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

NCT01912183 | Completed

• 1 other identifier: CEH - 126534
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

pediatric obesity; e-learning; personal health record; personal electronic device; pilot

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Acceptability of the personal electronic device and PHR

  2 and 4 months

• Acceptability of goal monitoring

  4 months

• Feasibility of the utilization of the PHR and personal electronic device

  4 months

• Health education

  4 months

Study Arms (2)

Monitoring device in PHR

ACTIVE COMPARATOR

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

Communication through PHR outside clinic

EXPERIMENTAL

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; Device: Physical activity and sleep monitor; Other: PHR

Interventions

Communication through PHR outside clinic BEHAVIORAL

Also known as: Communication with clinic staff through PHR

Communication through PHR outside clinic

Monitoring device in PHR BEHAVIORAL

Monitoring device in PHR

Physical activity and sleep monitor DEVICE

Communication through PHR outside clinic; Monitoring device in PHR

PHR OTHER

Access to their PHR

Communication through PHR outside clinic; Monitoring device in PHR

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• no access to internet/home computer

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• McMaster Children's Hospital: collaborator

Study Sites (1)

Pediatric Weight Management Clinic - McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Katherine Morrison, MD, FRCPC

  McMaster University/McMaster Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Pediatrics

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: July 31, 2013
• Study Start: July 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

CA (1)