Remote Patient Monitoring in Pediatric Obesity
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The goal of this study is to examine the feasibility and efficacy of a remote patient
      monitoring system for children who are obese.
    

Detailed description: 
      Pediatric obesity is a critical public health issue, as almost one-third of U.S. youth are
      overweight and about 17% are obese. Childhood obesity is associated with numerous co-morbid
      health conditions and psychological maladjustment and medical costs associated with treatment
      are staggering. Mississippi has the highest rates of overweight and obesity in youth 2 to 19
      years of age (over 44%). There is an important need for research to focus on treatments that
      prevent the development of chronic medical conditions in children at risk, specifically those
      who are obese and receiving specialty care to reduce morbidity and mortality.

      Standard care in multidisciplinary pediatric obesity clinics results in improved weight
      status in some youth. Remote patient monitoring system (RPMS) technology facilitates patient
      observations outside of clinical settings; thus, increasing access to medical information and
      medical care, and reducing health care costs. Use of RPMS in adult chronic illness
      populations has resulted in improved health outcomes but the implementation and examination
      of RPMS in pediatric populations has been limited. Mississippi is a rural state, which limits
      access to medical care in pediatric specialty clinics. The implementation of novel,
      technology-based strategies is needed to supplement current care to prevent long-term
      morbidity and reduce health care costs. There is a significant need to examine whether a RPMS
      is feasible and efficacious in a pilot sample of youth who are obese, which will provide
      support for larger external grant applications further evaluating the RPMS, as well as to
      inform clinical care in Mississippi and across the country.

      Purpose The main objective of this study is to pilot test a RPMS designed to provide
      supplemental health care to youth who are obese and receiving specialty medical care in a
      multidisciplinary pediatric obesity clinic. An open trial of the RPMS will enroll 50 children
      8 to 17 years of age who are obese and attending a multidisciplinary pediatric obesity clinic
      and their parents. During the study, participating youth will receive standard care in the
      clinic and the RPMS, which will consist of an iPad, weight scale, and pedometer, to use for a
      3-month period. The initial feasibility of providing the RPMS in combination with standard
      clinical care will be evaluated, as well as patient satisfaction. The initial efficacy of the
      RPMS at improving health related outcomes will also be examined. Families will complete
      pre-treatment (baseline), post-treatment (Month 3), and three month follow-up (Month 6)
      assessments consisting of weight status, dietary intake, physical activity, health-related
      quality of life, self-efficacy, and the home-food environment. Health outcomes (e.g., blood
      pressure, hemoglobin A1c, glucose) routinely assessed through standard medical care in the
      clinic will be obtained from child medical charts.

      Specific Aims

      The goals of the current study are to:

        -  Assess initial feasibility and satisfaction of implementing a RPMS with children
           attending a multidisciplinary pediatric obesity clinic.

           o Hypothesis: High feasibility is expected with use of the RPMS and satisfaction rates
           over 75%.

        -  Examine initial efficacy of using the RPMS for three months in youth attending a
           multidisciplinary pediatric obesity clinic (N = 50).

             -  Hypothesis 1.1: After the 3-month period and at follow-up, 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.

             -  Hypothesis 1.2: Parents will report improved child health-related quality of life
                and home-food environment after the 3-month treatment and follow-up period compared
                to pre-treatment.
    

Intervention name(s): Remote Patient Monitoring
Intervention type(s): Behavioral
Intervention description(s): Families participating in the study will receive standard medical care as well as the RPMS. The RPMS was developed in collaboration with the University of Mississippi Medical Center (UMMC) Center of Telehealth. Patients enrolled in this open trial of the RPMS will interact with the RPMS system on a daily basis and with UMMC's Center for Telehealth nurse care coordinators and research and clinical staff on an as needed basis. The RPMS will provide patients with include an electronic tablet (i.e., iPad) and the ability to receive data from the patient's 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 and healthy eating and engagement in physical activity will be presented daily through brief presentations and video clips.
Intervention model: Single Group Assignment
Intervention model description: open trial
Masking: None (Open Label)
Primary purpose: Treatment