A School-based Prevention Intervention to Promote Wellbeing in Preadolescents

Not Applicable

Completed

• Conditions: Major Risk Factors for Noncommunicable Diseases
• Interventions: Other: Diario della Salute (DDS)

• Registration Number: NCT01720199
• Lead Sponsor: Azienda Sanitaria Locale CN2 Alba-Bra

Brief Summary

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

Detailed 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 Timeline

• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-10-31
• Study Start: 2012-11
• Study First Posted: 2012-11-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-18
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2630

Inclusion Criteria

• schools providing consensus to study participation

Exclusion Criteria

• schools involved in structured prevention programs with similar objectives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Diario della Salute (DDS)	Preadolescents allocated to the Diario della Salute (DDS) intervention.

Primary Outcome Measures

Name	Time	Method
Self-reported Social And Emotional Well-Being	Past 30 Days	Subjective well-being is defined as 'a person's cognitive and affective evaluations of his or her life' (Diener, Lucas, \& Oshi, 2002, p. 63).

Secondary Outcome Measures

Name	Time	Method
Self-reported Cigarette Use	Past 30 Days	Frequency of cigarette smoking
Self-reported Drunkenness Episode(s)	Past 30 Days	Frequency of drunkenness episodes
Self-reported Dietary Habits	Past 30 Days	Consumption of beverages and foods such as pop drinks, chips, vegetables, fruits and others
Self-reported Frequency of Physical Exercise	Past 30 Days	Frequency of moderate and heavy physical exercise
Self-reported Physical and Verbal Aggression	Past 30 Days	Aggression is generally defined as behaviors that are intended to hurt or harm others by damaging their physical and psychological well-being and includes physically and verbally aggressive behaviors such as hitting, pushing, kicking, and threatening, etc (Dodge et al. 2007).

Trial Locations

Locations (1)

Azienda Sanitaria Locale CN2 Alba-Bra; 🇮🇹 Alba, Cuneo, Italy