Evaluation of a Digital School-Based Intervention for the Primary Prevention of Eating Disorders in Pre-Adolescents (PRETA Program)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Universal primary prevention program based on ICTs.
- Who it may be relevant to
- Registry conditions: Eating Disorders in Adolescence, Food Addiction. Basic parameters: 10 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
A matched-pair cluster random allocation will be used, with schools being asigned as clusters. Six schools will be assigned to each group.
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
Primary outcome measures
- Children's Eating Attitudes Test (ChEAT-26) Questionnaire score [Time frame: Before and inmediately after the intervention]
Secondary outcome measures (4)
- Evaluation of body image measured with the Adapted Contour Drawing Rating Scale (A-CDRS) visual analog scale. [Time frame: 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). [Time frame: 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 [Time frame: Before and inmediately after the intervention]
- Evaluation of global self-esteem measured with the Rosenberg Self-Esteem Scale [Time frame: Before and inmediately after treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Spain · 1 center
- Servicio de Evaluación y Planificación del Servicio Canario de Salud — Santa Cruz de Tenerife
Publications
- 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 fo PMID 41087111
Identifiers
NCT: NCT06792981 · PIFIISC21/06