Clinical Trial

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

Study acronym: PRETA
Recruiting
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Record status
This record was last updated September 19, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-01-20; most recent amendment 2025-09-15.
Status change: Not Yet Recruiting → Recruiting 2025-08-26
Trial Details
NCT Number NCT06792981
Lead Sponsor Servicio Canario de Salud
Collaborators: University of La Laguna, Fundación Canaria Instituto de Investigación Sanitaria de Canarias
Conditions Eating Disorders in Adolescence, Food Addiction
Enrollment 1,068 participants
Start Date 2025-03-10
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-19