• Lorraine R Buis, Felicia A McCant, Jennifer M Gierisch, Lori A Bastian, Eugene Z Oddone, Caroline R Richardson, Hyungjin Myra Kim, Richard Evans, Gwendolyn Hooks, Reema Kadri, Courtney White-Clark, and Laura J Damschroder.
• Department of Family Medicine, University of Michigan, Ann Arbor, MI, United States.
• JMIR Res Protoc. 2019 Jan 29; 8 (1): e12526.

BackgroundAlthough maintaining a healthy weight and physical conditioning are requirements of active military duty, many US veterans rapidly gain weight and lose conditioning when they separate from active-duty service. Mobile health (mHealth) interventions that incorporate wearables for activity monitoring have become common, but it is unclear how to optimize engagement over time. Personalized health coaching, either through tailored automated messaging or by individual health coaches, has the potential to increase the efficacy of mHealth programs. In an attempt to preserve conditioning and ward off weight gain, we developed Stay Strong, a mobile app that is tailored to veterans of recent conflicts and tracks physical activity monitored by Fitbit Charge 2 devices and weight measured on a Bluetooth-enabled scale.ObjectiveThe goal of this study is to determine the effect of activity monitoring plus health coaching compared with activity monitoring alone.MethodsIn this randomized controlled trial, with Stay Strong, a mobile app designed specifically for veterans, we plan to enroll 350 veterans to engage in an mHealth lifestyle intervention that combines the use of a wearable physical activity tracker and a Bluetooth-enabled weight scale. The Stay Strong app displays physical activity and weight data trends over time. Enrolled participants are randomized to receive the Stay Strong app (active comparator arm) or Stay Strong + Coaching, an enhanced version of the program that adds coaching features (automated tailored messaging with weekly physical activity goals and up to 3 telephone calls with a health coach-intervention arm) for 1 year. Our primary outcome is change in physical activity at 12 months, with weight, pain, patient activation, and depression serving as secondary outcome measures. All processes related to recruitment, eligibility screening, informed consent, Health Insurance Portability and Accountability Act authorization, baseline assessment, randomization, the bulk of intervention delivery, and outcome assessment will be accomplished via the internet or smartphone app.ResultsThe study recruitment began in September 2017, and data collection is expected to conclude in 2019. A total of 465 participants consented to participate and 357 (357/465, 77%) provided baseline levels of physical activity and were randomized to 1 of the 2 interventions.ConclusionsThis novel randomized controlled trial will provide much-needed findings about whether the addition of telephone-based human coaching and other automated supportive-coaching features will improve physical activity compared with using a smartphone app linked to a wearable device alone.Trial RegistrationClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293 (Archived by WebCite at http://www.webcitation.org/75KQeIFwh).International Registered Report Identifier (Irrid)DERR1-10.2196/12526.©Lorraine R Buis, Felicia A McCant, Jennifer M Gierisch, Lori A Bastian, Eugene Z Oddone, Caroline R Richardson, Hyungjin Myra Kim, Richard Evans, Gwendolyn Hooks, Reema Kadri, Courtney White-Clark, Laura J Damschroder. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.01.2019.

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