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

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912183
• Other study ID #: CEH - 126534
• Status: Completed
• Phase: N/A
• First received: July 26, 2013
• Last updated: April 6, 2015
• Start date: July 2014
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Behavioral:
• Communication through PHR outside clinic

• Monitoring device in PHR

Device:
• Physical activity and sleep monitor

Other:
• PHR
Access to their PHR

Locations

Country	Name	City	State
Canada	Pediatric Weight Management Clinic - McMaster Children's Hospital	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR), McMaster Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months	No
Secondary	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.	2 and 4 months	No
Secondary	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.	4 months	No
Secondary	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.	4 months	No
Secondary	Health education	The Health Education Impact Questionnaire (heIQ) will be administered to evaluate the impact of the health education intervention.	4 months	No