Clinical trial NCT01339390: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Hypertension
Diabetes Mellitus
Keywords: Obesity
Veteran
Self Care
Patient Education
Peer Group
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: The American Legion Department of Wisconsin
name: Veterans Of Foreign Wars Of The United States Department Of Wisconsin
name: All Saints Catholic Church, Milwaukee
name: Three Holy Women Catholic Parish
name: Veterans 76 Ltd.
name: Dryhootch of America, Inc.
First posted: 2011-04-20
Enrollment: 3169
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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 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.

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

Primary outcomes:
measure: Change in Weight (From Baseline)
timeFrame: Measured at 12 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Clement J. Zablocki VA Medical Center, Milwaukee, WI
state: Wisconsin
Study officials:
affiliation: Clement J. Zablocki VA Medical Center, Milwaukee, WI
name: Jeffrey C Whittle, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: