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Clinical Trials/NCT05630924
NCT05630924
Terminated
N/A

Children's Lifestyle, Diet, and Exercise Intervention - CHILDREN's Project

Icahn School of Medicine at Mount Sinai1 site in 1 country1,294 target enrollmentDecember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Healthy Lifestyle
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
1294
Locations
1
Primary Endpoint
Adapted Ideal Cardiovascular Health Score (ICH)
Status
Terminated
Last Updated
6 months ago

Overview

Brief Summary

Cluster randomized trial to evaluate the impact of a health promotion intervention (the SI! - Program NYC) on the adapted Ideal Cardiovascular Health score (aICH) in children enrolled in New York City elementary schools.

Detailed Description

Cluster randomized trial to evaluate the impact of a health promotion intervention (the SI! - Program NYC) on the adapted Ideal Cardiovascular Health score (aICH) in children enrolled in New York City elementary schools. This study will enroll children of ages 5 to 6 and teachers from participating schools. Participating schools will be randomized to an intervention group or a control (non-intervention group). The SI! Program intervention will incorporate a comprehensive vision of cardiovascular health promotion that encompasses four basic components: body and heart, physical activity, healthy diet, and emotional management. The intervention will take place at baseline and a reintervention will take place at 2 years-follow up. The research team will assess an adapted version of the Ideal Cardiovascular Health (aICH) score (that includes body-mass-index Z-score, physical activity, diet, sleep time and smoking exposure) and the Knowledge, Attitudes, and Habits (KAH) score. The aICH will be evaluated at baseline, 2 years and 4 years follow-up; the KAH will be evaluated at baseline and after the first intervention, and prior and after the second intervention. The research team will also study the influence of factors in parents (socioeconomic and health-related variables), teachers (stress, teaching motivation, and health status), and the environment (pollution, housing, and neighborhood conditions) through parent/caregiver questionnaires, teacher questionnaires, publicly available data, and pollution data sourced from NASA satellites.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
December 15, 2024
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Valentin Fuster

President of Mount Sinai Heart and Chairman

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Inclusion Criteria

  • NYC Elementary school Kindergarten Children
  • Parents and teachers of participating children

Exclusion Criteria

  • Children who are Wards of the State
  • Children or parents who cannot provide legally effective consent

Outcomes

Primary Outcomes

Adapted Ideal Cardiovascular Health Score (ICH)

Time Frame: 4 years

The adapted ideal cardiovascular health score (ICH) includes 5 components: body-mass-index Z-score, physical activity, diet, sleep/screen time, and passive smoking status. The score will be calculated for five factors on a 0 to 100 scale, according to pre-defined, age adjused cut-offs recommended by the American Heart Association. Higher values represent better health outcomes.

Secondary Outcomes

  • Knowledge, Attitudes, and Habits Score(2 years and 4 months)

Study Sites (1)

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