Mindfulness-Based Nutrition Group Therapy as an Adjunct to GLP-1 Treatment of Obesity

Registered clinical trial record on ClinicalTrials.gov (NCT07649759). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results. Status: active not recruiting. Study type: interventional. Phase: N/A. Sponsor: Bern University of Applied Sciences. Conditions: Obesity & Overweight, Emotional Eating Behaviour, Mindful Eating Intervention. Interventions: Mindfulness-based nutritional group therapy (MBNGT). Summary: The goal of this clinical trial is to learn whether a mindfulness-based nutrition group program is feasible and acceptable for adults with obesity who are taking GLP-1 receptor agonist medication and receiving usual medical care, including dietetic counselling. The main questions this study aims to answer are: Can this group program be successfully carried out with adults receiving GLP-1 treatment? Do participants find the program useful, acceptable, and manageable? Are participants willing to attend the sessions, complete the home exercises, and fill in the study questionnaires? Researchers will compare participants who receive the mindfulness-based nutrition group program plus usual care with participants who receive usual care only. Participants in the group program will take part in a 16-week intervention with nine group sessions. They will practice mindful eating, mindfulness exercises, journaling, and peer exchange. All participants will complete questionnaires and body measurements at the start of the study, after 16 weeks, and 12 months after the start of the study. The study does not test a new drug or device. The study team will not make decisions about participants' GLP-1 medication. All medication decisions remain part of usual medical care. This is a pilot, randomized, controlled, open-label, two-arm feasibility trial evaluating a mindfulness-based nutritional group therapy (MBNGT) as an adjunct to standard care in adults with obesity undergoing treatment with GLP-1 receptor agonists. The trial is designed to assess the feasibility of study procedures and the acceptability of the intervention, and to generate preliminary exploratory data to inform the design of a future adequately powered trial. The MBNGT intervention is a 16-week dietetic group program integrating principles from mindfulness-based stress reduction, mindful eating approaches, nutritional therapy, and behavioral psychology. The intervention targets eating-related self-regulation, emotional awareness, mindful eating, and weight-related self-stigma. It includes structured group sessions, guided mindfulness and mindful eating exercises, journaling, home practice, and peer exchange. The intervention is delivered in addition to ongoing standard medical and dietetic care. Participants randomized to the control group continue to receive standard care only. Standard care consists of routine medical management of obesity and dietetic counselling related to GLP-1 receptor agonist treatment. The study does not involve modification of pharmacological treatment, and decisions regarding continuation, dose adjustment, or discontinuation of GLP-1 receptor agonists remain under routine clinical care. The primary focus of this pilot trial is feasibility, including recruitment, randomization, retention, intervention attendance, adherence to intervention components, completeness of data collection, and participant acceptability. Exploratory assessments will examine changes in eating behavior, mindful eating, internalized weight bias, self-regulation, emotional competence, mindfulness, psychological well-being, quality of life, body-related outcomes, and anthropometric and cardiovascular parameters. Semi-structured interviews will be used to explore participants' experiences with the intervention and perceived mechanisms of change. Assessments are conducted at baseline, after the 16-week intervention period, and at 12 months after baseline. The results will be used to refine the intervention, assess participant burden, evaluate the suitability of outcome measures, and guide the selection of primary outcomes and procedures for a future larger randomized trial. Primary outcome measures: Recruitment rate; Retention rate; Adherence; Completeness of questionnaire data; Acceptability of the intervention; Session Attendance; Randomization Acceptance and Attrition. Eligibility: Inclusion criteria * Adults aged ≥18 * Use of GLP-1-RAs for ≥ 4 months * Ability to provide informed consent * Sufficient German language proficiency to participate in group sessions and complete questionnaires * Willingness and ability to participate in a 16-week program and attend follow-up assessments Exclusion Criteria: * Pregnant or lactating women * Diagnosed substance use disorders (e.g., alcohol) * Diagnosed severe psychiatric disorders (e.g., psychosis, acute major depression, binge-eating-disorder) * Medical contraindications that prevent participation in behavioral interventions (e.g., unstable chronic disease) * Current participation in another behavioral or weight-related intervention study * Cognitive impairment or language barriers that prevent meaningful participation