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Behavioural Intervention

Lifestyle and Diet Intervention for Children's Heart Health

N/A

Waitlist Available

Led By Valentin Fuster

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

NYC Elementary school Kindergarten Children

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial evaluates if a health program in NYC schools affects children's heart health.

Who is the study for?

This trial is for kindergarten children enrolled in NYC elementary schools, along with their parents and teachers. It's not open to children who are Wards of the State or those whose parents cannot give legal consent.Check my eligibility

What is being tested?

The CHILDREN's Project tests a health promotion program called SI! Program-NYC. The study randomly assigns schools to either receive this intervention or not, aiming to improve kids' cardiovascular health scores.See study design

What are the potential side effects?

Since this trial focuses on lifestyle changes like diet and exercise, side effects are minimal but may include typical reactions to new physical activities such as muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is in kindergarten in a NYC elementary school.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adapted Ideal Cardiovascular Health Score (ICH)

Secondary outcome measures

Knowledge, Attitudes, and Habits Score

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SI! Program-NYC ChildrenExperimental Treatment1 Intervention

Receives 4 month health promotion educational intervention.

Group II: NYC Elementary School ChildrenActive Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

858 Previous Clinical Trials

522,992 Total Patients Enrolled

Sesame WorkshopUNKNOWN

2 Previous Clinical Trials

2,899 Total Patients Enrolled

Valentin FusterPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

1 Previous Clinical Trials

1,900 Total Patients Enrolled

Media Library

SI! Program-NYC (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05630924 — N/A

Healthy Lifestyle Research Study Groups: SI! Program-NYC Children, NYC Elementary School Children

Healthy Lifestyle Clinical Trial 2023: SI! Program-NYC Highlights & Side Effects. Trial Name: NCT05630924 — N/A

SI! Program-NYC (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630924 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase of this experiment still in progress?

"Affirmative. According to the clinicaltrials.gov page, this medical trial is actively looking for participants. The study was listed on December 1st 2022 and has been updated as recently as November 18th 2022; 2810 people are needed to be enrolled from a single research centre."

Answered by AI

How many participants are currently taking part in this clinical research?

"Affirmative. According to the clinicaltrials.gov website, this experiment is looking for volunteers and was originally published on December 1st 2022 before its most recent update on November 18th of that same year. The study requires a total of 2810 subjects from one particular location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Valentin Fuster 2023. "Children's Lifestyle, Diet, and Exercise Intervention - CHILDREN's Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05630924.