Effect of Adding Telephone-based Brief Coaching to a mHealth App for Promoting Physical Activity Among Veterans: Results from the Stay Strong Randomized Controlled Trial (Preprint)

BACKGROUND Though maintaining physical conditioning and a healthy weight are requirements of active military duty, many U.S. Veterans lose conditioning and rapidly gain weight after discharge from active duty service. Mobile health (mHealth) interventions using wearable devices are appealing to users and can be effective in the shorter term, but adherence to study protocols and subsequent engagement often declines over time. We developed Stay Strong, a mobile app tailored to U.S. Veterans, to promote physical activity using a wrist-worn physical activity tracker, a Bluetooth-enabled scale, and app-based dashboard. We sought to determine whether adding personalized coaching components (Stay Strong+Coaching) would improve physical activity compared to Stay Strong alone. Personalized health coaching has potential to strengthen adherence and engagement with, and outcomes from, mHealth interventions. OBJECTIVE The goal was to compare 12-month outcomes from Stay Strong alone versus Stay Strong+Coaching. METHODS Participants (n=357) were recruited from a national random sample of U.S. Veterans of recent wars and randomly assigned to Stay Strong app alone (n=179) or Stay Strong+Coaching (n=178); both programs lasted 12 months. Personalized coaching components for Stay Strong+Coaching comprised of automated in-app motivational messages (3/week), telephone-based human health coaching (up to 3 calls), and personalized weekly goal-setting. All aspects of enrollment process and program delivery were accomplished virtually for both groups, except for the telephone-based coaching. The primary outcome was change in physical activity at 12 months post-baseline, measured by average weekly Active Minutes, captured by the Fitbit Charge 2 device. Secondary outcomes included changes in step counts, weight, and patient activation. RESULTS Average age of participants was 39.8 (8.7) years and 25.2% were female. Active Minutes decreased from baseline to 12-months for both groups (P<.001) with no between-group differences at 6- (P=.82) or 12-months (P=.98). However, at 12 months, many participants in both groups did not record Active Minutes, leading to missing data in 67.0% for Stay Strong and 61.8% for Stay Strong+Coaching. Average baseline weight for participants in Stay Strong and Stay Strong+Coaching was 214 and 198lbs, respectively, with no difference at baseline (P=.54) nor at 6- (P=.28), or 12-months (P=.18) post-baseline based on administrative weights, which had lower rates of missing data. Changes in number of steps recorded and patient activation also did not differ by arm. CONCLUSIONS Adding personalized health coaching comprised of in-app automated messages, up to 3 coaching calls, plus automated weekly personalized goals did not improve levels of physical activity compared to using a smartphone app alone. Physical activity in both groups decreased over time. Sustaining long-term adherence and engagement in this mHealth intervention proved difficult; approximately two-thirds of the trial's 357 participants failed to sync their Fitbit device at 12-months and thus, were lost to follow-up. CLINICALTRIAL clinicaltrials.gov identifier: NCT02360293. INTERNATIONAL REGISTERED REPORT RR2-10.2196/12526.