Clinical trial NCT04029597: Remote Patient Monitoring in Pediatric Obesity
Official title: Examining the Use of a Remote Patient Monitoring System in Pediatric Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2019-07-23
Enrollment: 94
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* child 8 to 17 years of age attending an outpatient pediatric obesity clinic visit,
* child weight status in the obese range (body mass index equal to or above the 95th percentile for age and gender)
* parent and child are fluent in English.

Exclusion Criteria:

* child or parent history of cognitive impairment (developmental delay or intellectual disability) by parent report that would impact ability to understand and complete questionnaires or interact with the RPMS
* child medical condition reported by parents that may prohibit wearing of the actigraph device (e.g., pacemaker).

Primary outcomes:
measure: Feasibility of using the RPMS
timeFrame: Post-Treatment (3 months)
measure: Satisfaction with using the RPMS
timeFrame: Post-Treatment (3 months)
Secondary outcomes:
measure: Weight Status
timeFrame: Post-Treatment (3 months) and Follow-up (6 months)
measure: Blood Pressure
timeFrame: Post-Treatment (3 months) and Follow-up (6 months)
measure: Glucose
timeFrame: Post-Treatment (3 months) and Follow-up (6 months)
measure: A1c
timeFrame: Post-Treatment (3 months) and Follow-up (6 months)
measure: Dietary Intake
timeFrame: Post-Treatment (3 months) and Follow-up (6 months)
measure: Physical Activity
timeFrame: Post-Treatment (3 months) and Follow-up (6 months)
measure: Health-related Quality of Life
timeFrame: Post-Treatment (3 months) and Follow-up (6 months)
measure: Self-efficacy
timeFrame: Post-Treatment (3 months) and Follow-up (6 months)
measure: Home food environment
timeFrame: Post-Treatment (3 months) and Follow-up (6 months)
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: UMMC
name: Crystal Lim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim C, Rutledge L, Sandridge S, King K, Jefferson D, Tucker T. Design, Implementation, and Examination of a Remote Patient Monitoring System for Pediatric Obesity: Protocol for an Open Trial Pilot Study. JMIR Res Protoc. 2021 Jul 28;10(7):e29858. doi: 10.2196/29858.