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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

Tracking Information
First Submitted Date  ICMJE July 12, 2019
First Posted Date  ICMJE July 23, 2019
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • 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
  • Satisfaction with using the RPMS [ Time Frame: Post-Treatment (3 months) ]
    ratings from child and parent satisfaction questionnaire developed for use in the study
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Weight Status [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    BMI z-score change
  • Blood Pressure [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    Systolic and Diastolic clinic assessed
  • Glucose [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    clinic assessed
  • A1c [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    clinic assessed
  • Dietary Intake [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    24 hour dietary recall
  • Physical Activity [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    actigraph assessed
  • Health-related Quality of Life [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    child and parent report from PedsQL
  • 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
  • Home food environment [ Time Frame: Post-Treatment (3 months) and Follow-up (6 months) ]
    Parent-report
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remote Patient Monitoring in Pediatric Obesity
Official Title  ICMJE Examining the Use of a Remote Patient Monitoring System in Pediatric Obesity
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
open trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pediatric Obesity
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Remote Patient Monitoring
Families participating in the study will receive standard medical care as well as the Remote Patient Monitoring System.
Intervention: Behavioral: Remote Patient Monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Crystal S Lim, PhD 601-984-6925 cstacklim@umc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04029597
Other Study ID Numbers  ICMJE 2017-0083
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Mississippi Medical Center
Study Sponsor  ICMJE University of Mississippi Medical Center
Collaborators  ICMJE Health Resources and Services Administration (HRSA)
Investigators  ICMJE
Principal Investigator: Crystal Lim, PhD UMMC
PRS Account University of Mississippi Medical Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP