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临床试验/NCT02189187
NCT02189187已完成不适用

Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2014年12月1日最近更新:
适应症
干预措施

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

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

Experimental

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)

Active Comparator

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

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carl Fulwiler

Associate Professor of Psychiatry

University of Massachusetts, Worcester

研究点 (2)

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