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Remote Patient Monitoring in Pediatric Obesity

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Patient Monitoring
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity

Eligibility Criteria

8 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Remote Patient Monitoring

Arm Description

Families participating in the study will receive standard medical care as well as the Remote Patient Monitoring System.

Outcomes

Primary Outcome Measures

Feasibility of using the RPMS
percent of queries answered and percent of health data collected from the RPMS via the weight scale and pedometer
Satisfaction with using the RPMS
ratings from child and parent satisfaction questionnaire developed for use in the study

Secondary Outcome Measures

Weight Status
BMI z-score change
Blood Pressure
Systolic and Diastolic clinic assessed
Glucose
clinic assessed
A1c
clinic assessed
Dietary Intake
24 hour dietary recall
Physical Activity
actigraph assessed
Health-related Quality of Life
child and parent report from PedsQL
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
Home food environment
Parent-report

Full Information

First Posted
July 12, 2019
Last Updated
March 13, 2023
Sponsor
University of Mississippi Medical Center
Collaborators
Health Resources and Services Administration (HRSA)
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1. Study Identification

Unique Protocol Identification Number
NCT04029597
Brief Title
Remote Patient Monitoring in Pediatric Obesity
Official Title
Examining the Use of a Remote Patient Monitoring System in Pediatric Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Mississippi Medical Center
Collaborators
Health Resources and Services Administration (HRSA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote Patient Monitoring
Arm Type
Experimental
Arm Description
Families participating in the study will receive standard medical care as well as the Remote Patient Monitoring System.
Intervention Type
Behavioral
Intervention Name(s)
Remote Patient Monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of using the RPMS
Description
percent of queries answered and percent of health data collected from the RPMS via the weight scale and pedometer
Time Frame
Post-Treatment (3 months)
Title
Satisfaction with using the RPMS
Description
ratings from child and parent satisfaction questionnaire developed for use in the study
Time Frame
Post-Treatment (3 months)
Secondary Outcome Measure Information:
Title
Weight Status
Description
BMI z-score change
Time Frame
Post-Treatment (3 months) and Follow-up (6 months)
Title
Blood Pressure
Description
Systolic and Diastolic clinic assessed
Time Frame
Post-Treatment (3 months) and Follow-up (6 months)
Title
Glucose
Description
clinic assessed
Time Frame
Post-Treatment (3 months) and Follow-up (6 months)
Title
A1c
Description
clinic assessed
Time Frame
Post-Treatment (3 months) and Follow-up (6 months)
Title
Dietary Intake
Description
24 hour dietary recall
Time Frame
Post-Treatment (3 months) and Follow-up (6 months)
Title
Physical Activity
Description
actigraph assessed
Time Frame
Post-Treatment (3 months) and Follow-up (6 months)
Title
Health-related Quality of Life
Description
child and parent report from PedsQL
Time Frame
Post-Treatment (3 months) and Follow-up (6 months)
Title
Self-efficacy
Description
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
Time Frame
Post-Treatment (3 months) and Follow-up (6 months)
Title
Home food environment
Description
Parent-report
Time Frame
Post-Treatment (3 months) and Follow-up (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crystal Lim, PhD
Organizational Affiliation
UMMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34319245
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.
Results Reference
derived

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Remote Patient Monitoring in Pediatric Obesity

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