Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
1000 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-09-30
Study Completion Date
2027-03-31
Brief Summary
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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.
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.
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Detailed Description
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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:
1. Co-design with adolescents and teachers from secondary schools and policymakers in socially disadvantaged settings a modular and digital eHealth platform for promoting healthy habits among adolescents.
2. Pilot test with adolescents and teachers from secondary schools the ePro-Schools platform
3. Conduct a randomized controlled trial (RCT) in a group of schools located in socially disadvantaged settings in Catalonia to evaluate the effectiveness, cost-effectiveness and implementation parameters of the ePro-Schools program in regard to physical activity, sedentary behaviour and dietary habits of adolescents in socially disadvantaged settings.
4. Evaluate to which extend changes in lifestyle behaviours (physical activity, sedentary behaviour and dietary habits) are associated with physical and mental health in adolescents from socially disadvantaged settings.
5. Co-design with adolescents, teachers and policymakers transferable evidence-based practices, methodologies and guidance for upscaling of the ePro-Schools platform as a public mental health policy for youth, and present it to EU, national and regional policymaker.
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:
1. Co-design (Objective 1): The platform will be co-created with input from various stakeholders-adolescents, teachers, school administrators, and policymakers. Focus group sessions with teachers and school directors will shape the content and features of the platform, while policymakers will provide feedback on potential barriers and strategies for large-scale implementation.
2. Project Survey (Objective 1): A survey will be conducted with teachers and students to gather feedback on the platform's content, particularly regarding physical activity and nutrition.
3. Pilot Testing (Objective 2): After the co-creation phase, alpha and beta testing of the platform will occur, including feedback from stakeholders and experts. A pilot test will assess usability, functionality, and integration of feedback to refine the platform before the main trial.
4. Randomized Controlled Trial and Evaluation (Objectives 3 \& 4): In a randomized controlled trial, control group will receive basic health-related information, while the intervention group will use the ePro-Schools platform. Participants will be evaluated at multiple time points to assess the impact on lifestyle behaviors, physical health, and mental well-being.
5. Co-design of Transferable Practices (Objective 5): A concluding workshop with stakeholders will consolidate findings and generate actionable recommendations for scaling the platform, resulting in a policy translation report to guide broader implementation.
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.
1. Co-design with adolescents and teachers from secondary schools and policymakers in socially disadvantaged settings a modular and digital eHealth platform for promoting healthy habits among adolescents.
2. Pilot test with adolescents and teachers from secondary schools the ePro-Schools platform
3. Conduct a randomized controlled trial (RCT) in a group of schools located in socially disadvantaged settings in Catalonia to evaluate the effectiveness, cost-effectiveness and implementation parameters of the ePro-Schools program in regard to physical activity, sedentary behaviour and dietary habits of adolescents in socially disadvantaged settings.
4. Evaluate to which extend changes in lifestyle behaviours (physical activity, sedentary behaviour and dietary habits) are associated with physical and mental health in adolescents from socially disadvantaged settings.
5. Co-design with adolescents, teachers and policymakers transferable evidence-based practices, methodologies and guidance for upscaling of the ePro-Schools platform as a public mental health policy for youth, and present it to EU, national and regional policymaker.
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:
1. Co-design (Objective 1): The platform will be co-created with input from various stakeholders-adolescents, teachers, school administrators, and policymakers. Focus group sessions with teachers and school directors will shape the content and features of the platform, while policymakers will provide feedback on potential barriers and strategies for large-scale implementation.
2. Project Survey (Objective 1): A survey will be conducted with teachers and students to gather feedback on the platform's content, particularly regarding physical activity and nutrition.
3. Pilot Testing (Objective 2): After the co-creation phase, alpha and beta testing of the platform will occur, including feedback from stakeholders and experts. A pilot test will assess usability, functionality, and integration of feedback to refine the platform before the main trial.
4. Randomized Controlled Trial and Evaluation (Objectives 3 \& 4): In a randomized controlled trial, control group will receive basic health-related information, while the intervention group will use the ePro-Schools platform. Participants will be evaluated at multiple time points to assess the impact on lifestyle behaviors, physical health, and mental well-being.
5. Co-design of Transferable Practices (Objective 5): A concluding workshop with stakeholders will consolidate findings and generate actionable recommendations for scaling the platform, resulting in a policy translation report to guide broader implementation.
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.
Conditions
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Health Promotion
Health Education
Physical Activity
Nutrition
Behaviour Change
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Schools will be randomized to one of the two groups and all students, their families, teachers and other school staff within those schools will be placed in the respective group.
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Intervention group
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).
Group Type
EXPERIMENTAL
Physical activity and nutritional behavioural intervention
Intervention Type
BEHAVIORAL
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
Control group
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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Physical activity and nutritional behavioural intervention
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
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
Adolescents:
* Students enrolled in 1st, 2nd, or 3rd year of ESO (ages approximately 11-16) at participating secondary schools located in the Central Catalonia region, particularly those in socially disadvantaged settings.
* All genders will be eligible.
* Written informed consent must be provided by both the adolescent and their parent(s)/legal guardian(s).
Physical Education Teachers:
* Physical education teachers currently working at the participating secondary schools.
* Must be 18 years of age or older.
* Must provide written informed consent to participate.
* Students enrolled in 1st, 2nd, or 3rd year of ESO (ages approximately 11-16) at participating secondary schools located in the Central Catalonia region, particularly those in socially disadvantaged settings.
* All genders will be eligible.
* Written informed consent must be provided by both the adolescent and their parent(s)/legal guardian(s).
Physical Education Teachers:
* Physical education teachers currently working at the participating secondary schools.
* Must be 18 years of age or older.
* Must provide written informed consent to participate.
Exclusion Criteria
* Individuals (adolescents or teachers) who do not provide written informed consent will be excluded.
Minimum Eligible Age
11 Years
Maximum Eligible Age
16 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Universitat Autonoma de Barcelona
OTHER
Sponsor Role
collaborator
Parc Sanitari Sant Joan de Déu
OTHER
Sponsor Role
collaborator
Universitat Oberta de Catalunya
OTHER
Sponsor Role
collaborator
Consorcio Centro Investigación Biomédica en RED (CIBER)-SAM
UNKNOWN
Sponsor Role
collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Sponsor Role
collaborator
Utrecht University
OTHER
Sponsor Role
collaborator
Klaipėda University
OTHER
Sponsor Role
collaborator
Technical University of Munich
OTHER
Sponsor Role
collaborator
Riga Stradins University
OTHER
Sponsor Role
collaborator
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Sponsor Role
collaborator
Wuerzburg University Hospital
OTHER
Sponsor Role
collaborator
Fundació Sant Joan de Déu
OTHER
Sponsor Role
lead
Responsible Party
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Rodrigo Antunes Lima
Researcher
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Rodrigo Antunes Lima, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundació Sant Joan de Déu
Locations
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Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, Spain
Site Status
RECRUITING
Countries
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Spain
Central Contacts
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Facility Contacts
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References
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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101095426
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
24/099-P
Identifier Type: -
Identifier Source: org_study_id
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