Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000885998
Ethics application status
Approved
Date submitted
16/08/2011
Date registered
19/08/2011
Date last updated
26/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effectiveness of Gain- vs. Loss-framed Health Messages to Improve Oral Health Among Iranian Adolescents:A Randomized Controlled Trial
Scientific title
The Effectiveness of Gain- vs. Loss-framed Health Messages to Improve Oral Health Among Iranian Adolescents:A Randomized Controlled Trial
Secondary ID [1] 262850 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oral health 270570 0
Condition category
Condition code
Public Health 270738 270738 0 0
Epidemiology
Oral and Gastrointestinal 270751 270751 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The adolescents will randomly assign to two groups: gain-framed message and loss- framed message. Each group of adolescences will read the respective pamphlets. The gain-framed pamphlet contains six positive messages with three related full-color images(6.1 X 4.5). Similarly the loss-framed pamphlet contains six negative messages with threerelated full-color images (6.1 X 4.5). The gain-framed pamphlet, entitled The Benefits of good oral hygiene", emphasizes the benefits of brushing, and flossing, whereas the loss-framed pamphlet, entitled The disadvantages of poor oral hygiene, emphasizes the costs of not brushing and flossing. the adolescents only read the pamphlets once and are then followed up later.
Intervention code [1] 269203 0
Behaviour
Comparator / control treatment
Gain-framed message group
Control group
Active

Outcomes
Primary outcome [1] 269436 0
changes in frequencies of dental brushing and flossing. this outcome will assess by a self report questionnaire.
Timepoint [1] 269436 0
changes from baseline, two weeks after the intervention and six months follow-up
Secondary outcome [1] 287642 0
Changes in psychological predictors of dental brushing (attitude, intention).
this outcome will assess by a self report questionnaire.
Timepoint [1] 287642 0
changes from baseline, two weeks after the intervention and six months follow-up
Secondary outcome [2] 287664 0
changes in Community Periodontal Index (CPI). this outcome will assess by a clinical examination.
Timepoint [2] 287664 0
changes from baseline, two weeks after the intervention and six months follow-up
Secondary outcome [3] 287665 0
changes in Turesky Modification of the Quigley-Hein Plaque Index. this outcome will assess by a clinical examination.
Timepoint [3] 287665 0
changes from baseline, two weeks after the intervention and six months follow-up

Eligibility
Key inclusion criteria
They are not involved in the oral health education
Ability to understand Persian language Adolescents attending high schools in Qazvin
Minimum age
14 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
They are involved in the oral health education
Inability to understand Persian language

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study will use a cluster-randomised design. In each school one classes will select and randomly will assign into three groups (i.e. loss framed group , gained framed group and control) after initial assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a study to explore the impact of two pamphlets with gain-framed and loss-framed messages on brushing and flossing attitudes, intentions , behaviors and clinical characteristics among a sample of adolescent students. stratified cluster randomization designs.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment outside Australia
Country [1] 3791 0
Iran, Islamic Republic Of
State/province [1] 3791 0
Qazvin

Funding & Sponsors
Funding source category [1] 269668 0
University
Name [1] 269668 0
Qazvin University Of Medical Sciences
Country [1] 269668 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Qazvin University Of Medical Sciences
Address
Qazvin University Of Medical Sciences, Shahid Bahonar Blv, Qazvin, Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 268718 0
None
Name [1] 268718 0
Address [1] 268718 0
Country [1] 268718 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269621 0
Qazvin University Of Medical Sciences
Ethics committee address [1] 269621 0
Ethics committee country [1] 269621 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 269621 0
Approval date [1] 269621 0
05/04/2011
Ethics approval number [1] 269621 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33026 0
Address 33026 0
Country 33026 0
Phone 33026 0
Fax 33026 0
Email 33026 0
Contact person for public queries
Name 16273 0
Amir H Pakpour
Address 16273 0
Department of Public Health,Qazvin University of Medical Sciences,. Shahid Bahonar Blv, Qazvin, Iran.
3419759811
Country 16273 0
Iran, Islamic Republic Of
Phone 16273 0
+98-281-3338127
Fax 16273 0
+98-281-3345862
Email 16273 0
[email protected]
Contact person for scientific queries
Name 7201 0
Amir H Pakpour
Address 7201 0
Department of Public Health,Qazvin University of Medical Sciences,. Shahid Bahonar Blv, Qazvin, Iran
3419759811
Country 7201 0
Iran, Islamic Republic Of
Phone 7201 0
+98-281-3338127
Fax 7201 0
+98-281-3345862
Email 7201 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.