Weight Management Demonstration Project: HEALTH

NCT ID: NCT01307280

Last Updated: 2012-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2395 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-12-31

Brief 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

Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Basic HEALTH

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

Group Type: EXPERIMENTAL

RCT1

Intervention Type: BEHAVIORAL

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

Interactive Internet

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

Group Type: EXPERIMENTAL

RCT2

Intervention Type: BEHAVIORAL

bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments

Behavioral Counseling

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.

Group Type: EXPERIMENTAL

RCT3

Intervention Type: BEHAVIORAL

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.

Interventions

RCT1

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

Intervention Type: BEHAVIORAL

RCT2

bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

The Cooper Institute

OTHER

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Hersey, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

RTI Study Center

Swansea, Illinois, United States

RTI International

Research Triangle Park, North Carolina, United States

RTI Study Center

Fairborn, Ohio, United States

Countries

United States

References

Hersey JC, Khavjou O, Strange LB, Atkinson RL, Blair SN, Campbell S, Hobbs CL, Kelly B, Fitzgerald TM, Kish-Doto J, Koch MA, Munoz B, Peele E, Stockdale J, Augustine C, Mitchell G, Arday D, Kugler J, Dorn P, Ellzy J, Julian R, Grissom J, Britt M. The efficacy and cost-effectiveness of a community weight management intervention: a randomized controlled trial of the health weight management demonstration. Prev Med. 2012 Jan;54(1):42-9. doi: 10.1016/j.ypmed.2011.09.018. Epub 2011 Oct 6.

Reference Type: DERIVED

PMID: 22001689 (View on PubMed)

Other Identifiers

H94002-05-C-003

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0209792

Identifier Type: -

Identifier Source: org_study_id