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Weight Management Demonstration Project: HEALTH

This study has been completed.
Sponsor:
Collaborators:
The Cooper Institute
University of South Carolina
Information provided by (Responsible Party):
RTI International
ClinicalTrials.gov Identifier:
NCT01307280
First received: February 22, 2011
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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 Intervention
Weight Loss
Behavioral: RCT1
Behavioral: RCT2
Behavioral: RCT3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weight Management Demonstration Project: Healthy Eating and Active Living in TRICARE Households

Resource links provided by NLM:


Further study details as provided by RTI International:

Primary Outcome Measures:
  • Body Mass Index BMI [ Time Frame: change in body mass index at baseline ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: change in body mass index at 6 months ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: change in body mass index at 12 months ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: change in body mass index at 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: change in blood pressure at baseline, and 6,12,18 months ] [ Designated as safety issue: No ]

Enrollment: 2395
Study Start Date: August 2006
Study Completion Date: December 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Basic HEALTH
Participants received the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention
Behavioral: RCT1
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.
Behavioral: RCT2
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.
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.

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307280

Locations
United States, Illinois
RTI Study Center
Swansea, Illinois, United States, 62226
United States, North Carolina
RTI International
Research Triangle Park, North Carolina, United States, 27709
United States, Ohio
RTI Study Center
Fairborn, Ohio, United States, 45324
Sponsors and Collaborators
RTI International
The Cooper Institute
University of South Carolina
Investigators
Principal Investigator: James Hersey, PhD RTI International
  More Information

No publications provided by RTI International

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT01307280     History of Changes
Other Study ID Numbers: 0209792, H94002-05-C-003
Study First Received: February 22, 2011
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by RTI International:
Behavioral Weight Management Intervention
weight loss
cost-effective analysis
high blood pressure
randomized clinical trial
behavioral interventions
physical activity
dietary change
obesity

Additional relevant MeSH terms:
Body Weight
Weight Loss
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014