COMPLETEDNA

School-Based Eating Disorder Prevention

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.

Sponsor

Villa Garda Hospital

Enrollment

1,205 participants

Sites

1 locations

Start Date

January 2020

Completion

June 2024

Prevention ProgramWait List ControlClaudia carraro prevention program

Enrollment & Timeline

Completed

Target N

1,205

participants

Sites

locations

Duration

4.9 years

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 20.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

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Primary Outcomes

Eating Disorder Examination Questionnaire

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

The Eating Disorder Examination Questionnaire (EDE-Q) (Calugi et al., 2017; Fairburn et al., 2008) is a validated Italian version that assesses the severity of eating disorder psychopathology over the past 28 days. The EDE-Q assesses eating disorder psychopathology with a global score and four subscales (restraint, eating concern, weight concern, shape concern) and eating disorder behaviours (objective binge-eating, self-induced vomiting, laxative misuse, excessive exercise). Scores range from 0 to 6. Higher scores indicate higher eating disorder psychopathology.

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Effects of the "Claudia Carraro" Universal Prevention Program on Eating Disorder Risk Factors in Adolescents: A Cluster Randomized Trial.

Calugi Simona, Dalle Grave Anna, Cattaneo Gianmatteo et al.Journal of prevention (2022)2026

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

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Fetching protocol from ClinicalTrials.gov…

COMPLETEDNA

School-Based Eating Disorder Prevention

Sponsor

Villa Garda Hospital

Enrollment

1,205 participants

Sites

1 locations

Start Date

January 2020

Completion

June 2024

Prevention ProgramWait List ControlClaudia carraro prevention program

Enrollment & Timeline

Completed

Target N

1,205

participants

Sites

locations

Duration

4.9 years

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 20.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Eating Disorder Examination Questionnaire

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

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Effects of the "Claudia Carraro" Universal Prevention Program on Eating Disorder Risk Factors in Adolescents: A Cluster Randomized Trial.

Calugi Simona, Dalle Grave Anna, Cattaneo Gianmatteo et al.Journal of prevention (2022)2026

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

11 Years

Max Age

19 Years

Sex

all

Healthy Volunteers

View full criteria

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)

Ask AI

School-Based Eating Disorder Prevention

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

School-Based Eating Disorder Prevention

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)