NCT04029597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

2.3 years

First QC Date

July 12, 2019

Last Update Submit

March 13, 2023

Conditions

Pediatric Obesity

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Satisfaction with using the RPMS

    ratings from child and parent satisfaction questionnaire developed for use in the study

    Post-Treatment (3 months)

Secondary Outcomes (9)

  • Weight Status

    Post-Treatment (3 months) and Follow-up (6 months)

  • Blood Pressure

    Post-Treatment (3 months) and Follow-up (6 months)

  • Glucose

    Post-Treatment (3 months) and Follow-up (6 months)

  • A1c

    Post-Treatment (3 months) and Follow-up (6 months)

  • Dietary Intake

    Post-Treatment (3 months) and Follow-up (6 months)

  • +4 more secondary outcomes

Study Arms (1)

Remote Patient Monitoring

EXPERIMENTAL

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

Behavioral: Remote Patient Monitoring

Interventions

Remote Patient MonitoringBEHAVIORAL

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.

Remote Patient Monitoring

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (1)

  • 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.

    PMID: 34319245DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Crystal Lim, PhD

    UMMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 23, 2019

Study Start

July 1, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2022

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations

US(1)