The Program SI! for Cardiovascular Health Promotion at Elementary School

Status Completed

Clinical Trial Summary

The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers and parents). For this purpose, 48 public schools from the Community of Madrid-South Area (Spain) were randomly assigned to Program SI! during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, their parents and teachers in regards to a healthy lifestyle. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry.

Clinical Trial Description

The Program SI! is a multilevel school-based intervention integrating four cardiovascular health-related components (diet, physical activity, human body and emotions management). Since the Program SI! for preschoolers has shown good results in improving healthy lifestyle habits in children aged 3 to 5 years, the investigators have developed the Program SI! for Elementary addressed to children from 6 to 11 years. The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers, parents and school). In the Community of Madrid-South Area (Spain), 48 public schools from were randomly assigned to Program SI! for Elementary during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, and the secondary outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of their parents and teachers in regards to a healthy lifestyle, as well as changes in the school environment. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry (weight, height, waist circumference and skinfold thickness). The Program SI! for Elementary is designed for different exposures in a sample of schools never intervened to asses when the intervention has the most effectiveness. Besides, as some schools involved in the preschool study continues the Program SI! for Elementary, the investigators can be able to evaluate the impact of the Program SI! in different school stages, concluding how children keep the adoption of healthy behaviors from early in life. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02428634
Study type	Interventional
Source	Foundation for Science, Health and Education, Spain
Contact
Status	Completed
Phase	N/A
Start date	October 2014
Completion date	June 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02122198` - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women	N/A
Completed	`NCT02502812` - Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects	Phase 1
Recruiting	`NCT04216342` - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers	Phase 1
Completed	`NCT03654313` - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus	Phase 1
Completed	`NCT03646656` - Heart Health Buddies: Peer Support to Decrease CVD Risk	N/A
Completed	`NCT02081066` - Identification of CETP as a Marker of Atherosclerosis	N/A
Completed	`NCT02147626` - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia	N/A
Not yet recruiting	`NCT06405880` - Pharmacist Case Finding and Intervention for Vascular Prevention Trial	N/A
Recruiting	`NCT03095261` - Incentives in Cardiac Rehabilitation	N/A
Completed	`NCT02711878` - Healing Hearts and Mending Minds in Older Adults Living With HIV	N/A
Not yet recruiting	`NCT02578355` - National Plaque Registry and Database	N/A
Completed	`NCT02868710` - Individual Variability to Aerobic Exercise Training	N/A
Completed	`NCT02998918` - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL	N/A
Completed	`NCT02589769` - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons	N/A
Recruiting	`NCT02885792` - Coronary Artery Disease in Patients Suffering From Schizophrenia	N/A
Completed	`NCT02657382` - Mental Stress Ischemia: Biofeedback Study	N/A
Completed	`NCT02272946` - Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk	Phase 2
Completed	`NCT02640859` - Investigation of Metabolic Risk in Korean Adults
Completed	`NCT02652975` - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium	N/A
Recruiting	`NCT02265250` - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Program SI! for Cardiovascular Health Promotion at Elementary School — PSIE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms