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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.
This is a pilot, randomized, controlled, open-label, two-arm feasibility trial evaluating a mindfulness-based nutritional group therapy (MBNGT) as an adjunct to standard care in adults with obesity undergoing treatment with GLP-1 receptor agonists. The trial is designed to assess the feasibility of study procedures and the acceptability of the intervention, and to generate preliminary exploratory data to inform the design of a future adequately powered trial.
The MBNGT intervention is a 16-week dietetic group program integrating principles from mindfulness-based stress reduction, mindful eating approaches, nutritional therapy, and behavioral psychology. The intervention targets eating-related self-regulation, emotional awareness, mindful eating, and weight-related self-stigma. It includes structured group sessions, guided mindfulness and mindful eating exercises, journaling, home practice, and peer exchange. The intervention is delivered in addition to ongoing standard medical and dietetic care.
Participants randomized to the control group continue to receive standard care only. Standard care consists of routine medical management of obesity and dietetic counselling related to GLP-1 receptor agonist treatment. The study does not involve modification of pharmacological treatment, and decisions regarding continuation, dose adjustment, or discontinuation of GLP-1 receptor agonists remain under routine clinical care.
The primary focus of this pilot trial is feasibility, including recruitment, randomization, retention, intervention attendance, adherence to intervention components, completeness of data collection, and participant acceptability. Exploratory assessments will examine changes in eating behavior, mindful eating, internalized weight bias, self-regulation, emotional competence, mindfulness, psychological well-being, quality of life, body-related outcomes, and anthropometric and cardiovascular parameters. Semi-structured interviews will be used to explore participants' experiences with the intervention and perceived mechanisms of change.
Assessments are conducted at baseline, after the 16-week intervention period, and at 12 months after baseline. The results will be used to refine the intervention, assess participant burden, evaluate the suitability of outcome measures, and guide the selection of primary outcomes and procedures for a future larger randomized trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | The control group will receive usual care with standard dietetic counseling. At baseline, post-intervention and at 12 months follow-up, the same standardized questionnaires will be administered to assess changes in psychosocial, emotional, and behavioral variables (e.g., emotion regulation, self-stigma, eating behavior, and quality of life). Body weight will also be recorded. Any changes in pharmacological treatment (e.g., continuation or discontinuation of GLP-1-RA therapy) will be documented post-intervention and at the 12-month follow-up. Throughout the study, retention and data completion will be monitored, and post-intervention participant feedback, including Likert-scale items on satisfaction, perceived usefulness, ease of participation, and willingness to recommend the intervention to others, will be collected to assess acceptability. | |
| 16-week Mindfulness-Based Nutrition Group Therapy (MBNGT) | Experimental | The intervention group will participate in a 16-week MBGNT 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The enrolment rate will be calculated as the number of participants successfully enrolled per month over the recruitment period | From start of recruitment to completion of recruitment |
| Retention rate | Retention rate is defined as the proportion of randomized participants who complete the post-intervention assessment | From randomization to week 16 (±2-weeks) |
| Adherence | Adherence will be evaluated via an adherence questionnaire post-intervention documenting daily mindfulness exercises, tandem meetings, and reflection diary. | At week 16 (±2-weeks) |
| Completeness of questionnaire data | Data completion will be evaluated based on the proportion of fully completed questionnaires. | At baseline and week 16 (±2-weeks) |
| Acceptability of the intervention | 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. | At week 16 (±2-weeks) |
| Session Attendance | Session attendance will be assessed as the mean number of intervention sessions attended per participant out of 9 planned sessions. | At week 16 (±2-weeks) |
| Randomization Acceptance and Attrition |
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| Measure | Description | Time Frame |
|---|---|---|
| Dutch Eating Behaviour Questionnaire | Eating behavior will be assessed using the German version of the Dutch Eating Behavior Questionnaire, the Fragebogen zum Ernährungsverhalten II (FEV-II). The questionnaire comprises 30 self-report items and assesses three eating behavior domains: emotional eating, external eating, and restrained eating. Items are rated on a Likert scale and summarized into subscale scores. Higher scores indicate a stronger tendency toward the respective eating behavior style. |
Inclusion criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bern University of Applied Sciences (BFH), Department of Health Professions, Division of Nutrition and Dietetics | Bern | 3006 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27658995 | Background | Ruffault A, Czernichow S, Hagger MS, Ferrand M, Erichot N, Carette C, Boujut E, Flahault C. The effects of mindfulness training on weight-loss and health-related behaviours in adults with overweight and obesity: A systematic review and meta-analysis. Obes Res Clin Pract. 2017 Sep-Oct;11(5 Suppl 1):90-111. doi: 10.1016/j.orcp.2016.09.002. Epub 2016 Sep 19. | |
| 31368631 |
| Label | URL |
|---|---|
| Related Info | View source |
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Due to the small sample size and privacy considerations, individual participant data will not be shared. Aggregated study results will be published in peer-reviewed journals and presented at scientific meetings.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D000068356 | Self-Control |
| D057545 | Social Stigma |
| D005247 | Feeding Behavior |
| 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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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. |
| At week 16 (±2-weeks) |
| At week 16 and twelve-months follow-up |
| Mindful Eating Inventory (MEI) | Mindful eating will be assessed using a self-report questionnaire comprising 30 items rated on a 6-point Likert scale ranging from "almost never" to "almost always". The questionnaire assesses mindful eating across several domains, including accepting and non-attached attitude towards one's own eating experience, awareness of senses while eating, eating in response to awareness of fullness, and awareness of eating triggers and motives. Higher scores indicate a higher level of mindful eating. | At week 16 and twelve-months follow-up |
| Weight Bias Internalization Scale (WBIS-M) | Weight bias internalization will be assessed using the validated modified Weight Bias Internalization Scale (WBIS-M). The WBIS-M is a 10-item self-report questionnaire assessing the extent to which individuals internalize negative weight-related stereotypes and apply them to themselves. Items are rated on a 7-point Likert scale ranging from "strongly disagree" to "strongly agree". Higher scores indicate greater internalized weight bias. | At week 16 and twelve-months follow-up |
| Big Five Inventory-10 (BFI-10) | Personality traits will be assessed using the Big Five Inventory-10 (BFI-10). The BFI-10 is a brief 10-item self-report questionnaire assessing the five major personality dimensions: extraversion, agreeableness, conscientiousness, neuroticism, and openness. Items are rated on a 5-point Likert scale ranging from "does not apply at all" to "applies completely". Each personality dimension is represented by two items, with negatively worded items reverse-coded before calculating mean subscale scores. Scores range from 1 to 5, with higher scores indicating a stronger expression of the respective personality trait. | At week 16 and twelve-months follow-up |
| Impulsive Behavior-8 Scale (I-8) | Impulsive behavior will be assessed using the Impulsive Behavior-8 Scale (I-8). The I-8 is an 8-item self-report questionnaire assessing four dimensions of impulsive behavior: urgency, intention, perseverance, and risk-taking. Each dimension is measured with two items. Items are rated on a 5-point Likert scale ranging from "does not apply at all" to "applies completely". Subscale scores are calculated as the mean of the two corresponding items and range from 1 to 5. Higher scores on urgency and risk-taking indicate higher impulsivity, whereas lower scores on intention and perseverance indicate higher impulsivity. | At week 16 and twelve-months follow-up |
| Five Facet Mindfulness Questionnaire (FFMQ) | Mindfulness will be assessed using the German version of the Five Facet Mindfulness Questionnaire (FFMQ-D). The questionnaire assesses mindfulness-related abilities such as observing internal experiences, describing feelings, acting with awareness, non-judging, and non-reactivity toward thoughts and emotions. Items are rated on a 5-point Likert scale ranging from "never or very rarely true" to "very often or always true". Higher scores indicate higher levels of mindfulness, after reverse-coding negatively worded items where applicable. | At week 16 and twelve-months follow-up |
| PERMA-Profiler | Well-being will be assessed using the PERMA-Profiler. The PERMA-Profiler is a self-report questionnaire assessing general well-being across the five domains of Seligman's PERMA model: positive emotions, engagement, relationships, meaning, and accomplishment. Items are rated on an 11-point scale, with response anchors depending on the item, for example from "not at all" to "completely" or from "never" to "always". Higher scores indicate higher levels of well-being in the respective domain and overall. | At week 16 and twelve-months follow-up |
| Depression Anxiety Stress Scales (DASS-21) | Symptoms of depression, anxiety, and stress will be assessed using the short version of the Depression Anxiety Stress Scales (DASS-21). The DASS-21 is a 21-item self-report questionnaire assessing symptoms experienced during the past week across three subscales: depression, anxiety, and stress. Items are rated on a 4-point scale ranging from 0 ("did not apply to me at all") to 3 ("applied to me very much or most of the time"). Higher scores indicate higher levels of depression, anxiety, and stress symptoms. | At week 16 and twelve-months follow-up |
| Self-Compassion Scale (SCS-D) | Self-compassion will be assessed using the German version of the Self-Compassion Scale (SCS-D). The SCS-D is a 26-item self-report questionnaire assessing how individuals typically relate to themselves during difficult times. Items are rated on a 5-point Likert scale ranging from 1 ("almost never") to 5 ("almost always"). The scale covers dimensions such as self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Higher scores indicate higher levels of self-compassion, after reverse-coding negatively worded items where applicable. | At week 16 and twelve-months follow-up |
| Body Appreciation Scale-2 | Body appreciation will be assessed using the German version of the Body Appreciation Scale-2 (BAS-2). The BAS-2 is a 10-item self-report questionnaire assessing positive body image, including respect for, acceptance of, and appreciation of one's body. Items are rated on a 5-point Likert scale ranging from "never" to "always". Higher scores indicate higher levels of body appreciation. | At week 16 and twelve-months follow-up |
| Appearance-related quality of life and functioning (BODY-Q) | Appearance-related quality of life and functioning will be assessed using the German version of selected BODY-Q scales. The selected scales assess appearance-related psychosocial distress, body image, physical function, physical symptoms, psychological function, and social function. The appearance-related psychosocial distress scale includes 8 items assessing distress, worry, anxiety, avoidance, and reduced motivation related to one's appearance. Body image is assessed with 7 items addressing positive attitudes toward, satisfaction with, and appreciation of one's body during the past week. Physical function is assessed with 7 items evaluating difficulties with everyday movements and activities, while physical symptoms are assessed with 10 items covering bodily symptoms and discomfort experienced during the past week. Psychological function and social function are each assessed with 10 items addressing self-confidence, self-acceptance, emotional well-being, perceived control, social ac | At week 16 and twelve-months follow-up |
| EuroQol 5 Dimensions (EQ-5D) | Health-related quality of life will be assessed using the German version of the EQ-5D. The EQ-5D assesses current health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, participants select the statement that best describes their health today, using five severity levels ranging from no problems to extreme problems or inability. In addition, participants rate their overall health today on a visual analogue scale from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health. Higher EQ-5D visual analogue scale scores indicate better self-rated health. | At week 16 and twelve-months follow-up |
| Standardized Self-Report Measure of Emotional Competence (SEK-27) | Emotional competence and self-regulation will be assessed using the Standardized Self-Report Measure of Emotional Competence (SEK-27). The SEK-27 is a 27-item self-report questionnaire assessing how individuals deal with difficult emotions during the past week. Items cover emotional awareness, understanding, acceptance, tolerance, regulation, self-support, body awareness, and goal-directed behavior despite negative emotions. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("almost always"). Higher scores indicate higher emotional competence and better emotion-related self-regulation. | At week 16 and twelve-months follow-up |
| Self-Regulation of Eating Behavior Questionnaire (SREBQ) | Self-regulation of eating behavior will be assessed using the German version of the Self-Regulation of Eating Behavior Questionnaire (SREBQ). The SREBQ is a brief self-report questionnaire assessing individuals' ability to regulate eating behavior, including resisting tempting foods, maintaining dietary intentions, monitoring food intake, and adjusting behavior when eating does not align with intentions. Items are rated on a 5-point scale ranging from "never" to "always". Higher scores indicate better self-regulation of eating behavior, after reverse-coding negatively worded items where applicable. | At week 16 and twelve-months follow-up |
| Fuentes Artiles R, Staub K, Aldakak L, Eppenberger P, Ruhli F, Bender N. Mindful eating and common diet programs lower body weight similarly: Systematic review and meta-analysis. Obes Rev. 2019 Nov;20(11):1619-1627. doi: 10.1111/obr.12918. Epub 2019 Aug 1. |
| 29076610 | Background | Carriere K, Khoury B, Gunak MM, Knauper B. Mindfulness-based interventions for weight loss: a systematic review and meta-analysis. Obes Rev. 2018 Feb;19(2):164-177. doi: 10.1111/obr.12623. Epub 2017 Oct 27. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D001522 | Behavior, Animal |