NCT01736748

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
55mo left

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Aug 2012Dec 2030

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
18 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

18.3 years

First QC Date

November 26, 2012

Last Update Submit

May 20, 2025

Conditions

Keywords

obesityphysical activitymetabolismenvironmentobese children, as defined by a body mass index > 95th percentilefor age and sex

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in blood pressure

    Baseline and 1 year

  • Change in glucose homeostasis

    Baseline and 1 year

  • Change in lipid status

    Baseline and 1 year

  • Change in body mass index

    Baseline and 1 year

Study Arms (2)

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.

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.

Behavioral: Traditional PA counseling

Interventions

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.

Sensor based PA intervention

Children will be encouraged to enhance their physical activity levels using traditional behavioral approaches.

Traditional PA counseling

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children ages 6 to 18 years of age with a BMI \> 95th percentile for age and sex

You may not qualify if:

  • children with a physical or psychological condition that would impair their ability to participate in physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

MeSH Terms

Conditions

ObesityMotor ActivityCoitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorSexual Behavior

Central Study Contacts

Melanie Henderson

CONTACT

Tracie A Barnett

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Endocrinologist and Assistant Clinical Professor

Study Record Dates

First Submitted

November 26, 2012

First Posted

November 29, 2012

Study Start

August 1, 2012

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

May 25, 2025

Record last verified: 2025-05

Locations