Online Group Programme on Mindful Eating During Medication-Supported Weight Loss
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBern University of Applied Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Online Group Intervention on Mindful Eating
BehavioralThe 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.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Online Group Intervention on Mindful EatingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
The number of participants enrolled per month over the recruitment period, calculated as: total enrolled ÷ number of recruitment months
Time frame
From start of recruitment to completion of recruitment2
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
Time frame
At week 16 (±2-weeks)3
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.
Time frame
At week 16 (±2-weeks)4
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.
Time frame
At week 16 (±2-weeks)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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