Obesity & OverweightNCT07701291
Online Group Programme on Mindful Eating During Medication-Supported Weight Loss
A study testing Online Group Intervention on Mindful Eating in people with Obesity & Overweight and Emotional Eating, run by Bern University of Applied Sciences.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight, Emotional Eating, Emotional Eating Behaviour
- What is being tested?
- Online Group Intervention on Mindful Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 15 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
None listed.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility and Acceptability of a Digital Mindfulness-Based Nutrition Group Intervention During Pharmacological Treatment for Weight Reduction
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:
Read more
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.
Read the detailed description
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.
- Being tested
- Online Group Intervention on Mindful Eating
- Keywords
- obesity, mindfulness, midnful eating, online intervention, group therapy, feasibility study, incretin-based therapy, dietetic counselling, acceptability, recruitement rate
- Medical subject headings
- Obesity, Overweight, Emotional Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Group Intervention on Mindful EatingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online Group Intervention on Mindful Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The number of participants enrolled per month over the recruitment period, calculated as: total enrolled ÷ number of recruitment months
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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 posted14 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 28 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
- NCT07701291
- Sponsor's protocol ID
- SOULFOOD-ONLINE-2026
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Digital Mindfulness-Based Nutrition Group Intervention During Pharmacological Treatment for Weight Reduction
- ClinicalTrials.gov ID
- NCT07701291
- Acronym / sponsor ID
- SOULFOOD-ONLINE-2026
- Keywords
- obesity, mindfulness, midnful eating, online intervention, group therapy, feasibility study, incretin-based therapy, dietetic counselling
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Bern University of Applied SciencesUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 14 Jul 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 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.
Detailed description
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.
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 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 | Behavioral: Online Group Intervention on Mindful EatingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Online Group Intervention on Mindful EatingThe 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. | Behavioural | Online Group Intervention on Mindful Eating |
Primary outcome
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
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
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.
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.
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.
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.
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 14 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Online Group Intervention on Mindful Eating in people with Obesity & Overweight and Emotional Eating, run by Bern University of Applied Sciences.
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 0 inclusion and 1 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: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Leonie H Bogl, PhD (+41 31 848 47 12, leonie-helen.bogl@bfh.ch), or a site near the patient. 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 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.