Healthy LifestyleNCT05630924

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

A study testing SI! Program-NYC in people with Healthy Lifestyle and Cardiovascular Health, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 4 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Lifestyle, Cardiovascular Health
What is being tested?: SI! Program-NYC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,294 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2022to 15 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

NYC Elementary school Kindergarten Children
Parents and teachers of participating children

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Read the detailed 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.

Conditions: Healthy Lifestyle, Cardiovascular Health
Being tested: SI! Program-NYC
Keywords: Children, Lifestyle, School-based Intervention, Cardiovascular Health, Health Promotion, Habits
Medical subject headings: Habits

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SI! Program-NYCOther
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.

Study groups in NCT05630924
Study group	Role	What they receive
SI! Program-NYC Children	Experimental	Receives 4 month health promotion educational intervention. Receives: Other: SI! Program-NYC
NYC Elementary School Children	No intervention	The control group will be participating school children not enrolled in the program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline
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.
Measured: 2 years
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.
Measured: 4 years

Secondary outcomes (4)

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).
Measured: Baseline
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.
Measured: 4 months
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.
Measured: 2 years
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.
Measured: 2 years and 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202215 Dec 2024

First posted30 Nov 2022
Study start1 Dec 2022
Primary completion15 Dec 2024
Study completion15 Dec 2024

Why it stopped: Not meeting recruitment targets

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy LifestyleStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,294 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05630924
Sponsor's protocol ID: GCO 20-0655
Status last verified: Oct 2025
First submitted: 18 Nov 2022
Last updated: 30 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Deidentified data will be available to external researchers upon request after approval with a signed data sharing agreement

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Walk Together Efficacy Trial
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Effectiveness of the "Aktivplan" Digital Intervention for Supporting Regular Heart-Healthy Physical Activity Following Phase II Cardiac Rehabilitation
Cardiovascular Diseases (CVD)
Active, not recruiting
Group Lifestyle Balance™ for Individuals With Stroke (GLB-CVA)
Stroke

All Healthy Lifestyle trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Children's Lifestyle, Diet, and Exercise Intervention - CHILDREN's Project
ClinicalTrials.gov ID: NCT05630924
Acronym / sponsor ID: GCO 20-0655
Conditions: Healthy Lifestyle, Cardiovascular Health
Keywords: Children, Lifestyle, School-based Intervention, Cardiovascular Health, Health Promotion, Habits
Study type: Interventional
Recruitment status: TerminatedReason stopped: Not meeting recruitment targets
Enrolment: 1,294 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Collaborators: Sesame Workshop
Study start: 1 Dec 2022 (actual)
Primary completion: 15 Dec 2024 (actual)
Study completion: 15 Dec 2024 (actual)
First posted: 30 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SI! Program-NYC Children	Experimental	Other: SI! Program-NYCReceives 4 month health promotion educational intervention.
NYC Elementary School Children	No intervention	–The control group will be participating school children not enrolled in the program

Who may qualify

Ages: 4 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

NYC Elementary school Kindergarten Children
Parents and teachers of participating children

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SI! Program-NYCSI! 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.	Other	SI! Program-NYC Children

Primary outcome

Adapted Ideal Cardiovascular Health Score (ICH)
Time frame: Baseline
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.
Adapted Ideal Cardiovascular Health Score (ICH)
Time frame: 2 years
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.
Adapted Ideal Cardiovascular Health Score (ICH)
Time frame: 4 years
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 secondary outcomes

Knowledge, Attitudes, and Habits Score
Time frame: Baseline
Knowledge, Attitudes, and Habits Score
Time frame: 4 months
Knowledge, Attitudes, and Habits Score
Time frame: 2 years
Knowledge, Attitudes, and Habits Score
Time frame: 2 years and 4 months

Results and safety

The study was stopped early (reason given: Not meeting recruitment targets). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
Individual participant dataSharing planned: Yes. Deidentified data will be available to external researchers upon request after approval with a signed data sharing agreement

Related trials for Healthy Lifestyle

Recruiting
LIfestyle MEtabotype Study B (LIME-B)
Nutritional and Metabolic Diseases, Prediabetes
Active, not recruiting
The Effect of Lifestyle Program Women With PCOS
Polycystic Ovary Syndrome
Not yet recruiting
Walk Together Efficacy Trial
Hypertension
Not yet recruiting
Effectiveness of the "Aktivplan" Digital Intervention for Supporting Regular Heart-Healthy Physical Activity Following Phase II Cardiac Rehabilitation
Cardiovascular Diseases (CVD)
Active, not recruiting
Group Lifestyle Balance™ for Individuals With Stroke (GLB-CVA)
Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Valentin Fuster principal investigator

Icahn School of Medicine at Mount Sinai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SI! Program-NYC in people with Healthy Lifestyle and Cardiovascular Health, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Not meeting recruitment targets). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adapted Ideal Cardiovascular Health Score (ICH) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05630924.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.