Study of the Effects of Mindfulness on Impulsive Eating, Motivation Toward Exercise, and Weight Loss in Obese Patients: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a daily 12-month computerized mindfulness-based intervention in obese patients diagnosed with Binge Eating Disorder (BED) on: impulsive eating, motivation toward exercise, and weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult aged between 18 and 65 years
- •Obese (BMI >= 30)
- •Recruited from the nutrition pole of Ambroise Paré Hospital
- •Diagnosed with Binge-Eating Disorder (BED) according to DSM5 criteria
- •Informed consent provided during inclusion interview
排除标准
- •Already participating in a clinical trial
- •Bariatric surgery patients (except for gastric band removed at least 3 years before)
- •Planned bariatric surgery
- •Central obese (genetic)
- •Pregnant women
- •No internet access at home
- •Difficulties to understand French language
- •Patients under social protection
- •Cognitive dysfunctions in understanding simple guidelines provided by the paramedical staff (e.g., diet or exercise guidelines)
- •Auditory disorders not allowing to hear audio files
- •Blurred vision not allowing to use Internet
研究组 & 干预措施
Mindfulness
Computerized mindfulness-based intervention. 10 minutes per day, every day for 12 months of MP3 listening. Guidelines are in line with main mindfulness-based interventions (MBSR, MBCT, ACT). Participants can choose between 4 audio recordings (sessions): awareness of the breathing, awareness of postures and bodily sensations, acceptance of thoughts and emotions, and awareness of bodily sensations and related thoughts and emotions while executing 5 squats.
干预措施: Mindfulness-based intervention (Behavioral)
Sham meditation
Computerized sham meditation intervention. 10 minutes per day, every day for 12 months of MP3 listening. The unique guideline is to "meditate" at the beginning of each session. Participants can choose between 4 audio backgrounds: forest, night, beach, and river.
干预措施: Sham meditation (Behavioral)
Treatment as usual
Usual care in a nutrition pole in France: nutrition, diet, exercise.
结局指标
主要结局
Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale)
时间窗: From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.
次要结局
- Change in motivational regulation toward exercise (BREQ-II)(From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.)
- Change in self-reported anxiety and depression (HADS)(From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.)
- Change in mindfulness skills (MAAS, AAQ-II)(From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.)
- Change in daily mindful responding (DMRS)(From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.)
- Change in self-reported physical activity (IPAQ)(From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.)
- Change in pedometers-measured physical activity(From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.)
- Change in body mass index (kg/m2)(From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.)
- Change in plasma concentration of leptin, adiponection and BDNF(From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.)
- Change in food intake(From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.)
研究者
Ruffault Alexis
Doctoral candidate
University of Paris 5 - Rene Descartes