Weight Management Demonstration Project: HEALTH
- Conditions
- Weight Loss
- Registration Number
- NCT01307280
- Lead Sponsor
- RTI International
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2395
- TRICARE Prime non-active-duty beneficiaries
- Body Mass Index of 25 to 50
- Living in 4 midwestern states (TRICARE region)
- Not able to engage in physical activity
- Pregnant
- Body mass index greater than 50
- Body mass index less than 25
- Human immunodeficiency virus infected
- current cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Body Mass Index BMI change in body mass index at baseline BMI change in body mass index at 18 months
- Secondary Outcome Measures
Name Time Method Blood Pressure change in blood pressure at baseline, and 6,12,18 months
Trial Locations
- Locations (2)
RTI Study Center
🇺🇸Fairborn, Ohio, United States
RTI International
🇺🇸Research Triangle Park, North Carolina, United States
RTI Study Center🇺🇸Fairborn, Ohio, United States