School-Based Eating Disorder Prevention

NCT07158593 | Completed

• 1 other identifier: 2505CESC
• Study Type: interventional
• Target: 1,205
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prevention Program; Wait List Control

Keywords

eating disorders; adolescents; cognitive behavior therapy; universal prevention program; risk factors; school-based interventions

Outcome Measures

Primary Outcomes (1)

• Eating Disorder Examination Questionnaire

  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.

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

Secondary Outcomes (2)

• Short Form of the International Physical Activity Questionnaire

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

• Mediterranean Diet Adherence Questionnaire

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

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention arm, includes studed who attended the "Claudia Carraro" prevention program. It is grounded in a cognitive-behavioral conceptualization of the development of eating disorders or disordered eating. The program was designed to address specific and non-specific risk factors that appear relevant: body dissatisfaction and unhealthy weight control behaviors. Its dual objective is to help participants reduce the importance they place on body weight and shape in self-evaluation while simultaneously promoting healthy weight regulation through adherence to Mediterranean dietary guidelines and an active lifestyle. The strategies and procedures used are derived from cognitive behavioral therapy protocols for eating disorders (Dalle Grave \& Calugi, 2020). The intervention is delivered by psychologists specialized in eating and weight disorders using an interactive, rather than didactic, format, involving small group activities and assigned homework tasks between sessions.

Other: Claudia carraro prevention program

Control

NO INTERVENTION

No intervention. The control group received the intervention after the 24 weeks

Interventions

Claudia carraro prevention program OTHER

The "Claudia Carraro" prevention program is grounded in a cognitive-behavioral conceptualization of the development of eating disorders or disordered eating. The program was designed to address specific and non-specific risk factors that appear relevant: body dissatisfaction and unhealthy weight control behaviors. Its dual objective is to help participants reduce the importance they place on body weight and shape in self-evaluation while simultaneously promoting healthy weight regulation through adherence to Mediterranean dietary guidelines and an active lifestyle. The strategies and procedures used are derived from cognitive behavioral therapy protocols for eating disorders (Dalle Grave \& Calugi, 2020). The intervention is delivered by psychologists specialized in eating and weight disorders using an interactive, rather than didactic, format, involving small group activities and assigned homework tasks between sessions.

Intervention

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Students in the first or second year of upper secondary school
• Students who signed a written informed consent
• Informed consent signed by their parents

You may not qualify if:

• Students who self-reported diagnosis of an eating disorder (these individuals could participate in the intervention but were excluded from data analysis)

Sponsors & Collaborators

• Villa Garda Hospital: lead

Study Sites (1)

Villa Garda Hospital

Verona, Veneto, 37138, Italy

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nutrition and Endocrinology at Villa Garda Hospital

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 8, 2025
• Study Start: January 10, 2020
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

IT (1)