Health PromotionePro-SchoolsNCT06792461
ePlatform for Promoting Health in Schools
A study testing Physical activity and nutritional behavioural intervention in people with Health Promotion and Health Education, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Promotion, Health Education, Physical Activity
- What is being tested?
- Physical activity and nutritional behavioural intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 8 Sep 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Individuals (adolescents or teachers) who do not provide written informed consent will be excluded.
- No other exclusion criteria will be applied.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mariona Perez Anton, MSc contact
Spain1 site, 1 recruiting
- Recruiting
Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, 08242
Rodrigo Antunes Lima, PhD, +34 93 640 63 50 ext. Ext. 127, rodrigoantunes.lima@sjd.es
Mariona Perez Anton, MSc, mariona.pereza@sjd.es
About this study
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
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.
Read the 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:
- 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.
- Pilot test with adolescents and teachers from secondary schools the ePro-Schools platform
- 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.
- 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.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- Being tested
- Physical activity and nutritional behavioural intervention
- Keywords
- eHealth, Adolescents, Socially disadvantaged settings, Randomized control trial, Co-design, School-based interventions, Health promotion
- Medical subject headings
- Health Education, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity and nutritional behavioural interventionBehavioural
The ePro-Schools intervention includes two digital platforms designed to promote physical activity and healthy nutrition among adolescents:
- The Intervention Platform, which provides interactive content for both students and PE teachers.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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). Receives: Behavioral: Physical activity and nutritional behavioural intervention |
| Control group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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)
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start8 Sep 2025
- Primary completionJul 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona, Parc Sanitari Sant Joan de Déu, Universitat Oberta de Catalunya, Consorcio Centro Investigación Biomédica en RED (CIBER)-SAM, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Utrecht University, Klaipėda University, Technical University of Munich, Riga Stradins University, Institut National de la Santé Et de la Recherche Médicale, France, Wuerzburg University Hospital
- Responsible party
- Principal investigator, Rodrigo Antunes Lima, Fundació Sant Joan de Déu
- Investigators
- Rodrigo Antunes Lima, PhD, Principal investigator, Fundació Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792461
- Sponsor's protocol ID
- 24/099-P
- Other IDs
- 101095426
- Acronym
- ePro-Schools
- Status last verified
- Apr 2026
- First submitted
- 14 Jan 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Kraft R, Hofmann F, Reichert M, Pryss R. Dealing With Inaccurate Sensor Data in the Context of Mobile Crowdsensing and mHealth. IEEE J Biomed Health Inform. 2022 Nov;26(11):5439-5449. doi: 10.1109/JBHI.2022.3198254. Epub 2022 Nov 10.
PubMed 35951560Reis RS, Salvo D, Ogilvie D, Lambert EV, Goenka S, Brownson RC; Lancet Physical Activity Series 2 Executive Committee. Scaling up physical activity interventions worldwide: stepping up to larger and smarter approaches to get people moving. Lancet. 2016 Sep 24;388(10051):1337-48. doi: 10.1016/S0140-6736(16)30728-0. Epub 2016 Jul 28.
PubMed 27475273Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Lee WJ, Peng LN, Lin CH, Chen RC, Lin SZ, Loh CH, Kao SL, Hung TS, Chang CY, Huang CF, Tang TC, Huang ST, Wen YW, Hsiao FY, Chen LK; Taiwan Integrated Geriatric Care Study Group. Effects of incorporating multidomain interventions into integrated primary care on quality of life: a randomised controlled trial. Lancet Healthy Longev. 2021 Nov;2(11):e712-e723. doi: 10.1016/S2666-7568(21)00248-8. Epub 2021 Oct 22.
PubMed 36098028Goodman R, Meltzer H, Bailey V. The Strengths and Difficulties Questionnaire: a pilot study on the validity of the self-report version. Eur Child Adolesc Psychiatry. 1998 Sep;7(3):125-30. doi: 10.1007/s007870050057.
PubMed 9826298Ringdal R, Bradley Eilertsen ME, Bjornsen HN, Espnes GA, Moksnes UK. Validation of two versions of the Warwick-Edinburgh Mental Well-Being Scale among Norwegian adolescents. Scand J Public Health. 2018 Nov;46(7):718-725. doi: 10.1177/1403494817735391. Epub 2017 Oct 10.
PubMed 29017402Bae S, Chung T, Ferreira D, Dey AK, Suffoletto B. Mobile phone sensors and supervised machine learning to identify alcohol use events in young adults: Implications for just-in-time adaptive interventions. Addict Behav. 2018 Aug;83:42-47. doi: 10.1016/j.addbeh.2017.11.039. Epub 2017 Nov 27.
PubMed 29217132Moshe I, Terhorst Y, Opoku Asare K, Sander LB, Ferreira D, Baumeister H, Mohr DC, Pulkki-Raback L. Predicting Symptoms of Depression and Anxiety Using Smartphone and Wearable Data. Front Psychiatry. 2021 Jan 28;12:625247. doi: 10.3389/fpsyt.2021.625247. eCollection 2021.
PubMed 33584388Dominguez-Berjon MF, Borrell C, Cano-Serral G, Esnaola S, Nolasco A, Pasarin MI, Ramis R, Saurina C, Escolar-Pujolar A. [Constructing a deprivation index based on census data in large Spanish cities(the MEDEA project)]. Gac Sanit. 2008 May-Jun;22(3):179-87. doi: 10.1157/13123961. Spanish.
PubMed 18579042Geissler J, Buchholz H, Meerson R, Kammerer K, Goster M, Schobel J, Ratz C, Taurines R, Pryss R, Romanos M. Smartphone-based behaviour analysis for challenging behaviour in intellectual and developmental disabilities and autism spectrum disorder - Study protocol for the ProVIA trial. Front Neurosci. 2022 Oct 13;16:984618. doi: 10.3389/fnins.2022.984618. eCollection 2022.
PubMed 36312036Vogel C, Schobel J, Schlee W, Engelke M, Pryss R. UNITI Mobile-EMI-Apps for a Large-Scale European Study on Tinnitus. Annu Int Conf IEEE Eng Med Biol Soc. 2021 Nov;2021:2358-2362. doi: 10.1109/EMBC46164.2021.9630482.
PubMed 34891756Schobel J, Pryss R, Probst T, Schlee W, Schickler M, Reichert M. Learnability of a Configurator Empowering End Users to Create Mobile Data Collection Instruments: Usability Study. JMIR Mhealth Uhealth. 2018 Jun 29;6(6):e148. doi: 10.2196/mhealth.9826.
PubMed 29959107Carducci B, Oh C, Keats EC, Roth DE, Bhutta ZA. Effect of Food Environment Interventions on Anthropometric Outcomes in School-Aged Children and Adolescents in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis. Curr Dev Nutr. 2020 May 26;4(7):nzaa098. doi: 10.1093/cdn/nzaa098. eCollection 2020 Jul.
PubMed 32666031Jacob CM, Hardy-Johnson PL, Inskip HM, Morris T, Parsons CM, Barrett M, Hanson M, Woods-Townsend K, Baird J. A systematic review and meta-analysis of school-based interventions with health education to reduce body mass index in adolescents aged 10 to 19 years. Int J Behav Nutr Phys Act. 2021 Jan 4;18(1):1. doi: 10.1186/s12966-020-01065-9.
PubMed 33397403Liu L, Villavicencio F, Yeung D, Perin J, Lopez G, Strong KL, Black RE. National, regional, and global causes of mortality in 5-19-year-olds from 2000 to 2019: a systematic analysis. Lancet Glob Health. 2022 Mar;10(3):e337-e347. doi: 10.1016/S2214-109X(21)00566-0.
PubMed 35180417
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06792461
- Acronym / sponsor ID
- ePro-Schools / 24/099-P
- Keywords
- eHealth, Adolescents, Socially disadvantaged settings, Randomized control trial, Co-design, School-based interventions, Health promotion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona, Parc Sanitari Sant Joan de Déu, Universitat Oberta de Catalunya, Consorcio Centro Investigación Biomédica en RED (CIBER)-SAM, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Utrecht University, Klaipėda University, Technical University of Munich, Riga Stradins University, Institut National de la Santé Et de la Recherche Médicale, France, Wuerzburg University Hospital
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- Pilot test with adolescents and teachers from secondary schools the ePro-Schools platform
- 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.
- 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.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Physical activity and nutritional behavioural interventionParticipants (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). |
| Control group | No 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. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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 currently working at the participating secondary schools.
- Must be 18 years of age or older.
Key exclusion criteria (2 listed)
- Individuals (adolescents or teachers) who do not provide written informed consent will be excluded.
- No other exclusion criteria will be applied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity and nutritional behavioural interventionThe 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 | Behavioural | Intervention group |
Primary outcome
Physical activity level
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)
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.
Physical activity intensities
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)
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.
Sedentary behaviour
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 will be measured with the IPAQ questionnaire using the question regarding sedentary behaviour (time spent in sedentary behaviours)
Dietary habits
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 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.
7 secondary outcomes
Child Health Utility
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
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
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
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
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
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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- Background: PubMed 27475273Reis RS, Salvo D, Ogilvie D, Lambert EV, Goenka S, Brownson RC; Lancet Physical Activity Series 2 Executive Committee. Scaling up physical activity interventions worldwide: stepping up to larger and smarter approaches to get people moving. Lancet. 2016 Sep 24;388(10051):1337-48. doi: 10.1016/S0140-6736(16)30728-0. Epub 2016 Jul 28.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 36098028Lee WJ, Peng LN, Lin CH, Chen RC, Lin SZ, Loh CH, Kao SL, Hung TS, Chang CY, Huang CF, Tang TC, Huang ST, Wen YW, Hsiao FY, Chen LK; Taiwan Integrated Geriatric Care Study Group. Effects of incorporating multidomain interventions into integrated primary care on quality of life: a randomised controlled trial. Lancet Healthy Longev. 2021 Nov;2(11):e712-e723. doi: 10.1016/S2666-7568(21)00248-8. Epub 2021 Oct 22.
- Background: PubMed 9826298Goodman R, Meltzer H, Bailey V. The Strengths and Difficulties Questionnaire: a pilot study on the validity of the self-report version. Eur Child Adolesc Psychiatry. 1998 Sep;7(3):125-30. doi: 10.1007/s007870050057.
- Background: PubMed 29017402Ringdal R, Bradley Eilertsen ME, Bjornsen HN, Espnes GA, Moksnes UK. Validation of two versions of the Warwick-Edinburgh Mental Well-Being Scale among Norwegian adolescents. Scand J Public Health. 2018 Nov;46(7):718-725. doi: 10.1177/1403494817735391. Epub 2017 Oct 10.
- Background: PubMed 29217132Bae S, Chung T, Ferreira D, Dey AK, Suffoletto B. Mobile phone sensors and supervised machine learning to identify alcohol use events in young adults: Implications for just-in-time adaptive interventions. Addict Behav. 2018 Aug;83:42-47. doi: 10.1016/j.addbeh.2017.11.039. Epub 2017 Nov 27.
- Background: PubMed 33584388Moshe I, Terhorst Y, Opoku Asare K, Sander LB, Ferreira D, Baumeister H, Mohr DC, Pulkki-Raback L. Predicting Symptoms of Depression and Anxiety Using Smartphone and Wearable Data. Front Psychiatry. 2021 Jan 28;12:625247. doi: 10.3389/fpsyt.2021.625247. eCollection 2021.
- Background: PubMed 18579042Dominguez-Berjon MF, Borrell C, Cano-Serral G, Esnaola S, Nolasco A, Pasarin MI, Ramis R, Saurina C, Escolar-Pujolar A. [Constructing a deprivation index based on census data in large Spanish cities(the MEDEA project)]. Gac Sanit. 2008 May-Jun;22(3):179-87. doi: 10.1157/13123961. Spanish.
- Background: PubMed 36312036Geissler J, Buchholz H, Meerson R, Kammerer K, Goster M, Schobel J, Ratz C, Taurines R, Pryss R, Romanos M. Smartphone-based behaviour analysis for challenging behaviour in intellectual and developmental disabilities and autism spectrum disorder - Study protocol for the ProVIA trial. Front Neurosci. 2022 Oct 13;16:984618. doi: 10.3389/fnins.2022.984618. eCollection 2022.
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- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariona Perez Anton, MSc contact
Rodrigo Antunes Lima, PhD principal investigator
Fundació Sant Joan de Déu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and nutritional behavioural intervention in people with Health Promotion and Health Education, run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Antunes Lima, PhD (+34 93 640 63 50 ext. Ext. 12719, rodrigoantunes.lima@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06792461, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.