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

Официальное название

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

Обзор

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.

Подробное описание

A matched-pair cluster random allocation will be used, with schools being asigned as clusters. Six schools will be assigned to each group.

Вмешательства

• Другое 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

Первичные конечные точки

• Children's Eating Attitudes Test (ChEAT-26) Questionnaire score [Срок оценки: Before and inmediately after the intervention]

Вторичные конечные точки (4)

• Evaluation of body image measured with the Adapted Contour Drawing Rating Scale (A-CDRS) visual analog scale. [Срок оценки: 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). [Срок оценки: 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 [Срок оценки: Before and inmediately after the intervention]
• Evaluation of global self-esteem measured with the Rosenberg Self-Esteem Scale [Срок оценки: Before and inmediately after treatment]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Servicio de Evaluación y Planificación del Servicio Canario de Salud — Santa Cruz de Tenerife

Публикации

• 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

Идентификаторы

NCT: NCT06792981 · PIFIISC21/06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗