Physical ActivityCIRCUITNCT04167124
Evaluation of a Spatio-behavioral Application
A study testing multi-sensor lifestyle intervention in people with Physical Activity, run by St. Justine's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Physical Activity
- What is being tested?
- multi-sensor lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jun 2010to 30 Aug 2012
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children at risk of cardiovascular disease, including children with diabetes mellitus, overweight/obesity, hypertension, dyslipidemia
Who cannot join
- Patients with physical or psychological problems that impair their ability to participate in physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Physical Activity
- Being tested
- multi-sensor lifestyle intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-sensor lifestyle interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| multi-sensor lifestyle intervention | Experimental | Not described Receives: Behavioral: multi-sensor lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Accelerometer measured physical activity
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start28 Jun 2010
- Primary completion30 Aug 2012
- Study completion30 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melanie Henderson, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167124
- Sponsor's protocol ID
- CIRCUIT2
- Acronym
- CIRCUIT
- Status last verified
- Nov 2022
- First submitted
- 26 Sep 2018
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Physical Activity Levels in Youth at Risk for Cardiovascular Disease: Evaluating a Spatio-behavioral Intervention.
- ClinicalTrials.gov ID
- NCT04167124
- Acronym / sponsor ID
- CIRCUIT / CIRCUIT2
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 28 Jun 2010 (actual)
- Primary completion
- 30 Aug 2012 (actual)
- Study completion
- 30 Aug 2012 (actual)
- First posted
- 18 Nov 2019 (actual)
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multi-sensor lifestyle intervention | Experimental | Behavioral: multi-sensor lifestyle intervention |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children at risk of cardiovascular disease, including children with diabetes mellitus, overweight/obesity, hypertension, dyslipidemia
Key exclusion criteria (1 listed)
- Patients with physical or psychological problems that impair their ability to participate in physical activity
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 |
|---|---|---|
| multi-sensor lifestyle intervention | Behavioural | multi-sensor lifestyle intervention |
Primary outcome
Physical activity
Time frame: Baseline
Accelerometer measured physical activity
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 3 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-sensor lifestyle intervention in people with Physical Activity, run by St. Justine's Hospital 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 1 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 3 Nov 2022. 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?
Physical activity (time frame: Baseline). 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 3 Nov 2022.