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Weight Loss clinical trials

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NCT ID: NCT05912699 Not yet recruiting - Stress Clinical Trials

A Study to Evaluate the Effect of SlimBiotics L. Fermentum K8 Postbiotic on Weight Management and Metabolic Health Outcomes

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

This study is to evaluate the efficacy of a postbiotic supplement on weight management and metabolic health. This study will be conducted as a hybrid trial consisting of both in-person visits and virtual assessments. Two groups will be included: the intervention (SlimBiotics postbiotic) and placebo. The SlimBiotics postbiotic formula is the first plant-based postbiotic targeting weight management and metabolic health. Other competing postbiotics are isolated from humans (feces) but the strains in SlimBiotics were isolated from a fermented plant (millet porridge cereal) This product contains L. fermentum K8 Postbiotic.

NCT ID: NCT05885074 Not yet recruiting - Obesity Clinical Trials

Mechanistic Insights to Weight Loss Maintenance Through SGLT2 Inhibitors

Start date: January 30, 2025
Phase: Phase 2
Study type: Interventional

Obesity increases the risk of cardiometabolic diseases such as hypertension and diabetes. Weight loss interventions such as low-calorie diet and physical activity are effective for weight loss in the short term, but weight loss maintenance (WLM) with low-calorie diet and physical activity is challenging. Weight loss is associated with a reduction in the amount of calories needed to maintain the body at rest, called the resting energy expenditure (REE), which may be a probable mechanism for this lack of WLM. Most individuals are unable to adequately change their diet and increase their physical activity levels to overcome this decrease in REE which prevents WLM. Therefore, techniques that increase REE may promote WLM in these individuals. Pre-clinical studies for Empagliflozin - Sodium-glucose Cotransporter-2 (SGLT2) inhibitor have shown an increase in REE. Thus, in addition to reducing the cardiovascular risk, SGLT2 inhibitor may promote WLM by increasing REE. This study aims to promote WLM in obese individuals by increasing the REE using SGLT2 inhibitor therapy.

NCT ID: NCT05861973 Not yet recruiting - Obesity Clinical Trials

SMARTer Weight Loss Management

SMARTer
Start date: March 2024
Phase: N/A
Study type: Interventional

The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and usual care assessment-only (Control). The trial will address whether a scalable, stepped-care intervention can stand up to gold-standard DPP by achieving comparable weight loss at a lower cost. Alongside evaluation of clinical non-inferiority, a comprehensive economic evaluation will inform relative affordability. Cost information is important to inform treatment policy and change standard of care, but is sorely lacking for behavioral interventions. The SMARTer intervention reduces costs by initially offering minimal intervention to all and stepping up to offer more costly treatment components only to non-responders who fail to attain the target weight loss. A rigorous economic evaluation planned and designed alongside the SMARTer trial will provide an accurate, robust head-to-head comparison of costs, cost-effectiveness, and projected lifetime health care costs between the three arms.

NCT ID: NCT05775497 Not yet recruiting - Obesity Clinical Trials

Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women

Start date: March 13, 2023
Phase: N/A
Study type: Interventional

Obesity disproportionately impacts sexual minority women. Behavioral weight loss programs are the gold standard treatment for mild to moderate obesity. The investigators have developed an online behavioral weight loss program that is effective, low-cost, and highly scalable. However, existing research suggests that tailoring treatment to address 3 well-established weight loss barriers in sexual minority women will be critical for maximizing the relevance and efficacy of behavioral weight loss for this group. In the Preparation Phase of this K23, the investigators developed 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), the investigators piloted the program among sexual minority women of higher weight, and the investigators conducted individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility, and this feedback was used to refine the program. In the Optimization Phase of this K23 (the current phase), 88 women will receive 12 weeks of Rx Weight Loss and will be randomized to receive 0-3 tailored components in a full factorial design with 23 (8) distinct combinations of components. Novel components that increase mean weight loss (by ≥2%) or the proportion of women achieving clinically meaningful weight loss (by ≥10%) at 6 months will be retained in a finalized obesity treatment package that the investigators will evaluate in a future randomized controlled trial (RCT) (Evaluation Phase). The aims of this study are to: Aim 2A (Optimization): Use a factorial experiment to determine how 3 novel components impact mean weight loss and the proportion of women achieving a 5+% weight loss at 6 months. Aim 2B (Mediation): Clarify how tailored components impact weight loss by testing hypothesized mechanisms of action (i.e., coping with stress, perceived social support, weight and shape concerns). This project will tailor and optimize an evidence-based online behavioral obesity treatment to enhance weight loss outcomes in sexual minority women.

NCT ID: NCT05769907 Not yet recruiting - Obesity Clinical Trials

Protocol for a Feasibility of a Motivational Interviewing for Weight Loss in Adults

MWL
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Abstract Introduction: This pilot study will determine the recruitment feasibility, retention, and adhesion for a motivational interviewing program for weight loss in adults according to the processes of change in weight loss. Methods and Analysis: The single-arm pilot study will be a feasibility study of the Motivation to Lose Weight version 1 (MLW v.1). The study includes presential and online sessions. Participants will be recruited through advertisements on social media and selected according to the inclusion criteria. Participants will receive 8 sessions of approximately 30-45 minutes of motivational interviewing (MI) according to the processes of change in weight loss, as measured by the S-Weight scale. The results will be evaluated at the beginning and the end of the program, which will last 8 weeks. The primary outcome of the study is feasibility. The intervention will be feasible if adherence to the proposed activities in the sessions is greater than 70%, we can recruit 10 patients within 8 weeks, the proportion of interested people and registered participants is greater than 30%, and more than 75% of participants attend the final study visit. The secondary outcome is weight loss, fat mass percentage, muscle mass, waist and hip measurements, and the scores of behavioral scales. Ethics and discussion: The feasibility of this project consists of proposing an individualized intervention based on MI strategy(s) for each participant, according to the stage of readiness, and thus, help to evolve in the process of losing weight. This intervention aims to increase the participant's confidence level to implement actions that lead to the progression of behavior and, consequently, the action and maintenance of the lost weight. This study was approved by the Research Ethics Committee (REC) of the Hospital de Clínicas de Porto Alegre (HCPA) under number 20220209 CAAE 59573622300005327.

NCT ID: NCT05715892 Not yet recruiting - Gastric Bypass Clinical Trials

Examining Patterns in the Involvement of Gastric Bypass Patients in Clinical Studies

Start date: February 2024
Phase:
Study type: Observational

Clinical trial participation has historically been heavily biased toward specific demographics. Several people will be invited to enroll in this study so that it may collect a variety of data about gastric bypass clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. The information collected from this study can be used to improve patient experience and outcomes for future patients and an opportunity to contribute to the advancement of medical knowledge and treatments for gastric bypass.

NCT ID: NCT05713071 Not yet recruiting - Obesity Clinical Trials

Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) as a Treatment for Obesity

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

In the proposed study, we will be evaluating the effects of pylorus sparing antral myotomy alone, without concomitant endoscopic sleeve gastroplasty (ESG), on weight loss for subjects undergoing the procedure with a history of obesity. This is referred to as Bariatric Endoscopic Antral Myotomy (BEAM). To better understand treatment effects, we will track weight loss, gastric emptying with gastric emptying breath tests (GEBT), and gut hormones (i.e. ghrelin). This pilot, single-center, randomized, controlled, clinical study aims to assess the safety, tolerability, and short-term efficacy of BEAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial that could be submitted for NIH grant funding.

NCT ID: NCT05654584 Not yet recruiting - Obesity Clinical Trials

Weight Loss and Aggression

Start date: December 15, 2022
Phase:
Study type: Observational

Obesity has become an important medical and social problem in western countries today. Although many surgical procedures are performed for obesity, Laparoscopic sleeve gastrectomy (LSG) has become the most common bariatric procedure in obesity. The absence of digestive anastomosis, the absence of mesenteric defects that may cause internal hernias and foreign materials such as gastric band are among the advantages of this surgical method. Obesity is a complex multifactorial disease. Obesity is not a mental disorder, but is associated with serious serious conditions and increases the risk of mental disorders. The social label of obesity will have long-lasting devastating effects on mental health. In addition, obesity is associated with undesirable conditions; Misperception of dietary needs, self-perceived health status and potential social isolation, negative attitude towards appearance, aggression, depression, anxiety, attention deficit/hyperactivity disorder, behavioral problem, and bullying are some of the problems associated with obesity. Body changes are important in the experience of being different from their peers and can result in lowered self-esteem and be a barrier to social functioning. Studies on this condition have shown that obese subjects have poor social functioning and social skills. There are many factors that cause aggression, but obesity is one of them. Although there are many studies examining the relationship between overweight and aggression in children and adolescent patient groups, studies examining the adult patient group are limited. Starting from this point, we aimed to determine the change in aggression after weight loss in patients who underwent LSG surgery in the study we created.

NCT ID: NCT05654571 Not yet recruiting - Breast Cancer Clinical Trials

Weight Loss and Breast Cancer

Start date: December 15, 2022
Phase:
Study type: Observational [Patient Registry]

Obesity is an important risk factor for postmenopausal breast cancer. A large meta-analysis concluded that obesity is associated with a 20% to 40% increased risk for receptor-positive postmenopausal breast cancer. The International Agency for Research on Cancer working group on obesity and cancer risk drew similar conclusions. Obesity seems to have the opposite effect among premenopausal women, with most studies suggesting that higher BMI is associated with a reduced risk of premenopausal breast cancer. Determining whether deliberate weight loss is associated with a reduced risk of breast cancer is difficult in part because sustained weight loss is difficult to achieve and few studies have sufficient statistical power to address this question. Bariatric surgery is one of the few weight loss interventions in which significant weight loss is maintained. A limited number of previous studies have suggested a reduced risk of cancer following bariatric surgery. Recently, it showed that bariatric surgery is associated with a lower risk of several types of cancer, including an approximately 40 % reduction in the risk of postmenopausal breast cancer. However, whether bariatric surgery affects breast cancer risk in premenopausal women and whether this association is altered by estrogen receptor (ER) status has not been addressed. The aim of this study is to examine the relationship between weight loss after laparoscopic sleeve gastrectomy (LSG) and breast cancer.

NCT ID: NCT05648617 Not yet recruiting - Weight Loss Clinical Trials

Effectiveness of Protein Supplementation on Frailty Improvement, Muscle Strength and Physical Performance Among Pre-Frail Elderly People

Start date: May 2023
Phase: Early Phase 1
Study type: Interventional

The goal of this randomized clinical trial is to study the effectiveness of protein supplements in frailty improvement, muscle strength, physical performance, energy intake and body composition of pre-frail elderly people. in Selangor, Malaysia. The main question[s] it aims to answer are: Does PS intervention significantly affect in frailty improvement, muscle strength, physical performance, energy intake and body composition of elderly people? For the interventional group, Participants will receive 30g of SUSTINEX Hydrolyzed Whey Protein. The participants will be asked to add it to their food or drinks to reach the goal of consuming 30g daily. For control group, participants will receive no intervention- usual care, will receive the standard care of the clinic without supplemented with PS.