Online Group Programme on Mindful Eating During Medication-Supported Weight Loss
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:
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.
調査の概要
状態
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Leonie H Bogl, PhD
- 電話番号：+41 31 848 47 12
- メール：leonie-helen.bogl@bfh.ch
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria: Sufficient German language skills, informed consent, and willingness to participate in a 16-week online program.
Exclusion Criteria:
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：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.
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実験的：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment rate
時間枠：From start of recruitment to completion of recruitment
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The number of participants enrolled per month over the recruitment period, calculated as: total enrolled ÷ number of recruitment months
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From start of recruitment to completion of recruitment
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Randomization acceptance
時間枠：At week 16 (±2-weeks)
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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
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At week 16 (±2-weeks)
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Retention rate
時間枠：At week 16 (±2-weeks)
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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.
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At week 16 (±2-weeks)
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Group session attendance & adherence
時間枠：At week 16 (±2-weeks)
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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.
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At week 16 (±2-weeks)
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Data completion
時間枠：At week 16 (±2-weeks)
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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.
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At week 16 (±2-weeks)
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Acceptability of the intervention
時間枠：At week 16 (±2-weeks)
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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.
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At week 16 (±2-weeks)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- SOULFOOD-ONLINE-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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