Keeping Weight Off: Brain Changes Associated With Healthy Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Functional connectivity on fMRI
研究概览
简要总结
The goal of this project is to characterize changes in emotion regulation pathways associated with healthy behaviors in people who have recently lost weight and are seeking to maintain weight loss over a 1-year period.
详细描述
Unhealthy behaviors such as overeating and a sedentary lifestyle are largely responsible for overweight and obesity which substantially increase risk for chronic conditions such as heart disease, high blood pressure, stroke, diabetes, arthritis and certain cancers. The rapid rise in obesity threatens to reverse recent gains in life expectancy and account for a large percentage of premature deaths in the U.S. Although there is evidence for the short-term efficacy of a number of methods for initiating health behavior change to lose weight, these interventions have shown only limited ability to affect significant, long-term behavioral changes in the majority of adults. In part this may be because they fail to adequately address how psychological factors that lead to relapse to unhealthy behaviors and failure to maintain long-term behavior change.
The purpose of the study is to understand brain changes that accompany participation in programs that foster healthy behaviors in people seeking to maintain weight loss. We will use MRI scans to study brain function in men and women 25-60 years old who have lost weight in the last year without surgery. Participants will be assigned to one of two programs to help them maintain weight loss and will be compensated for their time. Our goal is to gain a better understanding of the brain changes that lead to long-term success in keeping weight off, in the hope that this knowledge will assist in the development of improved treatments.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25 to 60 years old
- •Healthy individuals who have intentionally lost at least 5% of their body weight over the past year
- •BMI >20.5 kg/m2 at study entry and >25 in past 2 years
排除标准
- •Weight-loss surgery or medications
- •Serious Psychiatric or medical conditions
- •Substance abuse
- •Ineligible for MRI
- •Eating disorder
研究组 & 干预措施
Mindfulness Based Stress Reduction (MBSR) program
Mindfulness Based Stress Reduction (MBSR) is an 8-week program that consists of training in mindfulness practices, the application of mindfulness to daily life, and information about healthy living and the role played by thoughts and emotions in health.
干预措施: Mindfulness (Behavioral)
Healthy Living Course (HLC)
Healthy Living Course (HLC) an 8-week psycho-educational program that consists of lectures and discussion on healthy living, stress management, time management, and unhealthy behaviors (e.g. smoking, drinking).
干预措施: Psychoeducation (Behavioral)
结局指标
主要结局
Functional connectivity on fMRI
时间窗: 8 weeks
Functional Magnetic Resonance Imaging (fMRI)
次要结局
- Association of functional connectivity with maintenance of weight loss(6 months)
- Association of functional connectivity change with changes in depression symptoms(6 months)
研究者
Carl Fulwiler
Associate Professor of Psychiatry
University of Massachusetts, Worcester
