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A randomized trial of a small changes approach for weight loss in veterans: design, rationale, and baseline characteristics of the ASPIRE-VA trial.

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. Contemporary clinical trials. 2013 Jan 1; 34(1):161-72.

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BACKGROUND: Overweight/obesity rates among veterans are higher than the national average. While weight management treatment has been implemented in the Veterans Health Administration (VHA), program data shows low enrollment, participation, and weight loss. This paper presents the design, rationale and baseline characteristics of a multisite, multi-modality, randomized clinical trial assessing an innovative Small Changes (SC) approach on weight loss compared to the current weight management program in the VHA. METHOD: Overweight/obese veterans were recruited from two VHA medical centers. Participants were randomized to either: 1) sc group, 2) SC phone, or 3) usual care. Participants in the SC arms met with health coaches weekly in months 1-3, bi-weekly in months 4-9, and monthly in months 10-12. Usual care participants met weekly for 12 weeks with limited options for follow-up care. The primary outcome is weight at 12 months. Secondary outcomes include physiological, behavioral, psychosocial outcomes along with participation and adherence. RESULTS: Participants include 481 veterans who are middle-aged (M = 55.45, SD = 10.00), obese (BMI = 36.45, SD = 6.24), relatively sedentary (M = 4721 steps per day; SD = 3115), disabled (52%), men (85%) with a large minority of non-white race/ethnicity (43%) and high prevalence of physical co-morbidities (83%) (Charlson Co-morbidity Index M = 1.27, SD = 1.75) and mental health disorders (57%) at baseline. CONCLUSION: The present study seeks to determine if an SC approach, delivered either via phone or in-person, will result in greater weight loss and program participation and adherence at 12 months compared to usual care.

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