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

NCT06792981 | Recruiting

• 1 other identifier: PIFIISC21/06
• Study Type: interventional
• Target: 1,068
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

eating disorders; school-based intervention; efficacy; efficiency; Universal Prevention Program; Online Health

Outcome Measures

Primary Outcomes (1)

• Children's Eating Attitudes Test (ChEAT-26) Questionnaire score

  The ChEAT is an adaptation of the EAT-26 for children is a 26 items scored on a 6-option Likert scale. It is a validated, self-administered questionnaire in Spanish for children aged 8 and older, with a reading level of 5th grade. The questionnaire focuses on identifying issues related to a persistent concern with food, eating patterns, and abnormal attitudes for this age group. The total score is obtained by summing all items, resulting in a range from 0 to 78 points. A total score above 20 points may indicate a possible presence of ED

  Before and inmediately after the intervention

Secondary Outcomes (4)

• Evaluation of body image measured with the Adapted Contour Drawing Rating Scale (A-CDRS) visual analog scale.

  Before and inmediately after the intervention

• Body dissatisfaction, bulimia, and drive for thinness measured with the Spanish version of the Eating Disorder Inventory-2 (EDI-2).

  Before and inmediately after the intervention

• Internalization of the current aesthetic model and media pressure using the Spanish version of the Sociocultural Attitudes Towards Appearance Questionnaire-4

  Before and inmediately after the intervention

• Evaluation of global self-esteem measured with the Rosenberg Self-Esteem Scale

  Before and inmediately after treatment

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Universal primary prevention program based on ICTs

Control Group

NO INTERVENTION

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.

Interventions

Universal primary prevention program based on ICTs OTHER

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.

Also known as: PRETA Program

Intervention Group

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Enrolled in the fifth or sixth year of primary education.
• Informed consent provided by the student's legal guardians and responsible teacher to participate.

You may not qualify if:

• Significant comprehension difficulties that limit adequate participation in the program and questionnaires.

Sponsors & Collaborators

• Servicio Canario de Salud: lead
• University of La Laguna: collaborator
• Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias: collaborator

Study Sites (1)

Servicio de Evaluación y Planificación del Servicio Canario de Salud

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38109, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 41087111 DERIVED

MeSH Terms

Conditions

Food Addiction; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yolanda Ramallo-Fariña, PhD in Biomedical Sciences

  Servicio de Evaluación del Servicio Canario de la Salud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yolanda Ramallo-Fariña, PhD in Biomedical Sciences

CONTACT

+34922478266; yolanda.ramallofarina@sescs.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analysis
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of the Research Methodology and Data Analysis Group

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: March 10, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: All IPD, except for data related to outcome measures obtained at the post-intervention stage, will be available for sharing prior to the study's completion. The complete IPD will be available for sharing six months after the study's conclusion.
• Access Criteria: As an access criterion for Individual Participant Data (IPD), it is required that no information be requested that could compromise the anonymity of participants. This ensures adherence to ethical research standards and the protection of personal data, safeguarding the confidentiality and privacy of all individuals involved.

Locations

ES (1)