An open trial pilot study examining a remote patient monitoring system for pediatric obesity: Design and Methods (Preprint)
BACKGROUND Pediatric obesity is a critical public health issue in the US. There is a significant need to augment care in multidisciplinary pediatric obesity clinics with innovative evidence-based technology to improve weight status and health outcomes for children needing specialty pediatric obesity treatment. OBJECTIVE This manuscript describes the design and methods of an open trial pilot study to examine a remote patient monitoring system (RPMS) for children, 8 to 17 years of age, receiving treatment in a multidisciplinary pediatric obesity clinic. METHODS Participants will include 45 youth with obesity and their parents. Families will receive standard care in the clinic and the RPMS for three months. The RPMS consists of a tablet, weight scale, and pedometer. The system provides daily educational content and encourages daily use of the pedometer and weekly weigh-ins. Children and parents will complete baseline, post-treatment (Month 3), and follow-up assessments (Month 6). The main aim of the study is to examine feasibility and satisfaction with the RPMS, as well as assess initial effectiveness. RESULTS We hypothesize high feasibility and satisfaction, with rates over 75% and that after the treatment children will exhibit improved weight status, blood pressure, glucose, A1c, dietary intake, physical activity, health-related quality of life, and self-efficacy compared to pre-treatment and parents will report improved child health-related quality of life and home-food environment. These gains are expected to persist at follow-up. CONCLUSIONS This study is novel in that it is the first to design, implement, and examine a RPMS in a pediatric obesity clinic. If the RPMS is feasible, effective, and easily accessible for diverse and underserved families it may prove to be a practical, acceptable, and cost-effective weight management treatment for youth seeking treatment for severe obesity, which has important implications for the future of pediatric obesity treatments. CLINICALTRIAL Clinicaltrials.gov Identifier: NCT04029597