Short- and Long-term Effects of a Mobile Phone App in Conjunction With Brief In-Person Counseling on Physical Activity Among Physically Inactive Women: The mPED Randomized Clinical Trial.

Importance: Mobile phone applications (apps) and activity trackers allow researchers to remotely deliver an intervention and monitor physical activity but have not been rigorously evaluated for longer periods. Objective: To determine whether a mobile phone-based physical activity education app, in conjunction with brief in-person counseling, increases and then maintains levels of physical activity. Design, Setting, and Participants: In this parallel randomized clinical trial, community-dwelling physically inactive women recruited between May 2011 and April 2014 were randomized in equal proportions into the control (n = 69), regular (n = 71), and plus (n = 70) groups. Data were analyzed using intention to treat from September 16, 2016, through June 30, 2018. Interventions: The regular and plus groups were instructed to use the app on their mobile phone and an accelerometer every day for 3 months and attend brief in-person counseling. During the 6-month maintenance period, the plus group continued to use the app and accelerometer, while the regular group stopped using the app but continued using the accelerometer. The control group used the accelerometer throughout. Main Outcomes and Measures: The primary and secondary outcomes were daily accelerometer-measured total steps and time spent in moderate to vigorous physical activity (MVPA). Results: The 210 participants had a mean (SD) age of 52.4 (11.0) years. At baseline, the mean (SD) daily total steps by accelerometer in the control, regular, and plus groups were 5384 (2920), 5063 (2526), and 5837 (3235), respectively. During the 3-month intervention period, daily steps and MVPA increased in the combined regular and plus groups compared with the control group (between-group differences, 2060 steps per day; 95% CI, 1296-2825 steps per day; P < .001 and 18.2 min/d MVPA; 95% CI, 10.9-25.4 min/d MVPA; P < .001). During the subsequent 6-month maintenance period, mean activity level remained higher in the combined plus and regular groups than among controls (between-group difference, 1360 steps per day; 95% CI, 694-2026 steps per day; P <. 001), but trends in total daily steps and MVPA were similar in the plus and regular groups. Conclusions and Relevance: In this trial, the intervention groups substantially increased their physical activity. However, use of both the app and accelerometer for an additional 6 months after the initial 3-month intervention did not help to maintain increases in physical activity compared with continued use of the accelerometer alone. Trial Registration: ClinicalTrials.gov identifier: NCT01280812.