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Obesity clinical trials

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NCT ID: NCT03845283 Not yet recruiting - Obesity Clinical Trials

Creating an Optimized Technology-Based Weight Loss Program for Cardiac Rehabilitation Patients

Start date: March 15, 2019
Phase: N/A
Study type: Interventional

Cardiovascular disease (CVD) is the leading cause of death in the United States. Cardiac rehabilitation (CR) is the main treatment for heart attacks and other types of CVD. It is based on science, it saves money, and it is widely-available. Each session (of which there are a few each week for 3 months) combines supervised exercise and instruction. The goals are to improve overall health and reduce cardiovascular risk in individuals with established CVD. CR produces almost no weight loss (WL); if a person has excess weight while in CR (the majority of participants have overweight or obesity), losing weight could really reduce their risk of having another heart attack. The best treatment available for weight loss, in-person behavioral weight loss interventions (BWLs), produce enough WL that they improve health and disease risk/severity. However, in-person BWLs are too much work to be carried out in CR. A previous fully automated 3-month online program, Rx Weight Loss (RxWL), produced good WL in many different settings. Dr. Goldstein aims to tailor RxWL for use in CR. The study will use the Multiphase Optimization Strategy (MOST) to test innovative eHealth/mHealth intervention components that might work well for people when combined with RxWL. The study will include 160 patients (each randomized to receive 0-4 of the components). The components are: (a) a Fitbit with a goal-setting program; (b) a bite counting device; (c) a Web-based virtual reality (VR) intervention ; and (d) virtual meetings. By the 6-month follow-up, the investigators will know if any of those 4 components helped people lose more weight. If a component produced at least 2% WL, it will be studied further by being included in a new intervention to be tested in the next study.

NCT ID: NCT03845075 Not yet recruiting - Clinical trials for Hypothalamic Injury-induced Obesity (HIO)

48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)

Start date: February 20, 2019
Phase: Phase 2
Study type: Interventional

Double-blind, randomized, placebo-controlled, single- center study followed by an open-label extension period. • The study will have two parts: - Part 1: 24 weeks double-blind treatment, followed by - Part 2: 24 weeks open-label extension - all subjects still participating at the end of Part 1 will be given an option to continue for additional 24 weeks on the active drug if evaluated eligible by the Investigator

NCT ID: NCT03844230 Not yet recruiting - Obesity Clinical Trials

Role of Sweetness in Glucose Regulation

STS
Start date: February 25, 2019
Phase: N/A
Study type: Interventional

Data from several studies show that consuming a diet high in low-calorie sweeteners (LCS), mainly in diet sodas, is linked to the same metabolic disorders as consuming a diet high in added sugars, including an increased risk of developing type 2 diabetes. Sweet taste receptors, once thought to be unique to the mouth, have now been discovered in other parts of the body, including the intestine and the pancreas, where they play a role in blood sugar control. These newly identified receptors provide new avenues to explore how LCS may affect metabolism and health. This project is designed to examine the role of sweet taste signaling, both in the mouth and in the gut, on blood sugar control and how habitual consumption of LCS may affect sweet taste signaling and metabolism in people with obesity.

NCT ID: NCT03843801 Not yet recruiting - Obesity Clinical Trials

A Prospective Study to Evaluate the Suture Pattern With the Endomina Suturing Device for Endoscopic Sleeve Gastroplasty (ESG).

Pattern
Start date: March 4, 2019
Phase: N/A
Study type: Interventional

Advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. Although these procedures may not be as effective as their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with surgery (1). Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is CE mark device that may be attached to an endoscope inside the body and allows remote manipulation of the arms of the device during a peroral intervention. It offers the possibilities of making transoral surgical full thickness sutures and may allow performing endoscopic therapeutic interventions, via a transoral route. A first trial including 11 patients assessed feasibility and safety of the technique (2). There were no complications and the short-term results were encouraging. Then a multicentric efficacy study was conducted, including 51 patients (3). The results where EWL of 31% at one year and TBWL of 9% without complications. Finally a randomized controlled study was done including 73 patients in a 2/1 randomized fashion with a crossover at 6 months. Treated group was with the endomina device and controlled group was diet only. The follow-up was the same in each group. Primary endpoint was to reach the ASGE guideline "difference between a control group and a treatment group of minimum 15%" (4). Technique and suture pattern have evolved since the first study. The aim of this prospective evaluation is to compare different suture patterns and their mechanism of action.

NCT ID: NCT03843424 Not yet recruiting - Obesity, Childhood Clinical Trials

Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers

TEAM UP
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

The US Preventive Services Task Force (USPSTF) recommends that providers screen children aged 6 years and older for obesity and offer or refer them to a comprehensive behavioral intervention (≥26 hours over a period of up to 12 months) to promote improvement in weight status. Family-based behavioral treatment (FBT) is an effective treatment that targets both child and parents and meets the USPSTF recommendations. By contrast, the American Medical Association (AMA) recommends a staged approach to childhood obesity screening and counseling, which begins with prevention counseling by the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. Our study compares a staged approach enhanced standard of care (eSOC) vs. eSOC + FBT, to provide families and PCPs with information on the best intervention approach for the behavioral treatment of childhood obesity. Our project seeks to fill the gap in the evidence on family-based weight management in primary care settings among diverse and under-served populations with a special focus on Black children, families insured by Medicaid, and sex differences.

NCT ID: NCT03843190 Not yet recruiting - Obesity Clinical Trials

TOPS for Older AAW: Changes in Weight and Physical Function

Start date: April 2019
Phase: N/A
Study type: Interventional

The investigators approach will be a 12-month cluster randomized trial with a waitlist control that recruits 240 older AA women through public housing communities and senior centers in North Carolina. The rationale for these aims is that the successful completion is expected to provide evidence that a community-based, peer-led weight loss program with a national infrastructure can help a vulnerable, underserved population lose weight and improve their physical function. For older, obese, frail individuals, this could improve their CVD risk factors, quality of life, enhance their health; reduce their healthcare utilization, illness, and disability; and decrease their adverse geriatric outcomes. After completing these aims, the investigators expect that they will have proven that the community-based, peer-led weight loss program can improve both weight and physical function among older, obese AA women. This also could help other demographic groups with obesity and poor physical function. Eventually, it could help older adults maintain their health and independence in the community

NCT ID: NCT03843099 Not yet recruiting - Obesity Clinical Trials

Physical Activity Choices Everyday- A Pilot Study

PACE
Start date: March 4, 2019
Phase: N/A
Study type: Interventional

This study aims to test two strategies for weight loss. Participants will be randomly assigned to one of the two 4-week weight loss programs: (1) a behavioral weight loss program that involves recording weekly weight, physical activity, and caloric intake plus daily exercises in which information about a healthy lifestyle is reviewed or (2) a behavioral weight loss program that involves recording weekly weight, physical activity, and caloric intake plus daily exercises in which descriptions of positive future events are reviewed. Throughout the study, participants will complete assessments that examine the effects of the interventions on delay discounting, physical activity, weight, and other important health and psychosocial outcomes.

NCT ID: NCT03842202 Not yet recruiting - Obesity Clinical Trials

A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity

Start date: February 15, 2019
Phase: Phase 1
Study type: Interventional

This study will look at how the emptying of the participant's stomach after a meal is affected by semaglutide (a new medicine) compared to a "dummy" medicine. In addition, the study will also look at the effect of semaglutide on the participant's appetite and energy intake. Participants will either get semaglutide or "dummy" medicine - which treatment any participant gets is decided by chance. Participants will take 1 injection per week. The study medicine is injected with a thin needle in the stomach, thigh or upper arm. The study will last for about 27 weeks (from first treatment to last check-up). Participants will have 8 visits at the clinic with the study doctor.

NCT ID: NCT03837691 Not yet recruiting - Obesity Clinical Trials

A Feasibility Study for the Treatment of Primary Obesity

Start date: April 2019
Phase: N/A
Study type: Interventional

This is a single-center, open-label, pilot study evaluating a treatment for obesity.

NCT ID: NCT03835416 Not yet recruiting - Obesity Clinical Trials

Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein

VALOR-UP
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Diabetes is a major health concern in obese older Veterans, especially in those who are African American. The negative impact of diabetes on muscle and physical function contributes to metabolic as well as physical decline and is under-studied. This randomized controlled trial compares a higher-protein, weight loss regimen previously shown to improve physical function to an Recommended Dietary Allowance (RDA) protein intervention in obese older male Veterans with pre-diabetes and functional limitations. Equal numbers of white and black male Veterans will be studied, filling gaps in the investigators' knowledge of differential responses by race as well as obesity interventions for men in general. The primary outcome is functional performance by Short Physical Performance Battery and secondary measures include muscle quality, insulin sensitivity, lean body mass, physical activity, recent falls and fear of falling, instrumental activities of daily living, and quality of life measured at 0, 3 and 6 months. The goal of this research is to accelerate functional recovery and enhance independence in obese male Veterans, which is strongly aligned with the RR&D mission to "maximize the physical and social autonomy of Veterans".