101 Clinical Trials for Various Conditions
The study is testing how well semaglutide can help adolescents with excess body weight to lose weight and to maintain weight loss. All participants in the study will receive semaglutide as a weekly injection. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. All participants will get semaglutide treatment for a minimum of 3 years.
Fractyl is evaluating Revita Duodenal Mucosal Resurfacing (DMR) in the REMAIN-1 pivotal study, which is designed to include two cohorts - an open label cohort referred to as REVEAL-1, and a randomized cohort, which includes both a midpoint analysis and a pivotal analysis. Patients who previously lost at least 15% of their body weight on a GLP-1 can qualify for the open label REVEAL-1 cohort. The data generated from the REVEAL-1 cohort will be used for open label reporting as the study progresses. The REMAIN-1 randomized cohort will enroll patients living with obesity and a body mass index ("BMI") between 30 and 45 kg/m2 who are not currently on a GLP-1 drug. Patients will be prescribed tirzepatide and titrated to achieve at least 15% total body weight loss, at which time tirzepatide will be discontinued and patients will be randomized to Revita versus sham at 2:1. Midpoint Analysis of Randomized Cohort: The midpoint analysis of the randomized cohort will be performed at three months of follow-up on approximately 45 patients, allowing us to assess and report on safety and efficacy signals that could be anticipated in the pivotal analysis. These patients are distinct from those included in the pivotal analysis. Pivotal Analysis of Randomized Cohort: The pivotal analysis of the randomized cohort will be performed on approximately 315 patients (distinct from those included in the midpoint analysis) and will evaluate safety and efficacy in the first co-primary endpoint, which is weight regain from the time of tirzepatide discontinuation in Revita DMR versus sham patients at six months, with a primary objective of demonstrating a benefit of Revita DMR versus sham for weight maintenance after GLP-1 discontinuation. The second co-primary endpoint evaluates a responder rate among the Revita DMR treated group at one year to demonstrate the durability of the Revita DMR procedure for weight maintenance after discontinuation of a GLP-1-based therapy. Secondary objectives will include evaluation of the effectiveness of the Revita DMR procedure on the change in blood glucose levels, cardiovascular disease ("CVD") risk factors, body composition and pre-diabetes status. All patients enrolled in the study will receive diet and lifestyle counseling.
The aims of this randomized controlled trial are to determine the effects of a lifestyle program that supports weight maintenance and fat mass loss during pregnancy in women with obesity on changes in 1) maternal weight, fat mass, and cardiometabolic risk factors; 2) safety measures, including fetal and neonatal growth; 3) the mediators and moderators of the fat mass loss intervention and 4) the effects gestational fat mass loss has on reducing incidence of adverse obstetrical outcomes, including non-elective cesarean delivery, gestational diabetes, hypertension, and pre-eclampsia.
In this study, we plan to determine the efficacy of the Hunt Motivational Scale as a tool for weight loss compared to standard of care in the Penn Medicine Princeton Health weight management program.
Although bariatric surgery is highly effective for inducing significant weight loss and resolution of comorbidities, weight regain following surgery is a common problem. This pilot study will test the feasibility and acceptability of an intervention designed to help bariatric surgery patients maintain weight loss. Findings from this pilot will provide the foundation for a randomized controlled trial to evaluate the efficacy of the intervention.
Three of every four Veterans are overweight or obese, and weight loss is associated with reduced morbidity and mortality. The VA MOVE! program for weight loss is moderately effective but only reaches a small percentage of overweight Veterans. This proposed study will test whether a patient incentive program that gives Veterans non-financial incentives, such as Seattle Mariners baseball tickets, for losing one pound per week over 16 weeks is effective. An effective patient-incentive program could help more Veterans lose weight without requiring a substantial increase in VA staff.
The purpose of this study is to investigate the effects of consumption of sugar sweetened and diet beverages on overall fat mass and the fat mass of various tissues implicated in the dysregulation of glucose metabolism. In addition, hypothalamic activity will also be investigated after acute exposure to sugar sweetened and diet beverages, and again after 6 months of daily consumption.
The Investigational Weight Management Clinic now entitled the Weight Management Program at the University of Michigan was created to identify strategies that will result in cost-effective, long term weight management for overweight and obese individuals. The driving hypothesis of the clinic is that the 'one size fits all' philosophy is untenable with a complex disease such as obesity. The clinic will serve as a portal for patients to choose standard clinical care or to explore alternatives from a variety of clinical studies offered through the clinic. These studies will include further investigations into nutrition, the biological basis of weight and weight management and protocols using approved and experimental pharmaceuticals as well as technologies that aid in self-management of weight.
This randomized trial tested the hypothesis that there would be an incremental benefit of personalized coaching and PCP support in an EHR-based intervention designed to help primary care patients maintain recent intentional weight loss of at least 5%.
The purpose of this study is to determine if use of a virtual reality platform, Second Life, is more effective than traditional face-to-face methods for maintaining weight loss in overweight and obese individuals.
This is a study of overweight men and women. Everybody will receive a very low calorie diet to eat in place of meals for 10 weeks. During the last two weeks of the diet, half of the patients will receive an intervention to activate parts of their brain that can help them eat less. The other half of the patient will receive a placebo or sham intervention. The intervention will involve a small electric current given every day for 10 days. Everybody will be monitored for 16 more weeks (total of 26 weeks) while on a weight maintenance diet to see if the intervention helps people keep the weight off.
The purpose of the current study was to examine the impact of macronutrient intake (PRO, 15% vs. 35%) and meal frequency (3 vs. 6 meals/day) on body composition, postprandial thermogenesis and plasma adipokines before and after 28days each of EB (28days) and ED (25%; 28days) in overweight individuals. We hypothesize that HP will elicit more favorable body composition, thermogenic, and cardiometabolic changes than HC intakes and the magnitude of change will be greatest in those consuming HP meals more frequently.
The purpose of this 2-stage intervention study is to investigate the effect of a novel nutraceutical (containing tetrahydro iso-alpha acids derived from hops) on weight loss and weight loss maintenance in obese participants.
The purpose of this study is to compare an technology-based weight maintenance intervention using action plans, videos discussion boards and health behavior tracking (weight, calories in and out, pedometer steps) with a technology-based standard advice group to facilitate health management, resourcefulness and health status for rural middle-aged women.
This project will evaluate an Internet delivery strategy to address weight loss and maintenance among rural midlife and older women.
The proposed research will demonstrate that alternate day modified fasting (ADMF) is a suitable alternative to daily calorie restriction (CR) for weight loss, weight maintenance, and heart disease prevention. Since many overweight and obese individuals find it difficult to adhere to daily CR, this diet option may improve adherence with these dietary restriction protocols. This, in turn, will allow a greater percent of the overweight and obese population to lose weight, maintain weight loss, and prevent future occurrences of coronary heart disease.
The goal of the current study is to determine the role of dairy in similarly preventing weight and fat re-gain in obese adults who have successfully completed a weight loss diet program.240 obese subjects will undergo a meal-replacement-based weight loss plan designed to produce a 10 kg weight loss in 8-12 weeks. Upon achieving the weight loss goal, subjects will be randomly assigned to either a low-dairy or high-dairy eucaloric weight maintenance diet for two years. Macronutrient distribution will be maintained constant and set at approximately the U.S. average. Primary outcomes include changes in body weight, body fat and anatomical distribution of fat (via dual x-ray absorptiometry) and resting metabolic rate and substrate oxidation (via respiratory calorimetry); Secondary outcomes include blood pressure, circulating glucose, insulin, lipids and calcitrophic hormones. on prevention of weight regain in humans has not yet been assessed in clinical trials.
This study will focus on maintenance of weight loss achieved in the 2007 Shape-Up Rhode Island(SURI)program. We plan to recruit 180 individuals who participated in SURI and lost at least 10 pounds to take part in a 4-month weight loss maintenance program when the SURI ends. Participants will be randomly assigned to one of three groups: Education, Increased Exercise, or Daily Self-Weighing.
The obesity epidemic observed in recent years can be largely attributed to an obesogenic environment that encourages overeating and sedentary lifestyles. Behavioral weight control treatment, the most empirically validated intervention approach, produces initial weight losses of 10%; however, maintenance of initial weight loss and behavior change has not been achieved. These disappointing long-term results may reflect the fact that participants are given only minimal, indirect instruction on how to change their environment to support their new weight-regulating behaviors. While in theory, the behavioral model emphasizes environmental antecedents and consequences of eating and exercise, in practice, only 1 to 2 sessions in standard treatment are dedicated to stimulus control-types of skills. By teaching weight control skills in a contextual vacuum, participants remain vulnerable to the same environmental influences that maintained their unhealthy eating and exercise habits. Given that the majority of eating and exercise is home-based, a logical step in strengthening behavioral treatment and moving toward an ecological model of behavior is to expand the focus of treatment from the individual to the individual plus their home environment. We propose to test the long-term impact of a behavioral weight control program designed to directly modify both the physical and social home environment of weight loss participants. Two hundred overweight and obese men and women will be randomly assigned to either 18 months of standard behavioral treatment (SBT) or 18 months of standard behavioral treatment plus direct modifications to the home environment (SBT+Home). SBT+Home will incorporate many strategies that have shown promise in improving weight loss (e.g., food and exercise equipment provision, spouse involvement) but will be the first to study both physical and social factors within the home simultaneously and will be the longest examination of the home environment conducted to date. Participants and spouses will be assessed at baseline, 6, 12, and 18 months. We hypothesize that by broadening the focus of treatment from the individual to the individual plus their home environment, SBT+Home will produce both better long-term weight loss and better maintenance of initial weight loss and behavior change. This home environmental approach, if successful, has potential applications to the maintenance of other important health behaviors.
This study will be conducted over three phases. Phase I will be a 16-week weight lass phase. Phase II will be a 52-week maintenance phase. Phase III will be a follow-up phase. We will test three diet regimens: 1) an olestra group who will receive a weight-reducing diet that includes olestra-containing products; 2) a triglyceride group who will receive the same weight-reducing diet but with foods made with triglyceride (regular fat); 3) a low-fat group will be instructed to consume a diet made of traditionally low-fat foods that ate available in grocery stores (no olestra foods). These groups will be re-randomized for the maintenance phase and again assigned to one of the three weight loss regimens described above: olestra, triglyceride, or low-fat. In the double-blinded experimental design, groups receiving olestra foods will not be informed of the nutrient contents of the foods or told what fat substitute is used in the preparation. (The consent form will state that a new fat-substitute may be used in the study foods.) During a "run-in" phase, olestra versus regular-fat food sensory and tolerance tests will be conducted.
Effects of herbal products on weight loss, weight maintenance and metabolic rate. * The objective of this study is to evaluate the efficacy of two herbal weight loss products, BioLean and BioLean Free compared to each other and a matching placebo, in effects on appetite suppression, changes in metabolism, weight loss, and safety in overweight men and women over a 12 month active weight loss and weight maintenance program. * This is a randomized double-blind study. The planned sample size is 180 healthy, overweight (BMI 27-40) males and females aged 18-60.
This is an research study about clinical, psychosocial, and behavioral factors that impact weight loss, weight maintenance, and cardiovascular disease in socially disadvantaged persons.
This is an interventional research study about clinical, psychosocial, and behavioral factors that impact weight loss, weight maintenance, and cardiovascular disease in socially disadvantaged persons.
The purpose of this National Cancer Institute (NCI) funded study is to develop and test the acceptability and usability of a web \& text message based weight loss intervention for childhood acute lymphoblastic leukemia (ALL) survivors. Childhood cancer survivors ages 7 - 18 will provide feedback during focus groups on a web and text message based program that was developed.
The objective of this study will assess the feasibility of utilizing real-time data monitoring in future clinical trials of weight control medications and other treatment modalities, along with the feasibility of distinguishing different types of relapses over 16 weeks: There will be 4 weeks of high-intensity EMA and 12 weeks of low-intensity EMA. Each participant will be in the study for 52 weeks with 20 visits, including follow-up visits.
The study is sponsored by the National Heart, Lung, and Blood Institute, which is part of the National Institutes of Health. We expect to enroll 400 subjects into this study. We will be recruiting research participants that are finishing or will finish cardiac rehabilitation soon. Participants belong to one or more groups of people who are less often studied in cardiac rehabilitation research, may have less access to a formal cardiac rehabilitation maintenance program, or they may especially benefit from additional support after cardiac rehabilitation ends. The main purposes of this study are to evaluate which treatments work the best after cardiac rehabilitation, which order to deliver the treatments in, and which treatments are as minimally burdensome as possible while still working well. This study will make two comparisons (one comparison between a set of low-intensity interventions and another between a set of higher-intensity interventions) to determine which produces the best behavioral adherence immediately after Phase II (outpatient) cardiac rehabilitation
This randomized controlled trial (RCT) will test how well a fully remote weight management program (Noom Weight) helps adults with overweight or obesity (BMI 25-45) achieve weight loss in both the short-term (16 weeks) and the long-term (68 weeks), compared to an educational program). Participants will be randomly assigned to use the 16-week Noom Weight program or receive weekly emails with weight loss-related tips and information. Weight will be measured at baseline, 16, 29, 42, and 68 weeks. Changes in physical activity, eating disorder risk, and body appreciation will also be assessed.
The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction.
The main purpose of this study is to determine if combining tirzepatide with mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 74 weeks and may include up to 19 visits.
Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (\~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance.