Dynamo: a Tailored Lifestyle Promotion Intervention Among Pediatric Patients With Cardiometabolic Risk Factors

Obese Clinical Trial

— CIRCUIT  

Official title:

Implementing Dynamo: a Tailored Lifestyle Promotion Intervention Among Pediatric Patients With Cardiometabolic Risk Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01736748
• Other study ID #: CIRCUIT 1
• Status: Recruiting
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: St. Justine's Hospital
• Contact: Melanie Henderson
• Phone: 514-345-4735
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obese

Intervention

Behavioral:
• 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.
• Traditional PA counseling
Children will be encouraged to enhance their physical activity levels using traditional behavioral approaches.

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and 1 year
Secondary	Change in blood pressure	Both systolic and diastolic blood pressure will be measured	Baseline and 1 year
Secondary	Change in glucose homeostasis	Both fasting blood glucose, and glucose 2hr post load (oral glucose tolerance test) will be measured	Baseline and 1 year
Secondary	Change in lipid status	LDL, HDL, triglycerides and total cholesterol will be measured at baseline and after 1 year of follow-up	Baseline and 1 year
Secondary	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	Baseline and 1 year