Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07701291

Online Group Programme on Mindful Eating During Medication-Supported Weight Loss

The goal of this clinical trial is to evaluate the feasibility and acceptability of a digitally delivered, mindfulness-based nutrition group program 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 online group program be successfully delivered to adults receiving GLP-1 treatment? Do participants find the program useful, acceptable, and easy to engage with? Are participants willing to attend the online sessions, complete the home exercises, and complete the study questionnaires?

Researchers will compare participants who receive the online mindfulness-based nutrition group program in addition to usual care with participants who receive usual care alone.

Participants in the intervention group will take part in a 16-week online program consisting of nine live group sessions delivered via videoconference. They will practice mindful eating, mindfulness exercises, reflective journaling, and peer discussion. All participants will complete online questionnaires and body measurements at baseline, after 16 weeks, and 12 months after the start of the study.

This study does not evaluate a new drug or medical device. The study team will not make decisions regarding participants' GLP-1 medication. All medication management remains part of routine medical care.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Obesity & Overweight Behavior Body Weight Emotional Eating Emotional Eating Behaviour Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Online Intervention Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This is a pilot, randomized, controlled, open-label, two-arm feasibility trial evaluating a digitally delivered mindfulness-based nutrition group program as an adjunct to standard care in adults with obesity receiving incretin-based pharmacotherapy for weight loss. The trial aims to assess the feasibility and acceptability of the intervention and study procedures and to generate preliminary data to inform the design of a future fully powered randomized controlled trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Sufficient German language skills, informed consent, and willingness to participate in a 16-week online program.

Exclusion criteria

Recent diagnosis of diabetes, pregnancy or intention to become pregnant, breastfeeding, substance use, untreated thyroid disorders and severe psychiatric conditions (e.g., psychosis, major depression, binge eating disorder) and the previous participation of a mindfulness intervention. No vulnerable populations are specifically targeted or expected to be included.

Treatment and study plan

Online Group Intervention on Mindful Eating

Behavioral

The intervention group will participate in a 16-week online 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 messages.

Primary outcomes

  1. Recruitment rate

    Time frame: From start of recruitment to completion of recruitment

    The number of participants enrolled per month over the recruitment period, calculated as: total enrolled ÷ number of recruitment months

  2. Randomization acceptance

    Time frame: At week 16 (±2-weeks)

    This will be assessed by reporting the number of participants successfully randomized, any technical or procedural issues during the allocation process, and the number of participants who withdraw after allocation. Post-randomization attrition will also be described by study arm to explore whether allocation to the control group affected continued study participation

  3. Retention rate

    Time frame: At week 16 (±2-weeks)

    The number of participants who complete the post-intervention assessment, regardless of how many mindfulness sessions they attended. It is calculated as the percentage of participants who completed pre- and post-intervention assessments divided by the number randomized.

  4. Group session attendance & adherence

    Time frame: At week 16 (±2-weeks)

    Attendance will be assessed as an indicator of feasibility and participant engagement. The mean number of sessions attended across all participants will be calculated, with a target mean attendance of at least 7 out of 9 sessions to indicate acceptable engagement. Adherence will be evaluated via an adherence questionnaire post-intervention documenting daily mindfulness exercises, tandem meetings, and reflection diary.

  5. Data completion

    Time frame: At week 16 (±2-weeks)

    This will be evaluated based on the proportion of fully completed questionnaires at baseline and at the 16-week post-intervention assessment. Questionnaires classified as priority 1 are expected to be completed by at least 90% of participants. The remaining questionnaires are anticipated to have a completion rate of at least 75%. Similarly, it is expected that at least 75% of participants will attend the post-intervention visit. Reasons for drop-out will be evaluated if consent is given.

  6. Acceptability of the intervention

    Time frame: At week 16 (±2-weeks)

    Acceptability will be assessed using participant feedback collected through structured questionnaires and qualitative interviews following the intervention. Questionnaires may include Likert-scale items on satisfaction, perceived relevance, setting, and willingness to recommend the intervention to others.

Study contacts

Contact information is provided by the study sponsor or research team.

Leonie H Bogl, PhD

CONTACT

[email protected]

+41 31 848 47 12

Sponsors and collaborators

Lead sponsor

Bern University of Applied Sciences

Other

Registry information

Official study title

Feasibility and Acceptability of a Digital Mindfulness-Based Nutrition Group Intervention During Pharmacological Treatment for Weight Reduction

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.