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A School-based Prevention Intervention to Promote Wellbeing in Preadolescents (DDS)

Primary Purpose

Major Risk Factors for Noncommunicable Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Diario della Salute (DDS)
Sponsored by
Azienda Sanitaria Locale CN2 Alba-Bra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Major Risk Factors for Noncommunicable Diseases focused on measuring universal prevention, primary prevention, health promotion, wellbeing, smoking, alcohol, diet, physical activity, emotional and social skills

Eligibility Criteria

11 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • schools providing consensus to study participation

Exclusion Criteria:

  • schools involved in structured prevention programs with similar objectives

Sites / Locations

  • Azienda Sanitaria Locale CN2 Alba-Bra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Preadolescents allocated to the Diario della Salute (DDS) intervention.

Outcomes

Primary Outcome Measures

Self-reported Social And Emotional Well-Being
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

Self-reported Cigarette Use
Frequency of cigarette smoking
Self-reported Drunkenness Episode(s)
Frequency of drunkenness episodes
Self-reported Dietary Habits
Consumption of beverages and foods such as pop drinks, chips, vegetables, fruits and others
Self-reported Frequency of Physical Exercise
Frequency of moderate and heavy physical exercise
Self-reported Physical and Verbal Aggression
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).

Full Information

First Posted
October 31, 2012
Last Updated
January 18, 2014
Sponsor
Azienda Sanitaria Locale CN2 Alba-Bra
Collaborators
University of Eastern Piedmont, Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
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1. Study Identification

Unique Protocol Identification Number
NCT01720199
Brief Title
A School-based Prevention Intervention to Promote Wellbeing in Preadolescents
Acronym
DDS
Official Title
Diario Della Salute (DDS), a School-based Prevention Intervention to Promote Well-being for Grade 7 Students (12-13 Years)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Sanitaria Locale CN2 Alba-Bra
Collaborators
University of Eastern Piedmont, Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: social-cognitive theory (Bandura, 1977; 1986) theory of multiple intelligences (Gardner, 1987) emotional intelligence theory (Goleman, 1997) theory of planned behavior (Ajzen, 1991) transtheoretical model of change (Prochaska, Diclemente, 1982; 1992). DDS is composed by: tools for children and their parents on health and social and emotional well-being issues: 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), 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.); 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Risk Factors for Noncommunicable Diseases
Keywords
universal prevention, primary prevention, health promotion, wellbeing, smoking, alcohol, diet, physical activity, emotional and social skills

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2630 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Preadolescents allocated to the Diario della Salute (DDS) intervention.
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Diario della Salute (DDS)
Intervention Description
DDS is composed by tools for children and their parents on health and social and emotional well-being issues: 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), 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.); five highly-standardized interactive lessons (2-4 hours each) on health issues administered by previously trained teachers.
Primary Outcome Measure Information:
Title
Self-reported Social And Emotional Well-Being
Description
Subjective well-being is defined as 'a person's cognitive and affective evaluations of his or her life' (Diener, Lucas, & Oshi, 2002, p. 63).
Time Frame
Past 30 Days
Secondary Outcome Measure Information:
Title
Self-reported Cigarette Use
Description
Frequency of cigarette smoking
Time Frame
Past 30 Days
Title
Self-reported Drunkenness Episode(s)
Description
Frequency of drunkenness episodes
Time Frame
Past 30 Days
Title
Self-reported Dietary Habits
Description
Consumption of beverages and foods such as pop drinks, chips, vegetables, fruits and others
Time Frame
Past 30 Days
Title
Self-reported Frequency of Physical Exercise
Description
Frequency of moderate and heavy physical exercise
Time Frame
Past 30 Days
Title
Self-reported Physical and Verbal Aggression
Description
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).
Time Frame
Past 30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: schools providing consensus to study participation Exclusion Criteria: schools involved in structured prevention programs with similar objectives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrizio Faggiano, MD
Organizational Affiliation
University of Eastern Piedmont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonella Ermacora, MSc
Organizational Affiliation
Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elias Allara, MD
Organizational Affiliation
University of Eastern Piedmont
Official's Role
Study Director
Facility Information:
Facility Name
Azienda Sanitaria Locale CN2 Alba-Bra
City
Alba
State/Province
Cuneo
ZIP/Postal Code
12051
Country
Italy

12. IPD Sharing Statement

Citations:
Citation
Ajzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50, 179-211.
Results Reference
background
Citation
Bandura, A. (1977). Social Learning Theory. New York: General Learning Press.
Results Reference
background
Citation
Bandura, A. (1986). Social Foundations of Thought and Action. Englewood Cliffs, NJ: Prentice-Hall.
Results Reference
background
Citation
Dodge, K.A., Coie, J.D., & Lynam, D. (2006). Aggression and antisocial behavior in youth. In W. Damon (Series Ed.), & N. Eisenberg (Vol. Ed.) (Ed.). Handbook of Child Psychology, Vol. 3: Social, Emotional, and Personality Development6th edition (pp. 719-788). Wiley.
Results Reference
background
PubMed Identifier
16979751
Citation
Galanti MR, Siliquini R, Cuomo L, Melero JC, Panella M, Faggiano F; EU-DAP study group. Testing anonymous link procedures for follow-up of adolescents in a school-based trial: the EU-DAP pilot study. Prev Med. 2007 Feb;44(2):174-7. doi: 10.1016/j.ypmed.2006.07.019. Epub 2006 Sep 18.
Results Reference
background
Citation
Gardner, H. (1987). Beyond a modular view of mind. In W. Damon (Ed.), New Directions for Child Development, Tenth Anniversary Edition. Also in W. Damon (Ed.) (1988), Child Development Today and Tomorrow (222-239). San Francisco: Jossey-Bass.
Results Reference
background
Citation
Goleman, D. (1998). Working with emotional intelligence. New York: Bantam.
Results Reference
background
Citation
Prochaska J.O. and DiClemente C.C. (1982). Trans-theoretical therapy - toward a more integrative model of change. Psychotherapy: Theory, Research and Practice 19(3):276-288
Results Reference
background
PubMed Identifier
1329589
Citation
Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14. doi: 10.1037//0003-066x.47.9.1102.
Results Reference
background
Links:
URL
http://www.diariodellasalute.it/
Description
Project website (in Italian).

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A School-based Prevention Intervention to Promote Wellbeing in Preadolescents

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