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临床试验/NCT00643344
NCT00643344已完成不适用

Craving and Lifestyle Management Through Mindfulness Pilot Study

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
weight

研究概览

简要总结

The purpose of this study is to determine whether an innovative program that combines mindfulness-based stress reduction and mindful eating practices with diet and exercise guidelines (CALMM+ intervention) will lead to greater weight loss and more favorable body fat distribution than a conventional weight-loss program(Diet-Ex intervention).

详细描述

Obesity is an important growing epidemic, with about 65% of Americans overweight (Flegal, Carroll et al. 2002). Psychological stress is widely cited anecdotally as a factor that causes people to engage in overeating, and studies provide strong evidence that stress can promote obesity. Stress induces selective preference of sweet, high-fat food and increases visceral fat depots. Chronic stress has also been shown to impair immune responses, including decreasing immune responses to vaccination. The proposed study will pilot test an innovative program that combines stress reduction and mindful eating practices with diet and exercise, Craving and Lifestyle Management through Mindfulness (CALMM+). This program will be compared with diet and exercise intervention alone (Diet-Ex). Approximately 20 persons will be randomized to the two groups, which will meet weekly for 16 weeks. Key outcome measures are weight, fat distribution (as measured by waist/hip ratio), perceived stress, and mood. These measures will be assessed in visits performed at baseline, 3 months, and 6 months. Data from this study are intended to provide pilot data for use in planning a larger randomized, controlled trial that will compare the effects of the CALMM+ and Diet-Ex interventions on the metabolic and psychological processes assessed in this pilot study.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • healthy female
  • aged 18-50
  • BMI range 25-45
  • negative urine glucose test
  • must be able to provide informed consent

排除标准

  • age less than 18 or menopausal
  • clinical diagnosis of eating disorder, diabetes, polycystic ovary syndrome, and coronary artery disease
  • history of anginal chest pain without adequate evaluation
  • substance abuse, mental health or medical condition that might interfere with study participation
  • use of medications containing corticosteroids
  • breastfeeding
  • non- English speaker
  • pregnant or planning to get pregnant in the next 6 months
  • previous Mindfulness Based Stress Reduction training
  • initiation of new class of psychiatric medications in past 2 months
  • currently on a weight loss diet

结局指标

主要结局

weight

时间窗: baseline, 3 month, and 6 month assessments

次要结局

  • perceived stress(baseline, 3 month, and 6 month assessments)
  • fat distribution(baseline, 3 month, and 6 month assessments)
  • mood(baseline, 3 month, and 6 month assessments)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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