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RECRUITINGINTERVENTIONAL

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

Effectiveness and Cost-effectiveness of an Online School-based Program for Reducing Risk Factors in Pre-adolescents (PRETA): Protocol for a Cluster Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Enrolled in the fifth or sixth year of primary education. - willing to sign a consent form provided by the student's legal guardians and responsible teacher to participate. Who Should NOT Join This Trial: - Significant comprehension difficulties that limit adequate participation in the program and questionnaires. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Enrolled in the fifth or sixth year of primary education. * Informed consent provided by the student's legal guardians and responsible teacher to participate. Exclusion Criteria: * Significant comprehension difficulties that limit adequate participation in the program and questionnaires.

Treatments Being Tested

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.

Locations (1)

Servicio de Evaluación y Planificación del Servicio Canario de Salud
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain