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临床试验/NCT01858714
NCT01858714已完成不适用

Environmental and Acceptance-Based Innovations for Weight Loss Maintenance

Drexel University2 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2011年9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
238
试验地点
2
主要终点
Change in Nutritional Intake

研究概览

简要总结

The major goal of this project is to evaluate an innovative approach to obesity involving modification of the home environment. The project also will evaluate if home environment modification is more effective when supplemented with distress tolerance and related skills training.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have a BMI between 27 and 45 kg/m2
  • Have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest)
  • Successfully complete all steps in the enrollment process, including completion of a 7-day food diary and attendance at all pre-randomization clinic visits

排除标准

  • Have a medical condition (e.g., cancer) or psychiatric condition (e.g., psychotic disorder, substance dependence, bulimia nervosa) that may limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss
  • Are pregnant or plan to become pregnant in next 2 years
  • Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain
  • Are participating in or plan to participate in another weight loss program in the next 2 years

结局指标

主要结局

Change in Nutritional Intake

时间窗: Baseline, 12 months, 24 months

Measured by 24-hour food recall

Change in Body Weight

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

Change in Physical Activity

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

Objectively measured physical activity will be recorded at each time point.

Change in Psychosocial Status

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meghan Butryn

Ph.D.

Drexel University

研究点 (2)

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