INTRODUCTION: Direct-to-consumer mHealth devices are a potential asset to behavioral research but rarely tested as intervention tools. This trial examined the accelerometer-based Fitbit tracker and website as a low-touch physical activity intervention. The purpose of this study is to evaluate, within an RCT, the feasibility and preliminary efficacy of integrating the Fitbit tracker and website into a physical activity intervention for postmenopausal women. METHODS: Fifty-one inactive, postmenopausal women with BMI > 25.0 were randomized to a 16-week web-based self-monitoring intervention (n = 25) or comparison group (n = 26). The web-based tracking group received a Fitbit, instructional session, and follow-up call at 4 weeks. The comparison group received a standard pedometer. All were asked to perform 150 minutes/week of moderate to vigorous physical activity (MVPA). Physical activity outcomes were measured by the ActiGraph GT3X+ accelerometer. RESULTS: Data were collected and analyzed in 2013 to 2014. Participants were aged 60 (SD 7) years with BMI of 29.2 (3.5) kg/m2. Relative to baseline, the web-based tracking group increased MVPA by 62 (108) minutes/week (p < 0.01); 10-minute MVPA bouts by 38 (83) minutes/week (p = 0.008); and steps by 789 (1,979) (p = 0.01), compared to non-significant increases in the pedometer group (between-group p = 0.11, 0.28, and 0.30, respectively). The web-based tracking group wore the tracker on 95% of intervention days; 96% reported liking the website and 100% liked the tracker. CONCLUSIONS: The Fitbit was well accepted in this sample of women and associated with increased physical activity at 16 weeks. Leveraging direct-to-consumer mHealth technologies aligned with behavior change theories can strengthen physical activity interventions.

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