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NCT Number: NCT06792981

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

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.

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Key information

Age range

10 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Servicio de Evaluación y Planificación del Servicio Canario de Salud

Santa Cruz de Tenerife, 38109, Spain

Location status: Recruiting

Location contact

Yolanda Ramallo-Fariña, PhD

CONTACT

[email protected]

+34 922 478266

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

  • 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.

  • 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.

  • 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.

Other names: PRETA Program

Primary outcomes

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

    Time frame: Before and inmediately after the intervention

    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

Secondary outcomes

  1. 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

    It consists of 9 male and 9 female figure outlines that increase in size as the score increases. This scale measures the level of satisfaction with one's own body image. The degree of satisfaction or discrepancy index is obtained by calculating the difference between the desired and perceived images. A difference of 2 points is associated with body image disturbance. Age-appropriate images adapted for children aged 10 to 13 years will be used.

  2. 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

    The Eating Disorders Inventory-2 is a self-report instrument consisting of 91 items assessing psychological and behavioral traits associated with eating disorders, primarily anorexia and bulimia nervosa, across 11 different subscales. The response scale is a six-point Likert scale ranging from 0 (never) to 5 (always). The total score is obtained by summing all responses; a higher score indicates a greater presence of the trait.

  3. 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

    The original instrument includes 5 subscales; however, in this study, only the subscales related to body image internalization will be applied: the current aesthetic model based on thinness and the current aesthetic model based on athletic build (10 items), and the pressure to meet beauty ideals promoted by the media (4 items). Items are answered on a 5-point Likert scale, ranging from 1 "completely disagree" to 5 "completely agree." The score is calculated by summing all items; a higher score indicates greater internalization and influence of the aesthetic body model.

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

    Time frame: Before and inmediately after treatment

    consists of 10 items that assess global self-esteem in adolescents, including elements focused on feelings of self-respect and self-acceptance. The first 5 items are positively worded and scored from 4 (strongly agree) to 1 (strongly disagree); the last 5 items are negatively worded and scored from 1 (strongly agree) to 4 (strongly disagree). The total score is obtained by summing all item responses. A score above 30 indicates high self-esteem, a score between 26 and 29 is considered medium self-esteem, and a score below 25 reflects low self-esteem.

Study contacts

Contact information is provided by the study sponsor or research team.

Yolanda Ramallo-Fariña, PhD in Biomedical Sciences

CONTACT

[email protected]

+34922478266

Sponsors and collaborators

Lead sponsor

Servicio Canario de Salud

Other

Collaborators

  • Fundación Canaria Instituto de Investigación Sanitaria de Canarias
  • University of La Laguna

Registry information

Official study 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

Acronym: PRETA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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