Obesity & OverweightMBNGTNCT07649759
Mindfulness-Based Nutrition Group Therapy as an Adjunct to GLP-1 Treatment of Obesity
A study testing Mindfulness-based nutritional group therapy (MBNGT) in people with Obesity & Overweight and Emotional Eating Behaviour, run by Bern University of Applied Sciences at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight, Emotional Eating Behaviour, Mindful Eating Intervention
- What is being tested?
- Mindfulness-based nutritional group therapy (MBNGT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Bern University of Applied Sciences (BFH), Department of Health Professions, Division of Nutrition and Dietetics
Bern, 3006
About this study
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:
Read more
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.
Read the detailed description
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.
- Being tested
- Mindfulness-based nutritional group therapy (MBNGT)
- Keywords
- Obesity, Mindfulness, Mindful eating, Nutrition Therapy, Behavioral Intervention, Feasibility study, Group therapy, GLP-1 Receptor Agonist, Wegovy, Self-Regulation, Stigma, Eating behaviour
- Medical subject headings
- Obesity, Overweight, Self-Control, Social Stigma, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based nutritional group therapy (MBNGT)Behavioural
Also called Souldfoodprogram
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Mindfulness-based nutritional group therapy (MBNGT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The enrolment rate will be calculated as the number of participants successfully enrolled per month over the recruitment period
Measured: 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
Measured: 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.
Measured: At week 16 (±2-weeks)
Completeness of questionnaire data
Data completion will be evaluated based on the proportion of fully completed questionnaires.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At week 16 (±2-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Feb 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bern University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonie Bogl, Bern University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649759
- Sponsor's protocol ID
- 01654342
- Acronym
- MBNGT
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size and privacy considerations, individual participant data will not be shared. Aggregated study results will be published in peer-reviewed journals and presented at scientific meetings.
Publications
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.
PubMed 27658995Fuentes 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.
PubMed 31368631Carriere 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.
PubMed 29076610
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Nutrition Group Therapy as an Adjunct to GLP-1 Treatment of Obesity
- ClinicalTrials.gov ID
- NCT07649759
- Acronym / sponsor ID
- MBNGT / 01654342
- Keywords
- Obesity, Mindfulness, Mindful eating, Nutrition Therapy, Behavioral Intervention, Feasibility study, Group therapy, GLP-1 Receptor Agonist
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bern University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Mindfulness-based nutritional group therapy (MBNGT)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based nutritional group therapy (MBNGT)Also: SouldfoodprogramThe 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 | Behavioural | 16-week Mindfulness-Based Nutrition Group Therapy (MBNGT) |
Primary outcome
Recruitment rate
Time frame: From start of recruitment to completion of recruitment
The enrolment rate will be calculated as the number of participants successfully enrolled per month over the recruitment period
Retention rate
Time frame: From randomization to week 16 (±2-weeks)
Retention rate is defined as the proportion of randomized participants who complete the post-intervention assessment
Adherence
Time frame: At week 16 (±2-weeks)
Adherence will be evaluated via an adherence questionnaire post-intervention documenting daily mindfulness exercises, tandem meetings, and reflection diary.
Completeness of questionnaire data
Time frame: At baseline and week 16 (±2-weeks)
Data completion will be evaluated based on the proportion of fully completed questionnaires.
Acceptability of the intervention
Time frame: At week 16 (±2-weeks)
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.
Session Attendance
Time frame: At week 16 (±2-weeks)
Session attendance will be assessed as the mean number of intervention sessions attended per participant out of 9 planned sessions.
Randomization Acceptance and Attrition
Time frame: At week 16 (±2-weeks)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 27658995Ruffault 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.
- Background: PubMed 31368631Fuentes 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.
- Background: PubMed 29076610Carriere 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to the small sample size and privacy considerations, individual participant data will not be shared. Aggregated study results will be published in peer-reviewed journals and presented at scientific meetings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based nutritional group therapy (MBNGT) in people with Obesity & Overweight and Emotional Eating Behaviour, run by Bern University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From start of recruitment to completion of recruitment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07649759, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.