Major Risk Factors for Noncommunicable DiseasesDDSNCT01720199
A School-based Prevention Intervention to Promote Wellbeing in Preadolescents
A study testing Diario della Salute (DDS) in people with Major Risk Factors for Noncommunicable Diseases, run by Azienda Sanitaria Locale CN2 Alba-Bra at 1 site in Italy.
Trial summary
This is a field study aiming to evaluate a school-based prevention intervention, Diario della Salute (DDS). Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Risk Factors for Noncommunicable Diseases
- What is being tested?
- Diario della Salute (DDS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,630 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- schools providing consensus to study participation
Who cannot join
- schools involved in structured prevention programs with similar objectives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diario Della Salute (DDS), a School-based Prevention Intervention to Promote Well-being for Grade 7 Students (12-13 Years)
This is a field study aiming to evaluate a school-based prevention intervention, Diario della Salute (DDS).
Read the 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).
- Being tested
- Diario della Salute (DDS)
- Keywords
- universal prevention, primary prevention, health promotion, wellbeing, smoking, alcohol, diet, physical activity, emotional and social skills
- Medical subject headings
- Smoking, Motor Activity, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diario della Salute (DDS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Preadolescents allocated to the Diario della Salute (DDS) intervention. Receives: Other: Diario della Salute (DDS) |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Past 30 Days
Secondary outcomes (5)
Self-reported Cigarette Use
Frequency of cigarette smoking
Measured: Past 30 Days
Self-reported Drunkenness Episode(s)
Frequency of drunkenness episodes
Measured: Past 30 Days
Self-reported Dietary Habits
Consumption of beverages and foods such as pop drinks, chips, vegetables, fruits and others
Measured: Past 30 Days
Self-reported Frequency of Physical Exercise
Frequency of moderate and heavy physical exercise
Measured: Past 30 Days
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).
Measured: Past 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Major Risk Factors for Noncommunicable DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale CN2 Alba-Bra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Piedmont, Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
- Responsible party
- Sponsor
- Investigators
- Fabrizio Faggiano, MD, Principal investigator, University of Eastern PiedmontAntonella Ermacora, MSc, Study chair, Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.Elias Allara, MD, Study director, University of Eastern Piedmont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720199
- Sponsor's protocol ID
- CCM2011-CUPJ19E11002100001
- Acronym
- DDS
- Status last verified
- Jan 2014
- First submitted
- 31 Oct 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ajzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50, 179-211.
Bandura, A. (1977). Social Learning Theory. New York: General Learning Press.
Bandura, A. (1986). Social Foundations of Thought and Action. Englewood Cliffs, NJ: Prentice-Hall.
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.
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.
PubMed 16979751Gardner, 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.
Goleman, D. (1998). Working with emotional intelligence. New York: Bantam.
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
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.
PubMed 1329589
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diario Della Salute (DDS), a School-based Prevention Intervention to Promote Well-being for Grade 7 Students (12-13 Years)
- ClinicalTrials.gov ID
- NCT01720199
- Acronym / sponsor ID
- DDS / CCM2011-CUPJ19E11002100001
- Keywords
- universal prevention, primary prevention, health promotion, wellbeing, smoking, alcohol, diet, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,630 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale CN2 Alba-BraUniversity, hospital or other
- Collaborators
- University of Eastern Piedmont, Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Diario della Salute (DDS)Preadolescents allocated to the Diario della Salute (DDS) intervention. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- schools providing consensus to study participation
Key exclusion criteria (1 listed)
- schools involved in structured prevention programs with similar objectives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diario della Salute (DDS)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. | Other | Intervention group |
Primary outcome
Self-reported Social And Emotional Well-Being
Time frame: 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).
5 secondary outcomes
Self-reported Cigarette Use
Time frame: Past 30 Days
Self-reported Drunkenness Episode(s)
Time frame: Past 30 Days
Self-reported Dietary Habits
Time frame: Past 30 Days
Self-reported Frequency of Physical Exercise
Time frame: Past 30 Days
Self-reported Physical and Verbal Aggression
Time frame: Past 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- BackgroundAjzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50, 179-211.
- BackgroundBandura, A. (1977). Social Learning Theory. New York: General Learning Press.
- BackgroundBandura, A. (1986). Social Foundations of Thought and Action. Englewood Cliffs, NJ: Prentice-Hall.
- BackgroundDodge, 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.
- Background: PubMed 16979751Galanti 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.
- BackgroundGardner, 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.
- BackgroundGoleman, D. (1998). Working with emotional intelligence. New York: Bantam.
- BackgroundProchaska 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
- Background: PubMed 1329589Prochaska 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.
- Project website (in Italian).Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrizio Faggiano, MD principal investigator
University of Eastern Piedmont
Antonella Ermacora, MSc study chair
Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
Elias Allara, MD study director
University of Eastern Piedmont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diario della Salute (DDS) in people with Major Risk Factors for Noncommunicable Diseases, run by Azienda Sanitaria Locale CN2 Alba-Bra at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Social And Emotional Well-Being (time frame: Past 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01720199, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.