School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents

December 4, 2024 updated by: Rosa M Lamuela-Raventós, University of Barcelona

School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents: a Cluster-randomized Controlled Trial

Background and objective:

There is an alarming increase in obesity and unhealthy lifestyles in adolescents. This issue threatens to have a highly negative health and socioeconomic impact in the near future. The only way to tackle this epidemic is to implement effective preventive strategies able to positively impact on youth lifestyle behaviours. The school is the most appropriate environment for such an intervention. The main objective of this study is to evaluate the efficacy of a comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles. The project consortium constitutes a unique framework of research groups at the forefront of novel and successful approaches aiming to healthier behaviours and dietary habits.

Methodology:

A cluster-randomized controlled trial involving 24 secondary schools in Spain will be carried out. Schools will be 1:1:1 randomized to receive a short-term (2-year) or a long-term (4-year) comprehensive educational program, or to receive the usual curriculum (control). Participants will be evaluated at baseline, and after 2 and 4 years with the following: weight scale, circumference measuring tape, bioelectrical impedance, dual energy X-ray absorptiometry, sphygmomanometer, blood analysis, saliva and urine analysis, accelerometers, and questionnaires. The primary outcome is the change in obesity and other health parameters from baseline to year 2 and 4, as assessed by the Ideal Cardiovascular Health score. Secondary outcomes include the change in adiposity, anthropometry and body composition parameters, physical activity and dietary habits, polyphenol and carotenoid intake, metabolomics and attitudes. Participants will be measured again when they reach 20 years old.

Expected results:

The investigators expects to show that a school-based educational intervention induces favorable lifestyle changes and improves cardiovascular health among Spanish adolescents, including obesity/adiposity and metabolic profiles. If successful, this strategy could be widely adopted having a meaningful effect on obesity and cardiovascular health promotion. Additionally, associations between health parameters and bioactive dietary compounds intake and metabolic profiles will be stablished.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1326

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • School of Pharmacy. University of Barcelona.
      • Barcelona, Spain, 08037
        • Fundación SHE
      • Madrid, Spain, 28029
        • Centro Nacional de Investigaciones Cardiovasculares Carlos III

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Any student studying the first academic year of secondary school (Enseñanza Secundaria Obligatoria, ESO) in the selected high schools.

Exclusion Criteria:

  • No exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
The usual educational program is applied
Active Comparator: Short Intervention
A two-year specially designed educational program is applied. This program aims to encourage a healthy lifestyle through gamification, including diet education, physical activity and self esteem.
Behavioral: Short-term educational program
Comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles, through classroom intervention, and complementary intervention in the family setting, at school and on teachers.
Active Comparator: Long Intervention
A four-year specially designed educational program is applied. This program aims to encourage a healthy lifestyle through gamification, including diet education, physical activity and self esteem.
Behavioral: Long-term educational program
Comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles, through classroom intervention, and complementary intervention in the family setting, at school and on teachers.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in the composite ICH score of adolescents from baseline to year 2 and 4
Time Frame: 2 and 4 years

The ICH score measures cardiovascular health and includes 7 components:

- Behaviors factors:

  1. No smoking
  2. Being physically active
  3. Good nutritional habits

  4. Normal weight

    - Health factors:

  5. Normal blood pressure
  6. Normal cholesterol level
  7. Normal glucose levels To meet the complete definition of ideal cardiovascular health, an individual would need to meet the ideal levels of all 7 components.
2 and 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in body mass index from baseline to year 2 and 4
Time Frame: 2 and 4 years
Change in body mass index (kg/m^2), calculated after measure weight (kg) and height (meter).
2 and 4 years
Changes in waist circumference from baseline to year 2 and 4
Time Frame: 2 and 4 years
Change in waist circumference (cm) measured in triplicate
2 and 4 years
Changes in percentage of body fat from baseline to year 2 and 4
Time Frame: 2 and 4 years
Change in total adiposity measured by bioelectrical impedance (percentage of fat).
2 and 4 years
Changes in distribution of body fat from baseline to year 2 and 4
Time Frame: 2 and 4 years
Change in adiposity distribution measured by dual energy X-ray absorptiometry, that calculate total body fat, regional fat, including android, gynoid, visceral and lean mass.
2 and 4 years
Changes in dietary habits from baseline to year 2 and 4
Time Frame: 2 and 4 years
To evaluate the association between food and nutrient intake and changes in adiposity parameters. To assess changes in diet and adherence to the Mediterranean diet a validated Food Frequency Questionnaire (FFQ) (Tresserra-Rimbau et al., 2013) will be used. A shorter FFQ (Children's Eating Habits Questionnaire - Food Frequency Questionnaire (CEHQ-FFQ) (Lanfer et al., 2011; Bel-Serrat et al. 2014)) will also be used to analyze dietary patterns.
2 and 4 years
Changes in attitudes about eating from baseline to year 2 and 4 [ Time Frame: 2 and 4 years
Time Frame: 2 and 4 years
To evaluate the relationship between changes in attitudes and changes in adiposity parameters. A validated questionnaire will be used to assess attitudes about eating (Lima-Serrano et al., 2012).
2 and 4 years
Changes in polyphenol consumption from baseline to year 2 and 4
Time Frame: 2 and 4 years
Dietary polyphenol (PP) intake will be estimated from FFQ and data from the PP content in foods, obtained from the Phenol-explorer data base. With this methodology, it can obtain an estimation of total PP intake by each individual and different PP classes. For the determination of phenolics and their metabolites in human urine, will be used solid-phase extraction and ultra-HPLC coupled to mass spectrometry (Martinez-Huelamo et al., 2015).
2 and 4 years
Changes in carotenoids consumption from baseline to year 2 and 4
Time Frame: 2 and 4 years
Carotenoids and retinol consumption will be also estimated from the longer FFQ. Total energy and micronutrient intake will be obtained using the Food Processor Nutrition and Fitness Software (ESHA Research, Salem, OR).
2 and 4 years
Changes in energy and nutrients consumption from baseline to year 2 and 4
Time Frame: 2 and 4 years
Total energy and micronutrient intake will be obtained from a validated Food Frequency Questionnaire (Tresserra-Rimbau et al., 2013) using the Food Processor Nutrition and Fitness Software.
2 and 4 years
Changes in metabolomics from baseline to year 2 and 4
Time Frame: 2 and 4 years
To evaluate the effect of the intervention on metabolism through a metabolomic approach. Urine and salivary samples will be collected to perform a metabolomics analysis in order to evaluate metabolic changes due to educational intervention on dietary and physical activity habits. Liquid chromatography coupled to quadrupole time of-flight mass spectrometry (HPLC-q-TOF) will be used for such analysis which is able to measure thousands of metabolites simultaneously from only minimal amounts of sample. Data mining analysis will be performed using XCMS-R package. The preprocessed data obtained by XCMS in negative and positive ionization will be separately exported to SIMCA 13.0.3 software (Umetrics) to perform unsupervised and supervised multivariate analysis to detect metabolic changes among groups.
2 and 4 years
Changes in physical activity from baseline to year 2 and 4
Time Frame: 2 and 4 years
To study the association between changes in physical activity and changes in adiposity parameters . Actigraph wGT3X-BT accelerometers that allow the registration of the amount and intensity of physical activity will be used during 7 days per evaluation time-point. To complete this information a diary with questions about the type of physical activity performed during the 7 days will be collected. A validated questionnaire will be also used to assess physical activity habits (Barbosa et al., 2007).
2 and 4 years
Changes in sedentary habits from baseline to year 2 and 4
Time Frame: 2 and 4 years
To study the association between changes in sedentary habits and changes in adiposity parameters. Information on sedentary time from Actigraph wGT3X-BT accelerometers will be taken into account. In addition, we will measure sedentary leisure time spent with the computer/console/TV /mobile (ENSE 2012).
2 and 4 years
Changes in attitudes towards abuse substances from baseline to year 2 and 4
Time Frame: 2 and 4 years
The attitudes towards abuse substances will be assessed by a validated questionnaire (Lima-Serrano et al., 2013). An additional questionnaire will be used to assess self-efficacy (Markham et al., 2009).
2 and 4 years
Changes in smoking habits from baseline to year 2 and 4
Time Frame: 2 and 4 years
Validated questionnaires will be used to assess smoking status itself, and in its immediate environment (Moreno et al., 2012 Lana, 2010).
2 and 4 years
Changes in perception of the self-image from baseline to year 2 and 4
Time Frame: 2 and 4 years
A questionnaire to assess the perception of the self-image will be used to obtain a pattern of individual acceptance with his/her figure (Stunkard et al., 1990).
2 and 4 years
Changes in self-esteem from baseline to year 2 and 4
Time Frame: 2 and 4 years
Self-esteem will be assessed using validated questionnaire (Rajmil et al., 2003).
2 and 4 years
Changes in emotional eating from baseline to year 2 and 4
Time Frame: 2 and 4 years
Emotional eating will be assessed using validated questionnaire (Jauregui-Lobera et al., 2014)
2 and 4 years
Changes in mood from baseline to year 2 and 4
Time Frame: 2 and 4 years
Self-efficacy will be assessed using a validated questionnaire (Vázquez Fernández et al., 2013).
2 and 4 years
Evaluation of the shorter vs. longer educational intervention effectiveness by comparison of 2 and 4 year results on all outcomes
Time Frame: 4 years
The effectiveness of a shorter vs. longer educational intervention program (2 and 4 year) will be assessed by comparison of final (4 year) results on all proposed outcomes.
4 years
Cardiovascular score validation
Time Frame: 4 years
The BEWAT score, which includes the assessment of Blood pressure, Exercise, Weight, Alimentation (fruit and vegetables) and Tobacco consumption, will be also derived. This simple and non-invasive score (score from 0 to 15 points) will be validated against the ICH score, and will serve for future studies in adolescents.
4 years
Changes in the composite ICH score of adolescents from baseline to adulthood
Time Frame: 8 years
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Barcelona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundació La Marató de TV3
SHE Foundation
Centro Nacional de Investigaciones Cardiovasculares Carlos III
Obra social La Caixa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rosa M Lamuela-Raventós, PhD, University of Barcelona
  • Principal Investigator: Gloria Santos-Beneit, PhD, SHE Foundation
  • Principal Investigator: Juan M Fernández Alvira, PhD, Centro Nacional de Investigaciones Cardiovasculares Carlos III
  • Principal Investigator: Valentín Fuster, PhD, MD, Centro Nacional de Investigaciones Cardiovasculares Carlos III

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 369/C/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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