PRETA: a digital school program to prevent eating disorders in fifth- and sixth-grade students.
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
This trial will test a nine‑session online school program (PRETA) to see if it reduces eating-disorder risk and related factors in fifth- and sixth-grade students.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1068 (estimated) |
| Ages | 10 Years to 13 Years |
| Sex | All |
| Sponsor | Servicio Canario de Salud Academic / other |
| Locations | 1 site (Santa Cruz de Tenerife, Santa Cruz de Tenerife) |
| Trial ID | NCT06792981 on ClinicalTrials.gov |
What this trial studies
The PRETA program is a universal, ICT-delivered prevention intervention culturally adapted from the POtsdam Prevention at Schools (POPS) program for pre-adolescents. It consists of nine online sessions delivered within participating primary schools and targets modifiable risk factors such as body dissatisfaction and unhealthy eating attitudes. The study is a matched-pair cluster randomized trial with schools as clusters, assigning six schools to each arm to compare PRETA with control. Researchers will also conduct an analysis of program efficiency from a social perspective, and participation requires parental consent and adequate student comprehension.
Who should consider this trial
Good fit: Ideal candidates are students enrolled in the fifth or sixth year of primary school at participating schools whose legal guardians and responsible teacher provide informed consent and who can engage with online materials.
Not a fit: Children with significant comprehension difficulties that prevent adequate participation in the online sessions or questionnaires are unlikely to benefit from the program.
Why it matters
Potential benefit: If successful, PRETA could lower the number of pre-adolescents who go on to develop eating disorders by reducing key modifiable risk factors and reaching many students at relatively low cost.
How similar studies have performed: Previous school-based and ICT-facilitated prevention programs, including components of the POtsdam POPS approach, have shown positive effects in at-risk youth, although universal digital interventions for preadolescents are less extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Santa Cruz de Tenerife, Santa Cruz de Tenerife
- Servicio de Evaluación y Planificación del Servicio Canario de Salud — Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain (Recruiting)
Study contacts
- Principal investigator: Yolanda Ramallo-Fariña, PhD in Biomedical Sciences — Servicio de Evaluación del Servicio Canario de la Salud
- Study coordinator: Yolanda Ramallo-Fariña, PhD in Biomedical Sciences
- Email: yolanda.ramallofarina@sescs.es
- Phone: +34922478266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.