Protocol summary
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Study aim
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The aim of this study was to evaluate the effect of social marketing approach versus the traditional method on promotion of tooth brushing habits in primary school students of Kahak and Jafariyeh, Qom
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Design
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This quasi-experimental controlled trial had a parallel design. The study was conducted in the cities of Kahak and Jafariyeh, Qom, Iran. Considering the relatively small number of students in the two cities, sampling was not done and the whole target population entered the census. 1318 students participated in the study and enrolled in February 2017 and followed one and half months.
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Settings and conduct
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Intervention Group (Kahak)
In this city, intervention was done according to the social marketing approach. The SMART model was used to organize different phases of social marketing in the following order [6, 13]:
Phase 1: Preliminary planning
The main problem, to overcome which this study was designed, was lack of interest in tooth brushing with the proper length and frequency. Therefore, the main objective of the study was to improve tooth-brushing habits as at least two times a day for at least two minutes each time. The main method that was used for project assessment was a self-report checklist before and after the intervention and comparison of the checklists.
Phase 2: Audience analysis
Only the primary school students of the two cities were identified as the target population. To analyze the target population’s beliefs and prioritization of the reasons for irregular or no tooth brushing from the perspective of themselves or their parents, a checklist was provided to all students and its results (Table 1) were used in designing the intervention tools.
Phase 3: Channel analysis
Since most of the students’ time was spent at home or school, communication channels that were appropriate for these environments like face-to-face training sessions, printed material for use in the school, training through parents, and the effect of parents on their children were considered.
Phase 4: Market analysis
In this study, one of the supporting factors was the performance of some teachers that considered a day of the week as the “tooth brush day”. On this day, the teachers asked the students to bring their toothbrushes and brush their teeth under the teacher’s supervision.
One of the identified competitors was the parents’ low level of oral health knowledge in Iran [14]. Another competitor was the common belief among the students that brushing the teeth once a day is enough [15].
The second part of market analysis was implementation of market mix principles or 4P as the following:
1. Product: The main product was prevention of tooth decay and the real product was tooth brushing two times a day for two minutes each time.
2. Price: The time spent in the class (about 30 minutes), time spent on brushing the teeth and commitment to completing the tooth brushing calendar were among the expenses that the participants met.
3. Place: The place that was considered for the intervention was the students’ schools and houses because they were easily accessible.
4. Promotion: All the tools that were designed to persuade students to brush their teeth are placed in this group. These tools were planned based on the results of the first checklist.
Phase 5: Development
In this study, a sample of the tools was provided to school managers and health authorities to collect their comments. The intervention tools were approved in all schools and no comments were received.
Phase 6: Implementation
In this phase, the project was implemented as designed in the previous phases, and interventions were applied in the schools. At the beginning of this phase, a checklist containing questions on tooth-brushing habits was completed by the students to record their status before the intervention. This checklist was completed by the parents of students in grades 1 to 3 and by the students in grades 4-6. After the checklists were collected, the intervention was continued for one and a half months.
Phase 7: Evaluation
In this study, considering the students’ presence at school, it was possible to convey messages to the target population. On the other hand, due to the availability of teachers, they were requested to cooperate in the assessment of the project and review the main concepts of the project with the students and check the tooth-brushing calendar at least once a week.
At the end of this phase, the students completed the tooth-brushing habits checklist for the second time to evaluate the changes following the intervention.
Control Group (Jafariyeh)
The students in Jafariyeh completed the tooth-brushing habits checklist before the intervention (similar to students in Kahak). After collecting the checklists, since this city was considered as the control group, a traditional intervention, i.e. pamphlet that was exactly similar to the pamphlet distributed in Kahak, was applied. Then, the changes were assessed through completing the checklist for a second time.
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Participants/Inclusion and exclusion criteria
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Entry requirements: All primary school students (grade 1 to 6) of Kahak and Jafariyeh in the 2016-2017 academic year
Non-entry requirements: Non-cooperation of the students and their parents’ unwillingness
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Intervention groups
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Intervention group: All primary school students of Kahak city in the 2016-2017 academic year
Control group: All primary school students of Jafariyeh city in the 2016-2017 academic year
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Main outcome variables
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Duration of tooth brushing
Frequency of tooth brushing
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016123131675N1
Registration date:
2017-07-26, 1396/05/04
Registration timing:
retrospective
Last update:
2018-03-05, 1396/12/14
Update count:
1
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Registration date
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2017-07-26, 1396/05/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Funding of Tehran University of Medical Sciences for thesis and research projects
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Expected recruitment start date
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2017-02-25, 1395/12/07
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Expected recruitment end date
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2017-02-28, 1395/12/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of two types of intervention (based on the principles of social marketing and traditional education) on increase in self-reported frequency and duration of tooth brushing of elementary school students: A controlled quasi-experimental study
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Public title
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The application of social marketing to promote good habits of brushing (at least twice a day, each time at least two minutes)
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Students enrolled in grades of one to six in elementary schools of Kahak and Jafariye cities in the academic year 2016-2017
Exclusion criteria:
non-compliance or lack of consent of the student or parents
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
1720
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-10-25, 1395/08/04
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Ethics committee reference number
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IR.TUMS.VCR.REC.1395.852
Health conditions studied
1
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Description of health condition studied
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Oral health advice and education (tooth brushing habit)
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ICD-10 code
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Z72.9, Z71
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ICD-10 code description
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Problem related to lifestyle, unspecified---Other specified counselling
Primary outcomes
1
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Description
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Frequency of tooth brushing
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Timepoint
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Before and one month after intervention
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Method of measurement
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Answering checklist (self-reported)
2
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Description
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Duration of tooth brushing
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Timepoint
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Before and one month after intervention
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Method of measurement
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Answering checklist (self-reported)
Intervention groups
1
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Description
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Intervention in intervention city (Kahak city): The use of social marketing principles such as use of adware, masterclass, distributed toothbrushes, timers, brochures, etc. based on the assessed needs of students with using of SMART (Social marketing assessment and response tool) model in order to promote good habits of brushing (at least twice a day and each time at least two minutes)
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Category
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Prevention
2
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Description
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Intervention in the control city (Jafariye city): The use of traditional methods such as distributing pamphlets to increase the frequency and duration of brushing
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The total potential data can be shared after unidentifying people
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When the data will become available and for how long
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The start of access to data is 3 months after publishing the results
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To whom data/document is available
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Study data will be available to all individuals, including academic and industry researchers
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Under which criteria data/document could be used
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Access to data will be available for oral health promotion programs and any statistical analysis will be allowed.
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From where data/document is obtainable
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1. Dr Mahdia Gholami, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran
Call Phone: +982188015960
Email: m_gholami@sina.tums.ac.ir
2. Dr. Ahmadreza Shamshiri- Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran
Call Phone: +982188015960
Email: ar_shamshiri@yahoo.com
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What processes are involved for a request to access data/document
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The requester must send the application to the persons mentioned in previous section to receive the study data. It is expected to receive information within a week.
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Comments
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