Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07649759

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight, Emotional Eating Behaviour, Mindful Eating Intervention

Full registry criteria

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

Treatments and study arms

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

Primary outcomes

Recruitment rateFrom 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 rateFrom randomization to week 16 (±2-weeks)

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

AdherenceAt 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 dataAt baseline and week 16 (±2-weeks)

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

Acceptability of the interventionAt 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 AttendanceAt 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 AttritionAt 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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

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