Weight Management Demonstration Project: HEALTH

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Weight Loss

Intervention / Treatment
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* Behavioral: RCT1
* Behavioral: RCT2
* Behavioral: RCT3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basic HEALTH<br>Participants received the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention | Behavioral: RCT1<br>* the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention<br>|
| Experimental: Interactive Internet<br>Intervention intensity increased in RCT2, which included bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments. | Behavioral: RCT2<br>* bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments<br>|
| Experimental: Behavioral Counseling<br>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. | Behavioral: RCT3<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index BMI |  | change in body mass index at baseline | 
| BMI |  | change in body mass index at 6 months | 
| BMI |  | change in body mass index at 12 months | 
| BMI |  | change in body mass index at 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | change in blood pressure at baseline, and 6,12,18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral Weight Management Intervention, weight loss, cost-effective analysis, high blood pressure, randomized clinical trial, behavioral interventions, physical activity, dietary change, obesity