This repository contains code and documentation to reproduce the results of the publication, “Understanding the Effect of Adding Automated and Human Coaching to an mHealth Physical Activity App for Afghanistan and Iraq Veterans: Results of a Randomized Controlled Trial of the Stay Strong Intervention”
Authored by the following,
Laura J. Damschroder , MPH, MSc7 Lorraine R. Buis, PhD1 Felicia A. McCant, MSSW2 H. Myra Kim, ScD7 Richard Evans, MS7 Eugene Z. Oddone, MD, MHSc2,4 Lori A. Bastian, MD, MPH5,6 Gwen Hooks, MA7 Reema Kadri, MLIS1 Courtney White-Clark, MS2 Caroline R. Richardson, MD1 Jennifer M. Gierisch, PhD, MPH2,3,4
1University of Michigan, Department of Family Medicine, Ann Arbor, MI 48104
2Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Health Care System, Durham, NC, USA
3Department of Population Health Sciences, Duke University Medical Center, Durham, NC, USA
4Division of General Internal Medicine, Department of Medicine, Duke University Medical Center, Durham, NC, USA
5Division of General Internal Medicine, Department of Medicine, Yale University, New Haven, CT
6Pain Research, Informatics, Multimorbidities, and Education Center, VA Connecticut, West Haven, CT
7VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA
Background
Maintaining physical conditioning and a healthy weight are requirements of active military duty but many U.S. veterans lose conditioning and rapidly gain weight after they separate from active duty service. Mobile health (mHealth) interventions using wearable devices that track physical activity are common but most published trials report shorter-term outcomes and engagement often declines and it is unclear how to optimize engagement over time. Personalized health coaching approaches, through tailored automated messaging or by human coaches, has potential for increasing engagement and effectiveness of mHealth interventions. The Stay Strong Program, an mHealth intervention that is tailored for U.S. veterans of recent conflicts, tracked physical activity via Fitbit Charge 2 devices and weight via Bluetooth-enabled scale and provided a smartphone-based dashboard displaying physical activity and weight data trends over time.
Objectives
The goal of this study was to compare the effect of Stay Strong with the addition of automated and human-delivered health coaching versus Stay Strong alone, focusing on longer term physical activity levels and weight change among U.S. veterans of recent conflicts.
Methods
A comparative effectiveness randomized controlled trial to compare two active interventions to improve physical activity. Physical activity data were collected by a Fitibit Charge 2 device, and additional self-reported data were collected at baseline, six-months and twelve months post-baseline. Participants were recruited based on a U.S. national random sample of veterans of recent conflicts and were randomly assigned to Stay Strong + Coaching (N=178; intervention arm; automated tailored messaging with weekly physical activity goal plus up to three telephone calls with a health coach) or the Stay Strong app alone (N=179; smart phone app for self-monitoring of physical activity and weight); both programs lasted 12 months. Recruitment, eligibility screening, informed consent, HIPAA authorization, baseline assessment, randomization, intervention delivery (except for telephone-based health coaching) were all accomplished online or via smartphone app. The primary outcome was change in physical activity 12 months post-baseline as measured by Active Minutes (minutes of moderate/vigorous activity in bouts lasting at least 10 minutes); secondary outcomes were changes in weight and patient activation.
Results
Participants assigned to Stay Strong alone recorded 190 (IQR:83-354) Active Minutes in their baseline week and those assigned to Stay Strong+Coaching recorded 165 (IQR:75-328) Active Minutes. There were no differences between arms in changes in physical activity levels from baseline to 12 months post-baseline (P=.40). Both groups recorded 3.04? fewer Active Minutes per week at 12 months, which was significantly lower compared to baseline (P<.001). However, 59% (n=120) of participants randomized to Stay Strong and 62% (n=110) randomized to Stay Strong+Coaching failed to sync their Fitbit device at 12-months and were thus lost to follow-up.
Conclusions
This comparative effectiveness randomized controlled trial found that phone-based health coaching plus automated weekly personalized goal messages with personalized and standard motivational messaging via smartphone app did not improve levels of physical activity compared to using a smartphone app (Stay Strong) with Fitbit physical activity device alone among US veterans of recent conflicts. This trial relied on online/smartphone interactions without human interaction other than responding to technology issues over the phone as needed. Long-term engagement in mHealth interventions without human contact is challenging; nearly two-thirds of the trial’s 357 participants failed to sync their Fitbit device at 12-months and thus were lost to follow-up.
Trial Registration: clinicaltrials.gov identifier: NCT02360293
Complete analyses can be found at the project bookdown website(requires google login).