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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
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
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
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
863 Previous Clinical Trials
524,320 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is in kindergarten in a NYC elementary school.
Research Study Groups:
This trial has the following groups:- Group 1: SI! Program-NYC Children
- Group 2: NYC Elementary School Children
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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