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

NCT07649759 | Active Not Recruiting

• 1 other identifier: 01654342
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight; Emotional Eating Behaviour; Mindful Eating Intervention

Keywords

Obesity; Mindfulness; Mindful eating; Nutrition Therapy; Behavioral Intervention; Feasibility study; Group therapy; GLP-1 Receptor Agonist; Wegovy; Self-Regulation; Stigma; Eating behaviour

Outcome Measures

Primary Outcomes (7)

• Recruitment rate

  The enrolment rate will be calculated as the number of participants successfully enrolled per month over the recruitment period

  From start of recruitment to completion of recruitment

• Retention rate

  Retention rate is defined as the proportion of randomized participants who complete the post-intervention assessment

  From randomization to week 16 (±2-weeks)

• Adherence

  Adherence will be evaluated via an adherence questionnaire post-intervention documenting daily mindfulness exercises, tandem meetings, and reflection diary.

  At week 16 (±2-weeks)

• Completeness of questionnaire data

  Data completion will be evaluated based on the proportion of fully completed questionnaires.

  At baseline and week 16 (±2-weeks)

• Acceptability of the intervention

  Participant acceptability of the intervention will be assessed based on participants' subjective evaluation of whether the intervention was satisfactory and relevant and willingness to recommend the intervention to others. In addition, qualitative interviews will be conducted.

  At week 16 (±2-weeks)

• Session Attendance

  Session attendance will be assessed as the mean number of intervention sessions attended per participant out of 9 planned sessions.

  At week 16 (±2-weeks)

• Randomization Acceptance and Attrition

  Randomization acceptance will be assessed by evaluating the number of participants successfully randomized, any technical or procedural issues during allocation, and attrition rates after allocation, including potential differences in dropout between study arms that may indicate allocation-related dissatisfaction.

  At week 16 (±2-weeks)

Other Outcomes (14)

• Dutch Eating Behaviour Questionnaire

  At week 16 and twelve-months follow-up

• Mindful Eating Inventory (MEI)

  At week 16 and twelve-months follow-up

• Weight Bias Internalization Scale (WBIS-M)

  At week 16 and twelve-months follow-up

Study Arms (2)

Control group

NO INTERVENTION

The control group will receive usual care with standard dietetic counseling. At baseline, post-intervention and at 12 months follow-up, the same standardized questionnaires will be administered to assess changes in psychosocial, emotional, and behavioral variables (e.g., emotion regulation, self-stigma, eating behavior, and quality of life). Body weight will also be recorded. Any changes in pharmacological treatment (e.g., continuation or discontinuation of GLP-1-RA therapy) will be documented post-intervention and at the 12-month follow-up. Throughout the study, retention and data completion will be monitored, and post-intervention participant feedback, including Likert-scale items on satisfaction, perceived usefulness, ease of participation, and willingness to recommend the intervention to others, will be collected to assess acceptability.

16-week Mindfulness-Based Nutrition Group Therapy (MBNGT)

EXPERIMENTAL

The intervention group will participate in a 16-week MBGNT intervention with nine group sessions, led by a certified nutritionist and lecturer in nutrition psychology with expertise in obesity counseling and mindfulness-based interventions. The first four sessions will be held weekly. Thereafter, the intervals between sessions will be extended as the intervention incorporates additional components such as daily mindfulness exercises, journaling, and tandem peer support. Specifically, from session 4 onward, tandem exchange groups will be implemented and in group session 6, the digital application "insight timer" will be introduced. The app includes guided meditations and exercises designed to enhance emotional awareness and support self-regulation in participants' daily lives. Each group therapy session will include theoretical input, guided practices in meditation and mindful eating, take-home assignments, and journaling activities aimed

Behavioral: Mindfulness-based nutritional group therapy (MBNGT)

Interventions

Mindfulness-based nutritional group therapy (MBNGT) BEHAVIORAL

The intervention group will participate in a 16-week MBNT intervention with nine group sessions, led by a certified nutritionist and lecturer in nutrition psychology with expertise in obesity counseling and mindfulness-based interventions. The first four sessions will be held weekly. Thereafter, the intervals between sessions will be extended as the intervention incorporates additional components such as daily mindfulness exercises, journaling, and tandem peer support. Specifically, from session 4 onward, tandem exchange groups will be implemented and in group session 6, the digital application "insight timer" will be introduced. The app includes guided meditations and exercises designed to enhance emotional awareness and support self-regulation in participants' daily lives. Each group therapy session will include theoretical input, guided practices in meditation and mindful eating, take-home assignments, and journaling activities aimed

Also known as: Souldfoodprogram

16-week Mindfulness-Based Nutrition Group Therapy (MBNGT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bern University of Applied Sciences: lead

Study Sites (1)

Bern University of Applied Sciences (BFH), Department of Health Professions, Division of Nutrition and Dietetics

Bern, 3006, Switzerland

Location

Related Publications (3)

• Ruffault A, Czernichow S, Hagger MS, Ferrand M, Erichot N, Carette C, Boujut E, Flahault C. The effects of mindfulness training on weight-loss and health-related behaviours in adults with overweight and obesity: A systematic review and meta-analysis. Obes Res Clin Pract. 2017 Sep-Oct;11(5 Suppl 1):90-111. doi: 10.1016/j.orcp.2016.09.002. Epub 2016 Sep 19.

  PMID: 27658995 BACKGROUND

• Fuentes Artiles R, Staub K, Aldakak L, Eppenberger P, Ruhli F, Bender N. Mindful eating and common diet programs lower body weight similarly: Systematic review and meta-analysis. Obes Rev. 2019 Nov;20(11):1619-1627. doi: 10.1111/obr.12918. Epub 2019 Aug 1.

  PMID: 31368631 BACKGROUND

• Carriere K, Khoury B, Gunak MM, Knauper B. Mindfulness-based interventions for weight loss: a systematic review and meta-analysis. Obes Rev. 2018 Feb;19(2):164-177. doi: 10.1111/obr.12623. Epub 2017 Oct 27.

  PMID: 29076610 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Obesity; Overweight; Self-Control; Social Stigma; Feeding Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior; Behavior, Animal

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Feasibility study

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: June 16, 2026
• Study Start: February 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)