ePlatform for Promoting Health in Schools
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-16
SponsorFundació Sant Joan de Déu
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Individuals (adolescents or teachers) who do not provide written informed consent will be excluded.
No other exclusion criteria will be applied.
Trial design
Design model
Parallel
Treatments tested in this trial
Physical activity and nutritional behavioural intervention
BehavioralThe 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
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
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)2
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.
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)3
Sedentary behaviour
Sedentary behaviour will be measured with the IPAQ questionnaire using the question regarding sedentary behaviour (time spent in sedentary behaviours)
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)4
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.
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)Secondary outcomes
1
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.
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)2
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).
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)3
Water consumption
Participants will be asked how many glasses of water they drink per day.
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)4
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.
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundació Sant Joan de Déu
Lead sponsor
Universitat Autonoma de Barcelona
Collaborator
Parc Sanitari Sant Joan de Déu
Collaborator
Universitat Oberta de Catalunya
Collaborator
Consorcio Centro Investigación Biomédica en RED (CIBER)-SAM
Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborator
Utrecht University
Collaborator
Klaipėda University
Collaborator
Technical University of Munich
Collaborator
Riga Stradins University
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Wuerzburg University Hospital
Collaborator
Source ClinicalTrials.gov