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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Lifestyle, Cardiovascular Health

Intervention / Treatment
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* Other: SI! Program-NYC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SI! Program-NYC Children<br>Receives 4 month health promotion educational intervention. | Other: SI! Program-NYC<br>* 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.<br>|
| No Intervention: NYC Elementary School Children<br>The control group will be participating school children not enrolled in the program | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge, Attitudes, and Habits Score | Questionnaires 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). | Baseline | 
| Knowledge, Attitudes, and Habits Score | Questionnaires 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). Higher scores indicate better health outcomes. | 4 months | 
| Knowledge, Attitudes, and Habits Score | Questionnaires 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). Higher scores indicate better health outcomes. | 2 years | 
| Knowledge, Attitudes, and Habits Score | Questionnaires 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). Higher scores indicate better health outcomes. | 2 years and 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Lifestyle, School-based Intervention, Cardiovascular Health, Health Promotion, Habits