Evaluation of a Digital School-Based Intervention for the Primary Prevention of Eating Disorders in Pre-Adolescents (PRETA Program)

NCT06792981 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1068

Last updated 2025-09-19

No results posted yet for this study

Summary

Background:

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.

Conditions

  • Eating Disorders in Adolescence
  • Food Addiction

Interventions

OTHER

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.

Sponsors & Collaborators

  • University of La Laguna

    collaborator OTHER
  • Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias

    collaborator OTHER
  • Servicio Canario de Salud

    lead OTHER

Principal Investigators

  • Yolanda Ramallo-Fariña, PhD in Biomedical Sciences · Servicio de Evaluación del Servicio Canario de la Salud

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06792981 on ClinicalTrials.gov