Coaching Veterans to Healthy Weights and Wellness
ASPIRE
ASPIRE: Coaching Veterans to Healthy Weights and Wellness
1 other identifier
interventional
481
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jan 2010
Longer than P75 for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2009
CompletedFirst Posted
Study publicly available on registry
August 28, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
August 29, 2014
CompletedApril 24, 2015
February 1, 2014
2.8 years
August 26, 2009
July 29, 2014
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Weight
Expected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data
12 months after enrollment
Secondary Outcomes (1)
Change in Weight
24 months after enrollment
Study Arms (3)
ASPIRE-Phone Lifestyle Coaching
EXPERIMENTALPhone-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).
ASPIRE-Group Lifestyle Coaching
EXPERIMENTALOn-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).
MOVE! Usual Care
ACTIVE COMPARATORUsual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Current patient at Ann Arbor or Cleveland medical center.
- Current provider- or self-referral to MOVE! program and eligible to participate in MOVE!
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105, United States
VA Medical Center, Cleveland
Cleveland, Ohio, 44106, United States
Related Publications (6)
Lutes LD, Dinatale E, Goodrich DE, Ronis DL, Gillon L, Kirsh S, Richardson CR, Damschroder LJ. A randomized trial of a small changes approach for weight loss in veterans: design, rationale, and baseline characteristics of the ASPIRE-VA trial. Contemp Clin Trials. 2013 Jan;34(1):161-72. doi: 10.1016/j.cct.2012.09.007. Epub 2012 Oct 4.
PMID: 23041618RESULTDamschroder LJ, Lutes LD, Kirsh S, Kim HM, Gillon L, Holleman RG, Goodrich DE, Lowery JC, Richardson CR. Small-changes obesity treatment among veterans: 12-month outcomes. Am J Prev Med. 2014 Nov;47(5):541-53. doi: 10.1016/j.amepre.2014.06.016. Epub 2014 Sep 10.
PMID: 25217098RESULTJanney CA, Masheb RM, Lutes LD, Holleman RG, Kim HM, Gillon LR, Damschroder LJ, Richardson CR. Mental health and behavioral weight loss: 24-month outcomes in Veterans. J Affect Disord. 2017 Jun;215:197-204. doi: 10.1016/j.jad.2017.03.003. Epub 2017 Mar 11.
PMID: 28340446DERIVEDDamschroder LJ, Goodrich DE, Kim HM, Holleman R, Gillon L, Kirsh S, Richardson CR, Lutes LD. Development and validation of the ASPIRE-VA coaching fidelity checklist (ACFC): a tool to help ensure delivery of high-quality weight management interventions. Transl Behav Med. 2016 Sep;6(3):369-85. doi: 10.1007/s13142-015-0336-x.
PMID: 27528526DERIVEDVimalananda V, Damschroder L, Janney CA, Goodrich D, Kim HM, Holleman R, Gillon L, Lutes L. Weight loss among women and men in the ASPIRE-VA behavioral weight loss intervention trial. Obesity (Silver Spring). 2016 Sep;24(9):1884-91. doi: 10.1002/oby.21574. Epub 2016 Aug 4.
PMID: 27488278DERIVEDMasheb RM, Lutes LD, Kim HM, Holleman RG, Goodrich DE, Janney CA, Kirsh S, Higgins DM, Richardson CR, Damschroder LJ. Weight loss outcomes in patients with pain. Obesity (Silver Spring). 2015 Sep;23(9):1778-84. doi: 10.1002/oby.21160. Epub 2015 Aug 3.
PMID: 26237112DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laura Damschroder
- Organization
- VA Center for Clinical Management Research
Study Officials
- PRINCIPAL INVESTIGATOR
Julie C Lowery, PhD MHSA
VA Ann Arbor Healthcare System, Ann Arbor, MI
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2009
First Posted
August 28, 2009
Study Start
January 1, 2010
Primary Completion
October 1, 2012
Study Completion
December 1, 2013
Last Updated
April 24, 2015
Results First Posted
August 29, 2014
Record last verified: 2014-02