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

This is a pilot, randomized, controlled, open‐label, two‐arm feasibility trial evaluatinga mindfulness‐based nutritional group therapy (MBNGT) as an adjunct to standard care inadults with obesity undergoing treatment with GLP‐1 receptor agonists. The trial isdesigned to assess the feasibility of study procedures and the acceptability of theintervention, and to generate preliminary exploratory data to inform the design of afuture adequately powered trial.The MBNGT intervention is a 16‐week dietetic group program integrating principles frommindfulness‐based stress reduction, mindful eating approaches, nutritional therapy, andbehavioral psychology. The intervention targets eating‐related self‐regulation, emotionalawareness, mindful eating, and weight‐related self‐stigma. It includes structured groupsessions, guided mindfulness and mindful eating exercises, journaling, home practice, andpeer exchange. The intervention is delivered in addition to ongoing standard medical anddietetic care.Participants randomized to the control group continue to receive standard care only.Standard care consists of routine medical management of obesity and dietetic counsellingrelated to GLP‐1 receptor agonist treatment. The study does not involve modification ofpharmacological treatment, and decisions regarding continuation, dose adjustment, ordiscontinuation 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 assessmentswill examine changes in eating behavior, mindful eating, internalized weight bias,self‐regulation, emotional competence, mindfulness, psychological well‐being, quality oflife, body‐related outcomes, and anthropometric and cardiovascular parameters.Semi‐structured interviews will be used to explore participants' experiences with theintervention and perceived mechanisms of change.Assessments are conducted at baseline, after the 16‐week intervention period, and at 12months after baseline. The results will be used to refine the intervention, assessparticipant burden, evaluate the suitability of outcome measures, and guide the selectionof primary outcomes and procedures for a future larger randomized trial.