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mActive: a randomized clinical trial of an automated mHealth intervention for physical activity promotion
Martin SS, Feldman DI, Blumenthal RS, Jones SR, Post WS, McKibben RA, Michos ED, Ndumele CE, Ratchford EV, Coresh J, Blaha MJ
Journal of the American Heart Association 2015 Oct 29;4(11):e002239
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: We hypothesized that a fully automated mobile health (mHealth) intervention with tracking and texting components would increase physical activity. METHODS AND RESULTS: mActive enrolled smartphone users aged 18 to 69 years at an ambulatory cardiology center in Baltimore, Maryland. We used sequential randomization to evaluate the intervention's 2 core components. After establishing baseline activity during a blinded run-in (week 1), in phase I (weeks 2 to 3), we randomized 2:1 to unblinded versus blinded tracking. Unblinding allowed continuous access to activity data through a smartphone interface. In phase II (weeks 4 to 5), we randomized unblinded participants 1:1 to smart texts versus no texts. Smart texts provided smartphone-delivered coaching 3 times/day aimed at individual encouragement and fostering feedback loops by a fully automated, physician-written, theory-based algorithm using realtime activity data and 16 personal factors with a 10,000 steps/day goal. Forty-eight outpatients (46% women, 21% nonwhite) enrolled with a mean +/- SD age of 58 +/- 8 years, body mass index of 31 +/- 6 kg/m2, and baseline activity of 9,670 +/- 4,350 steps/day. Daily activity data capture was 97.4%. The phase I change in activity was nonsignificantly higher in unblinded participants versus blinded controls by 1,024 daily steps (95% confidence interval (CI) -580 to 2,628; p = 0.21). In phase II, participants receiving texts increased their daily steps over those not receiving texts by 2,534 (95% CI 1,318 to 3,750; p < 0.001) and over blinded controls by 3,376 (95% CI 1,951 to 4,801; p < 0.001). CONCLUSIONS: An automated tracking-texting intervention increased physical activity with, but not without, the texting component. These results support new mHealth tracking technologies as facilitators in need of behavior change drivers. CLINICAL TRIAL REGISTRATION: URL http://ClinicalTrials.gov/. Unique identifier NCT01917812.

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