Health BehaviorPhase 2NCT01421108
The Effectiveness of Gain- Versus Loss-framed Health Messages to Improve Oral Health Among Iranian Adolescents
A Phase 2 study testing Framing (Gain-framed messages) and Framing (Loss-framed messages) in people with Health Behavior, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial summary
This study explores the effectiveness of message framing, loss-framed vs. gain-framed messages on oral health in Iran. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Framing (Gain-framed messages) and Framing (Loss-framed messages)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteIran
- Study dates
- Jul 2011to Feb 2012
- Phase
- Phase 2
- 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- They are not involved in the oral health education
- Ability to understand Persian language Adolescents attending high schools in Qazvin
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Gain- Versus Loss-framed Health Messages to Improve Oral Health Among Iranian Adolescents:A Randomized Controlled Trial
This study explores the effectiveness of message framing, loss-framed vs. gain-framed messages on oral health in Iran.
Read the detailed description
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.
- Conditions
- Health Behavior
- Being tested
- Framing (Gain-framed messages), Framing (Loss-framed messages)
- Keywords
- oral health, dental brushing, dental flossing
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Framing (Gain-framed messages)Behavioural
Also called designing persuasive messages
The adolescents will randomly assign to three groups: gain-framed message and loss- framed message. Each group of adolescents will read the respective pamphlets with the exception of the control group. The gain-framed pamphlet contains six positive messages with three related 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.
Framing (Loss-framed messages)Behavioural
The adolescents will randomly assign to three groups: gain-framed message , loss- framed message and a control group. Each group of adolescents will read the respective pamphlets with the exception of the control group.
The loss-framed pamphlet contains six negative messages with three related full-color images (6.1 X 4.5). The loss-framed pamphlet, entitled The disadvantages of poor oral hygiene, emphasizes the costs of not brushing and flossing.
| Study group | Role | What they receive |
|---|---|---|
| Loss-framed messages | Experimental | Not described Receives: Behavioral: Framing (Loss-framed messages) |
| gain-framed messages | Experimental | Adolescents will randomly assign to three groups: gain-framed message , loss-framed message and a control group. Each group of adolescents will read the respective pamphlets with the exception of the control group. The gain-framed pamphlet contains six positive messages with three related 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. Receives: Behavioral: Framing (Gain-framed messages) |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in frequencies of dental brushing and flossing
Measured: changes from baseline, two weeks after the intervention and six months follow-up
Secondary outcomes (4)
Changes in psychological predictors of dental brushing (attitude, intention).
Measured: changes from baseline, two weeks after the intervention and six months follow-up
Changes in Community Periodontal Index (CPI)
Measured: changes from baseline, two weeks after the intervention and six months follow-up
Changes in Turesky Modification of the Quigley-Hein Plaque Index
Measured: changes from baseline, two weeks after the intervention and six months follow-up
Oral health related quality of life
Measured: changes from baseline and six months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
- Investigators
- Amir H Pakpour, PhD, Study chair, Qazvin university medical of sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421108
- Sponsor's protocol ID
- ACTRN12611000885998
- Status last verified
- Mar 2012
- First submitted
- 12 Aug 2011
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pakpour AH, Yekaninejad MS, Sniehotta FF, Updegraff JA, Dombrowski SU. The effectiveness of gain-versus loss-framed health messages in improving oral health in Iranian secondary schools: a cluster-randomized controlled trial. Ann Behav Med. 2014 Jun;47(3):376-87. doi: 10.1007/s12160-013-9543-1.
PubMed 24163187
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Gain- Versus Loss-framed Health Messages to Improve Oral Health Among Iranian Adolescents:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01421108
- Acronym / sponsor ID
- ACTRN12611000885998
- Conditions
- Health Behavior
- Keywords
- oral health, dental brushing, dental flossing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Aug 2011 (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 study explores the effectiveness of message framing, loss-framed vs. gain-framed messages on oral health in Iran.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loss-framed messages | Experimental | Behavioral: Framing (Loss-framed messages) |
| gain-framed messages | Experimental | Behavioral: Framing (Gain-framed messages)Adolescents will randomly assign to three groups: gain-framed message , loss-framed message and a control group. Each group of adolescents will read the respective pamphlets with the exception of the control group. The gain-framed pamphlet contains six positive messages with three related 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- They are not involved in the oral health education
- Ability to understand Persian language Adolescents attending high schools in Qazvin
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
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 |
|---|---|---|
| Framing (Gain-framed messages)Also: designing persuasive messagesThe adolescents will randomly assign to three groups: gain-framed message and loss- framed message. Each group of adolescents will read the respective pamphlets with the exception of the control group. The gain-framed pamphlet contains six positive messages with three related 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. | Behavioural | gain-framed messages |
| Framing (Loss-framed messages)The adolescents will randomly assign to three groups: gain-framed message , loss- framed message and a control group. Each group of adolescents will read the respective pamphlets with the exception of the control group. The loss-framed pamphlet contains six negative messages with three related full-color images (6.1 X 4.5). The loss-framed pamphlet, entitled The disadvantages of poor oral hygiene, emphasizes the costs of not brushing and flossing. | Behavioural | Loss-framed messages |
Primary outcome
changes in frequencies of dental brushing and flossing
Time frame: changes from baseline, two weeks after the intervention and six months follow-up
4 secondary outcomes
Changes in psychological predictors of dental brushing (attitude, intention).
Time frame: changes from baseline, two weeks after the intervention and six months follow-up
Changes in Community Periodontal Index (CPI)
Time frame: changes from baseline, two weeks after the intervention and six months follow-up
Changes in Turesky Modification of the Quigley-Hein Plaque Index
Time frame: changes from baseline, two weeks after the intervention and six months follow-up
Oral health related quality of life
Time frame: changes from baseline and six months follow-up
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 6 Mar 2012.
- Derived from this study: PubMed 24163187Pakpour AH, Yekaninejad MS, Sniehotta FF, Updegraff JA, Dombrowski SU. The effectiveness of gain-versus loss-framed health messages in improving oral health in Iranian secondary schools: a cluster-randomized controlled trial. Ann Behav Med. 2014 Jun;47(3):376-87. doi: 10.1007/s12160-013-9543-1.
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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.
Amir H Pakpour, PhD study chair
Qazvin university medical of sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Framing (Gain-framed messages) and Framing (Loss-framed messages) in people with Health Behavior, run by Qazvin University Of Medical Sciences at 1 site in Iran.
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 2 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 6 Mar 2012. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
changes in frequencies of dental brushing and flossing (time frame: changes from baseline, two weeks after the intervention and six months follow-up). 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 NCT01421108, which also lists 1 linked publication.
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 6 Mar 2012.