An interventional study of Physical activity and nutritional behavioural intervention in Health Promotion, Health Education and Physical Activity, sponsored by Fundació Sant Joan de Déu. Recruiting at 1 site in Spain. Open to participants aged 11 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Fundació Sant Joan de Déu · Not applicable, Interventional, and Prevention
There are few public health and educational policies specifically aimed at promoting physical activity, healthy dietary habits, and reducing sedentary behaviour among adolescents from socially disadvantaged backgrounds. ePro-Schools will co-design, pilot and evaluate an evidence-based program, delivered via a modular eHealth platform, to promote physical activity and healthy eating, and reduce time in sedentary behaviours. A profound co-creation process involving adolescents, school staff, and policymakers-alongside the adaptation of previous interventions by consortium members-will support the program's development. The ePro-Schools platform will contain modules for adolescents and their parents, teachers and school administration. Although the platform will be implemented through schools, it will include content to be implemented outside the school setting. The intervention program will be evaluated through a randomised controlled trial conducted in six secondary schools in Central Catalonia that aims to include 1000 adolescents. Schools have been randomised (1:1) into an intervention and a waiting-list control group.
The evaluation of the program includes effectiveness, cost-effectiveness and process evaluation. Physical activity, sedentary behaviour and eating habits are the primary effectiveness outcomes of the trial. Secondary outcomes include fitness, water consumption, quality of life, depressive symptoms, social isolation and sleep quality. Using implementation science methodology, ePro-Schools will co-design transferable evidence-based practices and methodologies and guidance for scaling up the platform with policymakers and stakeholders, as well as informing specialists, policymakers and the general public.
There is limited high-quality information regarding physical activity, sedentary behaviour and dietary habits focusing on adolescents from socially disadvantaged settings. Therefore, there is a limited number of public health and educational policies specifically designed for this population group. The ePro-Schools project will address both knowledge gaps in the state-of the-art by co-designing and testing the effectiveness of an intervention, which includes an eHealth platform (website), for promoting healthy habits among adolescents from socially disadvantaged settings in the area of Central Catalonia. For this reason, the main aim of the ePro-Schools project is to co-design and test the effectiveness of an eHealth platform for promoting healthy habits among adolescents from socially disadvantaged settings. The specific objectives of the project are to:
The study will be conducted in the area of Central Catalonia, particularly in six secondary schools from socially disadvantaged settings (intervention group vs control group size ratio 1:1). We will focus on students attending 1st, 2nd and 3rd year of secondary school, and in total, around 1000 adolescents will be involved. Moreover, physical activity teachers and school staff from the selected secondary schools will participate in the study as well. The families of the adolescents will also be involved in the study.
To achieve all the objectives, the project has several phases:
The RCT will be evaluated regarding its effectiveness, cost-effectiveness and process implementation.
Regarding the effectiveness of the program, statistical analyses will assess the impact of the program using Mixed Methods with Repeated Measurements (MMRM) for continuous data and Generalized Estimating Equations (GEE) for categorical data. The analyses will measure outcomes at both post-intervention and follow-up, adjusting for potential confounders (e.g., sex, sociodemographic status, and baseline outcomes). For the cost-effectiveness, a comparison of costs between the new intervention and regular care will be made, calculating the incremental cost-effectiveness ratio (ICER). The cost-effectiveness will be expressed as cost per Quality-Adjusted Life Year (QALY) gained. The implementation evaluation will focus on evaluating the adoption, acceptability, appropriateness, and feasibility of the program. Adoption will be assessed through multiple indicators, such as questionnaire completion and content interaction, instead of just logins or time spent on the platform. Acceptability and feasibility will be evaluated using questionnaires, interviews, and focus groups during the co-creation phase. Barriers and facilitators to intervention implementation will also be explored.
481 studies on the registry are indexed under Health Education; 110 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 132 across 450 interventional studies indexed under Health Education.
Browse Health Education studies →Fundació Sant Joan de Déu is the lead sponsor of 70 studies on the registry; 19 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adolescents:
Physical Education Teachers:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants (students, parents, teachers, and other school staff) will have access to a series of resources and training with the ultimate goal of promoting healthy lifestyles among adolescents. This material will be delivered via the ePro-Schools platform throughout one school year (2025/26). This platform will be available in web-based format and contents will be provided through two formats: the intervention platform (with content for teachers and students) and the information platform (with content for teachers, students, and families).
Behavioral: Physical activity and nutritional behavioural intervention
Participants in the control group will have access to the information platform, which will contain basic information about health-related habits (healthy eating and physical activity) during the 2025/26 school year. Participants in the control group will have access to the intervention platform after the completion of the trial.
The ePro-Schools intervention includes two digital platforms designed to promote physical activity and healthy nutrition among adolescents: 1. The Intervention Platform, which provides interactive content for both students and PE teachers. 2. The Information Platform, which offers educational resources for students, teachers, and families. The intervention content-currently being refined through a co-creation process-will feature engaging modules focused on physical activity and healthy eating. Adolescents will have access to more than 15 interactive modules, while PE teachers will benefit from 8 targeted pedagogical modules aimed at enhancing their lessons and encouraging greater student participation in physical activity. Control group will have access to the information platform
Physical activity level
The level of physical activity will be measured with the PAQ-A questionnaire. It consists of 10 questions that assess different aspects of physical activity levels, using a 5-point Likert scale, although only 9 questions are used to calculate the final score.
Time frame: Participants will be evaluated at baseline (pre-intervention), at the end of the school year (post-intervention) and at follow-up (nine months after post-intervention)
Physical activity intensities
The intensity of physical activity will be measured with the IPAQ questionnaire. It consists of a series of questions that assess three different intensities of physical activity: light, moderate and vigorous.
Time frame: Participants will be evaluated at baseline (pre-intervention), at the end of the school year (post-intervention) and at follow-up (nine months after post-intervention)
Sedentary behaviour
Sedentary behaviour will be measured with the IPAQ questionnaire using the question regarding sedentary behaviour (time spent in sedentary behaviours)
Time frame: Participants will be evaluated at baseline (pre-intervention), at the end of the school year (post-intervention) and at follow-up (nine months after post-intervention)
Dietary habits
Dietary habits and food consumption that will be assessed by PREDIMED test. This test is based on Mediterranean Diet items regarding healthy eating habits. It is composed by 13 questions. The PREDIMED score will be calculated as follow: \<9 points (classified as low adherence) and \>9 (classified as high adherence). The higher the score, the healthier the adolescent food habits are.
Time frame: Participants will be evaluated at baseline (pre-intervention), at the end of the school year (post-intervention) and at follow-up (nine months after post-intervention)
Child Health Utility
Quality of life which will be assessed by Child Health Utility 9D Index. It is a paediatric generic preference-based measure of health-related quality of life. The questionnaire has 9 questions with 5 response levels per question. Scoring: Each participant's responses define a unique health state, which is converted into a single utility score ranging from 0 (equivalent to being dead) to 1 (full health) considering their country and age group.
Time frame: Participants will be evaluated at baseline (pre-intervention), at the end of the school year (post-intervention) and at follow-up (nine months after post-intervention)
Physical fitness
The physical fitness assessed by the European physical fitness test: Eurofit. It is a standardized set of physical and functional tests designed to assess physical fitness. Teachers will report the students' results since this is a test already implemented in the school. The tests performed are: Cardiorespiratory endurance (20-meter endurance shuttle run), Muscle Strength (standing broad jump), Speed (30m sprint), and Agility (shuttle run: 10 x 5m).
Time frame: Participants will be evaluated at baseline (pre-intervention), at the end of the school year (post-intervention) and at follow-up (nine months after post-intervention)
Water consumption
Participants will be asked how many glasses of water they drink per day.
Time frame: Participants will be evaluated at baseline (pre-intervention), at the end of the school year (post-intervention) and at follow-up (nine months after post-intervention)
Well-being
Well-being assessed by the Kidscreen-10 test. The questionnaire use 5-point Likert-type scales to assess either the frequency (never-seldom-sometimes-often-always) of certain behaviors/feelings or, in a smaller number of cases, the intensity of an attitude (not at all-slightly moderately very-extremely). The Kidscreen-10 test measures quality of life in 10 dimensions: Physical Well-Being, Psychological Well-Being, Moods and Emotions, SelfPerception, Autonomy, Relations with Parents and Home Life, Social Support and Peers, School Environment, Social Acceptance (Bullying) and Financial Resources. Scoring: The scores for the 10 items are summed to produce a total score between 10 and 50 points, where the higher the score, the higher the wellbeing.
Time frame: Participants will be evaluated at baseline (pre-intervention), at the end of the school year (post-intervention) and at follow-up (nine months after post-intervention)
Depressive symptomatology
Depressive symptomatology assessed by the Center for Epidemiological Studies Depression. It is a short self-report scale designed to measure current level of depressive symptomatology, with emphasis on the affective component, depressed mood. Scoring: It has 20 items each scored from 0 (Rarely or at any moment, less than a day) to 3 (Most of the time, 5-7 days).
Time frame: Participants will be evaluated at baseline (pre-intervention), at the end of the school year (post-intervention) and at follow-up (nine months after post-intervention)
Social isolation
The Social isolation questionnaire is composed of 17 items that can be categorised into three domain: feelings of loneliness, friendships, and family support. Scoring: The score can assume values from 0 to 117, with lower scores indicating lower levels of social isolation.
Time frame: Participants will be evaluated at baseline (pre-intervention), at the end of the school year (post-intervention) and at follow-up (nine months after post-intervention)
Sleep Quality
Sleep quality will be evaluated throught the Pittsburgh Sleep Quality Index (PSQI) questionnaire. It is a self-reported questionnaire with 19 questions grouped into 10 items. Scoring: In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21).
Time frame: Participants will be evaluated at baseline (pre-intervention), at the end of the school year (post-intervention) and at follow-up (nine months after post-intervention)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — This information will be used by the Research Group in charge of the investigation/s (in particular, the study researcher and his collaborators, health authorities, the promoter's monitors and auditors) who will be subject to the duty of secrecy inherent in his profession, to verify the data and procedures of the study, but always maintaining confidentiality in accordance with current legislation. For transfers to third countries, only encoded data will be transferred, which will in no case contain information that can directly identify you. Should this transfer occur, it would be for the same purposes described in this document and guaranteeing confidentiality. If a transfer of coded data is made outside the European Economic Area, either to entities related to the center where you participate, to service providers to researchers who collaborate with us, your data will be protected by safeguards such as contracts or other mechanisms established by data protection authorities.
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Fundació Sant Joan de Déu