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

Healthy Lifestyle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05630924
• Other study ID #: GCO 20-0655
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: July 2029

Study information

• Verified date: October 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1294
• Est. completion date: July 2029
• Est. primary completion date: July 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Health
• Healthy Lifestyle

Intervention

Other:
• SI! 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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Sesame Workshop

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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