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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | The control group will receive usual care with standard dietetic counselling. At baseline and post-intervention, standardized questionnaires will be administered to assess changes in psychosocial, emotional, and behavioural variables, including emotion regulation, self-stigma, eating behaviour, and quality of life. Body weight will also be recorded. | |
| Online Group Intervention on Mindful Eating | Experimental | Participants in this arm will receive usual care and take part in a 16-week online mindfulness-based nutrition group intervention in addition to their pharmacological treatment for weight reduction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The number of participants enrolled per month over the recruitment period, calculated as: total enrolled ÷ number of recruitment months | From start of recruitment to completion of recruitment |
| Randomization acceptance | 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 | At week 16 (±2-weeks) |
| Retention rate | 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. | At week 16 (±2-weeks) |
| Group session attendance & adherence | 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. | At week 16 (±2-weeks) |
| Data completion | 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. |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonie H Bogl, PhD | Contact | +41 31 848 47 12 | leonie-helen.bogl@bfh.ch |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D000098382 | Emotional Eating |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Feasibility study
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| At week 16 (±2-weeks) |
| Acceptability of the intervention | 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. | At week 16 (±2-weeks) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |