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Family-centred E-health in Pediatric Weight Management: A Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by McMaster University
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
McMaster Children's Hospital
Information provided by (Responsible Party):
Katherine Morrison, McMaster University
ClinicalTrials.gov Identifier:
NCT01912183
First received: July 26, 2013
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

This is a pilot study to examine the feasibility of implementing an objective physical activity and sleep monitoring tool into a pediatric weight management program in conjunction with a personal health record (PHR) for children and their families. This feasibility study is intended to provide proof of concept in the incorporation of monitoring devices within the PHR for pediatric patients and their families. Additionally, the investigators will examine whether the PHR helps to empower pediatric patients, their families and the health care team to more effectively monitor the patient's behavior change. Participants will be randomized to receive, or not receive, augmented communication with the health care team between clinical in person visits.


Condition Intervention
Pediatric Obesity
Behavioral: Communication through PHR outside clinic
Behavioral: Monitoring device in PHR
Device: Physical activity and sleep monitor
Other: PHR

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family-centred E-health in Pediatric Weight Management: A Pilot Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Feasibility of the use of personal electronic devices for monitoring behavioural change in response to goal setting through a PHR will be evaluated and compared between the two groups by comparing: 1) percent of consenting families who successfully access the PHR, and 2) percent of children/youth who upload physical activity and sleep data for at least 4/7 days and 75% of weeks of the study.


Secondary Outcome Measures:
  • Acceptability of the personal electronic device and PHR [ Time Frame: 2 and 4 months ] [ Designated as safety issue: No ]

    Acceptability of the device to the family unit will be evaluated by collating the: 1) number of days per month the family uploads physical activity or sleep information, 2) number of times the family (in the randomized intervention group)interacts with the clinical team through the PHR and 3) number of times over the 4 month period that the family reviews the e-learning module.

    Acceptability of the device and PHR to the child and parent will be ascertained separately via standardized questionnaire at 2 and 4 months after randomization.


  • Acceptability of goal monitoring [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Acceptability of the method of monitoring goal achievement to the clinic staff will be evaluated by questionnaire at the end of the study.

  • Feasibility of the utilization of the PHR and personal electronic device [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Feasibility of the utilization of the PHR and personal electronic device will be measured by examining the percent of eligible, consecutive clinic patients who agree to take part in the study.

  • Health education [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The Health Education Impact Questionnaire (heIQ) will be administered to evaluate the impact of the health education intervention.


Estimated Enrollment: 60
Study Start Date: July 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Monitoring device in PHR
Both groups will receive routine clinical care in the pediatric weight management program at McMaster Children's Hospital. Children/youth in both groups will receive a physical activity and sleep monitor and access to their PHR. The Active Comparator group will not receive any feedback or communication outside of clinic visits from the clinical team regarding their goal progress.
Behavioral: Monitoring device in PHR Device: Physical activity and sleep monitor Other: PHR
Access to their PHR
Experimental: Communication through PHR outside clinic
Both groups will receive routine clinical care in the pediatric weight management program at McMaster Children's Hospital. Children/youth in both groups will receive a physical activity and sleep monitor and access to their PHR. The experimental group will receive regular communication with /access to the clinical team through a secure portal within the PHR(i.e. 2 way communication, weekly feedback to the families on their goal progress).
Behavioral: Communication through PHR outside clinic
Other Name: Communication with clinic staff through PHR
Device: Physical activity and sleep monitor Other: PHR
Access to their PHR

Detailed Description:

Lifestyle behaviour changes represent the foundation of pediatric weight management and are usually promoted through individual and/or group-based counseling to encourage the adoption and maintenance of health lifestyle behaviours including nutritional intake, sleep and physical activity. Consensus on the need for comprehensive, behavioural interventions exists, but the nature of these interventions vary considerably. The intensity of the intervention (i.e. number of contact hours) may be a key determinant of efficacy, but little detail on the characteristic of these contact hours for optimal delivery is currently available.

In this proof of concept study, we will evaluate the enhancement of behavioural change strategies utilizing technology that provides direct feedback on behaviour change. These devices will be incorporated into a PHR and supplemented with a related e-learning module.

This study will examine the feasibility and perceived usefulness of incorporation of a personal electronic device to encourage behaviour change in children and youth enrolled in a weight management program. We intend to incorporate this device within an established PHR and supplement with evidence-based e-learning.

This is a prospective, randomized pilot study of children and youth (ages 5-17 years) enrolled in a multidisciplinary pediatric weight management program (at McMaster Children's Hospital) for 4 months. This pilot study will include 10 children/youth and parent dyads from each of 3 age groups: 5-9 years, 10-13 years and 14-17 years. All families will utilize a personal electronic device that they can utilize with the individualized PHR. Participants will be randomized to receive, or not receive, regular communication with and access to the clinical team outside of their routine clinical visits, this will occur through a secure portal in the PHR.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children/youth between the ages of 5-17 years
  • enrolled in pediatric weight management program at McMaster Children's Hospital
  • provide informed written assent (child/youth)
  • provision of informed written consent (parent/caregiver)

Exclusion Criteria:

  • no access to internet/home computer
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912183

Contacts
Contact: Elizabeth A Gunn, MSc 905-525-9140 ext 28083 gunne@mcmaster.ca
Contact: Vivian B Vaughn Williams 905-525-9140 ext 21407 vaughn@mcmaster.ca

Locations
Canada, Ontario
Pediatric Weight Management Clinic - McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Elizabeth A Gunn, MSc    905-525-9140 ext 28083    gunne@mcmaster.ca   
Principal Investigator: Katherine Morrison, MD         
Sub-Investigator: Anthony Levinson, MSc, MD         
Sub-Investigator: Gita Wahi, MSc, MD         
Sub-Investigator: Linda Gillis, RD         
Sub-Investigator: David Chan, MSc, MD         
Sub-Investigator: Ofir Turel, PhD         
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
McMaster Children's Hospital
Investigators
Principal Investigator: Katherine Morrison, MD, FRCPC McMaster University/McMaster Children's Hospital
  More Information

No publications provided

Responsible Party: Katherine Morrison, Associate Professor, Department of Pediatrics, McMaster University
ClinicalTrials.gov Identifier: NCT01912183     History of Changes
Other Study ID Numbers: CEH - 126534
Study First Received: July 26, 2013
Last Updated: July 15, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
pediatric obesity
e-learning
personal health record
personal electronic device
pilot

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014