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MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in the Veterans Health Administration (VHA)

Primary Purpose

Obesity, Overweight, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MOVE OUT
MOVE!
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Veteran, Self Care, Patient Education, Peer Group

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Visit to ZVAMC primary provider within 3 months
  • BMI >= 30 OR BMI >= 25 and Hypertension or Diabetes Mellitus
  • No scheduled appointment for a MOVE program clinic
  • Age <= 75 years
  • Live in targeted geographic region

Exclusion Criteria:

  • None

Sites / Locations

  • Clement J. Zablocki VA Medical Center, Milwaukee, WI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: MOVE OUT

Arm 2: MOVE!

Arm Description

The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE! program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.

As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a "clinical reminder." This reminder prompts the primary care provider (PCP) to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial. The MOVE! program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.

Outcomes

Primary Outcome Measures

Change in Weight (From Baseline)
Weight as recorded in the medical record during a 6-month period around the follow-up point.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2011
Last Updated
March 28, 2016
Sponsor
VA Office of Research and Development
Collaborators
The American Legion Department of Wisconsin, Veterans Of Foreign Wars Of The United States Department Of Wisconsin, All Saints Catholic Church, Milwaukee, Three Holy Women Catholic Parish, Veterans 76 Ltd., Dryhootch of America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01339390
Brief Title
MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in the Veterans Health Administration (VHA)
Official Title
MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in VHA
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
The American Legion Department of Wisconsin, Veterans Of Foreign Wars Of The United States Department Of Wisconsin, All Saints Catholic Church, Milwaukee, Three Holy Women Catholic Parish, Veterans 76 Ltd., Dryhootch of America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Obesity has been linked to several serious medical conditions, including high blood pressure, diabetes, and poor cholesterol levels. For this reason, obesity is likely the most important single contributor to cardiovascular mortality in the United States. Fortunately, intensive weight management programs are an effective treatment for obesity. Such programs help people lose weight and improve their measures of cardiac risk. In response to the growing numbers of obese Veterans being treated at Veterans Health Administration (VHA) facilities, the VHA developed the MOVE! Program. Veterans who commit to MOVE! and participate actively do lose weight. Unfortunately, MOVE!, like other weight management programs, requires its participants to attend classes and to exercise, often at locations and times that are inconvenient. The investigators propose to make it easier for eligible patients at the Zablocki Veterans Affairs Medical Center (ZVAMC) to participate by offering MOVE-style classes and exercise groups at a variety of locations, days, and times. The investigators' program-MOVE OUT-may provide a model for VHA to use nationwide.
Detailed Description
Background: Obesity increases the prevalence and severity of cardiovascular risk factors such as hypertension, diabetes, and metabolic syndrome. It is also a leading contributor to cancer and osteoarthritis. Obesity and overweight are highly prevalent among VHA patients: As with the general population, over two-thirds of VHA users are either overweight or obese. There is good evidence that intensive weight reduction programs can have a modest-but clinically significant-impact on weight. VHA has developed a comprehensive weight management program known as MOVE! to address obesity among its patients. MOVE! evaluations to date have demonstrated success in helping Veterans lose weight, but participation is low. In the investigators' preliminary work, the investigators found that the timing (daytime) and location (ZVAMC) of MOVE! activities were viewed by eligible patients as barriers to participation. In addition, previous research has often demonstrated significant rebound in weight at the end of formal program activities, which may be mitigated if there is a convenient place for ongoing weight monitoring and healthy activities with peers. Objectives: The overall goal of the project is to increase participation in the ZVAMC MOVE! program by implementing an innovative community-based program known as MOVE OUT. MOVE OUT will incorporate the key elements of the proven MOVE! program (education, peer support, and planned physical activity), but in settings closer to the homes of eligible Zablocki patients. The investigators have the following objectives: To reduce the mean weight of high-risk overweight or obese Veterans who receive primary care at ZVAMC. To improve the physical activity and diet of high-risk overweight or obese Veterans who receive primary care at ZVAMC. To demonstrate that an innovative community-based program can increase the proportion of ZVAMC users who participate actively in a moderately intensive weight management program as recommended by the National Institutes of Health Consensus Conference on Obesity. Methods: The investigators will use a cluster randomized trial design. The investigators will allocate groups of eligible Veterans from ZVAMC to either a MOVE OUT invitation or a standard MOVE! invitation. The investigators will use clinically gathered weight data to determine overall rates of weight loss in the randomly assigned Veterans. In addition, the investigators will recruit a sample of Veterans from each randomized group to participate in a study of the effectiveness of the weight management program to which they are assigned. The investigators will use established methods to assess changes in diet, exercise and attitude, as well as physiologic outcomes including weight, blood pressure, Hemoglobin A1c, and lipid values. The investigators will use qualitative methods to learn what aspects of the two programs are most effective. Impact: The investigators will demonstrate that VHA can deliver effective weight management services in a community-based fashion. If this study finds that such a delivery approach leads to an increased number of at-risk Veterans participating in weight control programs, it will guide program design throughout VHA. Although weight management is particularly well suited to a disseminated delivery model, lessons learned from this research are likely to help VHA improve its ability to help patients self-manage a variety of chronic diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Hypertension, Diabetes Mellitus
Keywords
Obesity, Veteran, Self Care, Patient Education, Peer Group

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: MOVE OUT
Arm Type
Experimental
Arm Description
The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE! program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.
Arm Title
Arm 2: MOVE!
Arm Type
Active Comparator
Arm Description
As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a "clinical reminder." This reminder prompts the primary care provider (PCP) to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial. The MOVE! program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.
Intervention Type
Behavioral
Intervention Name(s)
MOVE OUT
Intervention Description
The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.
Intervention Type
Behavioral
Intervention Name(s)
MOVE!
Intervention Description
As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a "clinical reminder." This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.
Primary Outcome Measure Information:
Title
Change in Weight (From Baseline)
Description
Weight as recorded in the medical record during a 6-month period around the follow-up point.
Time Frame
Measured at 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Visit to ZVAMC primary provider within 3 months BMI >= 30 OR BMI >= 25 and Hypertension or Diabetes Mellitus No scheduled appointment for a MOVE program clinic Age <= 75 years Live in targeted geographic region Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey C Whittle, MD MPH
Organizational Affiliation
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clement J. Zablocki VA Medical Center, Milwaukee, WI
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295-1000
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in the Veterans Health Administration (VHA)

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