Coaching Veterans to Health Weights and Wellness - NCT00967668-48113 (Clinical Trial 307284)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy307284.aspx
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| City: |
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Ann Arbor |
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State:
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MI |
| Zip Code: |
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48113 |
| Conditions: |
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Obesity |
| Purpose: |
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The purpose of this 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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
1. Current provider- or self-referral to MOVE! program and eligible to participate in
MOVE!
2. 18 years of age and older
3. Willing to participate in an on-site weight loss intervention
4. Able to wear a pedometer daily
5. Able to communicate in English
6. Have access to personal home phone or cell phone
7. Report being able to walk 10 minutes continuously without sitting down to rest
8. Competent to provide written informed consent
Exclusion Criteria:
1. Unable to attend one of the on-site ASPIRE or MOVE! classes
2. Enrolled in another research study involving weight loss, nutrition, or physical
activity
3. Being treated for weight loss or on weight loss medications (OTC or prescribed)
4. Are currently pregnant |
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| Study is available at: |
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VA Ann Arbor Healthcare System
Ann Arbor, MI 48113
United States
Primary Contact:
Leah R Gillon, MSW BA
Email: leah.gillon@va.gov |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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November 17, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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