Diabetes Mellitus, Hypertension, Obesity, Overweight
Conditions
Keywords
Obesity, Veteran, Self Care, Patient Education, Peer Group
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.
Interventions
BEHAVIORALMOVE 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.
BEHAVIORALMOVE!
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.
Sponsors
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.
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight (From Baseline) | Measured at 12 and 24 months | Weight as recorded in the medical record during a 6-month period around the follow-up point. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: 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 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. | 1,571 |
| Arm 2: 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.
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. | 1,598 |
| Total | 3,169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 32 | 29 |
| Overall Study | Lost to Follow-up | 125 | 127 |
Baseline characteristics
| Characteristic | Arm 1: MOVE OUT | Total | Arm 2: MOVE! |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 550 Participants | 1120 Participants | 570 Participants |
| Age, Categorical Between 18 and 65 years | 1021 Participants | 2049 Participants | 1028 Participants |
| Age, Continuous | 59.26 years STANDARD_DEVIATION 10.8 | 59.54 years STANDARD_DEVIATION 10.6 | 59.80 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 1571 participants | 3169 participants | 1598 participants |
| Sex: Female, Male Female | 66 Participants | 120 Participants | 54 Participants |
| Sex: Female, Male Male | 1505 Participants | 3049 Participants | 1544 Participants |
| Weight | 230.16 pounds STANDARD_DEVIATION 43.82 | 229.58 pounds STANDARD_DEVIATION 43.28 | 229.01 pounds STANDARD_DEVIATION 42.74 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 32 / 1,571 | 29 / 1,598 |
Outcome results
Primary
Change in Weight (From Baseline)
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
Population: For the analysis, we included those lost to follow up by using the last observation carried forward to impute missing values
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: MOVE OUT | Change in Weight (From Baseline) | 12 months | -0.71 Pounds | Standard Deviation 12.04 |
| Arm 1: MOVE OUT | Change in Weight (From Baseline) | 24 months | -1.64 Pounds | Standard Deviation 15.34 |
| Arm 2: MOVE! | Change in Weight (From Baseline) | 12 months | -0.31 Pounds | Standard Deviation 12.49 |
| Arm 2: MOVE! | Change in Weight (From Baseline) | 24 months | -1.06 Pounds | Standard Deviation 15.22 |
Comparison: This is the analysis at 12 months, comparing the change in weight from 12 months to baseline in our Move Out (arm 1) vs Move (arm 2) groupsp-value: 0.493795% CI: [-0.7347, 1.5229]t-test, 2 sided
Comparison: This is the analysis at 24 months, comparing the change in weight from 24 months to baseline in our Move Out (arm 1) vs Move (arm 2) groupsp-value: 0.306295% CI: [-0.5395, 1.7181]t-test, 2 sided