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Dissemination of a Weight Management Program Among US Veterans

Primary Purpose

Body Weight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MOVE*VETS
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Weight focused on measuring Weight, Diet, Physical Activity, Veterans, MOVE! Program

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Receiving primary care at the one of the 10 selected VA centers
  • BMI 25 or over
  • 21 years old, no upper age limit
  • Pregnant women may participate in the study with the approval of the VA medical staff

Exclusion Criteria:

  • Not a patient at one of the 10 VA sites
  • BMI less than 25
  • Under 21 years of age
  • Pregnant without medical approval to participate

Sites / Locations

  • West LA VAMC
  • West Haven VAMC
  • Jesse Brown VAMC
  • Edward Hines Jr. VAMC
  • Boston VAMC
  • Minneapolis VAMC
  • Omaha VAMC
  • Lineberger Comprehensive Cancer Center at UNC-CH
  • Audie L. Murphy VAMC
  • George E. Wahlen VAMC
  • VA Puget Sound HCS

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

MOVE!

MOVE*VETS

Arm Description

Participants will receive the usual VA MOVE! Program. These elements include a baseline assessment, brief clinic counseling session about weight, printed targeted health information on weight management and behaviors, and opportunities to participate in group sessions at the VA site and telephone follow-up from MOVE! clinic staff.

Participants will receive the same MOVE! program as the control group plus 4 tailored newsletters on the study health behavior topics created from the baseline survey. Also 2-4 counseling calls from volunteer veteran peer counselors.

Outcomes

Primary Outcome Measures

Primary study outcome measures at the participant level will be program participation and effectiveness in achieving weight loss.

Secondary Outcome Measures

Secondary outcome measures include improved self-management behaviors (diet and physical activity),psychosocial factors, awareness and utilization of program components/activities, and perceptions of the program/organization.

Full Information

First Posted
October 19, 2009
Last Updated
April 21, 2017
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT00998452
Brief Title
Dissemination of a Weight Management Program Among US Veterans
Official Title
Dissemination of a Weight Management Program Among US Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being conducted with the Veterans Affairs National Center for Health Promotion and Disease Prevention (VANCP), which is overseeing the current dissemination of MOVE! (Managing Overweight/Obesity for Veterans Everywhere), a national weight management program for veterans. It will be based at 10 local sites in the national network of VA medical settings and community-based outpatient clinics and will compare two different models for disseminating and implementing MOVE! using a randomized experimental design. One study arm will implement the MOVE* VETS! (Volunteer Education and Tailored Self-management and support) model that includes tailored newsletters and peer counseling MI calls and activities, and the other will receive the standard MOVE! program.
Detailed Description
The purpose of this research is to study the dissemination and implementation of MOVE!. MOVE! is a national weight management program for veterans that has moved form pilot to full dissemination. Overweight and obesity are rapidly rising in the United States and interventions to combat this epidemic are desperately needed. Within the VA population, approximately 70% of veterans are overweight and or obese. Participants will be male and female Veterans, aged 21 and over receiving health services at one of the 10 study sites, who qualify for the MOVE! program. We are recruiting a minimum of 800 -1000 Veterans to complete a baseline survey at the 10 VA sites participating in the study. Participants at the 10 VA sites are recruited during a primary care visit by primary care provider, they will not be chosen based on the presence or absence of any disease, thus health status will vary. The primary outcome measures will be participation after enrollment into MOVE! and participant weight loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight
Keywords
Weight, Diet, Physical Activity, Veterans, MOVE! Program

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
MOVE!
Arm Type
No Intervention
Arm Description
Participants will receive the usual VA MOVE! Program. These elements include a baseline assessment, brief clinic counseling session about weight, printed targeted health information on weight management and behaviors, and opportunities to participate in group sessions at the VA site and telephone follow-up from MOVE! clinic staff.
Arm Title
MOVE*VETS
Arm Type
Active Comparator
Arm Description
Participants will receive the same MOVE! program as the control group plus 4 tailored newsletters on the study health behavior topics created from the baseline survey. Also 2-4 counseling calls from volunteer veteran peer counselors.
Intervention Type
Behavioral
Intervention Name(s)
MOVE*VETS
Intervention Description
Receiving 4 tailored newsletters on the study health behavior topics created from the baseline survey. Also 2-4 counseling calls from peer counselors.
Primary Outcome Measure Information:
Title
Primary study outcome measures at the participant level will be program participation and effectiveness in achieving weight loss.
Time Frame
At enrollment and 6 months post-enrollment
Secondary Outcome Measure Information:
Title
Secondary outcome measures include improved self-management behaviors (diet and physical activity),psychosocial factors, awareness and utilization of program components/activities, and perceptions of the program/organization.
Time Frame
enrollment to 6 months post-enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Receiving primary care at the one of the 10 selected VA centers BMI 25 or over 21 years old, no upper age limit Pregnant women may participate in the study with the approval of the VA medical staff Exclusion Criteria: Not a patient at one of the 10 VA sites BMI less than 25 Under 21 years of age Pregnant without medical approval to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Weiner, PhD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
West LA VAMC
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
West Haven VAMC
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Jesse Brown VAMC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Edward Hines Jr. VAMC
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Boston VAMC
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Minneapolis VAMC
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Omaha VAMC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at UNC-CH
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7294
Country
United States
Facility Name
Audie L. Murphy VAMC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
George E. Wahlen VAMC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
VA Puget Sound HCS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

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Dissemination of a Weight Management Program Among US Veterans

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