Cardiovascular HealthPSIRNCT06715358
The SI! Program Reintervention for Elementary Schools Trial
A study testing Reintervention and Late intervention in people with Cardiovascular Health and Obesity, run by Foundation for Science, Health and Education, Spain at 1 site in Spain.
Trial summary
Background and objectives: The SI! Program is a multilevel school-based intervention that has been previously evaluated in different ages in three countries. Schools were randomized to the SI! Program intervention or the control group, and prior to and after the intervention several questionnaires and direct measures… Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health, Obesity
- What is being tested?
- Reintervention and Late intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteSpain
- Study dates
- 24 Oct 2023to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schools from the Madrid Region or Catalonia.
- Public or charter schools
- Schools having from 1st to 6th grades and at least one classroom in 1st grade.
- Schools having a canteen
- Children in the 1st grade.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster Randomized Trial for the SI! Program Reintervention for Elementary Schools
Background and objectives:
The SI! Program is a multilevel school-based intervention that has been previously evaluated in different ages in three countries. Schools were randomized to the SI! Program intervention or the control group, and prior to and after the intervention several questionnaires and direct measures were used to assess changes in lifestyle and cardiovascular health indicators. In the SI! Program for Preschool, children in the intervention group increased significantly more their knowledge, attitudes and habits after 4 months of the implementation of the SI! Program compared to children in the control group. However, until now, results have shown that improvements in cardiovascular health between 3 and 5 years old do not sustain overtime. For this reason, the new project of the SI! Program proposes a reinforcement of the children's environment to boost the effect of the intervention and a reinforcement in the classroom after 2 years to favor the sustainability of the effect. The main objective of this study is to assess the effect of the reintervention of the SI! Program in the SI!-Child health score in Elementary school children (7-12 years old) and compare its effect with a single late exposure to the SI! Program.
Read more
Methodology:
A cluster-randomized trial involving 50 elementary schools in Spain will be carried out. Schools will be 1:1 randomized to either implement the SI! Program from 2nd grade throughout the whole Elementary Education (5 years) with two classroom interventions (one at 2nd grade and one at 5th grade) or to implement the SI! Program from 5th grade throughout the rest of the Elementary Education (2 years) with only one classroom intervention at 5th grade. Children in the first year of Elementary education at the beginning of the trial will be recruited. Participants will be evaluated at baseline, and after 3, 5 and 6 years using a battery of measurements on cardiovascular health parameters (anthropometry, bioimpedance, blood analysis, accelerometers, questionnaires). The primary endpoint will be the change in the SI!-Child score after 5 years. The SI! Child score includes sleep, diet, physical activity and nutritional status, and ranges from 0 to 100, with higher scores indicating better cardiovascular profiles. Secondary outcomes include the change in individual components of the SI!-Child score and other cardiovascular health indicators such as sedentarism, tobacco exposure, adiposity, blood pressure, lipid profile and blood glucose, and to assess the effect of the SI! Program reintervention to maintain or improve all cardiovascular health indicators previously mentioned one year after the reintervention.
Expected results:
The investigators expect to show that a school-based educational intervention with a reinforcement in the classroom after 2 years in addition to a school environment intervention will induce favorable and sustainable lifestyle changes in health behaviors among Spanish children. If successful, this strategy could be widely adopted having a meaningful effect on cardiovascular health promotion.
- Conditions
- Cardiovascular Health, Obesity
- Being tested
- Reintervention, Late intervention
- Keywords
- Cardiovascular health, Health promotion, School-based intervention, Children
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReinterventionBehavioural
- SI! Program environment intervention from 2nd grade through all Elementary Education.
- SI! Program classroom intervention in 2nd grade.
- SI! Program classroom intervention in 5th grade.
Late interventionBehavioural
- SI! Program environment intervention from 5th grade through all Elementary Education.
- SI! Program classroom intervention in 5th grade.
| Study group | Role | What they receive |
|---|---|---|
| Reintervention | Active comparator | Implement the SI! Program environment intervention from 2nd grade throughout the whole Elementary Education (5 years) and with two classroom interventions: one at 2nd grade and a reintervention at 5th grade. Receives: Behavioral: Reintervention |
| Late intervention | Active comparator | Implement the SI! Program environment intervention from 5th grade throughout the rest of the Elementary Education (2 years) with only one classroom intervention at 5th grade. Receives: Behavioral: Late intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the SI!-Child health score at the end of the intervention
The primary outcome will be the difference in the SI!-Child score (0-100 points for each component, higher scores indicating healthier habits) between the reintervention group and the late intervention group. The SI! Child score includes Sleep (measured as hours of sleep), Diet (fruits and vegetables, sugared beverages, fast-food, legumes and nuts, sweets and pastries), Physical activity (minutes of moderate and vigorous physical activity), Nutritional status (body mass index calculated as body weight divided by height squared (kg/m2).
Measured: From baseline assessment to the end of the intervention, an average of 5 years
Secondary outcomes (1)
Effect of the SI! Program reintervention in the individual components of the SI!-Child health score
Mean score and change at follow-up visits for each of the individual components of the SI! Child score (0-100 points for each component, higher scores indicating healthier habits): Sleep (measured as hours of sleep ), Diet (fruits and vegetables, sugared beverages, fast-food, legumes and nuts, sweets and pastries), Physical activity (minutes of moderate and vigorous physical activity), nutritional status (body mass index calculated as body weight divided by height squared (kg/m2)).
Measured: From baseline assessment to the end of the intervention, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start24 Oct 2023
- Primary completionJun 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- 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
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for Science, Health and Education, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- La Caixa Foundation, Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Responsible party
- Sponsor
- Investigators
- Valentin Fuster, Principal investigator, Mount Sinaí Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715358
- Sponsor's protocol ID
- SHE-004-SI
- Acronym
- PSIR
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be available upon request, with the approval of the Steering Committee and the signing of a data exchange agreement.
Publications
Penalvo JL, Sotos-Prieto M, Santos-Beneit G, Pocock S, Redondo J, Fuster V. The Program SI! intervention for enhancing a healthy lifestyle in preschoolers: first results from a cluster randomized trial. BMC Public Health. 2013 Dec 20;13:1208. doi: 10.1186/1471-2458-13-1208.
PubMed 24359285Penalvo JL, Santos-Beneit G, Sotos-Prieto M, Martinez R, Rodriguez C, Franco M, Lopez-Romero P, Pocock S, Redondo J, Fuster V. A cluster randomized trial to evaluate the efficacy of a school-based behavioral intervention for health promotion among children aged 3 to 5. BMC Public Health. 2013 Jul 15;13:656. doi: 10.1186/1471-2458-13-656.
PubMed 23855415Penalvo JL, Santos-Beneit G, Sotos-Prieto M, Bodega P, Oliva B, Orrit X, Rodriguez C, Fernandez-Alvira JM, Redondo J, Vedanthan R, Bansilal S, Gomez E, Fuster V. The SI! Program for Cardiovascular Health Promotion in Early Childhood: A Cluster-Randomized Trial. J Am Coll Cardiol. 2015 Oct 6;66(14):1525-1534. doi: 10.1016/j.jacc.2015.08.014.
PubMed 26429075Santos-Beneit G, Bodega P, de Miguel M, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, de Cos-Gandoy A, Penalvo JL, Gomez-Pardo E, Oliva B, Ibanez B, Fernandez-Alvira JM, Fernandez-Jimenez R, Fuster V. Rationale and design of the SI! Program for health promotion in elementary students aged 6 to 11 years: A cluster randomized trial. Am Heart J. 2019 Apr;210:9-17. doi: 10.1016/j.ahj.2018.12.011. Epub 2019 Jan 8.
PubMed 30716509Fernandez-Jimenez R, Santos-Beneit G, Tresserra-Rimbau A, Bodega P, de Miguel M, de Cos-Gandoy A, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, Ibanez B, Storniolo C, Domenech M, Estruch R, Fernandez-Alvira JM, Lamuela-Raventos RM, Fuster V. Rationale and design of the school-based SI! Program to face obesity and promote health among Spanish adolescents: A cluster-randomized controlled trial. Am Heart J. 2019 Sep;215:27-40. doi: 10.1016/j.ahj.2019.03.014. Epub 2019 Apr 10.
PubMed 31277052Santos-Beneit G, Fernandez-Jimenez R, de Cos-Gandoy A, Rodriguez C, Carral V, Bodega P, de Miguel M, Orrit X, Haro D, Penalvo JL, Fernandez-Alvira JM, Peyra C, Cespedes JA, Turco A, Hunn M, Jaslow R, Baxter J, Carvajal I, Fuster V. Lessons Learned From 10 Years of Preschool Intervention for Health Promotion: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Jan 25;79(3):283-298. doi: 10.1016/j.jacc.2021.10.046.
PubMed 35057915Santos-Beneit G, Fernandez-Alvira JM, Tresserra-Rimbau A, Bodega P, de Cos-Gandoy A, de Miguel M, Ramirez-Garza SL, Laveriano-Santos EP, Arancibia-Riveros C, Carral V, Orrit X, Rodriguez C, Carvajal I, Haro D, Peyra C, Martinez-Gomez J, Alvarez-Benavides A, Estruch R, Lamuela-Raventos RM, Fernandez-Jimenez R, Fuster V. School-Based Cardiovascular Health Promotion in Adolescents: A Cluster Randomized Clinical Trial. JAMA Cardiol. 2023 Sep 1;8(9):816-824. doi: 10.1001/jamacardio.2023.2231.
PubMed 37531100Santos-Beneit G, Bodega P, de Cos-Gandoy A, de Miguel M, Rodriguez C, Orrit X, Carral V, Haro D, Carvajal I, Peyra C, Martinez-Gomez J, Fernandez-Alvira JM, Fernandez-Jimenez R, Fuster V. Effect of Time-Varying Exposure to School-Based Health Promotion on Adiposity in Childhood. J Am Coll Cardiol. 2024 Aug 6;84(6):499-508. doi: 10.1016/j.jacc.2024.04.065.
PubMed 39084824Santos-Beneit G, de Cos-Gandoy A, Bodega P, Orrit X, Rodriguez C, de Miguel M, Montilla N, Fernandez-Alvira JM, Martinez-Gomez J, Diaz-Munoz R, Haro D, Peyra C, Carvajal I, Fernandez-Jimenez R, Fuster V. Design of the School-Based SI! Program Reintervention Trial for Child Health Promotion. JACC Adv. 2026 May;5(5):102748. doi: 10.1016/j.jacadv.2026.102748. Epub 2026 Apr 24.
PubMed 42034098
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Trial for the SI! Program Reintervention for Elementary Schools
- ClinicalTrials.gov ID
- NCT06715358
- Acronym / sponsor ID
- PSIR / SHE-004-SI
- Conditions
- Cardiovascular Health, Obesity
- Keywords
- Cardiovascular health, Health promotion, School-based intervention, Children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Foundation for Science, Health and Education, SpainUniversity, hospital or other
- Collaborators
- La Caixa Foundation, Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 4 Dec 2024 (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.
Background and objectives:
The SI! Program is a multilevel school-based intervention that has been previously evaluated in different ages in three countries. Schools were randomized to the SI! Program intervention or the control group, and prior to and after the intervention several questionnaires and direct measures were used to assess changes in lifestyle and cardiovascular health indicators. In the SI! Program for Preschool, children in the intervention group increased significantly more their knowledge, attitudes and habits after 4 months of the implementation of the SI! Program compared to children in the control group. However, until now, results have shown that improvements in cardiovascular health between 3 and 5 years old do not sustain overtime. For this reason, the new project of the SI! Program proposes a reinforcement of the children's environment to boost the effect of the intervention and a reinforcement in the classroom after 2 years to favor the sustainability of the effect. The main objective of this study is to assess the effect of the reintervention of the SI! Program in the SI!-Child health score in Elementary school children (7-12 years old) and compare its effect with a single late exposure to the SI! Program.
Methodology:
A cluster-randomized trial involving 50 elementary schools in Spain will be carried out. Schools will be 1:1 randomized to either implement the SI! Program from 2nd grade throughout the whole Elementary Education (5 years) with two classroom interventions (one at 2nd grade and one at 5th grade) or to implement the SI! Program from 5th grade throughout the rest of the Elementary Education (2 years) with only one classroom intervention at 5th grade. Children in the first year of Elementary education at the beginning of the trial will be recruited. Participants will be evaluated at baseline, and after 3, 5 and 6 years using a battery of measurements on cardiovascular health parameters (anthropometry, bioimpedance, blood analysis, accelerometers, questionnaires). The primary endpoint will be the change in the SI!-Child score after 5 years. The SI! Child score includes sleep, diet, physical activity and nutritional status, and ranges from 0 to 100, with higher scores indicating better cardiovascular profiles. Secondary outcomes include the change in individual components of the SI!-Child score and other cardiovascular health indicators such as sedentarism, tobacco exposure, adiposity, blood pressure, lipid profile and blood glucose, and to assess the effect of the SI! Program reintervention to maintain or improve all cardiovascular health indicators previously mentioned one year after the reintervention.
Expected results:
The investigators expect to show that a school-based educational intervention with a reinforcement in the classroom after 2 years in addition to a school environment intervention will induce favorable and sustainable lifestyle changes in health behaviors among Spanish children. If successful, this strategy could be widely adopted having a meaningful effect on cardiovascular health promotion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reintervention | Active comparator | Behavioral: ReinterventionImplement the SI! Program environment intervention from 2nd grade throughout the whole Elementary Education (5 years) and with two classroom interventions: one at 2nd grade and a reintervention at 5th grade. |
| Late intervention | Active comparator | Behavioral: Late interventionImplement the SI! Program environment intervention from 5th grade throughout the rest of the Elementary Education (2 years) with only one classroom intervention at 5th grade. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Schools from the Madrid Region or Catalonia.
- Public or charter schools
- Schools having from 1st to 6th grades and at least one classroom in 1st grade.
- Schools having a canteen
- Children in the 1st grade.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Reintervention* SI! Program environment intervention from 2nd grade through all Elementary Education. * SI! Program classroom intervention in 2nd grade. * SI! Program classroom intervention in 5th grade. | Behavioural | Reintervention |
| Late intervention* SI! Program environment intervention from 5th grade through all Elementary Education. * SI! Program classroom intervention in 5th grade. | Behavioural | Late intervention |
Primary outcome
Change in the SI!-Child health score at the end of the intervention
Time frame: From baseline assessment to the end of the intervention, an average of 5 years
The primary outcome will be the difference in the SI!-Child score (0-100 points for each component, higher scores indicating healthier habits) between the reintervention group and the late intervention group. The SI! Child score includes Sleep (measured as hours of sleep), Diet (fruits and vegetables, sugared beverages, fast-food, legumes and nuts, sweets and pastries), Physical activity (minutes of moderate and vigorous physical activity), Nutritional status (body mass index calculated as body weight divided by height squared (kg/m2).
1 secondary outcome
Effect of the SI! Program reintervention in the individual components of the SI!-Child health score
Time frame: From baseline assessment to the end of the intervention, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 24359285Penalvo JL, Sotos-Prieto M, Santos-Beneit G, Pocock S, Redondo J, Fuster V. The Program SI! intervention for enhancing a healthy lifestyle in preschoolers: first results from a cluster randomized trial. BMC Public Health. 2013 Dec 20;13:1208. doi: 10.1186/1471-2458-13-1208.
- Background: PubMed 23855415Penalvo JL, Santos-Beneit G, Sotos-Prieto M, Martinez R, Rodriguez C, Franco M, Lopez-Romero P, Pocock S, Redondo J, Fuster V. A cluster randomized trial to evaluate the efficacy of a school-based behavioral intervention for health promotion among children aged 3 to 5. BMC Public Health. 2013 Jul 15;13:656. doi: 10.1186/1471-2458-13-656.
- Background: PubMed 26429075Penalvo JL, Santos-Beneit G, Sotos-Prieto M, Bodega P, Oliva B, Orrit X, Rodriguez C, Fernandez-Alvira JM, Redondo J, Vedanthan R, Bansilal S, Gomez E, Fuster V. The SI! Program for Cardiovascular Health Promotion in Early Childhood: A Cluster-Randomized Trial. J Am Coll Cardiol. 2015 Oct 6;66(14):1525-1534. doi: 10.1016/j.jacc.2015.08.014.
- Background: PubMed 30716509Santos-Beneit G, Bodega P, de Miguel M, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, de Cos-Gandoy A, Penalvo JL, Gomez-Pardo E, Oliva B, Ibanez B, Fernandez-Alvira JM, Fernandez-Jimenez R, Fuster V. Rationale and design of the SI! Program for health promotion in elementary students aged 6 to 11 years: A cluster randomized trial. Am Heart J. 2019 Apr;210:9-17. doi: 10.1016/j.ahj.2018.12.011. Epub 2019 Jan 8.
- Background: PubMed 31277052Fernandez-Jimenez R, Santos-Beneit G, Tresserra-Rimbau A, Bodega P, de Miguel M, de Cos-Gandoy A, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, Ibanez B, Storniolo C, Domenech M, Estruch R, Fernandez-Alvira JM, Lamuela-Raventos RM, Fuster V. Rationale and design of the school-based SI! Program to face obesity and promote health among Spanish adolescents: A cluster-randomized controlled trial. Am Heart J. 2019 Sep;215:27-40. doi: 10.1016/j.ahj.2019.03.014. Epub 2019 Apr 10.
- Background: PubMed 35057915Santos-Beneit G, Fernandez-Jimenez R, de Cos-Gandoy A, Rodriguez C, Carral V, Bodega P, de Miguel M, Orrit X, Haro D, Penalvo JL, Fernandez-Alvira JM, Peyra C, Cespedes JA, Turco A, Hunn M, Jaslow R, Baxter J, Carvajal I, Fuster V. Lessons Learned From 10 Years of Preschool Intervention for Health Promotion: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Jan 25;79(3):283-298. doi: 10.1016/j.jacc.2021.10.046.
- Background: PubMed 37531100Santos-Beneit G, Fernandez-Alvira JM, Tresserra-Rimbau A, Bodega P, de Cos-Gandoy A, de Miguel M, Ramirez-Garza SL, Laveriano-Santos EP, Arancibia-Riveros C, Carral V, Orrit X, Rodriguez C, Carvajal I, Haro D, Peyra C, Martinez-Gomez J, Alvarez-Benavides A, Estruch R, Lamuela-Raventos RM, Fernandez-Jimenez R, Fuster V. School-Based Cardiovascular Health Promotion in Adolescents: A Cluster Randomized Clinical Trial. JAMA Cardiol. 2023 Sep 1;8(9):816-824. doi: 10.1001/jamacardio.2023.2231.
- Background: PubMed 39084824Santos-Beneit G, Bodega P, de Cos-Gandoy A, de Miguel M, Rodriguez C, Orrit X, Carral V, Haro D, Carvajal I, Peyra C, Martinez-Gomez J, Fernandez-Alvira JM, Fernandez-Jimenez R, Fuster V. Effect of Time-Varying Exposure to School-Based Health Promotion on Adiposity in Childhood. J Am Coll Cardiol. 2024 Aug 6;84(6):499-508. doi: 10.1016/j.jacc.2024.04.065.
- Derived from this study: PubMed 42034098Santos-Beneit G, de Cos-Gandoy A, Bodega P, Orrit X, Rodriguez C, de Miguel M, Montilla N, Fernandez-Alvira JM, Martinez-Gomez J, Diaz-Munoz R, Haro D, Peyra C, Carvajal I, Fernandez-Jimenez R, Fuster V. Design of the School-Based SI! Program Reintervention Trial for Child Health Promotion. JACC Adv. 2026 May;5(5):102748. doi: 10.1016/j.jacadv.2026.102748. Epub 2026 Apr 24.
- Web of the SHE FoundationLink provided by the sponsor.
- Web of the SI! ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be available upon request, with the approval of the Steering Committee and the signing of a data exchange agreement.
Related trials for Cardiovascular Health
RecruitingObservational study
Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women
Cardiovascular (CV) Risk
RecruitingObservational study
Targeted Health Dialogues in Primary Care
Health Behaviors, Risk Factors
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
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
Mount Sinaí Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reintervention and Late intervention in people with Cardiovascular Health and Obesity, run by Foundation for Science, Health and Education, Spain at 1 site in Spain.
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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in the SI!-Child health score at the end of the intervention (time frame: From baseline assessment to the end of the intervention, an average of 5 years). 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 NCT06715358, which also lists 9 linked publications.
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 16 Sep 2026.