Weight Management Demonstration Project: HEALTH

RTI International

Status: Completed

Conditions: Weight Loss

Treatments: Behavioral: RCT3; Behavioral: RCT2; Behavioral: RCT1

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01307280

0209792

H94002-05-C-003 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,395 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,395 participants in 3 patient groups

Basic HEALTH

Experimental group

Description:

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

Treatment:

Behavioral: RCT1

Interactive Internet

Experimental group

Description:

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

Treatment:

Behavioral: RCT2

Behavioral Counseling

Experimental group

Description:

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.

Treatment:

Behavioral: RCT3