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Coaching Veterans to Healthy Weights and Wellness - NCT00967668-48113(Clinical Trial 491204)



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City:  Ann Arbor
State:  
MI
Zip Code: 48113
Conditions: Obesity
Purpose: ASPIRE is enrolling patients at the Ann Arbor and Cleveland Medical Centers in a study is to examine the impact of an innovative approach to weight loss ("Aspiring to Lifelong Health in VA", aka "ASPIRE-VA"). ASPIRE-VA has 3 key features: 1) lifestyle coaches who encourage behavior change through a "small steps" approach; 2) a simplified "Stoplight" diet; and 3) user-friendly "enhanced" pedometers to help participants monitor their physical activity.
Study summary: Background and Rationale: Over 70% of veterans are overweight or obese, imposing a tremendous burden on the VHA healthcare system due to increased need for treatment of obesity-related chronic disease and disability. The MOVE! 5-level Weight Management Program for Veterans has been promoted in VHA to address this problem. Data suggest that engagement in ongoing treatment is low, clinically significant weight loss is not being achieved by many patients, and weight regain is likely. Although the MOVE! program description includes phone-based self-management support, most facilities have focused resources on developing facility-based group programs. Project Objective: To fill the gap in phone-based self-management support and to increase the number of patients who achieve a clinically significant amount of weight loss, we will examine the impact of an innovative approach to weight loss ("Aspiring to Lifelong Health in VA", aka "ASPIRE-VA"). ASPIRE-VA has 3 key features: 1) lifestyle coaches who encourage behavior change through a "small steps" approach; 2) a simplified "Stoplight" diet; and 3) user-friendly "enhanced" pedometers to help participants monitor their physical activity. ASPIRE-VA is not an alternative program to MOVE!; rather, it is a more structured approach within the existing MOVE! framework that is potentially more convenient and satisfying for patients, particularly those unable to participate in facility-based programs. Project Methods: 468 VA patients eligible for the MOVE! program at two VAMCs will be invited to participate in this 12-month randomized control trial. Willing participants will be randomized to one of 3 study arms: 1) ASPIRE-VA delivered only by phone; 2) ASPIRE-VA delivered through center-based group visits; or 3) the "usual care" MOVE! program in place at each VAMC. Our primary outcome is change in weight between baseline and 12 months. Secondary outcomes are changes in functional exercise capacity, nutrition, glucose levels, serum lipid levels, blood pressure, and health-related quality of life. We will also conduct exploratory analyses of cost and differences in response and experience by different races and genders, and formative evaluation. Progress: Recruitment began in January of 2010 and, as of the end of 2010, we have enrolled 264 patients, approximately 56% of our goal.
Criteria: Inclusion Criteria: 1. Current patient at Ann Arbor or Cleveland medical center. 2. Current provider- or self-referral to MOVE! program and eligible to participate in MOVE! 3. 18 years of age and older 4. Able to communicate in English 5. Report being able to walk 10 minutes continuously without sitting down to rest 6. Competent to provide written informed consent Exclusion Criteria: 1. Enrolled in another research study involving weight loss, nutrition, or physical activity 2. Being treated for weight loss or on weight loss medications (OTC or prescribed) 3. Are currently pregnant
Study is available at: VA Ann Arbor Healthcare System
Ann Arbor, MI 48113
United States

Primary Contact:
Leah R Gillon, MSW BA
Email: leah.gillon@va.gov

Secondary Contact:
Leah R Gillon, MSW BA
Email: leah.gillon@va.gov
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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