Clinical trial NCT05630924: Children's Lifestyle, Diet, and Exercise Intervention - CHILDREN's Project
Official title: Children's Lifestyle, Diet, and Exercise Intervention - CHILDREN's Project
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy Lifestyle
Cardiovascular Health
Keywords: Children
Lifestyle
School-based Intervention
Cardiovascular Health
Health Promotion
Habits
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Sesame Workshop
First posted: 2022-11-30
Enrollment: 1294
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Adapted Ideal Cardiovascular Health Score (ICH)
timeFrame: Baseline
measure: Adapted Ideal Cardiovascular Health Score (ICH)
timeFrame: 2 years
measure: Adapted Ideal Cardiovascular Health Score (ICH)
timeFrame: 4 years
Secondary outcomes:
measure: Knowledge, Attitudes, and Habits Score
timeFrame: Baseline
measure: Knowledge, Attitudes, and Habits Score
timeFrame: 4 months
measure: Knowledge, Attitudes, and Habits Score
timeFrame: 2 years
measure: Knowledge, Attitudes, and Habits Score
timeFrame: 2 years and 4 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Valentin Fuster
role: PRINCIPAL_INVESTIGATOR
References: