Oral Health Behavior ChangePhase 2NCT02066987
The Effects of Two Volitional Interventions to Improve Oral Health Behaviour Among Iranian Adolescents
A Phase 2 study testing Implementation intention and Action planning in people with Oral Health Behavior Change, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial summary
the present study had two main aims. First, due to the current underconsumption of dental brush adolescents, the investigators should apply a volitional intervention to increase oral health behvaiour in adolescents. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health Behavior Change
- What is being tested?
- Implementation intention and Action planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,110 participants
- Where
- 1 siteIran
- Study dates
- Feb 2014to Sep 2014
- 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
- 14 Years to 19 Years
- Ability to understand Persian language Adolescents attending high schools in Qazvin
Who cannot join
- participate in any kind of oral health education and promotion programs
- undergoing orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Iran1 site
Department of Public Health, Qazvin University of Medical Sciences
Qazvin, Qazvin Province, 3419759811
About this study
the present study had two main aims. First, due to the current underconsumption of dental brush adolescents, the investigators should apply a volitional intervention to increase oral health behvaiour in adolescents. Second, the investigators aim to compare the effectiveness of action planning intervention and implementation intention will improve oral health behavior in adolescents.
Read the detailed description
This is a study to explore the impact of two volitional interventions on brushing intentions , behaviors and clinical characteristics among a sample of adolescent students.
- Conditions
- Oral Health Behavior Change
- Being tested
- Implementation intention, Action planning, active control group
- Keywords
- Action planning, Implementation intention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation intentionBehavioural
It may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans.
If it is _____ (WHEN) at or in _______ (WHERE) before/after ______ (ACTIVITY), then I will brush my teeth! If it is _____ (WHEN) at or in _______ (WHERE) before/after ______ (ACTIVITY), then I will brush my teeth!
Action planningBehavioural
It may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans.
I will brush my teeth at ___(WHEN) at or in ____(WHERE) before/after ___ (ACTIVITY).
I will brush my teeth at ___(WHEN) at or in ____(WHERE) before/after ___ (ACTIVITY).
active control groupBehavioural
Participants in the active control group will receive an educational pamphlet containing what it is dental brushing, why it is done, and how it is done.
| Study group | Role | What they receive |
|---|---|---|
| Implementation intention | Experimental | It may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans.
If it is _____ (WHEN) at or in _______ (WHERE) before/after ______ (ACTIVITY), then I will brush my teeth! If it is _____ (WHEN) at or in _______ (WHERE) before/after ______ (ACTIVITY), then I will brush my teeth! Receives: Behavioral: Implementation intention |
| Action planning | Experimental | It may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans.
I will brush my teeth at ___(WHEN) at or in ____(WHERE) before/after ___ (ACTIVITY).
I will brush my teeth at ___(WHEN) at or in ____(WHERE) before/after ___ (ACTIVITY). Receives: Behavioral: Action planning |
| active control group | Active comparator | Participants in the active control group will receive an educational pamphlet containing what it is dental brushing, why it is done, and how it is done. Receives: Behavioral: active control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in frequencies of dental brushing
Measured: changes from baseline, one month after the intervention and six months follow-up
Secondary outcomes (5)
changes in psychological predictors of dental brushing (intention ,perceived behavioural control and Self-monitoring)
Measured: changes from baseline, one month after the intervention and six months follow-up
Changes in Community Periodontal Index (CPI)
Measured: changes from baseline, one month after the intervention and six months follow-up
Changes in Turesky Modification of the Quigley-Hein Plaque Index
Measured: changes from baseline, one month after the intervention and six months follow-up
Oral health related quality of life
Measured: changes from baseline and six months follow-up
The frequency of the use of planning
The number of planning strategies is used by the adolescents before, at baseline, one month after the intervention and six months follow-up
Measured: changes from baseline, one month after the intervention 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 posted20 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2014
- Study completionSep 2014
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 Oral Health Behavior ChangeStudies 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
- 1,110 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066987
- Sponsor's protocol ID
- QUMS-B23
- Status last verified
- Sep 2014
- First submitted
- 17 Feb 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
Publications
Pakpour AH, Gholami M, Gellert P, Yekaninejad MS, Dombrowski SU, Webb TL. The Effects of Two Planning Interventions on the Oral Health Behavior of Iranian Adolescents: A Cluster Randomized Controlled Trial. Ann Behav Med. 2016 Jun;50(3):409-18. doi: 10.1007/s12160-015-9767-3.
PubMed 26791023
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two Volitional Interventions to Improve Oral Health Behaviour Among Iranian Adolescents
- ClinicalTrials.gov ID
- NCT02066987
- Acronym / sponsor ID
- QUMS-B23
- Conditions
- Oral Health Behavior Change
- Keywords
- Action planning, Implementation intention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,110 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 20 Feb 2014 (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.
the present study had two main aims. First, due to the current underconsumption of dental brush adolescents, the investigators should apply a volitional intervention to increase oral health behvaiour in adolescents. Second, the investigators aim to compare the effectiveness of action planning intervention and implementation intention will improve oral health behavior in adolescents.
Detailed description
This is a study to explore the impact of two volitional interventions on brushing 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Implementation intention | Experimental | Behavioral: Implementation intentionIt may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans. If it is _____ (WHEN) at or in _______ (WHERE) before/after ______ (ACTIVITY), then I will brush my teeth! If it is _____ (WHEN) at or in _______ (WHERE) before/after ______ (ACTIVITY), then I will brush my teeth! |
| Action planning | Experimental | Behavioral: Action planningIt may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans. I will brush my teeth at ___(WHEN) at or in ____(WHERE) before/after ___ (ACTIVITY). I will brush my teeth at ___(WHEN) at or in ____(WHERE) before/after ___ (ACTIVITY). |
| active control group | Active comparator | Behavioral: active control groupParticipants in the active control group will receive an educational pamphlet containing what it is dental brushing, why it is done, and how it is done. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 14 Years to 19 Years
- Ability to understand Persian language Adolescents attending high schools in Qazvin
Key exclusion criteria (2 listed)
- participate in any kind of oral health education and promotion programs
- undergoing orthodontic treatment
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 |
|---|---|---|
| Implementation intentionIt may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans. If it is _____ (WHEN) at or in _______ (WHERE) before/after ______ (ACTIVITY), then I will brush my teeth! If it is _____ (WHEN) at or in _______ (WHERE) before/after ______ (ACTIVITY), then I will brush my teeth! | Behavioural | Implementation intention |
| Action planningIt may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans. I will brush my teeth at ___(WHEN) at or in ____(WHERE) before/after ___ (ACTIVITY). I will brush my teeth at ___(WHEN) at or in ____(WHERE) before/after ___ (ACTIVITY). | Behavioural | Action planning |
| active control groupParticipants in the active control group will receive an educational pamphlet containing what it is dental brushing, why it is done, and how it is done. | Behavioural | active control group |
Primary outcome
changes in frequencies of dental brushing
Time frame: changes from baseline, one month after the intervention and six months follow-up
5 secondary outcomes
changes in psychological predictors of dental brushing (intention ,perceived behavioural control and Self-monitoring)
Time frame: changes from baseline, one month after the intervention and six months follow-up
Changes in Community Periodontal Index (CPI)
Time frame: changes from baseline, one month after the intervention and six months follow-up
Changes in Turesky Modification of the Quigley-Hein Plaque Index
Time frame: changes from baseline, one month after the intervention and six months follow-up
Oral health related quality of life
Time frame: changes from baseline and six months follow-up
The frequency of the use of planning
Time frame: changes from baseline, one month after the intervention 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 16 Sep 2014.
- Derived from this study: PubMed 26791023Pakpour AH, Gholami M, Gellert P, Yekaninejad MS, Dombrowski SU, Webb TL. The Effects of Two Planning Interventions on the Oral Health Behavior of Iranian Adolescents: A Cluster Randomized Controlled Trial. Ann Behav Med. 2016 Jun;50(3):409-18. doi: 10.1007/s12160-015-9767-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Implementation intention and Action planning in people with Oral Health Behavior Change, 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 2 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 16 Sep 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 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 (time frame: changes from baseline, one month 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 NCT02066987, 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 16 Sep 2014.