Eating Disorders in AdolescencePRETANCT06792981
Evaluation of a Digital School-Based Intervention for the Primary Prevention of Eating Disorders in Pre-Adolescents (PRETA Program)
A study testing Universal primary prevention program based on ICTs in people with Eating Disorders in Adolescence and Food Addiction, run by Servicio Canario de Salud at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- Eating Disorders in Adolescence, Food Addiction
- What is being tested?
- Universal primary prevention program based on ICTs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,068 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Enrolled in the fifth or sixth year of primary education.
- Informed consent provided by the student's legal guardians and responsible teacher to participate.
Who cannot join
- Significant comprehension difficulties that limit adequate participation in the program and questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yolanda Ramallo-Fariña, PhD in Biomedical Sciences contact
Spain1 site, 1 recruiting
- Recruiting
Servicio de Evaluación y Planificación del Servicio Canario de Salud
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38109
Yolanda Ramallo-Fariña, PhD, +34 922 478266, yramfar@sescs.es
About this study
Official 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
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.
Read more
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.
Read the detailed description
A matched-pair cluster random allocation will be used, with schools being asigned as clusters. Six schools will be assigned to each group.
- Conditions
- Eating Disorders in Adolescence, Food Addiction
- Being tested
- Universal primary prevention program based on ICTs
- Keywords
- eating disorders, school-based intervention, efficacy, efficiency, Universal Prevention Program, Online Health
- Medical subject headings
- Food Addiction, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal primary prevention program based on ICTsOther
Also called PRETA Program
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Universal primary prevention program based on ICTs |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Eating Attitudes Test (ChEAT-26) Questionnaire score
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
Measured: Before and inmediately after the intervention
Secondary outcomes (4)
Evaluation of body image measured with the Adapted Contour Drawing Rating Scale (A-CDRS) visual analog scale.
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.
Measured: 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).
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.
Measured: 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
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.
Measured: Before and inmediately after the intervention
Evaluation of global self-esteem measured with the Rosenberg Self-Esteem Scale
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.
Measured: Before and inmediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start10 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating Disorders in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,068 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Servicio Canario de Salud
- Sponsor type
- University, hospital or other
- Collaborators
- University of La Laguna, Fundación Canaria Instituto de Investigación Sanitaria de Canarias
- Responsible party
- Principal investigator, Yolanda Ramallo Fariña, Servicio Canario de Salud
- Investigators
- Yolanda Ramallo-Fariña, PhD in Biomedical Sciences, Principal investigator, Servicio de Evaluación del Servicio Canario de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792981
- Sponsor's protocol ID
- PIFIISC21/06
- Acronym
- PRETA
- Status last verified
- Sep 2025
- First submitted
- 20 Jan 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request. The data to be shared will include all IPD that underlie results in a publication, as well as the statistical analysis plan, informed consent form and the analytic code. All sensitive data will be anonymized to ensure the privacy and confidentiality of the participants.
Publications
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 for a cluster-randomised controlled trial. BMJ Open. 2025 Oct 14;15(10):e104014. doi: 10.1136/bmjopen-2025-104014.
PubMed 41087111
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06792981
- Acronym / sponsor ID
- PRETA / PIFIISC21/06
- Conditions
- Eating Disorders in Adolescence, Food Addiction
- Keywords
- eating disorders, school-based intervention, efficacy, efficiency, Universal Prevention Program, Online Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,068 participants (estimated)
- Lead sponsor
- Servicio Canario de SaludUniversity, hospital or other
- Collaborators
- University of La Laguna, Fundación Canaria Instituto de Investigación Sanitaria de Canarias
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A matched-pair cluster random allocation will be used, with schools being asigned as clusters. Six schools will be assigned to each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Universal primary prevention program based on ICTsParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Enrolled in the fifth or sixth year of primary education.
- Informed consent provided by the student's legal guardians and responsible teacher to participate.
Key exclusion criteria (1 listed)
- Significant comprehension difficulties that limit adequate participation in the program and questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Universal primary prevention program based on ICTsAlso: PRETA ProgramThe 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 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. 3. 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 | Intervention Group |
Primary outcome
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
4 secondary outcomes
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
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
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
Evaluation of global self-esteem measured with the Rosenberg Self-Esteem Scale
Time frame: Before and inmediately after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 41087111Ramallo-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 for a cluster-randomised controlled trial. BMJ Open. 2025 Oct 14;15(10):e104014. doi: 10.1136/bmjopen-2025-104014.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request. The data to be shared will include all IPD that underlie results in a publication, as well as the statistical analysis plan, informed consent form and the analytic code. All sensitive data will be anonymized to ensure the privacy and confidentiality of the participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yolanda Ramallo-Fariña, PhD in Biomedical Sciences contact
Yolanda Ramallo-Fariña, PhD in Biomedical Sciences principal investigator
Servicio de Evaluación del Servicio Canario de la Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Universal primary prevention program based on ICTs in people with Eating Disorders in Adolescence and Food Addiction, run by Servicio Canario de Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yolanda Ramallo-Fariña, PhD in Biomedical Sciences (+34922478266, yolanda.ramallofarina@sescs.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Eating Attitudes Test (ChEAT-26) Questionnaire score (time frame: Before and inmediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06792981, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.