NCT05630924

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1,294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

November 18, 2022

Last Update Submit

October 29, 2025

Conditions

Healthy LifestyleCardiovascular Health

Keywords

ChildrenLifestyleSchool-based InterventionCardiovascular HealthHealth PromotionHabits

Outcome Measures

Primary Outcomes (3)

  • Adapted Ideal Cardiovascular Health Score (ICH)

    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.

    Baseline

  • Adapted Ideal Cardiovascular Health Score (ICH)

    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.

    2 years

  • Adapted Ideal Cardiovascular Health Score (ICH)

    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.

    4 years

Secondary Outcomes (4)

  • Knowledge, Attitudes, and Habits Score

    Baseline

  • Knowledge, Attitudes, and Habits Score

    4 months

  • Knowledge, Attitudes, and Habits Score

    2 years

  • Knowledge, Attitudes, and Habits Score

    2 years and 4 months

Study Arms (2)

SI! Program-NYC Children

EXPERIMENTAL

Receives 4 month health promotion educational intervention.

Other: SI! Program-NYC

NYC Elementary School Children

NO INTERVENTION

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

Interventions

SI! Program-NYCOTHER

SI! Program-NYC incorporates a comprehensive and integrated vision of CV health promotion that encompasses four (4) basic and interrelated components: body and heart, physical activity healthy diet; and emotional management.

SI! Program-NYC Children

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Habits

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Valentin Fuster

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of Mount Sinai Heart and Chairman

Study Record Dates

First Submitted

November 18, 2022

First Posted

November 30, 2022

Study Start

December 1, 2022

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

October 30, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Deidentified data will be available to external researchers upon request after approval with a signed data sharing agreement

Shared Documents
SAP, ICF, CSR
Time Frame
Starting 9 months after publication
Access Criteria
Research team will respond with any requests to share IPD.

Locations

US(1)