Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Remote Patient Monitoring in Pediatric Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04029597
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
University of Mississippi Medical Center

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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: Remote Patient Monitoring Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examining the Use of a Remote Patient Monitoring System in Pediatric Obesity
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: Remote Patient Monitoring
Families participating in the study will receive standard medical care as well as the Remote Patient Monitoring System.
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.




Primary Outcome Measures :
  1. Feasibility of using the RPMS [ Time Frame: Post-Treatment (3 months) ]
    percent of queries answered and percent of health data collected from the RPMS via the weight scale and pedometer

  2. Satisfaction with using the RPMS [ Time Frame: Post-Treatment (3 months) ]
    ratings from child and parent satisfaction questionnaire developed for use in the study


Secondary Outcome Measures :
  1. Weight Status [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    BMI z-score change

  2. Blood Pressure [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    Systolic and Diastolic clinic assessed

  3. Glucose [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    clinic assessed

  4. A1c [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    clinic assessed

  5. Dietary Intake [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    24 hour dietary recall

  6. Physical Activity [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    actigraph assessed

  7. Health-related Quality of Life [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    child and parent report from PedsQL

  8. Self-efficacy [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    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

  9. Home food environment [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    Parent-report



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029597


Contacts
Layout table for location contacts
Contact: Crystal S Lim, PhD 601-984-6925 cstacklim@umc.edu

Locations
Layout table for location information
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Crystal S. Lim, Ph.D.    601-815-1021      
Contact    601-984-5839      
Sponsors and Collaborators
University of Mississippi Medical Center
Health Resources and Services Administration (HRSA)
Investigators
Layout table for investigator information
Principal Investigator: Crystal Lim, PhD UMMC

Layout table for additonal information
Responsible Party: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT04029597     History of Changes
Other Study ID Numbers: 2017-0083
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms