Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 9:20 PM
Study NCT ID:
NCT06792461
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ePlatform for Promoting Health in Schools
Sponsor:
Fundació Sant Joan de Déu
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial to Evaluate the Implementation of an eHealth Platform for Promoting Healthy Habits Among Adolescents From Socially Disadvantaged Settings: the ePro-Schools Project
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ePro-Schools
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 101095426 | OTHER_GRANT | ERA4Health | View |