Clinical trial NCT01307280: Weight Management Demonstration Project: HEALTH
Official title: Weight Management Demonstration Project: Healthy Eating and Active Living in TRICARE Households
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Behavioral Weight Management Intervention
weight loss
cost-effective analysis
high blood pressure
randomized clinical trial
behavioral interventions
physical activity
dietary change
obesity
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: The Cooper Institute
name: University of South Carolina
First posted: 2011-03-02
Enrollment: 2395
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Body Mass Index BMI
timeFrame: change in body mass index at baseline
measure: BMI
timeFrame: change in body mass index at 6 months
measure: BMI
timeFrame: change in body mass index at 12 months
measure: BMI
timeFrame: change in body mass index at 18 months
Secondary outcomes:
measure: Blood Pressure
timeFrame: change in blood pressure at baseline, and 6,12,18 months
Other outcomes:
Locations:
city: Swansea
country: United States
facility: RTI Study Center
state: Illinois
city: Research Triangle Park
country: United States
facility: RTI International
state: North Carolina
city: Fairborn
country: United States
facility: RTI Study Center
state: Ohio
Study officials:
affiliation: RTI International
name: James Hersey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.