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临床试验/NCT01307280
NCT01307280已完成不适用

Weight Management Demonstration Project: Healthy Eating and Active Living in TRICARE Households

RTI International3 个研究点 分布在 1 个国家目标入组 2,395 人开始时间: 2006年8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
入组人数
2,395
试验地点
3
主要终点
Body Mass Index BMI

研究概览

简要总结

The study investigated the effectiveness and cost-effectiveness of a cognitive and behavioral weight management program, complemented by an interactive Web site and brief telephone coaching, implemented among TRICARE non-active-duty beneficiaries.

A total of 1,755 participants from four Midwestern states were randomized to one of three randomized controlled trial groups with increasing intervention intensity: mailed material and basic Web access (RCT1), plus an interactive Web site (RCT2), plus brief phone- and Web-based coaching support from health lifestyle coaches (RCT3). The study assessed changes in participants' weight, blood pressure, diet, and physical activity from baseline to 6, 12, and 15 to 18 months. Analyses estimated overall cost savings and calculated the cost-effectiveness ratio of each randomized controlled trial compared with a "do-nothing" alternative as the cost per quality-adjusted life year.

详细描述

Lifestyle modification interventions that promote healthful eating habits and physical activity can be effective in producing weight losses of 4% to 9% of initial bodyweight. If maintained, this level of weight loss can reduce hypertension, high blood glucose, and elevated lipids. However, weight losses often plateau after 6 months, and weight regain begins after 12 months. Accordingly, there is interest in interventions, such as Web-based reinforcement and brief counseling to maintain weight loss over time and in the relative cost-effectiveness of program delivery modes.

Most obesity treatment programs focus on outcomes for individuals without assessing population-based cost savings. This study suggests that a broader perspective can help to identify the benefit of weight management in adult populations. Accordingly, this study assessed the cost-effectiveness of a weight management program in a population of adults served by a large health care system-the TRICARE Management Activity (TMA), the agency that manages the TRICARE health care benefits for active-duty service members, retired service members, their families, National Guard/Reserve members, and their families. The annual direct medical costs of overweight/obesity for beneficiaries enrolled in TRICARE Prime are estimated to exceed $1.1 billion. This study investigated the effectiveness and cost-effectiveness of methods to deliver a cognitive-behavioral weight loss intervention.

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 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •TRICARE Prime non-active-duty beneficiaries
  • •Body Mass Index of 25 to 50
  • •Living in 4 midwestern states (TRICARE region)

排除标准

  • •Not able to engage in physical activity
  • •Body mass index greater than 50
  • •Body mass index less than 25
  • •Human immunodeficiency virus infected
  • •current cancer

研究组 & 干预措施

Basic HEALTH

Experimental

Participants received the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention

干预措施: RCT1 (Behavioral)

Interactive Internet

Experimental

Intervention intensity increased in RCT2, which included bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments.

干预措施: RCT2 (Behavioral)

Behavioral Counseling

Experimental

RCT3 included bookHEALTH, the interactive version of eHEALTH, and telephonic coaching support provided by trained health lifestyle coaches every 2 weeks alternating between a telephone call (typically 15 to 20 minutes) and a personalized e-mail. The coaches used motivational interviewing, helped participants solve problems, and reinforced their successes.

干预措施: RCT3 (Behavioral)

结局指标

主要结局

Body Mass Index BMI

时间窗: change in body mass index at baseline

BMI

时间窗: change in body mass index at 18 months

BMI

时间窗: change in body mass index at 6 months

BMI

时间窗: change in body mass index at 12 months

次要结局

  • Blood Pressure(change in blood pressure at baseline, and 6,12,18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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