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Weight Loss clinical trials

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NCT ID: NCT06151145 Recruiting - Obesity Clinical Trials

Stepped Care for Weight Loss Maintenance

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

This study is a 3-group, parallel design, randomized controlled trial (RCT) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss. 16-week run-in (Phase 1). To qualify for randomization, participants must lose ≥ 5% of initial weight in the 16-week run-in. This loss will be achieved with the provision of weekly-group lifestyle counseling, which includes a partial meal replacement diet. 52-week randomized trial of 3 weight loss maintenance strategies (Phase 2): Participants who have achieved ≥ 5% weight loss during Phase 1 will be randomly assigned to 1 of 3 groups: 1. Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss. 2. Participants in the SELF group will receive a wireless "smart" body weight scale and a wearable physical activity tracker, and daily text messages with tailored feedback to assist in weight loss maintenance. 3. Participants in the STEP group will be enrolled in an intervention that consists of 4 steps that are progressive and based on response to treatment. After 13 weeks at each step, participants who do not maintain a ≥5% weight loss or regain 2 percentage points of weight from the participants randomization value will move to a higher intensity step. Participants who maintain weight loss will stay at the same step.

NCT ID: NCT06147843 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis

FG-CoALS
Start date: January 20, 2024
Phase: N/A
Study type: Interventional

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease. Studies have shown the importance of weight loss at the time of diagnosis and during the progression of the disease. However, the pathophysiological mechanisms behind weight loss remain unknown. Identifying these mechanisms could make it possible to propose an effective therapeutic strategy against weight loss for ALS patients, which could improve their survival and quality of life. In this context, the investigators are proposing an innovative multidisciplinary project aimed at structuring a large Franco-German cohort to identify the markers associated with weight loss in ALS. Participants will undergo high quality standard care for ALS patients. In addition, participants will be asked to respond different questionnaires and blood samples will be taken for analysis to identify biological markers.

NCT ID: NCT06138821 Not yet recruiting - Obesity Clinical Trials

ESG vs GLP-1RA vs ESG + GLP-1RA in Patients With Obesity, NAFLD and Advanced Fibrosis: A Randomized Controlled Trial

Start date: July 2024
Phase: Phase 4
Study type: Interventional

Endoscopic bariatric and metabolic therapies (EBMT) are a non-invasive, safe alternative treatment for patients with obesity. Current FDA- approved devices include intragastric balloons (IGB) and suturing devices for endoscopic sleeve gastroplasty (ESG). These gastric interventions work by interfering with how the stomach expands to accept and process a meal, which slows down how fast the stomach empties. ESG, the procedure the investigators are doing in this study, involves endoscopic suturing to reduce the length and width of the stomach so that the patient feels full faster. Semaglutide is a popular medication for weight loss, and has shown significant weight loss with a good safety profile in clinical trials. In this study, the investigators will compare ESG, Semaglutide only, and an ESG + Semaglutide combination, on weight loss for subjects undergoing the procedure with a history of obesity, liver fibrosis and NAFLD. To better understand how these impact obesity and liver fibrosis, the investigators will track weight loss, laboratory values, liver stiffness, and the patients overall liver health. The suturing device used in the ESG procedure and the semaglutide are all approved by the U.S. Food and Drug Administration (FDA) for endoscopic procedures in the upper gastrointestinal tract and medication management of obesity. This is a study that will randomize patients to 1 of 3 different treatment options: ESG only, Semaglutide only or ESG + Semaglutide. The investigators want to see if adding the weight loss medication to the ESG procedure will increase weight loss and how it will impact liver health.

NCT ID: NCT06129110 Recruiting - Obesity Clinical Trials

Effect of Weight Loss on Intermuscular Adipose Tissue (IMAT) Signaling

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The goal of this intervention study is to learn about how weight loss impacts molecular signaling of intermuscular adipose tissue (IMAT) in individuals with obesity. The main question it aims to answer is how inflammatory molecules secreted by IMAT promote muscle insulin resistance and inflammation, and how these same molecules are diminished after weight loss. Following screening visits involving body composition measures, blood testing, strength testing, and a thigh muscle biopsy, participants will go through a 12-week dietary intervention for weight loss. After 12 weeks, this will be followed by the same testing and biopsies that were completed before the intervention. Researchers will then compare outcomes of individuals who lost weight to individuals who did not lose weight.

NCT ID: NCT06112964 Recruiting - Cancer Clinical Trials

Neurobehavioural and Cognitive Changes in Cancer Cachexia (CANCOG)

CANCOG
Start date: February 15, 2024
Phase:
Study type: Observational

The goal of this observational study is to to look for changes within the brain, and changes in body-to-brain signals in people with cancer and people who do not have cancer. The main questions it aims to answer are: 1. Are there differences in areas of the brain known to be related to appetite control, food reward and motivation, between participants with cancer related weight loss and healthy volunteers 2. Do responses to questionnaires and computer based tasks suggest participants with cancer related weight loss have reduced appetite and reduced motivation to eat compared to healthy volunteers, and if so, do questionnaires suggest that this is associated with any other symptoms? Researchers will compare the structure and blood flow in relevant areas of the brain using MRI images between participants with cancer related weight loss and healthy volunteers. Participants will complete questionnaires and computer based tasks to allow researchers to assess areas of the brain which become more active in response to different stimuli. Some computer based tasks will be performed during the MRI scan. This is called functional MRI. A further objective is to obtain an archive of blood samples which will be stored securely for future analysis if relevant hormones or analytes are identified that may be relevant to metabolism or body composition

NCT ID: NCT06104800 Not yet recruiting - Obesity Clinical Trials

Effect of Weight Loss on Hepcidin Levels and Iron Status in Subjects With Obesity.

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

Obesity and iron deficiency are the nutritional disorders with the highest prevalence worldwide. Different mechanisms have been proposed to explain iron deficiency secondary to obesity. Among the most studied is the deficit in dietary iron intake or the increase in blood volume that increases the need for the metal. However, one of the most plausible mechanisms linking obesity and iron deficiency is low-grade systemic inflammation, through the iron metabolism intermediate known as hepcidin. The investigators objective is to evaluate the effect of weight loss by caloric restriction on hepcidin and serum iron concentration in people living with obesity and iron deficiency. The study will be divided into two phases: Phase 1: A cross-sectional study (cases and controls) to compare hepcidin levels, iron status and inflammatory markers in people living with and without obesity. The second phase consists of an open-label randomized controlled clinical trial. Individuals living with obesity who are iron deficient will be recruited and randomized to one of 2 dietary intervention groups with 60-day follow-up. The intervention groups will be: diet with caloric restriction rich in protein (with red meat) and diet with caloric restriction rich in protein (without red meat). Hepcidin levels, iron status and inflammatory markers will be determined at the beginning and end of the intervention. The nutritional intervention will have the following distribution of macronutrients in the diet: protein 1.5 g/kg of ideal weight, 50% carbohydrates and 25-30% fats.

NCT ID: NCT06103552 Not yet recruiting - Obesity Clinical Trials

BLOOM Forward: Investigating Weight Loss Impact on TJAC Patients

Start date: December 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to prospectively assess the efficacy of the BLOOM program, a comprehensive weight loss dietary and lifestyle program, in a population of patients living with obesity and awaiting hip or knee surgery. The main questions it seeks to answer are: 1. Can the BLOOM program support these patients to lose up to 10% of their initial body weight? 2. Will patients continue to lose weight for the next six months after completing the program? 3. Does the BLOOM program help patients to improve their overall quality of life? Study participants will undergo the BLOOM program, a virtual pre-operative weight management program that spans 24 weeks and is carefully supervised by medical professionals. They will be recruited at the LEAF Clinic after being referred by their primary care physician. During the BLOOM program, they will meet with a physician (initially, then once monthly) and a dietitian (initially, and then biweekly as part of virtual group coaching). They will have access to LEAF's online learning portal. These are normal elements of the BLOOM program. Furthermore, as part of their participation in the research study, participants will be asked to complete the following questionnaires: the Mediterranean dietary score, the Oxford Hip and Knee Questionnaire and the EQ-D5-5L quality of life assessment. They will complete these initially, and then at completion of the program and 3 and 6 months post-program. We will also collect their height and weight at these intervals.

NCT ID: NCT06102538 Recruiting - Morbid Obesity Clinical Trials

"Hachi Barie" Project - A Multidisciplinary Program to Accompany Severely Obese Teenagers in the Weight Loss Process for the Benefit of Their Recruitment Into the Israel Defense Forces

Start date: October 9, 2023
Phase: N/A
Study type: Interventional

Teenagers with body mass values (BMI) above 35 kg/m2 and co-morbidity are designated for medical disqualification from service in the IDF. Data show that there has been an increase in the incidence of these teenagers, specifically among the lower socioeconomic status. The purpose of this pilot study is to carry out an intervention Based lifestyle modification among a group of boys and girls with morbid obesity accompanied by a comorbidity that disqualifies them from service in the IDF. Definition of success: meeting the threshold of weight and health status that allows recruitment into the IDF. Criteria for finding candidates: - Boys and girls from the age of 15 who suffer from morbid obesity and comorbidity that may prevent their enlistment in the IDF. (This age range was chosen to allow an ideal period of at least one year to make a significant change). - Boys and girls who have their own and their family's willingness and commitment to participate in the process - A basic state of health that allows participation in the program. The screening process will be done by the staff of the endocrine unit, under the management of Prof. Orit Pinhas-Hamiel. Duration of intervention: 26 weekly sessions for the trainees. The duration of the meeting will be about three hours in the afternoon A decision whether to extend the duration of the intervention will be taken according to the initial results of the program. Activity location: Potential sites vary: Sheba// academic complex // military base for trainees. Number of participants - 25, (dropout expected 30%) Research goals (main content elements in the program) - there are 3 main content areas (of similar importance) - Education about the importance of service in the IDF and the opportunities inherent in it - Ability-adapted physical activity education and training - Guidance for a healthy diet - Psychological support [The medical accompaniment to the program will take place on the basis of the patients' mother clinics and the medical follow-up of them will be done separately].

NCT ID: NCT06092840 Completed - Weight Loss Clinical Trials

Effect of Transform Burn on Weight Loss

Transform
Start date: March 23, 2016
Phase: N/A
Study type: Interventional

This study was undertaken to explore the effects of a Thermogenic Composition (TC) composed of dihydrocapsiate, red pepper (Capsicum annuum) fruit extract, citrus (Citrus spp) peel extract, coleus (Coleus forskholi) root extract, and african mango (Irvingia gabonensis) seed extract to support body composition, weight management, and improve parameters related to energy, hunger, and satiety on healthy adult women and men over a 12-week interval.

NCT ID: NCT06092372 Enrolling by invitation - Clinical trials for Body Mass Index (BMI)

The Role of Genetics in Weight Loss

GENEROOS
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

The prevalence of both overweight and obesity is increasing at an alarming rate worldwide. In fact, it is estimated that 2.16 billion adults (38%) will be overweight and 1.12 billion adults (20%) will be obese by 2030. Among other risk factors (e.g., environmental, behavioral, and medical), genetics holds an important role. Genome-wide association studies have discovered hundreds of loci associated with body mass index (BMI). Polygenic scores (PS) are generated from a combination of millions of genetic variants that are associated with BMI. Several diet intervention studies aimed at reducing body weight in overweight and obese individuals. However, the effect of genetic background on the effectiveness of diet interventions is largely unknown. To our knowledge, the Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) trial is the only prospective study that has been designed to evaluate the effect of genotypes in modifying the impact of a healthy low-fat diet vs a healthy low-carbohydrate diet on weight change, but this study did not consider PS. The aim of our study is to determine whether BMI PS impacts the effectiveness of dietary intervention in reducing BMI among individuals with elevated BMI. To achieve this, the investigators will leverage the unique opportunity provided by the Finnish biobanks research environment to re-contact 1200 individuals who have extreme genetic predisposition for high/low BMI as measured by a PS for BMI and evaluate how a randomized diet intervention effect varies between the two extreme groups. In brief, the investigators will invite overweight (25-35 BMI) individuals with very high (Top 5%; n=600) and very low (Bottom 5%; n=600) PS for BMI. Half of the participants in each group will be subsequently randomized to enroll in a dietary/lifestyle coaching intervention program or the placebo group and not receive any dietary advice or information. All participants will be asked to answer an online questionnaire and provide a fasting blood sample at baseline and at the end of the study. This well-powered prospective study leverages the unique opportunity to re-contact individuals at the extremes of BMI PS from a large pool of individuals with already available genetic information. This study will determine whether BMI PS can be used to identify overweight and obese individuals who are more likely to succeed in a reduced-energy dietary intervention, which will assist our efforts in curbing the overweight and obesity epidemic.