Coaching Veterans to Healthy Weights and Wellness (ASPIRE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00967668
First received: August 26, 2009
Last updated: August 19, 2014
Last verified: August 2014
  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 improve 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 ]
    Expected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data


Secondary Outcome Measures:
  • Change in Weight [ Time Frame: 24 months after enrollment ] [ Designated as safety issue: No ]
    Expected weight change from baseline to 24 months in kilograms based on linear mixed-effects model using all available data. Statistical analyses methods are the same as for the 12-month outcome.


Enrollment: 481
Study Start Date: January 2010
Study Completion Date: December 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASPIRE-Phone Lifestyle Coaching
Phone-based coaching using small change approach to improve physical activity and diet. Initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA).
Behavioral: Small change approach to improve physical activity and diet
The "Aspire to Lifelong Health" (ASPIRE) initial treatment program draws on the strengths of 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. 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). Baseline information provides a starting point for participants and their Lifestyle Coach to set one small, but potentially permanent, change in daily food choices and physical activity to promote a caloric deficit. Small changes are cumulative over the weeks and the participant makes their own goals within the context of their own lifestyle.
Experimental: ASPIRE-Group Lifestyle Coaching
On-site weekly group visits using small change approach to improve physical activity and diet. Initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA).
Behavioral: Small change approach to improve physical activity and diet
The "Aspire to Lifelong Health" (ASPIRE) initial treatment program draws on the strengths of 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. 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). Baseline information provides a starting point for participants and their Lifestyle Coach to set one small, but potentially permanent, change in daily food choices and physical activity to promote a caloric deficit. Small changes are cumulative over the weeks and the participant makes their own goals within the context of their own lifestyle.
Active Comparator: MOVE! Usual Care
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current patient at Ann Arbor or Cleveland medical center.
  • Current provider- or self-referral to MOVE! program and eligible to participate in MOVE!
  • 18 years of age and older
  • Able to communicate in English
  • Report being able to walk 10 minutes continuously without sitting down to rest
  • Competent to provide written informed consent

Exclusion Criteria:

  • Enrolled in another research study involving weight loss, nutrition, or physical activity
  • Being treated for weight loss or on weight loss medications (OTC or prescribed)
  • Are currently pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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
Results First Received: July 29, 2014
Last Updated: August 19, 2014
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 August 28, 2014