MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in VHA

Obesity Clinical Trial

— MOVE OUT  

Official title:

MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in VHA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01339390
• Other study ID #: IIR 10-327
• Secondary ID: 1I01HX000562-01A
• Status: Active, not recruiting
• Phase: N/A
• First received: April 19, 2011
• Last updated: May 18, 2015
• Start date: April 2012
• Est. completion date: August 2015

Study information

• Verified date: May 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 VHA facilities, the Department of Veterans Affairs 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 VAMC to participate by offering MOVE-style classes and exercise groups at a variety of locations, days, and times. Our program-MOVE OUT-may provide a model for VHA to use nationwide.

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 VA patients: As with the general population, over two-thirds of VA 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 our preliminary work, we found that the timing (daytime) and location (Zablocki VAMC) 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. We have the following objectives:

1. To reduce the mean weight of high-risk overweight or obese veterans who receive primary care at ZVAMC.

2. To improve the physical activity and diet of high-risk overweight or obese veterans who receive primary care at ZVAMC.

3. 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 NIH Consensus Conference on Obesity.

Methods: We will use a cluster randomized trial design. We will allocate groups of eligible veterans from ZVAMC to either a MOVE OUT invitation or a standard MOVE! invitation. We will use clinically gathered weight data to determine overall rates of weight loss in the randomly assigned veterans. In addition, we 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. We will use established methods to assess changes in diet, exercise and attitude, as well as physiologic outcomes including weight, blood pressure, HgbA1c, and lipid values. We will use qualitative methods to learn what aspects of the two programs are most effective.

Impact: We 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2300
• Est. completion date: August 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight + Diabetes Mellitus
• Overweight + Hypertension

Intervention

Behavioral:
• MOVE OUT
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.
• MOVE!
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.

Locations

Country	Name	City	State
United States	Clement J. Zablocki VA Medical Center, Milwaukee, WI	Milwaukee	Wisconsin

Sponsors (7)

Lead Sponsor	Collaborator
VA Office of Research and Development	All Saints Catholic Church, Dryhootch, St. Rita's Catholic Church, The American Legion Department of Wisconsin, Veterans Of Foreign Wars Of The United States Department Of Wisconsin, Vets 76

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Weight as recorded in the medical record during a 6-month period around the follow-up point.	Measured at 12 and 24 months	No