Weight Management Demonstration Project: HEALTH

Weight Loss Clinical Trial

— HEALTH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307280
• Other study ID #: 0209792
• Secondary ID: H94002-05-C-003
• Status: Completed
• Phase: N/A
• First received: February 22, 2011
• Last updated: January 25, 2012
• Start date: August 2006
• Est. completion date: December 2009

Study information

• Verified date: January 2012
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2395
• Est. completion date: December 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Behavioral:
• RCT1
the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention
• RCT2
bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments
• 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.

Locations

Country	Name	City	State
United States	RTI Study Center	Fairborn	Ohio
United States	RTI International	Research Triangle Park	North Carolina
United States	RTI Study Center	Swansea	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
RTI International	The Cooper Institute, United States Department of Defense, University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index BMI		change in body mass index at baseline	No
Primary	BMI		change in body mass index at 6 months	No
Primary	BMI		change in body mass index at 12 months	No
Primary	BMI		change in body mass index at 18 months	No
Secondary	Blood Pressure		change in blood pressure at baseline, and 6,12,18 months	No