Mindfulness-Based Nutrition Group Therapy as an Adjunct to GLP-1 Treatment of Obesity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Retention rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18
- •Use of GLP-1-RAs for ≥ 4 months
- •Ability to provide informed consent
- •Sufficient German language proficiency to participate in group sessions and complete questionnaires
- •Willingness and ability to participate in a 16-week program and attend follow-up assessments
排除标准
- •Pregnant or lactating women
- •Diagnosed substance use disorders (e.g., alcohol)
- •Diagnosed severe psychiatric disorders (e.g., psychosis, acute major depression, binge-eating-disorder)
- •Medical contraindications that prevent participation in behavioral interventions (e.g., unstable chronic disease)
- •Current participation in another behavioral or weight-related intervention study
- •Cognitive impairment or language barriers that prevent meaningful participation
研究组 & 干预措施
Control group
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)
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
干预措施: Mindfulness-based nutritional group therapy (MBNGT) (Behavioral)
结局指标
主要结局
Retention rate
时间窗: From randomization to week 16 (±2-weeks)
Retention rate is defined as the proportion of randomized participants who complete the post-intervention assessment
Recruitment rate
时间窗: From start of recruitment to completion of recruitment
The enrolment rate will be calculated as the number of participants successfully enrolled per month over the recruitment period
Adherence
时间窗: At week 16 (±2-weeks)
Adherence will be evaluated via an adherence questionnaire post-intervention documenting daily mindfulness exercises, tandem meetings, and reflection diary.
Completeness of questionnaire data
时间窗: At baseline and week 16 (±2-weeks)
Data completion will be evaluated based on the proportion of fully completed questionnaires.
Acceptability of the intervention
时间窗: At week 16 (±2-weeks)
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.
Session Attendance
时间窗: At week 16 (±2-weeks)
Session attendance will be assessed as the mean number of intervention sessions attended per participant out of 9 planned sessions.
Randomization Acceptance and Attrition
时间窗: At week 16 (±2-weeks)
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.
次要结局
未报告次要终点
研究者
Leonie Bogl
Principal Investigator
Bern University of Applied Sciences