Benefit of the Bathysmed® Diving Protocol on Emotional Eating in Obese Patients: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- DEBQ-EE
研究概览
简要总结
The goal of this clinical trial is to learn if a combined minfulness-diving program has an impact on emotional eating in adults with obesity. The main questions it aims to answer are:
Does the BathysMed protocol have an impact on emotional eating after the 2 months diving protocol? Researchers will compare the diving program to a control group of adult patients with obesity.
Participants will be asked to participate in the combined mindfulness-diving protocol for 2 months, and complete the questionnaires at baseline, 2, 5, and 8 months follow up.
详细描述
This unblinded randomized controlled trial is performed in the community setting, Montpellier, France. Adults with a BMI > 30kg/m2 were randomly assigned (1:1) to a Bathysmed® 2-month program (intervention group) therapeutic scuba-diving protocol with mindfulness exercises plus standard care, or stand-alone standard care including dietary and psychological support (control group). The primary outcome was the mean change in the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ-EE) at 2-months as intention to treat.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with obesity (Body Mass Index BMI > 30kg/m2),
- •adults over the age of 18 able to provide written consent
- •affiliated to public medical insurance.
排除标准
- •BMI > 45 kg/m2,
- •older than 60 years,
- •unable to walk,
- •known psychiatric pathology apart from anxiety and depression,
- •intellectual deficit,
- •routinely practising meditation,
- •a known contra-indication to scuba-diving
- •known past medical history of cardiac problems.
研究组 & 干预措施
Diving group
The program included ten scuba-diving sessions with mindfulness training, twice a week for five weeks, alongside standard care for obesity in a primary care centre in Montpellier
干预措施: A combined mindfulness and therapeutic scuba-diving protocol (Other)
Control group
Standard care included regular appointments and health education with their general practitioner and monthly appointments with the dietician and psychotherapist at the primary care centre in Montpellier, France throughout the study.
干预措施: Control group regular follow up in primary care (Other)
结局指标
主要结局
DEBQ-EE
时间窗: 2 months
The primary outcome was the mean change in the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ-EE) at the end of the two-month protocol.
次要结局
- DEBQ-EE at 5 and 8 months follow up(5 and 8 months follow up)
- DEBQ-RE(2, 5 and 8 months follow up)
- DEBQ-ExtE(2, 5 and 8 months follow up)
- WSSQ(2, 5 and 8 months follow up)
- EQVOD scale(2, 5 and 8 months follow up)
- PSS Score(2, 5 and 8 months follow up)
- Weight (kg)(2, 5 and 8 months follow up)
- BMI kg/m2(2, 5 and 8 months follow up)
- Waist circumference(2, 5 and 8 months follow up)