Clinical trial NCT06792461: Co-design and Implementation of an eHealth Platform for Promoting Healthy Habits Among Adolescents From Socially Disadvantaged Settings
Official title: A Randomized Controlled Trial to Test the Co-design and Implementation of an eHealth Platform for Promoting Healthy Habits Among Adolescents From Socially Disadvantaged Settings: the ePro-Schools Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Level of Physical Activity
Intensity of Physical Activity
Dietary Habits
Keywords: ePro-Schools
eHealth
Healthy habits
Adolescents
Schools
Socially disadvantaged settings
Randomized control trial
eHealth platform
Co-design
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Universitat Autonoma de Barcelona
name: Parc Sanitari Sant Joan de Déu
name: Institut Català de la Salut
name: Universitat Oberta de Catalunya
name: Consorcio Centro Investigación Biomédica en RED (CIBER)-SAM
First posted: 2025-01-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal of this randomized clinical trial called 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 main questions it aims to answer is:

- How does the use of a digital eHealth platform with adolescents from socially disadvantaged settings influence their physical activity levels and dietary habits in the context of secondary school settings?

Researchers will compare a web page with all the contents of the ePro-Schools program through the online platform who participants in the intervention group will have access, to a web page with basic information about health-related habits (healthy eating and physical activity) who participants in the control group will have access, to see if ePro-School program improve physical activity levels and dietary habits in adolescents from socially disadvantaged backgrounds.

Participants will:

* Co-create a digital eHealth platform (ePro-Shcools web page) together, taking part in a survey that will ask about the nutritional and physical activity content that stakeholders would like to have available on the platform.
* To participate in the follow-up asessment for the Alpha and Beta testing of the platform with a qualitative think-aloud user feedback and online-based survey to reduce program disparities and integration of subpopulation-specific demands and to take part in a pilot test too see if the platform is functioning well.
* To use the basic web page (3 secondary schools - control group) or ePro-Shcools web page (3 secondary schools - intervention group).
* To inform about dietary patterns and physical activity habits \[such as fruit intake, vegetable intake, fibre, consumption of added sugar and sugar-sweetened beverages, dairy, whole grains and red (processed meat); types of physical activity, as well as qualitative questions about the performance of this practice\], which will be assessed by dietary and physical activity questionnaires.

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. Evaluate the data from the DESKCohort study about lifestyle behaviours of the adolescent population in Central Catalonia to contextualize the situation and needs of this population and incorporate them in the eHealth platform.
3. Conduct a pilot testing of the ePro-Schools eHealth platform.
4. Conduct a randomized controlled trial (RCT) to test the effectiveness, cost-effectiveness and implementation parameters of the eHealth platform in regard to the physical activity, sedentary behaviour and dietary habits of the adolescents in socially disadvantaged settings.
5. 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.
6. 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 and 2nd of secondary school and in total around 1000 adolescents will be involved. Moreover, physical activity teachers from the selected secondary schools will participate in the study as well (co-creation process and by answering some questionnaires).

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 2): 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 3): 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 4 \& 5): 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 6): 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.

In the same line, we propose de following analysis. First, an implementation analysis will be carried out. These 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 implementation will also be explored, and all qualitative data will be recorded, transcribed, and analyzed.

Moreover, an effectiveness and cost-effectiveness analysis will be carried out. First, a 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 sex, sociodemographic status, and baseline outcomes. Effect size will be calculated using Cohen's coefficient and the Reliable Change Index (RCI) will measure reliable results. Second, 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. Data will be used in a Health Technology Assessment (HTA) to evaluate economic, organizational, and ethical aspects of the intervention.

Eligibility criteria: Inclusion Criteria:

Adolescents:

* Any adolescent studying 1st, 2nd and 3rd of ESO (12-15 years old) in secondary schools from socially disadvantaged settings and belonging to the area of study, Central Catalonia.
* Having the consent to participate from the parents/legal guardians and the adolescent.

Physical activity teachers:

* Any physical education teacher from the selected secondary schools.
* Having the consent to participate.

Exclusion Criteria:

Adolescents:

* Disinterest of the invited schools and uncommitted physical activity teachers.
* If consent to participate from the parents/legal guardians or the adolescent is not obtained.

Physical activity teachers:

* Disinterested or uncommitted physical activity teachers.
* If no consent is obtained.

Primary outcomes:
measure: Level of physical activity
timeFrame: Participants will be evaluated at baseline, at the end of the school year and a follow-up after nine months
measure: Intensity of physical activity
timeFrame: Participants will be evaluated at baseline, at the end of the school year and a follow-up after nine months
measure: Dietary habits
timeFrame: Participants will be evaluated at baseline, at the end of the school year and a follow-up after nine months
Secondary outcomes:
measure: Quality of life
timeFrame: Participants will be evaluated at baseline, at the end of the school year and a follow-up after nine months
measure: Social isolation
timeFrame: Participants will be evaluated at baseline, at the end of the school year and at 2 annual follow ups.
measure: Teachers and Classmate Support
timeFrame: Participants will be evaluated at baseline, at the end of the school year and a follow-up after nine months
measure: Depressive symptomatology
timeFrame: Participants will be evaluated at baseline, at the end of the school year and a follow-up after nine months
measure: Well-being
timeFrame: Participants will be evaluated at baseline, at the end of the school year and a follow-up after nine months
measure: Physical fitness
timeFrame: Participants will be evaluated at baseline, at the end of the school year and a follow-up after nine months
Other outcomes:
Locations:
city: Berga
country: Spain
facility: Institut Guillem de Berguedà
state: Barcelona
city: Els Hostalets de Pierola
country: Spain
facility: Institut Escola Renaixença
state: Barcelona
city: Gironella
country: Spain
facility: Institut Pere Fontdevila
state: Barcelona
city: Navàs
country: Spain
facility: Escola Diocesana de Navàs
state: Barcelona
city: Piera
country: Spain
facility: Institut Escola Piera
state: Barcelona
city: Torelló
country: Spain
facility: Institut Cirviànum
state: Barcelona
Study officials:
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