Weight Loss Clinical Trial
Official title:
Weight Management Demonstration Project: Healthy Eating and Active Living in TRICARE Households
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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