NCT04167124

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2012

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

2.2 years

First QC Date

September 26, 2018

Last Update Submit

November 2, 2022

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    Accelerometer measured physical activity

    Baseline

Study Arms (1)

multi-sensor lifestyle intervention

EXPERIMENTAL
Behavioral: multi-sensor lifestyle intervention

Interventions

multi-sensor lifestyle interventionBEHAVIORAL
multi-sensor lifestyle intervention

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- Children at risk of cardiovascular disease, including children with diabetes mellitus, overweight/obesity, hypertension, dyslipidemia

You may not qualify if:

  • \- Patients with physical or psychological problems that impair their ability to participate in physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sainte-Justine Hospital

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

September 26, 2018

First Posted

November 18, 2019

Study Start

June 28, 2010

Primary Completion

August 30, 2012

Study Completion

August 30, 2012

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

CA(1)