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Obesity clinical trials

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NCT ID: NCT03500835 Not yet recruiting - Pediatric Obesity Clinical Trials

An Addiction-Based Mobile Health Weight Loss Intervention With Coaching

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

New and creative approaches are needed to address childhood obesity. Current strategies result in suboptimal outcomes and are intensive and costly. It has been theorized that overeating, may have addictive qualities, although few weight management interventions have tested therapeutic techniques founded on addiction medicine principles, such as, withdrawal, tolerance and craving control1, 2. A pilot study utilizing an addiction model based mobile health (mHealth) weight-loss intervention in adolescents showed that the app intervention reduced BMI Z-score (zBMI) to a greater extent than youth participating in an in-clinic multidisciplinary weight management intervention, and appeared to be a cost-effective, labor efficient method for adolescent weight management. The proposed multi-site randomized control trial (RCT) will test the effectiveness of an addiction-based weight loss intervention, embodied first as a smartphone app with telephone coaching and second as an identical approach phone-coaching alone intervention compared to age matched controls participating in an in-clinic weight management interventions in a larger sample of economically, racially and ethnically diverse adolescents (ages 14-18). One hundred and fifty adolescents will be recruited from pediatric interdisciplinary weight management clinics operating out of five different hospital systems in Southern California. The adolescents will be randomized 1:1 via stratified block randomization to either receive 1) six-month interactive addiction model based mobile health (mHealth) weight-loss intervention with personalized phone-coaching, 2) six-month addiction-based phone coaching weight loss intervention alone or 3) six-month addiction model based mHealth weight loss intervention alone. Assessment of the intervention's effect on zBMI and percent over the 95th percentile (%BMIp95), fasting metabolic parameters, addictive eating habits, executive function, and motivation for change will be obtained at enrollment, 3, 6, 12 and 18 months (1 year post intervention follow up). In addition, a real-life economic analysis (cost, cost-saving and non-monetary benefits) analysis will be completed. We will further explore whether primary and secondary outcomes differ by race and whether race moderates the relationship between initial intervention efficacy and prolonged weight maintenance.

NCT ID: NCT03500484 Not yet recruiting - Obesity, Childhood Clinical Trials

Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.

Start date: April 30, 2018
Phase: Phase 2
Study type: Interventional

To study the effects of liraglutide on neural responses to high fructose corn syrup (HFCS) in individuals with obesity.

NCT ID: NCT03497988 Not yet recruiting - Obesity Clinical Trials

Intranasal Oxytocin and Food Intake in Obese Adolescents

Start date: July 2018
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine the effect of intranasal OXT caloric intake and eating behaviors in otherwise healthy obese adolescents. The primary objective of this study is to determine the effects of intranasal administration of oxytocin on food intake in obese, pubertal or post-pubertal adolescents (13 to <18 years in girls, and 15 to <20 years in boys).

NCT ID: NCT03497546 Not yet recruiting - Obesity, Morbid Clinical Trials

Exercise Following Bariatric Surgery for Severe/Morbid Obesity (EFIBAR)

EFIBAR
Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Severe/morbid obesity is an international public health issue that importantly increases the risk of cardiovascular events and cardiovascular and all-cause mortality. Likewise, severe/morbid obesity increases the risk of illness, reduces quality of life, and raises health-care costs. Bariatric surgery is the election method for the treatment of severe/morbid obesity, resulting in significant weight loss and remission of comorbidities. However, a relatively large proportion of bariatric patients regain weight and continue to be at high risk for cardiovascular disease and premature mortality. A healthy lifestyle following bariatric surgery is essential for optimizing and maintaining weight loss. Observational studies suggest that physical activity following bariatric surgery might be associated with additional weight loss and more effective weigh loss maintenance over time. However, very little experimental evidence exists regarding the effects of supervised exercise on obesity-related outcomes in this specific population. The aim of the EFIBAR (Ejercicio FÍsico tras cirugía BARiátrica) randomized controlled trial is to determine the effects of a 16-week supervised concurrent (aerobic and strength) exercise intervention program on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness and quality of life (secondary outcomes) in patients with severe/morbid obesity following bariatric surgery. According to the study aims the investigators pursue the following hypothesis: Supervised exercise will result in larger weight loss than control.

NCT ID: NCT03491930 Not yet recruiting - Obesity Clinical Trials

Weight Loss Using a Feedback Device in Obese People With the Metabolic Syndrome

Start date: April 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if a weight loss app (VA MOVE!® Coach App) along with regularly scheduled telephone counseling, will motivate obese people with metabolic syndrome to lose weight and improve the symptoms of the metabolic syndrome, compared to usual weight loss approaches. This study will randomly assign participants to one of two groups, interventional or control. The interventional group will use the app with phone coaching and standard of care for weight loss. The control group will receive standard weight loss care without the app and phone coaching. Weight loss motivation to adopt life-style changes to maintain weight loss and quality of life between the two groups will be compared. The metabolic syndrome (MetS) is a cluster of disorders including high blood pressure, pre-diabetes, the tendency to carry body weight around the waist, and increased fat in the blood. When these problems happen together, there is an increased risk for heart attack, stroke, diabetes and certain cancers. Although the metabolic syndrome is a serious condition, it can be treated with diet, weight loss and increased activity. It can even be reversed using these lifestyle changes. Due to poor success with routine short-term weight loss treatment (group and one-on-one counseling), it is time to address the problem by a different method. Studies have shown feedback devices and weight loss apps have been successful in weight loss and weight maintenance. They are economical (many apps are free), and convenient to use, without attendance at group sessions. Since weight loss is the corner stone for improvement in the symptoms of the MetS, this study will offer a unique approach to support individuals who are committed to losing weight and adopting a healthier lifestyle. Numerous studies demonstrated that feedback via text messaging, and interaction through social networking support groups, in addition to iPhone apps, are all more effective in weight loss measures than group sessions at a hospital site. (Duncan et al., 2011; Greene, Sacks, Piniewski, Kil, & Hahn, 2012; Shaw et al., 2013; Spring et al., 2013). The benefit of these various methods is that they appear to accelerate weight loss and prevent weight re-gain if employed long-term. With technology changing daily, these approaches must be considered an essential adjunct to, or replacement for, traditional group counselling sessions.

NCT ID: NCT03488212 Not yet recruiting - Clinical trials for Overweight and Obesity

Online Obesity Treatment in Primary Care (Rhode Island, USA)

Start date: April 9, 2018
Phase: N/A
Study type: Interventional

Behavioral obesity treatment produces clinically significant weight loss; for the greatest impact, it should be made available in the primary care setting where it can reach the many patients with overweight/obesity. The investigators developed a 3-month automated online behavioral weight loss program, Rx Weight Loss (RxWL), and showed that it produces clinically significant weight losses among primary care patients. The investigators' early efforts at pragmatic implementation of RxWL have been promising, and have shed light on challenges associated with implementation, and the need to study longer-term effectiveness. The investigators will therefore conduct a pragmatic study to improve the implementation and effectiveness of this behavioral obesity intervention delivered in routine and representative healthcare settings. The investigators are partnering with the Rhode Island Primary Care Physicians Corporation (RIPCPC), a large primary care network of 58 practices with 100 physicians and 16 nurse care managers. Using the framework for Effectiveness-Implementation Hybrid Designs, the investigators will simultaneously target effectiveness and implementation to maximize the public health impact of the research. Half of the 16 nurse care managers, and the practices they serve, will be randomized to either Basic Implementation (alerts generated using the electronic medical record [EMR] to direct eligible patients to RxWL), or to the Enhanced Implementation (alerts, clinician skills training to motivate and support weight loss, clinician dashboard with reports on patient progress and tools to facilitate patient engagement and behavior change). The investigators will test the hypothesis that the Enhanced Implementation will increase the proportion of patients directed to, enrolling, and completing the weight loss program. Because maintenance of weight loss is a critical problem, this project will also involve randomization of 600 patients with overweight/obesity and type 2 diabetes, hypertension, and/or hypercholesterolemia to the 3 month RxWL intervention followed by one of three maintenance conditions: (a) Control- 9 monthly online education sessions; (b) Monthly Lessons and Feedback- 9 monthly online video lessons teaching self-regulation with automated feedback on the self-monitoring record; (c) Refresher Campaigns- 9 monthly on-line video sessions, teaching self-regulation and providing two 4-week courses with novel strategies and behavioral challenges to improve long-term outcomes. The investigators will test the hypothesis that 12-month weight losses are better with Refresher Campaigns than Monthly Lessons and Feedback, and both are better than Control. Secondary outcomes include changes in weight, CVD risk factors, and medication use over a full 24 months. The project is significant and innovative because: it uses an empirically validated approach to obesity treatment that is integrated into the primary care setting, leveraging existing staff and EMR capabilities; it has a dual focus on improving effectiveness and implementation; it has a pragmatic design in partnership with a large primary care network that treats a diverse patient population; and it has potential to it provides a scalable, sustainable approach that can serve as a model for broader dissemination of obesity treatment intervention.

NCT ID: NCT03486223 Not yet recruiting - Obesity Clinical Trials

Soluble Epoxide Hydrolase Inhibition and Insulin Resistance

Start date: April 10, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test how soluble epoxide hydrolase (sEH) inhibition with GSK2256294 affects tissue sEH activity and insulin sensitivity.

NCT ID: NCT03485469 Not yet recruiting - Obesity Clinical Trials

The Impact of the Hypnosis on the Loss of Weight at Patients in Failure of Bariatric Surgery

BARIATHYPNOSE
Start date: June 2018
Phase: N/A
Study type: Interventional

The therapeutic problem of obesity is weight control, a major difficulty, involving a significant change in eating behavior. A number of studies show that there are many factors of resistance to weight loss whether they are physiological, genetic, environmental pressure related, or psychological and behavioral. For some patients, the surgical approach seems the best alternative. Indeed, bariatric surgery is an effective therapeutic weapon in patients with morbid obesity. However, it has been shown that approximately 25% of patients are failing at two years of this surgery (Reinhold's index). Some of the failed subjects may benefit from surgical revision. As for the others, no intervention is currently proposed to them. Studies have shown that the psychological profile of patients who are candidates for bariatric surgery is predominantly immature, impulsive, very anxious with a tendency to depression. The stress level of these patients would be important, and they would have low self-esteem. This study hypothesize that, in these patients, the establishment of hypnotherapeutic management associated with the usual dietary monitoring could modify eating habits thus promoting weight loss and an improvement in self-esteem , stress and anxiety compared to dietary monitoring alone. There are still no studies assessing the impact of hypnotherapeutic management and self-hypnosis on the weight curve, self-esteem, stress, anxiety, or the quality of life of patients Obese in failure of bariatric surgery.

NCT ID: NCT03482986 Not yet recruiting - Obesity Clinical Trials

Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C

Start date: April 2018
Phase: N/A
Study type: Interventional

The purpose of the study is to test how dietary habit interventions affect patients with poor weight loss outcomes after bariatric surgery.

NCT ID: NCT03479762 Not yet recruiting - Obesity Clinical Trials

In Market Utilisation of Liraglutide Used for Weight Management in the UK: a Study in the CPRD Primary Care Database

Start date: April 20, 2018
Phase:
Study type: Observational

This study is conducted in Europe. The aim of this study is to investigate usage of liraglutide for weight management in clinical practice using the CPRD (Clinical Practice Research Datalink) primary care database.