention-to-treat analysis. Results The intervention group significantly reduced body weight by 6.1 kg (p...

  10. Effect of a high protein diet and/or resistance exercise on the preservation of fat free mass during weight loss in overweight and obese older adults: a randomized controlled trial.

    Science.gov (United States)

    Verreijen, Amely M; Engberink, Mariëlle F; Memelink, Robert G; van der Plas, Suzanne E; Visser, Marjolein; Weijs, Peter J M

    2017-02-06

    Intentional weight loss in obese older adults is a risk factor for accelerated muscle mass loss. We investigated whether a high protein diet and/or resistance exercise preserves fat free mass (FFM) during weight loss in overweight and obese older adults. We included 100 overweight and obese adults (55-80 year) in a randomized controlled trial (RCT) with a 2 × 2 factorial design and intention-to-treat analysis. During a 10-week weight loss program all subjects followed a hypocaloric diet. Subjects were randomly allocated to either a high protein (1.3 g/kg body weight) or normal protein diet (0.8 g/kg), with or without a resistance exercise program 3 times/week. FFM was assessed by air displacement plethysmography. At baseline, mean (±SD) BMI was 32 ± 4 kg/m 2 . During intervention, protein intake was 1.13 ± 0.35 g/kg in the high protein groups vs. 0.98 ± 0.29 in the normal protein groups, which reflects a 16.3 ± 5.2 g/d higher protein intake in the high protein groups. Both high protein diet and exercise did not significantly affect change in body weight, FFM and fat mass (FM). No significant protein*exercise interaction effect was observed for FFM. However, within-group analysis showed that high protein in combination with exercise significantly increased FFM (+0.6 ± 1.3 kg, p = 0.011). A high protein diet, though lower than targeted, did not significantly affect changes in FFM during modest weight loss in older overweight and obese adults. There was no significant interaction between the high protein diet and resistance exercise for change in FFM. However, only the group with the combined intervention of high protein diet and resistance exercise significantly increased in FFM. Dutch Trial Register, number NTR4556, date 05-01-2014.

  11. Reducing undercarboxylated osteocalcin with vitamin K supplementation does not promote lean tissue loss or fat gain over three years in older women and men: a randomized controlled trial

    Science.gov (United States)

    Osteocalcin (OC) is a vitamin K-dependent protein synthesized during bone formation. Mice injected with the undercarboxylated form of OC (ucOC) had more skeletal muscle mass and less fat mass than sham-treated controls, suggesting a unique metabolic role for ucOC. UcOC decreases in response to vitam...

  12. Development of a Mobile Phone-Based Weight Loss Lifestyle Intervention for Filipino Americans with Type 2 Diabetes: Protocol and Early Results From the PilAm Go4Health Randomized Controlled Trial.

    Science.gov (United States)

    Bender, Melinda Sarmiento; Santos, Glenn-Milo; Villanueva, Carissa; Arai, Shoshana

    2016-09-08

    Filipino Americans are the second largest Asian subgroup in the United States, and were found to have the highest prevalence of obesity and type 2 diabetes (T2D) compared to all Asian subgroups and non-Hispanic whites. In addition to genetic factors, risk factors for Filipinos that contribute to this health disparity include high sedentary rates and high fat diets. However, Filipinos are seriously underrepresented in preventive health research. Research is needed to identify effective interventions to reduce Filipino diabetes risks, subsequent comorbidities, and premature death. The overall goal of this project is to assess the feasibility and potential efficacy of the Filipino Americans Go4Health Weight Loss Program (PilAm Go4Health). This program is a culturally adapted weight loss lifestyle intervention, using digital technology for Filipinos with T2D, to reduce their risk for metabolic syndrome. This study was a 3-month mobile phone-based pilot randomized controlled trial (RCT) weight loss intervention with a wait list active control, followed by a 3-month maintenance phase design for 45 overweight Filipinos with T2D. Participants were randomized to an intervention group (n=22) or active control group (n=23), and analyses of the results are underway. The primary outcome will be percent weight change of the participants, and secondary outcomes will include changes in waist circumference, fasting plasma glucose, glycated hemoglobin A1c, physical activity, fat intake, and sugar-sweetened beverage intake. Data analyses will include descriptive statistics to describe sample characteristics and a feasibility assessment based on recruitment, adherence, and retention. Chi-square, Fisher's exact tests, t-tests, and nonparametric rank tests will be used to assess characteristics of randomized groups. Primary analyses will use analysis of covariance and linear mixed models to compare primary and secondary outcomes at 3 months, compared by arm and controlled for baseline

  13. Randomized, Double-Blinded, Placebo-Controlled, Trial of Risedronate for the Prevention of Bone Mineral Density Loss in Nonmetastatic Prostate Cancer Patients Receiving Radiation Therapy Plus Androgen Deprivation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Choo, Richard [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States); Lukka, Himu [Department of Radiation Oncology, Juravinski Cancer Center, McMaster University, Hamilton (Canada); Cheung, Patrick [Department of Radiation Oncology, Odette Cancer Centre, University of Toronto, Toronto (Canada); Corbett, Tom [Department of Radiation Oncology, Juravinski Cancer Center, McMaster University, Hamilton (Canada); Briones-Urbina, Rosario [Department of Medicine, Women' s College Hospital, University of Toronto, Toronto (Canada); Vieth, Reinhold [Departments of Nutritional Sciences and Laboratory Medicine and Pathology, Mount Sinai Hospital, University of Toronto, Toronto (Canada); Ehrlich, Lisa [Department of Radiology, Sunnybrook Health Sciences Center, University of Toronto (Canada); Kiss, Alex [Department of Health Policy, Management, and Evaluation, Sunnybrook Health Sciences Center, University of Toronto, Toronto (Canada); Danjoux, Cyril, E-mail: Cyril.danjoux@sunnybrook.ca [Department of Radiation Oncology, Odette Cancer Centre, University of Toronto, Toronto (Canada)

    2013-04-01

    Purpose: Androgen deprivation therapy (ADT) has been used as an adjuvant treatment to radiation therapy (RT) for the management of locally advanced prostate carcinoma. Long-term ADT decreases bone mineral density (BMD) and increases the risk of osteoporosis. The objective of this clinical trial was to evaluate the efficacy of risedronate for the prevention of BMD loss in nonmetastatic prostate cancer patients undergoing RT plus 2 to 3 years of ADT. Methods and Materials: A double-blinded, placebo-controlled, randomized trial was conducted for nonmetastatic prostate cancer patients receiving RT plus 2 to 3 years of ADT. All had T scores > −2.5 on dual energy x-ray absorptiometry at baseline. Patients were randomized 1:1 between risedronate and placebo for 2 years. The primary endpoints were the percent changes in the BMD of the lumbar spine at 1 and 2 years from baseline, measured by dual energy x-ray absorptiometry. Analyses of the changes in BMD and bone turnover biomarkers were carried out by comparing mean values of the intrapatient changes between the 2 arms, using standard t tests. Results: One hundred four patients were accrued between 2004 and 2007, with 52 in each arm. Mean age was 66.8 and 67.5 years for the placebo and risedronate, respectively. At 1 and 2 years, mean (±SE) BMD of the lumbar spine decreased by 5.77% ± 4.66% and 13.55% ± 6.33%, respectively, in the placebo, compared with 0.12% ± 1.29% at 1 year (P=.2485) and 0.85% ± 1.56% (P=.0583) at 2 years in the risedronate. The placebo had a significant increase in serum bone turnover biomarkers compared with the risedronate. Conclusions: Weekly oral risedronate prevented BMD loss at 2 years and resulted in significant suppression of bone turnover biomarkers for 24 months for patients receiving RT plus 2 to 3 years of ADT.

  14. Randomized, Double-Blinded, Placebo-Controlled, Trial of Risedronate for the Prevention of Bone Mineral Density Loss in Nonmetastatic Prostate Cancer Patients Receiving Radiation Therapy Plus Androgen Deprivation Therapy

    International Nuclear Information System (INIS)

    Choo, Richard; Lukka, Himu; Cheung, Patrick; Corbett, Tom; Briones-Urbina, Rosario; Vieth, Reinhold; Ehrlich, Lisa; Kiss, Alex; Danjoux, Cyril

    2013-01-01

    Purpose: Androgen deprivation therapy (ADT) has been used as an adjuvant treatment to radiation therapy (RT) for the management of locally advanced prostate carcinoma. Long-term ADT decreases bone mineral density (BMD) and increases the risk of osteoporosis. The objective of this clinical trial was to evaluate the efficacy of risedronate for the prevention of BMD loss in nonmetastatic prostate cancer patients undergoing RT plus 2 to 3 years of ADT. Methods and Materials: A double-blinded, placebo-controlled, randomized trial was conducted for nonmetastatic prostate cancer patients receiving RT plus 2 to 3 years of ADT. All had T scores > −2.5 on dual energy x-ray absorptiometry at baseline. Patients were randomized 1:1 between risedronate and placebo for 2 years. The primary endpoints were the percent changes in the BMD of the lumbar spine at 1 and 2 years from baseline, measured by dual energy x-ray absorptiometry. Analyses of the changes in BMD and bone turnover biomarkers were carried out by comparing mean values of the intrapatient changes between the 2 arms, using standard t tests. Results: One hundred four patients were accrued between 2004 and 2007, with 52 in each arm. Mean age was 66.8 and 67.5 years for the placebo and risedronate, respectively. At 1 and 2 years, mean (±SE) BMD of the lumbar spine decreased by 5.77% ± 4.66% and 13.55% ± 6.33%, respectively, in the placebo, compared with 0.12% ± 1.29% at 1 year (P=.2485) and 0.85% ± 1.56% (P=.0583) at 2 years in the risedronate. The placebo had a significant increase in serum bone turnover biomarkers compared with the risedronate. Conclusions: Weekly oral risedronate prevented BMD loss at 2 years and resulted in significant suppression of bone turnover biomarkers for 24 months for patients receiving RT plus 2 to 3 years of ADT

  15. Asymmetric hearing loss in a random population of patients with mild to moderate sensorineural hearing loss.

    Science.gov (United States)

    Segal, Nili; Shkolnik, Mark; Kochba, Anat; Segal, Avichai; Kraus, Mordechai

    2007-01-01

    We evaluated the correlation of asymmetric hearing loss, in a random population of patients with mild to moderate sensorineural hearing loss, to several clinical factors such as age, sex, handedness, and noise exposure. We randomly selected, from 8 hearing institutes in Israel, 429 patients with sensorineural hearing loss of at least 30 dB at one frequency and a speech reception threshold not exceeding 30 dB. Patients with middle ear disease or retrocochlear disorders were excluded. The results of audiometric examinations were compared binaurally and in relation to the selected factors. The left ear's hearing threshold level was significantly higher than that of the right ear at all frequencies except 1.0 kHz (p < .05). One hundred fifty patients (35%) had asymmetric hearing loss (more than 10 dB difference between ears). In most of the patients (85%) the binaural difference in hearing threshold level, at any frequency, was less than 20 dB. Age, handedness, and sex were not found to be correlated to asymmetric hearing loss. Noise exposure was found to be correlated to asymmetric hearing loss.

  16. Efficacy and safety of a low-level laser device in the treatment of male and female pattern hair loss: a multicenter, randomized, sham device-controlled, double-blind study.

    Science.gov (United States)

    Jimenez, Joaquin J; Wikramanayake, Tongyu C; Bergfeld, Wilma; Hordinsky, Maria; Hickman, Janet G; Hamblin, Michael R; Schachner, Lawrence A

    2014-04-01

    Male and female pattern hair loss are common, chronic dermatologic disorders with limited therapeutic options. In recent years, a number of commercial devices using low-level laser therapy have been promoted, but there have been little peer-reviewed data on their efficacy. To determine whether treatment with a low-level laser device, the US FDA-cleared HairMax Lasercomb®, increases terminal hair density in both men and women with pattern hair loss. Randomized, sham device-controlled, double-blind clinical trials were conducted at multiple institutional and private practices. A total of 146 male and 188 female subjects with pattern hair loss were screened. A total of 128 male and 141 female subjects were randomized to receive either a lasercomb (one of three models) or a sham device in concealed sealed packets, and were treated on the whole scalp three times a week for 26 weeks. Terminal hair density of the target area was evaluated at baseline and at 16- and 26-week follow-ups, and analyzed to determine whether the hypothesis formulated prior to data collection, that lasercomb treatment would increase terminal hair density, was correct. The site investigators and the subjects remained blinded to the type of device they dispensed/received throughout the study. The evaluator of masked digital photographs was blinded to which trial arm the subject belonged. Seventy-eight, 63, 49, and 79 subjects were randomized in four trials of 9-beam lasercomb treatment in female subjects, 12-beam lasercomb treatment in female subjects, 7-beam lasercomb treatment in male subjects, and 9- and 12-beam lasercomb treatment in male subjects, compared with the sham device, respectively. Nineteen female and 25 male subjects were lost to follow-up. Among the remaining 122 female and 103 male subjects in the efficacy analysis, the mean terminal hair count at 26 weeks increased from baseline by 20.2, 20.6, 18.4, 20.9, and 25.7 per cm2 in 9-beam lasercomb-treated female subjects, 12-beam

  17. Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Lambert, Justin; Ghadry-Tavi, Rouzbeh; Knuff, Kate; Jutras, Marc; Siever, Jodi; Mick, Paul; Roque, Carolyn; Jones, Gareth; Little, Jonathan; Miller, Harry; Van Bergen, Colin; Kurtz, Donna; Murphy, Mary Ann; Jones, Charlotte Ann

    2017-01-28

    Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills, and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated. Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a

  18. Statistical quality control a loss minimization approach

    CERN Document Server

    Trietsch, Dan

    1999-01-01

    While many books on quality espouse the Taguchi loss function, they do not examine its impact on statistical quality control (SQC). But using the Taguchi loss function sheds new light on questions relating to SQC and calls for some changes. This book covers SQC in a way that conforms with the need to minimize loss. Subjects often not covered elsewhere include: (i) measurements, (ii) determining how many points to sample to obtain reliable control charts (for which purpose a new graphic tool, diffidence charts, is introduced), (iii) the connection between process capability and tolerances, (iv)

  19. EffectS of non-nutritive sWeetened beverages on appetITe during aCtive weigHt loss (SWITCH): Protocol for a randomized, controlled trial assessing the effects of non-nutritive sweetened beverages compared to water during a 12-week weight loss period and a follow up weight maintenance period.

    Science.gov (United States)

    Masic, U; Harrold, J A; Christiansen, P; Cuthbertson, D J; Hardman, C A; Robinson, E; Halford, J C G

    2017-02-01

    Acute and medium-term intervention studies suggest that non-nutritive sweeteners (NNS) are beneficial for weight loss, however there is limited human data on the long-term effects of consuming NNS on weight loss, maintenance, and appetite. Further research is therefore required to elucidate the prolonged impact of NNS consumption on these outcome measures. A randomized parallel groups design will be used to assess whether regular NNS beverage intake is equivalent to a water control in promoting weight loss over 12-weeks (weekly weight loss sessions; Phase I), then supporting weight maintenance over 40-weeks (monthly sessions; Phase II) and subsequently independent weight maintenance over 52-weeks (Phase III) in 432 participants. A subset of these participants (n=116) will complete laboratory-based appetite probe days (15 sessions; 3 sessions each at baseline, at the start of phase I and the end of each phase). A separate subset (n=50) will complete body composition scans (DXA) at baseline and at the end of each phase. All participants will regularly be weighed and will complete questionnaires and cognitive tasks to assess changes in body weight and appetitive behaviours. Measures of physical activity and biochemical markers will also be taken. The trial will assess the efficacy of NNS beverages compared to water during a behavioural weight loss and maintenance programme. We aim to understand whether the impact of NNS on weight, dietary adherence and well-being are beneficial or transient and effects on prolonged successful weight loss and weight maintenance through sustained changes in appetite and eating behaviour. Clinical Trials: NCT02591134; registered: 23.10.2015. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

  20. Moderate Walking Enhances the Effects of an Energy-Restricted Diet on Fat Mass Loss and Serum Insulin in Overweight and Obese Adults in a 12-Week Randomized Controlled Trial.

    Science.gov (United States)

    Kleist, Bernadette; Wahrburg, Ursel; Stehle, Peter; Schomaker, Ralph; Greiwing, Andreas; Stoffel-Wagner, Birgit; Egert, Sarah

    2017-08-09

    Background: Increased physical activity may be advantageous for weight loss. Objective: We investigated the effects of an energy-restricted diet with and without moderate walking on body weight, body composition, resting energy expenditure (REE), and endocrine and cardiometabolic risk variables in overweight and obese participants. Methods: A 12-wk, randomized, 2-arm, parallel, controlled, energy-restricted (500-800 kcal/d) dietary intervention study was conducted in 82 men and women [mean baseline characteristics: age, 39.4 y; weight, 99.3 kg; body mass index (in kg/m 2 ), 31.9]. Participants were divided into 2 groups. One group received a hypoenergetic diet (DI) only ( n = 44). The second group received the same DI and participated in a regular walking program of 2.5 h/wk (DI + walking; n = 38). Results: After the 12-wk intervention, body weight was significantly decreased in the DI + walking group and the DI group (-8.8 compared with -7.0 kg, P = 0.064 for intergroup differences). The decrease in body weight was accompanied by a significant reduction in total fat mass, which was significantly more pronounced in the DI + walking group than in the DI group (-6.4 ± 3.1 compared with -4.8 ± 3.0 kg; P = 0.020). REE after 12 wk was not significantly different compared with the baseline REE. Diastolic blood pressure, mean arterial pressure, LDL cholesterol, and non-HDL cholesterol were similarly significantly improved by both interventions. In the DI + walking group, insulin and the homeostasis model assessment of insulin resistance index were also significantly reduced. Serum free triiodothyronine was significantly decreased and serum cortisol was significantly increased in both groups. Conclusions: Participation in a 12-wk weight-loss study resulted in significant reductions in body weight and fat mass and was associated with significant improvements in biomarkers for cardiovascular disease risk. Moderate weight loss was not accompanied by a reduction in REE

  1. Effect of personal activity trackers on weight loss in families enrolled in a comprehensive behavioral family-lifestyle intervention program in the federally qualified health center setting: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Juan Espinoza

    2017-09-01

    Full Text Available Background: Childhood obesity continues to be a substantial problem despite major public health efforts, and disproportionately impacts children from low-income families. Digital health tools and consumer technology offer promising opportunities for interventions, but few studies have evaluated how they might be incorporated into existing interventions or used to create new types of interventions. It remains unclear which approaches would be most beneficial for underserved pediatric populations. Purpose: To describe the design and rationale of a single-center randomized, controlled trial evaluating the effects of personal activity tracker (PAT use by parents on weight-status improvement in both parents and overweight children enrolled in BodyWorks (BW, a comprehensive behavioral family-lifestyle intervention program (CBFLI, in a primary-care clinic serving a predominantly low-income Latino population. Methods: This study is being conducted in the AltaMed general pediatrics clinic at Children's Hospital Los Angeles. Eligible participants are families (child and adult caregiver in which the child is between 7 and 18 years of age, has a BMI ≥85th percentile for age and sex, and has been referred to BW by their AltaMed pediatrician. BW consists of one weekly, two-hour session for 7 weeks. In a given cycle, the program is offered on two separate nights: Monday (Spanish and Wednesday (English. Families self sort into one of two groups based on language preference. To ensure balanced allocation of language preference groups and prevent in-group cross contamination, block randomization is used to assign whole groups to either the intervention or control arms of the study. The control arm consists of usual care, while the intervention arm adds assigning a Fitbit PAT to the parents and training them in its proper use. Study personnel are blinded to group assignment during the analysis phase. Study outcomes include attendance rate, program completion

  2. a randomized, placebo- controlled study

    OpenAIRE

    Hall, Franziska van

    2012-01-01

    Introduction: Repetitive transcranial magnetic stimulation (rTMS) is a well-tolerated non-invasive method, which has also been proved to have mild antidepressant effects and is used as “add-on“-therapy in treating pharmaco-resistant major depression. Objective: The efficacy of an escitalopram plus rTMS-combination-treatment was evaluated and compared to escitalopram plus sham rTMS. Methods: We designed a four week-, randomized, rater-blinded, and controlled add-on study with two trea...

  3. Protein supplements after weight loss do not improve weight maintenance compared with recommended dietary protein intake despite beneficial effects on appetite sensation and energy expenditure: a randomized, controlled, double-blinded trial.

    Science.gov (United States)

    Kjølbæk, Louise; Sørensen, Lone Brinkmann; Søndertoft, Nadja Buus; Rasmussen, Carrie Klestrup; Lorenzen, Janne Kunchel; Serena, Anja; Astrup, Arne; Larsen, Lesli Hingstrup

    2017-08-01

    Background : High-protein diets increase weight loss (WL) during energy restriction; therefore, it has been suggested that additional protein intake may improve weight maintenance (WM) after WL. Objective: We investigated the effect of protein supplements from either whey with or without calcium or soy on WM success after WL compared with that of a control. Design: In a randomized, controlled, double-blinded trial, 220 participants aged 18-60 y with body mass index (in kg/m 2 ) from 27.6 to 40.4 were included. The study was initiated with an 8-wk WL period followed by a 24-wk WM period. During WM, participants consumed the following isocaloric supplements (45-48 g/d): whey and calcium (whey+), whey, soy, or maltodextrin (control). Data were collected at baseline, before WM, and after WM (weeks 0, 8, and 32, respectively) and included body composition, blood biochemistry, and blood pressure. Meal tests were performed to investigate diet-induced-thermogenesis (DIT) and appetite sensation. Compliance was tested by 24-h urinary nitrogen excretion. Results: A total of 151 participants completed the WM period. The control and 3 protein supplements did not result in different mean ± SD weight regains (whey+: 2.19 ± 4.6 kg; whey: 2.01 ± 4.6 kg; soy: 1.76 ± 4.7 kg; and control: 2.23 ± 3.8 kg; P = 0.96), fat mass regains (whey+: 0.46 ± 4.5 kg; whey: 0.11 ± 4.1 kg; soy: 0.15 ± 4.1 kg; and control: 0.54 ± 3.3 kg; P = 0.96), or improvements in lean body mass (whey+: 1.87 ± 1.7 kg; whey: 1.94 ± 1.3 kg; soy: 1.58 ± 1.4 kg; and control: 1.74 ± 1.4 kg; P = 0.50) during WM. Changes in blood pressure and blood biochemistry were not different between groups. Compared with the control, protein supplementation resulted in higher DIT (∼30 kJ/2.5 h) and resting energy expenditure (243 kJ/d) and an anorexigenic appetite-sensation profile. Conclusion: Protein supplementation does not result in improved WM success, or blood biochemistry after WL compared with the effects of

  4. A randomized, comparative pilot trial of family-based interpersonal psychotherapy for reducing psychosocial symptoms, disordered-eating, and excess weight gain in at-risk preadolescents with loss-of-control-eating.

    Science.gov (United States)

    Shomaker, Lauren B; Tanofsky-Kraff, Marian; Matherne, Camden E; Mehari, Rim D; Olsen, Cara H; Marwitz, Shannon E; Bakalar, Jennifer L; Ranzenhofer, Lisa M; Kelly, Nichole R; Schvey, Natasha A; Burke, Natasha L; Cassidy, Omni; Brady, Sheila M; Dietz, Laura J; Wilfley, Denise E; Yanovski, Susan Z; Yanovski, Jack A

    2017-09-01

    Preadolescent loss-of-control-eating (LOC-eating) is a risk factor for excess weight gain and binge-eating-disorder. We evaluated feasibility and acceptability of a preventive family-based interpersonal psychotherapy (FB-IPT) program. FB-IPT was compared to family-based health education (FB-HE) to evaluate changes in children's psychosocial functioning, LOC-eating, and body mass. A randomized, controlled pilot trial was conducted with 29 children, 8 to 13 years who had overweight/obesity and LOC-eating. Youth-parent dyads were randomized to 12-week FB-IPT (n = 15) or FB-HE (n = 14) and evaluated at post-treatment, six-months, and one-year. Changes in child psychosocial functioning, LOC-eating, BMI, and adiposity by dual-energy-X-ray-absorptiometry were assessed. Missing follow-up data were multiply imputed. FB-IPT feasibility and acceptability were indicated by good attendance (83%) and perceived benefits to social interactions and eating. Follow-up assessments were completed by 73% FB-IPT and 86% FB-HE at post-treatment, 60% and 64% at six-months, and 47% and 57% at one-year. At post-treatment, children in FB-IPT reported greater decreases in depression (95% CI -7.23, -2.01, Cohen's d = 1.23) and anxiety (95% CI -6.08, -0.70, Cohen's d = .79) and less odds of LOC-eating (95% CI -3.93, -0.03, Cohen's d = .38) than FB-HE. At six-months, children in FB-IPT had greater reductions in disordered-eating attitudes (95% CI -0.72, -0.05, Cohen's d = .66) and at one-year, tended to have greater decreases in depressive symptoms (95% CI -8.82, 0.44, Cohen's d = .69) than FB-HE. There was no difference in BMI gain between the groups. Family-based approaches that address interpersonal and emotional underpinnings of LOC-eating in preadolescents with overweight/obesity show preliminary promise, particularly for reducing internalizing symptoms. Whether observed psychological benefits translate into sustained prevention of disordered-eating or excess

  5. A Randomized, Comparative Pilot Trial of Family-Based Interpersonal Psychotherapy for Reducing Psychosocial Symptoms, Disordered-eating, and Excess Weight Gain in At-Risk Preadolescents with Loss-of-control-eating

    Science.gov (United States)

    Shomaker, Lauren B.; Tanofsky-Kraff, Marian; Matherne, Camden E.; Mehari, Rim D.; Olsen, Cara H.; Marwitz, Shannon E.; Bakalar, Jennifer L.; Ranzenhofer, Lisa M.; Kelly, Nichole R.; Schvey, Natasha A.; Burke, Natasha L.; Cassidy, Omni; Brady, Sheila M.; Dietz, Laura J.; Wilfley, Denise E.; Yanovski, Susan Z.; Yanovski, Jack A.

    2018-01-01

    Objective Preadolescent loss-of-control-eating (LOC-eating) is a risk factor for excess weight gain and binge-eating-disorder. We evaluated feasibility and acceptability of a preventive family-based interpersonal psychotherapy (FB-IPT) program. FB-IPT was compared to family-based health education (FB-HE) to evaluate changes in children’s psychosocial functioning, LOC-eating, and body mass. Method A randomized, controlled pilot trial was conducted with 29 children, 8 to 13 years who had overweight/obesity and LOC-eating. Youth-parent dyads were randomized to 12-week FB-IPT (n=15) or FB-HE (n=14) and evaluated at post-treatment, six-months, and one-year. Changes in child psychosocial functioning, LOC-eating, BMI, and adiposity by dual-energy-X-ray-absorptiometry were assessed. Missing follow-up data were multiply imputed. Results FB-IPT feasibility and acceptability were indicated by good attendance (83%) and perceived benefits to social interactions and eating. Follow-up assessments were completed by 73% FB-IPT and 86% FB-HE at post-treatment, 60% and 64% at six-months, and 47% and 57% at one-year. At post-treatment, children in FB-IPT reported greater decreases in depression (95% CI −7.23, −2.01, Cohen’s d=1.23) and anxiety (95% CI −6.08, −0.70, Cohen’s d=.79) and less odds of LOC-eating (95% CI −3.93, −0.03, Cohen’s d=.38) than FB-HE. At six-months, children in FB-IPT had greater reductions in disordered-eating attitudes (95% CI −0.72, −0.05, Cohen’s d=.66) and at one-year, tended to have greater decreases in depressive symptoms (95% CI −8.82, 0.44, Cohen’s d=.69) than FB-HE. There was no difference in BMI gain between the groups. Discussion Family-based approaches that address interpersonal and emotional underpinnings of LOC-eating in preadolescents with overweight/obesity show preliminary promise, particularly for reducing internalizing symptoms. Whether observed psychological benefits translate into sustained prevention of

  6. 5-year follow-up of a randomized controlled trial of immediate versus delayed zoledronic acid for the prevention of bone loss in postmenopausal women with breast cancer starting letrozole after tamoxifen: N03CC (Alliance) trial.

    Science.gov (United States)

    Wagner-Johnston, Nina D; Sloan, Jeff A; Liu, Heshan; Kearns, Ann E; Hines, Stephanie L; Puttabasavaiah, Suneetha; Dakhil, Shaker R; Lafky, Jacqueline M; Perez, Edith A; Loprinzi, Charles L

    2015-08-01

    Postmenopausal women with breast cancer receiving aromatase inhibitors are at an increased risk of bone loss. The current study was undertaken to determine whether upfront versus delayed treatment with zoledronic acid (ZA) impacted bone loss. This report described the 5-year follow-up results. A total of 551 postmenopausal women with breast cancer who completed tamoxifen treatment and were undergoing daily letrozole treatment were randomized to either upfront (274 patients) or delayed (277 patients) ZA at a dose of 4 mg intravenously every 6 months. In the patients on the delayed treatment arm, ZA was initiated for a postbaseline bone mineral density T-score of prevented bone loss compared with delayed treatment in postmenopausal women receiving letrozole and these differences were maintained at 5 years. The incidence of osteoporosis or fractures was not found to be significantly different between treatment arms. © 2015 American Cancer Society.

  7. Effect of the cumin cyminum L. Intake on Weight Loss, Metabolic Profiles and Biomarkers of Oxidative Stress in Overweight Subjects: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Taghizadeh, Mohsen; Memarzadeh, Mohammad Reza; Asemi, Zatollah; Esmaillzadeh, Ahmad

    2015-01-01

    The current study was performed to determine the effects of cumin cyminum L. intake on weight loss and metabolic profiles among overweight subjects. This randomized double-blind placebo-controlled clinical trial was conducted among 78 overweight subjects (male, n = 18; female, n = 60) aged 18-60 years old. Participants were randomly assigned into three groups to receive: (1) cumin cyminum L. capsule (n = 26); (2) orlistat120 capsule (n = 26) and (3) placebo (n = 26) three times a day for 8 weeks. Anthropometric measures and fasting blood samples were taken at baseline and after 8 weeks of intervention. Consumption of the Cuminum cyminum L. and orlistat120 resulted in a similar significant decrease in weight (-1.1 ± 1.2 and -0.9 ± 1.5 vs. 0.2 ± 1.5 kg, respectively, p = 0.002) and BMI (-0.4 ± 0.5 and -0.4 ± 0.6 vs. 0.1 ± 0.6 kg/m(2), respectively, p = 0.003) compared with placebo. In addition, taking Cuminum cyminum L., compared with orlistat and placebo, led to a significant reduction in serum insulin levels (-1.4 ± 4.5 vs. 1.3 ± 3.3 and 0.3 ± 2.2 µIU/ml, respectively, p = 0.02), HOMA-B (-5.4 ± 18.9 vs. 5.8 ± 13.3 and 1.0 ± 11.0, respectively, p = 0.02) and a significant rise in QUICKI (0.01 ± 0.01 vs. -0.005 ± 0.01 and -0.004 ± 0.01, respectively, p = 0.02). Taking cumin cyminum L. for eight weeks among overweight subjects had the same effects of orlistat120 on weight and BMI and beneficial effects on insulin metabolism compared with orlistat120 and placebo. © 2015 S. Karger AG, Basel.

  8. Effects of wireless packet loss in industrial process control systems.

    Science.gov (United States)

    Liu, Yongkang; Candell, Richard; Moayeri, Nader

    2017-05-01

    Timely and reliable sensing and actuation control are essential in networked control. This depends on not only the precision/quality of the sensors and actuators used but also on how well the communications links between the field instruments and the controller have been designed. Wireless networking offers simple deployment, reconfigurability, scalability, and reduced operational expenditure, and is easier to upgrade than wired solutions. However, the adoption of wireless networking has been slow in industrial process control due to the stochastic and less than 100% reliable nature of wireless communications and lack of a model to evaluate the effects of such communications imperfections on the overall control performance. In this paper, we study how control performance is affected by wireless link quality, which in turn is adversely affected by severe propagation loss in harsh industrial environments, co-channel interference, and unintended interference from other devices. We select the Tennessee Eastman Challenge Model (TE) for our study. A decentralized process control system, first proposed by N. Ricker, is adopted that employs 41 sensors and 12 actuators to manage the production process in the TE plant. We consider the scenario where wireless links are used to periodically transmit essential sensor measurement data, such as pressure, temperature and chemical composition to the controller as well as control commands to manipulate the actuators according to predetermined setpoints. We consider two models for packet loss in the wireless links, namely, an independent and identically distributed (IID) packet loss model and the two-state Gilbert-Elliot (GE) channel model. While the former is a random loss model, the latter can model bursty losses. With each channel model, the performance of the simulated decentralized controller using wireless links is compared with the one using wired links providing instant and 100% reliable communications. The sensitivity of the

  9. A Randomized Pilot Study of a Phone-Based Mindfulness and Weight Loss Program.

    Science.gov (United States)

    Carpenter, Kelly M; Vickerman, Katrina A; Salmon, Erica E; Javitz, Harold S; Epel, Elissa S; Lovejoy, Jennifer C

    2017-10-06

    This study evaluated the feasibility and efficacy of integrating mindfulness training into a phone-based weight loss program to improve outcomes in those with high levels of emotional eating. Participants were 75 enrollees into an employer-sponsored weight loss program who reported high levels of overeating in response to thoughts and feelings. Seventy-five overweight and obese participants (92% female, 65% Caucasian, aged 26 to 68 years) were randomized to the new mindfulness weight loss program (n = 50) or the standard behavioral weight loss program (n = 25). Both programs consisted of 11 coaching calls with health coaches and registered dietitians with supplemental online materials. Satisfaction, engagement, and percent weight lost did not significantly differ for intervention vs. control at six months. Intervention participants had significantly better scores at six-month follow-up on mindful eating, binge eating, experiential avoidance, and one mindfulness subscale. Exploratory analyses showed that improvements on several measures predicted more weight loss in the intervention group. This pilot study found that integrating mindfulness into a brief phone-based behavioral weight loss program was feasible and acceptable to participants, but did not produce greater weight loss on average, despite hypothesized changes in mindful eating. Only one third of intervention participants reported participating in mindfulness exercises regularly. Mechanisms of change observed within the intervention group suggest that for adults with high levels of emotional eating those who embrace mindful eating and meditation may lose more weight with a mindfulness intervention.

  10. "De-Randomizing" Congestion Losses to Improve TCP Performance over Wired-Wireless Networks

    National Research Council Canada - National Science Library

    Biaz, Saad; Vaidya, Nitin H

    2004-01-01

    .... This paper proposes a simple biased queue management scheme that "de-randomizes" congestion losses and enables a TCP receiver to diagnose accurately the cause of a loss and inform the TCP sender to react appropriately...

  11. Pounds Off Digitally study: a randomized podcasting weight-loss intervention.

    Science.gov (United States)

    Turner-McGrievy, Gabrielle M; Campbell, Marci K; Tate, Deborah F; Truesdale, Kimberly P; Bowling, J Michael; Crosby, Lelia

    2009-10-01

    As obesity rates rise, new weight-loss methods are needed. Little is known about the use of podcasting (audio files for a portable music player or computer) to promote weight loss, despite its growing popularity. A 12-week RCT was conducted. The study sample comprised overweight men and women (BMI=25-40 kg/m(2); n=78) in the Raleigh-Durham NC area. In 2008, participants were randomly assigned to receive 24 episodes of a currently available weight-loss podcast (control podcast) or a weight-loss podcast based on social cognitive theory (SCT) designed by the researchers (enhanced podcast) for 12 weeks. Weight was measured on a digital scale at baseline and follow-up. Both groups also completed questionnaires assessing demographic information, food intake, physical activity, and SCT constructs at the introductory and 12-week meetings. Additional questionnaires at the 12-week meeting assessed perceptions of the intervention. Data collection and analysis occurred in 2008 and intention-to-treat was used. Enhanced group participants (n=41) had a greater decrease in weight (-2.9+/-3.5 kg enhanced group vs -0.3+/-2.1 control group; p<0.001 between groups) and BMI (-1.0+/-1.2 kg/m(2) enhanced group vs -0.1+/-0.7 kg/m(2) control group; p<0.001 between groups) than the control group (n=37) and had greater weight-loss-related knowledge (p<0.05), elaboration (p<0.001), and user control (p<0.001) and less cognitive load (p<0.001). The results of this study suggest that the use of behavioral, theory-based podcasting may be an effective way to promote weight loss. NCT00771095.

  12. A double-blind, placebo-controlled randomized clinical trial to evaluate the efficacy of tranexamic acid in irrigant solution on blood loss during percutaneous nephrolithotomy: a pilot study from tertiary care center of North India.

    Science.gov (United States)

    Bansal, Ankur; Arora, Aditi

    2017-08-01

    To evaluate the efficacy and safety of 0.1% tranexamic acid in irrigant fluid in reducing blood loss during PCNL. The study involved 400 patients who were planned for PCNL and were prospectively randomized into two equal groups. In tranexamic group, 0.1% tranexamic acid was given in irrigant fluid, while in placebo group, distilled water was added to irrigant fluid during surgery. Operative data were recorded which included fall in hemoglobin, total blood loss, operative time, irrigation fluid, length of stay in hospital, requirement of blood transfusion, complications related to PCNL and adverse events of tranexamic acid. Baseline parameters were comparable between two groups. The fall in hemoglobin and total blood loss in the tranexamic group was significantly lower than placebo group (1.71 vs. 2.67 gm/dL, 154.55 vs. 212.61 mL, respectively, p tranexamic group were significantly less compared to placebo (p tranexamic group versus 82% in placebo (p = 0.12). The blood transfusion requirement was significantly lower in the tranexamic group versus placebo (5 vs. 12.5%, p = 0.012), as was the complication rate (19 vs. 28%, p = 0.044). The requirement of angioembolization in the tranexamic group was significantly less as compared to placebo (0.5 vs. 4%, p = 0.03). No adverse events related to administration of tranexamic acid were noted. 0.1% tranexamic acid in irrigant fluid is safe and significantly reduces perioperative blood loss and requirement of blood transfusion during percutaneous nephrolithotomy. It is associated with lower perioperative complication rates.

  13. Comparison of the effect of daily consumption of probiotic compared with low-fat conventional yogurt on weight loss in healthy obese women following an energy-restricted diet: a randomized controlled trial.

    Science.gov (United States)

    Madjd, Ameneh; Taylor, Moira A; Mousavi, Neda; Delavari, Alireza; Malekzadeh, Reza; Macdonald, Ian A; Farshchi, Hamid R

    2016-02-01

    Despite evidence for the beneficial effects of probiotics and low-fat dairy products, to our knowledge, no study has compared the beneficial effect on weight loss of consuming a probiotic yogurt (PY) compared with a standard low-fat yogurt (LF) during a hypoenergetic program. We compared the effect of the PY with LF yogurt consumption on body weight and cardiometabolic risk factors in women during a weight-loss program. Overweight and obese women [body mass index (in kg/m(2)): 27-40; age: 18-50 y) who usually consumed standard LFs were asked to consume either PY or LF every day with their main meals for 12 wk while following a weight-loss program. A total of 89 participants were randomly assigned to one of the 2 intervention groups. Baseline variables were not significantly different between groups. A statistically significant reduction in anthropometric measurements and significant improvements in cardiometabolic risk characteristics were observed over the 12 wk in both groups. However, no significant differences in weight loss and anthropometric measurements were seen between groups after the intervention. Compared with the LF group, the PY group had a greater (mean ± SD) decrease in total cholesterol (PY = -0.36 ± 0.10 mmol/L, LF = -0.31 ± 0.10 mmol/L; P = 0.024), low-density lipoprotein cholesterol (PY = -0.35 ± 0.10 mmol/L, LF = -0.31 ± 0.11 mmol/L; P = 0.018), homeostasis model assessment of insulin resistance (PY = -0.55 ± 0.32, LF = -0.42 ± 0.20; P = 0.002), 2-h postprandial glucose (PY = -0.61 ± 0.24 mmol/L, LF = -0.44 ± 0.19 mmol/L; P < 0.001), and fasting insulin concentration (PY = -1.76 ± 1.01 mU/mL, LF = -1.32 ± 0.62 mU/mL; P = 0.002), as secondary endpoints after the study. No significant differences were found for fasting plasma glucose, high-density lipoprotein cholesterol, or triglycerides within both groups after the 12 wk. Consumption of PY compared with LF with main meals showed no significant effects on weight loss. However, it may

  14. Effects of anti-obesity drugs, diet, and exercise on weight-loss maintenance after a very-low-calorie diet or low-calorie diet: a systematic review and meta-analysis of randomized controlled trials123

    Science.gov (United States)

    Neovius, Martin; Hemmingsson, Erik

    2014-01-01

    Background: Weight-loss maintenance remains a major challenge in obesity treatment. Objective: The objective was to evaluate the effects of anti-obesity drugs, diet, or exercise on weight-loss maintenance after an initial very-low-calorie diet (VLCD)/low-calorie diet (LCD) period (obesity drugs (3 arms; n = 658), meal replacements (4 arms; n = 322), high-protein diets (6 arms; n = 865), dietary supplements (6 arms; n = 261), other diets (3 arms; n = 564), and exercise (5 arms; n = 347). During the VLCD/LCD period, the pooled mean weight change was −12.3 kg (median duration: 8 wk; range 3–16 wk). Compared with controls, anti-obesity drugs improved weight-loss maintenance by 3.5 kg [95% CI: 1.5, 5.5 kg; median duration: 18 mo (12–36 mo)], meal replacements by 3.9 kg [95% CI: 2.8, 5.0 kg; median duration: 12 mo (10–26 mo)], and high-protein diets by 1.5 kg [95% CI: 0.8, 2.1 kg; median duration: 5 mo (3–12 mo)]. Exercise [0.8 kg; 95% CI: −1.2, 2.8 kg; median duration: 10 mo (6–12 mo)] and dietary supplements [0.0 kg; 95% CI: −1.4, 1.4 kg; median duration: 3 mo (3–14 mo)] did not significantly improve weight-loss maintenance compared with control. Conclusion: Anti-obesity drugs, meal replacements, and high-protein diets were associated with improved weight-loss maintenance after a VLCD/LCD period, whereas no significant improvements were seen for dietary supplements and exercise. PMID:24172297

  15. Effects of anti-obesity drugs, diet, and exercise on weight-loss maintenance after a very-low-calorie diet or low-calorie diet: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Johansson, Kari; Neovius, Martin; Hemmingsson, Erik

    2014-01-01

    Weight-loss maintenance remains a major challenge in obesity treatment. The objective was to evaluate the effects of anti-obesity drugs, diet, or exercise on weight-loss maintenance after an initial very-low-calorie diet (VLCD)/low-calorie diet (LCD) period (obesity drugs (3 arms; n = 658), meal replacements (4 arms; n = 322), high-protein diets (6 arms; n = 865), dietary supplements (6 arms; n = 261), other diets (3 arms; n = 564), and exercise (5 arms; n = 347). During the VLCD/LCD period, the pooled mean weight change was -12.3 kg (median duration: 8 wk; range 3-16 wk). Compared with controls, anti-obesity drugs improved weight-loss maintenance by 3.5 kg [95% CI: 1.5, 5.5 kg; median duration: 18 mo (12-36 mo)], meal replacements by 3.9 kg [95% CI: 2.8, 5.0 kg; median duration: 12 mo (10-26 mo)], and high-protein diets by 1.5 kg [95% CI: 0.8, 2.1 kg; median duration: 5 mo (3-12 mo)]. Exercise [0.8 kg; 95% CI: -1.2, 2.8 kg; median duration: 10 mo (6-12 mo)] and dietary supplements [0.0 kg; 95% CI: -1.4, 1.4 kg; median duration: 3 mo (3-14 mo)] did not significantly improve weight-loss maintenance compared with control. Anti-obesity drugs, meal replacements, and high-protein diets were associated with improved weight-loss maintenance after a VLCD/LCD period, whereas no significant improvements were seen for dietary supplements and exercise.

  16. Vector Control Using Series Iron Loss Model of Induction, Motors and Power Loss Minimization

    OpenAIRE

    Kheldoun Aissa; Khodja Djalal Eddine

    2009-01-01

    The iron loss is a source of detuning in vector controlled induction motor drives if the classical rotor vector controller is used for decoupling. In fact, the field orientation will not be satisfied and the output torque will not truck the reference torque mostly used by Loss Model Controllers (LMCs). In addition, this component of loss, among others, may be excessive if the vector controlled induction motor is driving light loads. In this paper, the series iron loss model ...

  17. The randomized shortened dental arch study: tooth loss over five years.

    Science.gov (United States)

    Walter, M H; Hannak, W; Kern, M; Mundt, T; Gernet, W; Weber, A; Wöstmann, B; Stark, H; Werner, D; Hartmann, S; Range, U; Jahn, F; Passia, N; Pospiech, P; Mitov, G; Brückner, J; Wolfart, S; Busche, E; Luthardt, R G; Heydecke, G; Marré, B

    2013-04-01

    The study was designed to provide clinical outcome data for two treatments of the shortened dental arch (SDA). In a multicenter randomized controlled clinical trial, patients with complete molar loss in one jaw were provided with either a partial removable dental prosthesis (PRDP) retained with precision attachments or treated according to the SDA concept preserving or restoring a premolar occlusion. No implants were placed. The primary outcome was tooth loss. Of 152 treated patients, 132 patients reached the 5-year examination. Over 5 years, 38 patients experienced tooth loss. For the primary outcome tooth loss, the Kaplan-Meier survival rates at 5 years were 0.74 (95% CI 0.64, 0.84) in the PRDP group and 0.74 (95% CI 0.63, 0.85) in the SDA group. For tooth loss in the study jaw, the survival rates at 5 years were 0.88 (95% CI 0.80, 0.95) in the PRDP group and 0.84 (95% CI 0.74, 0.93) in the SDA group. The differences were not significant. No Cox regression models of appropriate fit explaining tooth loss on the patient level could be found. The overall treatment goals of a sustainable oral rehabilitation and the avoidance of further tooth loss over longer periods were not reliably achievable. The influence of the type of prosthetic treatment on tooth loss might have been overestimated. Regarding our results, the patient's view will gain even more importance in the clinical decision between removable and fixed restorations in SDAs.

  18. Piecewise linearisation of the first order loss function for families of arbitrarily distributed random variables

    NARCIS (Netherlands)

    Rossi, R.; Hendrix, E.M.T.

    2014-01-01

    We discuss the problem of computing optimal linearisation parameters for the first order loss function of a family of arbitrarily distributed random variable. We demonstrate that, in contrast to the problem in which parameters must be determined for the loss function of a single random variable,

  19. Randomized trial of weight-loss-diets for young adults varying in fish and fish oil content

    NARCIS (Netherlands)

    Thorsdottir, I.; Tomasson, H.; Gunnarsdottir, I.; Gisladottir, E.; Kiely, M.; Parra, M.D.; Bandarra, N.M.; Schaafsma, G.; Martinez, J.A.

    2007-01-01

    Objective: To investigate the effect of including seafood and fish oils, as part of an energy-restricted diet, on weight loss in young overweight adults. Design: Randomized controlled trial of energy-restricted diet varying in fish and fish oil content was followed for 8 weeks. Subjects were

  20. Dynamic Output Feedback Control for Nonlinear Networked Control Systems with Random Packet Dropout and Random Delay

    Directory of Open Access Journals (Sweden)

    Shuiqing Yu

    2013-01-01

    Full Text Available This paper investigates the dynamic output feedback control for nonlinear networked control systems with both random packet dropout and random delay. Random packet dropout and random delay are modeled as two independent random variables. An observer-based dynamic output feedback controller is designed based upon the Lyapunov theory. The quantitative relationship of the dropout rate, transition probability matrix, and nonlinear level is derived by solving a set of linear matrix inequalities. Finally, an example is presented to illustrate the effectiveness of the proposed method.

  1. Vitamin D3 Loading Is Superior to Conventional Supplementation After Weight Loss Surgery in Vitamin D-Deficient Morbidly Obese Patients: a Double-Blind Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    Luger, Maria; Kruschitz, Renate; Kienbacher, Christian; Traussnigg, Stefan; Langer, Felix B; Prager, Gerhard; Schindler, Karin; Kallay, Enikö; Hoppichler, Friedrich; Trauner, Michael; Krebs, Michael; Marculescu, Rodrig; Ludvik, Bernhard

    2017-05-01

    Bariatric patients often suffer from vitamin D deficiency (VDD), and both, morbid obesity and VDD, are related to non-alcoholic fatty liver disease. However, limited data are available regarding best strategies for treating VDD, particularly, in bariatric patients undergoing omega-loop gastric bypass (OLGB). Therefore, we examined the efficacy and safety of a forced vitamin D dosing regimen and intervention effects in liver fibrotic patients. In this double-blind, randomized, placebo-controlled trial, 50 vitamin D-deficient patients undergoing OLGB were randomly assigned to receive, in the first month postoperatively, oral vitamin D 3 (≤3 doses of 100,000 IU; intervention group) or placebo as loading dose (control group) with subsequent maintenance dose (3420 IU/day) in both groups until 6-month visit. Compared with control group, higher increase of 25(OH)D (67.9 (21.1) vs. 55.7 nmol/L (21.1); p = 0.049) with lower prevalence of secondary hyperparathyroidism (10 vs. 24 %; p = 0.045) was observed in intervention group. No (serious) adverse events related to study medication were found. The loading dose regimen was more effective in increasing 25(OH)D in patients with significant liver fibrosis while this was not the case for conventional supplementation (placebo with maintenance dose) (71.5 (20.5) vs. 22.5 nmol/L (13.8); p = 0.022; n = 14). Our findings indicate that a high vitamin D 3 loading dose, in the first month postoperatively, with subsequent maintenance dose is effective and safe in achieving higher vitamin D concentrations in OLGB patients. Unexpectedly, it is more effective in patients with significant liver fibrosis which is of potentially high clinical relevance and requires further investigation.

  2. Effect of a Nine-Month Web- and App-Based Workplace Intervention to Promote Healthy Lifestyle and Weight Loss for Employees in the Social Welfare and Health Care Sector: A Randomized Controlled Trial

    Science.gov (United States)

    Poulsen, Sanne Kellebjerg; Larsen, Thomas Meinert

    2017-01-01

    Background General health promoting campaigns are often not targeted at the people who need them the most. Web- and app-based tools are a new way to reach, motivate, and help people with poor health status. Objective The aim of our study was to test a Web- and mobile app-based tool (“SoSu-life”) on employees in the social welfare and health care sector in Denmark. Methods A randomized controlled trial was carried out as a workplace intervention. The tool was designed to help users make healthy lifestyle changes such as losing weight, exercise more, and quit smoking. A team competition between the participating workplaces took place during the first 16 weeks of the intervention. Twenty nursing homes for elderly people in 6 municipalities in Denmark participated in the study. The employees at the nursing homes were randomized either 1:1 or 2:1 on a municipality level to use the SoSu-life tool or to serve as a control group with no intervention. All participants underwent baseline measurements including body weight, waist circumference, body fat percentage, blood pressure, and blood cholesterol level and they filled in a questionnaire covering various aspects of health. The participants were measured again after 16 and 38 weeks. Results A total of 566 (SoSu-life: n=355, control: n=211) participants were included in the study. At 16 weeks there were 369 participants still in the study (SoSu-life: n=227, control: n=142) and 269 participants completed the 38 week intervention (SoSu-life: n=152, control: n=117). At 38 weeks, the SoSu-life group had a larger decrease in body weight (−1.01 kg, P=.03), body fat percentage (−0.8%, P=.03), and waist circumference (−1.8 cm, P=.007) compared with the control group. Conclusions The SoSu-life Web- and app-based tool had a modest yet beneficial effect on body weight and body fat percentage in the health care sector staff. Trial Registration Clinicaltrials.gov NCT02438059; http://clinicaltrials.gov/ct2/show/NCT02438059

  3. Predicting Loss-of-Control Boundaries Toward a Piloting Aid

    Science.gov (United States)

    Barlow, Jonathan; Stepanyan, Vahram; Krishnakumar, Kalmanje

    2012-01-01

    This work presents an approach to predicting loss-of-control with the goal of providing the pilot a decision aid focused on maintaining the pilot's control action within predicted loss-of-control boundaries. The predictive architecture combines quantitative loss-of-control boundaries, a data-based predictive control boundary estimation algorithm and an adaptive prediction method to estimate Markov model parameters in real-time. The data-based loss-of-control boundary estimation algorithm estimates the boundary of a safe set of control inputs that will keep the aircraft within the loss-of-control boundaries for a specified time horizon. The adaptive prediction model generates estimates of the system Markov Parameters, which are used by the data-based loss-of-control boundary estimation algorithm. The combined algorithm is applied to a nonlinear generic transport aircraft to illustrate the features of the architecture.

  4. A high whey protein-, leucine-, and vitamin D-enriched supplement preserves muscle mass during intentional weight loss in obese older adults: a double-blind randomized controlled trial

    NARCIS (Netherlands)

    Verreijen, A.M.; Verlaan, S.; Engberink, M.F.; Swinkels, S.; Bosch, J.; Weijs, P.J.M.

    2015-01-01

    Background: Intentional weight loss in obese older adults is a risk factor for muscle loss and sarcopenia. Objective: The objective was to examine the effect of a high whey protein-, leucine-, and vitamin D-enriched supplement on muscle mass preservation during intentional weight loss in obese older

  5. Effect of a high protein diet and/or resistance exercise on the preservation of fat free mass during weight loss in overweight and obese older adults : a randomized controlled trial

    NARCIS (Netherlands)

    Verreijen, Amely M; Engberink, Mariëlle F; Memelink, Robert G; van der Plas, Suzanne E; Visser, Marjolein; Weijs, Peter J M

    2017-01-01

    BACKGROUND: Intentional weight loss in obese older adults is a risk factor for accelerated muscle mass loss. We investigated whether a high protein diet and/or resistance exercise preserves fat free mass (FFM) during weight loss in overweight and obese older adults. METHODS: We included 100

  6. H-Infinity Control Design Considering Packet Loss as a Disturbance for Networked Control Systems

    OpenAIRE

    OGURA, Takashi; KOBAYASHI, Kentaro; OKADA, Hiraku; KATAYAMA, Masaaki

    2017-01-01

    This paper studies H∞ control for networked control systems with packet loss. In networked control systems, packet loss is one of major weakness because the control performance deteriorates due to packet loss. H∞ control, which is one of robust control, can design a controller to reduce the influence of disturbances acting on the controlled object. This paper proposes an H∞ control design that considers packet loss as a disturbance. Numerical examples show that the proposed H∞ control design ...

  7. Phase II prospective randomized trial of weight loss prior to radical prostatectomy.

    Science.gov (United States)

    Henning, Susanne M; Galet, Colette; Gollapudi, Kiran; Byrd, Joshua B; Liang, Pei; Li, Zhaoping; Grogan, Tristan; Elashoff, David; Magyar, Clara E; Said, Jonathan; Cohen, Pinchas; Aronson, William J

    2017-12-04

    Obesity is associated with poorly differentiated and advanced prostate cancer and increased mortality. In preclinical models, caloric restriction delays prostate cancer progression and prolongs survival. We sought to determine if weight loss (WL) in men with prostate cancer prior to radical prostatectomy affects tumor apoptosis and proliferation, and if WL effects other metabolic biomarkers. In this Phase II prospective trial, overweight and obese men scheduled for radical prostatectomy were randomized to a 5-8 week WL program consisting of standard structured energy-restricted meal plans (1200-1500 Kcal/day) and physical activity or to a control group. The primary endpoint was apoptotic index in the radical prostatectomy malignant epithelium. Secondary endpoints were proliferation (Ki67) in the radical prostatectomy tissue, body weight, body mass index (BMI), waist to hip ratio, body composition, and serum PSA, insulin, triglyceride, cholesterol, testosterone, estradiol, leptin, adiponectin, interleukin 6, interleukin 8, insulin-like growth factor 1, and IGF binding protein 1. In total 23 patients were randomized to the WL intervention and 21 patients to the control group. Subjects in the intervention group had significantly more weight loss (WL:-3.7 ± 0.5 kg; Control:-1.6 ± 0.5 kg; p = 0.007) than the control group and total fat mass was significantly reduced (WL:-2.1 ± 0.4; Control: 0.1 ± 0.3; p = 0.015). There was no significant difference in apoptotic or proliferation index between the groups. Among the other biomarkers, triglyceride, and insulin levels were significantly decreased in the WL compared with the control group. In summary, this short-term WL program prior to radical prostatectomy resulted in significantly more WL in the intervention vs. the control group and was accompanied by significant reductions in body fat mass, circulating triglycerides, and insulin. However, no significant changes were observed in malignant

  8. 76 FR 22336 - Controlled Groups; Deferral of Losses

    Science.gov (United States)

    2011-04-21

    ... intercompany loss when B recognizes a corresponding gain. For example, if S sells 30 percent of T's stock to B... occurrence of either of two events. The deferred loss is taken into account to the extent of any... Controlled Groups; Deferral of Losses AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of...

  9. ASSISTments Dataset from Multiple Randomized Controlled Experiments

    Science.gov (United States)

    Selent, Douglas; Patikorn, Thanaporn; Heffernan, Neil

    2016-01-01

    In this paper, we present a dataset consisting of data generated from 22 previously and currently running randomized controlled experiments inside the ASSISTments online learning platform. This dataset provides data mining opportunities for researchers to analyze ASSISTments data in a convenient format across multiple experiments at the same time.…

  10. Motivation for Participating in a Weight Loss Program and Financial Incentives: An Analysis from a Randomized Trial

    Science.gov (United States)

    Crane, Melissa M.; Tate, Deborah F.; Finkelstein, Eric A.; Linnan, Laura A.

    2012-01-01

    This analysis investigated if changes in autonomous or controlled motivation for participation in a weight loss program differed between individuals offered a financial incentive for weight loss compared to individuals not offered an incentive. Additionally, the same relationships were tested among those who lost weight and either received or did not receive an incentive. This analysis used data from a year-long randomized worksite weight loss program that randomly assigned employees in each worksite to either a low-intensity weight loss program or the same program plus small financial incentives for weight loss ($5.00 per percentage of initial weight lost). There were no differences in changes between groups on motivation during the study, however, increases in autonomous motivation were consistently associated with greater weight losses. This suggests that the small incentives used in this program did not lead to increases in controlled motivation nor did they undermine autonomous motivation. Future studies are needed to evaluate the magnitude and timing of incentives to more fully understand the relationship between incentives and motivation. PMID:22577524

  11. Interaction effect of psychological distress and asthma control on productivity loss?

    Science.gov (United States)

    Moullec, Grégory; FitzGerald, J Mark; Rousseau, Roxanne; Chen, Wenjia; Sadatsafavi, Mohsen

    2015-06-01

    Little is known about the potential synergistic effect of comorbid psychological distress (PD) and uncontrolled asthma (UA) on productivity loss. We estimated the productivity loss associated with the combination of these two potentially preventable conditions in employed adults with asthma. A population-based random sample of 300 adults with asthma in British Columbia, Canada, was prospectively recruited between Dec 2010 and Aug 2012. PD and productivity loss due to absenteeism and presenteeism was measured using validated instruments, and asthma control was ascertained using 2010 Global Initiative for Asthma management strategy. We used two-part regression models to study the contribution of UA and PD to productivity loss. Compared with reference group (controlled asthma (CA)+noPD), those with UA+noPD had CAD$286 (95%CI $276-297) weekly productivity loss, and those with CA+PD had CAD$465 ($445-485). Those with UA+PD had CAD$449 (437-462) in productivity loss. There was no significant interaction effect of PD with asthma control levels on productivity loss (p=0.22). In patients without PD, uncontrolled asthma was associated with a higher productivity loss than controlled asthma, but this was not the case in patients with PD. This finding can be explained by the fact that the contribution of PD to productivity loss is so large that there is no room for synergy with asthma control. Future studies should assess the impact of interventions that modify PD in patients with asthma. Copyright ©ERS 2015.

  12. 76 FR 31543 - Controlled Groups; Deferral of Losses; Hearing

    Science.gov (United States)

    2011-06-01

    ... DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-118761-09] RIN 1545-BI92 Controlled Groups; Deferral of Losses; Hearing AGENCY: Internal Revenue Service (IRS), Treasury. ACTION... deferred losses on the sale or exchange of property between members of a controlled group. DATES: The...

  13. 76 FR 30052 - Controlled Groups; Deferral of Losses; Correction

    Science.gov (United States)

    2011-05-24

    ... DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-118761-09] RIN 1545-BI92 Controlled Groups; Deferral of Losses; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION... deferred losses on the sale or exchange of property between members of a controlled group. FOR FURTHER...

  14. Text messaging approach improves weight loss in patients with nonalcoholic fatty liver disease: A randomized study.

    Science.gov (United States)

    Axley, Page; Kodali, Sudha; Kuo, Yong-Fang; Ravi, Sujan; Seay, Toni; Parikh, Nina M; Singal, Ashwani K

    2018-05-01

    Nonalcoholic fatty liver disease (NAFLD) is emerging as the most common liver disease. The only effective treatment is 7%-10% weight loss. Mobile technology is increasingly used in weight management. This study was performed to evaluate the effects of text messaging intervention on weight loss in patients with NAFLD. Thirty well-defined NAFLD patients (mean age 52 years, 67% females, mean BMI 38) were randomized 1:1 to control group: counselling on healthy diet and exercise, or intervention group: text messages in addition to healthy life style counselling. NAFLD text messaging program sent weekly messages for 22 weeks on healthy life style education. Primary outcome was change in weight. Secondary outcomes were changes in liver enzymes and lipid profile. Intervention group lost an average of 6.9 lbs. (P = .03) compared to gain of 1.8 lbs. in the control group (P = .45). Intervention group also showed a decrease in ALT level (-12.5 IU/L, P = .035) and improvement in serum triglycerides (-28 mg/dL, P = .048). There were no changes in the control group on serum ALT level (-6.1 IU/L, P = .46) and on serum triglycerides (-20.3 mg/dL P = .27). Using one-way analysis of variance, change in outcomes in intervention group compared to control group was significant for weight (P = .02) and BMI (P = .02). Text messaging on healthy life style is associated with reduction in weight in NAFLD patients. Larger studies are suggested to examine benefits on liver histology, and assess long-term impact of this approach in patients with NAFLD. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. The effect of a dietary supplement (N-oleyl-phosphatidyl-ethanolamine and epigallocatechin gallate on dietary compliance and body fat loss in adults who are overweight: A double-blind, randomized control trial

    Directory of Open Access Journals (Sweden)

    Mangine Gerald T

    2012-10-01

    Full Text Available Abstract Background A dietary supplement containing a blend of 170 mg of N-oleyl-phosphatidylethanolamine (NOPE and 100 mg of epigallocatechin-3-gallate (EGCG has been shown to improve compliance to low caloric diets. Considering the cost of dietary ingredients, many manufacturers attempt to determine the lowest efficacious dose. Thus, the purpose of this study was to evaluate the efficacy of 8-weeks of supplementation with a daily intake of 120 mg of NOPE and 105 mg of EGCG in conjunction with a low caloric diet and regular, moderate exercise on dietary compliance in healthy, overweight adults. An additional purpose was to examine the effect of this supplement/diet/exercise paradigm on changes in body composition, sensation of appetite, mood and severity of binge eating. Methods Fifty healthy, overweight (BMI > 25 m·kg2 men (15 and women (35 (SUP; n = 25; 32.7 ± 13.75 y; BMI = 33.4 ± 6.2; PLA; n = 25, 34.3 ± 12.7 years; BMI = 33.2 ± 6.8 were recruited for a double-blind, placebo controlled study. Each volunteer was randomly assigned to either the supplement (SUP; n = 25 or placebo group (PLA; n = 25. Based upon a self-reported 3-day dietary recall all volunteers were recommended a 500 kcal or 30% (maximum of 1000 kcal reduction in caloric intake. Volunteers were also encouraged to exercise 30 minutes per day, three times per week. Results Subjects in SUP were significantly more compliant (x2 = 3.86, p = 0.049 in maintaining a low caloric diet at week 4, but this was not able to be maintained through the 8-week study. In addition, a significant difference in mood, feelings of fatigue and confusion were noted between the groups at week 4, but again not maintained by week 8 where only feelings of tension were improved. No differences between groups (p > 0.05 were observed for body mass, body composition, feelings of hunger, and binge eating after eight weeks. Conclusion

  16. Coherent active polarization control without loss

    Science.gov (United States)

    Ye, Yuqian; Hay, Darrick; Shi, Zhimin

    2017-11-01

    We propose a lossless active polarization control mechanism utilizing an anisotropic dielectric medium with two coherent inputs. Using scattering matrix analysis, we derive analytically the required optical properties of the anisotropic medium that can behave as a switchable polarizing beam splitter. We also show that such a designed anisotropic medium can produce linearly polarized light at any azimuthal direction through coherent control of two inputs with a specific polarization state. Furthermore, we present a straightforward design-on-demand procedure of a subwavelength-thick metastructure that can possess the desired optical anisotropy at a flexible working wavelength. Our lossless coherent polarization control technique may lead to fast, broadband and integrated polarization control elements for applications in imaging, spectroscopy, and telecommunication.

  17. Coherent active polarization control without loss

    Directory of Open Access Journals (Sweden)

    Yuqian Ye

    2017-11-01

    Full Text Available We propose a lossless active polarization control mechanism utilizing an anisotropic dielectric medium with two coherent inputs. Using scattering matrix analysis, we derive analytically the required optical properties of the anisotropic medium that can behave as a switchable polarizing beam splitter. We also show that such a designed anisotropic medium can produce linearly polarized light at any azimuthal direction through coherent control of two inputs with a specific polarization state. Furthermore, we present a straightforward design-on-demand procedure of a subwavelength-thick metastructure that can possess the desired optical anisotropy at a flexible working wavelength. Our lossless coherent polarization control technique may lead to fast, broadband and integrated polarization control elements for applications in imaging, spectroscopy, and telecommunication.

  18. Text Message Support for Weight Loss in Patients With Prediabetes: A Randomized Clinical Trial.

    Science.gov (United States)

    Fischer, Henry H; Fischer, Ilana P; Pereira, Rocio I; Furniss, Anna L; Rozwadowski, Jeanne M; Moore, Susan L; Durfee, Michael J; Raghunath, Silvia G; Tsai, Adam G; Havranek, Edward P

    2016-08-01

    Although the benefits of in-person Diabetes Prevention Program (DPP) classes for diabetes prevention have been demonstrated in trials, effectiveness in clinical practice is limited by low participation rates. This study explores whether text message support enhances weight loss in patients offered DPP classes. English- and Spanish-speaking patients with prediabetes (n = 163) were randomized to the control group, which only received an invitation to DPP classes as defined by the Centers for Disease Control and Prevention, or to the text message-augmented intervention group, which also received text messages adapted from the DPP curriculum for 12 months. Mean weight decreased 0.6 pounds (95% CI -2.7 to 1.6) in the control group and 2.6 pounds (95% CI -5.5 to 0.2) in the intervention group (P value 0.05). Three percent weight loss was achieved by 21.5% of participants in the control group (95% CI 12.5-30.6), compared with 38.5% in the intervention group (95% CI 27.7-49.3) (absolute difference 17.0%; P value 0.02). Mean glycated hemoglobin (HbA1c) increased by 0.19% or 2.1 mmol/mol (95% CI -0.1 to 0.5%) and decreased by 0.09% or 1.0 mmol/mol (95% CI -0.2 to 0.0%) in the control group and intervention participants, respectively (absolute difference 0.28%; P value 0.07). Stratification by language demonstrated a significant treatment effect in Spanish speakers but not in English speakers. Text message support can lead to clinically significant weight loss in patients with prediabetes. Further study assessing effect by primary language and in an operational setting is warranted. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  19. Coordination of a Random Yield Supply Chain with a Loss-Averse Supplier

    Directory of Open Access Journals (Sweden)

    Jiarong Luo

    2015-01-01

    Full Text Available This paper investigates the coordination of a supply chain consisting of a loss-averse supplier and a risk-neutral buyer who orders products from the supplier who suffers from random yield to meet a deterministic demand. We derive the risk-neutral buyer’s optimal order policy and the loss-averse supplier’s optimal production policy under shortage-penalty-surplus-subsidy (SPSS contracts. We also analyze the impacts of loss aversion on the loss-averse supplier’s production decision making and find that the loss-averse supplier may produce less than, equal to, or more than the risk-neutral supplier. Then, we provide explicit conditions on which the random yield supply chain with a loss-averse supplier can be coordinated under SPSS contracts. Finally, adopting numerical examples, we find that when the shortage penalty is low, the buyer’s optimal order quantity will increase, while the supplier’s optimal production quantity will first decrease and then increase as the loss aversion level increases. When the shortage penalty is high, the buyer’s optimal order quantity will decrease but the supplier’s optimal production quantity will always increase as the loss aversion level increases. Furthermore, the numerical examples provide strong evidence for the view that SPSS contracts can effectively improve the performance of the whole supply chain.

  20. Recent randomized controlled trials in otolaryngology.

    Science.gov (United States)

    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  1. Cohort Analysis of a 24-Week Randomized Controlled Trial to Assess the Efficacy of a Novel, Partial Meal Replacement Program Targeting Weight Loss and Risk Factor Reduction in Overweight/Obese Adults.

    Science.gov (United States)

    Brindal, Emily; Hendrie, Gilly A; Taylor, Pennie; Freyne, Jill; Noakes, Manny

    2016-05-04

    Our aim was to design and evaluate a weight-loss program, including a partial meal replacement program, point-of-care testing and face-to-face and smartphone app support, appropriate for delivery in a community pharmacy setting. Overweight or obese adults (n = 146, 71.2% female, 48.18 ± 11.75 years old) were recruited to participate in a 24-week weight loss study and randomised to two app conditions. The dietary intervention was consistent regardless of app. Twelve weeks of clinic appointments with a trained consultant were followed by only app support for an additional 12 weeks. By week 24, retention was 57.5%. There were no differences between app conditions. Based on a cohort analysis of the trial, the mean decrease in weight from baseline to week 24 was 6.43 ± 1.06 kg for males (p < 0.001) and 5.66 ± 0.70 kg for females (p < 0.001). Mixed models also revealed decreases for LDL Cholesterol (-0.13 ± 0.08 mmol/L, nonsignificant), triglycerides (-0.08 ± 0.05 mmol/L, nonsignificant) and an increase in HDL cholesterol (+0.08 ± 0.04 mmol/L, ns) were not significant by week 24. Blood glucose (-0.23 ± 0.08 mmol/L, p = 0.040) and blood pressure (Systolic blood pressure -5.77 ± 1.21 Hg/mm, p < 0.001) were significantly lower at week 24 compared to baseline. Weight loss self-efficacy increased and remained significantly higher than baseline at week 24 (16.85 ± 2.93, p < 0.001). Overall, the program supported participants and was successful in achieving significant weight loss and improvements in health outcomes over 24 weeks.

  2. Loss Minimization Sliding Mode Control of IPM Synchronous Motor Drives

    Directory of Open Access Journals (Sweden)

    Mehran Zamanifar

    2010-01-01

    Full Text Available In this paper, a nonlinear loss minimization control strategy for an interior permanent magnet synchronous motor (IPMSM based on a newly developed sliding mode approach is presented. This control method sets force the speed control of the IPMSM drives and simultaneously ensures the minimization of the losses besides the uncertainties exist in the system such as parameter variations which have undesirable effects on the controller performance except at near nominal conditions. Simulation results are presented to show the effectiveness of the proposed controller.

  3. Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

    Science.gov (United States)

    Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

    2017-12-01

    Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

  4. Effects of protein intake and gender on body composition changes: a randomized clinical weight loss trial

    Directory of Open Access Journals (Sweden)

    Evans Ellen M

    2012-06-01

    Full Text Available Abstract Limited data on sex differences in body composition changes in response to higher protein diets (PRO compared to higher carbohydrate diets (CARB suggest that a PRO diet helps preserve lean mass (LM in women more so than in men. Objective To compare male and female body composition responses to weight loss diets differing in macronutrient content. Design Twelve month randomized clinical trial with 4mo of weight loss and 8mo weight maintenance. Subjects Overweight (N = 130; 58 male (M, 72 female (F; BMI = 32.5 ± 0.5 kg/m2 middle-aged subjects were randomized to energy-restricted (deficit ~500 kcal/d diets providing protein at 1.6 g.kg-1.d-1 (PRO or 0.8 g.kg-1.d-1 (CARB. LM and fat mass (FM were measured using dual X-ray absorptiometry. Body composition outcomes were tested in a repeated measures ANOVA controlling for sex, diet, time and their two- and three-way interactions at 0, 4, 8 and 12mo. Results When expressed as percent change from baseline, males and females lost similar amounts of weight at 12mo (M:-11.2 ± 7.1 %, F:-9.9 ± 6.0 %, as did diet groups (PRO:-10.7 ± 6.8 %, CARB:-10.1 ± 6.2 %, with no interaction of gender and diet. A similar pattern emerged for fat mass and lean mass, however percent body fat was significantly influenced by both gender (M:-18.0 ± 12.8 %, F:-7.3 ± 8.1 %, p  Conclusion PRO was more effective in reducing percent body fat vs. CARB over 12mo weight loss and maintenance. Men lost percent total body fat and trunk fat more effectively than women. No interactive effects of protein intake and gender are evident.

  5. Celiac Patients: A Randomized, Controlled Clinical Study

    Directory of Open Access Journals (Sweden)

    Giuseppe Mazzarella

    2012-01-01

    Full Text Available A lifelong gluten-free diet (GFD is mandatory for celiac disease (CD but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12 or transamidated (35 flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (=0.04 whereas intestinal permeability was mainly altered in the control group (50% versus 20%, =0.06. On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (=0.63, Marsh-Oberhuber grading (=0.08, or intestinal IFN-γ mRNA (>0.05. Creatinine clearance did not vary after 90 days of treatment (=0.46. In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.

  6. PEAK COVARIANCE STABILITY OF A RANDOM RICCATI EQUATION ARISING FROM KALMAN FILTERING WITH OBSERVATION LOSSES

    Institute of Scientific and Technical Information of China (English)

    Li XIE; Lihua XIE

    2007-01-01

    We consider the stability of a random Riccati equation with a Markovian binary jump coefficient. More specifically, we are concerned with the boundedness of the solution of a random Riccati difference equation arising from Kalman filtering with measurement losses. A sufficient condition for the peak covariance stability is obtained which has a simpler form and is shown to be less conservative in some cases than a very recent result in existing literature. Furthermore, we show that a known sufficient condition is also necessary when the observability index equals one.

  7. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial.

    Science.gov (United States)

    Shukla, Vivek V; Bansal, Satvik; Nimbalkar, Archana; Chapla, Apurva; Phatak, Ajay; Patel, Dipen; Nimbalkar, Somashekhar

    2018-04-15

    To compare individual efficacy and additive effects of pain control interventions in preterm neonates. Randomized controlled trial. Level-3 University affiliated neonatal intensive care unit. 200 neonates (26-36 wk gestational age) requiring heel-prick for bedside glucose assessment. Exclusion criteria were neurologic impairment and critical illness precluding study interventions. Neonates were randomly assigned to Kangaroo mother care with Music therapy, Music therapy, Kangaroo Mother care or Control (no additional intervention) groups. All groups received expressed breast milk with cup and spoon as a baseline pain control intervention. Assessment of pain using Premature Infant Pain Profile (PIPP) score on recorded videos. The mean (SD) birth weight and gestational age of the neonates was 1.9 (0.3) kg and 34 (2.3) wk, respectively. Analysis of variance showed significant difference in total PIPP score across groups (P<0.001). Post-hoc comparisons using Sheffe's test revealed that the mean (SD) total PIPP score was significantly lower in Kangaroo mother care group [7.7 (3.9) vs. 11.5 (3.4), 95% CI(-5.9, -1.7), P<0.001] as well as Kangaroo mother care with Music therapy group [8.5 (3.2) vs. 11.5 (3.4), 95%CI (-5.1, -0.9), P=0.001] as compared to Control group. PIPP score was not significantly different between Control group and Music therapy group. Kangaroo mother care with and without Music therapy (with expressed breast milk) significantly reduces pain on heel-prick as compared to expressed breast milk alone. Kangaroo mother care with expressed breast milk should be the first choice as a method for pain control in preterm neonates.

  8. Do randomized controlled trials discuss healthcare costs?

    Directory of Open Access Journals (Sweden)

    G Michael Allan

    Full Text Available BACKGROUND: Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. METHODS AND FINDINGS: We randomly sampled 188 RCTs spanning three years (2003-2005 from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188 of RCTs; any actual costs were included in 7.4% (14/188 of RCTs; and any mention of costs was included in 27.7% (52/188 of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005 and any mention of costs (Cochran-Armitage test, p = 0.02. Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009 or any mention of costs (OR = 0.63, p = 0.02. Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. CONCLUSION: While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

  9. Do randomized controlled trials discuss healthcare costs?

    Science.gov (United States)

    Allan, G Michael; Korownyk, Christina; LaSalle, Kate; Vandermeer, Ben; Ma, Victoria; Klein, Douglas; Manca, Donna

    2010-08-23

    Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs) routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. We randomly sampled 188 RCTs spanning three years (2003-2005) from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188) of RCTs; any actual costs were included in 7.4% (14/188) of RCTs; and any mention of costs was included in 27.7% (52/188) of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005) and any mention of costs (Cochran-Armitage test, p = 0.02). Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009) or any mention of costs (OR = 0.63, p = 0.02). Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

  10. Preference towards Control in Risk Taking: Control, No Control, or Randomize?

    OpenAIRE

    Li, King King

    2010-01-01

    This paper experimentally investigates preference towards different methods of control in risk taking. Participants are asked to choose between different ways for choosing which numbers to bet on for a gamble. They can choose the numbers themselves (control), let the experimenter choose (no control), or randomize. It is found that in addition to the more conventional preference for control, some participants prefer not to control, or randomization. These preferences are robust as participants...

  11. Decreased postural control in people with moderate hearing loss

    Science.gov (United States)

    Thomas, Ewan; Martines, Francesco; Bianco, Antonino; Messina, Giuseppe; Giustino, Valerio; Zangla, Daniele; Iovane, Angelo; Palma, Antonio

    2018-01-01

    Abstract Balance is a complex process that involves multiple sensory integrations. The auditory, visual, and vestibular systems are the main contributors. Hearing loss or hearing impairment may induce inappropriate postural strategies that could affect balance and therefore increase the risk of falling. The aim of this study was to understand whether hearing loss could influence balance, cervical posture, and muscle activation in the cervical region. Thirteen patients (61 ± 13 years; 161.8 ± 11.0 cm; 70.5 ± 15.9 kg) with moderate hearing loss (Right ear −60 ± 21 dB; Left ear −61 ± 24 dB) underwent: an audiometric examination, a postural examination (with open and closed eyes) through a stabilometric platform, a cervical ROM examination through a head accelerometer, and a sternocleidomastoid electromyography (EMG) examination. A linear regression analysis has shown a regression coefficient (R2) 0.76 and 0.69 between hearing loss and the posturographic parameters, on the sagittal sway, with open and closed eyes, respectively. The combination of frontal and sagittal sway is able to explain up to 84% of the variance of the audiometric assessment. No differences were found between right and left hemibody between the audiometric, posturographic, cervical ROM parameters, and in EMG amplitude. ROM and EMG parameters have not shown any significant associations with hearing loss, for both right and left head rotation. Hearing loss is associated to increased posturographic measures, especially the sagittal sway, underlining a reduced postural control in people with hearing impairments. No association was found between the heads posture and neck activation with hearing loss. Hearing loss may be associated with an increased risk of falls. PMID:29620637

  12. Decreased postural control in people with moderate hearing loss.

    Science.gov (United States)

    Thomas, Ewan; Martines, Francesco; Bianco, Antonino; Messina, Giuseppe; Giustino, Valerio; Zangla, Daniele; Iovane, Angelo; Palma, Antonio

    2018-04-01

    Balance is a complex process that involves multiple sensory integrations. The auditory, visual, and vestibular systems are the main contributors. Hearing loss or hearing impairment may induce inappropriate postural strategies that could affect balance and therefore increase the risk of falling.The aim of this study was to understand whether hearing loss could influence balance, cervical posture, and muscle activation in the cervical region.Thirteen patients (61 ± 13 years; 161.8 ± 11.0 cm; 70.5 ± 15.9 kg) with moderate hearing loss (Right ear -60 ± 21 dB; Left ear -61 ± 24 dB) underwent: an audiometric examination, a postural examination (with open and closed eyes) through a stabilometric platform, a cervical ROM examination through a head accelerometer, and a sternocleidomastoid electromyography (EMG) examination.A linear regression analysis has shown a regression coefficient (R) 0.76 and 0.69 between hearing loss and the posturographic parameters, on the sagittal sway, with open and closed eyes, respectively. The combination of frontal and sagittal sway is able to explain up to 84% of the variance of the audiometric assessment. No differences were found between right and left hemibody between the audiometric, posturographic, cervical ROM parameters, and in EMG amplitude. ROM and EMG parameters have not shown any significant associations with hearing loss, for both right and left head rotation.Hearing loss is associated to increased posturographic measures, especially the sagittal sway, underlining a reduced postural control in people with hearing impairments. No association was found between the heads posture and neck activation with hearing loss. Hearing loss may be associated with an increased risk of falls.

  13. The Effect of Cost Sharing on an Employee Weight Loss Program: A Randomized Trial.

    Science.gov (United States)

    John, Leslie K; Troxel, Andrea B; Yancy, William S; Friedman, Joelle; Zhu, Jingsan; Yang, Lin; Galvin, Robert; Miller-Kovach, Karen; Halpern, Scott D; Loewenstein, George; Volpp, Kevin

    2018-01-01

    To test the effects of employer subsidies on employee enrollment, attendance, and weight loss in a nationally available weight management program. A randomized trial tested the impact of employer subsidy: 100%; 80%, 50%, and a hybrid 50% subsidy that could become a 100% subsidy by attaining attendance targets. NCT01756066. Twenty three thousand twenty-three employees of 2 US companies. The primary outcome was the percentage of employees who enrolled in the weight management program. We also tested whether the subsidies were associated with differential attendance and weight loss over 12 months, as might be predicted by the expectation that they attract employees with differing degrees of motivation. Analysis and Results: Enrollment differed significantly by subsidy level ( P < .0001). The 100% subsidy produced the highest enrollment (7.7%), significantly higher than each of the lower subsidies (vs 80% subsidy: 6.2%, P = .002; vs 50% subsidy: 3.9%, P < .0001; vs hybrid: 3.7%, P < .0001). Enrollment in the 80% subsidy group was significantly higher than both lower subsidy groups (vs 50% subsidy: 3.9%, P < .0001; vs hybrid: 3.7%, P < .0001). Among enrollees, there were no differences among the 4 groups in attendance or weight loss. This pragmatic trial, conducted in a real-world workplace setting, suggests that higher rates of employer subsidization help individuals to enroll in weight loss programs, without a decrement in program effectiveness. Future research could explore the cost-effectiveness of such subsidies or alternative designs.

  14. Long-term weight-loss maintenance in obese patients with knee osteoarthritis: a randomized trial.

    Science.gov (United States)

    Christensen, Pia; Henriksen, Marius; Bartels, Else M; Leeds, Anthony R; Meinert Larsen, Thomas; Gudbergsen, Henrik; Riecke, Birgit F; Astrup, Arne; Heitmann, Berit L; Boesen, Mikael; Christensen, Robin; Bliddal, Henning

    2017-09-01

    Background: A formula low-energy diet (LED) reduces weight effectively in obese patients with knee osteoarthritis, but the role of LED in long-term weight-loss maintenance is unclear. Objective: We aimed to determine the effect of intermittent LED compared with daily meal replacements on weight-loss maintenance and number of knee replacements over 3 y. Design: The design was a randomized trial with participants aged >50 y who had knee osteoarthritis and a body mass index [BMI (in kg/m 2 )] ≥30. Participants were recruited from the osteoarthritis outpatient clinic at Copenhagen University Hospital in Frederiksberg, Denmark; they had previously completed a 68-wk lifestyle intervention trial and achieved an average weight loss of 10.5 kg (10% of initial body weight). Participants were randomly assigned to either the intermittent treatment (IN) group with LED for 5 wk every 4 mo for 3 y or to daily meal replacements of 1-2 meals for 3 y [regular (RE) group]. Attention by dietitians and the amount of formula products were similar. Primary outcomes were changes in body weight and proportion of participants receiving knee replacements. Outcomes were analyzed on the intention-to-treat-population with the use of baseline-carried-forward imputation for missing data. Results: A total of 153 participants (means ± SDs: BMI: 33.3 ± 4.6; age: 63.8 ± 6.3 y; 83% women) were recruited between June and December 2009 and randomly assigned to the IN ( n = 76) or RE ( n = 77) group. A total of 53 and 56 participants, respectively, completed the trial. Weight increased by 0.68 and 1.75 kg in the IN and RE groups, respectively (mean difference: -1.06 kg; 95% CI: -2.75, 0.63 kg; P = 0.22). Alloplasty rates were low and did not differ (IN group: 8 of 76 participants; RE group: 12 of 77 participants; P = 0.35). Conclusions: After a mean 10% weight-loss and 1-y maintenance, additional use of daily meal replacements or intermittent LED resulted in weight-loss maintenance for 3 y. These

  15. Rotor Field Oriented Control with adaptive Iron Loss Compensation

    DEFF Research Database (Denmark)

    Rasmussen, Henrik; Vadstrup, P.; Børsting, H.

    1999-01-01

    It is well known from the literature that iron loses in an induction motor implies field angle estimation errors and hence detuning problems. In this paper a new method for estimating the iron loss resistor in an induction motor is presented. The method is based on a traditional dynamic model...... controlled in a Field Oriented Control scheme. This deviation is used to force a MIT-rule based adaptive estimator. An adaptive compensator containing the developed estimator is introduced and verified by simulations and tested by real time experiments....

  16. Digital servo control of random sound fields

    Science.gov (United States)

    Nakich, R. B.

    1973-01-01

    It is necessary to place number of sensors at different positions in sound field to determine actual sound intensities to which test object is subjected. It is possible to determine whether specification is being met adequately or exceeded. Since excitation is of random nature, signals are essentially coherent and it is impossible to obtain true average.

  17. Features predicting weight loss in overweight or obese participants in a web-based intervention: randomized trial.

    Science.gov (United States)

    Brindal, Emily; Freyne, Jill; Saunders, Ian; Berkovsky, Shlomo; Smith, Greg; Noakes, Manny

    2012-12-12

    Obesity remains a serious issue in many countries. Web-based programs offer good potential for delivery of weight loss programs. Yet, many Internet-delivered weight loss studies include support from medical or nutritional experts, and relatively little is known about purely web-based weight loss programs. To determine whether supportive features and personalization in a 12-week web-based lifestyle intervention with no in-person professional contact affect retention and weight loss. We assessed the effect of different features of a web-based weight loss intervention using a 12-week repeated-measures randomized parallel design. We developed 7 sites representing 3 functional groups. A national mass media promotion was used to attract overweight/obese Australian adults (based on body mass index [BMI] calculated from self-reported heights and weights). Eligible respondents (n = 8112) were randomly allocated to one of 3 functional groups: information-based (n = 183), supportive (n = 3994), or personalized-supportive (n = 3935). Both supportive sites included tools, such as a weight tracker, meal planner, and social networking platform. The personalized-supportive site included a meal planner that offered recommendations that were personalized using an algorithm based on a user's preferences for certain foods. Dietary and activity information were constant across sites, based on an existing and tested 12-week weight loss program (the Total Wellbeing Diet). Before and/or after the intervention, participants completed demographic (including self-reported weight), behavioral, and evaluation questionnaires online. Usage of the website and features was objectively recorded. All screening and data collection procedures were performed online with no face-to-face contact. Across all 3 groups, attrition was high at around 40% in the first week and 20% of the remaining participants each week. Retention was higher for the supportive sites compared to the information-based site only

  18. Autoshaping, random control, and omission training in the rat.

    Science.gov (United States)

    Locurto, C; Terrace, H S; Gibbon, J

    1976-11-01

    The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping.

  19. Autoshaping, random control, and omission training in the rat1

    Science.gov (United States)

    Locurto, Charles; Terrace, H. S.; Gibbon, John

    1976-01-01

    The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping. PMID:16811960

  20. Development and Validation of the Eating Loss of Control Scale

    Science.gov (United States)

    Blomquist, Kerstin K.; Roberto, Christina A.; Barnes, Rachel D.; White, Marney A.; Masheb, Robin M.; Grilo, Carlos M.

    2014-01-01

    Recurrent objective bulimic episodes (OBE) are a defining diagnostic characteristic of binge eating disorder (BED) and bulimia nervosa (BN). OBEs are characterized by experiencing loss of control (LOC) while eating an unusually large quantity of food. Despite nosological importance and complex heterogeneity across patients, measurement of LOC has been assessed dichotomously (present/absent). This study describes the development and initial validation of the Eating Loss of Control Scale (ELOCS), a self-report questionnaire that examines the complexity of the LOC construct. Participants were 168 obese treatment-seeking individuals with BED who completed the Eating Disorder Examination interview and self-report measures. Participants rated their LOC-related feelings or behaviors on continuous Likert-type scales and reported the number of LOC episodes in the past 28 days. Principal component analysis identified a single-factor, 18-item scale, which demonstrated good internal reliability (α=0.90). Frequency of LOC episodes was significantly correlated with frequency of OBEs and subjective bulimic episodes. The ELOCS demonstrated good convergent validity and was significantly correlated with greater eating pathology, greater emotion dysregulation, greater depression, and lower self-control, but not with BMI. The findings suggest that the ELOCS is a valid self-report questionnaire that may provide important clinical information regarding experiences of LOC in obese persons with BED. Future research should examine the ELOCS in other eating disorders and non-clinical samples. PMID:24219700

  1. Narcolepsy-cataplexy and loss of sphincter control.

    Science.gov (United States)

    Vgontzas, A. N.; Sollenberger, S. E.; Kales, A.; Bixler, E. O.; Vela-Bueno, A.

    1996-01-01

    We describe the case of a 34-year-old man who presented intermittent faecal incontinence as a manifestation of cataplexy. The patient's sleep history was positive for the full narcoleptic tetrad (sleep attacks, cataplexy, sleep paralysis and hypnagogic hallucinations) while extensive neuropsychiatric work up was negative for any neurologic or psychiatric illness. Repeat polysomnograms (including a polysomnogram with a full seizure montage) were positive for pathologic sleepiness, but there was no evidence of a seizure disorder. The course of the patient's symptomatology and the favourable response of his symptoms to stimulants and imipramine support the theory that his intermittent loss of sphincter control is part of his narcolepsy-cataplexy. PMID:8796217

  2. Control rod drive mechanism stator loss of coolant test

    International Nuclear Information System (INIS)

    Besel, L.; Ibatuan, R.

    1977-04-01

    This report documents the stator loss of coolant test conducted at HEDL on the lead unit Control Rod Drive Mechanism (CRDM) in February, 1977. The purpose of the test was to demonstrate scram capability of the CRDM with an uncooled stator and to obtain a time versus temperature curve of an uncooled stator under power. Brief descriptions of the test, hardware used, and results obtained are presented in the report. The test demonstrated that the CRDM could be successfully scrammed with no anomalies in both the two-phase and three-phase stator winding hold conditions after the respective equilibrium stator temperatures had been obtained with no stator coolant

  3. Control of phase transition dynamics in media with nanoscale nonuniformities by coherence loss spectroscopy

    International Nuclear Information System (INIS)

    Brodsky, Anatol M

    2010-01-01

    The optical nondestructive characterization of chemical transformation dynamics and diffusion kinetics, including phase transitions, in heterogeneous media with a random distribution of nanoparticles (nano-nonuniformities), is of great theoretical and practical importance. Such characterization, with the help of coherence loss spectroscopy, considered in this paper can be applied for the control of a number of industrial processes dynamics, environmental monitoring, and medical diagnostics and therapy. As a specific example, the growth of crystal nuclei (embrions) as a result of the diffusion to them of a substance from the surrounding supersaturated solution is considered

  4. Fast state estimation subject to random data loss in discrete-time nonlinear stochastic systems

    Science.gov (United States)

    Mahdi Alavi, S. M.; Saif, Mehrdad

    2013-12-01

    This paper focuses on the design of the standard observer in discrete-time nonlinear stochastic systems subject to random data loss. By the assumption that the system response is incrementally bounded, two sufficient conditions are subsequently derived that guarantee exponential mean-square stability and fast convergence of the estimation error for the problem at hand. An efficient algorithm is also presented to obtain the observer gain. Finally, the proposed methodology is employed for monitoring the Continuous Stirred Tank Reactor (CSTR) via a wireless communication network. The effectiveness of the designed observer is extensively assessed by using an experimental tested-bed that has been fabricated for performance evaluation of the over wireless-network estimation techniques under realistic radio channel conditions.

  5. Randomized Controlled Trials: The Most Powerful Tool In Modern ...

    African Journals Online (AJOL)

    Randomized controlled trial (RCT) can be said to be one of the simplest but most powerful tool of research. It is the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost effectiveness of a treatment. Through the randomization, bias will be avoided ...

  6. Evaluating the Flipped Classroom: A Randomized Controlled Trial

    Science.gov (United States)

    Wozny, Nathan; Balser, Cary; Ives, Drew

    2018-01-01

    Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

  7. Treatment of periodontal disease during pregnancy: a randomized controlled trial.

    Science.gov (United States)

    Newnham, John P; Newnham, Ian A; Ball, Colleen M; Wright, Michelle; Pennell, Craig E; Swain, Jonathan; Doherty, Dorota A

    2009-12-01

    To investigate whether treating periodontal disease prevents preterm birth and other major complications of pregnancy. This single-center trial was conducted across six obstetric sites in metropolitan Perth, Western Australia. Pregnant women identified by history to be at risk (n=3,737) were examined for periodontal disease. Approximately 1,000 women with periodontal disease were allocated at random to receive periodontal treatment commencing around 20 weeks of gestation (n=542) or 6 weeks after the pregnancy was completed (controls; n=540). The treatment included mechanical removal of oral biofilms together with oral hygiene instruction and motivation at a minimum of three weekly visits, with further visits if required. There were no differences between the control and treatment groups in preterm birth (9.3% compared with 9.7%, odds ratio [OR] 1.05, 95% confidence interval [CI 0.7-1.58], P=.81), birth weight (3,450 compared with 3,410 g, P=.12), preeclampsia (4.1% compared with 3.4%, OR 0.82, 95% CI 0.44-1.56, P=.55), or other obstetric endpoints. There were four unexplained stillbirths in the control group and no pregnancy losses in the treated group (P=.12). Measures of fetal and neonatal well-being were similar in the two groups, including abnormalities in fetal heart rate recordings (P=.26), umbilical artery flow studies (P=.96), and umbilical artery blood gas values (P=.37). The periodontal treatment was highly successful in improving health of the gums (Pperiodontal disease during pregnancy in this population prevents preterm birth, fetal growth restriction, or preeclampsia. Periodontal treatment was not hazardous to the women or their pregnancies. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00133926. I.

  8. "Tandem duplication-random loss" is not a real feature of oyster mitochondrial genomes

    Directory of Open Access Journals (Sweden)

    Zhang Guofan

    2009-02-01

    Full Text Available Abstract Duplications and rearrangements of coding genes are major themes in the evolution of mitochondrial genomes, bearing important consequences in the function of mitochondria and the fitness of organisms. Yu et al. (BMC Genomics 2008, 9:477 reported the complete mt genome sequence of the oyster Crassostrea hongkongensis (16,475 bp and found that a DNA segment containing four tRNA genes (trnK1, trnC, trnQ1 and trnN, a duplicated (rrnS and a split rRNA gene (rrnL5' was absent compared with that of two other Crassostrea species. It was suggested that the absence was a novel case of "tandem duplication-random loss" with evolutionary significance. We independently sequenced the complete mt genome of three C. hongkongensis individuals, all of which were 18,622 bp and contained the segment that was missing in Yu et al.'s sequence. Further, we designed primers, verified sequences and demonstrated that the sequence loss in Yu et al.'s study was an artifact caused by placing primers in a duplicated region. The duplication and split of ribosomal RNA genes are unique for Crassostrea oysters and not lost in C. hongkongensis. Our study highlights the need for caution when amplifying and sequencing through duplicated regions of the genome.

  9. Efficacy of a randomized trial examining commercial weight loss programs and exercise on metabolic syndrome in overweight and obese women.

    Science.gov (United States)

    Baetge, Claire; Earnest, Conrad P; Lockard, Brittanie; Coletta, Adriana M; Galvan, Elfego; Rasmussen, Christopher; Levers, Kyle; Simbo, Sunday Y; Jung, Y Peter; Koozehchian, Majid; Oliver, Jonathan; Dalton, Ryan; Sanchez, Brittany; Byrd, Michael J; Khanna, Deepesh; Jagim, Andrew; Kresta, Julie; Greenwood, Mike; Kreider, Richard B

    2017-02-01

    While commercial dietary weight-loss programs typically advise exercise, few provide actual programing. The goal of this study was to compare the Curves Complete 90-day Challenge (CC, n = 29), which incorporates exercising and diet, to programs advocating exercise (Weight Watchers Points Plus (WW, n = 29), Jenny Craig At Home (JC, n = 27), and Nutrisystem Advance Select (NS, n = 28)) or control (n = 20) on metabolic syndrome (MetS) and weight loss. We randomized 133 sedentary, overweight women (age, 47 ± 11 years; body mass, 86 ± 14 kg; body mass index, 35 ± 6 kg/m 2 ) into respective treatment groups for 12 weeks. Data were analyzed using chi square and general linear models adjusted for age and respective baseline measures. Data are means ± SD or mean change ± 95% confidence intervals (CIs). We observed a significant trend for a reduction in energy intake for all treatment groups and significant weight loss for all groups except control: CC (-4.32 kg; 95% CI, -5.75, -2.88), WW (-4.31 kg; 95% CI, -5.82, -2.96), JC (-5.34 kg; 95% CI, -6.86, -3.90), NS (-5.03 kg; 95% CI, -6.49, -3.56), and control (0.16 kg, 95% CI, -1.56, 1.89). Reduced MetS prevalence was observed at follow-up for CC (35% vs. 14%, adjusted standardized residuals (adjres.) = 3.1), but not WW (31% vs. 28% adjres. = 0.5), JC (37% vs. 42%, adjres. = -0.7), NS (39% vs. 50% adjres. = -1.5), or control (45% vs. 55% adjres. = -1.7). While all groups improved relative fitness (mL·kg -1 ·min -1 ) because of weight loss, only the CC group improved absolute fitness (L/min). In conclusion, commercial programs offering concurrent diet and exercise programming appear to offer greater improvements in MetS prevalence and cardiovascular function after 12 weeks of intervention.

  10. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  11. Prospective Randomized Controlled Comparison of Caudal ...

    African Journals Online (AJOL)

    including 50 consecutive patients in the age group of 1‑10 years, who underwent urogenital surgeries ... The duration of absolute analgesia was defined as the time from caudal injection until the pain score was >2. Motor block was assessed by modified Bromage scale. .... double-blind, phase III, controlled trial comparing.

  12. Executive function in weight loss and weight loss maintenance: a conceptual review and novel neuropsychological model of weight control.

    Science.gov (United States)

    Gettens, Katelyn M; Gorin, Amy A

    2017-10-01

    Weight loss maintenance is a complex, multifaceted process that presents a significant challenge for most individuals who lose weight. A growing body of literature indicates a strong relationship between cognitive dysfunction and excessive body weight, and suggests that a subset of high-order cognitive processes known as executive functions (EF) likely play an important role in weight management. Recent reviews cover neuropsychological correlates of weight status yet fail to address the role of executive function in the central dilemma of successful weight loss maintenance. In this paper, we provide an overview of the existing literature examining executive functions as they relate to weight status and initial weight loss. Further, we propose a novel conceptual model of the relationships between EF, initial weight loss, and weight loss maintenance, mapping specific executive functions onto strategies known to be associated with both phases of the weight control process. Implications for the development of more efficacious weight loss maintenance interventions are discussed.

  13. THERAPY: A RANDOMIZED CONTROLLED PILOT STUDY

    Directory of Open Access Journals (Sweden)

    SOFIA VON HUMBOLDT

    2013-01-01

    Full Text Available El objetivo del estudio que se informa fue ex- plorar si una intervención individual de terapia centrada en la persona (TCP en personas adul- tas mayores puede promover su sentido de cohe- rencia, en comparación con un grupo control (lista de espera. Se plantea que los participantes asignados al azar a TCP informarían mejoras en SDC de pre y post-intervención en comparación con el grupo control. Un grupo de 87 participantes de 65 a 86 años (M = 72.4; DE = 5.15 fue evaluado con la Escala de Sentido de Coherencia (ESDC y el cuestio- nario sociodemográfico en tres momentos dife- rentes: al inicio del estudio (t1, post-tratamiento (t2 y a los 12 meses de seguimiento (t3. Los resultados indicaron que los participan- tes en TCP evidenciaron un aumento significa- tivo en cuanto a su SDC (16.7%, mientras que en el grupo control se encontró una disminu- ción significativa (-2.7%, entre el inicio del es- tudio y el momento de seguimiento. El tamaño del efecto en el grupo TCP fue alto (η2p = .776. En concreto, tanto en la post-intervención como en el momento del seguimiento, los participan- tes que se sometieron a TCP tenían un SDC sig- nificativamente mayor (M = 3.84, DE = .219 Se encontraron diferencias significativas entre el grupo de intervención y el grupo control en la post-intervención y en el seguimiento. Se concluye que los cambios en SDC fueron positivos y mantenidos, por lo tanto, los resul- tados sugieren que la TCP es favorable a la me- jora de SDC. Por otra parte, ya que la SDC se asocia con el bienestar relacionado con la salud de las poblaciones de mayor edad, hay que en- fatizar el desarrollo de SDC en la vejez.

  14. Effects of a mindfulness‐based weight loss intervention in adults with obesity: A randomized clinical trial

    Science.gov (United States)

    Moran, Patricia J.; Kristeller, Jean; Acree, Michael; Bacchetti, Peter; Kemeny, Margaret E.; Dallman, Mary; Lustig, Robert H.; Grunfeld, Carl; Nixon, Douglas F.; Milush, Jeffrey M.; Goldman, Veronica; Laraia, Barbara; Laugero, Kevin D.; Woodhouse, Leslie; Epel, Elissa S.

    2016-01-01

    Objective To determine whether adding mindfulness‐based eating and stress management practices to a diet‐exercise program improves weight loss and metabolic syndrome components. Methods In this study 194 adults with obesity were randomized to a 5.5‐month program with or without mindfulness training and identical diet‐exercise guidelines. Intention‐to‐treat analyses with multiple imputation were used for missing data. The primary outcome was 18‐month weight change. Results Estimated effects comparing the mindfulness to control arm favored the mindfulness arm in (a) weight loss at 12 months, −1.9 kg (95% CI: −4.5, 0.8; P = 0.17), and 18 months, −1.7 kg (95% CI: −4.7, 1.2; P = 0.24), though not statistically significant; (b) changes in fasting glucose at 12 months, −3.1 mg/dl (95% CI: −6.3, 0.1; P = 0.06), and 18 months, −4.1 mg/dl (95% CI: −7.3, −0.9; P = 0.01); and (c) changes in triglyceride/HDL ratio at 12 months, −0.57 (95% CI: −0.95, −0.18; P = 0.004), and 18 months, −0.36 (95% CI: −0.74, 0.03; P = 0.07). Estimates for other metabolic risk factors were not statistically significant, including waist circumference, blood pressure, and C‐reactive protein. Conclusions Mindfulness enhancements to a diet‐exercise program did not show substantial weight loss benefit but may promote long‐term improvement in some aspects of metabolic health in obesity that requires further study. PMID:26955895

  15. Effects of a mindfulness-based weight loss intervention in adults with obesity: A randomized clinical trial.

    Science.gov (United States)

    Daubenmier, Jennifer; Moran, Patricia J; Kristeller, Jean; Acree, Michael; Bacchetti, Peter; Kemeny, Margaret E; Dallman, Mary; Lustig, Robert H; Grunfeld, Carl; Nixon, Douglas F; Milush, Jeffrey M; Goldman, Veronica; Laraia, Barbara; Laugero, Kevin D; Woodhouse, Leslie; Epel, Elissa S; Hecht, Frederick M

    2016-04-01

    To determine whether adding mindfulness-based eating and stress management practices to a diet-exercise program improves weight loss and metabolic syndrome components. In this study 194 adults with obesity were randomized to a 5.5-month program with or without mindfulness training and identical diet-exercise guidelines. Intention-to-treat analyses with multiple imputation were used for missing data. The primary outcome was 18-month weight change. Estimated effects comparing the mindfulness to control arm favored the mindfulness arm in (a) weight loss at 12 months, -1.9 kg (95% CI: -4.5, 0.8; P = 0.17), and 18 months, -1.7 kg (95% CI: -4.7, 1.2; P = 0.24), though not statistically significant; (b) changes in fasting glucose at 12 months, -3.1 mg/dl (95% CI: -6.3, 0.1; P = 0.06), and 18 months, -4.1 mg/dl (95% CI: -7.3, -0.9; P = 0.01); and (c) changes in triglyceride/HDL ratio at 12 months, -0.57 (95% CI: -0.95, -0.18; P = 0.004), and 18 months, -0.36 (95% CI: -0.74, 0.03; P = 0.07). Estimates for other metabolic risk factors were not statistically significant, including waist circumference, blood pressure, and C-reactive protein. Mindfulness enhancements to a diet-exercise program did not show substantial weight loss benefit but may promote long-term improvement in some aspects of metabolic health in obesity that requires further study. © 2016 The Authors. Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

  16. Randomized algorithms in automatic control and data mining

    CERN Document Server

    Granichin, Oleg; Toledano-Kitai, Dvora

    2015-01-01

    In the fields of data mining and control, the huge amount of unstructured data and the presence of uncertainty in system descriptions have always been critical issues. The book Randomized Algorithms in Automatic Control and Data Mining introduces the readers to the fundamentals of randomized algorithm applications in data mining (especially clustering) and in automatic control synthesis. The methods proposed in this book guarantee that the computational complexity of classical algorithms and the conservativeness of standard robust control techniques will be reduced. It is shown that when a problem requires "brute force" in selecting among options, algorithms based on random selection of alternatives offer good results with certain probability for a restricted time and significantly reduce the volume of operations.

  17. A whey-protein supplement increases fat loss and spares lean muscle in obese subjects: a randomized human clinical study

    Directory of Open Access Journals (Sweden)

    Ward Loren S

    2008-03-01

    Full Text Available Abstract Background This study evaluated a specialized whey fraction (Prolibra™, high in leucine, bioactive peptides and milk calcium for use as a dietary supplement to enhance weight loss. Methods This was a randomized, double-blind, parallel-arm, 12-week study. Caloric intake was reduced 500 calories per day. Subjects consumed Prolibra or an isocaloric ready-to-mix beverage 20 minutes before breakfast and 20 minutes before dinner. Body fat and lean muscle tissue were measured by dual-energy x-ray absorptiometry (DEXA. Body weight and anthropometric measurements were recorded every 4 weeks. Blood samples were taken at the beginning and end of the study. Statistical analyses were performed on all subjects that completed (completer analysis and all subjects that lost at least 2.25 kg of body weight (responder analysis. Within group significance was determined at P Results Both groups lost a significant amount of weight and the Prolibra group tended to lose more weight than the control group; however the amount of weight loss was not significantly different between groups after 12 weeks. Prolibra subjects lost significantly more body fat compared to control subjects for both the completer (2.81 vs. 1.62 kg P = 0.03 and responder (3.63 vs. 2.11 kg, P = 0.01 groups. Prolibra subjects lost significantly less lean muscle mass in the responder group (1.07 vs. 2.41 kg, P = 0.02. The ratio of fat to lean loss (kg fat lost/kg lean lost was much larger for Prolibra subjects for both completer (3.75 vs. 1.05 and responder (3.39 vs. 0.88 groups. Conclusion Subjects in both the control and treatment group lost a significant amount of weight with a 500 calorie reduced diet. Subjects taking Prolibra lost significantly more body fat and showed a greater preservation of lean muscle compared to subjects consuming the control beverage. Because subjects taking Prolibra lost 6.1% of their body fat mass, and because a 5% reduction of body fat mass has been shown to

  18. Asthma control and productivity loss in those with work-related asthma: A population-based study.

    Science.gov (United States)

    Wong, Alyson; Tavakoli, Hamid; Sadatsafavi, Mohsen; Carlsten, Chris; FitzGerald, J Mark

    2017-06-01

    In Canada, asthma is the third leading cause of work loss, yet little is known about the associated productivity loss. The goal of this study was to look at the relationship between asthma control and productivity loss, particularly contrasting those with work-related asthma (WRA) and non-work-related asthma (NWRA). A population-based random sample of adults with asthma in British Columbia, Canada, was prospectively recruited. Asthma control was graded according to Global Initiative for Asthma classification, while productivity loss and presence of WRA was assessed using questionnaires. Ordinal regression models were then used to associate WRA with asthma control. Generalized linear models were applied to estimate the average productivity loss associated with different levels of asthma control among those with WRA and NWRA. The study included 300 employed adults. Sixty (20%) had WRA. The odds of being controlled were significantly lower in those with WRA (OR = 0.23, 95% CI: 0.09, 0.56; P asthma had a significant difference in productivity loss due to presenteeism ($659.1 [95% CI: 12.9, 1581.5; P = 0.04]), but not absenteeism ($88.7 [95% CI: -86.5, 279.6; P = 0.35]), when compared to those with NWRA and uncontrolled asthma. There was no significant difference when a similar comparison was made for those with controlled or partially controlled asthma. WRA is associated with worse asthma control and increased productivity loss. Presenteeism makes a significant contribution to productivity loss and should be considered when evaluating the overall economic burden of asthma, particularly WRA.

  19. Event-Driven Control for Networked Control Systems With Quantization and Markov Packet Losses.

    Science.gov (United States)

    Yang, Hongjiu; Xu, Yang; Zhang, Jinhui

    2016-05-23

    In this paper, event-driven is used in a networked control system (NCS) which is subjected to the effect of quantization and packet losses. A discrete event-detector is used to monitor specific events in the NCS. Both an arbitrary region quantizer and Markov jump packet losses are also considered for the NCS. Based on zoom strategy and Lyapunov theory, a complete proof is given to guarantee mean square stability of the closed-loop system. Stabilization of the NCS is ensured by designing a feedback controller. Lastly, an inverted pendulum model is given to show the advantages and effectiveness of the proposed results.

  20. Weighing every day matters: daily weighing improves weight loss and adoption of weight control behaviors.

    Science.gov (United States)

    Steinberg, Dori M; Bennett, Gary G; Askew, Sandy; Tate, Deborah F

    2015-04-01

    Daily weighing is emerging as the recommended self-weighing frequency for weight loss. This is likely because it improves adoption of weight control behaviors. To examine whether weighing every day is associated with greater adoption of weight control behaviors compared with less frequent weighing. Longitudinal analysis of a previously conducted 6-month randomized controlled trial. Overweight men and women in Chapel Hill, NC, participated in the intervention arm (N=47). The intervention focused on daily weighing for weight loss using an e-scale that transmitted weights to a study website, along with weekly e-mailed lessons and tailored feedback on daily weighing adherence and weight loss progress. We gathered objective data on self-weighing frequency from the e-scales. At baseline and 6 months, weight change was measured in the clinic and weight control behaviors (total items=37), dietary strategies, and calorie expenditure from physical activity were assessed via questionnaires. Calorie intake was assessed using an online 24-hour recall tool. We used χ(2) tests to examine variation in discrete weight control behaviors and linear regression models to examine differences in weight, dietary strategies, and calorie intake and expenditure by self-weighing frequency. Fifty-one percent of participants weighed every day (n=24) over 6 months. The average self-weighing frequency among those weighing less than daily (n=23) was 5.4±1.2 days per week. Daily weighers lost significantly more weight compared with those weighing less than daily (mean difference=-6.1 kg; 95% CI -10.2 to -2.1; P=0.004). The total number of weight control behaviors adopted was greater among daily weighers (17.6±7.6 vs 11.2±6.4; P=0.004). There were no differences by self-weighing frequency in dietary strategies, calorie intake, or calorie expenditure. Weighing every day led to greater adoption of weight control behaviors and produced greater weight loss compared with weighing most days of the

  1. Garcinia cambogia (hydroxycitric acid) as a potential antiobesity agent: a randomized controlled trial.

    Science.gov (United States)

    Heymsfield, S B; Allison, D B; Vasselli, J R; Pietrobelli, A; Greenfield, D; Nunez, C

    1998-11-11

    Hydroxycitric acid, the active ingredient in the herbal compound Garcinia cambogia, competitively inhibits the extramitochondrial enzyme adenosine triphosphate-citrate (pro-3S)-lyase. As a citrate cleavage enzyme that may play an essential role in de novo lipogenesis inhibition, G cambogia is claimed to lower body weight and reduce fat mass in humans. To evaluate the efficacy of G cambogia for body weight and fat mass loss in overweight human subjects. Twelve-week randomized, double-blind, placebo-controlled trial. Outpatient weight control research unit. Overweight men and women subjects (mean body mass index [weight in kilograms divided by the square of height in meters], approximately 32 kg/m2). Subjects were randomized to receive either active herbal compound (1500 mg of hydroxycitric acid per day) or placebo, and both groups were prescribed a high-fiber, low-energy diet. The treatment period was 12 weeks. Body weight was evaluated every other week and fat mass was measured at weeks 0 and 12. Body weight change and fat mass change. A total of 135 subjects were randomized to either active hydroxycitric acid (n = 66) or placebo (n = 69); 42 (64%) in the active hydroxycitric acid group and 42 (61%) in the placebo group completed 12 weeks of treatment (P = .74). Patients in both groups lost a significant amount of weight during the 12-week treatment period (P<.001); however, between-group weight loss differences were not statistically significant (mean [SD], 3.2 [3.3] kg vs 4.1 [3.9] kg; P = .14). There were no significant differences in estimated percentage of body fat mass loss between treatment groups, and the fraction of subject weight loss as fat was not influenced by treatment group. Garcinia cambogia failed to produce significant weight loss and fat mass loss beyond that observed with placebo.

  2. Adolescent exergame play for weight loss and psychosocial improvement: a controlled physical activity intervention.

    Science.gov (United States)

    Staiano, Amanda E; Abraham, Anisha A; Calvert, Sandra L

    2013-03-01

    Overweight and obese youth, who face increased risk of medical complications including heart disease and type II diabetes, can benefit from sustainable physical activity interventions that result in weight loss. This study examined whether a 20-week exergame (i.e., videogame that requires gross motor activity) intervention can produce weight loss and improve psychosocial outcomes for 54 overweight and obese African-American adolescents. Participants were recruited from a public high school and randomly assigned to competitive exergame, cooperative exergame, or control conditions. All exergame participants were encouraged to play the Nintendo Wii Active game for 30-60 min per school day in a lunch-time or after-school program. Cooperative exergame participants worked with a peer to expend calories and earn points together, whereas competitive exergame participants competed against a peer. Control participants continued regular daily activities. Outcome measures included changes in weight, peer support, self-efficacy, and self-esteem, measured at baseline, and at ∼10 and 20 weeks. Growth curve analysis revealed that cooperative exergame players lost significantly more weight (mean = 1.65 kg; s.d. = 4.52) than the control group, which did not lose weight. The competitive exergame players did not differ significantly from the other conditions. Cooperative exergame players also significantly increased in self-efficacy compared to the control group, and both exergame conditions significantly increased in peer support more than the control group. Exergames, especially played cooperatively, can be an effective technological tool for weight loss among youth. Copyright © 2012 The Obesity Society.

  3. Prevention of bone loss by vitamin D supplementation in elderly women : A randomized double-blind trial

    NARCIS (Netherlands)

    Ooms, Marcel E.; Roos, Jan C.; Bezemer, P. Dick; van der Vijgh, Wim J F; Bouter, Lex M.; Lips, Paul

    1995-01-01

    The purpose of the study was to determine the effect of vitamin D supplementation on bone turnover and bone loss in elderly women. Three hundred forty-eight women, ages 70 yr and older, were randomized to receive 400 IU vitamin D3 per day (n = 177) or placebo (n = 171), double-blind, for a period of

  4. Long-term effects of a weight loss intervention with or without exercise component in postmenopausal women : A randomized trial

    NARCIS (Netherlands)

    de Roon, Martijn; van Gemert, Willemijn A; Peeters, Petra H; Schuit, A.J.; Monninkhof, Evelyn M

    2017-01-01

    The aim of this study was to determine the long-term effects of a weight loss intervention with or without an exercise component on body weight and physical activity. Women were randomized to diet (n = 97) or exercise (N = 98) for 16 weeks. During the intervention, both groups had achieved the set

  5. Design and protocol of the weight loss lottery- a cluster randomized trial.

    Science.gov (United States)

    van der Swaluw, Koen; Lambooij, Mattijs S; Mathijssen, Jolanda J P; Schipper, Maarten; Zeelenberg, Marcel; Polder, Johan J; Prast, Henriëtte M

    2016-07-01

    People often intend to exercise but find it difficult to attend their gyms on a regular basis. At times, people seek and accept deadlines with consequences to realize their own goals (i.e. commitment devices). The aim of our cluster randomized controlled trial is to test whether a lottery-based commitment device can promote regular gym attendance. The winners of the lottery always get feedback on the outcome but can only claim their prize if they attended their gyms on a regular basis. In this paper we present the design and baseline characteristics of a three-arm trial which is performed with 163 overweight participants in six in-company fitness centers in the Netherlands. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Examination of Icing Induced Loss of Control and Its Mitigations

    Science.gov (United States)

    Reehorst, Andrew L.; Addy, Harold E., Jr.; Colantonio, Renato O.

    2010-01-01

    Factors external to the aircraft are often a significant causal factor in loss of control (LOC) accidents. In today s aviation world, very few accidents stem from a single cause and typically have a number of causal factors that culminate in a LOC accident. Very often the "trigger" that initiates an accident sequence is an external environment factor. In a recent NASA statistical analysis of LOC accidents, aircraft icing was shown to be the most common external environmental LOC causal factor for scheduled operations. When investigating LOC accident or incidents aircraft icing causal factors can be categorized into groups of 1) in-flight encounter with super-cooled liquid water clouds, 2) take-off with ice contamination, or 3) in-flight encounter with high concentrations of ice crystals. As with other flight hazards, icing induced LOC accidents can be prevented through avoidance, detection, and recovery mitigations. For icing hazards, avoidance can take the form of avoiding flight into icing conditions or avoiding the hazard of icing by making the aircraft tolerant to icing conditions. Icing detection mitigations can take the form of detecting icing conditions or detecting early performance degradation caused by icing. Recovery from icing induced LOC requires flight crew or automated systems capable of accounting for reduced aircraft performance and degraded control authority during the recovery maneuvers. In this report we review the icing induced LOC accident mitigations defined in a recent LOC study and for each mitigation describe a research topic required to enable or strengthen the mitigation. Many of these research topics are already included in ongoing or planned NASA icing research activities or are being addressed by members of the icing research community. These research activities are described and the status of the ongoing or planned research to address the technology needs is discussed

  7. 40 CFR 1060.104 - What running loss emission control requirements apply?

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 32 2010-07-01 2010-07-01 false What running loss emission control... STATIONARY EQUIPMENT Emission Standards and Related Requirements § 1060.104 What running loss emission control requirements apply? (a) Engines and equipment must meet running loss requirements as follows: (1...

  8. Decentralized Model Predictive Control for Cooperative Multiple Vehicles Subject to Communication Loss

    Directory of Open Access Journals (Sweden)

    Hojjat A. Izadi

    2011-01-01

    Full Text Available The decentralized model predictive control (DMPC of multiple cooperative vehicles with the possibility of communication loss/delay is investigated. The neighboring vehicles exchange their predicted trajectories at every sample time to maintain the cooperation objectives. In the event of a communication loss (packet dropout, the most recent available information, which is potentially delayed, is used. Then the communication loss problem changes to a cooperative problem when random large communication delays are present. Such large communication delays can lead to poor cooperation performance and unsafe behaviors such as collisions. A new DMPC approach is developed to improve the cooperation performance and achieve safety in the presence of the large communication delays. The proposed DMPC architecture estimates the tail of neighbor's trajectory which is not available due to the large communication delays for improving the performance. The concept of the tube MPC is also employed to provide the safety of the fleet against collisions, in the presence of large intervehicle communication delays. In this approach, a tube shaped trajectory set is assumed around the trajectory of the neighboring vehicles whose trajectory is delayed/lost. The radius of tube is a function of the communication delay and vehicle's maneuverability (in the absence of model uncertainty. The simulation of formation problem of multiple vehicles is employed to illustrate the effectiveness of the proposed approach.

  9. A randomized controlled trial of an electronic informed consent process.

    Science.gov (United States)

    Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

    2014-12-01

    A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

  10. Randomized, Controlled Study of Adderall XR in ADHD

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2002-08-01

    Full Text Available The efficacy and safety of Adderall XR in the treatment of attention deficit/hyperactivity disorder and diurnal variation in responses were assessed by a multicenter, randomized, double-blind, parallel group, placebo-controlled trial at 47 sites, and reported from the Massachusetts General Hospital, Boston, MA.

  11. Yoga for High‑Risk Pregnancy: A Randomized Controlled Trial ...

    African Journals Online (AJOL)

    The study was a single‑blind randomized controlled clinical trial. Perceived stress scale (PSS) was measured during the 12th, 20th, and 28th weeks of pregnancy. SPSS version 16.0 (Chicago, IL, USA) was used for all data analysis. When the data were found to be normally distributed,the RMANOVA were used to assess ...

  12. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  13. Asthma Self-Management Model: Randomized Controlled Trial

    Science.gov (United States)

    Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

    2016-01-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

  14. Beam loss control in the LINAC4 design

    CERN Document Server

    Stovall, J; Crandall, K

    2010-01-01

    The Linac4 DTL reference design has been modified to reduce the power consumption in tank 1 by modifying the accelerating field and phase law. In addition we have adopted an FFDD focusing lattice throughout to minimize expected losses resulting from alignment errors. We have observed, however, that this design suffers from decreasing transverse acceptance and a sensitivity to misalignments that causes any expected beam loss to occcur at the high energy end of the DTL. In this note we investigate two solutions to increase the acceptance, decrease its sensitivity to misalignments and eliminate the potential for a beam-loss “bottleneck” at 50 MeV.

  15. Randomized comparison of a multidisciplinary job-retention vocational rehabilitation program with usual outpatient care in patients with chronic arthritis at risk for job loss.

    Science.gov (United States)

    de Buck, Petronella D M; le Cessie, Saskia; van den Hout, Wilbert B; Peeters, Andreas J; Ronday, Herman K; Westedt, Marie-Louise; Breedveld, Ferdinand C; Vliet Vlieland, Theodora P M

    2005-10-15

    Work disability is a major consequence of inflammatory rheumatic conditions. Evidence regarding the effectiveness of interventions aimed at the prevention or reduction of work disability in rheumatic diseases is limited. We conducted a randomized controlled trial to investigate the effectiveness of a multidisciplinary job-retention vocational rehabilitation (VR) program in patients with a rheumatic condition who were at risk for job loss. A total of 140 patients with a chronic rheumatic condition were randomly assigned to either a multidisciplinary job-retention VR program (n = 74) or usual outpatient care (UC) (n = 66). Patients in the VR group were assessed and guided by a multidisciplinary team, whereas patients in the UC group received care as initiated by their rheumatologist, supplemented with written information. The main outcome measure was the occurrence of job loss (complete work disability or unemployment); additional outcome measures included job satisfaction, pain, functional status, emotional status, and quality of life. There was no difference between the 2 groups regarding the proportion of patients having lost their job at any time point, with 24% and 23% of the patients in the VR and UC groups, respectively, having lost their job after 24 months. Over the total period of 24 months, patients in the VR group had a significantly greater improvement of the fatigue visual analog scale and of emotional status (all P values job-retention VR program did not reduce the risk of job loss but improved fatigue and mental health in patients with chronic rheumatic diseases at risk for job loss.

  16. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    Science.gov (United States)

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  17. Filtering, control and fault detection with randomly occurring incomplete information

    CERN Document Server

    Dong, Hongli; Gao, Huijun

    2013-01-01

    This book investigates the filtering, control and fault detection problems for several classes of nonlinear systems with randomly occurring incomplete information. It proposes new concepts, including RVNs, ROMDs, ROMTCDs, and ROQEs. The incomplete information under consideration primarily includes missing measurements, time-delays, sensor and actuator saturations, quantization effects and time-varying nonlinearities. The first part of this book focuses on the filtering, control and fault detection problems for several classes of nonlinear stochastic discrete-time systems and

  18. [Randomized double-blind comparative study of minaprine (200mg/j) and of placebo on memory loss].

    Science.gov (United States)

    Allain, H; Belliard, S; Lieury, A; Menard, G; Patat, A; Le Coz, F; Gandon, J M

    1996-01-01

    Thirty five subjects (age: 45-69 years) with subjective memory loss, without any other neuropsychiatric or somatic disease, were recruited in a phase II study. This double blind randomized versus placebo controlled study compared the effects of minaprine (200 mg/d) with placebo, in two parallel groups, during 2 months, on memory, attention and vigilance. Three psychometric tests were the main criteria of assessment: a standardized battery of memory tests (SM 5), the dual-coding test, the analysis of choice reaction times (CRT) and the critical flicker fusion point (CFF). A positive effect of minaprine was detected on words delayed recall (p = 0.028) and immediate recognition of words (p = 0.049). The global clinical tests (CGI, MacNair scale) were not statistically modified. Tolerability of minaprine and placebo were comparable. A positive pharmacodynamic activity on mnemonic performance is thus demonstrated in favour of minaprine (200 mg/d) in this specific population characterized by a memory complaint. These results would lead to a phase III study in which the main criteria would be global scales in order to confirm the clinical reliability of the present results.

  19. Effect of cryotherapy after elbow arthrolysis: a prospective, single-blinded, randomized controlled study.

    Science.gov (United States)

    Yu, Shi-yang; Chen, Shuai; Yan, He-de; Fan, Cun-yi

    2015-01-01

    To investigate the effect of cryotherapy after elbow arthrolysis on elbow pain, blood loss, analgesic consumption, range of motion, and long-term elbow function. Prospective, single-blinded, randomized controlled study. University hospital. Patients (N=59; 27 women, 32 men) who received elbow arthrolysis. Patients were randomly assigned into a cryotherapy group (n=31, cryotherapy plus standard care) or a control group (n=28, standard care). Elbow pain at rest and in motion were measured using a visual analog scale (VAS) on postoperative day (POD) 1 to POD 7 and at 2 weeks and 3 months after surgery. Blood loss and analgesic consumption were recorded postoperatively. Elbow range of motion (ROM) was measured before surgery and on POD 1, POD 7, and 3 months after surgery. The Mayo Elbow Performance Score (MEPS) was evaluated preoperatively and 3 months postoperatively. VAS scores were significantly lower in the cryotherapy group during the first 7 PODs, both at rest and in motion (Pcryotherapy group than the control group for pain relief (P.05). Cryotherapy is effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis. The application of cryotherapy will not affect blood loss, ROM, or elbow function. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  20. The effect of a motivational intervention on weight loss is moderated by level of baseline controlled motivation

    Directory of Open Access Journals (Sweden)

    Tate Deborah F

    2010-01-01

    Full Text Available Abstract Background Clinic-based behavioral weight loss programs are effective in producing significant weight loss. A one-size-fits-all approach is often taken with these programs. It may be beneficial to tailor programs based on participants' baseline characteristics. Type and level of motivation may be an important factor to consider. Previous research has found that, in general, higher levels of controlled motivation are detrimental to behavior change while higher levels of autonomous motivation improve the likelihood of behavior modification. Methods This study assessed the outcomes of two internet behavioral weight loss interventions and assessed the effect of baseline motivation levels on program success. Eighty females (M (SD age 48.7 (10.6 years; BMI 32.0 (3.7 kg/m2; 91% Caucasian were randomized to one of two groups, a standard group or a motivation-enhanced group. Both received a 16-week internet behavioral weight loss program and attended an initial and a four-week group session. Weight and motivation were measured at baseline, four and 16 weeks. Hierarchical regression analysis was conducted to test for moderation. Results There was significant weight loss at 16-weeks in both groups (p p = 0.57 (standard group 3.4 (3.6 kg; motivation-enhanced group 3.9 (3.4 kg. Further analysis was conducted to examine predictors of weight loss. Baseline controlled motivation level was negatively correlated with weight loss in the entire sample (r = -0.30; p = 0.01. Statistical analysis revealed an interaction between study group assignment and baseline level of controlled motivation. Weight loss was not predicted by baseline level of controlled motivation in the motivation-enhanced group, but was significantly predicted by controlled motivation in the standard group. Baseline autonomous motivation did not predict weight change in either group. Conclusions This research found that, in participants with high levels of baseline controlled motivation

  1. Adding evidence-based behavioral weight loss strategies to a statewide wellness campaign: a randomized clinical trial.

    Science.gov (United States)

    Leahey, Tricia M; Thomas, Graham; Fava, Joseph L; Subak, Leslee L; Schembri, Michael; Krupel, Katie; Kumar, Rajiv; Weinberg, Brad; Wing, Rena R

    2014-07-01

    We determined the efficacy and cost-effectiveness of adding an evidence-based Internet behavioral weight loss intervention alone or combined with optional group sessions to ShapeUp Rhode Island 2011 (SURI), a 3-month statewide wellness campaign. We randomized participants (n = 230; body mass index = 34.3 ±6.8 kg/m(2); 84% female) to the standard SURI program (S) or to 1 of 2 enhanced programs: SURI plus Internet behavioral program (SI) or SI plus optional group sessions (SIG). The primary outcome was weight loss at the end of the 3-month program. Weight losses differed among all 3 conditions (S: 1.1% ±0.9%; SI: 4.2% ±0.6%; SIG: 6.1% ±0.6%; Ps ≤ .04). Both SI and SIG increased the percentage of individuals who achieved a 5% weight loss (SI: 42%; SIG: 54%; S: 7%; Ps < .001). Cost per kilogram of weight loss was similar for S ($39) and SI ($35); both were lower than SIG ($114). Although weight losses were greatest at the end of SURI with optional group sessions, the addition of an Internet behavioral program was the most cost-effective method to enhance weight losses.

  2. Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study.

    Science.gov (United States)

    Steinberg, Dori M; Levine, Erica L; Askew, Sandy; Foley, Perry; Bennett, Gary G

    2013-11-18

    Daily self-monitoring of diet and physical activity behaviors is a strong predictor of weight loss success. Text messaging holds promise as a viable self-monitoring modality, particularly among racial/ethnic minority populations. This pilot study evaluated the feasibility of a text messaging intervention for weight loss among predominantly black women. Fifty obese women were randomized to either a 6-month intervention using a fully automated system that included daily text messages for self-monitoring tailored behavioral goals (eg, 10,000 steps per day, no sugary drinks) along with brief feedback and tips (n=26) or to an education control arm (n=24). Weight was objectively measured at baseline and at 6 months. Adherence was defined as the proportion of text messages received in response to self-monitoring prompts. The average daily text messaging adherence rate was 49% (SD 27.9) with 85% (22/26) texting self-monitored behavioral goals 2 or more days per week. Approximately 70% (16/23) strongly agreed that daily texting was easy and helpful and 76% (16/21) felt the frequency of texting was appropriate. At 6 months, the intervention arm lost a mean of 1.27 kg (SD 6.51), and the control arm gained a mean of 1.14 kg (SD 2.53; mean difference -2.41 kg, 95% CI -5.22 to 0.39; P=.09). There was a trend toward greater text messaging adherence being associated with greater percent weight loss (r=-.36; P=.08), but this did not reach statistical significance. There was no significant association between goal attainment and text messaging adherence and no significant predictors of adherence. Given the increasing penetration of mobile devices, text messaging may be a useful self-monitoring tool for weight control, particularly among populations most in need of intervention. Clinicaltrials.gov: NCT00939081; http://clinicaltrials.gov/show/NCT00939081 (Archived by WebCite at http://www.webcitation.org/6KiIIcnk1).

  3. Preoperative clonidine use in trans-sphenoidal pituitary adenoma surgeries - a randomized controlled trial.

    Science.gov (United States)

    Bajaj, Jitin; Mittal, Radhe Shyam; Sharma, Achal

    2017-02-01

    Pituitary masses are common lesions accounting for about 15-20% of all brain tumours. Oozing blood is an annoyance in microscopic sublabial trans-sphenoidal approach for these masses. There have been many ways of reducing the ooze, having their own pros and cons. To find out the efficacy and safety of clonidine in reducing blood loss in pituitary adenoma surgery through a randomized masked trial. It was a prospective randomized controlled trial done. Total 50 patients of pituitary adenomas were randomized into two groups. Group A (25 patients) was given 200 μg clonidine orally, while Group B (25 patients) was given placebo. Surgeon, anaesthesiologist and patient were blinded for the trial. Sublabial trans-septal trans-sphenoidal approach to sella and excision of mass was performed in each patient. Patients were studied for pre-, intra- and post-operative blood pressure and heart rate, pre- and post-operative imaging findings, intra-operative blood loss, bleeding grading by surgeon, surgeon's satisfaction about condition of specific part and quality of surgical field, operative time and extent of resection. Blood loss during the surgery, operative time and bleeding grading by the surgeon were found significantly less in the clonidine group, while quality of surgical field, condition of the specific part and extent of resection were found significantly better in the clonidine group (p value trans-sphenoidal microscopic pituitary adenoma surgeries.

  4. Set-shifting abilities, mood and loss of control over eating in binge eating disorder: An experimental study.

    Science.gov (United States)

    Dingemans, Alexandra E; Visser, Hiske; Paul, Linda; van Furth, Eric F

    2015-12-15

    Executive functions play an important role in problem-solving and self-control. Set-shifting is an aspect of executive functioning and represents cognitive flexibility. The inability to control eating in Binge Eating Disorder (BED) may imply deficits in set-shifting which could be exacerbated by negative mood and depressive symptoms. The aim of the study was to test whether there is a causal relationship between set-shifting ability, changes in mood and loss of control over eating in BED. Seventy-five participants diagnosed with BED were randomly assigned to a negative or neutral mood induction. Set-shifting abilities, depressive symptoms, current mood and loss of control over eating were assessed. Having depressive symptoms and poorer set-shifting abilities resulted in a more negative mood after a negative mood induction, whereas this was not observed in the neutral mood induction. Post-hoc analyses revealed that individuals with poorer set-shifting abilities and more changes in negative mood, experienced more feelings of loss of control over eating than individuals whose set-shifting abilities were better and whose mood did not change. The results suggest that both depressive symptoms and deficits in set-shifting abilities may decrease an individual's ability to handle negative affect and increase loss of control over eating in individuals with BED. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  5. Missing data in randomized clinical trials for weight loss: scope of the problem, state of the field, and performance of statistical methods.

    Directory of Open Access Journals (Sweden)

    Mai A Elobeid

    2009-08-01

    Full Text Available Dropouts and missing data are nearly-ubiquitous in obesity randomized controlled trails, threatening validity and generalizability of conclusions. Herein, we meta-analytically evaluate the extent of missing data, the frequency with which various analytic methods are employed to accommodate dropouts, and the performance of multiple statistical methods.We searched PubMed and Cochrane databases (2000-2006 for articles published in English and manually searched bibliographic references. Articles of pharmaceutical randomized controlled trials with weight loss or weight gain prevention as major endpoints were included. Two authors independently reviewed each publication for inclusion. 121 articles met the inclusion criteria. Two authors independently extracted treatment, sample size, drop-out rates, study duration, and statistical method used to handle missing data from all articles and resolved disagreements by consensus. In the meta-analysis, drop-out rates were substantial with the survival (non-dropout rates being approximated by an exponential decay curve (e(-lambdat where lambda was estimated to be .0088 (95% bootstrap confidence interval: .0076 to .0100 and t represents time in weeks. The estimated drop-out rate at 1 year was 37%. Most studies used last observation carried forward as the primary analytic method to handle missing data. We also obtained 12 raw obesity randomized controlled trial datasets for empirical analyses. Analyses of raw randomized controlled trial data suggested that both mixed models and multiple imputation performed well, but that multiple imputation may be more robust when missing data are extensive.Our analysis offers an equation for predictions of dropout rates useful for future study planning. Our raw data analyses suggests that multiple imputation is better than other methods for handling missing data in obesity randomized controlled trials, followed closely by mixed models. We suggest these methods supplant last

  6. Influence of Weight Loss, Body Composition, and Lifestyle Behaviors on Plasma Adipokines: A Randomized Weight Loss Trial in Older Men and Women with Symptomatic Knee Osteoarthritis

    Directory of Open Access Journals (Sweden)

    Gary D. Miller

    2012-01-01

    Full Text Available Objective. To investigate effects of weight loss on adipokines and health measures in obese older adults with symptomatic knee osteoarthritis. Methods. Participants were randomly assigned to either weight loss (WL (men: 12, women: 14 or weight stable (WS group (men: 12, women: 13. WL intervention included meal replacements and structured exercise training. Measurements of leptin, adiponectin, soluble leptin receptor, lifestyle behaviors, and body composition were collected at baseline and 6 months. Univariate analysis of covariance was performed on 6 month variables, and Spearman and partial correlations were made between variables. Results. Weight loss was 13.0% and 6.7% in WL for men and women, respectively. Women in WL had lower whole body and trunk fat than WS. The leptin : adiponectin ratio was lower for women in WL than WS at 6 months, with no group differences in adipokines for men. Leptin and free leptin index correlated with body fat in both genders at baseline. Interestingly, only women showed reductions in leptin (P<0.100 and correlations between the percentage change leptin and trunk fat and the percentage changes in free leptin index with total fat and trunk fat. Partial correlations between 6 month adipokines after adjustments for covariates and group/time period show potential multivariate influences. Conclusions. In the presence of an effective weight loss intervention in older obese adults, there are significant relationships between weight and fat loss and leptin in women, but not men, suggesting gender-specific features of adipokine metabolism in this age group.

  7. Future Integrated Systems Concept for Preventing Aircraft Loss-of-Control Accidents

    Science.gov (United States)

    Belcastro, Christine M.; Jacobson, Steven r.

    2010-01-01

    Loss of control remains one of the largest contributors to aircraft fatal accidents worldwide. Aircraft loss-of-control accidents are highly complex in that they can result from numerous causal and contributing factors acting alone or (more often) in combination. Hence, there is no single intervention strategy to prevent these accidents. This paper presents future system concepts and research directions for preventing aircraft loss-of-control accidents.

  8. Unexpected perturbations training improves balance control and voluntary stepping times in older adults - a double blind randomized control trial.

    Science.gov (United States)

    Kurz, Ilan; Gimmon, Yoav; Shapiro, Amir; Debi, Ronen; Snir, Yoram; Melzer, Itshak

    2016-03-04

    Falls are common among elderly, most of them occur while slipping or tripping during walking. We aimed to explore whether a training program that incorporates unexpected loss of balance during walking able to improve risk factors for falls. In a double-blind randomized controlled trial 53 community dwelling older adults (age 80.1±5.6 years), were recruited and randomly allocated to an intervention group (n = 27) or a control group (n = 26). The intervention group received 24 training sessions over 3 months that included unexpected perturbation of balance exercises during treadmill walking. The control group performed treadmill walking with no perturbations. The primary outcome measures were the voluntary step execution times, traditional postural sway parameters and Stabilogram-Diffusion Analysis. The secondary outcome measures were the fall efficacy Scale (FES), self-reported late life function (LLFDI), and Performance-Oriented Mobility Assessment (POMA). Compared to control, participation in intervention program that includes unexpected loss of balance during walking led to faster Voluntary Step Execution Times under single (p = 0.002; effect size [ES] =0.75) and dual task (p = 0.003; [ES] = 0.89) conditions; intervention group subjects showed improvement in Short-term Effective diffusion coefficients in the mediolateral direction of the Stabilogram-Diffusion Analysis under eyes closed conditions (p = 0.012, [ES] = 0.92). Compared to control there were no significant changes in FES, LLFDI, and POMA. An intervention program that includes unexpected loss of balance during walking can improve voluntary stepping times and balance control, both previously reported as risk factors for falls. This however, did not transferred to a change self-reported function and FES. ClinicalTrials.gov NCT01439451 .

  9. Rotor Field Oriented Control with adaptive Iron Loss Compensation

    DEFF Research Database (Denmark)

    Rasmussen, Henrik; Vadstrup, P.; Børsting, H.

    1999-01-01

    of the motor referenced to the rotor magnetizing current, and with the extension of an iron loss resistor added in parallel to the magnetizing inductance. The resistor estimator is based on the observation that the actual applied stator voltages deviates from the voltage estimated, when a motor is current......It is well known from the literature that iron loses in an induction motor implies field angle estimation errors and hence detuning problems. In this paper a new method for estimating the iron loss resistor in an induction motor is presented. The method is based on a traditional dynamic model...

  10. On a multi-channel transportation loss system with controlled input and controlled service

    Directory of Open Access Journals (Sweden)

    Jewgeni Dshalalow

    1987-01-01

    Full Text Available A multi-channel loss queueing system is investigated. The input stream is a controlled point process. The service in each of m parallel channels depends on the state of the system at certain moments of time when input and service may be controlled. To obtain explicitly the limiting distribution of the main process (Zt (the number of busy channels in equilibrium, an auxiliary three dimensional process with two additional components (one of them is a semi-Markov process is treated as semi-regenerative process. An optimization problem is discussed. Simple expressions for an objective function are derived.

  11. Randomized Controlled Trial of Preconception Interventions in Infertile Women With Polycystic Ovary Syndrome.

    Science.gov (United States)

    Legro, Richard S; Dodson, William C; Kris-Etherton, Penny M; Kunselman, Allen R; Stetter, Christy M; Williams, Nancy I; Gnatuk, Carol L; Estes, Stephanie J; Fleming, Jennifer; Allison, Kelly C; Sarwer, David B; Coutifaris, Christos; Dokras, Anuja

    2015-11-01

    Lifestyle modification is recommended in women with polycystic ovary syndrome (PCOS) prior to conception but there are few randomized trials to support its implementation or benefit. This study aimed to determine the relative efficacy of preconception intervention on reproductive and metabolic abnormalities in overweight/obese women with PCOS. This was a randomized controlled trial of preconception and infertility treatment at Academic Health Centers in women with infertility due to PCOS, age 18-40 y and body mass index 27-42 kg/m(2). Women were randomly assigned to receive either 16 weeks of 1) continuous oral contraceptive pills (OCPs) (ethinyl estradiol 20 mcg/1 mg norethindrone acetate) ("OCP"); 2) lifestyle modification consisting of caloric restriction with meal replacements, weight loss medication (either sibutramine, or orlistat), and increased physical activity to promote a 7% weight loss ("Lifestyle"); or 3) combined treatment with both OCP and lifestyle modification ("Combined"). After preconception intervention, women underwent standardized ovulation induction with clomiphene citrate and timed intercourse for four cycles. Pregnancies were followed with trimester visits until delivery. Weight, ovulation, and live birth were measured. We consented 216 and randomly assigned 149 women (Lifestyle: n = 50; OCP: n = 49; Combined: n = 50). We achieved significant weight loss with both Lifestyle (mean weight loss, -6.2%; 95% confidence interval (CI), -7.4--5.0; and Combined (mean weight loss, -6.4%; 95% CI, -7.6--5.2) compared with baseline and OCP (both P syndrome at the end of preconception treatment compared with baseline within OCP (odds ratio [OR, 2.47; 95% CI, 1.42-4.27) whereas no change in metabolic syndrome was detected in the Lifestyle (OR, 1.18; 95% CI, 0.63-2.19) or Combined (OR, 0.72; 95% CI, 0.44-1.17) groups. Cumulative ovulation rates were superior after weight loss: OCP, 46%; Lifestyle, 60%; and Combined, 67% (P weight loss intervention

  12. Determination of the Reliability of Product Quality Loss and Control ...

    African Journals Online (AJOL)

    Product quality loss was determined to be 22. However, the X-chart was found to be the most suitable and effective. The values indicate that by using the X-chart model, about 96.4% of the suspected defective products would actually survive standard tests. This model has successfully eliminated the number of the proposed ...

  13. Loss Minimization and Voltage Control in Smart Distribution Grid

    DEFF Research Database (Denmark)

    Juelsgaard, Morten; Sloth, Christoffer; Wisniewski, Rafal

    2014-01-01

    This work presents a strategy for increasing the installation of electric vehicles and solar panels in low-voltage grids, while obeying voltage variation constraints. Our approach employs minimization of active power losses for coordinating consumption and generation of power, as well as reactive...

  14. Calibrated delivery drape versus indirect gravimetric technique for the measurement of blood loss after delivery: a randomized trial.

    Science.gov (United States)

    Ambardekar, Shubha; Shochet, Tara; Bracken, Hillary; Coyaji, Kurus; Winikoff, Beverly

    2014-08-15

    Trials of interventions for PPH prevention and treatment rely on different measurement methods for the quantification of blood loss and identification of PPH. This study's objective was to compare measures of blood loss obtained from two different measurement protocols frequently used in studies. Nine hundred women presenting for vaginal delivery were randomized to a direct method (a calibrated delivery drape) or an indirect method (a shallow bedpan placed below the buttocks and weighing the collected blood and blood-soaked gauze/pads). Blood loss was measured from immediately after delivery for at least one hour or until active bleeding stopped. Significantly greater mean blood loss was recorded by the direct than by the indirect measurement technique (253.9 mL and 195.3 mL, respectively; difference = 58.6 mL (95% CI: 31-86); p 500 mL (8.7% vs. 4.7%, p = 0.02). The study suggests a real and significant difference in blood loss measurement between these methods. Research using blood loss measurement as an endpoint needs to be interpreted taking measurement technique into consideration. This study has been registered at clinicaltrials.gov as NCT01885845.

  15. Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial.

    Science.gov (United States)

    Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D

    2017-09-15

    Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m 2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. ClinicalTrials.gov NCT01826591. Registered 27 March 2013.

  16. Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma.

    Science.gov (United States)

    Sano, Takeshi; Sasako, Mitsuru; Mizusawa, Junki; Yamamoto, Seiichiro; Katai, Hitoshi; Yoshikawa, Takaki; Nashimoto, Atsushi; Ito, Seiji; Kaji, Masahide; Imamura, Hiroshi; Fukushima, Norimasa; Fujitani, Kazumasa

    2017-02-01

    To clarify the role of splenectomy in total gastrectomy for proximal gastric cancer. Splenectomy in total gastrectomy is associated with increased operative morbidity and mortality, but its survival benefit is unclear. Previous randomized controlled trials were underpowered and inconclusive. We conducted a multiinstitutional randomized controlled trial. Proximal gastric adenocarcinoma of T2-4/N0-2/M0 not invading the greater curvature was eligible. During the operation, surgeons confirmed that R0 resection was possible with negative lavage cytology, and patients were randomly assigned to either splenectomy or spleen preservation. The primary endpoint was overall survival (OS) and the secondary endpoints were relapse-free survival, operative morbidity, operation time, and blood loss. The trial was designed to confirm noninferiority of spleen preservation to splenectomy in OS with a noninferiority margin of the hazard ratio as 1.21 and 1-sided alpha of 5%. Between June 2002 and March 2009, 505 patients (254 splenectomy, 251 spleen preservation) were enrolled from 36 institutions. Splenectomy was associated with higher morbidity and larger blood loss, but the operation time was similar. The 5-year survivals were 75.1% and 76.4% in the splenectomy and spleen preservation groups, respectively. The hazard ratio was 0.88 (90.7%, confidence interval 0.67-1.16) (splenectomy should be avoided as it increases operative morbidity without improving survival.

  17. Weight control behaviors of highly successful weight loss maintainers: the Portuguese Weight Control Registry.

    Science.gov (United States)

    Santos, Inês; Vieira, Paulo N; Silva, Marlene N; Sardinha, Luís B; Teixeira, Pedro J

    2017-04-01

    To describe key behaviors reported by participants in the Portuguese Weight Control Registry and to determine associations between these behaviors and weight loss maintenance. A total of 388 adults participated in this cross-sectional study. Assessments included demographic information, weight history, weight loss and weight maintenance strategies, dietary intake, and physical activity. Participants lost on average 18 kg, which they had maintained for ~28 months. Their average dietary intake was 2199 kcal/day, with 33 % of energy coming from fat. About 78 % of participants engaged in levels of moderate-plus-vigorous physical activity exceeding 150 min/week (51 % above 250 min/week), with men accumulating 82 more minutes than women (p breakfast. Greater weight loss maintenance was associated with higher levels of physical activity, walking, weight self-monitoring, establishing specific goals, and with reduced portion size use, reduced consumption of carbohydrates, and increased consumption of protein, (p < 0.05). Results indicate that weight loss maintenance is possible through the adoption of a nutritionally-balanced diet and regular participation in physical activity, but also suggest that adopting different (and, to a degree, individualized) set of behavioral strategies is key for achieving success.

  18. Portion controlled ready-to-eat meal replacement is associated with short term weight loss: a randomised controlled trial.

    Science.gov (United States)

    Kuriyan, Rebecca; Lokesh, Deepa P; D'Souza, Ninoshka; Priscilla, Divya J; Peris, Chandni Halcyon; Selvam, Sumithra; Kurpad, Anura V

    2017-01-01

    Strategies to prevent and treat overweight/obesity are urgently needed. This study assessed the effect of a short-term intake of ready-to-eat cereal on body weight and waist circumference of overweight/obese individuals in comparison to a control group. A randomized, controlled 2-arm trial was carried out on 101 overweight/obese (Body Mass Index - 29.2±2.4 kg/m2) females aged 18 to 44 years, at St. John's Medical College Hospital. The intervention group received a low fat, ready to eat cereal, replacing two meals/day for two weeks. The control group was provided with standard dietary guidelines for weight loss and energy requirements for both groups were calculated similarly. Anthropometric, dietary, appetite and health status assessments were carried out at baseline and at the end of two weeks. At the end of two weeks, the mean reductions in body weight and waist circumference were significantly greater in the intervention group, -0.53 kg; 95% CI (-0.86 to -0.19) for body weight and -1.39 cm; 95% CI (-1.78, -0.99) for waist circumference. The intervention group had a significantly higher increase in dietary intakes of certain vitamins, fiber and sugar, and significantly higher reductions in total and polyunsaturated fats and sodium intakes, as compared to the control group (peat cereal could be effective for short-term weight loss, with some improvements in the nutrient intake profile. However, studies of longer duration are needed.

  19. Building research in diet and cognition: The BRIDGE randomized controlled trial.

    Science.gov (United States)

    Tussing-Humphreys, Lisa; Lamar, Melissa; Blumenthal, James A; Babyak, Michael; Fantuzzi, Giamila; Blumstein, Lara; Schiffer, Linda; Fitzgibbon, Marian L

    2017-08-01

    Obesity has been linked to cognitive impairment, cognitive decline and dementia. Given that 38.5% of U.S. adults 60years and older are obese and these numbers are rapidly increasing, strategies to decouple obesity from cognitive decline are needed. Innovative lifestyle strategies that may postpone the onset of subclinical symptoms or even arrest the transition to overt dementia in at-risk individuals are critically needed. Poor diet is central to the development of obesity and diet may affect cognition. Adherence to a Mediterranean Diet (MedDiet) is associated with reduced risk of cognitive impairment and dementia. Furthermore, weight loss through caloric restriction improves cognitive function. This paper describes the Building Research in Diet and CoGnition (BRIDGE) study, a randomized trial examining the effect of the MedDiet, with and without weight loss, on cognitive functioning in obese older adults. Obese (BMI≥30 and ≤50kg/m 2 ) older adults (≥55years) (n=180) will be randomized in a 2:2:1 allocation scheme to: Typical Diet Control; MedDiet alone, without weight loss; or MedDiet lifestyle intervention to promote weight loss and weight loss maintenance. Both MedDiet intervention groups will meet for one individual session and 27 group sessions over an 8-month period. Individuals in the control group will not receive instruction on changing lifestyle habits. Outcomes will be assessed at baseline, 8 and 14months. The primary outcome is cognitive functioning; secondary outcomes will include changes in body weight, diet, cardiovascular, metabolic, and inflammatory biomarkers. Copyright © 2017. Published by Elsevier Inc.

  20. Randomized, Controlled Trial of CBT Training for PTSD Providers

    Science.gov (United States)

    2016-10-29

    clinician applicants occurred. b. SP baseline interviews with eligible clinicians occurred. c. Automated random assignment of participants with Completed SP...intervention without web-centered supervision and a wait-list control with regard to improvements in two CBT-based skill areas (behavioral task...Secondary Aim #1: To compare improvements in knowledge and attitudes following internet- based training with or without web-centered supervision and

  1. Random Forest Application for NEXRAD Radar Data Quality Control

    Science.gov (United States)

    Keem, M.; Seo, B. C.; Krajewski, W. F.

    2017-12-01

    Identification and elimination of non-meteorological radar echoes (e.g., returns from ground, wind turbines, and biological targets) are the basic data quality control steps before radar data use in quantitative applications (e.g., precipitation estimation). Although WSR-88Ds' recent upgrade to dual-polarization has enhanced this quality control and echo classification, there are still challenges to detect some non-meteorological echoes that show precipitation-like characteristics (e.g., wind turbine or anomalous propagation clutter embedded in rain). With this in mind, a new quality control method using Random Forest is proposed in this study. This classification algorithm is known to produce reliable results with less uncertainty. The method introduces randomness into sampling and feature selections and integrates consequent multiple decision trees. The multidimensional structure of the trees can characterize the statistical interactions of involved multiple features in complex situations. The authors explore the performance of Random Forest method for NEXRAD radar data quality control. Training datasets are selected using several clear cases of precipitation and non-precipitation (but with some non-meteorological echoes). The model is structured using available candidate features (from the NEXRAD data) such as horizontal reflectivity, differential reflectivity, differential phase shift, copolar correlation coefficient, and their horizontal textures (e.g., local standard deviation). The influence of each feature on classification results are quantified by variable importance measures that are automatically estimated by the Random Forest algorithm. Therefore, the number and types of features in the final forest can be examined based on the classification accuracy. The authors demonstrate the capability of the proposed approach using several cases ranging from distinct to complex rain/no-rain events and compare the performance with the existing algorithms (e

  2. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    OpenAIRE

    Pruitt, Sandi L.; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2014-01-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5,628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient’s CRC test use. This potentially import...

  3. Ammonia volatilization losses from paddy fields under controlled irrigation with different drainage treatments.

    Science.gov (United States)

    He, Yupu; Yang, Shihong; Xu, Junzeng; Wang, Yijiang; Peng, Shizhang

    2014-01-01

    The effect of controlled drainage (CD) on ammonia volatilization (AV) losses from paddy fields under controlled irrigation (CI) was investigated by managing water table control levels using a lysimeter. Three drainage treatments were implemented, namely, controlled water table depth 1 (CWT1), controlled water table depth 2 (CWT2), and controlled water table depth 3 (CWT3). As the water table control levels increased, irrigation water volumes in the CI paddy fields decreased. AV losses from paddy fields reduced due to the increases in water table control levels. Seasonal AV losses from CWT1, CWT2, and CWT3 were 59.8, 56.7, and 53.0 kg N ha(-1), respectively. AV losses from CWT3 were 13.1% and 8.4% lower than those from CWT1 and CWT2, respectively. A significant difference in the seasonal AV losses was confirmed between CWT1 and CWT3. Less weekly AV losses followed by TF and PF were also observed as the water table control levels increased. The application of CD by increasing water table control levels to a suitable level could effectively reduce irrigation water volumes and AV losses from CI paddy fields. The combination of CI and CD may be a feasible water management method of reducing AV losses from paddy fields.

  4. Hybrid Electric Vehicle Control Strategy Based on Power Loss Calculations

    OpenAIRE

    Boyd, Steven J

    2006-01-01

    Defining an operation strategy for a Split Parallel Architecture (SPA) Hybrid Electric Vehicle (HEV) is accomplished through calculating powertrain component losses. The results of these calculations define how the vehicle can decrease fuel consumption while maintaining low vehicle emissions. For a HEV, simply operating the vehicle's engine in its regions of high efficiency does not guarantee the most efficient vehicle operation. The results presented are meant only to define a literal str...

  5. Beneficial effect of high energy intake at lunch rather than dinner on weight loss in healthy obese women in a weight-loss program: a randomized clinical trial.

    Science.gov (United States)

    Madjd, Ameneh; Taylor, Moira A; Delavari, Alireza; Malekzadeh, Reza; Macdonald, Ian A; Farshchi, Hamid R

    2016-10-01

    The association between the time of nutrient intake and health has been described in a few studies. To our knowledge, no study has evaluated the relation between high energy intakes at lunch compared with at dinner on weight loss in overweight and obese subjects. We compared the effect of high energy intake at lunch with that at dinner on weight loss and cardiometabolic risk factors in women during a weight-loss program. Overweight and obese women [n = 80; body mass index (BMI; in kg/m 2 ): 27-35; age: 18-45 y] were asked to eat either a main meal at lunch (LM) or a main meal at dinner (DM) for 12 wk while in a weight-loss program. A total of 80 participants were randomly assigned to one of 2 intervention groups. Sixty-nine subjects (86%) completed the trial (34 subjects in the DM group, and 35 subjects in the LM group). Baseline variables were not significantly different between groups. A significant reduction in anthropometric measurements and significant improvements in cardiometabolic risk characteristics were observed over 12 wk in both groups. Compared with the DM group, the LM group had greater mean ± SD reductions in weight (LM: -5.85 ± 1.96 kg; DM: -4.35 ± 1.98 kg; P = 0.003), BMI (LM: 2.27± 0.76; DM: 1.68 ± 0.76; P = 0.003), homeostasis model assessment of insulin resistance (LM: -0.66 ± 0.33; DM: -0.46 ± 0.24; P = 0.001), and fasting insulin (LM: -2.01 ± 1.10 mIU/mL; DM: -1.16 ± 0.72 mIU/mL; P dinner may result in favorable changes in weight loss in overweight and obese women after a weight-loss program of 12 wk. The consumption may also offer clinical benefits to improve insulin resistance. This trial was registered at clinicaltrials.gov as NCT02399280. © 2016 American Society for Nutrition.

  6. ISS Contingency Attitude Control Recovery Method for Loss of Automatic Thruster Control

    Science.gov (United States)

    Bedrossian, Nazareth; Bhatt, Sagar; Alaniz, Abran; McCants, Edward; Nguyen, Louis; Chamitoff, Greg

    2008-01-01

    In this paper, the attitude control issues associated with International Space Station (ISS) loss of automatic thruster control capability are discussed and methods for attitude control recovery are presented. This scenario was experienced recently during Shuttle mission STS-117 and ISS Stage 13A in June 2007 when the Russian GN&C computers, which command the ISS thrusters, failed. Without automatic propulsive attitude control, the ISS would not be able to regain attitude control after the Orbiter undocked. The core issues associated with recovering long-term attitude control using CMGs are described as well as the systems engineering analysis to identify recovery options. It is shown that the recovery method can be separated into a procedure for rate damping to a safe harbor gravity gradient stable orientation and a capability to maneuver the vehicle to the necessary initial conditions for long term attitude hold. A manual control option using Soyuz and Progress vehicle thrusters is investigated for rate damping and maneuvers. The issues with implementing such an option are presented and the key issue of closed-loop stability is addressed. A new non-propulsive alternative to thruster control, Zero Propellant Maneuver (ZPM) attitude control method is introduced and its rate damping and maneuver performance evaluated. It is shown that ZPM can meet the tight attitude and rate error tolerances needed for long term attitude control. A combination of manual thruster rate damping to a safe harbor attitude followed by a ZPM to Stage long term attitude control orientation was selected by the Anomaly Resolution Team as the alternate attitude control method for such a contingency.

  7. Electroacupuncture treatment for pancreatic cancer pain: a randomized controlled trial.

    Science.gov (United States)

    Chen, Hao; Liu, Tang-Yi; Kuai, Le; Zhu, Ji; Wu, Cai-Jun; Liu, Lu-Ming

    2013-01-01

    Pancreatic cancer is often accompanied by severe abdominal or back pain. It's the first study to evaluate the analgesic effect of electroacupuncture on pancreatic cancer pain. A randomized controlled trial compared electroacupuncture with control acupuncture using the placebo needle. Sixty patients with pancreatic cancer pain were randomly assigned to the electroacupuncture group (n = 30) and the placebo control group (n = 30). Patients were treated on Jiaji (Ex-B2) points T8-T12 bilaterally for 30 min once a day for 3 days. Pain intensity was assessed with numerical rated scales (NRS) before the treatment (Baseline), after 3 treatments, and 2 days follow-up. Baseline characteristics were similar in the two groups. After 3 treatment, pain intensity on NRS decreased compared with Baseline (-1.67, 95% confidence interval [CI] -1.46 to -1.87) in the electroacupuncture group; there was little change (-0.13, 95% CI 0.08 to -0.35) in control group; the difference between two groups was statistically significant (P electroacupuncture group compared with the control group (P Electroacupuncture was an effective treatment for relieving pancreatic cancer pain. Copyright © 2013 IAP and EPC. Published by Elsevier B.V. All rights reserved.

  8. The Effect of the Feedback Controller on Superconducting Tokamak AC Losses + AC-CRPP user manual

    International Nuclear Information System (INIS)

    Schaerz, B.; Bruzzone, P.; Favez, J.Y.; Lister, J.B.; Zapretilina, E.

    2001-11-01

    Superconducting coils in a Tokamak are subject to AC losses when the field transverse to the coil current varies. A simple model to evaluate the AC losses has been derived and benchmarked against a complete model used in the ITER design procedure. The influence of the feedback control strategy on the AC losses is examined using this model. An improved controller is proposed, based on this study. (author)

  9. Hearing loss in civilian airline and helicopter pilots compared to air traffic control personnel.

    Science.gov (United States)

    Wagstaff, Anthony S; Arva, Per

    2009-10-01

    In order to investigate possible hearing loss as a consequence of aviation noise, a comparative analysis of audiometric data from Norwegian Air Traffic Control (ATC) personnel, airline (fixed-wing) pilots, and helicopter pilots was performed. The results may be of use in giving advice regarding preventive measures. Male ATC, airline, and helicopter pilots were selected randomly from the Civil Aviation Authority (CAA) medical files. There were 182 subjects included in the study: 50, 81, and 51 subjects for ATC, helicopter, and airline pilots, respectively. Two audiograms with a 2-3-yr interval were analyzed for each individual. Age correction was performed using data from ISO 7129. Threshold changes per year for the frequencies 3, 4, and 6 kHz were examined in particular after age correction. For all three groups, mean hearing threshold levels were above (worse than) ISO 7129 predictions for most frequencies. As expected, hearing thresholds increased with age in the group as a whole. Looking at the 3-, 4-, and 6-kHz frequencies in particular, all groups had small but highly significant increases in hearing thresholds at 4 kHz between the first and second audiogram. The mean hearing thresholds for this group of aviation personnel are higher than International Standard ISO-7129 would predict according to age. Highly significant changes in hearing threshold after age correction, indicating possible noise-induced hearing loss, were found in all groups at 4 kHz. The fact that helicopter pilots had similar hearing loss to their other aviation colleagues indicates that current hearing protection for these pilots is effective in counteracting the increased noise levels in helicopters.

  10. Aneuploidy in immortalized human mesenchymal stem cells with non-random loss of chromosome 13 in culture.

    Science.gov (United States)

    Takeuchi, Masao; Takeuchi, Kikuko; Ozawa, Yutaka; Kohara, Akihiro; Mizusawa, Hiroshi

    2009-01-01

    Aneuploidy (an abnormal number of chromosomes) is commonly observed in most human cancer cells, highlighting the need to examine chromosomal instability in tumorigenesis. Previously, the immortalized human mesenchymal stem cell line UE6E7T-3 was shown to undergo a preferential loss of one copy of chromosome 13 after prolonged culture. Here, the loss of chromosome 13 was found to be caused by chromosome missegregation during mitosis, which involved unequal segregation, exclusion of the misaligned chromosome 13 on the metaphase plate, and trapping of chromosome 13 in the midbody region, as observed by fluorescence in situ hybridization. Near-diploid aneuploidy, not tetraploidy, was the direct result. The loss of chromosome 13 was non-random, and was detected by analysis of microsatellites and single nucleotide polymorphism-based loss of heterozygosity (LOH). Of the five microsatellite loci on chromosome 13, four loci showed microsatellite instability at an early stage in culture, and LOH was apparent at a late stage in culture. These results suggest that the microsatellite mutations cause changes in centromere integrity provoking loss of this chromosome in the UE6E7T-3 cell line. Thus, these results support the use of this cell line as a useful model for understanding the mechanism of aneuploid formation in cell cultures.

  11. Intranasal oxytocin enhances neural processing of monetary reward and loss in post-traumatic stress disorder and traumatized controls.

    Science.gov (United States)

    Nawijn, Laura; van Zuiden, Mirjam; Koch, Saskia B J; Frijling, Jessie L; Veltman, Dick J; Olff, Miranda

    2016-04-01

    Anhedonia is a significant clinical problem in post-traumatic stress disorder (PTSD). PTSD patients show reduced motivational approach behavior, which may underlie anhedonic symptoms. Oxytocin administration is known to increase reward sensitivity and approach behavior. We therefore investigated whether oxytocin administration affected neural responses during motivational processing in PTSD patients and trauma-exposed controls. 35 police officers with PTSD (21 males) and 37 trauma-exposed police officers without PTSD (19 males) were included in a within-subjects, randomized, placebo-controlled fMRI study. Neural responses during anticipation of monetary reward and loss were investigated with a monetary incentive delay task (MID) after placebo and oxytocin (40 IU) administration. Oxytocin increased neural responses during reward and loss anticipation in PTSD patients and controls in the striatum, dorsal anterior cingulate cortex and insula, key regions in the reward pathway. Although PTSD patients did not differ from controls in motivational processing under placebo, anhedonia severity in PTSD patients was negatively related to reward responsiveness in the ventral striatum. Furthermore, oxytocin effects on reward processing in the ventral striatum were positively associated with anhedonia. Oxytocin administration increased reward pathway sensitivity during reward and loss anticipation in PTSD patients and trauma-exposed controls. Thus, oxytocin administration may increase motivation for goal-directed approach behavior in PTSD patients and controls, providing evidence for a neurobiological pathway through which oxytocin could potentially increase motivation and reward sensitivity in PTSD patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Weed flora, yield losses and weed control in cotton crop

    OpenAIRE

    Jabran, Khawar

    2016-01-01

    Cotton (Gossypium spp.) is the most important fiber crop of world and provides fiber, oil, and animals meals. Weeds interfere with the growth activities of cotton plants and compete with it for resources. All kinds of weeds (grasses, sedges, and broadleaves) have been noted to infest cotton crop. Weeds can cause more than 30% decrease in cotton productivity. Several methods are available for weed control in cotton. Cultural control carries significance for weed control up to a certain extent....

  13. The effectiveness of propolis on gingivitis: a randomized controlled trial.

    Science.gov (United States)

    Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre

    2014-12-01

    A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days -14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). The 38 persons who completed the study (age 13-22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period.

  14. Yoga in Correctional Settings: A Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Nóra Kerekes

    2017-10-01

    Full Text Available BackgroundThe effect of yoga in the reduction of depressive symptoms, anxiety, stress, anger as well as in the increased ability of behavioral control has been shown. These effects of yoga are highly relevant for prison inmates who often have poor mental health and low impulse control. While it has been shown that yoga and meditation can be effective in improving subjective well-being, mental health, and executive functioning within prison populations, only a limited number of studies have proved this, using randomized controlled settings.MethodsA total of 152 participants from nine Swedish correctional facilities were randomly assigned to a 10-week yoga group (one class a week; N = 77 or a control group (N = 75. Before and after the intervention period, participants answered questionnaires measuring stress, aggression, affective states, sleep quality, and psychological well-being and completed a computerized test measuring attention and impulsivity.ResultsAfter the intervention period, significant improvements were found on 13 of the 16 variables within the yoga group (e.g., less perceived stress, better sleep quality, an increased psychological and emotional well-being, less aggressive, and antisocial behavior and on two within the control group. Compared to the control group, yoga class participants reported significantly improved emotional well-being and less antisocial behavior after 10 weeks of yoga. They also showed improved performance on the computerized test that measures attention and impulse control.ConclusionIt can be concluded that the yoga practiced in Swedish correctional facilities has positive effects on inmates’ well-being and on considerable risk factors associated with recidivism, such as impulsivity and antisocial behavior. Accordingly, the results show that yoga practice can play an important part in the rehabilitation of prison inmates.

  15. Biomimetic propulsion under random heaving conditions, using active pitch control

    Science.gov (United States)

    Politis, Gerasimos; Politis, Konstantinos

    2014-05-01

    Marine mammals travel long distances by utilizing and transforming wave energy to thrust through proper control of their caudal fin. On the other hand, manmade ships traveling in a wavy sea store large amounts of wave energy in the form of kinetic energy for heaving, pitching, rolling and other ship motions. A natural way to extract this energy and transform it to useful propulsive thrust is by using a biomimetic wing. The aim of this paper is to show how an actively pitched biomimetic wing could achieve this goal when it performs a random heaving motion. More specifically, we consider a biomimetic wing traveling with a given translational velocity in an infinitely extended fluid and performing a random heaving motion with a given energy spectrum which corresponds to a given sea state. A formula is invented by which the instantaneous pitch angle of the wing is determined using the heaving data of the current and past time steps. Simulations are then performed for a biomimetic wing at different heave energy spectra, using an indirect Source-Doublet 3-D-BEM, together with a time stepping algorithm capable to track the random motion of the wing. A nonlinear pressure type Kutta condition is applied at the trailing edge of the wing. With a mollifier-based filtering technique, the 3-D unsteady rollup pattern created by the random motion of the wing is calculated without any simplifying assumptions regarding its geometry. Calculated unsteady forces, moments and useful power, show that the proposed active pitch control always results in thrust producing motions, with significant propulsive power production and considerable beneficial stabilizing action to ship motions. Calculation of the power required to set the pitch angle prove it to be a very small percentage of the useful power and thus making the practical application of the device very tractable.

  16. Effect of an Internet-Based Program on Weight Loss for Low-Income Postpartum Women: A Randomized Clinical Trial.

    Science.gov (United States)

    Phelan, Suzanne; Hagobian, Todd; Brannen, Anna; Hatley, Karen E; Schaffner, Andrew; Muñoz-Christian, Karen; Tate, Deborah F

    2017-06-20

    Postpartum weight retention increases lifetime risk of obesity and related morbidity. Few effective interventions exist for multicultural, low-income women. To test whether an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) for low-income postpartum women could produce greater weight loss than the WIC program alone over 12 months. A 12-month, cluster randomized, assessor-blind, clinical trial enrolling 371 adult postpartum women at 12 clinics in WIC programs from the California central coast between July 2011 and May 2015 with data collection completed in May 2016. Clinics were randomized to the WIC program (standard care group) or the WIC program plus a 12-month primarily internet-based weight loss program (intervention group), including a website with weekly lessons, web diary, instructional videos, computerized feedback, text messages, and monthly face-to-face groups at the WIC clinics. The primary outcome was weight change over 12 months, based on measurements at baseline, 6 months, and 12 months. Secondary outcomes included proportion returning to preconception weight and changes in physical activity and diet. Participants included 371 women (mean age, 28.1 years; Hispanic, 81.6%; mean weight above prepregnancy weight, 7.8 kg; mean months post partum, 5.2 months) randomized to the intervention group (n = 174) or standard care group (n = 197); 89.2% of participants completed the study. The intervention group produced greater mean 12-month weight loss compared with the standard care group (3.2 kg in the intervention group vs 0.9 kg in standard care group, P income postpartum women, an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) compared with the WIC program alone resulted in a statistically significant greater weight loss over 12 months. Further research is needed to

  17. Event-triggered control systems under packet losses

    NARCIS (Netherlands)

    Dolk, V.S.; Heemels, W.P.M.H.

    2017-01-01

    Networked control systems (NCSs) offer many benefits in terms of increased flexibility and maintainability but might also suffer from inevitable imperfections such as packet dropouts and limited communications resources. In this paper, (static and dynamic) event-triggered control (ETC) strategies

  18. Analysis of pressure losses in the diffuser of a control valve

    Science.gov (United States)

    Turecký, Petr; Mrózek, Lukáš; Tajč, Ladislav; Kolovratník, Michal

    The pressure loss in the diffuser of a control valve is evaluated by using CFD computations. Pressure ratios and lifts of a cone for the recommended flow characteristics of an experimental turbine are considered. The pressure loss in a valve is compared with the pressure loss in a nozzle, i.e. the embodiment of the valve without a cone. Computations are carried out for the same mass flow. Velocity profiles are evaluated in both versions of computations. Comparison of computed pressure losses, with the loss evaluated by using relations for diffusers with the ideal velocity conditions in the input cross-section, is carried out.

  19. Analysis of pressure losses in the diffuser of a control valve

    Directory of Open Access Journals (Sweden)

    Turecký Petr

    2017-01-01

    Full Text Available The pressure loss in the diffuser of a control valve is evaluated by using CFD computations. Pressure ratios and lifts of a cone for the recommended flow characteristics of an experimental turbine are considered. The pressure loss in a valve is compared with the pressure loss in a nozzle, i.e. the embodiment of the valve without a cone. Computations are carried out for the same mass flow. Velocity profiles are evaluated in both versions of computations. Comparison of computed pressure losses, with the loss evaluated by using relations for diffusers with the ideal velocity conditions in the input cross-section, is carried out.

  20. Carbohydrate- vs fat-controlled diet effect on weight loss and coronary artery disease risk: a pilot feeding study.

    Science.gov (United States)

    Mueller, Charles; Masri, Basem; Hogg, Jeannette; Mastrogiacomo, Maddalena; Chiu, Ya-Lin

    2010-10-01

    This pilot study compared weight loss and serum indicators of coronary artery disease (CAD) risk between 2 weight loss (energy-deficit) diets, one controlled for carbohydrate as a percentage of total calories and the other controlled for fat as percentage of total calories. Participants were randomized to 1 of 2 diets and fed on an outpatient basis for 70 days, after which they followed their diets using their own resources for an additional 70 days. Energy deficit for the diets was determined by indirect calorimetry with a 500- to 750-calorie per day adjustment. Weight and CAD risk indicators and serum lipid and C-reactive protein levels were measured at baseline, day 70, and day 140. The study was completed by 16 of 20 participants who were able to comply with the feeding portion of the study as well as with follow-up appointments during the second (self-management) period of the study. Participants lost weight in both diet groups (24.4 lbs, carbohydrate controlled; 18.5 lbs, fat controlled), and serum CAD risk factors decreased in both groups. There were no significant differences in CAD risk factors between diet groups, although there was a trend toward lighter low-density lipoprotein (LDL) size in the carbohydrate-controlled group. During the self-management portion of the study, weight loss stalled or regained from loss during the previous feeding period. The results, although underpowered, are consistent with recent studies in which macronutrient ratio of total calories in diet did not affect degree of weight loss and in which carbohydrate-controlled diets produced a predominance of lighter LDLs.

  1. Non-random species loss in bacterial communities reduces antifungal volatile production

    NARCIS (Netherlands)

    Hol, G.; Garbeva, P.; Hordijk, C.; Hundscheid, M.P.J.; Klein Gunnewiek, P.J.A.; Agtmaal, van M.; Boer, de W.

    2015-01-01

    The contribution of low-abundance microbial species to soil ecosystems is easily overlooked because there is considerable overlap between metabolic abilities (functional redundancy) of dominant and subordinate microbial species. Here we studied how loss of less abundant soil bacteria affected the

  2. Building Kindergartners' Number Sense: A Randomized Controlled Study.

    Science.gov (United States)

    Jordan, Nancy C; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2012-08-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups ( n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures.

  3. Building Kindergartners’ Number Sense: A Randomized Controlled Study

    Science.gov (United States)

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2015-01-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups (n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures. PMID:25866417

  4. Effects of nattokinase on blood pressure: a randomized, controlled trial.

    Science.gov (United States)

    Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

    2008-08-01

    The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; pnattokinase group compared with the control group (pnattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension.

  5. Tranexamic Acid Safely Reduced Blood Loss in Hemi- and Total Hip Arthroplasty for Acute Femoral Neck Fracture: A Randomized Clinical Trial.

    Science.gov (United States)

    Watts, Chad D; Houdek, Matthew T; Sems, S Andrew; Cross, William W; Pagnano, Mark W

    2017-07-01

    We aimed to determine whether (1) tranexamic acid (TXA) reduces the incidence of transfusion (2) TXA reduces the calculated blood loss, and (3) there are any observable differences in 30- and 90-day complications with TXA administration during arthroplasty for femoral neck fracture (FNF). Prospective, double-blinded, randomized controlled trial. Level 1 Academic Trauma Center. One hundred thirty-eight patients who presented with a low-energy, isolated, FNF (AO 31B) treated with either hemi- or total hip arthroplasty within 72 hours of injury were randomized to either the TXA group (69 patients) or placebo group (69 patients). In the TXA group, patients received 2 doses of 15 mg/kg intravenous TXA dissolved in 100 mL of saline, each administered over 10 minutes; 1 dose just before incision, and the second at wound closure. In the placebo group, 100 mL of saline solution was administered in a similar fashion. Perioperative care was otherwise standardized including conservative transfusion criteria. Our primary outcome was to determine the proportion of patients who underwent blood transfusion during hospitalization. Secondary outcomes were calculated blood loss, number of units transfused during hospitalization, and incidence of adverse events at 30 and 90 days including thromboembolic event, wound complications, reoperation, hospital readmission, and all-cause mortality. TXA reduced mean incidence of transfusion by 305 mL (P = 0.0005). There was a trend toward decreased transfusion rate in the TXA group (17% vs. 26%, P = 0.22). TXA was safe with no differences in adverse events at 30 and 90 days. This randomized clinical trial found that TXA administration safely reduced blood loss with a tendency for decreased transfusion rate and total blood product consumption for patients undergoing hip arthroplasty for acute FNF. More studies are needed to further ascertain the role of TXA in the management of patients with FNF. Therapeutic Level I. See Instructions for Authors

  6. Losses in chopper-controlled DC series motors

    Science.gov (United States)

    Hamilton, H. B.

    1982-01-01

    Motors for electric vehicle (EV) applications must have different features than dc motors designed for industrial applications. The EV motor application is characterized by the following requirements: (1) the need for highest possible efficiency from light load to overload, for maximum EV range, (2) large short time overload capability (The ratio of peak to average power varies from 5/1 in heavy city traffic to 3/1 in suburban driving situations) and (3) operation from power supply voltage levels of 84 to 144 volts (probably 120 volts maximum). A test facility utilizing a dc generator as a substitute for a battery pack was designed and utilized. Criteria for the design of such a facility are presented. Two motors, differing in design detail, commercially available for EV use were tested. Losses measured are discussed, as are waves forms and their harmonic content, the measurements of resistance and inductance, EV motor/chopper application criteria, and motor design considerations.

  7. Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study.

    Science.gov (United States)

    Ozkurt, Seçil; Dönmez, Arif; Zeki Karagülle, M; Uzunoğlu, Emel; Turan, Mustafa; Erdoğan, Nergis

    2012-07-01

    We aimed to evaluate the effectiveness of balneotherapy in fibromyalgia management. Fifty women with fibromyalgia under pharmacological treatment were randomly assigned to either the balneotherapy (25) or the control (25) group. Four patients from the balneotherapy group and one patient from the control group left the study after randomization. The patients in the balneotherapy group (21) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center. The patients in the control group (24) continued to have their medical treatment and routine daily life. An investigator who was blinded to the study arms assessed the patients. All patients were assessed four times; at the beginning of the study, at the end of the 2nd week, the 1st month, and the 3rd month after balneotherapy. Outcome measures of the study were pain intensity, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), patient's global assessment, investigator's global assessment, SF-36 scores, and tender point count. Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity, FIQ, Beck Depression Inventory, patient's global assessment, investigator's global assessment scores, and tender point count as compared to the control group. The superiority of balneotherapy lasted up to the end of the 3rd month, except for the Beck Depression Inventory score and the investigator's global assessment score. Significant improvements were observed in PF, GH, and MH subscales of SF-36 during the study period in the balneotherapy group; however, no such improvement was observed in the control group. Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls. It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia.

  8. Use of intravenous tranexamic acid in total knee arthroplasty: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    FU De-jie

    2013-04-01

    Full Text Available 【Abstract】 Objective: The effect of tranexamic acid (TA on patients receiving total knee arthroplasty (TKA has been reported in many small clinical trials. But single trials are not sufficient enough to clarify the effectiveness and safety of TA. So, we carried out a meta-analysis of randomized controlled trials to investigate the efficacy and safety of the intravenous use of TA in TKA. Methods: Literatures were retrieved in Cochrane Library, OVID, PubMed, EMBASE, CNKI and Wanfang Data. All the related literatures were checked by two independent investigators and only the high quality randomized con-trolled trials were enrolled. Relevant data were analyzed using RevMan 5.1 to compare the difference of blood loss, transfusion and complications between TA group and con-trol group. Results: There were 353 related literatures and only 22 randomized controlled trials met the inclusion criteria. The use of TA in TKA significantly reduced total blood loss by a mean of 435.41 ml (95% CI 300.62-570.21, P<0.01, post-operative blood loss by a mean of 406.69 ml (95% CI 333.16-480.22, P<0.01. TA also significantly lowered the transfu-sion rate (risk difference 0.30, 95% CI 0.21-0.39, P<0.01 and transfusion volume (mean difference 0.95 unit, 95% CI 0.53-1.37, P<0.01. The risks between TA group and control group in developing deep vein thrombosis and pulmonary embo-lism were not statistically significant. Conclusion: TA is beneficial for patients undergoing TKA, which can significantly reduce total blood loss, post-operative blood loss, transfusion rate, and transfusion volume. Meanwhile TA is recommended to reduce deep vein thrombosis and pulmonary embolism following TKA. Key words: Tranexamic acid; Arthroplasty; Knee; Blood loss, surgical; Meta-analysis

  9. Self-governance, control and loss of control amongst drink-drivers

    DEFF Research Database (Denmark)

    Järvinen, Margaretha; Fynbo, Lars

    2011-01-01

    This paper analyses driving under the influence of alcohol and drugs (DUI) from a governmentality perspective. The paper is based on qualitative interviews with 25 persons, convicted of drink-driving and at the time of the interviews participating in Alcohol/Traffic courses in Denmark (mandatory...... feelings of control loss; and occasional drinkers or drug users with limited experience of drink-driving. The paper analyses drink-driving as a form of “failed self-governance” and shows how some of the convicted drink-drivers negotiate quilt and blame by either justifying their DUI (they were “in full...... courses for DUI-convicted people). Four drink-driver profiles are identified: regular heavy drinkers who regard themselves as addicted; regular drinkers who claim they are in control of both their alcohol use and their drink-driving; occasional multi-substance users who associate their DUI with strong...

  10. Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial.

    Science.gov (United States)

    de Rooij, Thijs; van Hilst, Jony; Vogel, Jantien A; van Santvoort, Hjalmar C; de Boer, Marieke T; Boerma, Djamila; van den Boezem, Peter B; Bonsing, Bert A; Bosscha, Koop; Coene, Peter-Paul; Daams, Freek; van Dam, Ronald M; Dijkgraaf, Marcel G; van Eijck, Casper H; Festen, Sebastiaan; Gerhards, Michael F; Groot Koerkamp, Bas; Hagendoorn, Jeroen; van der Harst, Erwin; de Hingh, Ignace H; Dejong, Cees H; Kazemier, Geert; Klaase, Joost; de Kleine, Ruben H; van Laarhoven, Cornelis J; Lips, Daan J; Luyer, Misha D; Molenaar, I Quintus; Nieuwenhuijs, Vincent B; Patijn, Gijs A; Roos, Daphne; Scheepers, Joris J; van der Schelling, George P; Steenvoorde, Pascal; Swijnenburg, Rutger-Jan; Wijsman, Jan H; Abu Hilal, Moh'd; Busch, Olivier R; Besselink, Marc G

    2017-04-08

    Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting. LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs. The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting. Dutch Trial Register, NTR5188 . Registered on 9 April 2015.

  11. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  12. Standards for reporting randomized controlled trials in neurosurgery.

    Science.gov (United States)

    Kiehna, Erin N; Starke, Robert M; Pouratian, Nader; Dumont, Aaron S

    2011-02-01

    The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05). Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could

  13. Time-delayed feedback control of diffusion in random walkers

    Science.gov (United States)

    Ando, Hiroyasu; Takehara, Kohta; Kobayashi, Miki U.

    2017-07-01

    Time delay in general leads to instability in some systems, while specific feedback with delay can control fluctuated motion in nonlinear deterministic systems to a stable state. In this paper, we consider a stochastic process, i.e., a random walk, and observe its diffusion phenomenon with time-delayed feedback. As a result, the diffusion coefficient decreases with increasing delay time. We analytically illustrate this suppression of diffusion by using stochastic delay differential equations and justify the feasibility of this suppression by applying time-delayed feedback to a molecular dynamics model.

  14. Acupucture as pain relief during delivery - a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    Background: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. Methods: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... to existing pain relief methods. (BIRTH 36:1 March 2009)...

  15. Medication reconciliation at patient admission: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mendes AE

    2016-03-01

    Full Text Available Objective: To measure length of hospital stay (LHS in patients receiving medication reconciliation. Secondary characteristics included analysis of number of preadmission medications, medications prescribed at admission, number of discrepancies, and pharmacists interventions done and accepted by the attending physician. Methods: A 6 month, randomized, controlled trial conducted at a public teaching hospital in southern Brazil. Patients admitted to general wards were randomized to receive usual care or medication reconciliation, performed within the first 72 hours of hospital admission. Results: The randomization process assigned 68 patients to UC and 65 to MR. LHS was 10±15 days in usual care and 9±16 days in medication reconciliation (p=0.620. The total number of discrepancies was 327 in the medication reconciliation group, comprising 52.6% of unintentional discrepancies. Physicians accepted approximately 75.0% of the interventions. Conclusion: These results highlight weakness at patient transition care levels in a public teaching hospital. LHS, the primary outcome, should be further investigated in larger studies. Medication reconciliation was well accepted by physicians and it is a useful tool to find and correct discrepancies, minimizing the risk of adverse drug events and improving patient safety.

  16. A two-year randomized weight loss trial comparing a vegan diet to a more moderate low-fat diet.

    Science.gov (United States)

    Turner-McGrievy, Gabrielle M; Barnard, Neal D; Scialli, Anthony R

    2007-09-01

    The objective was to assess the effect of a low-fat, vegan diet compared with the National Cholesterol Education Program (NCEP) diet on weight loss maintenance at 1 and 2 years. Sixty-four overweight, postmenopausal women were randomly assigned to a vegan or NCEP diet for 14 weeks, and 62 women began the study. The study was done in two replications. Participants in the first replication (N = 28) received no follow-up support after the 14 weeks, and those in the second replication (N = 34) were offered group support meetings for 1 year. Weight and diet adherence were measured at 1 and 2 years for all participants. Weight loss is reported as median (interquartile range) and is the difference from baseline weight at years 1 and 2. Individuals in the vegan group lost more weight than those in the NCEP group at 1 year [-4.9 (-0.5, -8.0) kg vs. -1.8 (0.8, -4.3); p vegan diet was associated with significantly greater weight loss than the NCEP diet at 1 and 2 years. Both group support and meeting attendance were associated with significant weight loss at follow-up.

  17. Empowerment Program for People With Prediabetes: A Randomized Controlled Trial.

    Science.gov (United States)

    Chen, Mei-Fang; Hung, Shu-Ling; Chen, Shu-Lin

    2017-04-01

    Practicing a health-promoting lifestyle is believed to be effective for delaying or preventing the onset of diabetes. However, although empowerment interventions have proven effective for encouraging the adoption of a health-promoting lifestyle in people with diabetes, these interventions are rarely promoted to people with prediabetes. The aims of this study were to develop an empowerment program for people with prediabetes and to examine its efficacy in terms of the adoption of a health-promoting lifestyle and improvements in blood sugar, body mass index, and self-efficacy. A randomized controlled trial was conducted between May and December 2013. A convenience sample of people with a fasting blood sugar level of 100-125 mg/dl during the previous 3 months was recruited from the health examination center of a hospital in Kaohsiung, Taiwan. Participants were assigned to either the experimental group or the control group using block randomization with a block size of 8. The experimental group (n = 38) participated in a 4-month empowerment program (the ABC empowerment program), which encouraged participants to practice a health-promoting lifestyle in three phases: awareness raising, behavior building, and results checking. The control group (n = 40) received routine clinical care. Statistical analyses included descriptive statistics, independent t test, paired t test, and generalized estimated equations. After controlling for the differences at baseline and considering the interaction between group and time from baseline to 1 week and 3 months after completing the intervention, the generalized estimating equation showed significantly larger improvements in a health-promoting lifestyle, blood sugar, and self-efficacy in the experimental group than in the control group (p empowerment program was shown to have short-term, positive effects on behavioral, physical, and psychosocial outcomes in a Taiwan population with prediabetes. The results of this study provide a useful

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

    Science.gov (United States)

    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

  19. A randomized, controlled trial of oral propranolol in infantile hemangioma.

    Science.gov (United States)

    Léauté-Labrèze, Christine; Hoeger, Peter; Mazereeuw-Hautier, Juliette; Guibaud, Laurent; Baselga, Eulalia; Posiunas, Gintas; Phillips, Roderic J; Caceres, Hector; Lopez Gutierrez, Juan Carlos; Ballona, Rosalia; Friedlander, Sheila Fallon; Powell, Julie; Perek, Danuta; Metz, Brandie; Barbarot, Sebastien; Maruani, Annabel; Szalai, Zsuzsanna Zsofia; Krol, Alfons; Boccara, Olivia; Foelster-Holst, Regina; Febrer Bosch, Maria Isabel; Su, John; Buckova, Hana; Torrelo, Antonio; Cambazard, Frederic; Grantzow, Rainer; Wargon, Orli; Wyrzykowski, Dariusz; Roessler, Jochen; Bernabeu-Wittel, Jose; Valencia, Adriana M; Przewratil, Przemyslaw; Glick, Sharon; Pope, Elena; Birchall, Nicholas; Benjamin, Latanya; Mancini, Anthony J; Vabres, Pierre; Souteyrand, Pierre; Frieden, Ilona J; Berul, Charles I; Mehta, Cyrus R; Prey, Sorilla; Boralevi, Franck; Morgan, Caroline C; Heritier, Stephane; Delarue, Alain; Voisard, Jean-Jacques

    2015-02-19

    Oral propranolol has been used to treat complicated infantile hemangiomas, although data from randomized, controlled trials to inform its use are limited. We performed a multicenter, randomized, double-blind, adaptive, phase 2-3 trial assessing the efficacy and safety of a pediatric-specific oral propranolol solution in infants 1 to 5 months of age with proliferating infantile hemangioma requiring systemic therapy. Infants were randomly assigned to receive placebo or one of four propranolol regimens (1 or 3 mg of propranolol base per kilogram of body weight per day for 3 or 6 months). A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis. The primary end point was success (complete or nearly complete resolution of the target hemangioma) or failure of trial treatment at week 24, as assessed by independent, centralized, blinded evaluations of standardized photographs. Of 460 infants who underwent randomization, 456 received treatment. On the basis of an interim analysis of the first 188 patients who completed 24 weeks of trial treatment, the regimen of 3 mg of propranolol per kilogram per day for 6 months was selected for the final efficacy analysis. The frequency of successful treatment was higher with this regimen than with placebo (60% vs. 4%, P<0.001). A total of 88% of patients who received the selected propranolol regimen showed improvement by week 5, versus 5% of patients who received placebo. A total of 10% of patients in whom treatment with propranolol was successful required systemic retreatment during follow-up. Known adverse events associated with propranolol (hypoglycemia, hypotension, bradycardia, and bronchospasm) occurred infrequently, with no significant difference in frequency between the placebo group and the groups receiving propranolol. This trial showed that propranolol was effective at a dose of 3 mg per kilogram per day for 6 months in the treatment of infantile hemangioma. (Funded by

  20. MiDAS ENCORE: Randomized Controlled Study Design and Protocol.

    Science.gov (United States)

    Benyamin, Ramsin M; Staats, Peter S

    2015-01-01

    Epidural steroid injections (ESIs) are commonly used for treatment of symptomatic lumbar spinal stenosis (LSS). ESIs are generally administered after failure of conservative therapy. For LSS patients suffering from neurogenic claudication, the mild® procedure provides an alternative to ESIs via minimally invasive lumbar decompression. Both ESIs and mild offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. Prospective, multi-center, randomized controlled, clinical study. Twenty-six interventional pain management centers throughout the United States. To compare patient outcomes following treatment with either mild or ESIs in LSS patients with neurogenic claudication and having verified ligamentum flavum hypertrophy. Study participants include Medicare beneficiaries who meet study inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment arms, mild (treatment group) or ESI (control group). Each study group will include approximately 150 patients who have experienced neurogenic claudication symptoms for ≥ 3 months duration who have failed to respond to physical therapy, home exercise programs, and oral analgesics. Those randomized to mild are prohibited from receiving lumbar ESIs during the study period, while those randomized to ESI may receive ESIs up to 4 times per year. Patient assessments will occur at baseline, 6 months, and one year. An additional assessment will be conducted for the mild patient group at 2 years. The primary efficacy outcome measure is the proportion of Oswestry Disability Index (ODI) responders from baseline to one year follow-up in the treatment group (mild) versus the control group (ESI). ODI responders are defined as those patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up as a clinically significant efficacy threshold. Secondary

  1. Changes in weight control behaviors and hedonic hunger during a 12-week commercial weight loss program.

    Science.gov (United States)

    O'Neil, Patrick M; Theim, Kelly R; Boeka, Abbe; Johnson, Gail; Miller-Kovach, Karen

    2012-12-01

    Greater use of key self-regulatory behaviors (e.g., self-monitoring of food intake and weight) is associated with greater weight loss within behavioral weight loss treatments, although this association is less established within widely-available commercial weight loss programs. Further, high hedonic hunger (i.e., susceptibility to environmental food cues) may present a barrier to successful behavior change and weight loss, although this has not yet been examined. Adult men and women (N=111, body mass index M±SD=31.5±2.7kg/m(2)) were assessed before and after participating in a 12-week commercial weight loss program. From pre- to post-treatment, reported usage of weight control behaviors improved and hedonic hunger decreased, and these changes were inversely associated. A decrease in hedonic hunger was associated with better weight loss. An improvement in reported weight control behaviors (e.g., self-regulatory behaviors) was associated with better weight loss, and this association was even stronger among individuals with high baseline hedonic hunger. Findings highlight the importance of specific self-regulatory behaviors within weight loss treatment, including a commercial weight loss program developed for widespread community implementation. Assessment of weight control behavioral skills usage and hedonic hunger may be useful to further identify mediators of weight loss within commercial weight loss programs. Future interventions might specifically target high hedonic hunger and prospectively examine changes in hedonic hunger during other types of weight loss treatment to inform its potential impact on sustained behavior change and weight control. Copyright © 2012 Elsevier Ltd. All rights reserved.

  2. Random fiber lasers based on artificially controlled backscattering fibers

    Science.gov (United States)

    Chen, Daru; Wang, Xiaoliang; She, Lijuan; Qiang, Zexuan; Yu, Zhangwei

    2017-10-01

    The random fiber laser (RFL) which is a milestone in laser physics and nonlinear optics, has attracted considerable attention recently. Most previous RFLs are based on distributed feedback of Rayleigh scattering amplified through stimulated Raman/Brillouin scattering effect in single mode fibers, which required long-distance (tens of kilometers) single mode fibers and high threshold up to watt-level due to the extremely small Rayleigh scattering coefficient of the fiber. We proposed and demonstrated a half-open cavity RFL based on a segment of a artificially controlled backscattering SMF(ACB-SMF) with a length of 210m, 310m or 390m. A fiber Bragg grating with the central wavelength of 1530nm and a segment of ACB-SMF forms the half-open cavity. The proposed RFL achieves the threshold of 25mW, 30mW and 30mW, respectively. Random lasing at the wavelength of 1530nm and the extinction ratio of 50dB is achieved when a segment of 5m EDF is pumped by a 980nm LD in the RFL. Another half-open cavity RFL based on a segment of a artificially controlled backscattering EDF(ACBS-EDF) is also demonstrated without an ACB-SMF. The 3m ACB-EDF is fabricated by using the femtosecond laser with pulse energy of 0.34mJ which introduces about 50 reflectors in the EDF. Random lasing at the wavelength of 1530nm is achieved with the output power of 7.5mW and the efficiency of 1.88%. Two novel RFLs with much short cavities have been achieved with low threshold and high efficiency.

  3. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    Science.gov (United States)

    Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

    2014-01-01

    Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. SLEEP 2014;37(9):1553-1563. PMID:25142566

  4. Effect of Playful Balancing Training - A Pilot Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Lund, Henrik Hautop; Jessen, Jari Due

    2013-01-01

    We used the modular playware in the form of modular interactive tiles for playful training of community-dwelling elderly with balancing problem. During short-term play on the modular interactive tiles, the elderly were playing physical, interactive games that were challenging their dynamic balance...... increase in balancing performance (DGI score: 21.3) after short-term playful training with the modular interactive tiles, whereas the control group remained with a score indicating balancing problems and risk of falling (DGI score: 16.6). The small pilot randomized controlled trial suggests...... that the playful interaction with the modular interactive tiles has a significant effect even after a very short time of play. The average total training time to obtain the statistical significant effect amounted to just 2h45m....

  5. Antenatal hypnosis training and childbirth experience: a randomized controlled trial.

    Science.gov (United States)

    Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Wu, Chun Sen; Nohr, Ellen A

    2013-12-01

    Childbirth is a demanding event in a woman's life. The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience. In a randomized, controlled, single-blinded trial, 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy: A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth, a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness, and a usual care group receiving ordinary antenatal care only. Wijmas Delivery Expectancy/Experience Questionnaire (W-DEQ) was used to measure the childbirth experience 6 weeks postpartum. The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups (mean W-DEQ score of 42.9 in the Hypnosis group, 47.2 in the Relaxation group, and 47.5 in the Care as usual group (p = 0.01)). The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear. In this large randomized controlled trial, a brief course in self-hypnosis improved the women's childbirth experience. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.

  6. Random fiber laser based on artificially controlled backscattering fibers.

    Science.gov (United States)

    Wang, Xiaoliang; Chen, Daru; Li, Haitao; She, Lijuan; Wu, Qiong

    2018-01-10

    The random fiber laser (RFL), which is a milestone in laser physics and nonlinear optics, has attracted considerable attention recently. Most previously reported RFLs are based on distributed feedback of Rayleigh scattering amplified through the stimulated Raman-Brillouin scattering effect in single-mode fibers, which require long-distance (tens of kilometers) single-mode fibers and high threshold, up to watt level, due to the extremely small Rayleigh scattering coefficient of the fiber. We proposed and demonstrated a half-open-cavity RFL based on a segment of an artificially controlled backscattering single-mode fiber with a length of 210 m, 310 m, or 390 m. A fiber Bragg grating with a central wavelength of 1530 nm and a segment of artificially controlled backscattering single-mode fiber fabricated by using a femtosecond laser form the half-open cavity. The proposed RFL achieves thresholds of 25 mW, 30 mW, and 30 mW, respectively. Random lasing at a wavelength of 1530 nm and extinction ratio of 50 dB is achieved when a segment of 5 m erbium-doped fiber is pumped by a 980 nm laser diode in the RFL. A novel RFL with many short cavities has been achieved with low threshold.

  7. Review of Randomized Controlled Trials of Massage in Preterm Infants

    Directory of Open Access Journals (Sweden)

    Anna-Kaisa Niemi

    2017-04-01

    Full Text Available Preterm birth affects about 10% of infants born in the United States. Massage therapy is being used in some neonatal intensive care units for its potential beneficial effects on preterm infants. This article reviews published randomized controlled trials on the effects of massage in preterm infants. Most studies evaluating the effect of massage in weight gain in premature infants suggest a positive effect on weight gain. Increase in vagal tone has been reported in infants who receive massage and has been suggested as a possible mechanism for improved weight gain. More studies are needed on the underlying mechanisms of the effects of massage therapy on weight gain in preterm infants. While some trials suggest improvements in developmental scores, decreased stress behavior, positive effects on immune system, improved pain tolerance and earlier discharge from the hospital, the number of such studies is small and further evidence is needed. Further studies, including randomized controlled trials, are needed on the effects of massage in preterm infants.

  8. Moxibustion for breech version: a randomized controlled trial.

    Science.gov (United States)

    Guittier, Marie-Julia; Pichon, Michelle; Dong, Hongguang; Irion, Olivier; Boulvain, Michel

    2009-11-01

    To estimate the efficacy of moxibustion between 34 and 38 weeks of gestation to facilitate the cephalic version of fetuses in breech presentation and the acceptability of this method by women. We conducted a randomized controlled trial in a Swiss university hospital maternity unit. We proposed to stimulate the acupoint BL 67 by moxibustion daily for 2 weeks for 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation. We did the intervention three times weekly in the hospital and a teaching session and information leaflet on the technique for additional daily therapy at home. The control group received expectant management care. The availability of external cephalic version was maintained for both groups. The main outcome measure was the comparison of the proportion of women with cephalic presentation at delivery. Baseline characteristics were similar between groups, except more nulliparous women were randomized to moxibustion. The percentage of versions was similar between groups: 18% in the moxibustion group compared with 16% in the control group (relative risk 1.12, 95% confidence interval 0.62 to 2.03). Adjustment for the imbalance in parity did not change these results. The frequency of cesarean delivery was similar (64% compared with 58% in the moxibustion group and the control group, respectively). Acceptability of the intervention and women's perceptions of moxibustion were favorable. We observed no beneficial effect of moxibustion to facilitate the cephalic version of fetuses in breech presentation. Despite this lack of proven effectiveness, women had positive opinions on the intervention. ClinicalTrials.gov, www.clinicaltrials.gov,NCT00890474. I.

  9. Endurance exercise training in orthostatic intolerance: a randomized, controlled trial.

    Science.gov (United States)

    Winker, Robert; Barth, Alfred; Bidmon, Daniela; Ponocny, Ivo; Weber, Michael; Mayr, Otmar; Robertson, David; Diedrich, André; Maier, Richard; Pilger, Alex; Haber, Paul; Rüdiger, Hugo W

    2005-03-01

    Orthostatic intolerance is a syndrome characterized by chronic orthostatic symptoms of light-headedness, fatigue, nausea, orthostatic tachycardia, and aggravated norepinephrine levels while standing. The aim of this study was to assess the protective effect of exercise endurance training on orthostatic symptoms and to examine its usefulness in the treatment of orthostatic intolerance. 2768 military recruits were screened for orthostatic intolerance by questionnaire. Tilt-table testing identified 36 cases of orthostatic intolerance out of the 2768 soldiers. Subsequently, 31 of these subjects with orthostatic intolerance entered a randomized, controlled trial. The patients were allocated randomly to either a "training" (3 months jogging) or a "control" group. The influence of exercise training on orthostatic intolerance was assessed by determination of questionnaire scores and tilt-table testing before and after intervention. After training, only 6 individuals of 16 still had orthostatic intolerance compared with 10 of 11 in the control group. The Fisher exact test showed a highly significant difference in diagnosis between the 2 groups (P=0.008) at the end of the study. Analysis of the questionnaire-score showed significant interaction between time and group (P=0.001). The trained subjects showed an improvement in the average symptom score from 1.79+/-0.4 to 1.04+/-0.4, whereas the control subjects showed no significant change in average symptom score (2.09+/-0.6 and 2.14+/-0.5, respectively). Our data demonstrate that endurance exercise training leads to an improvement of symptoms in the majority of patients with orthostatic intolerance. Therefore, we suggest that endurance training should be considered in the treatment of orthostatic intolerance patients.

  10. Weight loss maintenance in relation to locus of control: The MedWeight study.

    Science.gov (United States)

    Anastasiou, Costas A; Fappa, Evaggelia; Karfopoulou, Eleni; Gkza, Anastasia; Yannakoulia, Mary

    2015-08-01

    Locus of control, i.e. the degree of an individual's belief on the control of his/her life, has been related to many health outcomes, including weight loss in overweight/obese individuals. No information is available on the impact of locus of control in maintaining weight loss. We aimed to investigate the effect of locus of control in weight loss maintenance and explore potential associations with lifestyle factors. Study participants included 239 individuals (41% males) who had lost at least 10% of body weight in the past and either maintained the loss (maintainers: weight maintenance of at least 10% of initial weight) or regained it (regainers). Locus of control was defined by a relevant multi-dimensional scale; participants were categorised to internals and externals, based on "internal" and "others" sub-scales. A significant interaction was found between locus of control and weight loss maintenance status (p locus of control. Individualised treatment, according to locus of control, may increase weight loss maintenance rates in former overweight/obese individuals. Copyright © 2015 Elsevier Ltd. All rights reserved.

  11. Reducing Runoff Loss of Applied Nutrients in Oil Palm Cultivation Using Controlled-Release Fertilizers

    Directory of Open Access Journals (Sweden)

    A. Bah

    2014-01-01

    Full Text Available Controlled-release fertilizers are expected to minimize nutrient loss from crop fields due to their potential to supply plant-available nutrients in synchrony with crop requirements. The evaluation of the efficiency of these fertilizers in tropical oil palm agroecological conditions is not yet fully explored. In this study, a one-year field trial was conducted to determine the impact of fertilization with water soluble conventional mixture and controlled-release fertilizers on runoff loss of nutrients from an immature oil palm field. Soil and nutrient loss were monitored for one year in 2012/2013 under erosion plots of 16 m2 on 10% slope gradient. Mean sediments concentration in runoff amounted to about 6.41 t ha−1. Conventional mixture fertilizer posed the greatest risk of nutrient loss in runoff following fertilization due to elevated nitrogen (6.97%, potassium (13.37%, and magnesium (14.76% as percentage of applied nutrients. In contrast, this risk decreased with the application of controlled-release fertilizers, representing 0.75–2.44% N, 3.55–5.09% K, and 4.35–5.43% Mg loss. Meanwhile, nutrient loss via eroded sediments was minimal compared with loss through runoff. This research demonstrates that the addition of controlled-release fertilizers reduced the runoff risks of nutrient loss possibly due to their slow-release properties.

  12. Nutrient Intake During Diet-Induced Weight Loss and Exercise Interventions in a Randomized Trial in Older Overweight and Obese Adults.

    Science.gov (United States)

    Miller, G D; Beavers, D P; Hamm, D; Mihalko, S L; Messier, S P

    2017-01-01

    Dietary restriction in obese older adults undergoing weight loss may exacerbate nutrient deficiencies common in this group; the nutritional health of older adults is a factor in their quality of life, disability, and mortality. This study examined the effect of an 18-month weight loss program based in social cognitive theory incorporating partial meal replacements, on nutrient intake in older overweight and obese adults. The following analysis is from the Intensive Diet and Exercise for Arthritis (IDEA) trial, a single-blind, randomized controlled trial. Individuals were randomized into one of three 18-month interventions: exercise (E); intensive diet-induced weight loss (D); or intensive diet-induced weight loss plus exercise (D+E). The study setting was at a university research facility. Overweight and obese older adults (n=388; BMI=33.7±3.8 kg/m2; 65.8±6.1 years) were recruited. The D and D+E interventions (group mean goal of ≥10% loss by 18-months) utilized partial meal replacements (2 meal replacement shakes/day for 6-months). Exercise training for E and D+E was 3 days/week, 60 minutes/day. Three day food records were collected at baseline, 6-months, and 18-months and analyzed for total energy and macro- and micronutrient intake. Comparisons of dietary intake among treatment groups were performed at 6 and 18 months using mixed linear models. Weight loss at 18-months was 11.3±8.3% (D), 10.3±6.8% (D+E), and 1.2±4.2% (E). Meal replacements were used by more than 60% (6-months) and 50% (18-months) of D and D+E participants, compared to ≤15% for E. Both D and D+E consumed less energy and fat, and more carbohydrates and selected micronutrients than E during follow-up. More than 50% of all participants consumed less than the recommended intake of particular vitamins and minerals. The diet intervention improved intakes of several nutrients. However, inadequate intake of several vitamins and minerals of concern for older adults suggests they need further

  13. Effect of a High-Protein Diet versus Standard-Protein Diet on Weight Loss and Biomarkers of Metabolic Syndrome: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Ismael Campos-Nonato

    2017-06-01

    Full Text Available Background: Some studies have shown that protein-enriched diets can lead to greater weight loss and improvements in biomarkers of metabolic syndrome (MeS than standard protein diets. Therefore, the aim of this study was to determine the effect of increased protein intake on weight loss in Mexican adults with MeS. Methods: Randomized controlled trial in 118 adults aged 47.4 ± 11.5 years and meeting the established criteria for MeS were randomized to prescribed hypocaloric diets (500 kcal less than resting metabolic rate providing either 0.8 g/kg body weight (standard protein diet (SPD or 1.34 g/kg body weight (higher protein diet (HPD for 6 months. Body weight, waist circumference, percent body fat by bioimpedance analysis, fasting blood glucose, fasting insulin, hemoglobin A1c, total cholesterol, high-density lipoprotein (HDL cholesterol, very-low-density lipoprotein (VLDL cholesterol, triglycerides, C-reactive protein, creatinine, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase were measured at baseline, 3 months and at 6 months. Results: There were 105 subjects (51 for SPD and 54 for HPD who completed the trial. Overall weight loss was 5.1 ± 3.6 kg in the SPD group compared to 7.0 ± 3.7 kg in the in HPD group. Both groups lost a significant percent of centimeters of waist circumference (SPD -6.5 ± 2.6 cm and HPD -8.8 ± 2.6 cm. There was no statistical difference Except for the varying weight losses the two groups did not show any further differences overall. However in the subgroup judged to be adherent more than 75% of the time with the prescribed diets, there was a significant difference in mean weight loss (SPD -5.8% vs. HPD -9.5% after adjusting for baseline BMI. Both groups demonstrated significant decreases in waist circumference, glucose, insulin, triglycerides, and VLDL cholesterol, but there were no differences between the groups. There were no changes in blood tests for

  14. Effect of a High-Protein Diet versus Standard-Protein Diet on Weight Loss and Biomarkers of Metabolic Syndrome: A Randomized Clinical Trial.

    Science.gov (United States)

    Campos-Nonato, Ismael; Hernandez, Lucia; Barquera, Simon

    2017-01-01

    Some studies have shown that protein-enriched diets can lead to greater weight loss and improvements in biomarkers of metabolic syndrome (MeS) than standard protein diets. Therefore, the aim of this study was to determine the effect of increased protein intake on weight loss in Mexican adults with MeS. Randomized controlled trial in 118 adults aged 47.4 ± 11.5 years and meeting the established criteria for MeS were randomized to prescribed hypocaloric diets (500 kcal less than resting metabolic rate) providing either 0.8 g/kg body weight (standard protein diet (SPD)) or 1.34 g/kg body weight (higher protein diet (HPD)) for 6 months. Body weight, waist circumference, percent body fat by bioimpedance analysis, fasting blood glucose, fasting insulin, hemoglobin A1c, total cholesterol, high-density lipoprotein (HDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, triglycerides, C-reactive protein, creatinine, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase were measured at baseline, 3 months and at 6 months. There were 105 subjects (51 for SPD and 54 for HPD) who completed the trial. Overall weight loss was 5.1 ± 3.6 kg in the SPD group compared to 7.0 ± 3.7 kg in the in HPD group. Both groups lost a significant percent of centimeters of waist circumference (SPD -6.5 ± 2.6 cm and HPD -8.8 ± 2.6 cm). There was no statistical difference Except for the varying weight losses the two groups did not show any further differences overall. However in the subgroup judged to be adherent more than 75% of the time with the prescribed diets, there was a significant difference in mean weight loss (SPD -5.8% vs. HPD -9.5%) after adjusting for baseline BMI. Both groups demonstrated significant decreases in waist circumference, glucose, insulin, triglycerides, and VLDL cholesterol, but there were no differences between the groups. There were no changes in blood tests for liver or renal function. There were no

  15. Calorie restriction in overweight seniors: response of older adults to a dieting study: the CROSSROADS randomized controlled clinical trial.

    Science.gov (United States)

    Haas, Marilyn C; Bodner, Eric V; Brown, Cynthia J; Bryan, David; Buys, David R; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S; Roth, David L; Wingo, Brooks C; Ard, Jamy; Locher, Julie L

    2014-01-01

    We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling obese older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), and functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article.

  16. A randomized controlled trial of interim methadone maintenance.

    Science.gov (United States)

    Schwartz, Robert P; Highfield, David A; Jaffe, Jerome H; Brady, Joseph V; Butler, Carol B; Rouse, Charles O; Callaman, Jason M; O'Grady, Kevin E; Battjes, Robert J

    2006-01-01

    Effective alternatives to long waiting lists for entry into methadone hydrochloride maintenance treatment are needed to reduce the complications of continuing heroin dependence and to increase methadone treatment entry. To compare the effectiveness of interim methadone maintenance with that of the usual waiting list condition in facilitating methadone treatment entry and reducing heroin and cocaine use and criminal behavior. Randomized, controlled, clinical trial using 2 conditions, with treatment assignment on a 3:2 basis to interim maintenance-waiting list control. A methadone treatment program in Baltimore. A total of 319 individuals meeting the criteria for current heroin dependence and methadone maintenance treatment. Participants were randomly assigned to either interim methadone maintenance, consisting of an individually determined methadone dose and emergency counseling only for up to 120 days, or referral to community-based methadone treatment programs. Entry into comprehensive methadone maintenance therapy at 4 months from baseline; self-reported days of heroin use, cocaine use, and criminal behavior; and number of urine drug test results positive for heroin and cocaine at the follow-up interview conducted at time of entry into comprehensive methadone treatment (or at 4 months from baseline for participants who did not enter regular treatment). Significantly more participants assigned to the interim methadone maintenance condition entered comprehensive methadone maintenance treatment by the 120th day from baseline (75.9%) than those assigned to the waiting list control condition (20.8%) (Pmethadone maintenance results in a substantial increase in the likelihood of entry into comprehensive treatment, and is an effective means of reducing heroin use and criminal behavior among opioid-dependent individuals awaiting entry into a comprehensive methadone treatment program.

  17. Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial.

    Science.gov (United States)

    Sharara-Chami, Rana; Lakissian, Zavi; Charafeddine, Lama; Milad, Nadine; El-Hout, Yaser

    2017-12-01

    There is no consensus on the most effective pain management for neonatal circumcision. We sought to compare different modalities. This is a double-blinded randomized controlled trial comparing 3 combination analgesics used during circumcision (EMLA + sucrose; EMLA + sucrose + dorsal penile nerve block [DPNB]; EMLA + sucrose + ring block [RB]) with the traditional topical analgesic cream EMLA alone. The trial was set in the normal nursery of a teaching hospital. The sample included 70 healthy male newborns, randomly assigned to intervention and control groups at a 2:1 ratio. Infants were videotaped (face and torso) during the procedure for assessment of pain by 2 blinded, independent reviewers. The primary outcome measure is the Neonatal Infant Pain Scale score. Secondary outcomes include heart rate, oxygen saturation, and crying time. Neonatal Infant Pain Scale scores were significantly lower in the intervention groups (EMLA + sucrose, mean [SD]: 3.1 [1.33]; EMLA + sucrose + DPNB: 3 [1.33]; EMLA + sucrose + RB: 2.45 [1.27]) compared with the control (5.5 [0.53]). Between-group analyses showed RB + EMLA + sucrose to be significantly more effective than EMLA + sucrose; EMLA + sucrose + DPNB ( P = .009 and P = .002, respectively). Interrater reliability was κ = 0.843. Significant increase in heart rate (139.27 [9.63] to 163 [13.23] beats per minute) and crying time (5.78 [6.4] to 45.37 [12.39] seconds) were noted in the EMLA group. During neonatal circumcision in boys, the most effective analgesia is RB combined with oral sucrose and EMLA cream. Copyright © 2017 by the American Academy of Pediatrics.

  18. Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial.

    Science.gov (United States)

    Patel, Mitesh S; Asch, David A; Rosin, Roy; Small, Dylan S; Bellamy, Scarlett L; Heuer, Jack; Sproat, Susan; Hyson, Chris; Haff, Nancy; Lee, Samantha M; Wesby, Lisa; Hoffer, Karen; Shuttleworth, David; Taylor, Devon H; Hilbert, Victoria; Zhu, Jingsan; Yang, Lin; Wang, Xingmei; Volpp, Kevin G

    2016-03-15

    Financial incentive designs to increase physical activity have not been well-examined. To test the effectiveness of 3 methods to frame financial incentives to increase physical activity among overweight and obese adults. Randomized, controlled trial. (ClinicalTrials.gov: NCT 02030119). University of Pennsylvania. 281 adult employees (body mass index ≥27 kg/m2). 13-week intervention. Participants had a goal of 7000 steps per day and were randomly assigned to a control group with daily feedback or 1 of 3 financial incentive programs with daily feedback: a gain incentive ($1.40 given each day the goal was achieved), lottery incentive (daily eligibility [expected value approximately $1.40] if goal was achieved), or loss incentive ($42 allocated monthly upfront and $1.40 removed each day the goal was not achieved). Participants were followed for another 13 weeks with daily performance feedback but no incentives. Primary outcome was the mean proportion of participant-days that the 7000-step goal was achieved during the intervention. Secondary outcomes included the mean proportion of participant-days achieving the goal during follow-up and the mean daily steps during intervention and follow-up. The mean proportion of participant-days achieving the goal was 0.30 (95% CI, 0.22 to 0.37) in the control group, 0.35 (CI, 0.28 to 0.42) in the gain-incentive group, 0.36 (CI, 0.29 to 0.43) in the lottery-incentive group, and 0.45 (CI, 0.38 to 0.52) in the loss-incentive group. In adjusted analyses, only the loss-incentive group had a significantly greater mean proportion of participant-days achieving the goal than control (adjusted difference, 0.16 [CI, 0.06 to 0.26]; P = 0.001), but the adjusted difference in mean daily steps was not significant (861 [CI, 24 to 1746]; P = 0.056). During follow-up, daily steps decreased for all incentive groups and were not different from control. Single employer. Financial incentives framed as a loss were most effective for achieving physical

  19. A randomized controlled trial to promote volunteering in older adults.

    Science.gov (United States)

    Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

    2014-12-01

    Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

  20. The Effect of Platelet-Rich Plasma in Hair Regrowth: A Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    Gentile, Pietro; Garcovich, Simone; Bielli, Alessandra; Scioli, Maria Giovanna; Orlandi, Augusto; Cervelli, Valerio

    2015-11-01

    Platelet-rich plasma (PRP) has emerged as a new treatment modality in regenerative plastic surgery, and preliminary evidence suggests that it might have a beneficial role in hair regrowth. Here, we report the results of a randomized, evaluator-blinded, placebo-controlled, half-head group study to compare, with the aid of computerized trichograms, hair regrowth with PRP versus placebo. The safety and clinical efficacy of autologous PRP injections for pattern hair loss were investigated. PRP, prepared from a small volume of blood, was injected on half of the selected patients' scalps with pattern hair loss. The other half was treated with placebo. Three treatments were administered to each patient at 30-day intervals. The endpoints were hair regrowth, hair dystrophy as measured by dermoscopy, burning or itching sensation, and cell proliferation as measured by Ki67 evaluation. Patients were followed for 2 years. Of the 23 patients enrolled, 3 were excluded. At the end of the 3 treatment cycles, the patients presented clinical improvement in the mean number of hairs, with a mean increase of 33.6 hairs in the target area, and a mean increase in total hair density of 45.9 hairs per cm² compared with baseline values. No side effects were noted during treatment. Microscopic evaluation showed the increase of epidermis thickness and of the number of hair follicles 2 weeks after the last PRP treatment compared with baseline value (p plastic surgery, and preliminary evidence suggests that it might have a beneficial role in hair regrowth. Here, the results of a randomized, placebo-controlled, half-head group study to compare the hair regrowth with PRP versus placebo are reported. Hair regrowth was quantified by a blinded evaluator using computerized trichograms. The safety and clinical efficacy of autologous PRP injections for pattern hair loss were investigated. Of the 23 patients enrolled, 3 were excluded. At the end of the 3 treatment cycles, the patients presented clinical

  1. Calorie Restriction in Overweight SeniorS: Response of Older Adults to a Dieting Study: The CROSSROADS Randomized Controlled Clinical Trial

    OpenAIRE

    Haas, Marilyn C.; Bodner, Eric V.; Brown, Cynthia J.; Bryan, David; Buys, David R.; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S.; Roth, David L.; Wingo, Brooks C.; Ard, Jamy

    2014-01-01

    © 2014,Taylor & Francis Group, LLC. We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling obese older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose t...

  2. Effect of a high-protein diet on maintenance of blood pressure levels achieved after initial weight loss : the DiOGenes randomized study

    NARCIS (Netherlands)

    Engberink, M. F.; Geleijnse, J. M.; Bakker, S. J. L.; Larsen, T. M.; Handjieva-Darlesnka, T.; Kafatos, A.; Martinez, J. A.; Pfeiffer, A. F. H.; Kunesova, M.; Jebb, S. A.; Holst, C.; Astrup, A.; Saris, W. H. M.; Brink, E. J.; van Baak, M. A.

    Randomized trials have shown significant blood pressure (BP) reductions after increased protein compared with carbohydrate intake, but the effect on BP maintenance after initial weight loss is unclear. We examined the effect of a high-protein diet on the maintenance of reduced BP after weight loss

  3. Effect of a high-protein diet on maintenance of blood pressure levels achieved after initial weight loss: the DiOGenes randomized study

    NARCIS (Netherlands)

    Engberink, M.F.; Geleijnse, J.M.; Bakker, S.J.L.; Larsen, T.

    2015-01-01

    Randomized trials have shown significant blood pressure (BP) reductions after increased protein compared with carbohydrate intake, but the effect on BP maintenance after initial weight loss is unclear. We examined the effect of a high-protein diet on the maintenance of reduced BP after weight loss

  4. Robotic-assisted versus laparoscopic colorectal surgery: a meta-analysis of four randomized controlled trials

    Science.gov (United States)

    2014-01-01

    Background Robotic-assisted laparoscopy is popularly performed for colorectal disease. The objective of this meta-analysis was to compare the safety and efficacy of robotic-assisted colorectal surgery (RCS) and laparoscopic colorectal surgery (LCS) for colorectal disease based on randomized controlled trial studies. Methods Literature searches of electronic databases (Pubmed, Web of Science, and Cochrane Library) were performed to identify randomized controlled trial studies that compared the clinical or oncologic outcomes of RCS and LCS. This meta-analysis was performed using the Review Manager (RevMan) software (version 5.2) that is provided by the Cochrane Collaboration. The data used were mean differences and odds ratios for continuous and dichotomous variables, respectively. Fixed-effects or random-effects models were adopted according to heterogeneity. Results Four randomized controlled trial studies were identified for this meta-analysis. In total, 110 patients underwent RCS, and 116 patients underwent LCS. The results revealed that estimated blood losses (EBLs), conversion rates and times to the recovery of bowel function were significantly reduced following RCS compared with LCS. There were no significant differences in complication rates, lengths of hospital stays, proximal margins, distal margins or harvested lymph nodes between the two techniques. Conclusions RCS is a promising technique and is a safe and effective alternative to LCS for colorectal surgery. The advantages of RCS include reduced EBLs, lower conversion rates and shorter times to the recovery of bowel function. Further studies are required to define the financial effects of RCS and the effects of RCS on long-term oncologic outcomes. PMID:24767102

  5. Random and externally controlled occurrences of Dansgaard–Oeschger events

    Directory of Open Access Journals (Sweden)

    J. Lohmann

    2018-05-01

    Full Text Available Dansgaard–Oeschger (DO events constitute the most pronounced mode of centennial to millennial climate variability of the last glacial period. Since their discovery, many decades of research have been devoted to understand the origin and nature of these rapid climate shifts. In recent years, a number of studies have appeared that report emergence of DO-type variability in fully coupled general circulation models via different mechanisms. These mechanisms result in the occurrence of DO events at varying degrees of regularity, ranging from periodic to random. When examining the full sequence of DO events as captured in the North Greenland Ice Core Project (NGRIP ice core record, one can observe high irregularity in the timing of individual events at any stage within the last glacial period. In addition to the prevailing irregularity, certain properties of the DO event sequence, such as the average event frequency or the relative distribution of cold versus warm periods, appear to be changing throughout the glacial. By using statistical hypothesis tests on simple event models, we investigate whether the observed event sequence may have been generated by stationary random processes or rather was strongly modulated by external factors. We find that the sequence of DO warming events is consistent with a stationary random process, whereas dividing the event sequence into warming and cooling events leads to inconsistency with two independent event processes. As we include external forcing, we find a particularly good fit to the observed DO sequence in a model where the average residence time in warm periods are controlled by global ice volume and cold periods by boreal summer insolation.

  6. Random and externally controlled occurrences of Dansgaard-Oeschger events

    Science.gov (United States)

    Lohmann, Johannes; Ditlevsen, Peter D.

    2018-05-01

    Dansgaard-Oeschger (DO) events constitute the most pronounced mode of centennial to millennial climate variability of the last glacial period. Since their discovery, many decades of research have been devoted to understand the origin and nature of these rapid climate shifts. In recent years, a number of studies have appeared that report emergence of DO-type variability in fully coupled general circulation models via different mechanisms. These mechanisms result in the occurrence of DO events at varying degrees of regularity, ranging from periodic to random. When examining the full sequence of DO events as captured in the North Greenland Ice Core Project (NGRIP) ice core record, one can observe high irregularity in the timing of individual events at any stage within the last glacial period. In addition to the prevailing irregularity, certain properties of the DO event sequence, such as the average event frequency or the relative distribution of cold versus warm periods, appear to be changing throughout the glacial. By using statistical hypothesis tests on simple event models, we investigate whether the observed event sequence may have been generated by stationary random processes or rather was strongly modulated by external factors. We find that the sequence of DO warming events is consistent with a stationary random process, whereas dividing the event sequence into warming and cooling events leads to inconsistency with two independent event processes. As we include external forcing, we find a particularly good fit to the observed DO sequence in a model where the average residence time in warm periods are controlled by global ice volume and cold periods by boreal summer insolation.

  7. Effect of weight reduction on the quality of life in obese patients with fibromyalgia syndrome: a randomized controlled trial.

    Science.gov (United States)

    Senna, Mohammed Kamal; Sallam, Rehab Abd-El Raouf; Ashour, Hala Salah; Elarman, Mohammed

    2012-11-01

    The aim of the study was to examine whether weight reduction can result in improvement of fibromyalgia impact questionnaire (FIQ) in the patients with fibromyalgia syndrome (FMS). This study was a randomized controlled trial. Obese patients with fibromyalgia were randomly assigned to 6-month dietary weight loss (n = 41) and no weight loss (n = 42) groups. Patients were assessed at baseline and at 6 months. The primary outcome measure was FIQ. Secondary measures included the tender point (TP) examination, Beck Depression Inventory-II, and Pittsburg Sleep Quality Index. Compared to the control group, patients who underwent weight reduction obtained significantly better FIQ (p = 0.007), lower mean TP count (p = 0.015), and lower mean TP pain rating in the lower body (p quality than the controls. Patients who lost weight had significantly lower interleukin 6 and C-reactive protein levels than those in the control group (p = 0.034 and p = 0.007, respectively). Weight loss in obese patients with FMS leads to significant improvement in the quality of life as shown by the decrease in the FIQ score. Depression, sleep quality, and tender point count are also significantly improved by weight loss in obese patients with fibromyalgia. Our results suggest that weight reduction should be a part of fibromyalgia treatment.

  8. Cohort Study of the Success of Controlled Weight Loss Programs for Obese Dogs.

    Science.gov (United States)

    German, A J; Titcomb, J M; Holden, S L; Queau, Y; Morris, P J; Biourge, V

    2015-01-01

    Most weight loss studies in obese dogs assess rate and percentage of weight loss in the first 2-3 months, rather than the likelihood of successfully reaching target weight. To determine outcome of controlled weight loss programs for obese dogs, and to determine the factors associated with successful completion. 143 obese dogs undergoing a controlled weight loss program. This was a cohort study of obese dogs attending a referral weight management clinic. Dogs were studied during their period of weight loss, and cases classified according to outcome as "completed" (reached target weight), "euthanized" (was euthanized before reaching target weight), or "stopped prematurely" (program stopped early for other reasons). Factors associated with successful completion were assessed using simple and multiple logistic regression. 87/143 dogs (61%) completed their weight loss program, 11 [8%] died or were euthanized, and the remaining 45 [32%] stopped prematurely. Reasons for dogs stopping prematurely included inability to contact owner, refusal to comply with weight management advice, or development of another illness. Successful weight loss was positively associated with a faster rate (P obese dogs on a controlled weight loss program reach their target weight. Future studies should better clarify reasons for success in individual cases, and also the role of factors such as activity and behavioral modification. Copyright © 2015 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  9. Dry cupping for plantar fasciitis: a randomized controlled trial.

    Science.gov (United States)

    Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

    2017-05-01

    [Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested.

  10. Reiki for the treatment of fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra

    2008-11-01

    Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.

  11. A randomized controlled trial of nasolaryngoscopy training techniques.

    Science.gov (United States)

    Smith, Matthew E; Leung, Billy C; Sharma, Rishi; Nazeer, Sammar; McFerran, Don J

    2014-09-01

    Flexible nasolaryngoscopy is an essential skill for otolaryngology trainees to develop, but there is a lack of standardized training for this procedure. The aim of this study was to assess whether using training on a realistic human mannequin together with structured video feedback improved trainees' performance at flexible nasolaryngoscopy. Three-armed, single-blinded, randomized controlled study. Thirty-six junior doctors and final-year medical students were randomly allocated to one of three groups. All received a lecture and video presentation on flexible nasolaryngoscopy. One group received additional tuition using a training mannequin. The last group received mannequin training and feedback on their performance using a video recording. The trainees then undertook flexible nasolaryngoscopy on volunteers with these endoscopies recorded. Blinded observers scored the trainees on a range of objective and subjective measures. The volunteers who were also blinded to the candidates' training scored the comfort of the procedure. Adding mannequin training showed a trend toward improvement of performance but did not reach statistical significance. Mannequin training together with video feedback produced significant performance improvement in patient comfort (P = .0065), time to reach the vocal folds (P = .017), and global ability (P = .0006). Inter-rater reliability was excellent with P training using an anatomically correct model of the upper airway together with formalized video-assisted feedback on that training is a simple and effective way to improve endoscopy skills prior to starting flexible nasolaryngoscopy on patients. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

  12. Cognitive training in Alzheimer's disease: a controlled randomized study.

    Science.gov (United States)

    Giovagnoli, A R; Manfredi, V; Parente, A; Schifano, L; Oliveri, S; Avanzini, G

    2017-08-01

    This controlled randomized single-blind study evaluated the effects of cognitive training (CT), compared to active music therapy (AMT) and neuroeducation (NE), on initiative in patients with mild to moderate Alzheimer's disease (AD). Secondarily, we explored the effects of CT on episodic memory, mood, and social relationships. Thirty-nine AD patients were randomly assigned to CT, AMT, or NE. Each treatment lasted 3 months. Before, at the end, and 3 months after treatment, neuropsychological tests and self-rated scales assessed initiative, episodic memory, depression, anxiety, and social relationships. At the end of the CT, initiative significantly improved, whereas, at the end of AMT and NE, it was unchanged. Episodic memory showed no changes at the end of CT or AMT and a worsening after NE. The rates of the patients with clinically significant improvement of initiative were greater after CT (about 62%) than after AMT (about 8%) or NE (none). At the 3-month follow-up, initiative and episodic memory declined in all patients. Mood and social relationships improved in the three groups, with greater changes after AMT or NE. In patients with mild to moderate AD, CT can improve initiative and stabilize memory, while the non-cognitive treatments can ameliorate the psychosocial aspects. The combining of CT and non-cognitive treatments may have useful clinical implications.

  13. Impact of CD4 and CD8 dynamics and viral rebounds on loss of virological control in HIV controllers

    DEFF Research Database (Denmark)

    Chereau, Fanny; Madec, Yoann; Sabin, Caroline

    2017-01-01

    OBJECTIVE: HIV controllers (HICs) spontaneously maintain HIV viral replication at low level without antiretroviral therapy (ART), a small number of whom will eventually lose this ability to control HIV viremia. The objective was to identify factors associated with loss of virological control. MET...

  14. Harmonic scalpel versus electrocautery dissection in modified radical mastectomy: a randomized controlled trial.

    Science.gov (United States)

    Khan, Salma; Khan, Shaista; Chawla, Tabish; Murtaza, Ghulam

    2014-03-01

    To test the hypothesis that the use of a harmonic scalpel increases operative time but results in less estimated blood loss, postoperative pain, drainage volume, and duration of surgery, as well as fewer complications, such as flap necrosis, seroma, and surgical site infection (SSI), than electrocautery. This parallel-group, single-institution blinded randomized controlled trial was conducted at the department of surgery of our institute between April 2010 and July 2011. Women undergoing modified radical mastectomy were randomly allocated to either harmonic dissection (n = 76) or electrocautery (n = 76). Both the groups were comparable for baseline variables with age of 50.5 ± 12.2 and 48.5 ± 14.5 years in the harmonic and electrocautery groups, respectively. Harmonic dissection yielded better outcomes compared to electrocautery with lower estimated blood loss (100 ± 62 vs. 182 ± 92, p electrocautery (r2 = 0.28, β = 11.8, p < 0.001). The harmonic scalpel significantly reduces postoperative discomfort and morbidity to the patient without increasing operating time. We thus recommend preferential use of harmonic dissection in modified radical mastectomy. (ClinicalTrials.gov NCT01587248).

  15. Privacy-preserving smart meter control strategy including energy storage losses

    OpenAIRE

    Avula, Chinni Venkata Ramana R.; Oechtering, Tobias J.; Månsson, Daniel

    2018-01-01

    Privacy-preserving smart meter control strategies proposed in the literature so far make some ideal assumptions such as instantaneous control without delay, lossless energy storage systems etc. In this paper, we present a one-step-ahead predictive control strategy using Bayesian risk to measure and control privacy leakage with an energy storage system. The controller estimates energy state using a three-circuit energy storage model to account for steady-state energy losses. With numerical exp...

  16. Loss minimization control and efficiency determination of electric drives in traction applications

    Energy Technology Data Exchange (ETDEWEB)

    Windisch, Thomas; Hofmann, Wilfried [Technische Univ. Dresden (Germany). Lehrstuhl fuer Elektrische Maschinen und Antriebe

    2012-11-01

    High-power electric drives in automotive traction applications consume a large part of the disposable electric energy. For this reason the energy efficiency of the drives is of great importance for range and fuel consumption of the hybrid electric vehicle. The paper describes two possible drives with different electric motors from a control point of view. The electric power losses in the drive system are determined depending on the operating point of the machine. With these loss characteristics the control of the drives is optimized to produce minimal losses. Finally the energy efficiency for a realistic urban bus drive cycle is calculated to compare the two types. (orig.)

  17. Food irradiation in the control of storage and handling losses in the Philippine onions and garlic

    International Nuclear Information System (INIS)

    Lustre, A.O.; Dianco, A.M.; Vito, F.R.; Manalastas, Z.L.

    1996-01-01

    Information will be provided on the nature and magnitude of the control of postharvest losses in onions and garlic from the application of irradiation. Control of losses is measured in storage and during post storage marketing of the commodities. Information will also be presented on market tests and survey of consumer reaction to irradiated onions. The benefits of irradiation will be discussed in relation to the need to reduce postharvest losses in the food supply and to address consumer concerns over the safety of food due to the use of chemicals. (author)

  18. Comparing Weight Loss-Maintenance Outcomes of a Worksite-Based Lifestyle Program Delivered via DVD and Face-to-Face: A Randomized Trial.

    Science.gov (United States)

    Ing, Claire Townsend; Miyamoto, Robin E S; Fang, Rui; Antonio, Mapuana; Paloma, Diane; Braun, Kathryn L; Kaholokula, Joseph Keawe'aimoku

    2018-03-01

    Native Hawaiians and other Pacific Islanders have high rates of overweight and obesity compared with other ethnic groups in Hawai'i. Effective weight loss and weight loss-maintenance programs are needed to address obesity and obesity-related health inequities for this group. Compare the effectiveness of a 9-month, worksite-based, weight loss-maintenance intervention delivered via DVD versus face-to-face in continued weight reduction and weight loss maintenance beyond the initial weight loss phase. We tested DVD versus face-to-face delivery of the PILI@Work Program's 9-month, weight loss-maintenance phase in Native Hawaiian-serving organizations. After completing the 3-month weight loss phase, participants ( n = 217) were randomized to receive the weight loss-maintenance phase delivered via trained peer facilitators or DVDs. Participant assessments at randomization and postintervention included weight, height, blood pressure, physical functioning, exercise frequency, and fat intake. Eighty-three face-to-face participants were retained at 12 months (74.1%) compared with 73 DVD participants (69.5%). There was no significant difference between groups in weight loss or weight loss maintenance. The number of lessons attended in Phase 1 of the intervention (β = 0.358, p = .022) and baseline systolic blood pressure (β = -0.038, p = .048) predicted percent weight loss at 12 months. Weight loss maintenance was similar across groups. This suggests that low-cost delivery methods for worksite-based interventions targeting at-risk populations can help address obesity and obesity-related disparities. Additionally, attendance during the weight loss phase and lower baseline systolic blood pressure predicted greater percent weight loss during the weight loss-maintenance phase, suggesting that early engagement and initial physical functioning improve long-term weight loss outcomes.

  19. Acupuncture as pain relief during delivery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    BACKGROUND: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. METHODS: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... with the intention-to-treat principle. RESULTS: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin...

  20. Prenatal emotion management improves obstetric outcomes: a randomized control study.

    Science.gov (United States)

    Huang, Jian; Li, He-Jiang; Wang, Jue; Mao, Hong-Jing; Jiang, Wen-Ying; Zhou, Hong; Chen, Shu-Lin

    2015-01-01

    Negative emotions can cause a number of prenatal problems and disturb obstetric outcomes. We determined the effectiveness of prenatal emotional management on obstetric outcomes in nulliparas. All participants completed the PHQ-9 at the baseline assessment. Then, the participants were randomly assigned to the emotional management (EM) and usual care (UC) groups. The baseline evaluation began at 31 weeks gestation and the participants were followed up to 42 days postpartum. Each subject in the EM group received an extra EM program while the participants in the UC groups received routine prenatal care and education only. The PHQ-9 and Edinburgh Postnatal Depression scale (EPDS) were used for assessment. The EM group had a lower PHQ-9 score at 36 weeks gestation, and 7 and 42 days after delivery (P Prenatal EM intervention could control anxiety and depressive feelings in nulliparas, and improve obstetric outcomes. It may serve as an innovative approach to reduce the cesarean section rate in China.

  1. [Critical of the additive model of the randomized controlled trial].

    Science.gov (United States)

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.

  2. Neighborhood effects in a behavioral randomized controlled trial.

    Science.gov (United States)

    Pruitt, Sandi L; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2014-11-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient's CRC test use. This potentially important spatially-varying covariate has not previously been considered in a RCT. Our results suggest that future RCTs of health behavior interventions should assess potential social interactions between participants, which may cause intervention arm contamination and may bias effect size estimation. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. Synthesis of results of randomized controlled trials of contrast media

    International Nuclear Information System (INIS)

    Kinnison, M.L.; Powe, N.R.; Steinberg, E.P.

    1988-01-01

    The authors review 100 randomized controlled trials (RCTs) that examine the safety or efficacy of new low-osmolality contrast media (LOM) and focus on the 43 RCTs judged to be of the highest quality. These RCTs showed no consistent differences in nephrotoxicity between high- and low-osmolality contrast media. Certain cardiovascular parameters were altered less with low-osmolality agents during intracardiac injection, but the clinical significance of these differences in unclear. Heat and pain sensations occurred less often with low-osmolality contrast media. No differences were noted in the incidence of nausea, vomiting, urticaria, or bronchospasm. Even with numerous RCTs comparing these media, physicians still must make economically significant choices about contrast media without sufficient data about their relative safety

  4. Coping with loss of ability vs. emotional control and self-esteem in women after mastectomy.

    Science.gov (United States)

    Cieślak, Katarzyna; Golusiński, Wojciech

    2018-01-01

    Does coping with the loss of ability depend on self-esteem and emotional control? Persons who experience losses in two dimensions, i.e. health and ability can deal with the loss by physical therapy, and also by mental and socio-professional rehabilitation. But far and foremost, it is the personality of the person who experiences the loss that matters most. The study included 37 patients after mastectomy. They were divided into two groups according to the time elapsed from cancer diagnosis. The study was conducted using the Questionnaire on Coping With Ability Loss (P. Wolski), Self-Esteem Loss (M. Rosenberg,) and the Courtauld Emotional Control Scale - CECS. In Group I, the higher level of acceptance in the QCAL test, the higher self-esteem. The more depression experienced by individuals, the lower is their level of self-esteem or the less depression experienced, the higher the self-esteem. In Group II, the higher the level of depression, the lower the level of anger. The greater the struggle, the lower level of anger. The lower the level of depression and struggle, the higher the level of emotion control. Women diagnosed no longer than five years back do not differ from those diagnosed further back in terms of copying with the loss of ability, self-esteem and emotional control.

  5. Biofeedback Training in Crisis Managers: A Randomized Controlled Trial.

    Science.gov (United States)

    Janka, A; Adler, C; Brunner, B; Oppenrieder, S; Duschek, S

    2017-06-01

    Working in crisis environments represents a major challenge, especially for executive personnel engaged in directing disaster operations, i.e. crisis managers. Crisis management involves operating under conditions of extreme stress resulting, for instance, from high-level decision-making, principal responsibility for personnel, multitasking or working under conditions of risk and time pressure. The present study aimed to investigate the efficacy of a newly developed biofeedback training procedure based on electrodermal activity, especially designed for the target group of crisis managers. The training comprised exercises promoting acquisition of control over sympathetic arousal under resting conditions and during exposure to visual, acoustic and cognitive stressors resembling situations related to crisis management. In a randomized controlled design, 36 crisis managers were assigned to either a biofeedback training group or waiting list control group. Subjective stress was assessed using the Perceived Stress Scale. In the training group, stress level markedly decreased; the decrease remained stable at follow-up 2 months after the training. The results indicate that biofeedback training in crisis management is an effective method for stress management that may help to reduce vulnerability to stress-related performance decline and stress-related disease.

  6. Qigong and Fibromyalgia: Randomized Controlled Trials and Beyond

    Directory of Open Access Journals (Sweden)

    Jana Sawynok

    2014-01-01

    Full Text Available Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6–8 weeks produces improvements in core domains for fibromyalgia (pain, sleep, impact, and physical and mental function that are maintained at 4–6 months compared to wait-list subjects or baselines. Comparisons with active controls show little difference, but compared to baseline there are significant and comparable effects in both groups. Open-label studies provide information that supports benefit but remain exploratory. An extension trial and case studies involving extended practice (daily, 6–12 months indicate marked benefits but are limited by the number of participants. Benefit appears to be related to amount of practice. Conclusions. There is considerable potential for qigong to be a useful complementary practice for the management of fibromyalgia. However, there are unique methodological challenges, and exploration of its clinical potential will need to focus on pragmatic issues and consider a spectrum of trial designs. Mechanistic considerations need to consider both system-wide and more specific effects.

  7. Random number generation as an index of controlled processing.

    Science.gov (United States)

    Jahanshahi, Marjan; Saleem, T; Ho, Aileen K; Dirnberger, Georg; Fuller, R

    2006-07-01

    Random number generation (RNG) is a functionally complex process that is highly controlled and therefore dependent on Baddeley's central executive. This study addresses this issue by investigating whether key predictions from this framework are compatible with empirical data. In Experiment 1, the effect of increasing task demands by increasing the rate of the paced generation was comprehensively examined. As expected, faster rates affected performance negatively because central resources were increasingly depleted. Next, the effects of participants' exposure were manipulated in Experiment 2 by providing increasing amounts of practice on the task. There was no improvement over 10 practice trials, suggesting that the high level of strategic control required by the task was constant and not amenable to any automatization gain with repeated exposure. Together, the results demonstrate that RNG performance is a highly controlled and demanding process sensitive to additional demands on central resources (Experiment 1) and is unaffected by repeated performance or practice (Experiment 2). These features render the easily administered RNG task an ideal and robust index of executive function that is highly suitable for repeated clinical use. ((c) 2006 APA, all rights reserved).

  8. Wellness program for anesthesiology residents: a randomized, controlled trial.

    Science.gov (United States)

    Saadat, H; Snow, D L; Ottenheimer, S; Dai, F; Kain, Z N

    2012-10-01

    Multiple reports illustrate the deleterious effects of stress on physicians' mental and physical health, as well as on patient care. This study evaluates the effects of a wellness program on anesthesiology residents' well-being. Sixty residents were randomly assigned to one of three groups: (1) wellness intervention group, (2) no-treatment control with release time, and (3) no-treatment control with routine duties. Coping, stressors, social support, psychological symptoms, and alcohol and tobacco use were measured using a pre-test-post-test design. Residents in the wellness program reported significantly fewer stressors in their role as parent, increased social support at work, greater problem-solving coping, and less anxiety as compared with one or both of the control groups. Findings related to reducing avoidance coping and alcohol consumption also were suggestive of positive intervention effects. An intervention to increase the use of active coping and social support, to reduce reliance on avoidance coping, and to decrease work and family stressors had an overall pattern of beneficial effects on residents' well-being. The importance of offering such programs during residency training, ways to strengthen intervention effectiveness, and areas for future research are discussed. © 2012 The Authors. Acta Anaesthesiologica Scandinavica © 2012 The Acta Anaesthesiologica Scandinavica Foundation.

  9. Behavioral neurocardiac training in hypertension: a randomized, controlled trial.

    Science.gov (United States)

    Nolan, Robert P; Floras, John S; Harvey, Paula J; Kamath, Markad V; Picton, Peter E; Chessex, Caroline; Hiscock, Natalie; Powell, Jonathan; Catt, Michael; Hendrickx, Hilde; Talbot, Duncan; Chen, Maggie H

    2010-04-01

    It is not established whether behavioral interventions add benefit to pharmacological therapy for hypertension. We hypothesized that behavioral neurocardiac training (BNT) with heart rate variability biofeedback would reduce blood pressure further by modifying vagal heart rate modulation during reactivity and recovery from standardized cognitive tasks ("mental stress"). This randomized, controlled trial enrolled 65 patients with uncomplicated hypertension to BNT or active control (autogenic relaxation), with six 1-hour sessions over 2 months with home practice. Outcomes were analyzed with linear mixed models that adjusted for antihypertensive drugs. BNT reduced daytime and 24-hour systolic blood pressures (-2.4+/-0.9 mm Hg, P=0.009, and -2.1+/-0.9 mm Hg, P=0.03, respectively) and pulse pressures (-1.7+/-0.6 mm Hg, P=0.004, and -1.4+/-0.6 mm Hg, P=0.02, respectively). No effect was observed for controls (P>0.10 for all indices). BNT also increased RR-high-frequency power (0.15 to 0.40 Hz; P=0.01) and RR interval (P0.10). In contrast to relaxation therapy, BNT with heart rate variability biofeedback modestly lowers ambulatory blood pressure during wakefulness, and it augments tonic vagal heart rate modulation. It is unknown whether efficacy of this treatment can be improved with biofeedback of baroreflex gain. BNT, alone or as an adjunct to drug therapy, may represent a promising new intervention for hypertension.

  10. Infant Sleep After Immunization: Randomized Controlled Trial of Prophylactic Acetaminophen

    Science.gov (United States)

    Gay, Caryl L.; Lynch, Mary; Lee, Kathryn A.

    2011-01-01

    OBJECTIVE: To determine the effects of acetaminophen and axillary temperature responses on infant sleep duration after immunization. METHODS: We conducted a prospective, randomized controlled trial to compare the sleep of 70 infants monitored by using ankle actigraphy for 24 hours before and after their first immunization series at ∼2 months of age. Mothers of infants in the control group received standard care instructions from their infants' health care provider, and mothers of infants in the intervention group were provided with predosed acetaminophen and instructed to administer a dose 30 minutes before the scheduled immunization and every 4 hours thereafter, for a total of 5 doses. Infant age and birth weight and immunization factors, such as acetaminophen use and timing of administration, were evaluated for changes in infant sleep times after immunization. RESULTS: Sleep duration in the first 24 hours after immunization was increased, particularly for infants who received their immunizations after 1:30 pm and for those who experienced elevated temperatures in response to the vaccines. Infants who received acetaminophen at or after immunization had smaller increases in sleep duration than did infants who did not. However, acetaminophen use was not a significant predictor of sleep duration when other factors were controlled. CONCLUSIONS: If further research confirms the relationship between time of day of vaccine administration, increased sleep duration after immunization, and antibody responses, then our findings suggest that afternoon immunizations should be recommended to facilitate increased sleep in the 24 hours after immunization, regardless of acetaminophen administration. PMID:22123869

  11. Acupuncture Improves Peri-menopausal Insomnia: A Randomized Controlled Trial.

    Science.gov (United States)

    Fu, Cong; Zhao, Na; Liu, Zhen; Yuan, Lu-Hua; Xie, Chen; Yang, Wen-Jia; Yu, Xin-Tong; Yu, Huan; Chen, Yun-Fei

    2017-11-01

    To evaluate the short-term efficacy of acupuncture for the treatment of peri-menopausal insomnia (PMI). Design: A randomized, participant-blind, placebo-controlled trial consisted of the acupuncture group (n = 38) and placebo-acupuncture group (n = 38). Setting: A tertiary teaching and general hospital. Participants: 76 peri-menopausal women with insomnia disorder based on the International Classification of Sleep Disorders, Third Edition. Interventions: A 10-session of acupuncture at bilateral Shenshu (BL 23) and Ganshu (BL 18) with unilateral Qimen (LR 14) and Jingmen (GB 25) or Streitberger needles at the same acupoints was performed for over 3 weeks. Measurements: Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with over-night polysomnography (PSG) exam were completed at baseline and post-treatment. After the treatments, the decrease from baseline in PSQI score was 8.03 points in acupuncture group and 1.29 points in placebo-acupuncture group. The change from baseline in ISI score was 11.35 points in acupuncture group and 2.87 points in placebo-acupuncture group. In PSG data, acupuncture significantly improved the sleep efficiency and total sleep time, associated with less wake after sleep onset and lower percent stage 1 after the treatment. No significant differences from baseline to post-treatment were found in placebo-acupuncture group. Acupuncture can contribute to a clinically relevant improvement in the short-term treatment of PMI, both subjectively and objectively. Acupuncture for peri-menopause insomnia: a randomized controlled trial, http://www.chictr.org.cn/showproj.aspx?proj=12118 ChiCTR-IPR-15007199, China. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

  12. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

  13. Acupuncture intervention in ischemic stroke: a randomized controlled prospective study.

    Science.gov (United States)

    Shen, Peng-Fei; Kong, Li; Ni, Li-Wei; Guo, Hai-Long; Yang, Sha; Zhang, Li-Li; Zhang, Zhi-Long; Guo, Jia-Kui; Xiong, Jie; Zhen, Zhong; Shi, Xue-Min

    2012-01-01

    Stroke is one of the most common causes of death and few pharmacological therapies show benefits in ischemic stroke. In this study, 290 patients aged 40-75 years old with first onset of acute ischemic stroke (more than 24 hours but within 14 days) were treated with standard treatments, and then were randomly allocated into an intervention group (treated with resuscitating acupuncture) and a control group (treated using sham-acupoints). Primary outcome measures included Barthel Index (BI), relapse and death up to six months. For the 290 patients in both groups, one case in the intervention group died, and two cases in the control group died from the disease (p = 0.558). Six patients of the 144 cases in the intervention group had relapse, whereas 34 of 143 patients had relapse in the control group (p two groups, respectively (p two groups for the National Institute of Health Stroke Scale (NIHSS), not at two weeks (7.03 ± 3.201 vs. 8.13 ± 3.634; p = 0.067), but at four weeks (4.15 ± 2.032 vs. 6.35 ± 3.131, p Stroke Scale (CSS) at four weeks showed more improvement in the intervention group than that in the control group (9.40 ± 4.51 vs. 13.09 ± 5.80, p Stroke Specific Quality of Life Scale (SS-QOL) at six months was higher in the intervention group (166.63 ± 45.70) than the control group (143.60 ± 50.24; p < 0.01). The results of this clinical trial showed a clinically relevant decrease of relapse in patients treated with resuscitating acupuncture intervention by the end of six months, compared with needling at the sham-acupoints. The resuscitating acupuncture intervention could also improve self-care ability and quality of life, evaluated with BI, NIHSS, CSS, Oxford Handicap Scale (OHS), and SS-QOL.

  14. Nuclear safeguard assessment in nuclear power plants (NPPs) using loss function with modified random numbers

    International Nuclear Information System (INIS)

    Woo, Tae Ho

    2012-01-01

    Highlights: ► The safeguard is analyzed by quantification. ► Newly introduced SF is analyzed by the electrical power output. ► The relative value of SF is shown in the month level. ► The better operation could be indicated numerical values. ► There are several secure operation factors to be suggested. - Abstract: The energy production in nuclear power plants (NPPs) is investigated for the safeguard risk management using economic factors. The economic loss function is used for the life quality in the social and natural objects. For the basic event elements, the game theory is applied for the basic elements of the incidents in non-secure situations. The Safeguard Factor (SF) is introduced for the quantifications of simulation. The results are shown by the standard productivity comparisons with the designed power operations, which is obtained as the range of secure life extension in 2000 MW e is between 0.0000 and 9.1985 and the range in 600 MW e is between 0.0000 and 2.7600. So, the highest value in the range of secure power operation increases about 3.33 times higher than that of the interested power operation in this study, which means the safeguard assessment is quantified by the power rate in the life extension of the NPPs. The Nuclear Safeguard Protocol (NSP) is constructed for the safe operation successfully.

  15. Loss of long-range magnetic order in a nanoparticle assembly due to random anisotropy

    International Nuclear Information System (INIS)

    Binns, C; Howes, P B; Baker, S H; Marchetto, H; Potenza, A; Steadman, P; Dhesi, S S; Roy, M; Everard, M J; Rushforth, A

    2008-01-01

    We have used soft x-ray photoemission electron microscopy (XPEEM) combined with x-ray magnetic circular dichroism (XMCD) and DC SQUID (superconducting quantum interference device) magnetometry to probe the magnetic ground state in Fe thin films produced by depositing size-selected gas-phase Fe nanoparticles with a diameter of 1.7 nm (∼200 atoms) onto Si substrates. The depositions were carried out in ultrahigh vacuum conditions and thicknesses of the deposited film in the range 5-50 nm were studied. The magnetometry data are consistent with the film forming a correlated super-spin glass with a magnetic correlation length ∼5 nm. The XPEEM magnetic maps from the cluster-assembled films were compared to those for a conventional thin Fe film with a thickness of 20 nm produced by a molecular beam epitaxy (MBE) source. Whereas a normal magnetic domain structure is observed in the conventional MBE thin film, no domain structure could be observed in any of the nanoparticle films down to the resolution limit of the XMCD based XPEEM (100 nm) confirming the ground state indicated by the magnetometry measurements. This observation is consistent with the theoretical prediction that an arbitrarily weak random anisotropy field will destroy long-range magnetic order

  16. Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

    Science.gov (United States)

    Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

    2010-01-01

    In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

  17. ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

    Directory of Open Access Journals (Sweden)

    Chhangur Rabia R

    2012-10-01

    Full Text Available Abstract Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes. However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-environment interactions to obtain more insight into a moderating effects of polymorphisms on the link between parenting and child behavior, and b behavioral mechanisms that underlie these gene-(gene-environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training. In a screening, families with children aged 4–8 who show mild to (subclinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest, after 6 months (i.e., posttest, and after 10 months (i.e., follow-up. Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and

  18. Random myosin loss along thick-filaments increases myosin attachment time and the proportion of bound myosin heads to mitigate force decline in skeletal muscle

    Science.gov (United States)

    Tanner, Bertrand C.W.; McNabb, Mark; Palmer, Bradley M.; Toth, Michael J.; Miller, Mark S.

    2014-01-01

    Diminished skeletal muscle performance with aging, disuse, and disease may be partially attributed to the loss of myofilament proteins. Several laboratories have found a disproportionate loss of myosin protein content relative to other myofilament proteins, but due to methodological limitations, the structural manifestation of this protein loss is unknown. To investigate how variations in myosin content affect ensemble cross-bridge behavior and force production we simulated muscle contraction in the half-sarcomere as myosin was removed either i) uniformly, from the Z-line end of thick-filaments, or ii) randomly, along the length of thick-filaments. Uniform myosin removal decreased force production, showing a slightly steeper force-to-myosin content relationship than the 1:1 relationship that would be expected from the loss of cross-bridges. Random myosin removal also decreased force production, but this decrease was less than observed with uniform myosin loss, largely due to increased myosin attachment time (ton) and fractional cross-bridge binding with random myosin loss. These findings support our prior observations that prolonged ton may augment force production in single fibers with randomly reduced myosin content from chronic heart failure patients. These simulation also illustrate that the pattern of myosin loss along thick-filaments influences ensemble cross-bridge behavior and maintenance of force throughout the sarcomere. PMID:24486373

  19. Bright Light for Weight Loss: Results of a Controlled Crossover Trial

    Directory of Open Access Journals (Sweden)

    Konstantin V. Danilenko

    2013-02-01

    Full Text Available Objective: To investigate whether bright light treatment can reduce body mass in overweight subjects irrespective of their seasonal (= light dependence. Methods: A crossover, placebo-controlled, randomized clinical trial was performed between November and April in Novosibirsk, Russia (55° N. The trial comprised a 3-week in-home session of morning bright light treatment using a device of light-emitting diodes and a 3-week placebo session by means of a deactivated ion generator, separated by an off-protocol period of at least 23 days. The number of placebo and light sessions was matched with respect to season. Data were obtained from 34 overweight women, aged 20-54 years, 10 were seasonal-dependent according to the Seasonal Pattern Assessment Questionnaire. Weekly measures included body weight, percentage body fat by bioimpedancemetry, and subjective scores (appetite, mood, energy levels. Results: Motivation and expectation towards weight loss were similar for the two intervention sessions. With light, compared to the placebo session, weight did not reduce significantly, but percentage fat, fat mass, and appetite were significantly lower (average fat reduction 0.35 kg. The latter two results remained significant after excluding seasonal-dependent subjects from the analysis. Irrespective of the type of intervention, seasonal-dependent subjects had greater weight and fat mass changes during treatment (decline p 0.036 or between sessions (regain p 0.003. Photoperiod (p = 0.0041, air temperature to a lesser extent (p = 0.012, but not sunshine (p = 0.29 was associated with the weight change (greater weight reduction if the second session was in spring. Conclusion: Morning bright light treatment reduces body fat and appetite in overweight women and may be included in weight control programs.

  20. Results of a prospective randomized controlled trial of early ambulation for patients with lower extremity autografts.

    Science.gov (United States)

    Lorello, David John; Peck, Michael; Albrecht, Marlene; Richey, Karen J; Pressman, Melissa A

    2014-01-01

    It is common practice to keep those patients with lower extremity autografts immobile until post-operative day (POD) 5. There is however inherent risks associated with even short periods of immobility. As of now there are no randomized controlled trials looking at early ambulation of patients with lower extremity autografts in the burn community.The objective of this study was to show that patients who begin ambulation within 24 hours of lower extremity autografting will have no increased risk of graft failure than those patients who remain immobile until POD 5. Thirty-one subjects who received autografts to the lower extremity were randomized after surgery into either the early ambulation group (EAG;17 subjects) or the standard treatment group (STG;14 subjects). Those subjects randomized to the EAG began ambulating with physical therapy on POD 1. Subjects in the STG maintained bed rest until POD 5. There was no difference in the number of patients with graft loss in either the EAG or STG on POD 5, and during any of the follow-up visits. No subjects required regrafting. There was a significant difference in the mean minutes of ambulation, with the EAG ambulating longer than the STG (EAG 23.4 minutes [SD 12.03], STG 14.1 [SD 9.00], P=.0235) on POD 5. Burn patients with lower extremity autografts can safely ambulate on POD 1 without fear of graft failure compared with those patients that remain on bed rest for 5 days.

  1. Psychosocial benefits of workplace physical exercise: cluster randomized controlled trial.

    Science.gov (United States)

    Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Andersen, Lars L

    2017-10-10

    While benefits of workplace physical exercise on physical health is well known, little is known about the psychosocial effects of such initiatives. This study evaluates the effect of workplace versus home-based physical exercise on psychosocial factors among healthcare workers. A total of 200 female healthcare workers (Age: 42.0, BMI: 24.1) from 18 departments at three hospitals were cluster-randomized to 10 weeks of: 1) home-based physical exercise (HOME) performed alone during leisure time for 10 min 5 days per week or 2) workplace physical exercise (WORK) performed in groups during working hours for 10 min 5 days per week and up to 5 group-based coaching sessions on motivation for regular physical exercise. Vitality and mental health (SF-36, scale 0-100), psychosocial work environment (COPSOQ, scale 0-100), work- and leisure disability (DASH, 0-100), control- (Bournemouth, scale 0-10) and concern about pain (Pain Catastrophizing Scale, scale 0-10) were assessed at baseline and at 10-week follow-up. Vitality as well as control and concern about pain improved more following WORK than HOME (all p health remained unchanged. Between-group differences at follow-up (WORK vs. HOME) were 7 [95% confidence interval (95% CI) 3 to 10] for vitality, -0.8 [95% CI -1.3 to -0.3] for control of pain and -0.9 [95% CI -1.4 to -0.5] for concern about pain, respectively. Performing physical exercise together with colleagues during working hours was more effective than home-based exercise in improving vitality and concern and control of pain among healthcare workers. These benefits occurred in spite of increased work pace. NCT01921764 at ClinicalTrials.gov . Registered 10 August 2013.

  2. A Randomized Controlled Trial of an Eczema Care Plan.

    Science.gov (United States)

    Rea, Corinna J; Tran, Katherine D; Jorina, Maria; Wenren, Larissa M; Hawryluk, Elena B; Toomey, Sara L

    2018-03-02

    To test whether an eczema care plan (ECP) would improve provider documentation and management, decrease eczema severity, and increase patient quality of life (QOL) in the pediatric primary care setting. We conducted a randomized controlled trial from June 2015 to September 2016 at a large hospital-based pediatric primary care clinic. Participants included children from 1 month to 16 years of age with a diagnosis of eczema. The intervention group received the ECP and the control group received usual care. Both groups completed a validated eczema severity scale (Patient-Oriented Eczema Measure [POEM]) and a QOL scale (Infant's Dermatitis Quality of Life Index [IDQOL]) or Children's Dermatology Life Quality Index [CDLQI]) before the visit and again ~1 month later. A total of 211 caregivers completed both the pre- and postintervention surveys (100 control group and 111 intervention group [94% completion]). Intervention group providers were more likely to recommend a comprehensive "step-up" plan (88%) vs 28%; P plan to families (80%) vs 2%; P improved between the pre- and postintervention periods. However, there was not a significant difference between the groups on either measure: POEM difference -0.8, 95% confidence interval (CI) -3.2 to 1.7; IDQOL difference -0.1, 95% CI -1.8 to 1.6; CDLQI difference 0.8, 95% CI -0.9 to 2.6. Intervention group providers documented more comprehensive eczema care than control group providers. Although patients improved on all measures in the postintervention period, the ECP did not augment that improvement. Copyright © 2018 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  3. Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Milagros C. Rosal

    2016-09-01

    Full Text Available Abstract Background Overweight and obesity are prevalent among young women and are greater among minority and low-income women. The postpartum period is critical in women’s weight trajectories as many women do not lose their pregnancy weight, and others lose some and then plateau or experience weight gain. Excess weight puts women at greater risk of chronic disease and thus weight loss in the postpartum period may be key to the long-term health of young women. This paper describes the design and methods of a randomized clinical trial of Fresh Start, an innovative narrative-based group intervention aimed at promoting postpartum weight loss among low-income, diverse women. Methods/design Study participants were recruited from the five sites of the Women, Infants and Children (WIC program in central Massachusetts. Participants were English-speaking, age ≥ 18 years, 6 weeks to 6 months postpartum, with a body mass index (BMI ≥ 27 kg/m2. The Fresh Start postpartum weight loss intervention, adapted from the Diabetes Prevention Program (DPP in collaboration with WIC staff and clients, consisted of an 8-week group-based curriculum followed by nine monthly telephone calls. It included a narrative component (i.e., storytelling, group discussions, print materials and access to exercise facilities. The study is a two-arm randomized controlled trial. The control condition included print materials and access to exercise facilities. In-person assessments were conducted at baseline and at 6 and 12 months following the eight-week intervention phase. Discussion The Fresh Start intervention translated key elements of an evidence-based weight loss protocol into a format that is hypothesized to be relevant, acceptable and effective for the target audience of low-SES postpartum women. This novel intervention was developed in collaboration with WIC to be sustainable within the context of its clinics, which reach approximately 9 million individuals

  4. Low eddy loss axial hybrid magnetic bearing with gimballing control ability for momentum flywheel

    International Nuclear Information System (INIS)

    Tang, Jiqiang; Sun, Jinji; Fang, Jiancheng; Shuzhi Sam, Ge

    2013-01-01

    For a magnetically suspended momentum flywheel (MSMF), the spinning rotor can be tilted by a pair of the presented axial hybrid magnetic bearing (AHMB) with eight poles and rotates around the radial axes to generate a large torque to maneuver the spacecraft. To improve the control performance and gimballing control ability of the AHMB, characteristics such as magnetic suspension force, angular stiffness and tilting momentum are researched. These segmented stator poles cause the magnetic density in the thrust rotor plate to be uneven unavoidably and the rotational loss is large at high speed, but we optimized the stator poles configuration and caused the thrust rotor plate formed by bulk DT4C and laminated material to make the magnetic density in the thrust rotor plate change less and be smoother. Laminated material such as 1J50 film with a thickness of 0.1 mm can make the variation of the magnetic density in DT4C become very small and the eddy loss of it be negligible, but the stress produced in the “O” shape stacks by reeling has a bad effect on its power loss. Nanocrystalline can reduce eddy losses and is not affected by the reeling process. Based on the AHBM consisting of the stator with eight improved poles and the presented thrust rotor plate with DT4 and nanocrystalline, the rotational loss of 5-DOF magnetically suspended momentum flywheel with angular momentum of 15 N m s at 5000 rpm has reduced from 23.4 W to 3.2 W, which proved that this AHMB has low eddy loss for the gimballing control ability. - Highlights: ► Control methods of rotor driven by AHMBs and their characteristics are researched. ► Optimized stator and rotor of AHMB reduce its eddy losses greatly. ► Presented the factors affecting the eddy losses of AHMBs. ► The good performances of AHMB with low eddy loss are proved by experiments.

  5. Improving aerobic capacity through active videogames: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jorge Luiz de Brito-Gomes

    2015-09-01

    Full Text Available AbstractThe rate of peak workload improvement between different types of Active Video Games (AVG in young sedentary adults was investigated. Aerobic capacity improvement after a 6-week intervention between AVG types was also compared. Twenty participants, after baseline assessments, were randomized into one of three parallel groups: structured AVG (n= 6, unstructured AVG (n= 7 and a control group (n= 7. Participants played their respective AVG 3 times a week for 6-weeks (30 minutes-session. The control group maintained normal activities. Both structured and unstructured AVG improved peak workload after four weeks but only the structured group maintained this improvement through week five and six. Aerobic capacity improved in the unstructured (Pre: 36.0 ± 5.2ml.kg.min-¹,Post: 39.7 ± 4.9ml.kg.min-¹, p = .038 and structured AVG (Pre: 39.0 ± 5.9ml.kg.min-¹,Post: 47.8 ± 4.3ml.kg.min-¹, p = .006 groups. Structured AVG provide greater health benefits to aerobic capacity and peak workload in young sedentary but otherwise healthy males relative to unstructured AVG.

  6. Biofeedback treatment for Tourette syndrome: a preliminary randomized controlled trial.

    Science.gov (United States)

    Nagai, Yoko; Cavanna, Andrea E; Critchley, Hugo D; Stern, Jeremy J; Robertson, Mary M; Joyce, Eileen M

    2014-03-01

    To study the clinical effectiveness of biofeedback treatment in reducing tics in patients with Tourette syndrome. Despite advances in the pharmacologic treatment of patients with Tourette syndrome, many remain troubled by their tics, which may be resistant to multiple medications at tolerable doses. Electrodermal biofeedback is a noninvasive biobehavioral intervention that can be useful in managing neuropsychiatric and neurologic conditions. We conducted a randomized controlled trial of electrodermal biofeedback training in 21 patients with Tourette syndrome. After training the patients for 3 sessions a week over 4 weeks, we observed a significant reduction in tic frequency and improved indices of subjective well-being in both the active-biofeedback and sham-feedback (control) groups, but there was no difference between the groups in these measurements. Furthermore, the active-treatment group did not demonstrably learn to reduce their sympathetic electrodermal tone using biofeedback. Our findings indicate that this form of biofeedback training was unable to produce a clinical effect greater than placebo. The main confounding factor appeared to be the 30-minute duration of the training sessions, which made it difficult for patients to sustain a reduction in sympathetic tone when their tics themselves were generating competing phasic electrodermal arousal responses. Despite a negative finding in this study, electrodermal biofeedback training may have a role in managing tics if optimal training schedules can be identified.

  7. Comparison of ultrasonic shears and traditional suture ligature for vaginal hysterectomy: randomized controlled trial.

    Science.gov (United States)

    Fitz-Gerald, Alison Louise; Tan, Jason; Chan, Kok-Weng; Polyakov, Alex; Edwards, Geoff N; Najjar, Haider; Tsaltas, Jim; Vollenhoven, Beverley

    2013-01-01

    To compare operating time, intraoperative blood loss, postoperative analgesia, and length of hospital stay using ultrasonic shears vs traditional suture ligature in vaginal hysterectomy. Randomized controlled trial (Canadian Task Force classification I). Gynecology units within a single health network, university hospital. Forty women requiring vaginal hysterectomy because of benign disease. Vaginal hysterectomy performed using either ultrasonically activated shears (USS) or traditional suture ligatures. Twenty-one patients were randomized to the USS arm, and 19 patients to the traditional suture ligature arm. Patient characteristics were comparable. Mean (SD) hysterectomy time and was similar in both the USS and traditional arms, 28.66 (4.0) minutes vs 32.37 (3.18) minutes (p = .47), as was total operating time, 97.38 (8.9) minutes vs 91.63 (7.69) minutes (p = .63). Operative blood loss was significantly decreased in the USS group: 62.63 (12.46) mL vs 136.05 (21.54) mL (p = .006). There was, however, no significant change in hemoglobin concentration between the 2 groups: 19.53 (1.79) g/L vs -16.72 (2.5) g/L. There was no significant difference in mean oxycodone use: 9.29 (2.66) mg vs 8.06 (3.19) mg (p = .77). Length of hospital stay was similar in both groups: 58.98 (3.27) hours vs 60.05 (6.48) hours (p = .88). There was no significant difference in overall complication rates between the groups. Although the Harmonic scalpel system, compared with the traditional suture ligation method, seems to be a safe alternative for securing the pedicles in vaginal hysterectomy, it offers no benefit insofar as operative time, reduction in clinically significant blood loss, and analgesic requirements. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

  8. Laparoscopic Versus Open Resection for Colorectal Liver Metastases: The OSLO-COMET Randomized Controlled Trial.

    Science.gov (United States)

    Fretland, Åsmund Avdem; Dagenborg, Vegar Johansen; Bjørnelv, Gudrun Maria Waaler; Kazaryan, Airazat M; Kristiansen, Ronny; Fagerland, Morten Wang; Hausken, John; Tønnessen, Tor Inge; Abildgaard, Andreas; Barkhatov, Leonid; Yaqub, Sheraz; Røsok, Bård I; Bjørnbeth, Bjørn Atle; Andersen, Marit Helen; Flatmark, Kjersti; Aas, Eline; Edwin, Bjørn

    2018-02-01

    To perform the first randomized controlled trial to compare laparoscopic and open liver resection. Laparoscopic liver resection is increasingly used for the surgical treatment of liver tumors. However, high-level evidence to conclude that laparoscopic liver resection is superior to open liver resection is lacking. Explanatory, assessor-blinded, single center, randomized superiority trial recruiting patients from Oslo University Hospital, Oslo, Norway from February 2012 to January 2016. A total of 280 patients with resectable liver metastases from colorectal cancer were randomly assigned to undergo laparoscopic (n = 133) or open (n = 147) parenchyma-sparing liver resection. The primary outcome was postoperative complications within 30 days (Accordion grade 2 or higher). Secondary outcomes included cost-effectiveness, postoperative hospital stay, blood loss, operation time, and resection margins. The postoperative complication rate was 19% in the laparoscopic-surgery group and 31% in the open-surgery group (12 percentage points difference [95% confidence interval 1.67-21.8; P = 0.021]). The postoperative hospital stay was shorter for laparoscopic surgery (53 vs 96 hours, P < 0.001), whereas there were no differences in blood loss, operation time, and resection margins. Mortality at 90 days did not differ significantly from the laparoscopic group (0 patients) to the open group (1 patient). In a 4-month perspective, the costs were equal, whereas patients in the laparoscopic-surgery group gained 0.011 quality-adjusted life years compared to patients in the open-surgery group (P = 0.001). In patients undergoing parenchyma-sparing liver resection for colorectal metastases, laparoscopic surgery was associated with significantly less postoperative complications compared to open surgery. Laparoscopic resection was cost-effective compared to open resection with a 67% probability. The rate of free resection margins was the same in both groups. Our results support the continued

  9. Rural providers’ access to online resources: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jonathan D. Eldredge

    2016-01-01

    Full Text Available Objective: The research determined the usage and satisfaction levels with one of two point-of-care (PoC resources among health care providers in a rural state. Methods: In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants’ attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA, paired t tests, and Cohen’s d statistic to compare pre- and post-study effects sizes. Results: Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to ‘‘about right amounts of information’’ at the completion of the study. DynaMed users reported a Cohen’s d increase of þ1.50 compared to AccessMedicine users’ reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen’s d. Conclusion: Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine.

  10. Dextrose Prolotherapy for Knee Osteoarthritis: A Randomized Controlled Trial

    Science.gov (United States)

    Rabago, David; Patterson, Jeffrey J.; Mundt, Marlon; Kijowski, Richard; Grettie, Jessica; Segal, Neil A.; Zgierska, Aleksandra

    2013-01-01

    PURPOSE Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. METHODS Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. RESULTS No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. CONCLUSIONS Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises. PMID:23690322

  11. Rural providers' access to online resources: a randomized controlled trial

    Science.gov (United States)

    Hall, Laura J.; McElfresh, Karen R.; Warner, Teddy D.; Stromberg, Tiffany L.; Trost, Jaren; Jelinek, Devin A.

    2016-01-01

    Objective The research determined the usage and satisfaction levels with one of two point-of-care (PoC) resources among health care providers in a rural state. Methods In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants' attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA), paired t tests, and Cohen's d statistic to compare pre- and post-study effects sizes. Results Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to “about right amounts of information” at the completion of the study. DynaMed users reported a Cohen's d increase of +1.50 compared to AccessMedicine users' reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen's d. Conclusion Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine. PMID:26807050

  12. Effect of intermittent versus continuous energy restriction on weight loss, maintenance and cardiometabolic risk: A randomized 1-year trial.

    Science.gov (United States)

    Sundfør, T M; Svendsen, M; Tonstad, S

    2018-07-01

    Long-term adherence to conventional weight-loss diets is limited while intermittent fasting has risen in popularity. We compared the effects of intermittent versus continuous energy restriction on weight loss, maintenance and cardiometabolic risk factors in adults with abdominal obesity and ≥1 additional component of metabolic syndrome. In total 112 participants (men [50%] and women [50%]) aged 21-70 years with BMI 30-45 kg/m 2 (mean 35.2 [SD 3.7]) were randomized to intermittent or continuous energy restriction. A 6-month weight-loss phase including 10 visits with dieticians was followed by a 6-month maintenance phase without additional face-to-face counselling. The intermittent energy restriction group was advised to consume 400/600 kcal (female/male) on two non-consecutive days. Based on dietary records both groups reduced energy intake by ∼26-28%. Weight loss was similar among participants in the intermittent and continuous energy restriction groups (8.0 kg [SD 6.5] versus 9.0 kg [SD 7.1]; p = 0.6). There were favorable improvements in waist circumference, blood pressure, triglycerides and HDL-cholesterol with no difference between groups. Weight regain was minimal and similar between the intermittent and continuous energy restriction groups (1.1 kg [SD 3.8] versus 0.4 kg [SD 4.0]; p = 0.6). Intermittent restriction participants reported higher hunger scores than continuous restriction participants on a subjective numeric rating scale (4.7 [SD 2.2] vs 3.6 [SD 2.2]; p = 0.002). Both intermittent and continuous energy restriction resulted in similar weight loss, maintenance and improvements in cardiovascular risk factors after one year. However, feelings of hunger may be more pronounced during intermittent energy restriction. www.clinicaltrials.govNCT02480504. Copyright © 2018 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine

  13. History of weight control attempts among adolescent girls with loss of control eating.

    Science.gov (United States)

    Vannucci, Anna; Shomaker, Lauren B; Field, Sara E; Sbrocco, Tracy; Stephens, Mark; Kozlosky, Merel; Reynolds, James C; Yanovski, Jack A; Tanofsky-Kraff, Marian

    2014-05-01

    Loss of control (LOC) eating and a weight control attempt (WCA) history during adolescence are important behavioral risk factors for eating disorders and obesity. The current study investigated the significance of the presence of a WCA history among adolescent girls with LOC eating. Participants were 114 obesity-prevention-seeking 12-17-year-old (M = 14.5, SD = 1.7 years) girls who were between the 75th and 97th body mass index (BMI) percentile (BMI-z: M = 1.5, SD = 0.3) and reported LOC eating episodes during the previous month (M = 4.0, SD = 4.9 episodes; Median = 2.0). Measures included the Eating Disorder Examination to assess LOC eating, eating pathology, and WCA history, and self-report questionnaires for symptoms of general psychopathology. Eating behavior was observed during a laboratory meal designed to capture a LOC eating episode. 67.5% reported a WCA history. As compared to girls without a WCA history (no-WCA), those with a WCA history (WCA) had greater disordered eating attitudes and depressive symptoms (ps frequency (ps > .10). During the laboratory meal, WCA consumed less energy from snack-type foods than no-WCA (M = 245.0, SD = 156.1 vs. M = 341.6, SD = 192.3 kcal; p = .01). Reported WCAs are highly prevalent and are associated with greater psychopathology symptoms among adolescent girls with LOC eating. Prospective data are needed to determine whether these overlapping risk behaviors confer differential vulnerability for developing eating disorders and obesity. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  14. Encouraging GPs to undertake screening and a brief intervention in order to reduce problem drinking: a randomized controlled trial

    DEFF Research Database (Denmark)

    Hansen, Lars Jørgen; Olivarius, Niels de Fine; Beich, Anders

    1999-01-01

    intervention, problem drinking, randomized controlled trial, family practice, marketing of health services......intervention, problem drinking, randomized controlled trial, family practice, marketing of health services...

  15. Job maintenance through Supported Employment PLUS: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nils-Torge Telle

    2016-09-01

    Full Text Available Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58 received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41 received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention and at a 3-month follow up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.

  16. Job Maintenance through Supported Employment PLUS: A Randomized Controlled Trial.

    Science.gov (United States)

    Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram

    2016-01-01

    Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N  = 99 employees who reported mental distress due to work-related problems. The intervention group ( n  = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group ( n  = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.

  17. A Hybrid Optimization Method for Reactive Power and Voltage Control Considering Power Loss Minimization

    DEFF Research Database (Denmark)

    Liu, Chengxi; Qin, Nan; Bak, Claus Leth

    2015-01-01

    This paper proposes a hybrid optimization method to optimally control the voltage and reactive power with minimum power loss in transmission grid. This approach is used for the Danish automatic voltage control (AVC) system which is typically a non-linear non-convex problem mixed with both...

  18. Control of Refrigeration Systems for Trade-off between Energy Consumption and Food Quality Loss

    DEFF Research Database (Denmark)

    Cai, Junping

    In supermarkets, control strategies determine both the energy consumption of refrigeration systems and the quality loss of refrigerated foodstuffs. The question is, what can be done to optimize the balance between quality loss and energy consumption? This thesis tries to answer this question...... by applying two main optimization strategies to traditional refrigeration systems. The first strategy is a new defrost-on-demand scheme, which based on an objective function between quality loss and energy consumption, continuously seeks an optimal time interval for defrosting in dynamic situation. The second...... strategy is through utilization of the thermal mass of the refrigerated foodstuffs, the day-night temperature variation and the capacity control of the compressor, to realize a trade-off between system energy consumption and food quality loss....

  19. Examination of Cognitive Function During Six Months of Calorie Restriction: Results of a Randomized Controlled Trial

    Science.gov (United States)

    Martin, Corby K.; Anton, Stephen D.; Han, Hongmei; York-Crowe, Emily; Redman, Leanne M.; Ravussin, Eric; Williamson, Donald A.

    2009-01-01

    Background Calorie restriction increases longevity in many organisms, and calorie restriction or its mimetic might increase longevity in humans. It is unclear if calorie restriction/dieting contributes to cognitive impairment. During this randomized controlled trial, the effect of 6 months of calorie restriction on cognitive functioning was tested. Methods Participants (n = 48) were randomized to one of four groups: (1) control (weight maintenance), (2) calorie restriction (CR; 25% restriction), (3) CR plus structured exercise (CR + EX, 12.5% restriction plus 12.5% increased energy expenditure via exercise), or (4) low-calorie diet (LCD; 890 kcal/d diet until 15% weight loss, followed by weight maintenance). Cognitive tests (verbal memory, visual memory, attention/concentration) were conducted at baseline and months 3 and 6. Mixed linear models tested if cognitive function changed significantly from baseline to months 3 and 6, and if this change differed by group. Correlation analysis was used to determine if average daily energy deficit (quantified from change in body energy stores) was associated with change in cognitive test performance for the three dieting groups combined. Results No consistent pattern of verbal memory, visual retention/memory, or attention/concentration deficits emerged during the trial. Daily energy deficit was not significantly associated with change in cognitive test performance. Conclusions This randomized controlled trial suggests that calorie restriction/dieting was not associated with a consistent pattern of cognitive impairment. These conclusions must be interpreted in the context of study limitations, namely small sample size and limited statistical power. Previous reports of cognitive impairment might reflect sampling biases or information processing biases. PMID:17518698

  20. LIBER8 design and methods: an integrative intervention for loss of control eating among African American and White adolescent girls.

    Science.gov (United States)

    Mazzeo, Suzanne E; Kelly, Nichole R; Stern, Marilyn; Palmberg, Allison A; Belgrave, Faye Z; Tanofsky-Kraff, Marian; Latzer, Yael; Bulik, Cynthia M

    2013-01-01

    Loss of control (LOC) eating affects a significant number of adolescents of all racial and ethnic backgrounds and is associated with numerous psychosocial problems, including depression, anxiety, low self-esteem, body dissatisfaction, and weight concerns. However, empirically validated, culturally sensitive treatments for adolescents with these disordered eating behaviors are not available. This pilot project involved designing a developmentally and culturally appropriate treatment for LOC eating for adolescent girls. We intend to conduct multiple focus groups with adolescent girls who engage in LOC eating, and their primary caregivers. Data from these groups will inform the subsequent creation of a manualized treatment protocol. We will then evaluate the efficacy of this intervention (LIBER8-Linking Individuals Being Emotionally Real) to reduce LOC eating. This intervention will integrate components of dialectical behavior therapy, such as mindfulness and distress tolerance skills training, and cognitive-behavioral therapy. We will also integrate text-messaging, a key adolescent communication strategy, as a means of self-monitoring. Participants meeting study criteria will be offered participation in this 12-week randomized controlled trial comparing LIBER8 to a weight management control condition (2BFit). We hypothesize that this intervention will serve to reduce LOC eating, as well as improve psychosocial functioning as evidenced by decreased depression, anxiety, eating disorder cognitions, emotional eating, impulsivity, and improved quality of life. The feasibility and acceptability of this intervention will be extensively evaluated with the explicit intent of informing a subsequent larger randomized controlled trial. Copyright © 2012 Elsevier Inc. All rights reserved.

  1. [Ultrafiltration versus intravenous diuretics in decompensated heart failure: a meta-analysis of randomized controlled trials].

    Science.gov (United States)

    Zhao, Yu-liang; Zhang, Ling; Yang, Ying-ying; Tang, Yi; Liu, Fang; Fu, Ping

    2013-08-13

    To explore whether ultrafiltration is superior to intravenous diuretics in ameliorating fluid overload and preserving renal functions in decompensated heart failure patients. By searching in Pubmed, Cochrane Library, Embase, Springer, WanFang, CQVIP, CNKI and CBM database as well as related Chinese journals, qualified randomized controlled trials (RCTs) were included for meta-analysis by Revman 5.0 and STATA 10.0. Six RCTs were included with 241 patients in ultrafiltration group and 240 patients in intravenous diuretics group. Pooled analyses demonstrated ultrafiltration was superior to intravenous diuretics in the aspects of weight loss (WMD = 1.44 kg, 95%CI:0.33-2.55 kg, P = 0.01) and fluid removal (WMD = 1.23 kg, 95%CI:0.63-1.82 kg, P diuretics in mitigating fluid overload. No intergroup difference was observed in renal function preservation, mortality or rehospitalization.

  2. Investigation of some copolymers based on acrylic salts as circulation loss control agents

    Directory of Open Access Journals (Sweden)

    Ahmed Mohamed Alsabagh

    2013-12-01

    The prepared copolymers were investigated as loss circulation control materials by measuring different filtration parameters such as; spurt loss, fluid loss and permeability plugging tester value according to the American Petroleum Institute (API standard. From the obtained data, it was found that the 0.6% from the poly[PA-co-AM](0.4:0.6 exhibited the best results of the filtration parameters among the other copolymers. At the same time all the studied copolymers enhanced the rheological properties of the drilling mud. These results were discussed on the light of the swelling capacity of the copolymers.

  3. Effect of Mozart music on heel prick pain in preterm infants: a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Cristina Cavaiuolo

    2015-02-01

    Full Text Available Objective: The aim of this pilot study was to determine the effect of music by Mozart on heel prick procedural pain in premature infants.Background: Painful procedures are routinely performed in the setting of neonatal intensive care unit (NICU. Pain may exert short- and long-term deleterious effects on premature babies. Many non-pharmacological interventions have been proven efficacious for blunting neonatal pain.Study design: Randomized, controlled trial.Methods: The study was carried out in the NICU of the “G. Rummo” Hospital in Benevento, Italy. The sample consisted of 42 preterm infants, with no hearing loss or significant cerebral lesions on cranial ultrasound. They were randomized to receive heel lance during a music condition or a no-music control condition. We set strict criteria for selecting and delivering the music. Baseline and postprocedural heart rate and transcutaneous oxygen saturation were manually recorded. The Premature Infant Pain Profile (PIPP score was used to measure the behavioral response to prick. An unpaired t-test was performed for the intergroup comparisons.Results: There were significant differences between groups on heart rate increase, oxygen saturation reduction and PIPP score following the procedure.Conclusions: Listening to Mozart music during heel prick is a simple and inexpensive tool for pain alleviating in preterm stable neonates.

  4. Arginine and antioxidant supplement on performance in elderly male cyclists: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Carpenter Catherine L

    2010-03-01

    Full Text Available Abstract Background Human exercise capacity declines with advancing age. These changes often result in loss of physical fitness and more rapid senescence. Nitric oxide (NO has been implicated in improvement of exercise capacity through vascular smooth muscle relaxation in both coronary and skeletal muscle arteries, as well as via independent mechanisms. Antioxidants may prevent nitric oxide inactivation by oxygen free radicals. The purpose of this study was to investigate the effects of an L-arginine and antioxidant supplement on exercise performance in elderly male cyclists. Methods This was a two-arm prospectively randomized double-blinded and placebo-controlled trial. Sixteen male cyclists were randomized to receive either a proprietary supplement (Niteworks®, Herbalife International Inc., Century City, CA or a placebo powder. Exercise parameters were assessed by maximal incremental exercise testing performed on a stationary cycle ergometer using breath-by-breath analysis at baseline, week one and week three. Results There was no difference between baseline exercise parameters. In the supplemented group, anaerobic threshold increased by 16.7% (2.38 ± 0.18 L/min, p 2 max between control and intervention groups at either week 1 or week 3 by comparison to baseline. Conclusion An arginine and antioxidant-containing supplement increased the anaerobic threshold at both week one and week three in elderly cyclists. No effect on VO2 max was observed. This study indicated a potential role of L-arginine and antioxidant supplementation in improving exercise performance in elderly.

  5. Motivation by potential gains and losses affects control processes via different mechanisms in the attentional network.

    Science.gov (United States)

    Paschke, Lena M; Walter, Henrik; Steimke, Rosa; Ludwig, Vera U; Gaschler, Robert; Schubert, Torsten; Stelzel, Christine

    2015-05-01

    Attentional control in demanding cognitive tasks can be improved by manipulating the motivational state. Motivation to obtain gains and motivation to avoid losses both usually result in faster reaction times and stronger activation in relevant brain areas such as the prefrontal cortex, but little is known about differences in the underlying neurocognitive mechanisms of these types of motivation in an attentional control context. In the present functional magnetic resonance imaging (fMRI) study, we tested whether potential gain and loss as motivating incentives lead to overlapping or distinct neural effects in the attentional network, and whether one of these conditions is more effective than the other. A Flanker task with word stimuli as targets and distracters was performed by 115 healthy participants. Using a mixed blocked and event-related design allowed us to investigate transient and sustained motivation-related effects. Participants could either gain money (potential gain) or avoid losing money (potential loss) in different task blocks. Participants showed a congruency effect with increased reaction times for incongruent compared to congruent trials. Potential gain led to generally faster responses compared to the neutral condition and to stronger improvements than potential loss. Potential loss also led to shorter response times compared to the neutral condition, but participants improved mainly during incongruent and not during congruent trials. The event-related fMRI data revealed a main effect of congruency with increased activity in the left inferior frontal gyrus (IFG) and inferior frontal junction area (IFJ), the pre-supplementary motor area (pre-SMA), bilateral insula, intraparietal sulcus (IPS) and visual word form area (VWFA). While potential gain led to increased activity in a cluster of the IFJ and the VWFA only during incongruent trials, potential loss was linked to activity increases in these regions during incongruent and congruent trials. The

  6. Naturopathic care for anxiety: a randomized controlled trial ISRCTN78958974.

    Directory of Open Access Journals (Sweden)

    Kieran Cooley

    Full Text Available BACKGROUND: Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial. METHODS: Employees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC (n = 41 or standardized psychotherapy intervention (PT (n = 40 over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (Withania somnifera (300 mg b.i.d. standardized to 1.5% with anolides, prepared from root. The PT intervention received psychotherapy, and matched deep breathing relaxation techniques, and placebo. The primary outcome measure was the Beck Anxiety Inventory (BAI and secondary outcome measures included the Short Form 36 (SF-36, Fatigue Symptom Inventory (FSI, and Measure Yourself Medical Outcomes Profile (MY-MOP to measure anxiety, mental health, and quality of life respectively. Participants were blinded to the placebo-controlled intervention. RESULTS: Seventy-five participants (93% were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (p<0.0001 in the NC group and 30.5% (p<0.0001 in the PT group. BAI group scores were significantly decreased in the NC group compared to PT group (p = 0.003. Significant differences between groups were also observed in mental health, concentration, fatigue, social functioning, vitality, and overall quality of life with the NC group exhibiting greater clinical benefit. No serious adverse reactions

  7. The role of prophylactic internal iliac artery ligation in abnormally invasive placenta undergoing caesarean hysterectomy: a randomized control trial.

    Science.gov (United States)

    Hussein, Ahmed M; Dakhly, Dina Mohamed Refaat; Raslan, Ayman N; Kamel, Ahmed; Abdel Hafeez, Ali; Moussa, Manal; Hosny, Ahmed Samir; Momtaz, Mohamed

    2018-04-25

    To identify the role of bilateral internal iliac artery (IIA) ligation on reducing blood loss in abnormally invasive placenta (AIP) undergoing caesarean hysterectomy. In this parallel-randomized control trial, 57 pregnant females with ultrasound features suggestive of AIP were enrolled. They were randomized into two groups; IIA group (n = 29 cases) performed bilateral IIA ligation followed by caesarean hysterectomies, while Control group (n = 28 cases) underwent caesarean hysterectomy only. The main outcome was the difference in the estimated intraoperative blood loss between the two groups. There was no significant difference between the two groups regarding the intraoperative estimated blood loss (1632 ± 804 versus 1698 ± 1251, p value .83). The operative procedure duration (minutes) (223 ± 66 versus 171 ± 41.4, p value .001) varied significantly between the two groups. Bilateral internal iliac artery ligation, in cases of AIP undergoing caesarean hysterectomy, is not recommended for routine practice to minimize blood loss intraoperatively.

  8. Asthma and obesity: does weight loss improve asthma control? a systematic review

    Directory of Open Access Journals (Sweden)

    Juel CTB

    2012-06-01

    Full Text Available Caroline Trunk-Black Juel,1 Zarqa Ali,1 Lisbeth Nilas,2 Charlotte Suppli Ulrik11Respiratory Section, Internal Medicine Unit, 2Department of Obstetrics and Gynaecology, Hvidovre Hospital and University of Copenhagen, Hvidovre, DenmarkAim and methods: Obesity is a major health problem, and obesity is associated with a high incidence of asthma and poor asthma control. The aim of the present paper is to systematically review the current knowledge of the effect on overall asthma control of weight reduction in overweight and obese adults with asthma.Results: Weight loss in obese individuals with doctor-diagnosed asthma is associated with a 48%–100% remission of asthma symptoms and use of asthma medication. Published studies, furthermore, reveal that weight loss in obese asthmatics improves asthma control, and that especially surgically induced weight loss results in significant improvements in asthma severity, use of asthma medication, dyspnoea, exercise tolerance, and acute exacerbations, including hospitalizations due to asthma. Furthermore, weight loss in obese asthmatics is associated with improvements in level of lung function and airway responsiveness to inhaled methacholine, whereas no significant improvements have been observed in exhaled nitric oxide or other markers of eosinophilic airway inflammation.Conclusion: Overweight and obese adults with asthma experience a high symptomatic remission rate and significant improvements in asthma control, including objective measures of disease activity, after weight loss. Although these positive effects of weight loss on asthma-related health outcomes seem not to be accompanied by remission or improvements in markers of eosinophilic airway inflammation, it has potentially important implications for the future burden of asthma.Keywords: asthma, weight loss, diet, bariatric surgery, asthma control

  9. A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. Methods This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. Results This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight −0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2, p yoga intervention and walking control over the course of the study. Conclusion Among Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing

  10. Eye Movement Training and Suggested Gaze Strategies in Tunnel Vision - A Randomized and Controlled Pilot Study.

    Science.gov (United States)

    Ivanov, Iliya V; Mackeben, Manfred; Vollmer, Annika; Martus, Peter; Nguyen, Nhung X; Trauzettel-Klosinski, Susanne

    2016-01-01

    Degenerative retinal diseases, especially retinitis pigmentosa (RP), lead to severe peripheral visual field loss (tunnel vision), which impairs mobility. The lack of peripheral information leads to fewer horizontal eye movements and, thus, diminished scanning in RP patients in a natural environment walking task. This randomized controlled study aimed to improve mobility and the dynamic visual field by applying a compensatory Exploratory Saccadic Training (EST). Oculomotor responses during walking and avoiding obstacles in a controlled environment were studied before and after saccade or reading training in 25 RP patients. Eye movements were recorded using a mobile infrared eye tracker (Tobii glasses) that measured a range of spatial and temporal variables. Patients were randomly assigned to two training conditions: Saccade (experimental) and reading (control) training. All subjects who first performed reading training underwent experimental training later (waiting list control group). To assess the effect of training on subjects, we measured performance in the training task and the following outcome variables related to daily life: Response Time (RT) during exploratory saccade training, Percent Preferred Walking Speed (PPWS), the number of collisions with obstacles, eye position variability, fixation duration, and the total number of fixations including the ones in the subjects' blind area of the visual field. In the saccade training group, RTs on average decreased, while the PPWS significantly increased. The improvement persisted, as tested 6 weeks after the end of the training. On average, the eye movement range of RP patients before and after training was similar to that of healthy observers. In both, the experimental and reading training groups, we found many fixations outside the subjects' seeing visual field before and after training. The average fixation duration was significantly shorter after the training, but only in the experimental training condition

  11. Puberty and the manifestations of loss of control eating in children and adolescents.

    Science.gov (United States)

    Vannucci, Anna; Tanofsky-Kraff, Marian; Ranzenhofer, Lisa M; Kelly, Nichole R; Hannallah, Louise M; Pickworth, C Katie; Grygorenko, Mariya V; Brady, Sheila M; Condarco, Tania A; Kozlosky, Merel; Demidowich, Andrew P; Yanovski, Susan Z; Shomaker, Lauren B; Yanovski, Jack A

    2014-11-01

    We investigated the manifestations of pediatric loss of control (LOC) eating at different stages of pubertal development. Participants were a nonclinical sample of 468 youth (8-17 years). Physical examination determined pubertal stage. LOC eating and disordered eating attitudes were assessed with the Eating Disorder Examination. In a randomized crossover design, a subset (n = 244) ate ad libitum from two test meals designed to capture normal and LOC eating. There were no differences in the prevalence rates or frequency of reported LOC eating episodes across pubertal stages (ps ≥ 0.50). There were, however, puberty by LOC eating interactions in disordered eating attitudes and palatable food consumption (ps ≤ .05), even after adjusting for age and body composition. LOC eating was associated with elevated global disordered eating attitudes, weight concern, and shape concern in post-pubertal youth (ps ≤ .001), but not pre-pubertal youth (ps ≥ .49). In late-puberty, youth with LOC eating consumed less energy from protein (p puberty was not associated with differences in eating behavior (ps ≥ 0.20). Findings suggest that puberty may be a critical risk period, when LOC eating behaviors in boys and girls may become accompanied by greater weight and shape concerns and more obesogenic food consumption patterns. Interventions for LOC eating during pre-puberty should be evaluated to determine if they are particularly beneficial for the prevention of exacerbated eating disorder psychopathology and adverse weight outcomes. © 2014 Wiley Periodicals, Inc.

  12. Treatment for symptomatic bacterial vaginosis: a randomized controlled trial

    International Nuclear Information System (INIS)

    Tariq, N.; Basharat, A.; Fahim, A.

    2017-01-01

    Objective: To compare the efficacy of multiple doses of vaginal clindamycin with a single oral dose of secnidazole for the treatment of bacterial vaginosis. Study Design: Double-blinded randomized controlled trial. Place and Duration of Study: Shifa Foundation Community Health Center, from March 2012 till February 2015. Methodology: After obtaining written informed consent, a pelvic examination was performed for the confirmation of symptoms of milky white vaginal discharge on speculum examination, positive Amine test and presence of clue cells on microscopy. Pregnant women, known diabetes or any immunocompromised condition, were excluded. Blinding of the patient, doctor, and the pharmacist was done. Study cohort was then divided into two groups, Group A received medicine pack A which contained active clindamycin and placebo oral preparation, whereas group B was given pack B which contained active 2-gm secnidazole with placebo vaginal cream. Primary outcome and therapeutic success were defined by correction of two out of three (normal Nugent score, negative Amine test, and no milky white discharge) on day 15. Results: At 15th day of treatment, 96.6% participants in vaginal clindamycin group (Group A), recovered from the bacterial vaginosis; whereas, (group B) 23% patients were cured in oral secnidazole group. Conclusion: Multiple doses of vaginal clindamycin are superior to single dose of oral secnidazole for the treatment of bacterial vaginosis. (author)

  13. Prenatal docosahexaenoic acid supplementation and infant morbidity: randomized controlled trial.

    Science.gov (United States)

    Imhoff-Kunsch, Beth; Stein, Aryeh D; Martorell, Reynaldo; Parra-Cabrera, Socorro; Romieu, Isabelle; Ramakrishnan, Usha

    2011-09-01

    Long-chain polyunsaturated fatty acids such as docosahexaenoic acid (DHA) influence immune function and inflammation; however, the influence of maternal DHA supplementation on infant morbidity is unknown. We investigated the effects of prenatal DHA supplementation on infant morbidity. In a double-blind randomized controlled trial conducted in Mexico, pregnant women received daily supplementation with 400 mg of DHA or placebo from 18 to 22 weeks' gestation through parturition. In infants aged 1, 3, and 6 months, caregivers reported the occurrence of common illness symptoms in the preceding 15 days. Data were available at 1, 3, and 6 months for 849, 834, and 834 infants, respectively. The occurrence of specific illness symptoms did not differ between groups; however, the occurrence of a combined measure of cold symptoms was lower in the DHA group at 1 month (OR: 0.76; 95% CI: 0.58-1.00). At 1 month, the DHA group experienced 26%, 15%, and 30% shorter duration of cough, phlegm, and wheezing, respectively, but 22% longer duration of rash (all P ≤ .01). At 3 months, infants in the DHA group spent 14% less time ill (P DHA group experienced 20%, 13%, 54%, 23%, and 25% shorter duration of fever, nasal secretion, difficulty breathing, rash, and "other illness," respectively, but 74% longer duration of vomiting (all P DHA supplementation during pregnancy decreased the occurrence of colds in children at 1 month and influenced illness symptom duration at 1, 3, and 6 months.

  14. Measurement model choice influenced randomized controlled trial results.

    Science.gov (United States)

    Gorter, Rosalie; Fox, Jean-Paul; Apeldoorn, Adri; Twisk, Jos

    2016-11-01

    In randomized controlled trials (RCTs), outcome variables are often patient-reported outcomes measured with questionnaires. Ideally, all available item information is used for score construction, which requires an item response theory (IRT) measurement model. However, in practice, the classical test theory measurement model (sum scores) is mostly used, and differences between response patterns leading to the same sum score are ignored. The enhanced differentiation between scores with IRT enables more precise estimation of individual trajectories over time and group effects. The objective of this study was to show the advantages of using IRT scores instead of sum scores when analyzing RCTs. Two studies are presented, a real-life RCT, and a simulation study. Both IRT and sum scores are used to measure the construct and are subsequently used as outcomes for effect calculation. The bias in RCT results is conditional on the measurement model that was used to construct the scores. A bias in estimated trend of around one standard deviation was found when sum scores were used, where IRT showed negligible bias. Accurate statistical inferences are made from an RCT study when using IRT to estimate construct measurements. The use of sum scores leads to incorrect RCT results. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Electrical stimulation enhances sensory recovery: a randomized controlled trial.

    Science.gov (United States)

    Wong, Joshua N; Olson, Jaret L; Morhart, Michael J; Chan, K Ming

    2015-06-01

    Brief postsurgical electrical stimulation (ES) has been shown to enhance peripheral nerve regeneration in animal models following axotomy and crush injury. However, whether this treatment is beneficial in humans with sensory nerve injury has not been tested. The goal of this study was to test the hypothesis that ES would enhance sensory nerve regeneration following digital nerve transection compared to surgery alone. Patients with complete digital nerve transection underwent epineurial nerve repair. After coaptation of the severed nerve ends, fine wire electrodes were implanted before skin closure. Postoperatively, patients were randomized to receiving either 1 hour of 20Hz continuous ES or sham stimulation in a double-blinded manner. Patients were followed monthly for 6 months by a blinded evaluator to monitor physiological recovery of spatial discrimination, pressure threshold, and quantitative small fiber sensory testing. Functional disability was measured using the Disability of Arm, Shoulder, and Hand questionnaire. A total of 36 patients were recruited, with 18 in each group. Those in the ES group showed consistently greater improvements in all sensory modalities by 5 to 6 months postoperatively compared to the controls. Although there was a trend of greater functional improvements in the ES group, it was not statistically significant (p > 0.01). Postsurgical ES enhanced sensory reinnervation in patients who sustained complete digital nerve transection. The conferred benefits apply to a wide range of sensory functions. © 2015 American Neurological Association.

  16. Validating Obstetric Emergency Checklists using Simulation: A Randomized Controlled Trial.

    Science.gov (United States)

    Bajaj, Komal; Rivera-Chiauzzi, Enid Y; Lee, Colleen; Shepard, Cynthia; Bernstein, Peter S; Moore-Murray, Tanya; Smith, Heather; Nathan, Lisa; Walker, Katie; Chazotte, Cynthia; Goffman, Dena

    2016-10-01

    Background The World Health Organization's Surgical Safety Checklist has demonstrated significant reduction in surgical morbidity. The American Congress of Obstetricians and Gynecologists District II Safe Motherhood Initiative (SMI) safety bundles include eclampsia and postpartum hemorrhage (PPH) checklists. Objective To determine whether use of the SMI checklists during simulated obstetric emergencies improved completion of critical actions and to elicit feedback to facilitate checklist revision. Study Design During this randomized controlled trial, teams were assigned to use a checklist during one of two emergencies: eclampsia and PPH. Raters scored teams on critical step completion. Feedback was elicited through structured debriefing. Results In total, 30 teams completed 60 scenarios. For eclampsia, trends toward higher completion were noted for blood pressure and airway management. For PPH, trends toward higher completion rates were noted for PPH stage assessment and fundal massage. Feedback resulted in substantial checklist revision. Participants were enthusiastic about using checklists in a clinical emergency. Conclusion Despite trends toward higher rates of completion of critical tasks, teams using checklists did not approach 100% task completion. Teams were interested in the application of checklists and provided feedback necessary to substantially revise the checklists. Intensive implementation planning and training in use of the revised checklists will result in improved patient outcomes. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  17. Efficacy of Exercise for Menopausal Symptoms: A Randomized Controlled Trial

    Science.gov (United States)

    Sternfeld, Barbara; Guthrie, Katherine A.; Ensrud, Kristine E.; LaCroix, Andrea Z.; Larson, Joseph C.; Dunn, Andrea L.; Anderson, Garnet L.; Seguin, Rebecca A.; Carpenter, Janet S.; Newton, Katherine M.; Reed, Susan D.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Roberts, Melanie; Caan, Bette J.

    2013-01-01

    OBJECTIVE To determine efficacy of exercise training for alleviating vasomotor and other menopausal symptoms. METHODS Late-peri and post-menopausal, sedentary women with frequent vasomotor symptoms (VMS) participated in a randomized controlled trial conducted at three sites: 106 to exercise and 142 to usual activity. The exercise intervention consisted of individual, facility-based aerobic exercise training 3 times/week for 12 weeks. VMS frequency and bother were recorded on daily diaries at baseline and weeks 6 and 12. Intent to treat analyses compared between group differences in changes in VMS frequency and bother, sleep symptoms (Insomnia Severity Index, Pittsburgh Sleep Quality Index) and mood (Patient Health Questionnaire-8 and Generalized Anxiety Disorder-7 questionnaire). RESULTS At the end of week 12, changes in VMS frequency in the exercise group (mean change of −2.4/day, 95% CI −3.0, −1.7) and VMS bother (mean change of −0.5 on a 4 point scale, 95% CI −0.6, −0.4) were not significantly different from those in the control group (−2.6 VMS/day, 95% CI −3.2, −2.0, p=0.43; −0.5 points, 95% CI −0.6, −0.4, p=0.75). The exercise group reported greater improvement in insomnia symptoms (p=0.03), subjective sleep quality (p=0.01), and depressive symptoms (p=0.04), but differences were small and not statistically significant when p values were adjusted for multiple comparisons. Results were similar when considering treatment-adherent women only. CONCLUSION These findings provide strong evidence that 12-weeks of moderate-intensity aerobic exercise does not alleviate VMS but may result in small improvements in sleep quality, insomnia and depression in midlife, sedentary women. PMID:23899828

  18. The Dietary Intervention to Enhance Tracking with Mobile Devices (DIET Mobile) Study: A 6-Month Randomized Weight Loss Trial.

    Science.gov (United States)

    Turner-McGrievy, Gabrielle M; Wilcox, Sara; Boutté, Alycia; Hutto, Brent E; Singletary, Camelia; Muth, Eric R; Hoover, Adam W

    2017-08-01

    To examine the use of two different mobile dietary self-monitoring methods for weight loss. Adults with overweight (n = 81; mean BMI 34.7 ± 5.6 kg/m 2 ) were randomized to self-monitor their diet with a mobile app (App, n = 42) or wearable Bite Counter device (Bite, n = 39). Both groups received the same behavioral weight loss information via twice-weekly podcasts. Weight, physical activity (International Physical Activity Questionnaire), and energy intake (two dietary recalls) were assessed at 0, 3, and 6 months. At 6 months, 75% of participants completed the trial. The App group lost significantly more weight (-6.8 ± 0.8 kg) than the Bite group (-3.0 ± 0.8 kg; group × time interaction: P < 0.001). Changes in energy intake (kcal/d) (-621 ± 157 App, -456 ± 167 Bite; P = 0.47) or number of days diet was tracked (90.7 ± 9.1 App, 68.4 ± 9.8 Bite; P = 0.09) did not differ between groups, but the Bite group had significant increases in physical activity metabolic equivalents (+2015.4 ± 684.6 min/wk; P = 0.02) compared to little change in the App group (-136.5 ± 630.6; P = 0.02). Total weight loss was significantly correlated with number of podcasts downloaded (r = -0.33, P < 0.01) and number of days diet was tracked (r = -0.33, P < 0.01). While frequency of diet tracking was similar between the App and Bite groups, there was greater weight loss observed in the App group. © 2017 The Obesity Society.

  19. Effects of a resistance training program on balance and fatigue perception in patients with Parkinson's disease: A randomized controlled trial.

    Science.gov (United States)

    Ortiz-Rubio, Araceli; Cabrera-Martos, Irene; Torres-Sánchez, Irene; Casilda-López, Jesús; López-López, Laura; Valenza, Marie Carmen

    2017-11-22

    Fatigue and balance impairment leads to a loss of independence and are important to adequately manage. The objective of this study was to examine the effects of a resistance training program on dynamic balance and fatigue in patients with Parkinson's disease (PD). Randomized controlled trial. Forty-six patients with PD were randomly allocated to an intervention group receiving a 8-week resistance training program focused on lower limbs or to a control group. Balance was assessed using the Mini-BESTest and fatigue was assessed by the Piper Fatigue Scale. Patients in the intervention group improved significantly (p<0.05) on dynamic balance (reactive postural control and total values) and perceived fatigue. An 8-week resistance training program was found to be effective at improving dynamic balance and fatigue in patients with PD. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  20. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

  1. Postural control assessment in students with normal hearing and sensorineural hearing loss.

    Science.gov (United States)

    Melo, Renato de Souza; Lemos, Andrea; Macky, Carla Fabiana da Silva Toscano; Raposo, Maria Cristina Falcão; Ferraz, Karla Mônica

    2015-01-01

    Children with sensorineural hearing loss can present with instabilities in postural control, possibly as a consequence of hypoactivity of their vestibular system due to internal ear injury. To assess postural control stability in students with normal hearing (i.e., listeners) and with sensorineural hearing loss, and to compare data between groups, considering gender and age. This cross-sectional study evaluated the postural control of 96 students, 48 listeners and 48 with sensorineural hearing loss, aged between 7 and 18 years, of both genders, through the Balance Error Scoring Systems scale. This tool assesses postural control in two sensory conditions: stable surface and unstable surface. For statistical data analysis between groups, the Wilcoxon test for paired samples was used. Students with hearing loss showed more instability in postural control than those with normal hearing, with significant differences between groups (stable surface, unstable surface) (ppostural control compared to normal hearing students of the same gender and age. Copyright © 2014 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  2. Synthesis for robust synchronization of chaotic systems under output feedback control with multiple random delays

    International Nuclear Information System (INIS)

    Wen Guilin; Wang Qingguo; Lin Chong; Han Xu; Li Guangyao

    2006-01-01

    Synchronization under output feedback control with multiple random time delays is studied, using the paradigm in nonlinear physics-Chua's circuit. Compared with other synchronization control methods, output feedback control with multiple random delay is superior for a realistic synchronization application to secure communications. Sufficient condition for global stability of delay-dependent synchronization is established based on the LMI technique. Numerical simulations fully support the analytical approach, in spite of the random delays

  3. Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

    Science.gov (United States)

    Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

    2012-12-24

    Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

  4. Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial

    Directory of Open Access Journals (Sweden)

    Mash Bob

    2012-12-01

    Full Text Available Abstract Background Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Methods Trial design: Pragmatic cluster randomized controlled trial Participants: Type 2 diabetic patients attending 45 public sector community health centres in Cape Town Interventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. Objective: To evaluate the effectiveness of the group diabetes education programme Outcomes: Primary outcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. Secondary outcomes: self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of life Randomisation: Computer generated random numbers Blinding: Patients, health promoters and research assistants could not be blinded to the health centre’s allocation Numbers randomized: Seventeen health centres (34 in total will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. Discussion The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can

  5. Effect of Alternate-Day Fasting on Weight Loss, Weight Maintenance, and Cardioprotection Among Metabolically Healthy Obese Adults: A Randomized Clinical Trial.

    Science.gov (United States)

    Trepanowski, John F; Kroeger, Cynthia M; Barnosky, Adrienne; Klempel, Monica C; Bhutani, Surabhi; Hoddy, Kristin K; Gabel, Kelsey; Freels, Sally; Rigdon, Joseph; Rood, Jennifer; Ravussin, Eric; Varady, Krista A

    2017-07-01

    Alternate-day fasting has become increasingly popular, yet, to date, no long-term randomized clinical trials have evaluated its efficacy. To compare the effects of alternate-day fasting vs daily calorie restriction on weight loss, weight maintenance, and risk indicators for cardiovascular disease. A single-center randomized clinical trial of obese adults (18 to 64 years of age; mean body mass index, 34) was conducted between October 1, 2011, and January 15, 2015, at an academic institution in Chicago, Illinois. Participants were randomized to 1 of 3 groups for 1 year: alternate-day fasting (25% of energy needs on fast days; 125% of energy needs on alternating "feast days"), calorie restriction (75% of energy needs every day), or a no-intervention control. The trial involved a 6-month weight-loss phase followed by a 6-month weight-maintenance phase. The primary outcome was change in body weight. Secondary outcomes were adherence to the dietary intervention and risk indicators for cardiovascular disease. Among the 100 participants (86 women and 14 men; mean [SD] age, 44 [11] years), the dropout rate was highest in the alternate-day fasting group (13 of 34 [38%]), vs the daily calorie restriction group (10 of 35 [29%]) and control group (8 of 31 [26%]). Mean weight loss was similar for participants in the alternate-day fasting group and those in the daily calorie restriction group at month 6 (-6.8% [95% CI, -9.1% to -4.5%] vs -6.8% [95% CI, -9.1% to -4.6%]) and month 12 (-6.0% [95% CI, -8.5% to -3.6%] vs -5.3% [95% CI, -7.6% to -3.0%]) relative to those in the control group. Participants in the alternate-day fasting group ate more than prescribed on fast days, and less than prescribed on feast days, while those in the daily calorie restriction group generally met their prescribed energy goals. There were no significant differences between the intervention groups in blood pressure, heart rate, triglycerides, fasting glucose, fasting insulin, insulin resistance, C

  6. Fundamental movement skills in preschoolers: a randomized controlled trial targeting object control proficiency.

    Science.gov (United States)

    Donath, L; Faude, O; Hagmann, S; Roth, R; Zahner, L

    2015-11-01

    Adequately developed fundamental movement skills, particularly object control dimensions, are considered essential to learn more complex movement patterns and to increase the likelihood to successfully participate in organized and non-organized sports during later years. Thus, the present randomized controlled trial aimed at improving object control dimensions at an early state in a kindergarten setting. Catching, throwing, kicking, rolling and stationary dribbling were assessed via gross motor development 2 (TGMD-2) testing in 41 normally developed preschoolers. On a cluster-randomized basis [strata: age, sex and body mass index (BMI)], three kindergartens were randomly assigned to an intervention group (n = 22, INT, age: 4.6 ± 1.0 years; BMI: 16.2 ± 1.1 kg/m(2) ) and three to a control group (n = 19, CON: age: 4.5 ± 1.2 years; BMI: 16.8 ± 1.2 kg/m(2) ). Twelve structured training sessions were given within 6 weeks (12 sessions). The total training volume was 330 min. Moderate time × group interaction were observed for the total sum score (Δ+22%, P = 0.05) and dribbling (Δ+41%, P = 0.002). Adjusting for baseline differences analyses of covariance did not affect these results. Interestingly, likely to most likely practically worthwhile effects were detected for the total sum score, catching and dribbling. Object control dimensions such as dribbling and catching that apparently rely on rhythmical movement patterns and anticipatory eye-hand coordination seem to benefit from short-term object control training. These skills are considered important for successful team-sport participation and appropriate sportive motor development. © 2015 John Wiley & Sons Ltd.

  7. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients

    DEFF Research Database (Denmark)

    Husted, Henrik; Blønd, Lars; Sonne-Holm, Stig

    2003-01-01

    INTRODUCTION: We performed a prospective, randomized, double-blind study on 40 patients scheduled for primary total hip arthroplasty due to arthrosis or osteonecrosis to determine the effect of tranexamic acid on per- and postoperative blood losses and on the number of blood transfusions needed....... PATIENTS AND METHODS: 40 patients were randomized to tranexamic acid (10 mg/kg given as a bolus intravenous injection, followed by a continuous infusion of 1 mg/kg/hour for 10 hours) or placebo (20 mL saline given intravenously) 15 minutes before the incision. We recorded the peroperative and postoperative...... blood losses at removal of the drain 24 hours after the operation and the number of blood transfusions. RESULTS: Patients receiving tranexamic acid had a mean peroperative blood loss of 480 mL versus 622 mL in patients receiving placebo (p = 0.3), a postoperative blood loss of 334 mL versus 609 mL (p...

  8. Efficacy of paraffin bath therapy in hand osteoarthritis: a single-blinded randomized controlled trial.

    Science.gov (United States)

    Dilek, Banu; Gözüm, Mehtap; Şahin, Ebru; Baydar, Meltem; Ergör, Gül; El, Ozlem; Bircan, Çigdem; Gülbahar, Selmin

    2013-04-01

    To evaluate the efficacy of paraffin bath therapy on pain, function, and muscle strength in patients with hand osteoarthritis. Prospective single-blinded randomized controlled trial. Department of physical medicine and rehabilitation in a university hospital. Patients with bilateral hand osteoarthritis (N=56). Patients were randomized into 2 groups with a random number table by using block randomization with 4 patients in a block. Group 1 (n=29) had paraffin bath therapy (5 times per week, for 3-week duration) for both hands. Group 2 (n=27) was the control group. All patients were informed about joint-protection techniques, and paracetamol intake was recorded. The primary outcome measures were pain (at last 48h) at rest and during activities of daily living (ADL), assessed with a visual analog scale (0-10cm) at 12 weeks. The secondary outcome measures were the Australian Canadian Osteoarthritis Hand Index (AUSCAN) and the Dreiser Functional Index (DFI), used for subjective functional evaluation, loss of range of motion (ROM), grip and pinch strength, painful and tender joint counts, and paracetamol intake. A researcher blind to group allocation recorded the measures for both hands at baseline, 3 weeks, and 12 weeks at the hospital setting. At baseline, there were no significant differences between groups in any of the parameters (P>.05). After treatment, the paraffin group exhibited significant improvement in pain at rest and during ADL, ROM of the right hand, and pain and stiffness dimensions of the AUSCAN (P.05). The control group showed a significant deterioration in right hand grip and bilateral lateral pinch and right chuck pinch strength (Pparaffin group (Pparaffin group were significantly higher than the control group at 12 weeks (PParaffin bath therapy seemed to be effective both in reducing pain and tenderness and maintaining muscle strength in hand osteoarthritis. It may be regarded as a beneficial short-term therapy option, which is effective for a 12

  9. Cost--effectiveness analysis of salpingectomy prior to IVF, based on a randomized controlled trial.

    Science.gov (United States)

    Strandell, Annika; Lindhard, Anette; Eckerlund, Ingemar

    2005-12-01

    In patients with ultrasound-visible hydrosalpinges, salpingectomy prior to IVF increases the chance of a live birth. This study compared the cost-effectiveness of this strategy (intervention) with that of optional salpingectomy after a failed cycle (control). Data from a Scandinavian randomized controlled trial were used to calculate the individual number of treatments and their outcomes. Only patients with ultrasound-visible hydrosalpinges were considered in the main analysis, and a maximum of three fresh cycles were included. The costs for surgical procedures, IVF treatment, medication, complications, management of pregnancy and delivery as well as of early pregnancy losses were calculated from standardized hospital charges. Among the 51 patients in the intervention group, the live birth rate was 60.8% compared with 40.9% in 44 controls. The average cost per patient was 13,943 euro and 12,091 euro, respectively. Thus, the average cost per live birth was 22,823 euro in the intervention group and 29,517 euro in the control group. The incremental cost-effectiveness ratio for adopting the intervention strategy was estimated at 9306 euro. The incremental cost to achieve the higher birth rate of the intervention strategy seems reasonable.

  10. Randomised, double-blinded, placebo-controlled, clinical trial of ozone therapy as treatment of sudden sensorineural hearing loss.

    Science.gov (United States)

    Ragab, A; Shreef, E; Behiry, E; Zalat, S; Noaman, M

    2009-01-01

    To investigate the safety and efficacy of ozone therapy in adult patients with sudden sensorineural hearing loss. Prospective, randomised, double-blinded, placebo-controlled, parallel group, clinical trial. Forty-five adult patients presented with sudden sensorineural hearing loss, and were randomly allocated to receive either placebo (15 patients) or ozone therapy (auto-haemotherapy; 30 patients). For the latter treatment, 100 ml of the patient's blood was treated immediately with a 1:1 volume, gaseous mixture of oxygen and ozone (from an ozone generator) and re-injected into the patient by intravenous infusion. Treatments were administered twice weekly for 10 sessions. The following data were recorded: pre- and post-treatment mean hearing gains; air and bone pure tone averages; speech reception thresholds; speech discrimination scores; and subjective recovery rates. Significant recovery was observed in 23 patients (77 per cent) receiving ozone treatment, compared with six (40 per cent) patients receiving placebo (p < 0.05). Mean hearing gains, pure tone averages, speech reception thresholds and subjective recovery rates were significantly better in ozone-treated patients compared with placebo-treated patients (p < 0.05). Ozone therapy is a significant modality for treatment of sudden sensorineural hearing loss; no complications were observed.

  11. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Evelim L F D Gomes

    Full Text Available The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma.A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20 or a treadmill group (TG; n = 16. Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO, maximum exercise testing (Bruce protocol and lung function.No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05. Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG.The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation.Clinicaltrials.gov NCT01438294.

  12. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    Science.gov (United States)

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  13. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    Science.gov (United States)

    Gomes, Evelim L F D; Carvalho, Celso R F; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation. Clinicaltrials.gov NCT01438294.

  14. A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss.

    Science.gov (United States)

    Yancy, William S; Westman, Eric C; McDuffie, Jennifer R; Grambow, Steven C; Jeffreys, Amy S; Bolton, Jamiyla; Chalecki, Allison; Oddone, Eugene Z

    2010-01-25

    Two potent weight loss therapies, a low-carbohydrate, ketogenic diet (LCKD) and orlistat therapy combined with a low-fat diet (O + LFD), are available to the public but, to our knowledge, have never been compared. Overweight or obese outpatients (n = 146) from the Department of Veterans Affairs primary care clinics in Durham, North Carolina, were randomized to either LCKD instruction (initially, carbohydrate daily) or orlistat therapy, 120 mg orally 3 times daily, plus low-fat diet instruction (fat, 500-1000 kcal/d deficit) delivered at group meetings over 48 weeks. Main outcome measures were body weight, blood pressure, fasting serum lipid, and glycemic parameters. The mean age was 52 years and mean body mass index was 39.3 (calculated as weight in kilograms divided by height in meters squared); 72% were men, 55% were black, and 32% had type 2 diabetes mellitus. Of the study participants, 57 of the LCKD group (79%) and 65 of the O + LFD group (88%) completed measurements at 48 weeks. Weight loss was similar for the LCKD (expected mean change, -9.5%) and the O + LFD (-8.5%) (P = .60 for comparison) groups. The LCKD had a more beneficial impact than O + LFD on systolic (-5.9 vs 1.5 mm Hg) and diastolic (-4.5 vs 0.4 mm Hg) blood pressures (P Low-density lipoprotein cholesterol levels improved within the O + LFD group only, whereas glucose, insulin, and hemoglobin A(1c) levels improved within the LCKD group only; comparisons between groups, however, were not statistically significant. In a sample of medical outpatients, an LCKD led to similar improvements as O + LFD for weight, serum lipid, and glycemic parameters and was more effective for lowering blood pressure. clinicaltrials.gov Identifier: NCT00108524.

  15. Perioperative celecoxib administration for pain management after total knee arthroplasty – A randomized, controlled study

    Directory of Open Access Journals (Sweden)

    Lin Wei-Peng

    2008-06-01

    Full Text Available Abstract Background Non-steroidal anti-inflammatory drugs (NSAIDs are recommended for multimodal postoperative pain management. We evaluated opioid-sparing effects and rehabilitative results after perioperative celecoxib administration for total knee arthroplasty. Methods This was a prospective, randomized, observer-blind control study. Eighty patients that underwent total knee arthroplasty were randomized into two groups of 40 each. The study group received a single 400 mg dose of celecoxib, one hour before surgery, and 200 mg of celecoxib every 12 hours for five days, along with patient-controlled analgesic (PCA morphine. The control group received only PCA morphine for postoperative pain management. Visual analog scale (VAS pain scores, active range of motion (ROM, total opioid use and postoperative nausea/vomiting were analyzed. Results Groups were comparable for age, pre-operative ROM, operation duration and intraoperative blood loss. Resting VAS pain scores improved significantly in the celecoxib group, compared with controls, at 48 hrs (2.13 ± 1.68 vs. 3.43 ± 1.50, p = 0.03 and 72 hrs (1.78 ± 1.66 vs. 3.17 ± 2.01, p = 0.02 after surgery. Active ROM also increased significantly in the patients that received celecoxib, especially in the first 72 hrs [40.8° ± 17.3° vs. 25.8° ± 11.5°, p = 0.01 (day 1; 60.7° ± 18.1° vs. 45.0° ± 17.3°, p = 0.004 (day 2; 77.7° ± 15.1° vs. 64.3° ± 16.9°, p = 0.004 (day 3]. Opioid requirements decreased about 40% (p = 0.03 in the celecoxib group. Although patients suffering from post-operative nausea/vomiting decreased from 43% in control group to 28% in celecoxib group, this was not significant (p = 0.57. There were no differences in blood loss (intra- and postoperative between the groups. Celecoxib resulted in no significant increase in the need for blood transfusions. Conclusion Perioperative celecoxib significantly improved postoperative resting pain scores at 48 and 72 hrs, opioid

  16. Pediatric selective mutism therapy: a randomized controlled trial.

    Science.gov (United States)

    Esposito, Maria; Gimigliano, Francesca; Barillari, Maria R; Precenzano, Francesco; Ruberto, Maria; Sepe, Joseph; Barillari, Umberto; Gimigliano, Raffaele; Militerni, Roberto; Messina, Giovanni; Carotenuto, Marco

    2017-10-01

    Selective mutism (SM) is a rare disease in children coded by DSM-5 as an anxiety disorder. Despite the disabling nature of the disease, there is still no specific treatment. The aims of this study were to verify the efficacy of six-month standard psychomotor treatment and the positive changes in lifestyle, in a population of children affected by SM. Randomized controlled trial registered in the European Clinical Trials Registry (EuDract 2015-001161-36). University third level Centre (Child and Adolescent Neuropsychiatry Clinic). Study population was composed by 67 children in group A (psychomotricity treatment) (35 M, mean age 7.84±1.15) and 71 children in group B (behavioral and educational counseling) (37 M, mean age 7.75±1.36). Psychomotor treatment was administered by trained child therapists in residential settings three times per week. Each child was treated for the whole period by the same therapist and all the therapists shared the same protocol. The standard psychomotor session length is of 45 minutes. At T0 and after 6 months (T1) of treatments, patients underwent a behavioral and SM severity assessment. To verify the effects of the psychomotor management, the Child Behavior Checklist questionnaire (CBCL) and Selective Mutism Questionnaire (SMQ) were administered to the parents. After 6 months of psychomotor treatment SM children showed a significant reduction among CBCL scores such as in social relations, anxious/depressed, social problems and total problems (Pselective mutism, even if further studies are needed. The present study identifies in psychomotricity a safe and efficacy therapy for pediatric selective mutism.

  17. Difficulties in recruitment for a randomized controlled trial involving hysterosalpingography

    Directory of Open Access Journals (Sweden)

    Helmerhorst Frans M

    2006-06-01

    Full Text Available Abstract Background The usefulness of hysterosalpingography (HSG as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial. Recruiting subjects to the study was more difficult than anticipated. The objective of this study was to explore possible reasons for non-participation in the trial. Methods All newly referred subfertile women admitted to the Reproductive Medicine Clinic of Leiden University Medical Centre between 1 April 1997 and 31 December 1999, were eligible for the study. The reasons for non-participation were evaluated by scrutinizing the medical records. Results Out of 759 women, a total of 127 (17% agreed to participate in the trial. The most important reason for non-participation was because of exclusion criteria (73%. Other reasons were inattentive clinicians (3% and patient-associated reasons (24%. Patient refusal and indecisiveness to enroll in the study were the most common patient-associated reasons. The most frequently stated reason for trial refusal was reluctance to undergo laparoscopy and dye mainly due to issues related to anesthesia and scheduling of procedure. Conclusion Almost three-quarters of recruitment difficulties in this study were due to unavoidable reasons. To overcome the remaining avoidable reasons for non-participation, attention should be paid to appropriate instruction of the study protocol to the participating doctors and to provide adequate information, in layman's terms, to the patients. Reminding patients by notes or telephone calls for attending the clinic are helpful. It may be contingent upon tracing the reasons of clinicians and patients for non-participation to improve enrollment during a trial.

  18. On reporting results from randomized controlled trials with recurrent events

    Directory of Open Access Journals (Sweden)

    Sobolev Boris G

    2008-05-01

    Full Text Available Abstract Background Evidence-based medicine has been advanced by the use of standards for reporting the design and methodology of randomized controlled trials (RCT. Indeed, without this information it is difficult to assess the quality of evidence from an RCT. Although a variety of statistical methods are available for the analysis of recurrent events, reporting the effect of an intervention on outcomes that recur is an area that remains poorly understood in clinical research. The purpose of this paper is to outline guidelines for reporting results from RCTs where the outcome of interest is a recurrent event. Methods We used a simulation study to relate an event process and results from analyses of the gamma-Poisson, independent-increment, conditional, and marginal Cox models. We reviewed the utility of regression models for the rate of a recurrent event by articulating the associated study questions, preenting the risk sets, and interpreting the regression coefficients. Results Based on a single data set produced by simulation, we reported and contrasted results from statistical methods for evaluating treatment effect from an RCT with a recurrent outcome. We showed that each model has different study questions, assumptions, risk sets, and rate ratio interpretation, and so inferences should consider the appropriateness of the model for the RCT. Conclusion Our guidelines for reporting results from an RCT involving a recurrent event suggest that the study question and the objectives of the trial, such as assessing comparable groups and estimating effect size, should determine the statistical methods. The guidelines should allow clinical researchers to report appropriate measures from an RCT for understanding the effect of intervention on the occurrence of a recurrent event.

  19. A randomized controlled trial of storytelling as a communication tool.

    Directory of Open Access Journals (Sweden)

    Lisa Hartling

    Full Text Available INTRODUCTION: Stories may be an effective tool to communicate with patients because of their ability to engage the reader. Our objective was to evaluate the effectiveness of story booklets compared to standard information sheets for parents of children attending the emergency department (ED with a child with croup. METHODS: Parents were randomized to receive story booklets (n=208 or standard information sheets (n=205 during their ED visit. The primary outcome was change in anxiety between triage to ED discharge as measured by the State-Trait Anxiety Inventory. Follow-up telephone interviews were conducted at 1 and 3 days after discharge, then every other day until 9 days (or until resolution of symptoms, and at 1 year. Secondary outcomes included: expected future anxiety, event impact, parental knowledge, satisfaction, decision regret, healthcare utilization, time to symptom resolution. RESULTS: There was no significant difference in the primary outcome of change in parental anxiety between recruitment and ED discharge (change of 5 points for the story group vs. 6 points for the comparison group, p=0.78. The story group showed significantly greater decision regret regarding their decision to go to the ED (p<0.001: 6.7% of the story group vs. 1.5% of the comparison group strongly disagreed with the statement "I would go for the same choice if I had to do it over again". The story group reported shorter time to resolution of symptoms (mean 3.7 days story group vs. 4.0 days comparison group, median 3 days both groups; log rank test, p=0.04. No other outcomes were different between study groups. CONCLUSIONS: Stories about parent experiences managing a child with croup did not reduce parental anxiety. The story group showed significantly greater decision regret and quicker time to resolution of symptoms. Further research is needed to better understand whether stories can be effective in improving patient-important outcomes. TRIAL REGISTRATION

  20. Clinical and radiological results of patients treated with three treatment modalities for overdentures on implants of the ITI (R) Dental Implant System - A randomized controlled clinical trial

    NARCIS (Netherlands)

    Wismeijer, D; van Waas, MAJ; Mulder, J; Vermeeren, JIJF; Kalk, W

    In a randomized controlled clinical trial carried out at the Ignatius teaching hospital in Breda, The Netherlands, 110 edentulous patients with severe mandibular bone loss were treated with implants of the ITI(R) Dental Implant System using 3 different treatment strategies: a mandibular overdenture

  1. Effectiveness of green tea on weight reduction in obese Thais: A randomized, controlled trial.

    Science.gov (United States)

    Auvichayapat, Paradee; Prapochanung, Montira; Tunkamnerdthai, Oratai; Sripanidkulchai, Bung-orn; Auvichayapat, Narong; Thinkhamrop, Bandit; Kunhasura, Soontorn; Wongpratoom, Srisuda; Sinawat, Supat; Hongprapas, Pranithi

    2008-02-27

    This study was undertaken to investigate the effects of green tea on weight reduction in obese Thais. A randomized, controlled trial involving 60 obese subjects (body mass index, BMI > 25 kg/m2) was conducted. All subjects consumed a Thai diet containing 3 meals (8373.6 kJ/day) for 12 weeks, prepared by the Nutritional Unit at Srinagarind Hospital. The diet contained 65% carbohydrates, 15% protein, and 20% fat. Body weight, BMI, body composition, resting energy expenditure, and substrate oxidation were measured at baseline, and during weeks 4, 8, and 12 of the study. Serum levels of leptin and urine VMA were measured at baseline and during the 12th week. Differences over time and between the treatments (green tea or placebo) over time were determined using two-factor ANOVA with repeated measures. In comparing the two groups, differences in weight loss were 2.70, 5.10, and 3.3 kg during the 4th, 8th, and 12th weeks of the study, respectively. At the 8th and 12th weeks of the study, body weight loss was significantly different (P tea can reduce body weight in obese Thai subjects by increasing energy expenditure and fat oxidation.

  2. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial.

    Science.gov (United States)

    Farrell, Richard J; Alsahli, Mazen; Jeen, Yoon-Tae; Falchuk, Kenneth R; Peppercorn, Mark A; Michetti, Pierre

    2003-04-01

    We assessed the relationship between antibodies to infliximab (ATI) and the loss of response postinfliximab, infusion reactions and, in a randomized trial, investigated whether intravenous hydrocortisone premedication can reduce ATI. Initially, we prospectively evaluated clinical response, adverse events, and ATI levels in 53 consecutive patients with Crohn's disease who received 199 infliximab (5 mg/kg) infusions. Subsequently, 80 patients with Crohn's disease were randomized to intravenous hydrocortisone 200 mg or placebo immediately before their first and subsequent infliximab infusions. The primary endpoint was reduction in median ATI levels at week 16. Analysis was by intention to treat. Nineteen of our initial 53 patients (36%) developed ATI, including all 7 patients with serious infusion reactions (median ATI level, 19.6 microg/mL). Eleven of 15 patients (73%) who lost their initial response were ATI positive compared with none of 21 continuous responders, (8.9 vs. 0.7 microg/mL, P < 0.0001). Administering a second infusion within 8 weeks of the first (OR, 0.13; 95% CI, 0.03-0.5; P = 0.0007) or concurrent immunosuppressants (OR, 0.19; 95% CI, 0.04-1.03; P = 0.007) significantly reduced ATI formation. In the placebo-controlled trial, ATI levels were lower at week 16 among hydrocortisone-treated patients (1.6 vs. 3.4 microg/mL, P = 0.02), and 26% of hydrocortisone-treated patients developed ATI compared with 42% of placebo-treated patients, P = 0.06. Loss of initial response and infusion reactions post-infliximab is strongly related to ATI formation and level. Administering a second infusion within 8 weeks of the first and concurrent immunosuppressant therapy significantly reduce ATI formation. Intravenous hydrocortisone premedication significantly reduces ATI levels but does not eliminate ATI formation or infusion reactions.

  3. Efficacy and safety of adjunctive topiramate for schizophrenia: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zheng, W; Xiang, Y-T; Xiang, Y-Q; Li, X-B; Ungvari, G S; Chiu, H F K; Correll, C U

    2016-11-01

    To systematically examine the randomized controlled trial (RCT) evidence regarding efficacy and tolerability of topiramate cotreatment with antipsychotics in schizophrenia-spectrum disorders. Random-effects meta-analysis of RCTs of topiramate cotreatment with antipsychotics vs. placebo/ongoing antipsychotic treatment in schizophrenia-spectrum disorders. Standardized or weighted mean difference (SMD/WMD), risk ratio (RR) ±95% confidence intervals (CIs), and number needed to harm (NNH) were calculated. Across 16 RCTs (n = 934, duration = 11.8 ± 5.6 weeks), topiramate outperformed the comparator regarding change/endpoint of total (SMD: -0.58, 95% CI: -0.82, -0.35, P weight loss was greater in prevention/co-initiation vs. intervention/augmentation RCTs (-4.11 kg, 95% CI: -6.70, -1.52 vs. -1.41 kg, 95% CI: -2.23, -0.59, P schizophrenia-spectrum disorders. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. Minimal stimulation IVF vs conventional IVF: a randomized controlled trial

    NARCIS (Netherlands)

    Zhang, John J.; Merhi, Zaher; Yang, Mingxue; Bodri, Daniel; Chavez-Badiola, Alejandro; Repping, Sjoerd; van Wely, Madelon

    2016-01-01

    Minimal stimulation in vitro fertilization (mini-in vitro fertilization) is an alternative in vitro fertilization treatment protocol that may reduce ovarian hyperstimulation syndrome, multiple pregnancy rates, and cost while retaining high live birth rates. We performed a randomized noninferiority

  5. A randomized controlled trial comparing haemodynamic stability in ...

    African Journals Online (AJOL)

    Methods: Thirty two elderly patients scheduled for lower limb or pelvic surgery under spinal anaesthesia were randomized .... conducted and that their personal information would be kept .... file which was stored in a lockable filing drawer.

  6. Quality of Life after Diet or Exercise-Induced Weight Loss in Overweight to Obese Postmenopausal Women: The SHAPE-2 Randomised Controlled Trial.

    Science.gov (United States)

    van Gemert, Willemijn A M; van der Palen, Job; Monninkhof, Evelyn M; Rozeboom, Anouk; Peters, Roelof; Wittink, Harriet; Schuit, Albertine J; Peeters, Petra H

    2015-01-01

    This study investigates the effect of a modest weight loss either by a calorie restricted diet or mainly by increased physical exercise on health related quality of life (HRQoL) in overweight-to-obese and inactive postmenopausal women. We hypothesize that HRQoL improves with weight loss, and that exercise-induced weight loss is more effective for this than diet-induced weight loss. The SHAPE-2 trial was primarily designed to evaluate any additional effect of weight loss by exercise compared with a comparable amount of weight loss by diet on biomarkers relevant for breast cancer risk. In the present analysis we focus on HRQoL. We randomly assigned 243 eligible women to a diet (n = 97), exercise (n = 98), or control group (n = 48). Both interventions aimed for 5-6 kg weight loss. HRQoL was measured at baseline and after 16 weeks by the SF-36 questionnaire. Data of 214 women were available for analysis. Weight loss was 4.9 kg (6.1%) and 5.5 kg (6.9%) with diet and exercise, respectively. Scores of the SF-36 domain 'health change' increased significantly by 8.8 points (95% CI 1.6;16.1) with diet, and by 20.5 points (95% CI 13.2;27.7) with exercise when compared with control. Direct comparison of diet and exercise showed a statistically significantly stronger improvement with exercise. Both intervention groups showed a tendency towards improvements in most other domains, which were more pronounced in the exercise group, but not statistically different from control or each other. In a randomized trial in overweight-to-obese and inactive postmenopausal women a comparable 6%-7% weight loss was achieved by diet-only or mainly by exercise and showed improvements in physical and mental HRQoL domains, but results were not statistically significant in either the diet or exercise group. However, a modest weight loss does lead to a positive change in self-perceived health status. This effect was significantly larger with exercise-induced weight loss than with comparable diet

  7. Quality of Life after Diet or Exercise-Induced Weight Loss in Overweight to Obese Postmenopausal Women: The SHAPE-2 Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Willemijn A M van Gemert

    Full Text Available This study investigates the effect of a modest weight loss either by a calorie restricted diet or mainly by increased physical exercise on health related quality of life (HRQoL in overweight-to-obese and inactive postmenopausal women. We hypothesize that HRQoL improves with weight loss, and that exercise-induced weight loss is more effective for this than diet-induced weight loss.The SHAPE-2 trial was primarily designed to evaluate any additional effect of weight loss by exercise compared with a comparable amount of weight loss by diet on biomarkers relevant for breast cancer risk. In the present analysis we focus on HRQoL. We randomly assigned 243 eligible women to a diet (n = 97, exercise (n = 98, or control group (n = 48. Both interventions aimed for 5-6 kg weight loss. HRQoL was measured at baseline and after 16 weeks by the SF-36 questionnaire.Data of 214 women were available for analysis. Weight loss was 4.9 kg (6.1% and 5.5 kg (6.9% with diet and exercise, respectively. Scores of the SF-36 domain 'health change' increased significantly by 8.8 points (95% CI 1.6;16.1 with diet, and by 20.5 points (95% CI 13.2;27.7 with exercise when compared with control. Direct comparison of diet and exercise showed a statistically significantly stronger improvement with exercise. Both intervention groups showed a tendency towards improvements in most other domains, which were more pronounced in the exercise group, but not statistically different from control or each other.In a randomized trial in overweight-to-obese and inactive postmenopausal women a comparable 6%-7% weight loss was achieved by diet-only or mainly by exercise and showed improvements in physical and mental HRQoL domains, but results were not statistically significant in either the diet or exercise group. However, a modest weight loss does lead to a positive change in self-perceived health status. This effect was significantly larger with exercise-induced weight loss than with comparable

  8. Changes of renal sinus fat and renal parenchymal fat during an 18-month randomized weight loss trial.

    Science.gov (United States)

    Zelicha, Hila; Schwarzfuchs, Dan; Shelef, Ilan; Gepner, Yftach; Tsaban, Gal; Tene, Lilac; Yaskolka Meir, Anat; Bilitzky, Avital; Komy, Oded; Cohen, Noa; Bril, Nitzan; Rein, Michal; Serfaty, Dana; Kenigsbuch, Shira; Chassidim, Yoash; Sarusi, Benjamin; Thiery, Joachim; Ceglarek, Uta; Stumvoll, Michael; Blüher, Matthias; Haviv, Yosef S; Stampfer, Meir J; Rudich, Assaf; Shai, Iris

    2018-08-01

    Data regarding the role of kidney adiposity, its clinical implications, and its dynamics during weight-loss are sparse. We investigated the effect of long-term weight-loss induced intervention diets on dynamics of renal-sinus-fat, an ectopic fat depot, and %renal-parenchymal-fat, lipid accumulation within the renal parenchyma. We randomized 278 participants with abdominal obesity/dyslipidemia to low-fat or Mediterranean/low-carbohydrate diets, with or without exercise. We quantified renal-sinus-fat and %renal-parenchymal-fat by whole body magnetic-resonance-imaging. Participants (age = 48 years; 89% men; body-mass-index = 31 kg/m 2 ) had 86% retention to the trial after 18 months. Both increased renal-sinus-fat and %renal-parenchymal-fat were directly associated with hypertension, and with higher abdominal deep-subcutaneous-adipose-tissue and visceral-adipose-tissue (p of trend vs. baseline) but not %renal-parenchymal-fat (-1.7%; p = 0.13 vs. baseline) significantly decreased, and similarly across the intervention groups. Renal-sinus-fat and %renal-parenchymal-fat changes were correlated with weight-loss per-se (p < 0.05). In a model adjusted for age, sex, and visceral-adipose-tissue changes, 18 months reduction in renal-sinus-fat associated with decreased pancreatic, hepatic and cardiac fats (p < 0.05 for all) and with decreased cholesterol/high-density lipoprotein-cholesterol (HDL-c) (β = 0.13; p = 0.05), triglycerides/HDL-c (β = 0.13; p = 0.05), insulin (β = 0.12; p = 0.05) and gamma glutamyl transpeptidase (β = 0.24; p = 0.001), but not with improved renal function parameters or blood pressure. Decreased intake of sodium was associated with a reduction in %renal-parenchymal-fat, after adjustment for 18 months weight-loss (β = 0.15; p = 0.026) and hypertension (β = 0.14; p = 0.04). Renal-sinus-fat and renal-parenchymal-fat are fairly related to weight-loss. Decreased renal-sinus-fat is associated with improved hepatic

  9. Factors Leading to the Loss of Natural Elite Control of HIV-1 Infection.

    Science.gov (United States)

    Pernas, María; Tarancón-Diez, Laura; Rodríguez-Gallego, Esther; Gómez, Josep; Prado, Julia G; Casado, Concepción; Dominguez-Molina, Beatriz; Olivares, Isabel; Coiras, Maite; León, Agathe; Rodriguez, Carmen; Benito, Jose Miguel; Rallón, Norma; Plana, Montserrat; Martinez-Madrid, Onofre; Dapena, Marta; Iribarren, Jose Antonio; Del Romero, Jorge; García, Felipe; Alcamí, José; Muñoz-Fernández, M Ángeles; Vidal, Francisco; Leal, Manuel; Lopez-Galindez, Cecilio; Ruiz-Mateos, Ezequiel

    2017-12-06

    HIV-1 elite controllers (EC) maintain undetectable viral load (VL) in the absence of antiretroviral treatment. However, these subjects have heterogeneous clinical outcomes including a proportion loosing HIV-1 control over time. In this work we compared, in a longitudinal design, transient EC, analyzed before and after the loss of virological control, versus persistent EC. The aim was to identify factors leading to the loss of natural virological control of HIV-1-infection with a longitudinal retrospective study design. Gag-specific T-cell response was assessed by in vitro intracellular poly-cytokine production quantified by flow cytometry. Viral diversity and sequence-dating were performed in proviral DNA by PCR amplification at limiting dilution in env and gag genes. The expression profile of 70 serum cytokines and chemokines was assessed by multiplex immunoassays. We identified transient EC as subjects with low Gag-specific T-cell polyfunctionality, high viral diversity and high proinflammatory cytokines levels before the loss of control. Gag-specific T-cell polyfunctionality was inversely associated with viral diversity in transient controllers before the loss of control (r=-0.8; p =0.02). RANTES was a potential biomarker of transient control. This study identified, virological and immunological factors including inflammatory biomarkers associated with two different phenotypes within EC. These results may allow a more accurate definition of EC, which could help in a better clinical management of these individuals and in the development of future curative approaches. IMPORTANCE There is a rare group of HIV-infected patients who have the extraordinary capacity to maintain undetectable viral load levels in the absence of antiretroviral treatment, the so called HIV-1 elite controllers (EC). However, there is a proportion within these subjects that eventually loses this capability. In this work we found differences in virological and immune factors including soluble

  10. Accuracy of body image perception and preferred weight loss strategies in schizophrenia: a controlled pilot study.

    Science.gov (United States)

    Loh, C; Meyer, J M; Leckband, S G

    2008-02-01

    Obesity in severely mentally ill (SMI) populations is an increasing problem, but there is no controlled data regarding the relationship between SMI and weight perception. Fifty patients with schizophrenia and 50 demographically matched control participants were recruited. Weight, height, and body image accuracy were assessed for all participants, and assessments of mood, psychotic symptom severity and anxiety, and preferred modes of weight loss were assessed for the schizophrenia sample. Patients with schizophrenia were significantly more likely to be obese than controls (46% vs. 18%, P < 0.005), and most patients expressed an interest in losing weight. Obese participants with schizophrenia underestimated their body size (11.0%) more than controls (4.9%) (P < 0.05). Patients with schizophrenia are more likely to underestimate their body size, independent of the effects of obesity. However, they also express concern about weight issues and willingness to participate in psychoeducational groups targeted at weight loss.

  11. Developmental Regulation with Progressive Vision Loss: Use of Control Strategies and Affective Well-Being

    Science.gov (United States)

    Schilling, Oliver K.; Wahl, Hans-Werner; Boerner, Kathrin; Horowitz, Amy; Reinhardt, Joann P.; Cimarolli, Verena R.; Brennan-Ing, Mark; Heckhausen, Jutta

    2016-01-01

    The present study addresses older adults' developmental regulation when faced with progressive and irreversible vision loss. We used the motivational theory of life span development as a conceptual framework and examined changes in older adults' striving for control over everyday goal achievement, and their association with affective well-being,…

  12. Effect of gear shift and engine start losses on control strategies for hybrid electric vehicles

    NARCIS (Netherlands)

    Ngo, V.; Hofman, T.; Steinbuch, M.; Serrarens, A.

    2012-01-01

    In this paper, energetic loss models in the events of shifting gear and starting engine in a parallel Hybrid Electric Vehicle equipped with an Automated Manual Transmission (AMT) will be introduced. The optimal control algorithm for the start-stop, power split and gear shift problem based on Dynamic

  13. Control and modulation for loss minimization for dc/dc converters in wind farm

    DEFF Research Database (Denmark)

    Dincan, Catalin Gabriel; Kjær, Philip Carne

    2016-01-01

    For a DC wind turbine, a single phase series-resonant converter for unidirectional power is studied. This paper aims to identify and compare impact on electrical losses and component ratings from the choice of three candidate control strategies. The evaluation is purely based on circuit simulatio...

  14. 40 CFR 52.246 - Control of dry cleaning solvent vapor losses.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Control of dry cleaning solvent vapor... cleaning solvent vapor losses. (a) For the purpose of this section, “dry cleaning operation” means that process by which an organic solvent is used in the commercial cleaning of garments and other fabric...

  15. Day care PNL using 'Santosh-PGI hemostatic seal' versus standard PNL: A randomized controlled study.

    Science.gov (United States)

    Kumar, Santosh; Singh, Shivanshu; Singh, Prashant; Singh, Shrawan Kumar

    2016-01-01

    To compare the outcomes of tubeless day care PNL using hemostatic seal in the access tract versus standard PNL. It was a prospective randomized controlled study. Cases were randomized to either the day care group with hemostatic seal (DCS) or the control group where patients were admitted and a nephrostomy tube was placed at the conclusion of surgery. A total of 180 cases were screened and out of these, 113 were included in the final analysis. The stone clearance rates were comparable in both the groups. The mean drop in hemoglobin was significantly lower in DCS group than the control group (1.05 ±0.68 vs. 1.30 ±0.58 gm/dl, p = 0.038).Mean postoperative pain score, analgesic requirement (paracetamol) and duration of hospital stay were also significantly lower in the DCS group (3.79 ±1.23 vs. 6.12 ±0.96, 1.48 ±0.50 vs. 4.09 ±1.11 grams and 0.48 ±0.26 vs. 4.74 ±1.53 days respectively; p PNL with composite hemostatic tract seal is considered safe. It resulted in a significant reduction of blood loss and analgesic requirement with significantly reduced hospital stay, nephrostomy tube site morbidity and time required to resume normal activity when compared to the standard PNL. However, patients must be compliant with the given instructions and should have access to a health care facility, as few of them may need re-admission.

  16. Bone marrow-derived cells and biophysical stimulation for talar osteochondral lesions: a randomized controlled study.

    Science.gov (United States)

    Cadossi, Matteo; Buda, Roberto Emanuele; Ramponi, Laura; Sambri, Andrea; Natali, Simone; Giannini, Sandro

    2014-10-01

    Osteochondral lesions of the talus (OLT) frequently occur after ankle sprains in young patients participating in sports activities. These injuries may lead to chronic pain, joint swelling, and finally osteoarthritis, therefore, surgical repair is frequently needed. A collagen scaffold seeded with bone marrow-derived cells (BMDCs) harvested from patient's iliac crest and implanted into the OLT through a single arthroscopic procedure has been recently proposed as an effective treatment option. Nevertheless, BMDCs, embedded in an inflammatory environment, tend to differentiate toward a fibroblast phenotype with a consequential loss of mechanical characteristics. Biophysical stimulation with pulsed electromagnetic fields (PEMFs) has been shown to promote anabolic chondrocyte activity, stimulate proteoglycan synthesis, and reduce the release of the most relevant pro-inflammatory cytokines. The aim of this randomized controlled trial was to evaluate the effects of PEMFs on clinical outcome in patients who underwent BMDCs transplantation for OLT. Thirty patients affected by grade III and IV Outerbridge OLT underwent BMDCs transplantation. After surgery, patients were randomly assigned to either experimental group (PEMFs 4 hours per day for 60 days starting within 3 days after operation) or control group. Clinical outcome was evaluated with (American Orthopaedic Foot and Ankle Society) AOFAS score, Visual Analog Scale (VAS), and Short Form-36 (SF-36). Significantly higher AOFAS score was recorded in the experimental group both at 6 or 12 months follow-up. At 60 days and 6 and 12 months follow-up, significant lower pain was observed in the experimental group. No significant difference was found in SF-36 between groups. A superior clinical outcome was found in the experimental group with more than 10 points higher AOFAS score at final follow-up. Biophysical stimulation started soon after surgery aided patient recovery leading to pain control and a better clinical outcome

  17. Randomized controlled trial of SecondStory, an intervention targeting posttraumatic growth, with bereaved adults.

    Science.gov (United States)

    Roepke, Ann Marie; Tsukayama, Eli; Forgeard, Marie; Blackie, Laura; Jayawickreme, Eranda

    2018-06-01

    People often report positive psychological changes after adversity, a phenomenon known as posttraumatic growth (PTG). Few PTG-focused interventions have been rigorously tested, and measurement strategies have had significant limitations. This study evaluated the effects of a new group-format psychosocial intervention, SecondStory, aimed at facilitating PTG by helping participants make meaning of the past and plan a purposeful future. In a randomized controlled trial, adults (N = 112, 64% women) bereaved within 5 years were randomly assigned to SecondStory or an active control, expressive writing. The primary outcome, PTG, was measured using two contrasting methods: the Posttraumatic Growth Inventory, which asks participants retrospectively how much they believe they have changed due to struggling with adversity, and the Current-Standing Posttraumatic Growth Inventory, which tracks quantifiable change in participants' standing in PTG domains over time. Secondary outcomes included depression symptoms, posttraumatic stress symptoms, and life satisfaction. Outcomes were measured at 2-week intervals: pretest, posttest, and three follow-up occasions. Hierarchical linear modeling was used to assess whether SecondStory participants experienced greater gains in primary and/or secondary outcomes over the 8-week trial. Results indicated that SecondStory participants did not show significantly greater improvements than control participants on measures of PTG, posttraumatic stress, or life satisfaction, but they did show greater decreases in depression symptoms by the first follow-up. These findings suggest that SecondStory may not facilitate PTG more effectively than existing interventions but may be promising for addressing depression. Positive interventions may productively be refined to support people experiencing trauma and loss. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

  18. Considering linear generator copper losses on model predictive control for a point absorber wave energy converter

    International Nuclear Information System (INIS)

    Montoya Andrade, Dan-El; Villa Jaén, Antonio de la; García Santana, Agustín

    2014-01-01

    Highlights: • We considered the linear generator copper losses in the proposed MPC strategy. • We maximized the power transferred to the generator side power converter. • The proposed MPC increases the useful average power injected into the grid. • The stress level of the PTO system can be reduced by the proposed MPC. - Abstract: The amount of energy that a wave energy converter can extract depends strongly on the control strategy applied to the power take-off system. It is well known that, ideally, the reactive control allows for maximum energy extraction from waves. However, the reactive control is intrinsically noncausal in practice and requires some kind of causal approach to be applied. Moreover, this strategy does not consider physical constraints and this could be a problem because the system could achieve unacceptable dynamic values. These, and other control techniques have focused on the wave energy extraction problem in order to ma