Mindfulness Based Eating Awareness Training (MB-EAT) for Bariatric Surgery Patients: The Effects of Mindfulness on Psychosocial and Physical Functioning
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Height
研究概览
简要总结
The purpose of this study is to evaluate the effects of Mindfulness Based Eating Awareness Training (MB-EAT) for patients who have had bariatric surgery on their weight and mental and physical health compared to patients who do not do this group. All participants will complete questionnaires evaluating eating and mental health before and after the group and 6 and 12 months later. They will have blood pressure readings at these times and complete a questionnaire about their digestive health. Our hypothesis is that participants will maintain their weight loss after bariatric surgery and have improvements in the other outcomes.
详细描述
MB-EAT may be helpful for reducing emotional eating, overeating and grazing, eating patterns that can lead to weight gain after bariatric surgery. Participants will receive MB-EAT 6 months or more following bariatric surgery. They will be randomly assigned to receive MB-EAT right away or 8 weeks later. Individuals in the group starting in 8 weeks will serve as a waitlist control group.The primary outcome measures will be changes in self-reported eating problems, depression, anxiety, and mindfulness. There will be a follow-up at 6 months and 12 months to establish stability of symptoms post-intervention. Participants will receive one introductory information session about the MB-EAT program, as well as 8 MB-EAT scheduled consecutively over eight weeks. Each session is approximately two hours in length. During MB-EAT, participants will practice mindfulness to help improve their decision making abilities about when and how much to eat. Through MB-EAT, participants will learn to address mindless or out-of-control eating, which can lead to weight gain. Homework will include daily meditations and mindful eating exercises.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Post-bariatric surgery patients recruited from the Toronto Western Hospital-Bariatric Surgery Program (TWH-BSP) who are six months or more post-surgery, are experiencing self-reported difficulties adhering to post-surgery eating guidelines, and can commit to attending the group.
- •Fluent in English.
- •Have the capacity to provide informed consent.
排除标准
- •Active suicidal ideation.
- •Active serious mental illness (i.e., psychotic disorder, bipolar disorder).
- •Active severe depression (i.e., current major depressive disorder diagnosis and PHQ-9 score > 20 [severe depression]).
- •Active severe anxiety (i.e., current anxiety disorder diagnosis and GAD-7 score > 15 [severe anxiety]).
- •Active symptoms of post-traumatic stress disorder (i.e., current diagnosis of post-traumatic stress disorder).
研究组 & 干预措施
Waitlist Control
Wait list control.
MB-EAT
Behavioral: group psychotherapy. Eight weekly sessions, each session is 2 hours in duration.
干预措施: Mindfulness Based Eating and Awareness Training (Behavioral)
结局指标
主要结局
Height
时间窗: Baseline
Height in centimetres will be obtained by measuring participants
Change in Body Mass Index (BMI)
时间窗: Change from baseline to 8 weeks, 6 months, and 12 months
BMI as calculated by weight (kg) / height (cm)\^2
Change in weight
时间窗: Change from baseline to 8 weeks, 6 months, and 12 months
Weight in kilograms will be obtained by weighing participants
次要结局
- Generalized Anxiety Disorder Questionnaire (GAD-7)(Change from baseline to 8 weeks, 6 months, and 12 months)
- The Dichotomous Thinking Scale (DTS)(Change from baseline to 8 weeks, 6 months, and 12 months)
- Patient Health Questionnaire (PHQ-9)(Change from baseline to 8 weeks, 6 months, and 12 months)
- The Three Factor Eating Questionnaire -R18 (TFEQ-R18)(Change from baseline to 8 weeks, 6 months, and 12 months)
- Five Facets of Mindfulness Questionnaire (FFMQ)(Change from baseline to 8 weeks, 6 months, and 12 months)
- Body Satisfaction Questionnaire (BSQ)(Change from baseline to 8 weeks, 6 months, and 12 months)
- Body Parts Satisfaction Scale (BPSS)(Change from baseline to 8 weeks, 6 months, and 12 months)
- The Obesity Cognitions Scale(Change from baseline to 8 weeks, 6 months, and 12 months)
- Self-Compassion Scale (SCS)(Change from baseline to 8 weeks, 6 months, and 12 months)
- Difficulties in Emotion Regulation Scale (DERS)(Change from baseline to 8 weeks, 6 months, and 12 months)
- Gastrointestinal Symptom Rating Scale (GSRS)(Change from baseline to 8 weeks, 6 months, and 12 months)