Rationale and design of the STAR randomized controlled trial to accelerate adoption of childhood obesity comparative effectiveness research

Abstract

Background: Comparative effectiveness research (CER) evidence on childhood obesity provides the basis for effective screening and management strategies in pediatric primary care. The uses of health information technology including decision support tools in the electronic health records (EHRs), as well as remote and mobile support to families, offer the potential to accelerate the adoption of childhood obesity CER evidence.

Methods/design: The Study of Technology to Accelerate Research (STAR) is a three-arm, cluster-randomized controlled trial being conducted in 14 pediatric offices in Massachusetts designed to enroll 800, 6 to 12 year old children with a body mass index (BMI)≥ 95th percentile seen in primary care at those practices. We will examine the extent to which computerized decision support tools in the EHR delivered to primary care providers at the point of care, with or without direct-to-parent support and coaching, will increase adoption of CER evidence for management of obese children. Direct-to-parent intervention components include telephone coaching and twice-weekly text messages. Point-of-care outcomes include obesity diagnosis, nutrition and physical activity counseling, and referral to weight management. One-year child-level outcomes include changes in BMI and improvements in diet, physical activity, screen time, and sleep behaviors, as well as cost and cost-effectiveness.

Conclusions: STAR will determine the extent to which decision support tools in EHRs with or without direct-to-parent support will increase adoption of evidence-based obesity management strategies in pediatric practice and improve childhood obesity-related outcomes.

Trial registration: ClinicalTrials.gov NCT01537510.