Weight Management Demonstration Project: HEALTH (HEALTH)
|ClinicalTrials.gov Identifier: NCT01307280|
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : January 26, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Weight Loss||Behavioral: RCT1 Behavioral: RCT2 Behavioral: RCT3||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2395 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Weight Management Demonstration Project: Healthy Eating and Active Living in TRICARE Households|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||December 2009|
Experimental: Basic HEALTH
Participants received the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention
the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention
Experimental: 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.
bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments
Experimental: 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.
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.
- Body Mass Index BMI [ Time Frame: change in body mass index at baseline ]
- BMI [ Time Frame: change in body mass index at 6 months ]
- BMI [ Time Frame: change in body mass index at 12 months ]
- BMI [ Time Frame: change in body mass index at 18 months ]
- Blood Pressure [ Time Frame: change in blood pressure at baseline, and 6,12,18 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307280
|United States, Illinois|
|RTI Study Center|
|Swansea, Illinois, United States, 62226|
|United States, North Carolina|
|Research Triangle Park, North Carolina, United States, 27709|
|United States, Ohio|
|RTI Study Center|
|Fairborn, Ohio, United States, 45324|
|Principal Investigator:||James Hersey, PhD||RTI International|