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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00967668 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: Small change approach to improving physical activity and diet Behavioral: MOVE! Usual Care |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | ASPIRE: Coaching Veterans to Healthy Weights and Wellness |
| Estimated Enrollment: | 468 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Phone-based initial treatment, followed by 9 months of follow-up phone support (phone-only ASPIRE-VA)
|
Behavioral: Small change approach to improving physical activity and diet
The "Aspire to Lifelong Health" (ASPIRE) initial treatment program is an innovative approach to weight management that draws on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. To learn more about their current behavioral patterns, for the first week in the program participants use a food diary to track caloric intake and a pedometer to log their daily physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set one small, but potentially permanent, change in daily food choices and physical activity behavior that will promote a caloric deficit. These small changes are cumulative over the weeks and, most importantly, the participant makes their own goals within the context of their own lifestyle.
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2: Experimental
On-site weekly group visits based on the ASPIRE protocols for initial treatment, followed by 9 months of follow-up phone support (on-site+phone ASPIRE-VA)
|
Behavioral: Small change approach to improving physical activity and diet
The "Aspire to Lifelong Health" (ASPIRE) initial treatment program is an innovative approach to weight management that draws on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. To learn more about their current behavioral patterns, for the first week in the program participants use a food diary to track caloric intake and a pedometer to log their daily physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set one small, but potentially permanent, change in daily food choices and physical activity behavior that will promote a caloric deficit. These small changes are cumulative over the weeks and, most importantly, the participant makes their own goals within the context of their own lifestyle.
|
|
3: Active Comparator
Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
|
Behavioral: MOVE! Usual Care
The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Leah R Gillon, MSW BA | leah.gillon@va.gov | |
| Contact: Laura J Damschroder, MPH | laura.damschroder@va.gov |
| United States, Michigan | |
| VA Ann Arbor Healthcare System | Recruiting |
| Ann Arbor, Michigan, United States, 48113-0170 | |
| Contact: Leah R Gillon, MSW BA leah.gillon@va.gov | |
| Contact: Janet G Adams-Watson, MHSA BA (734) 845-3604 jan.adams-watson@va.gov | |
| Sub-Investigator: Laura J. Damschroder, MPH | |
| Sub-Investigator: Caroline R Richardson, MD | |
| Principal Investigator: Julie C. Lowery, PhD MHSA | |
| Sub-Investigator: David E Goodrich, EdD MA | |
| United States, Ohio | |
| VA Medical Center, Cleveland | Not yet recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Susan Kirsh, MD 216-701-0519 Susan.Kirsh@va.gov | |
| Principal Investigator: | Julie C. Lowery, PhD MHSA | VA Ann Arbor Healthcare System |
More Information
| Responsible Party: | Department of Veterans Affairs ( Lowery, Julie - Principal Investigator ) |
| Study ID Numbers: | IBB 09-034 |
| Study First Received: | August 26, 2009 |
| Last Updated: | February 3, 2010 |
| ClinicalTrials.gov Identifier: | NCT00967668 History of Changes |
| Health Authority: | United States: Federal Government |
|
Counseling Veterans Weight loss Physical activity Diet |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
