Weight Management Demonstration Project: HEALTH

NCT01307280 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2395

Last updated 2012-01-26

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

RCT1

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

BEHAVIORAL

RCT2

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

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED
  • The Cooper Institute

    collaborator OTHER
  • University of South Carolina

    collaborator OTHER
  • RTI International

    lead OTHER

Principal Investigators

  • James Hersey, PhD · RTI International

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-08-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01307280 on ClinicalTrials.gov