- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167124
Evaluation of a Spatio-behavioral Application (CIRCUIT)
November 2, 2022 updated by: Melanie Henderson, St. Justine's Hospital
Enhancing Physical Activity Levels in Youth at Risk for Cardiovascular Disease: Evaluating a Spatio-behavioral Intervention.
The CIRCUIT program (Centre pédiatrique d'interventions en prévention et en réadaptation cardiovasculaire) of the CHU Sainte-Justine is a multidisciplinary, personalized intervention for children with cardiovascular risk.
This program includes an evaluation of the physical activity pattern using wearable sensors (accelerometer, heart rate monitor and GPS), to replace the physical activity practice of the patients in their respective real life context.
The accelerometer will measure physical activity and heart rate, while the GPS will serve to obtain precise information about places visited and travels in the neighborhood.
The data obtained with these tools will serve to develop indicators of the "environmental diagnosis".
This information will help to personalize the intervention for each patient.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
115
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 Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3T1C5
- Sainte-Justine Hospital
-
-
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
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children at risk of cardiovascular disease, including children with diabetes mellitus, overweight/obesity, hypertension, dyslipidemia
Exclusion Criteria:
- Patients with physical or psychological problems that 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: multi-sensor lifestyle intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: Baseline
|
Accelerometer measured physical activity
|
Baseline
|
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)
June 28, 2010
Primary Completion (Actual)
August 30, 2012
Study Completion (Actual)
August 30, 2012
Study Registration Dates
First Submitted
September 26, 2018
First Submitted That Met QC Criteria
November 15, 2019
First Posted (Actual)
November 18, 2019
Study Record Updates
Last Update Posted (Actual)
November 3, 2022
Last Update Submitted That Met QC Criteria
November 2, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- CIRCUIT2
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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