CompletedNot Applicable

School-Based Eating Disorder Prevention

Italy1,205 participantsStarted 2020-01-10

Plain-language summary

This is a cluster randomized controlled trial with two assessment points (baseline and 24-week follow-up) comparing the Claudia Carraro prevention program to a no-intervention control group. The intervention group was also assessed at post-intervention. To ensure that all students benefit from the intervention, the control group received the intervention after the 24 weeks. Randomization was performed at the school level, not the student level.

Who can participate

Age range

11 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Students in the first or second year of upper secondary school * Students who signed a written informed consent * Informed consent signed by their parents Exclusion Criteria: * Students who self-reported diagnosis of an eating disorder (these individuals could participate in the intervention but were excluded from data analysis)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Eating Disorder Examination Questionnaire

Timeframe: Baseline and 24-week follow-up. The intervention group was also assessed at post-intervention

Trial details

NCT IDNCT07158593

SponsorVilla Garda Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

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