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

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Communication through PHR outside clinic
Monitoring device in PHR
Physical activity and sleep monitor
PHR
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring pediatric obesity, e-learning, personal health record, personal electronic device, pilot

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pediatric Weight Management Clinic - McMaster Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Monitoring device in PHR

Communication through PHR outside clinic

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Feasibility
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
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
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
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
The Health Education Impact Questionnaire (heIQ) will be administered to evaluate the impact of the health education intervention.

Full Information

First Posted
July 26, 2013
Last Updated
April 6, 2015
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), McMaster Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01912183
Brief Title
Family-centred E-health in Pediatric Weight Management: A Pilot Study
Official Title
Family-centred E-health in Pediatric Weight Management: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), McMaster Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
pediatric obesity, e-learning, personal health record, personal electronic device, pilot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monitoring device in PHR
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Communication through PHR outside clinic
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Communication through PHR outside clinic
Other Intervention Name(s)
Communication with clinic staff through PHR
Intervention Type
Behavioral
Intervention Name(s)
Monitoring device in PHR
Intervention Type
Device
Intervention Name(s)
Physical activity and sleep monitor
Intervention Type
Other
Intervention Name(s)
PHR
Intervention Description
Access to their PHR
Primary Outcome Measure Information:
Title
Feasibility
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Acceptability of the personal electronic device and PHR
Description
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.
Time Frame
2 and 4 months
Title
Acceptability of goal monitoring
Description
Acceptability of the method of monitoring goal achievement to the clinic staff will be evaluated by questionnaire at the end of the study.
Time Frame
4 months
Title
Feasibility of the utilization of the PHR and personal electronic device
Description
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.
Time Frame
4 months
Title
Health education
Description
The Health Education Impact Questionnaire (heIQ) will be administered to evaluate the impact of the health education intervention.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Morrison, MD, FRCPC
Organizational Affiliation
McMaster University/McMaster Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Weight Management Clinic - McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada

12. IPD Sharing Statement

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

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