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Weight Management Demonstration Project: HEALTH (HEALTH)

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RCT1
RCT2
RCT3
Sponsored by
RTI International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring Behavioral Weight Management Intervention, weight loss, cost-effective analysis, high blood pressure, randomized clinical trial, behavioral interventions, physical activity, dietary change, obesity

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RTI Study Center
  • RTI International
  • RTI Study Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Basic HEALTH

Interactive Internet

Behavioral Counseling

Arm Description

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

Intervention intensity increased in RCT2, which included bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments.

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.

Outcomes

Primary Outcome Measures

Body Mass Index BMI
BMI
BMI
BMI

Secondary Outcome Measures

Blood Pressure

Full Information

First Posted
February 22, 2011
Last Updated
January 25, 2012
Sponsor
RTI International
Collaborators
United States Department of Defense, The Cooper Institute, University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01307280
Brief Title
Weight Management Demonstration Project: HEALTH
Acronym
HEALTH
Official Title
Weight Management Demonstration Project: Healthy Eating and Active Living in TRICARE Households
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI International
Collaborators
United States Department of Defense, The Cooper Institute, University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2395 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Basic HEALTH
Arm Type
Experimental
Arm Description
Participants received the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention
Arm Title
Interactive Internet
Arm Type
Experimental
Arm Description
Intervention intensity increased in RCT2, which included bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments.
Arm Title
Behavioral Counseling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
RCT1
Intervention Description
the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention
Intervention Type
Behavioral
Intervention Name(s)
RCT2
Intervention Description
bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments
Intervention Type
Behavioral
Intervention Name(s)
RCT3
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index BMI
Time Frame
change in body mass index at baseline
Title
BMI
Time Frame
change in body mass index at 6 months
Title
BMI
Time Frame
change in body mass index at 12 months
Title
BMI
Time Frame
change in body mass index at 18 months
Secondary Outcome Measure Information:
Title
Blood Pressure
Time Frame
change in blood pressure at baseline, and 6,12,18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Hersey, PhD
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
RTI Study Center
City
Swansea
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Facility Name
RTI International
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States
Facility Name
RTI Study Center
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22001689
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.
Results Reference
derived

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Weight Management Demonstration Project: HEALTH

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