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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Leonie H Bogl, PhD
- Telefonní číslo: +41 31 848 47 12
- E-mail: leonie-helen.bogl@bfh.ch
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: 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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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Recruitment rate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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