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49 clinical studies listed.
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Tundra lists 49 Obesity (Disorder) clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT07787546
The Effectiveness of Respiratory Muscle Training and Exercise in Obese Adolescents
This study aims to investigate the effects of respiratory muscle training and exercise on respiratory muscle strength, pulmonary function, and exercise tolerance in obese adolescents diagnosed with specific learning disabilities. A total of 44 participants will be included and assigned to two different intervention groups, with 22 participants in each group. Participants will undergo baseline assessment, followed by assessments after routine treatment and after the intervention period. The study will compare changes in respiratory and functional outcomes between the two intervention groups.
Gender: All
Ages: 10 Years - 16 Years
Updated: 2026-08-31
NCT07152028
Exercise Supervision Duration and Adherence in Obese Women
Obesity is one of the most common health problems worldwide and is associated with many chronic diseases. Regular physical activity is known to play an important role in weight control, balance, quality of life, and mental health. However, obese individuals often have low adherence to exercise programs, and long-term maintenance of physical activity remains a major challenge. Previous studies have shown that supervised exercise programs are effective in improving functional capacity and psychological well-being. On the other hand, home-based programs are less costly and more accessible, but adherence and effectiveness may be limited without professional supervision. To date, there is limited evidence on the optimal supervision duration needed to achieve sustainable improvements in obese women. In the present study, it is aimed to investigate the effects of a 12-week individualized multimodal exercise program with different supervision durations (6 weeks supervised + 6 weeks home-based vs. 12 weeks fully supervised) on adherence and health outcomes in obese women. It is thought that prolonged supervision may increase exercise adherence, improve balance and functional performance, reduce depressive symptoms, and contribute positively to the quality of life. The results of this study may guide the design of future exercise programs for obesity management and provide evidence for more effective and sustainable rehabilitation approaches.
Gender: FEMALE
Ages: 18 Years - 60 Years
Updated: 2026-08-20
1 state
NCT07759544
I-OPERA: A European Study Testing a New Way to Do Health Research.
The goal of this observational pilot study is to evaluate whether a participant-mediated, direct-to-participant research approach is a feasible and effective way to collect health data from adults living with obesity in England, France, and Germany. This approach allows participants to take part remotely and to help researchers access their medical records using their data access rights, while also providing information directly through an online questionnaire. The main questions it aims to answer are: 1. Can medical records be successfully obtained through participant-authorized data subject access requests (DSARs), and how long does the process take? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.) 2. How well do healthcare providers comply with requests for medical records? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest. Therefore, their healthcare providers are not contacted.) 3. Is the information collected through this approach complete and of sufficient quality for research purposes? 4. How closely does information reported by participants match the information contained in their medical records? 5. Are there differences in outcomes between countries and regions? Researchers will also explore the demographic, clinical and socio-economic characteristics of participants, assess health-related quality of life, evaluate experiences related to "food noise", and compare quality-of-life results across countries. There is no comparison group or study treatment, as this is an observational study. Participants will: * Provide electronic informed consent to participate in the study. * Authorize requests for their medical records using their legal right to access personal health information (DSAR). (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.) * Complete an online questionnaire about their health, quality of life, and experiences related to obesity. * Allow researchers to combine information from questionnaire with data obtained from their medical records. * Participate entirely remotely through the IQVIA Health Research Space (HRS) platform, with no study site visits required. Participation lasts for up to 90 days and includes completion of questionnaire and the medical record retrieval process. The study plans to enroll approximately 105 participants, with around 35 participants in each participating country.
Gender: All
Ages: 18 Years - Any
Updated: 2026-08-12
NCT07728669
Digital Dietary Intervention for Patients Receiving GLP-1 Receptor Agonist Therapy
The goal of this clinical trial is to learn whether adding the NutriSteppe digital dietary intervention to routine medical care improves metabolic health in adults aged 21 to 65 years with type 2 diabetes mellitus, obesity, or overweight with related health conditions. Participants are already receiving or have been prescribed glucagon-like peptide-1 (GLP-1) receptor agonist therapy by their treating physicians outside the study. The main question is: Does the NutriSteppe digital dietary intervention improve glycated hemoglobin (HbA1c), a measure of average blood glucose, after 12 weeks compared with routine medical care alone? The study will also assess changes in fasting blood glucose, body weight, body mass index, waist circumference, cholesterol, triglycerides, blood pressure, diet quality, quality of life, dietary adherence, and safety. Researchers will randomly assign participants to one of two groups. The control group will continue routine medical care and receive general lifestyle advice. The intervention group will continue routine medical care and use the NutriSteppe application for 12 weeks to receive personalized dietary support. Participants in both groups will: * Attend study visits and complete the examinations, laboratory tests, and questionnaires specified in the study protocol. * Photograph everything they eat and drink. * Have their food photographs automatically analyzed using Tagam-AI, a system developed for this study. * Be able to view the results of the food photograph analysis. The photography and automated analysis procedures will be the same in both groups. Only participants in the intervention group will receive personalized dietary recommendations generated from these data through the NutriSteppe application.
Gender: All
Ages: 21 Years - 65 Years
Updated: 2026-08-11
NCT07313384
Dietary Insights and Nutrition Experiences in Adults on GLP-1 Therapy - A Study on Diet Quality Changes in Adults on GLP-1 Therapy
The DINE-GLP1 study aims to understand how people on GLP-1 therapy change their eating habits and what kind of dietary support they need. As more people use GLP-1 medications, there's not much guidance on what they should eat, mostly just focusing on managing symptoms and cutting calories. Since these medications reduce food intake, it's important to ensure the diet is nutritious even with fewer calories to help with long-term weight control and health. Most research has looked at how the body responds to the medication and whether patients take it as prescribed, but not much is known about what patients actually experience, what they think they need, or how they could use additional support. Understanding patients' views can help create better lasting solutions. Note that this study does not provide free GLP-1 medication.
Gender: All
Ages: 18 Years - Any
Updated: 2026-07-23
1 state
NCT07257484
Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors
This study will explore whether tirzepatide is a practical and acceptable treatment for postmenopausal females with a history of hormone receptor-positive breast cancer and obesity. The investigators aim to understand whether participants are willing and able to take this medication once weekly for 6 months and whether it may help improve weight and overall health. There will be monthly check-ins to monitor progress and safety. At the beginning and end of the study, participants will undergo body composition assessments, blood tests and a stool sample will be collected, and surveys will be completed.
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2026-07-22
1 state
NCT07653412
Precision Obesity Medicine: Genetic Prediction of Response to GLP-1/GIP Agonists.
Obesity is a chronic multifactorial disease with a strong genetic component. Although glucagon-like peptide-1 (GLP-1) receptor agonists such as semaglutide and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonists, such as tirzepatide, are highly effective treatments for obesity, substantial inter-individual variability in weight loss response remains. Genetic factors may contribute to these differences in treatment outcomes. The aim of this prospective cohort study is to investigate whether a Genetic Risk Score (GRS) and selected obesity-related single nucleotide polymorphisms (SNPs) can predict weight loss response to semaglutide or tirzepatide in adults with obesity. Participants initiating treatment with either medication will undergo clinical, biochemical, and genetic assessment at baseline and will be followed for six months. The study will evaluate the association between genetic markers and treatment response and develop predictive models integrating genetic and clinical variables. The findings may contribute to the development of personalized treatment strategies for obesity.
Gender: All
Ages: 18 Years - Any
Updated: 2026-07-10
NCT07095972
Continuous Glucose Monitoring in Metabolic Surgery
We will recruit 20 severely obese participants at Metamor Institute. Participants with obesity who are eligible for MBS will be randomized to either CGM group or self-monitoring of blood glucose (SMBG) group before the surgery based on a 1:1 ratio. All participants live in Baton Rouge, Louisiana. The surgeon in Metamor will introduce our study to the patients. If the patients are interested, the evaluation process includes verifying basic personal information, assessing health status and medical history, and evaluating specific eligibility criteria relevant to the study. The study coordinator will be discussing informed consent, ensuring participants understand the study's purpose, procedures, and any associated risks or benefits. Participants are encouraged to ask questions, ensuring clarity and comfort with the study. All collected data is documented and securely stored, respecting data privacy protocols. Eligible individuals are informed about the screening visit, while those not suitable are considered for future studies.
Gender: All
Ages: 20 Years - 60 Years
Updated: 2026-07-09
1 state
NCT07676656
Neck-to-Waist Ratio Identifies Chronic Hypertensive Phenotype and Occlusive Myocardial Infarction in Patients Presenting With Acute Coronary Syndrome
aim of this study was to evaluate the relationship between multiple conventional and novel anthropometric measurements and hypertension in patients presenting to the ED with ACS and whether anthropometric indices differ according to admission BP status and evaluated the relationship between regional adiposity-related anthropometric phenotypes and cardiovascular stress response in ACS presentations. Rather than representing a general population-based study, this study evaluates the association between ACS and elevated admission BP in a population already characterized by a substantial metabolic disease burden.
Gender: All
Ages: 18 Years - Any
Updated: 2026-06-30
NCT07668492
3D Reconstruction, VR and Machine Learning in Body Image in Bariatrics
Studies have shown that following bariatric metabolic surgery (BMS), patients continue to experience dissatisfaction with their new body image and identity). The reason for this is poorly understood but negative body image perception after surgery is linked to poor psychological and clinical outcomes. Our pilot study looking at the acceptability and feasibility of 3D reconstruction and virtual reality (VR) in addressing body image in BMS found that participants felt better informed about how their body will change following significant weight loss and agreed this novel intervention would be beneficial in helping patients adjust to changes in their body after BMS. The investigators propose a randomised control trial comparing group body image counselling and group body image counselling with 3D reconstruction and VR in addressing body image in BMS. The study aims to enrol 80 participants from the Tier 4 bariatric group at St Mary's Hospital and Chelsea \& Westminster Hospital. After consent, participants will be divided into two groups: the control group will receive traditional group body image counselling, and the intervention group will receive the same counselling supplemented with VR and 3D reconstructed images depicting 15% and 25% total less body weight. Both groups will undergo four sessions over six months. The investigators will collect data including body measurements and 3D images of the participant in their underwear using a secure password protected device at baseline and follow participants at 3, 6, 9, 12, 18, 24, and 36 months post-BMS. Patient reported outcomes will be assessed through patient-reported questionnaires. This trial seeks to determine if integrating 3D reconstruction and VR technology into body image counselling can provide better support for patients adjusting to body image changes post-BMS, potentially leading to improved psychological and clinical outcomes.
Gender: All
Ages: 18 Years - 75 Years
Updated: 2026-06-25
NCT07227051
Optimizing Self-Monitoring Feedback Delivery for the Treatment of Overweight and Obesity
The purpose of this research study is to learn how to best provide weekly feedback on individual progress toward intervention goals during a weight loss program.
Gender: All
Ages: 18 Years - Any
Updated: 2026-06-24
1 state
NCT07663942
Targeting Sedentary Behavior Reduction and Physical Fitness Enhancement in Women Before and Beyond Bariatric Surgery- BARIMOV Study Protocol
Introduction: Sedentary behavior (SB) and insufficient physical activity (PA) interact to worsen physical fitness (PF), obesity-related complications and diseases (ORCD), and all-cause mortality in women with obesity. Replacing SB with low-intensity PA may improve PF and ameliorate ORCD, with potential lasting effects after bariatric surgery (BS). However, strong evidence on how PF influences BS outcomes and whether preoperative PA interventions can improve postoperative outcomes is lacking. The BARIMOV study aims to evaluate the effects of a structured sedentary behavior reduction program (SBRPro) on PF, investigate whether PF improvements influence BS outcomes, and explore potential mechanistic pathways by characterizing molecular adaptations in peripheral blood, skeletal muscle, and visceral adipose tissue (VAT). Methods: BARIMOV is a prospective cohort study with five assessment time points. Adult women (≥18 years) with BMI 30-45 kg/m² scheduled for BS will be recruited (n = 72). At T0, participants will undergo a baseline assessment of PF - body composition, muscle strength, cardiorespiratory fitness - PA patterns, and ORCD screening. Participants will be instructed in the SBRPro and asked to maintain weekly PA diaries throughout the pre- and post-operative periods. At T1, adherence to SBRPro will be evaluated via diary review and PF reassessment, to enable participants' allocation into two adherence-based groups. At T2, during surgery, skeletal muscle and VAT biopsies will be collected for proteomic analysis to compare molecular adaptations of adherent and non-adherent groups. At T3 and T4, primary outcomes, including weight loss, body composition, ORCD, and quality of life (QoL), will be evaluated at 3±1 and 12±1 months postoperatively, respectively. Blood multiomics profiling will be performed at T0, T1, and T3 to explore dynamic changes in systemic metabolic pathways over time. Conclusion: This study will determine whether PF improvement, achieved through structured SB reduction and PA engagement, is associated with better BS outcomes. By integrating clinical and molecular endpoints, the study will provide mechanistic insights into the pathways by which PF enhances BS outcomes and inform physical activity intervention strategies.
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2026-06-23
NCT07448090
Real-World Case Registry Study on Obesity
Obesity is a major risk factor for cardiovascular disease, diabetes, cancer, and other chronic conditions. Due to its complex etiology and frequent comorbidities, effective obesity management requires comprehensive and individualized approaches. This study is a multicenter, prospective, real-world registry designed to evaluate integrated traditional Chinese medicine (TCM) and Western medicine interventions for obesity. The study will enroll at least 10,000 individuals with obesity from urban and rural populations. Multimodal data, including electronic medical records, laboratory test results, imaging data, and lifestyle information, will be collected. The effectiveness of integrated TCM and Western medicine interventions will be assessed across different age groups, disease stages, and obesity-related constitution types. In addition, disease progression patterns and key prevention and treatment points will be explored. Health economic analyses will be conducted to evaluate the cost-effectiveness of different obesity management strategies, providing real-world evidence to support public health policy and the optimization of integrated obesity prevention and management approaches.
Gender: All
Ages: 18 Years - 75 Years
Updated: 2026-06-12
1 state
NCT07505212
Effects of Gallotannins on the Gut Microbiome and How it Affects Inflammatory Markers Among Obese Individuals.
The goal of this clinical trial is to understand how gallotannin-rich (GT-rich) mangoes can reduce the inflammatory markers in obese individuals in vitro. The study will also seek to explore how gallotannins are metabolized in the gut microbiome. The main questions the research aims to answer are: * What is the impact of GT extract from mango and Lactiplantibacillus pentosus supplementation on inflammatory biomarkers in obese individuals? * Does the combination of GTs and L. pentosus exhibit synergistic effects in modulating specific microbial taxa associated with obesity and inflammation compared to either intervention alone? * Does genetic variation among individuals with obesity account for the ability to metabolize gallotannins? Researchers will compare the effects of GT extract from mango juice, a combination of GT-rich extract, and L. pentosus probiotic supplement on samples (stool) provided by obese individuals, to samples provided by a lean control group to see if gallotannins and gallotannins + probiotic supplementation reduce inflammation in obesity. Participants will * Be grouped into 4 treatment groups 1. Mango juice only 2. Mango + L. pentosus 3. L. pentosus only 4. Control (lean individuals) * Visit sample collection site one time during the study (week 1)
Gender: All
Ages: 18 Years - 55 Years
Updated: 2026-06-09
1 state
NCT07634302
Effects of Resveratrol Supplementation Combined With a Low-Calorie Diet in Postmenopausal Women With Obesity and Knee Osteoarthritis
Obesity is a major modifiable risk factor for knee osteoarthritis and is associated with chronic low-grade inflammation, pain, functional impairment, and cartilage degradation. Weight reduction is recommended as a core component of osteoarthritis management, while resveratrol has demonstrated anti-inflammatory and chondroprotective properties in experimental and clinical studies. However, the potential additional benefit of resveratrol supplementation when combined with dietary intervention remains uncertain. This randomized controlled trial evaluated the effects of 150 mg/day trans-resveratrol supplementation as an adjunct to a low-calorie diet in postmenopausal women with obesity and knee osteoarthritis. Ninety-seven participants were randomized to receive either a low-calorie diet alone or the same diet combined with resveratrol for 10 days. Outcomes included pain intensity, functional status, urinary C-terminal telopeptide of type II collagen (CTX-II), anthropometric parameters, body composition, metabolic markers, lipid profile, and inflammatory biomarkers.
Gender: FEMALE
Ages: 45 Years - 75 Years
Updated: 2026-06-08
NCT07618741
Improving Outcomes After AF Ablation in Obese Patients
Improving Outcomes After AF Ablation in Obese Patients
Gender: All
Ages: 20 Years - Any
Updated: 2026-06-01
NCT07317115
Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes
Compare use of the Magnet System in side-to-side duodeno-ileostomy (Surgery) with semaglutide (Medication).
Gender: All
Ages: 18 Years - Any
Updated: 2026-05-19
1 state
NCT07567378
CARTIZ Registry: Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts - A Four-Institute Mexican Observational Registry
CARTIZ is a prospective observational clinical registry of adults in Mexico receiving tirzepatide (a dual GLP-1/GIP receptor agonist) under an independent clinical indication - typically type 2 diabetes, insulin resistance, obesity, renal protection, metabolic hypertension, or associated off-label metabolic use. The registry is entirely observational: CARTIZ does not initiate, modify, interrupt, or supply tirzepatide, and does not dictate dose, route, or duration. All pharmacological exposure decisions are made by the treating physician independently of study participation. The registry is operationalized through a four-institute architecture integrating three Mexican National Institutes of Health and one national imaging laboratory. Core 1 (Knee Cartilage Imaging, Ci3M UAM-Iztapalapa) performs bilateral 3T MRI with quantitative T2 mapping at Week 0 and Week 52. Core 2 (Cardiac Imaging, Instituto Nacional de Cardiología Ignacio Chávez) performs non-contrast cardiac computed tomography for radiomic phenotyping of epicardial adipose tissue at Week 0 and Week 52 under cardiovascular Co-Principal Investigator Dr. Erick Alexánderson Rosas. Core 3 (HLA Typing, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Transplant Department) performs Class I and Class II HLA typing by PCR-SSO Reverse Luminex. Core 4 (Body Composition, Universidad La Salle México) performs multi-frequency bioelectrical impedance analysis (seca mBCA) at six longitudinal timepoints capturing visceral adipose tissue trajectory, phase-angle trajectory, appendicular skeletal muscle mass, and hydration ratios at zero marginal cost. The registry enrolls n=30 patients across three clinical sites with identical protocol (IMSS Clínica Río Magdalena, INCMNSZ outpatient clinic, and a private practice site in Mexico City), generating 60 evaluable knees and 30 paired cardiac CT studies. The primary co-endpoints address a mechanistic question no other tirzepatide study is positioned to answer: whether the articular response to tirzepatide in inflammatory arthropathy precedes and mechanistically precedes weight loss, through formal mediation analysis of Week-4 ACR20 response via high-sensitivity C-reactive protein, SERPINB2, and dipeptidyl peptidase-4 activity, restricted to the Mechanistic Analysis Set of patients with tirzepatide exposure ≤16 weeks at Week 0 and delta-BMI \<1.0 kg/m² through Week 4. A prespecified Surgical Tissue Subcohort is declared at initial registration to establish public scientific priority on direct human epicardial adipose tissue transcriptomic characterization under dual GIP/GLP-1 receptor agonism. Subcohort participants who undergo clinically indicated cardiac surgery at INCar during follow-up (coronary artery bypass grafting, valve replacement, or combined procedures) are invited to provide specific additional informed consent for collection of epicardial adipose tissue fragments routinely excised during operative access and otherwise discarded as surgical waste. Operational launch is contingent on separate INCar tissue-specific approvals and will proceed via PRS record amendment when ready
Gender: All
Ages: 18 Years - Any
Updated: 2026-05-12
1 state
NCT07131605
Effects of Bariatric Surgery on Cardiovascular Risk Profile in Relation to Inflammatory Parameters: Endothelial Phenotyping and Analysis of the Cross-talk Between Adipose Tissue and Endothelium
This research project aims to study how obesity affects the heart and metabolism, and how these effects change after significant weight loss following bariatric surgery. In particular, we want to look at how blood vessels and fat tissue function in people with obesity, to detect early signs of vascular problems and understand how fat tissue communicates with blood vessels. Our main idea is that obesity disrupts the normal function of blood vessels, partly due to substances released by fat tissue and changes in gut bacteria. We believe that 6 and 12 months after surgery - with proper weight loss - these problems will gradually improve. We expect to see better blood vessel function and lower levels of inflammation and fat-related substances in the blood, which could significantly reduce the overall risk of heart disease.
Gender: All
Ages: 18 Years - Any
Updated: 2026-05-08
1 state
NCT07543666
The ISAR InflEx Trial (Inflammation and Exercise)
A sedentary lifestyle and obesity are associated with chronic low-grade inflammation and an elevated risk of cardiovascular disease (CVD). This study aims to systematically characterize and compare the effects of three distinct exercise modalities - moderate-intensity, vigorous-intensity, and short-duration maximal exercise - each differing in duration and intensity, on systemic inflammation and immune function. The study investigates the potential of exercise as an effective anti-inflammatory intervention for the prevention of CVD.
Gender: All
Ages: 18 Years - 45 Years
Updated: 2026-04-24
1 state
NCT07545174
Role of the Environment in Pediatric Obesity
Childhood obesity is a particular concern in developed countries such as the United States, the United Kingdom, Canada, and certain European countries. According to the World Health Organization (WHO), approximately 6% of children under the age of 5 worldwide were obese in 2016, a figure that continues to rise. The pathophysiology of pediatric obesity can be explained by several interconnected biological and behavioral mechanisms. In particular, it involves dysfunctions in the hormones that regulate appetite and satiety, as well as dysfunctions in lipid metabolism. Per- and polyfluoroalkyl substances (PFAS) are a large family of synthetic chemical compounds. The main PFAS are perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), and perfluorohexanesulfonic acid (PFHxS). PFAS are present in many everyday consumer products. Bisphenol A (BPA) is a chemical compound used primarily in the manufacture of plastics and resins. It is commonly found in polycarbonate plastics, used to make food containers and water bottles, as well as in epoxy resins, which are used to coat the inside of food cans and water pipes. Non-persistent pesticides, such as organophosphates and polychlorinated biphenyls, are chemicals used primarily in agriculture to control insects and other pests. There are arguments suggesting that PFAS, bisphenol A, and non-persistent pesticides may play a role in the onset of pediatric obesity, particularly by acting.
Gender: All
Ages: 6 Years - 15 Years
Updated: 2026-04-22
NCT07341113
Positional Effects on Lung Ventilation and Perfusion in Obesity
Electrical Impedance Tomography (EIT) is a non-invasive, bedside monitoring tool that provides real-time information on regional ventilation and perfusion. In particular, EIT has the potential to guide individualized mechanical ventilation in obese patients by revealing how gravitational and positional factors alter regional lung behavior. Assessing the effects of different horizontal positions on both ventilation and perfusion may help optimize respiratory management strategies tailored to body habitus. By comparing obese and non-obese healthy participants across different positions, this study aims to provide novel insights into the postural effects on lung aeration and perfusion distribution, and to highlight the role of EIT in tailoring individualized ventilation strategies.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2026-04-15
NCT07505459
AI-INFORMED PEER-MENTORING BEHAVIORAL INTERVENTION FOR OBESITY AND CARDIOVASCULAR DISEASE PRIMARY PREVENTION IN YOUTH
The goal of this clinical trial is to learn if an AI-based peer-mentoring works to prevent obesity in adolescents and young adults. The main questions it aims to answer are: Does the AI-based peer-mentoring improve dietary habits and increase physical activity in healthy individuals 12-25 yrs old? Does the AI-based peer-mentoring reduces the risk of obesity? Researchers will compare the AI-based behavioral peer-mentoring intervention to traditional peer-mentoring and to health education intervention to see if AI-based peer-mentoring is more effective. Participants will: Follow either a structured AI-based peer-mentoring program or a traditional peer-mentoring program or health education sessions focusing on diet and physical activity They will be evaluated at baseline, at 6 months and at 12 months
Gender: All
Ages: 12 Years - 25 Years
Updated: 2026-04-14
2 states
NCT07268508
Impact of a Pro-diversity Gut Microbiota Diet After a Bariatric Surgery on Gut Microbiota, Eating Behaviour and Sensory Function
Bariatric surgery is the most effective treatment for long-term weight loss and reducing obesity-related health risks. It alters the gastrointestinal tract as well as metabolic and hormonal functions, influencing eating behaviour. However, weight loss outcomes and long-term maintenance vary between patients, likely due to changes in the gut microbiota. Dietary recommendations aimed at improving microbiota diversity could help support sustained weight loss after surgery. The BariaGut Taste study aims to compare two dietary approaches following bariatric surgery: nutritional counselling promoting gut microbiota diversity versus standard nutritional counselling. One year after surgery, the study will evaluate differences in microbiota diversity, changes in food preferences and eating behaviours, sensory profiles (taste, smell), levels of digestive and gut hormones fasting, before and after eating, cardiometabolic parameters, mental health, physical activity, and more, to better understand Bariatric surgery is the most effective treatment for long-term weight loss and reducing obesity-related health risks. It alters the gastrointestinal tract as well as metabolic and hormonal functions, influencing eating behaviour. However, weight loss outcomes and long-term maintenance vary between patients, likely due to changes in the gut microbiota. Dietary recommendations aimed at improving microbiota diversity could help support sustained weight loss after surgery. The BariaGut Taste study aims to compare two dietary approaches following bariatric surgery: nutritional counselling promoting gut microbiota diversity versus standard nutritional counselling. One year after surgery, the study will evaluate differences in microbiota diversity, changes in food preferences and eating behaviours, sensory profiles (taste, smell), levels of digestive and gut hormones fasting, before and after eating, cardiometabolic parameters, mental health, physical activity, and more, to better understand the mechanisms that may explain variations in response to bariatric surgery. The BariaGut Taste study is a prospective, randomized, controlled trial with two parallel groups, involving non-diabetic patients aged 25 to 65 y undergoing either sleeve gastrectomy or Roux-en-Y gastric bypass. The trial will be conducted at the digestive surgery department of Edouard Herriot Hospital, the endocrinology-diabetes-nutrition department of Lyon Sud Hospital Center, and the Human Nutrition Research Center Rhône-Alpes. 60 participants are expected to be recruited, with 30 in each arm. Participants will be enrolled before surgery during a routine care visit with the surgeon. They will then undergo a metabolic assessment visit conducted exclusively for research purposes. This visit will allow to collect baseline data on primary outcomes via blood, expired air, and stool samples, anthropometric measurements, indirect calorimetry, a battery of questionnaires (TFEQ-21, DEBQ, PHQ-9, SF36, GSES, PANAS, ESUL, BES, DERS, GAD-7, IPAQ, BAQ, GSRS, sensory alterations, Bristol and Likert scales, and FNS), computerized food preference tests (LFPQ), and a standardized, video-recorded ad libitum buffet. Participants will be followed up at 3, 6, and 12 months after surgery through visits combining clinical care and research assessments. The dietary interventions specific to each group will be provided since the 3-month visit. The assessments conducted before surgery will be repeated at 6 and 12 months, also integrating clinical care objectives. Additional blood, stool, and adipose tissue samples collected during surgery will be stored to create a biobank.
Gender: All
Ages: 25 Years - 65 Years
Updated: 2026-04-03