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

This study is not yet open for participant recruitment.
Verified July 2013 by Melanie Henderson, St. Justine's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01736748
First Posted: November 29, 2012
Last Update Posted: July 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Melanie Henderson, St. Justine's Hospital
  Purpose
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.

Condition Intervention
Obese Behavioral: Sensor based PA intervention Behavioral: Traditional PA counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Implementing Dynamo: a Tailored Lifestyle Promotion Intervention Among Pediatric Patients With Cardiometabolic Risk Factors

Further study details as provided by Melanie Henderson, St. Justine's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Change in blood pressure [ Time Frame: Baseline and 1 year ]
    Both systolic and diastolic blood pressure will be measured

  • Change in glucose homeostasis [ Time Frame: Baseline and 1 year ]
    Both fasting blood glucose, and glucose 2hr post load (oral glucose tolerance test) will be measured

  • Change in lipid status [ Time Frame: Baseline and 1 year ]
    LDL, HDL, triglycerides and total cholesterol will be measured at baseline and after 1 year of follow-up

  • Change in body mass index [ Time Frame: Baseline and 1 year ]
    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


Estimated Enrollment: 100
Study Start Date: January 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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
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.
Behavioral: Traditional PA counseling
Children will be encouraged to enhance their physical activity levels using traditional behavioral approaches.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736748


Contacts
Contact: Melanie Henderson 514-345-4735
Contact: Tracie A Barnett 514-345-4931 ext 5461

Locations
Canada, Quebec
CHU Sainte-Justine Not yet recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Melanie Henderson    514-345-4735      
Principal Investigator: Melanie Henderson         
Sponsors and Collaborators
St. Justine's Hospital
  More Information

Responsible Party: Melanie Henderson, Endocrinologist and Assistant Clinical Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01736748     History of Changes
Other Study ID Numbers: CIRCUIT 1
First Submitted: November 26, 2012
First Posted: November 29, 2012
Last Update Posted: July 12, 2013
Last Verified: July 2013

Keywords provided by Melanie Henderson, St. Justine's Hospital:
obesity
physical activity
metabolism
environment
obese children, as defined by a body mass index > 95th percentile
for age and sex