Evaluation of a Digital School-Based Intervention for the Primary Prevention of Eating Disorders in Pre-Adolescents (PRETA Program)
NCT ID: NCT06792981
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1068 participants
INTERVENTIONAL
2025-03-10
2025-12-31
Brief Summary
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Eating Disorders (ED) are mental health conditions, characterized by pathological behaviors toward food intake or a persistent obsession with weight control. EDs have a high prevalence among pre-adolescents in developed countries and pose a significant economic burden. Preventive interventions targeting at-risk populations for ED have proven effective. The use of Information and Communication Technologies (ICTs) facilitates access to larger population groups while also reducing costs.
Objectives:
* Develop and validate a universally applied intervention (PRETA), mediated by ICTs, to reduce eating-disorder risk and modifiable risk factors, through cultural adaptation and adjustment of the POtsdam Prevention at Schools (POPS) Program to preadolescents.
* Assess the efficacy of the PRETA Program through a randomized controlled trial (RCT).
* Evaluate the efficiency of the PRETA Program from a social perspective. Methodology The PRETA Program uses 9 online sessions with interactive activities for pre- adolescents, plus education for their families and teachers.
Its content includes addressing key factors in the development of ED, such as eating habits, beauty standards, and media literacy, as well as activities aimed at strengthening psychological dimensions (self-esteem, emotional regulation, problem-solving, psychological flexibility, and resilience) and social skills, including communication styles and distinguishing between jokes and bullying.
The study involves schools being randomly assigned to either the PRETA Program or regular health activities. The effect of the intervention will be evaluated 3 months after its start.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention Group
Participants in the intervention group will complete a baseline assessment and receive project information. Then, students from the schools randomly allocated to the intervention group will participate in the PRETA program, specifically designed for the primary prevention of Eating Disorders (ED) in a school setting. These sessions will involve educational activities and participatory dynamics to foster a healthy relationship with body image and eating. At the end of the program, participants will complete questionnaires to assess the outcomes.
Additionally, parents and teachers in the intervention group will receive targeted training and resources.
Universal primary prevention program based on ICTs
The intervention adopts a multicomponent approach, addressing three agents in the prevention and management of eating disorders: parents, teachers and students.
1. Intervention with parents:
Parents will receive specific materials, including an informative guide on early identification of warning signs, promoting healthy lifestyle habits, and fostering effective communication with their children.
2. Intervention with teachers:
A two-hour in-person session will train teachers on platform use and provide tools for eating disorder prevention through role-playing techniques. Online resources will complement the training, while researchers ensure adherence via weekly follow-ups and parent reminders.
3. e-Preta program: The intervention for minors is delivered through an online platform, structured into 9 sessions of 45 minutes each, over 3 months. Weekly, platform-guided activities are proposed for classroom use with minimal teacher interaction, along with voluntary at-home activities.
Control Group
The students randomly allocated to control condition will not receive any type of intervention. They will continue with their regular school activities but will complete the questionnaires and surveys to contrast the effects of the intervention.
No interventions assigned to this group
Interventions
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Universal primary prevention program based on ICTs
The intervention adopts a multicomponent approach, addressing three agents in the prevention and management of eating disorders: parents, teachers and students.
1. Intervention with parents:
Parents will receive specific materials, including an informative guide on early identification of warning signs, promoting healthy lifestyle habits, and fostering effective communication with their children.
2. Intervention with teachers:
A two-hour in-person session will train teachers on platform use and provide tools for eating disorder prevention through role-playing techniques. Online resources will complement the training, while researchers ensure adherence via weekly follow-ups and parent reminders.
3. e-Preta program: The intervention for minors is delivered through an online platform, structured into 9 sessions of 45 minutes each, over 3 months. Weekly, platform-guided activities are proposed for classroom use with minimal teacher interaction, along with voluntary at-home activities.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent provided by the student's legal guardians and responsible teacher to participate.
Exclusion Criteria
10 Years
13 Years
ALL
No
Sponsors
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University of La Laguna
OTHER
Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias
OTHER
Servicio Canario de Salud
OTHER
Responsible Party
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Yolanda Ramallo Fariña
Coordinator of the Research Methodology and Data Analysis Group
Principal Investigators
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Yolanda Ramallo-Fariña, PhD in Biomedical Sciences
Role: PRINCIPAL_INVESTIGATOR
Servicio de Evaluación del Servicio Canario de la Salud
Locations
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Servicio de Evaluación y Planificación del Servicio Canario de Salud
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Ramallo-Farina Y, Del Pino-Sedeno T, Pinto Robayna B, Capafons-Sosa JI, Cuesta-Rubio M, Garcia-Bello MA, Torres-Castano A, Vallejo Torres L, Benitez Brito N, Martin Corral J, Hernandez Rodriguez AI, Diaz Melian CD, Paz Lopez M, Gonzalez-Gonzalez CS. Effectiveness and cost-effectiveness of an online school-based programme to reduce eating disorder risk factors in preadolescents (PRETA): protocol for a cluster-randomised controlled trial. BMJ Open. 2025 Oct 14;15(10):e104014. doi: 10.1136/bmjopen-2025-104014.
Other Identifiers
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PIFIISC21/06
Identifier Type: -
Identifier Source: org_study_id
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