Feasibility and Acceptability of a Digital Mindfulness-Based Nutrition Group Intervention During Pharmacological Treatment for Weight Reduction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 主要终点
- Randomization acceptance
研究概览
简要总结
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.
详细描述
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.
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
- •Sufficient German language skills, informed consent, and willingness to participate in a 16-week online program.
排除标准
- •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.
研究组 & 干预措施
Control group
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
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.
干预措施: Online Group Intervention on Mindful Eating (Behavioral)
结局指标
主要结局
Randomization acceptance
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Recruitment rate
时间窗: 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
次要结局
未报告次要终点
研究者
Leonie Bogl
Principal Investigator
Bern University of Applied Sciences