Clinical trial NCT01912183: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: pediatric obesity
e-learning
personal health record
personal electronic device
pilot
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: McMaster Children's Hospital
First posted: 2013-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility
timeFrame: 4 months
Secondary outcomes:
measure: Acceptability of the personal electronic device and PHR
timeFrame: 2 and 4 months
measure: Acceptability of goal monitoring
timeFrame: 4 months
measure: Feasibility of the utilization of the PHR and personal electronic device
timeFrame: 4 months
measure: Health education
timeFrame: 4 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Pediatric Weight Management Clinic - McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: McMaster University/McMaster Children's Hospital
name: Katherine Morrison, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: