Design, Implementation, and Examination of a Remote Patient Monitoring System for Pediatric Obesity: Protocol for an Open Trial Pilot Study

Abstract

Background Pediatric obesity is a critical public health issue. Augmenting care in multidisciplinary pediatric obesity clinics with innovative evidence-based technology to improve weight status and health outcomes is needed. Objective This study describes the design and methods of an open trial pilot study to examine a remote patient monitoring system (RPMS) for children aged 8-17 years who are 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 3 months. The RPMS consists of a tablet, weight scale, and pedometer. The system provides daily educational content and involves the use of the pedometer and weekly weigh-ins. Children and parents will complete baseline, posttreatment (month 3), and follow-up assessments (month 6). The primary aim of the study is to examine feasibility and satisfaction with the RPMS and assess its initial effectiveness. Results We hypothesize high feasibility and satisfaction, with rates over 75%. Furthermore, after RPMS treatment, children will exhibit improved weight status, health outcomes, dietary intake, physical activity, health-related quality of life, self-efficacy, and home-food environment compared to before treatment. 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 an RPMS in a pediatric obesity clinic. If the RPMS is feasible, effective, and easily accessible, it may prove to be a practical, acceptable, and cost-effective weight management treatment for youth seeking treatment for severe obesity. Trial Registration ClinicalTrials.gov NCT04029597; https://clinicaltrials.gov/ct2/show/NCT04029597 International Registered Report Identifier (IRRID) DERR1-10.2196/29858

Usability and Satisfaction Outcomes from a Pilot Open Trial Examining Remote Patient Monitoring to Treat Pediatric Obesity during the COVID-19 Pandemic

“…The initial effectiveness of the RPMS was also explored. There is a lack of accessible treatments that address severe pediatric obesity for youth from rural and underserved areas [5]. Bariatric surgery is effective [27,28], but in the clinic where the study was conducted, it was not available when the RPMS was developed.…”

“…The study is registered at ClinicalTrials.gov (Identifier: NCT04029597) and was approved by the University of Mississippi Medical Center (UMMC) Institutional Review Board (IRB) (Study #2017-0083). Detailed design and methods have been previously reported [5]. In summary, we utilized an open trial pilot design.…”

“…The RPMS was developed in consultation with the UMMC Center of Telehealth and based on a group-based behavioral family weight management intervention previously implemented in the pediatric weight management clinic. Details of the RPMS are reported elsewhere [5]. In summary, the RPMS developed and examined in this study consisted of a tablet device, scale to measure weight, and pedometer to assess physical activity.…”

“…Pediatric obesity is a burden on health care systems [3]; for example, it is estimated to account for over USD 14 billion a year in health care costs [4]. There is a need for treatments focused on pediatric obesity in order to reduce the development of comorbidities and lower health care costs [5].…”

“…Patients living in Mississippi also experience numerous health disparities, including pediatric obesity prevalence rates that are the highest in the country [11]. Thus, there is a significant need to develop and evaluate technology-based interventions that have the potential to reduce health disparities and improve weight status in youth living in Mississippi [5].…”