Weight Management Demonstration Project: HEALTH
HEALTH
2 other identifiers
interventional
2,395
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2006
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 22, 2011
CompletedFirst Posted
Study publicly available on registry
March 2, 2011
CompletedJanuary 26, 2012
January 1, 2012
2 years
February 22, 2011
January 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Body Mass Index BMI
change in body mass index at baseline
BMI
change in body mass index at 6 months
BMI
change in body mass index at 12 months
BMI
change in body mass index at 18 months
Secondary Outcomes (1)
Blood Pressure
change in blood pressure at baseline, and 6,12,18 months
Study Arms (3)
Basic HEALTH
EXPERIMENTALParticipants received the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention
Interactive Internet
EXPERIMENTALIntervention intensity increased in RCT2, which included bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments.
Behavioral Counseling
EXPERIMENTALRCT3 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.
Interventions
the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention
bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments
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.
Eligibility Criteria
You may qualify if:
- TRICARE Prime non-active-duty beneficiaries
- Body Mass Index of 25 to 50
- Living in 4 midwestern states (TRICARE region)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RTI Internationallead
- United States Department of Defensecollaborator
- The Cooper Institutecollaborator
- University of South Carolinacollaborator
Study Sites (3)
RTI Study Center
Swansea, Illinois, 62226, United States
RTI International
Research Triangle Park, North Carolina, 27709, United States
RTI Study Center
Fairborn, Ohio, 45324, United States
Related Publications (1)
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.
PMID: 22001689DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Hersey, PhD
RTI International
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2011
First Posted
March 2, 2011
Study Start
August 1, 2006
Primary Completion
August 1, 2008
Study Completion
December 1, 2009
Last Updated
January 26, 2012
Record last verified: 2012-01