Clinical trial NCT06792981: Evaluation of a Digital School-Based Intervention for the Primary Prevention of Eating Disorders in Pre-Adolescents (PRETA Program)
Official title: Effectiveness and Cost-effectiveness of a Digital School-based Program for Primary Prevention of Eating Disorders in Preadolescents - PRETA
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Eating Disorders in Adolescence
Food Addiction
Keywords: eating disorders
school-based intervention
efficacy
efficiency
Primary Prevention Program
Lead sponsor: Servicio Canario de Salud
Sponsor class: OTHER
Collaborators: name: University of La Laguna
name: Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias
First posted: 2025-01-27
Enrollment: 890
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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, mediated by ICTs, for the Primary Prevention of Eating Disorders (PRETA), 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. Five schools will be assigned to each group.

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.

Primary outcomes:
measure: Children's Eating Attitudes Test (ChEAT) Questionnaire score
timeFrame: Before and inmediately after the intervention
Secondary outcomes:
measure: Evaluation of body image measured with the Contour Drawing Rating Scale (CDRS) visual analog scale.
timeFrame: Before and inmediately after the intervention
measure: Body dissatisfaction, bulimia, and drive for thinness measured with the Spanish version of the Eating Disorder Inventory-Child (EDI-C).
timeFrame: Before and inmediately after the intervention
measure: Evaluation of global self-esteem measured with the Rosenberg Self-Esteem Scaleº
timeFrame: Before and inmediately after treatment
measure: Internalization of the current aesthetic model and media pressure using the Spanish version of the Sociocultural Attitudes Towards Appearance Questionnaire-4
timeFrame: Before and inmediately after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Servicio de Evaluación del Servicio Canario de la Salud
name: Yolanda Ramallo-Fariña, PhD in Biomedical Sciences
role: PRINCIPAL_INVESTIGATOR
References: