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

Servicio Canario de Salud

Status: Enrolling

Conditions: Eating Disorders in Adolescence; Food Addiction

Treatments: Other: Universal primary prevention program based on ICTs

Study type: Interventional

Funder types: Other

Identifiers

NCT06792981

PIFIISC21/06

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,068 estimated patients

Sex: All

Ages: 10 to 13 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,068 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Other: Universal primary prevention program based on ICTs

Control Group

No Intervention group

Description:

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.