Prevention ProgramNCT07158593
School-Based Eating Disorder Prevention
A study testing Claudia carraro prevention program in people with Prevention Program and Wait List Control, run by Villa Garda Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Prevention Program, Wait List Control
- What is being tested?
- Claudia carraro prevention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,205 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2020to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Students in the first or second year of upper secondary school
- Students who signed a written informed consent
- Informed consent signed by their parents
Who cannot join
- Students who self-reported diagnosis of an eating disorder (these individuals could participate in the intervention but were excluded from data analysis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Universal Prevention Program "Claudia Carraro" for Improving Body Image and Promoting Healthy Lifestyles in Adolescent Boys and Girls: a Cluster Randomized Controlled Trial With 24-week Follow-up
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.
Read the detailed description
Participants were recruited from January 2020 and December 2024. Secondary school administrators were contacted via telephone and/or email and provided with a letter outlining the core principles of the prevention program. If the school principal (or a designated representative) agreed to participate, they were asked to sign a formal agreement to take part in the intervention.
Students in the first or second year of upper secondary school and those who signed a written informed consent were included. Also, the informed consent should be signed by their parents. However, were excluded from the study students who self-reported diagnosis of an ED (these individuals could participate in the intervention but were excluded from data analysis).
Theoretical Framework 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.
Facilitator Training and Supervision Facilitators received formal training through a one-day seminar conducted by the principal and co-investigators. To assess adherence to the intervention protocol, all sessions were audio-recorded, and the program coordinators reviewed a random sample.
Facilitators were selected based on documented expertise in eating disorders and cognitive-behavioral therapy.
Program Structure The program consists of three sessions, each lasting 2.5 hours, delivered over three consecutive weeks. Each session builds on the previous one and begins with a review of key concepts and skills. Sessions involve interactive teaching, slide presentations, group work, and homework assignments to be completed between meetings. See Table 1 for an overview of the activities.
Measures Case Report Form (CRF) The CRF, to be completed by each participant, included general demographic and anthropometric data (date of birth, weight, height, gender) and two screening questions regarding the presence or being in treatment for an eating disorder.
Self-report Questionnaires Eating Disorder Examination Questionnaire (EDE-Q) (Calugi et al., 2017; Fairburn et al., 2008): 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).
Short Form of the International Physical Activity Questionnaire (IPAQ-SF) (Craig et al., 2003; Mannocci et al., 2010): A validated Italian questionnaire assessing self-reported physical activity across four domains: walking, moderate-intensity activity, vigorous-intensity activity, and time spent sitting.
Mediterranean Diet Adherence Questionnaire (QueMD) (Gnagnarella et al., 2018): A validated Italian-language instrument measuring adherence to the Mediterranean diet.
Questionnaire Administration Timeline Baseline: Administered approximately 30 minutes before the first intervention session (if permitted by the school) or during the first 30 minutes of the session itself in participants allocated to the intervention. Administered about 24 weeks before the intervention in participants allocated to the control group. All questionnaires were collected immediately after completion.
Post-intervention: Administered and collected during the final 30 minutes of the third (final) intervention session (only in participants who attended the intervention).
24-week follow-up: Administered during a dedicated 30-minute session held 24 weeks after the intervention in participants allocated to the intervention. Administered after 24 weeks from the baseline and corresponding to the first intervention session in participants allocated to the control group.
All informed consent forms and data privacy agreements were collected by the professional responsible for delivering the intervention.
- Conditions
- Prevention Program, Wait List Control
- Being tested
- Claudia carraro prevention program
- Keywords
- eating disorders, adolescents, cognitive behavior therapy, universal prevention program, risk factors, school-based interventions
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Claudia carraro prevention programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Claudia carraro prevention program |
| Control | No intervention | No intervention. The control group received the intervention after the 24 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Short Form of the International Physical Activity Questionnaire (IPAQ-SF) (Craig et al., 2003; Mannocci et al., 2010) is a validated Italian questionnaire assessing self-reported physical activity across four domains: walking, moderate-intensity activity, vigorous-intensity activity, and time spent sitting. Scores are categorized as follow: Low Activity (<600 MET-min/week), Moderate Activity (600-2999 MET-min/week), and High Activity (≥3000 MET-min/week).
Measured: Baseline and 24-week follow-up. The intervention group was also assessed at post-intervention
Mediterranean Diet Adherence Questionnaire
The Mediterranean Diet Adherence Questionnaire (QueMD) (Gnagnarella et al., 2018) is a validated Italian-language instrument measuring adherence to the Mediterranean diet. The score ranges from a minimum of 0 to a maximum of 9, with higher scores indicating greater adherence to the Mediterranean diet.
Measured: Baseline and 24-week follow-up. The intervention group was also assessed at post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start10 Jan 2020
- Primary completion1 Jun 2024
- Study completion1 Dec 2024
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 Prevention ProgramStudies 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
- 1,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Villa Garda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Dalle Grave, Villa Garda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158593
- Sponsor's protocol ID
- 2505CESC
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Calugi S, Dalle Grave A, Cattaneo G, Chimini M, Dalle Grave R. Effects of the "Claudia Carraro" Universal Prevention Program on Eating Disorder Risk Factors in Adolescents: A Cluster Randomized Trial. J Prev (2022). 2026 Jun 1. doi: 10.1007/s10935-026-00927-5. Online ahead of print.
PubMed 42223574
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Prevention Program "Claudia Carraro" for Improving Body Image and Promoting Healthy Lifestyles in Adolescent Boys and Girls: a Cluster Randomized Controlled Trial With 24-week Follow-up
- ClinicalTrials.gov ID
- NCT07158593
- Acronym / sponsor ID
- 2505CESC
- Conditions
- Prevention Program, Wait List Control
- Keywords
- eating disorders, adolescents, cognitive behavior therapy, universal prevention program, risk factors, school-based interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,205 participants (actual)
- Lead sponsor
- Villa Garda HospitalUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 8 Sep 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.
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.
Detailed description
Participants were recruited from January 2020 and December 2024. Secondary school administrators were contacted via telephone and/or email and provided with a letter outlining the core principles of the prevention program. If the school principal (or a designated representative) agreed to participate, they were asked to sign a formal agreement to take part in the intervention.
Students in the first or second year of upper secondary school and those who signed a written informed consent were included. Also, the informed consent should be signed by their parents. However, were excluded from the study students who self-reported diagnosis of an ED (these individuals could participate in the intervention but were excluded from data analysis).
Theoretical Framework 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.
Facilitator Training and Supervision Facilitators received formal training through a one-day seminar conducted by the principal and co-investigators. To assess adherence to the intervention protocol, all sessions were audio-recorded, and the program coordinators reviewed a random sample.
Facilitators were selected based on documented expertise in eating disorders and cognitive-behavioral therapy.
Program Structure The program consists of three sessions, each lasting 2.5 hours, delivered over three consecutive weeks. Each session builds on the previous one and begins with a review of key concepts and skills. Sessions involve interactive teaching, slide presentations, group work, and homework assignments to be completed between meetings. See Table 1 for an overview of the activities.
Measures Case Report Form (CRF) The CRF, to be completed by each participant, included general demographic and anthropometric data (date of birth, weight, height, gender) and two screening questions regarding the presence or being in treatment for an eating disorder.
Self-report Questionnaires Eating Disorder Examination Questionnaire (EDE-Q) (Calugi et al., 2017; Fairburn et al., 2008): 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).
Short Form of the International Physical Activity Questionnaire (IPAQ-SF) (Craig et al., 2003; Mannocci et al., 2010): A validated Italian questionnaire assessing self-reported physical activity across four domains: walking, moderate-intensity activity, vigorous-intensity activity, and time spent sitting.
Mediterranean Diet Adherence Questionnaire (QueMD) (Gnagnarella et al., 2018): A validated Italian-language instrument measuring adherence to the Mediterranean diet.
Questionnaire Administration Timeline Baseline: Administered approximately 30 minutes before the first intervention session (if permitted by the school) or during the first 30 minutes of the session itself in participants allocated to the intervention. Administered about 24 weeks before the intervention in participants allocated to the control group. All questionnaires were collected immediately after completion.
Post-intervention: Administered and collected during the final 30 minutes of the third (final) intervention session (only in participants who attended the intervention).
24-week follow-up: Administered during a dedicated 30-minute session held 24 weeks after the intervention in participants allocated to the intervention. Administered after 24 weeks from the baseline and corresponding to the first intervention session in participants allocated to the control group.
All informed consent forms and data privacy agreements were collected by the professional responsible for delivering the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Claudia carraro prevention programThe 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. |
| Control | No intervention | –No intervention. The control group received the intervention after the 24 weeks |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Students in the first or second year of upper secondary school
- Students who signed a written informed consent
- Informed consent signed by their parents
Key exclusion criteria (1 listed)
- Students who self-reported diagnosis of an eating disorder (these individuals could participate in the intervention but were excluded from data analysis)
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 |
|---|---|---|
| Claudia carraro prevention programThe "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. | Other | Intervention |
Primary outcome
Eating Disorder Examination Questionnaire
Time frame: 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.
2 secondary outcomes
Short Form of the International Physical Activity Questionnaire
Time frame: Baseline and 24-week follow-up. The intervention group was also assessed at post-intervention
Mediterranean Diet Adherence Questionnaire
Time frame: Baseline and 24-week follow-up. The intervention group was also assessed at post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Derived from this study: PubMed 42223574Calugi S, Dalle Grave A, Cattaneo G, Chimini M, Dalle Grave R. Effects of the "Claudia Carraro" Universal Prevention Program on Eating Disorder Risk Factors in Adolescents: A Cluster Randomized Trial. J Prev (2022). 2026 Jun 1. doi: 10.1007/s10935-026-00927-5. Online ahead of print.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Claudia carraro prevention program in people with Prevention Program and Wait List Control, run by Villa Garda Hospital at 1 site in Italy.
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 3 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: finished, as of the sponsor's last update on 26 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Examination Questionnaire (time frame: Baseline and 24-week follow-up. The intervention group was also assessed at post-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 NCT07158593, 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 26 Sep 2025.