Pediatric ObesityNCT01912183
Family-centred E-health in Pediatric Weight Management: A Pilot Study
A study testing Communication through PHR outside clinic, Monitoring device in PHR and Physical activity and sleep monitor in people with Pediatric Obesity, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Communication through PHR outside clinic, Monitoring device in PHR and Physical activity and sleep monitor
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- no access to internet/home computer
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pediatric Weight Management Clinic - McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
About this study
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.
Read the 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
- Being tested
- Communication through PHR outside clinic, Monitoring device in PHR, Physical activity and sleep monitor, PHR
- Keywords
- pediatric obesity, e-learning, personal health record, personal electronic device, pilot
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication through PHR outside clinicBehavioural
Also called Communication with clinic staff through PHR
Monitoring device in PHRBehavioural
Physical activity and sleep monitorDevice
PHROther
Access to their PHR
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Communication through PHR outside clinic; Device: Physical activity and sleep monitor; Other: PHR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (4)
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.
Measured: 2 and 4 months
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.
Measured: 4 months
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.
Measured: 4 months
Health education
The Health Education Impact Questionnaire (heIQ) will be administered to evaluate the impact of the health education intervention.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), McMaster Children's Hospital
- Responsible party
- Principal investigator, Katherine Morrison, McMaster University
- Investigators
- Katherine Morrison, MD, FRCPC, Principal investigator, McMaster University/McMaster Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912183
- Sponsor's protocol ID
- CEH - 126534
- Status last verified
- Apr 2015
- First submitted
- 26 Jul 2013
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-centred E-health in Pediatric Weight Management: A Pilot Study
- ClinicalTrials.gov ID
- NCT01912183
- Acronym / sponsor ID
- CEH - 126534
- Conditions
- Pediatric Obesity
- Keywords
- pediatric obesity, e-learning, personal health record, personal electronic device, pilot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), McMaster Children's Hospital
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring device in PHR | Active comparator | Behavioral: Monitoring device in PHR, Device: Physical activity and sleep monitor, Other: PHRBoth 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. |
| Communication through PHR outside clinic | Experimental | Behavioral: Communication through PHR outside clinic, Device: Physical activity and sleep monitor, Other: PHRBoth 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). |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- no access to internet/home computer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication through PHR outside clinicAlso: Communication with clinic staff through PHR | Behavioural | Communication through PHR outside clinic |
| Monitoring device in PHR | Behavioural | Monitoring device in PHR |
| Physical activity and sleep monitor | Device | Communication through PHR outside clinic, Monitoring device in PHR |
| PHRAccess to their PHR | Other | Communication through PHR outside clinic, Monitoring device in PHR |
Primary outcome
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.
4 secondary outcomes
Acceptability of the personal electronic device and PHR
Time frame: 2 and 4 months
Acceptability of goal monitoring
Time frame: 4 months
Feasibility of the utilization of the PHR and personal electronic device
Time frame: 4 months
Health education
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Morrison, MD, FRCPC principal investigator
McMaster University/McMaster Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication through PHR outside clinic, Monitoring device in PHR and Physical activity and sleep monitor in people with Pediatric Obesity, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.