Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT07158593
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
School-Based Eating Disorder Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eating Disorder Examination Questionnaire', 'timeFrame': 'Baseline and 24-week follow-up. The intervention group was also assessed at post-intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Short Form of the International Physical Activity Questionnaire', 'timeFrame': 'Baseline and 24-week follow-up. The intervention group was also assessed at post-intervention', 'description': '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).'}, {'measure': 'Mediterranean Diet Adherence Questionnaire', 'timeFrame': 'Baseline and 24-week follow-up. The intervention group was also assessed at post-intervention', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eating disorders', 'adolescents', 'cognitive behavior therapy', 'universal prevention program', 'risk factors', 'school-based interventions'], 'conditions': ['Prevention Program', 'Wait List Control']}, 'descriptionModule': {'briefSummary': '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.\n\nRandomization was performed at the school level, not the student level.', 'detailedDescription': '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.\n\nStudents 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).\n\nTheoretical 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.\n\nThe 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.\n\nFacilitator 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.\n\nFacilitators were selected based on documented expertise in eating disorders and cognitive-behavioral therapy.\n\nProgram 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.\n\nMeasures 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.\n\nSelf-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).\n\nShort 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.\n\nMediterranean Diet Adherence Questionnaire (QueMD) (Gnagnarella et al., 2018): A validated Italian-language instrument measuring adherence to the Mediterranean diet.\n\nQuestionnaire 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.\n\nPost-intervention: Administered and collected during the final 30 minutes of the third (final) intervention session (only in participants who attended the intervention).\n\n24-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.\n\nAll informed consent forms and data privacy agreements were collected by the professional responsible for delivering the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students in the first or second year of upper secondary school\n* Students who signed a written informed consent\n* Informed consent signed by their parents\n\nExclusion Criteria:\n\n* Students who self-reported diagnosis of an eating disorder (these individuals could participate in the intervention but were excluded from data analysis)'}, 'identificationModule': {'nctId': 'NCT07158593', 'briefTitle': 'School-Based Eating Disorder Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Villa Garda Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2505CESC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '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.\n\nThe 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.', 'interventionNames': ['Other: Claudia carraro prevention program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention. The control group received the intervention after the 24 weeks'}], 'interventions': [{'name': 'Claudia carraro prevention program', 'type': 'OTHER', 'description': '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.\n\nThe 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.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37138', 'city': 'Verona', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Villa Garda Hospital', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Villa Garda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Nutrition and Endocrinology at Villa Garda Hospital', 'investigatorFullName': 'Riccardo Dalle Grave', 'investigatorAffiliation': 'Villa Garda Hospital'}}}}