ObeseCIRCUITNCT01736748
Dynamo: a Tailored Lifestyle Promotion Intervention Among Pediatric Patients With Cardiometabolic Risk Factors
A study testing Sensor based PA intervention and Traditional PA counseling in people with Obese, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Obese
- What is being tested?
- Sensor based PA intervention and Traditional PA counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children ages 6 to 18 years of age with a BMI > 95th percentile for age and sex
Who cannot join
- children with a physical or psychological condition that would impair their ability to participate in physical activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melanie Henderson contact
Tracie A Barnett contact
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Melanie Henderson, 514-345-4735
Melanie Henderson
About this study
Official title: 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.
- Conditions
- Obese
- Being tested
- Sensor based PA intervention, Traditional PA counseling
- Keywords
- obesity, physical activity, metabolism, environment, obese children, as defined by a body mass index > 95th percentile, for age and sex
- Medical subject headings
- Obesity, Motor Activity, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor based PA interventionBehavioural
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.
Traditional PA counselingBehavioural
Children will be encouraged to enhance their physical activity levels using traditional behavioral approaches.
| Study group | Role | What they receive |
|---|---|---|
| Sensor based PA intervention | Experimental | 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. Receives: Behavioral: Sensor based PA intervention |
| Traditional PA counseling | Other | 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. Receives: Behavioral: Traditional PA counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity levels
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
Measured: Baseline and 1 year
Secondary outcomes (4)
Change in blood pressure
Both systolic and diastolic blood pressure will be measured
Measured: Baseline and 1 year
Change in glucose homeostasis
Both fasting blood glucose, and glucose 2hr post load (oral glucose tolerance test) will be measured
Measured: Baseline and 1 year
Change in lipid status
LDL, HDL, triglycerides and total cholesterol will be measured at baseline and after 1 year of follow-up
Measured: Baseline and 1 year
Change in body mass index
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
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
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
- NCT01736748
- Sponsor's protocol ID
- CIRCUIT 1
- Acronym
- CIRCUIT
- Status last verified
- May 2025
- First submitted
- 26 Nov 2012
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Dynamo: a Tailored Lifestyle Promotion Intervention Among Pediatric Patients With Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT01736748
- Acronym / sponsor ID
- CIRCUIT / CIRCUIT 1
- Conditions
- Obese
- Keywords
- obesity, physical activity, metabolism, environment, obese children, as defined by a body mass index > 95th percentile, for age and sex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 29 Nov 2012 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensor based PA intervention | Experimental | Behavioral: Sensor based PA interventionChildren 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. |
| Traditional PA counseling | Other | Behavioral: Traditional PA counselingIn 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children ages 6 to 18 years of age with a BMI > 95th percentile for age and sex
Key exclusion criteria (1 listed)
- children with a physical or psychological condition that would 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 |
|---|---|---|
| Sensor based PA interventionChildren 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. | Behavioural | Sensor based PA intervention |
| Traditional PA counselingChildren will be encouraged to enhance their physical activity levels using traditional behavioral approaches. | Behavioural | Traditional PA counseling |
Primary outcome
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
4 secondary outcomes
Change in blood pressure
Time frame: Baseline and 1 year
Change in glucose homeostasis
Time frame: Baseline and 1 year
Change in lipid status
Time frame: Baseline and 1 year
Change in body mass index
Time frame: Baseline and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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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.
Melanie Henderson contact
Tracie A Barnett contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor based PA intervention and Traditional PA counseling in people with Obese, 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: looking for participants now, as of the sponsor's last update on 25 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie Henderson (514-345-4735), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity levels (time frame: Baseline and 1 year). 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 25 May 2025.