This study was approved by the institutional review board at the University of Mississippi Medical Center (protocol# 2017-0083) and is registered on ClinicalTrials.gov (protocol# NCT04029597).

The primary objective of this open trial is to pilot test an RPMS designed to provide supplemental health care to youth who are receiving specialty medical care in a multidisciplinary pediatric obesity clinic. Specifically, we will assess initial feasibility and satisfaction and examine initial effectiveness of the RPMS for 3 months. We hypothesize high feasibility with the use of the RPMS and satisfaction rates over 75%, and after treatment children are expected to exhibit improved health outcomes compared to before treatment and their parents are expected to report improvements in their children’s health-related quality of life and home-food environment.

This study will utilize an open trial design to examine the initial feasibility and effectiveness of implementing an RPMS in a pediatric obesity clinic. Participating families will receive standard care and the RPMS. After providing consent and assent, children and parents will complete questionnaires and objective measures as part of the pretreatment assessment. After using the RPMS for 3 months, families will complete the posttreatment assessment during a regularly scheduled follow-up appointment with health care providers at the pediatric weight management clinic. After an additional 3 months, participating families will also complete a follow-up assessment, similar to the pre- and posttreatment assessments, during a regularly scheduled clinic visit.

The study will be conducted at the University of Mississippi Medical Center (UMMC) Pediatric Weight Management Clinic, a multidisciplinary outpatient medical clinic designed to treat children with obesity and related medical comorbidities. The clinic providers include a pediatric nurse practitioner and pediatric dietician who see every patient, as well as a clinical psychologist and mental health specialists who assess and treat patients with suspected mental health concerns. The study is being conducted in partnership with the UMMC Center for Telehealth, who assisted with the development of the RPMS intervention materials and provides oversight regarding RPMS equipment and participants’ use and interaction with the RPMS.

The study will recruit 45 families with a child aged 8-17 years who attends an outpatient pediatric obesity clinic and has a weight status in the obese range (BMI equal to or above the 95th percentile for age and gender), and parents and children who are fluent in English. Exclusion criteria are the following: (1) the child or parent having a history of cognitive impairment (developmental delay or intellectual disability) reported by the parent, which would impact their ability to understand and complete questionnaires or interact with the RPMS; and (2) the child having a medical condition, reported by parents, which may prohibit wearing of the actigraph device (eg, pacemaker).

Potentially eligible participants will be recruited through the pediatric weight management outpatient multidisciplinary clinic. When families present for a scheduled appointment, providers will provide them information about the study and ask if they are interested in knowing more about it. A trained research team member will discuss the study in more detail and obtain child assent, parent permission, and parent consent to participate. The research assistant will then assist the child and parent with the completion of baseline questionnaires and assessments.

The RPMS was developed in collaboration with UMMC Center of Telehealth. Patients enrolled in this open trial of the RPMS will interact with the system on a daily basis and with UMMC Center for Telehealth nurse care coordinators and research and clinical staff on an as-needed basis. The RPMS consists of an electronic tablet, weight scale, and pedometer. Patients will be asked to wear the pedometer daily to track engagement in physical activity and weigh themselves weekly to track weight during the 3-month period. Educational information specific to pediatric obesity–related medical complications and healthy eating and engagement in physical activity will be presented daily through brief presentations and video clips. Educational material and information were developed on the basis of behavioral family weight management treatments for pediatric obesity [19,20] and the social cognitive theory [21]. Daily assessments, which will include questions regarding health status and health behaviors, will be self-reported by the patient through the software program on the electronic tablet. Responses and vital signs and symptoms will be monitored by nurse care coordinators. The program contains a care management platform software that allows for data trends to be developed and analyzed to identify at-risk patients requiring action, such as follow-up phone calls to patients from the nurse coordinator and nurse coordinator informing the research and clinical team about patient symptoms. Solutions discussed and provided by the nurse coordinator and clinical research team may consist of the following: personalized interventions, targeted education, health coaching, behavior modification, medication adherence, and content to motivate patients. All health sessions are designed for patient engagement by providing quality educational content and self-management skills. The UMMC Center for Telehealth RPMS is linked to patients’ electronic medical record (ie, Epic) to facilitate communication between the nurse care coordinators and the medical team at the pediatric obesity. In addition, if patients have questions or need to contact the medical team the nurse care coordinators can facilitate that process, but patients and families are also able to contact (via secure messages, call, etc) the medical team providers, consistent with standard clinic procedures.

Children and parents will complete the following measures and assessments at pretreatment (baseline), posttreatment (month 3), and follow-up (month 6) unless otherwise specified.

To examine aim 1, descriptive statistics (including mean [SD] and percentage values) of engagement with the RPMS will be used to examine feasibility and satisfaction scores on the basis of child and parent reports completed during the posttreatment assessment. To examine aim 2—initial effectiveness of the RPMS—repeated-measures analysis of variance will be conducted to determine whether there are significant differences in outcomes over time. Two-sample t tests will be used to compare differences in outcomes from pre- to posttreatment, pretreatment to follow-up, and posttreatment to follow-up. If necessary (eg, outcome data are skewed), nonparametric tests will be used to compare pretreatment, posttreatment, and follow-up scores. Maximum likelihood techniques will be utilized for missing data to provide unbiased and accurate estimates of variables regardless of the pattern of missing data (ie, random or completely random). Statistical significance will be set at P<.05.