Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03504059
Recruitment Status : Active, not recruiting
First Posted : April 20, 2018
Last Update Posted : January 21, 2019
Sponsor:
Collaborators:
SHE Foundation
Centro Nacional de Investigaciones Cardiovasculares Carlos III
Fundació La Marató de TV3
Obra social La Caixa
Information provided by (Responsible Party):
Rosa M Lamuela-Raventós, University of Barcelona

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Cardiovascular Health Diabetes Mellitus Behavioral: Long-term educational program Behavioral: Short-term educational program Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents: a Cluster-randomized Controlled Trial
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2025

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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

  3. 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).

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. 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).

  9. 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.

  10. 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.

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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)

  18. 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).

  19. 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.

  20. 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.

  21. Changes in the composite ICH score of adolescents from baseline to adulthood [ Time Frame: 8 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504059


Locations
Layout table for location information
Spain
School of Pharmacy. University of Barcelona.
Barcelona, Spain, 08028
Fundación SHE
Barcelona, Spain, 08037
Centro Nacional de Investigaciones Cardiovasculares Carlos III
Madrid, Spain, 28029
Sponsors and Collaborators
University of Barcelona
SHE Foundation
Centro Nacional de Investigaciones Cardiovasculares Carlos III
Fundació La Marató de TV3
Obra social La Caixa
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Rosa M Lamuela-Raventós, Associate Professor, University of Barcelona
ClinicalTrials.gov Identifier: NCT03504059     History of Changes
Other Study ID Numbers: 369/C/2016
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rosa M Lamuela-Raventós, University of Barcelona:
Obesity
Cardiovascular Health
Diabetes
Adolescents
Physical Activity
Diet
School-Based

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms