Lifestyle and Diet Intervention for Children's Heart Health

Overseen By Valentin Fuster

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Wards of the state, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a program designed to improve heart health in children through lifestyle and diet changes. The program, called SI! Program-NYC, will be tested for its impact on children's overall heart health in select New York City elementary schools. One group of children will receive the health education intervention, while another group will serve as a comparison without the intervention. Children in kindergarten at NYC elementary schools, along with their parents and teachers, are welcome to participate if they can legally consent. As an unphased trial, this study offers participants a unique opportunity to contribute to important research that could shape future heart health programs for children.

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 prior data suggests that this health promotion intervention is safe for children?

Research shows that the SI! Program-NYC aims to improve heart health in children. Studies on similar programs have shown good results in schools. For instance, one study found that children in the program had a 4.9% better heart health score after three years compared to those not in the program. This suggests that the program is effective, safe, and well-received over time. Reports have not indicated any negative effects from this type of educational program, suggesting it is a safe way to boost heart health in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SI! Program-NYC because it offers a fresh approach to improving children's heart health through lifestyle and diet changes. Unlike typical treatments that might focus on medication or clinical interventions, this program emphasizes health education, aiming to instill lifelong healthy habits in children. By engaging kids directly in learning about nutrition and physical activity, the program hopes to create a sustainable impact on heart health from an early age. This proactive educational strategy could complement existing treatments, potentially reducing the need for medical interventions later in life.

What evidence suggests that the SI! Program-NYC is effective for children's heart health?

Research has shown that the SI! Program-NYC, which participants in this trial may receive, can improve heart health in children. In earlier studies, children in a similar program had heart health scores 4.9% higher than those who didn't participate. These scores assess key heart health factors such as diet and exercise habits. The program educates children and teachers on living heart-healthy lives. This suggests that the SI! Program-NYC could effectively enhance children's heart health in schools. ^{1 3 5 6 7}

Who Is on the Research Team?

Valentin Fuster

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: SI! Program-NYC Children Experimental Treatment 1 Intervention

Receives 4 month health promotion educational intervention.

Group II: NYC Elementary School Children Active Control 1 Intervention

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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular intervention for high-risk families: the Heart Smart Program. Johnson, CC., Nicklas, TA., Arbeit, ML., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26429075/

The SI! Program for Cardiovascular Health Promotion in Early ... After 3 years of follow-up, the overall KAH score was 4.9% higher in children in the intervention group compared with the control group (21.7 vs ...

2. reports.mountsinai.org reports.mountsinai.org/article/card2022-1-_chsei-heart-health

Project Promoting Children's Heart Health Will Expand to ... The program, the Children's Health and Socioeconomic Implications Project (CHSEI), works closely with children and teachers to instill heart-healthy behaviors.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05630924?locStr=United+States&country=United+States&aggFilters=status%3A

Children's Lifestyle, Diet, and Exercise Intervention Cluster randomized trial to evaluate the impact of a health promotion intervention (the SI! - Program NYC) on the adapted Ideal Cardiovascular Health score ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0735109715048603

The SI! Program for Cardiovascular Health Promotion in ... After 3 years of follow-up, the overall KAH score was 4.9% higher in children in the intervention group compared with the control group (21.7 vs. 16.4; p < ...

5. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2807849

School-Based Cardiovascular Health Promotion in ... The Salud Integral Program (SI! Program) is a multidimensional educational intervention aimed at promoting lifelong CVH by instilling healthy ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05630924

Children's Lifestyle, Diet, and Exercise Intervention The SI! Program intervention will incorporate a comprehensive vision of cardiovascular health promotion that encompasses four basic components: body and heart, ...

7. mountsinai.org mountsinai.org/care/heart/childrens-project

The Children's Project | Mount Sinai - New York The CHILDREN's Project aims to define the cardiovascular health of thousands of New York City elementary school children.