Design and rationale of the STRIVE trial to improve cardiometabolic health among children and families

Abstract

Background Many of the health behaviors known to contribute to cardiometabolic risk and disease (CMRD), including physical activity, diet, sleep, and screen time, begin during childhood. Given the population-wide burden of CMRD, novel ways of assessing risk and providing feedback to support behavior change are needed. Purpose This paper describes the design and rationale for the Study for using Technology to Reach Individual Excellence (STRIVE), a randomized controlled trial testing the use of an integrated, closed-loop feedback system that incorporates longitudinal, patient-generated, mobile health technology (mHealth) data on health behaviors and provides clinical recommendations to help manage CMRD among at-risk families. Methods STRIVE is a 6-month trial among 68 children, ages 6-12 year olds with a body mass index ≥ 85th percentile from Massachusetts with at least one parent with CMRD. Data on several health behaviors will be collected daily over 6 months. Children and parents will each wear wristbands that collect objective physical activity, sleep, and screen time data via accelerometry, noise, and infrared detection. Sugar sweetened beverage consumption will be assessed by self-report via a smartphone application. Weight will be collected using a wireless scale. Intervention group parents receive feedback on their child's health behaviors and personalized CMRD counseling via mobile messaging. Control parents receive standard of care recommendations and weekly health behavior reports for self-guided care. Conclusion The STRIVE trial will test the use of mHealth and closed-loop feedback systems to improve health behaviors among families at-risk for or with established CMRD.