Remote Patient Monitoring in Pediatric Obesity

Pediatric Obesity Clinical Trial

Official title:

Examining the Use of a Remote Patient Monitoring System in Pediatric Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029597
• Other study ID #: 2017-0083
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2023
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Remote Patient Monitoring
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.

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of using the RPMS	percent of queries answered and percent of health data collected from the RPMS via the weight scale and pedometer	Post-Treatment (3 months)
Primary	Satisfaction with using the RPMS	ratings from child and parent satisfaction questionnaire developed for use in the study	Post-Treatment (3 months)
Secondary	Weight Status	BMI z-score change	Post-Treatment (3 months) and Follow-up (6 months)
Secondary	Blood Pressure	Systolic and Diastolic clinic assessed	Post-Treatment (3 months) and Follow-up (6 months)
Secondary	Glucose	clinic assessed	Post-Treatment (3 months) and Follow-up (6 months)
Secondary	A1c	clinic assessed	Post-Treatment (3 months) and Follow-up (6 months)
Secondary	Dietary Intake	24 hour dietary recall	Post-Treatment (3 months) and Follow-up (6 months)
Secondary	Physical Activity	actigraph assessed	Post-Treatment (3 months) and Follow-up (6 months)
Secondary	Health-related Quality of Life	child and parent report from PedsQL	Post-Treatment (3 months) and Follow-up (6 months)
Secondary	Self-efficacy	Child Report - combined summed total scores from Child Dietary Self-Efficacy Scale and Self-Efficacy for Physical Activity Scale, total scores range from 20-60, higher scores indicate higher self efficacy	Post-Treatment (3 months) and Follow-up (6 months)
Secondary	Home food environment	Parent-report	Post-Treatment (3 months) and Follow-up (6 months)