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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Leonie H Bogl, PhD
- Número de telefone: +41 31 848 47 12
- E-mail: leonie-helen.bogl@bfh.ch
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: 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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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Recruitment rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SOULFOOD-ONLINE-2026
Plano para dados de participantes individuais (IPD)
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