Clinical Research Directory

Pilot Testing a Novel Approach to Pediatric Obesity Treatment

The goal of this clinical trial is to learn if an emotion regulation and self-monitoring intervention can help treat overweight and obesity in teens. The main question it aims to answer is: * Does emotion regulation and self-monitoring help reduce biases in teens with overweight and obesity? * Do changes in biases relate to changes in health functioning and health behavior? Researchers will compare the intervention to the provision of educational handouts about overweight and obesity to see if the intervention is more effective. Participants will: * Complete self-report questionnaires, an fMRI scan, and have their blood drawn * Received educational handouts or attend weekly telehealth group sessions weekly for four weeks and be asked to self-monitor their mood and behavior between sessions * Return to complete the same questionnaires, fMRI and blood draw procedures

A Study of XW003 Injection in Chinese Adolescents With Obesity

The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XW003 injection in Chinese adolescents with obesity

Building Healthy Food Environment in Schools: Evaluating Co-created Interventions in Low Resource Settings. #BetterNutrition4Adolescent

The goal of this clinical trial is to learn if a multicomponent nutrition program developed together with the students, parents, teachers and canteen operators will improve nutrition status of adolescents. It will also learn about the acceptability and feasibility of implementing the program in the school settings. The main questions it aims to answer are: What is the effect of co-created multicomponent intervention promoting healthy food behavior and environment in schools on the proportion of normal weight adolescents? What proportion of the target adolescents and teachers does the intervention reach? What proportion of the schools are willing to implement the intervention? What was the level of fidelity of implementation of all components of the intervention and the barriers and facilitators to implementation? What is the cost for maintenance, and facilitators and barriers of sustainment? School going adolescents studying in grades 7 to 9 from 26 schools in India and 26 schools in Nepal will be enrolled in the trial and their height, weight, dietary behavior, mental well-being and physical activity will be measured at baseline and at 12 months follow up. After the baseline assessment the school community (students, school environment, parents, teachers, canteen operators) will receive the intervention.

ESG in Obese Adolescents

The primary goal of this pilot study is to learn if the use of the Apollo Endosurgery ESG System is a safe, well tolerated intervention for weight loss in adolescents with obesity. Secondary outcomes will evaluate the effectiveness of Endoscopic Sleeve Gastroplasty (ESG) in long-term reduction of weight, improvements in obesity-related co-morbidities and improvements in quality of life. Participants will: * Have their stomach volume reduced with the ESG procedure (study intervention), rather than with a bariatric surgery, under general anesthesia * Undergo pregnancy testing (female participants only) * Be admitted overnight to the hospital for recovery and monitoring following the ESG procedure * Have a physical examination performed at study follow-up visits * Participate in surveys about any side effects from the procedure and about quality of life * Follow-up with the study team. * Participants will still be seen in the multidisciplinary Bariatrics Clinic team consisting of an obesity medicine doctor, registered dietician, physical activity specialist, and psychologist as part of normal standard of care.

Comparison Between Gastric Band, Laparoscopic Sleeve Gastrectomy, Gastric Bypass Surgeries

Determine the short and long term safety and efficacy of the Gastric bypass , laparoscopic sleeve gastrectomy, and Gastric banding (LAGB) on severely obese adolescents. The procedure selection is made by the patient or patient and guardian. This is not a randomized trial.

Co-creating School Community Intervention Program on Physical Activity to Increase Health Equity in Children and Adolescents

The goal of this observational and interventional study is to understand whether environmental and behavioral interventions can improve physical activity and health outcomes in children aged 12-16 years attending VDU Atžalynas Progymnasium, Lithuania. The main questions it aims to answer are: 1. Does higher physical activity and improved lifestyle reduce health disparities among children living in disadvantaged social and economic conditions? 2. What is the relationship between environmental pollution, physical activity, and children's health indicators? Researchers will compare data from the cross-sectional group (baseline measurements only) and the intervention group (7-day activity tracking and follow-up after 3 months) to see if targeted environmental interventions improve children's physical activity, sleep quality, and health outcomes. Participants will: * Fill in questionnaires about health behaviors, well-being, and living environment (children and parents). * Undergo physical measurements (blood pressure, height, weight, body composition). * Wear a smart wristband for 7 days to monitor activity, sleep, and heart rate (only for selected participants). * Attend a follow-up visit after 3 months (intervention group only).

Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

The goal of this clinical trial is to learn if the drug semaglutide changes markers of disease risk as it relates to weight in children ages 12-15 years old who are obese (class 2 or 3). The main questions it aims to answer are: * How do the rate of weight loss, body mass index (BMI), body composition, heart structure and function, and exercise ability interact with one another in the study population at enrollment? * How do risk markers of disease change over the study in the study participants who are given semaglutides to help with weight loss? * Are there differences in the above factors between males and females and are there key factors to help improve the outcomes? Participants will be given semaglutide for this study. During the course of the study, participants will: * have two cardiac MRI scans OR two cardiac echocardiograms (one before starting semaglutide and one around 12 months after taking the drug) * have body composition and fitness levels assessed twice (before semaglutide and around 12 months after taking it) and have urine specific gravity (USG) measured * have extra blood drawn when labs their doctor orders are already being drawn (once at the beginning of the study, once around 6 months after enrollment, and once at the end of the study) * have follow up visits with the study doctor * be asked to take a pregnancy test if they are female and have started menstruation

Study of the Effect of Capsinoid Supplementation on Brown Adipose Tissue in Obese Adolescents

Among the new strategies being considered for the treatment of obesity and its metabolic complications, the activation of brown adipose tissue (BAT) from white adipose tissue looks promising. Interest in the study of BAT has increased over the last 5-10 years in response to the discovery of functional BAT in humans. The BAT is a tissue specialized in regulating energy expenditure by producing heat through the oxidation of fatty acids contained in the multiple lipid droplets of brown adipocytes. This adipose tissue does not play a storage role, but rather an anti-obesogenic one, thanks to its high metabolic and energetic activity. In addition to exposure to cold, which is the major physiological inducer of brown adipocytes, it seems that exercise and the intake of "adrenergic" foods can activate the TAB and potentially induce a change from white to brown tissue via the production of adrenalin and myokines. Acute and/or chronic effects of thermogenic food supplements have been reported on BAT activation and energy metabolism. The most conclusive of these involve the capsinoids found in sweet peppers and chillies. Weight loss also improves BAT activation. The BAT has already been identified in children. A decrease in its volume and activity from childhood to adolescence and during puberty has been reported. The main objective of this randomized controlled double-blind study is to investigate the effects of capsinoid dietary supplementation on BAT activity in obese adolescents. Our general working hypothesis is that capsinoid supplementation, combined with dietary management, leads to an increase in BAT activity.

Exercise-snacks for Breaking the Sedentary Lifestyle and Improving the Physical Fitness of Obese Adolescents?

The management of a person with obesity involves long-term behavioral changes with a balanced diet in both quantity and quality, along with the adoption of a more active lifestyle: increasing physical activities and reducing sedentary behaviors. The school setting has been identified as a favorable environment for interventions aimed at reducing and interrupting the time adolescents spend sitting and preventing the associated negative health consequences. Recently, very short (\< 1 minute) and intense exercises, called 'exercise-snacks,' have been reported to be effective in adults for 1) improving physical fitness over 6 weeks, and 2) improving vascular function and lowering blood glucose levels over a single day. Additionally, in adolescents with diabetes, they have been shown to reduce body fat. This raises the question of whether adding \'exercise-snack\' sessions to a multidimensional care program for hospitalized obese adolescents could further improve their physical fitness in the short and medium term. The objective of this project is to compare the effects of a traditional multidimensional care program with the addition of 'exercise-snacks' to the same care program without \'exercise-snacks\' on the physical fitness, body composition, vascular function, and physical activity and sedentary behaviors of obese children in the short and medium term. Thirty-six obese adolescents will be included. The \'exercise-snack\' group will perform six exercise sessions per day for three weeks in addition to the standard care. The control group will receive only the standard care. Assessments of physical fitness, body composition, vascular health, and questionnaires on physical activity, sedentary behavior, and cognitive restraint will be conducted at the beginning and end of the three-week program, as well as 1 and 3 months after the end of the program.