Coaching Veterans to Healthy Weights and Wellness (ASPIRE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00967668
First received: August 26, 2009
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

ASPIRE has completed enrollment of patients at the Ann Arbor and Cleveland Medical Centers in a study that is examining 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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: ASPIRE: Coaching Veterans to Healthy Weights and Wellness

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in weight [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Behavioral antecedents of functional exercise capacity and diet [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
  • Endpoint outcomes of health related quality of life and cardiovascular risk factors [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
  • Cost analysis [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
  • Describe and test changes for the Outcomes 1-3 [ Time Frame: 18 and 24 months after enrollment ] [ Designated as safety issue: No ]

Enrollment: 481
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Phone-based initial treatment of 3 months, followed by 21 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.
Experimental: Arm 2
On-site weekly group visits based on the ASPIRE protocols for initial treatment for 3 months, followed by 21 months of follow-up groups. (on-site 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.
Active Comparator: Arm 3
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.

Detailed Description:

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 ended in October 2011 and 481 patients were enrolled, 103% of our goal. In the spring of 2011, a decision was made to add a second year of treatment for interested participants. Thus, describing and testing outcomes at 18 and 24 months was added as another secondary aim. Three-month and twelve-month assessments are complete and analysis is on-going. Eighteen-month and twenty-four month assessments are ongoing.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967668

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Investigators
Principal Investigator: Julie C. Lowery, PhD MHSA VA Ann Arbor Healthcare System
  More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00967668     History of Changes
Other Study ID Numbers: IBB 09-034
Study First Received: August 26, 2009
Last Updated: April 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Counseling
Veterans
Weight loss
Physical activity
Diet

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013