Online Group Programme on Mindful Eating During Medication-Supported Weight Loss

Официальное название

Feasibility and Acceptability of a Digital Mindfulness-Based Nutrition Group Intervention During Pharmacological Treatment for Weight Reduction

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Online Group Intervention on Mindful Eating
  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 sessi

Первичные конечные точки

• Recruitment rate [Срок оценки: From start of recruitment to completion of recruitment]
• Randomization acceptance [Срок оценки: At week 16 (±2-weeks)]
• Retention rate [Срок оценки: At week 16 (±2-weeks)]
• Group session attendance & adherence [Срок оценки: At week 16 (±2-weeks)]
• Data completion [Срок оценки: At week 16 (±2-weeks)]
• Acceptability of the intervention [Срок оценки: At week 16 (±2-weeks)]

Критерии участия

Inclusion Criteria: Sufficient German language skills, informed consent, and willingness to participate in a 16-week online program.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07701291 · SOULFOOD-ONLINE-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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