Family-centred E-health in Pediatric Weight Management: A Pilot Study
|ClinicalTrials.gov Identifier: NCT01912183|
Recruitment Status : Completed
First Posted : July 31, 2013
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Obesity||Behavioral: Communication through PHR outside clinic Behavioral: Monitoring device in PHR Device: Physical activity and sleep monitor Other: PHR||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Family-centred E-health in Pediatric Weight Management: A Pilot Study|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Active Comparator: 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.
Behavioral: Monitoring device in PHR
Device: Physical activity and sleep monitor
Access to their PHR
Experimental: 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).
Behavioral: Communication through PHR outside clinic
Other Name: Communication with clinic staff through PHRDevice: Physical activity and sleep monitor Other: PHR
Access to their PHR
- Feasibility [ Time Frame: 4 months ]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.
- Acceptability of the personal electronic device and PHR [ Time Frame: 2 and 4 months ]
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 [ Time Frame: 4 months ]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 [ Time Frame: 4 months ]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 [ Time Frame: 4 months ]The Health Education Impact Questionnaire (heIQ) will be administered to evaluate the impact of the health education intervention.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912183
|Pediatric Weight Management Clinic - McMaster Children's Hospital|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator:||Katherine Morrison, MD, FRCPC||McMaster University/McMaster Children's Hospital|