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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,205
- Locations
- 1
- Primary Endpoint
- Eating Disorder Examination Questionnaire
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 11 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Intervention
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.
Intervention: Claudia carraro prevention program (Other)
Control
No intervention. The control group received the intervention after the 24 weeks
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
Investigators
Riccardo Dalle Grave
Head of Nutrition and Endocrinology at Villa Garda Hospital
Villa Garda Hospital