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

Mount Sinai Health System

Status: Terminated

Conditions: Healthy Lifestyle; Cardiovascular Health

Treatments: Other: SI! Program-NYC

Study type: Interventional

Funder types: Other

Identifiers

NCT05630924

GCO 20-0655

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,294 patients

Sex: All

Ages: 4+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,294 participants in 2 patient groups

SI! Program-NYC Children

Experimental group

Description:

Receives 4 month health promotion educational intervention.

Treatment:

Other: SI! Program-NYC

NYC Elementary School Children

No Intervention group

Description:

The control group will be participating school children not enrolled in the program