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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Physical activity intensities
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Individuals (adolescents or teachers) who do not provide written informed consent will be excluded.
- •No other exclusion criteria will be applied.
结局指标
主要结局
Physical activity intensities
时间窗: 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
时间窗: 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
时间窗: 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.
Physical activity level
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Water consumption(Participants will be evaluated at baseline (pre-intervention), at the end of the school year (post-intervention) and at follow-up (nine months after post-intervention))
- Child Health Utility(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(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(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(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(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(Participants will be evaluated at baseline (pre-intervention), at the end of the school year (post-intervention) and at follow-up (nine months after post-intervention))
- Child Health Utility(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(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 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(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(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(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(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))
研究者
Rodrigo Antunes Lima
Researcher
Fundació Sant Joan de Déu