Trials / Completed
CompletedNCT01307280
Weight Management Demonstration Project: HEALTH
Weight Management Demonstration Project: Healthy Eating and Active Living in TRICARE Households
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,395 (actual)
- Sponsor
- RTI International · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | RCT1 | the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention |
| BEHAVIORAL | RCT2 | bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments |
| BEHAVIORAL | RCT3 | 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. |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2008-08-01
- Completion
- 2009-12-01
- First posted
- 2011-03-02
- Last updated
- 2012-01-26
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01307280. Inclusion in this directory is not an endorsement.