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临床试验/NCT00967668
NCT00967668已完成不适用

ASPIRE: Coaching Veterans to Healthy Weights and Wellness

US Department of Veterans Affairs4 个研究点 分布在 1 个国家目标入组 481 人开始时间: 2010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
481
试验地点
4
主要终点
Change in Weight

研究概览

简要总结

ASPIRE has completed enrollment of patients at the Ann Arbor and Cleveland Medical Centers in a study that is examining the impact of an innovative approach to weight loss ("Aspiring to Lifelong Health in VA", aka "ASPIRE-VA"). ASPIRE-VA has 3 key features: 1) lifestyle coaches who encourage behavior change through a "small steps" approach; 2) a simplified "Stoplight" diet; and 3) user-friendly "enhanced" pedometers to help participants monitor their physical activity.

详细描述

Background:

Nearly 78% of Veterans are overweight or obese, imposing a tremendous burden on the Veterans Health Administration (VHA) healthcare system for the treatment of obesity-related chronic disease and disability. While weight management treatment has been implemented in VHA, program data shows low enrollment, participation, and weight loss. Traditional behavioral weight loss trials frequently exclude individuals with multiple chronic health conditions. Additionally, men are less likely than women to participate in these trials. New weight loss approaches may be needed to treat these populations.

Objectives:

To test whether a small-changes intervention (The Aspiring to Lifelong Health Program; aka ASPIRE), delivered in groups or individually via telephone, promotes greater weight loss than standard obesity treatment in a predominantly male, high-risk Veteran population. Data were collected in 2010-13.

Methods:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Current patient at Ann Arbor or Cleveland medical center.
  • Current provider- or self-referral to MOVE! program and eligible to participate in MOVE!
  • 18 years of age and older
  • Able to communicate in English
  • Report being able to walk 10 minutes continuously without sitting down to rest
  • Competent to provide written informed consent

排除标准

  • Enrolled in another research study involving weight loss, nutrition, or physical activity
  • Being treated for weight loss or on weight loss medications (OTC or prescribed)
  • Are currently pregnant

结局指标

主要结局

Change in Weight

时间窗: 12 months after enrollment

Expected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data

次要结局

  • Change in Weight(24 months after enrollment)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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