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

NCT ID: NCT01912183

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-02-28

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.

Conditions

Pediatric Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Monitoring device in PHR

Intervention Type: BEHAVIORAL

Physical activity and sleep monitor

Intervention Type: DEVICE

PHR

Intervention Type: OTHER

Access to their PHR

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).

Group Type: EXPERIMENTAL

Communication through PHR outside clinic

Intervention Type: BEHAVIORAL

Physical activity and sleep monitor

Intervention Type: DEVICE

PHR

Intervention Type: OTHER

Access to their PHR

Interventions

Communication through PHR outside clinic

Intervention Type: BEHAVIORAL

Monitoring device in PHR

Intervention Type: BEHAVIORAL

Physical activity and sleep monitor

Intervention Type: DEVICE

PHR

Access to their PHR

Intervention Type: OTHER

Other Intervention Names

Communication with clinic staff through PHR

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McMaster Children's Hospital

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Katherine Morrison

Associate Professor, Department of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Morrison, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

McMaster University/McMaster Children's Hospital

Locations

Pediatric Weight Management Clinic - McMaster Children's Hospital

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

CEH - 126534

Identifier Type: -

Identifier Source: org_study_id