- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01736748
Dynamo: a Tailored Lifestyle Promotion Intervention Among Pediatric Patients With Cardiometabolic Risk Factors (CIRCUIT)
May 20, 2025 updated by: Melanie Henderson, St. Justine's Hospital
Implementing Dynamo: a Tailored Lifestyle Promotion Intervention Among Pediatric Patients With Cardiometabolic Risk Factors
The Dyn@mo lifestyle intervention (CHU Sainte-Justine, Quebec, Canada) targets children and adolescents aged 6 to 17 years old with cardiometabolic risk factors, such as obesity, hypertension, disorders in glucose regulation or dyslipidemia.
Its primary goal is to promote physical activity and reduce sedentary time to improve childrens' cardiometabolic profile.
To do so, the intervention relies on gathering data on mobility and physical activity using wearable sensors.
These data provide a detailed picture of real-life conditions and physical activity levels, improving the health care professional's ability to tailor counseling.
The investigators are presently in the implementation phase of this intervention.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Melanie Henderson
- Phone Number: 514-345-4735
Study Contact Backup
- Name: Tracie A Barnett
- Phone Number: 5461 514-345-4931
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1C5
- Recruiting
- CHU Sainte-Justine
-
Principal Investigator:
- Melanie Henderson
-
Contact:
- Melanie Henderson
- Phone Number: 514-345-4735
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- children ages 6 to 18 years of age with a BMI > 95th percentile for age and sex
Exclusion Criteria:
- children with a physical or psychological condition that would impair their ability to participate in physical activity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sensor based PA intervention
Children will be equipped with a heart rate monitor, a GPS receiver and an accelerometer for collection of heart rate, mobility and physical activity free-living data during a 7-day period.
This will provide a 'spatio-behavioural diagnosis' using a map-based interactive web application.
This data will be used to developed a tailored plan to promote physical activity in the child's every day environment.
|
Children will be equipped with a heart rate monitor, a GPS receiver and an accelerometer for collection of heart rate, mobility and physical activity free-living data during a 7-day period.
This will provide a 'spatio-behavioural diagnosis' using a map-based interactive web application.
This data will be used to developed a tailored plan to promote physical activity in the child's every day environment.
|
|
Other: Traditional PA counseling
In this arm, while children will wear the same sensors as in the intervention arm, the intervention will not rely on data gathered using the wearable sensors.
Rather, a traditional physical activity counseling strategy will be adopted in this control group.
|
Children will be encouraged to enhance their physical activity levels using traditional behavioral approaches.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in physical activity levels
Time Frame: Baseline and 1 year
|
Physical activity will be measured using accelerometry and we will use time spent in moderate to vigorous physical activity as our primary measure of PA
|
Baseline and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in blood pressure
Time Frame: Baseline and 1 year
|
Both systolic and diastolic blood pressure will be measured
|
Baseline and 1 year
|
|
Change in glucose homeostasis
Time Frame: Baseline and 1 year
|
Both fasting blood glucose, and glucose 2hr post load (oral glucose tolerance test) will be measured
|
Baseline and 1 year
|
|
Change in lipid status
Time Frame: Baseline and 1 year
|
LDL, HDL, triglycerides and total cholesterol will be measured at baseline and after 1 year of follow-up
|
Baseline and 1 year
|
|
Change in body mass index
Time Frame: Baseline and 1 year
|
We will measure height and weight at baseline and at 1 year of follow-up and calculate differences in body mass index over the 1 year period
|
Baseline and 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2012
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Study Registration Dates
First Submitted
November 26, 2012
First Submitted That Met QC Criteria
November 28, 2012
First Posted (Estimated)
November 29, 2012
Study Record Updates
Last Update Posted (Actual)
May 25, 2025
Last Update Submitted That Met QC Criteria
May 20, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CIRCUIT 1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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