Obesity Clinical Trial
Official title:
MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in VHA
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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