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Clinical Trial Summary

This is a field study aiming to evaluate a school-based prevention intervention, Diario della Salute (DDS).


Clinical Trial Description

Diario della Salute (DDS) is a school-based prevention intervention based on the following theories:

1. social-cognitive theory (Bandura, 1977; 1986)

2. theory of multiple intelligences (Gardner, 1987)

3. emotional intelligence theory (Goleman, 1997)

4. theory of planned behavior (Ajzen, 1991)

5. transtheoretical model of change (Prochaska, Diclemente, 1982; 1992).

DDS is composed by:

1. tools for children and their parents on health and social and emotional well-being issues:

1. a diary for teens telling the story of four same-age students (e.g. experimenting with risky behaviors, conflicting feelings and thoughts, need for independence and control),

2. a diary for parents telling the experience of a mum and a dad with teenage children (e.g. problems in the relationship with teenage children, family conflict, parental disappointment, etc.);

2. five highly-standardized interactive lessons (2-4 hours each) on health issues administered by previously trained teachers.

Assignment of schools to study arms (DDS intervention vs. no intervention) will be cluster-randomized. Schools will be matched by number of students and average socioeconomic status. In some study areas schools will not be allocated by chance, but they will be analyzed separately from other schools.

Two anonymous surveys focusing on main outcomes (wellbeing, tobacco smoking, alcohol, physical activity and diet) will be before and after the intervention. Pre and post surveys will be linked through an anonymous code (Galanti, 2006). ;


Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms

  • Major Risk Factors for Noncommunicable Diseases

NCT number NCT01720199
Study type Interventional
Source Azienda Sanitaria Locale CN2 Alba-Bra
Contact
Status Completed
Phase N/A
Start date November 2012
Completion date June 2013