1294 Participants Needed

Lifestyle and Diet Intervention for Children's Heart Health

AS
VF
Overseen ByValentin Fuster
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my child's current medications for the trial?

The trial information does not specify whether children need to stop taking their current medications.

What data supports the effectiveness of the treatment SI! Program-NYC for children's heart health?

The SI! Program has shown effectiveness in promoting healthy lifestyle habits in children by improving their diet, physical activity, and understanding of heart health, as well as managing emotions. Studies have demonstrated that such school-based interventions can improve cardiovascular health markers like blood pressure and body composition in preschoolers, which are important for long-term heart health.12345

Is the Lifestyle and Diet Intervention for Children's Heart Health generally safe for children?

The Program SI!, which is similar to the Lifestyle and Diet Intervention for Children's Heart Health, has been used in schools to promote healthy habits in children. The studies focus on improving lifestyle behaviors and cardiovascular health without reporting any safety concerns, suggesting it is generally safe for children.12346

How is the SI! Program-NYC treatment different from other treatments for children's heart health?

The SI! Program-NYC is unique because it is a school-based intervention that focuses on promoting healthy lifestyle habits in children through diet, physical activity, understanding the body and heart, and managing emotions. Unlike other treatments that may focus solely on medical or dietary interventions, this program takes a comprehensive approach by integrating education and behavioral changes in a school setting to improve children's overall heart health.12789

What is the purpose of this trial?

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.

Research Team

VF

Valentin Fuster

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Inclusion Criteria

Parents and teachers of participating children
My child is in kindergarten in a NYC elementary school.

Exclusion Criteria

Children who are Wards of the State
Children or parents who cannot provide legally effective consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a 4-month health promotion educational intervention

4 months

Reintervention

A reintervention takes place at 2 years follow-up

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Treatment Details

Interventions

  • SI! Program-NYC
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Sesame Workshop

Collaborator

Trials
3
Recruited
4,200+

Findings from Research

The Prevention Education Program (PEP) is a long-term, home-based intervention aimed at improving cardiovascular health in children and their families, involving 1740 families across 37 schools over a 10-year period.
Baseline data revealed a high prevalence of cardiovascular risk factors among both adults and children, highlighting the urgent need for this type of intervention in Germany.
The prevention education program (PEP). A prospective study of the efficacy of family-oriented life style modification in the reduction of cardiovascular risk and disease: design and baseline data.Schwandt, P., Geiss, HC., Ritter, MM., et al.[2022]
The Heart Smart Family Health Promotion Program, involving 19 high-risk children and 23 parents over 12 weeks, successfully improved eating habits, physical activity, and cardiovascular knowledge, leading to significant health benefits.
Both children and parents experienced positive changes, including reduced blood pressure and stabilized weight gain in children, demonstrating the program's effectiveness as a cardiovascular risk intervention that can be adapted for clinical settings.
Cardiovascular intervention for high-risk families: the Heart Smart Program.Johnson, CC., Nicklas, TA., Arbeit, ML., et al.[2019]

References

The Program SI! intervention for enhancing a healthy lifestyle in preschoolers: first results from a cluster randomized trial. [2021]
Development and validation of a questionnaire to evaluate lifestyle-related behaviors in elementary school children. [2018]
A cluster randomized trial to evaluate the efficacy of a school-based behavioral intervention for health promotion among children aged 3 to 5. [2021]
Association between anthropometry and high blood pressure in a representative sample of preschoolers in madrid. [2016]
Findings from Project HeartBeat! Their importance for CVD prevention. [2021]
The prevention education program (PEP). A prospective study of the efficacy of family-oriented life style modification in the reduction of cardiovascular risk and disease: design and baseline data. [2022]
Cardiovascular intervention for high-risk families: the Heart Smart Program. [2019]
Implementation of "Heart Smart:" a cardiovascular school health promotion program. [2019]
Longitudinal Impact of a Park-Based Afterschool Healthy Weight Program on Modifiable Cardiovascular Disease Risk Factors in Youth. [2019]
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