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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05630924
Enrollment
1294
Registered
2022-11-30
Start date
2022-12-01
Completion date
2024-12-15
Last updated
2025-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Health, Healthy Lifestyle

Keywords

Children, Lifestyle, School-based Intervention, Cardiovascular Health, Health Promotion, Habits

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.

Interventions

OTHERSI! Program-NYC

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.

Sponsors

Sesame Workshop
CollaboratorUNKNOWN
Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Adapted Ideal Cardiovascular Health Score (ICH)BaselineThe 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

MeasureTime frameDescription
Knowledge, Attitudes, and Habits ScoreBaselineQuestionnaires will be given to assess the knowledge (K), attitudes (A) and habits (H) of the children representing each of the components of the intervention (KAH-diet, KAH-physical activity, and KAH-human body). An overall score representing the intervention as a whole (overall KAH) will be derived from the 39 items, ranging from 0-80. The overall KAH score is derived from the sum of each component-specific score (Diet, 0 to 30 points; Physical activity, 0 to 30 points; and Human body, 0 to 20 points).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026