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Completed

NCT Number: NCT01307280

Weight Management Demonstration Project: HEALTH

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.

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Key information

Conditions

Weight Loss Behavior Body Weight Body Weight Changes Cardiovascular Diseases Hypertension Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RTI Study Center, Swansea, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RCT1

Behavioral

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

RCT2

Behavioral

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

RCT3

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.

Primary outcomes

  1. Body Mass Index BMI

    Time frame: change in body mass index at baseline

  2. BMI

    Time frame: change in body mass index at 6 months

  3. BMI

    Time frame: change in body mass index at 12 months

  4. BMI

    Time frame: change in body mass index at 18 months

Secondary outcomes

  1. Blood Pressure

    Time frame: change in blood pressure at baseline, and 6,12,18 months

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • The Cooper Institute
  • United States Department of Defense
  • University of South Carolina

Registry information

Official study title

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

Acronym: HEALTH

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Mar 2, 2011
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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