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Protocol summary

Study aim
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
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
Duration of tooth brushing Frequency of tooth brushing

General information

Reason for update
Acronym
IRCT registration information
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
Registration date
2017-07-26, 1396/05/04
Registrant information
Name
AliAsghar Habibi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 4039
Email address
dreamstar890@gmail.com
Recruitment status
Recruitment complete
Funding source
Funding of Tehran University of Medical Sciences for thesis and research projects
Expected recruitment start date
2017-02-25, 1395/12/07
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The application of social marketing to promote good habits of brushing (at least twice a day, each time at least two minutes)
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 1720
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
room No. 604, sixth floor, the Central Organization of Tehran University of Medical Sciences, St. Qods, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2016-10-25, 1395/08/04
Ethics committee reference number
IR.TUMS.VCR.REC.1395.852

Health conditions studied

1

Description of health condition studied
Oral health advice and education (tooth brushing habit)
ICD-10 code
Z72.9, Z71
ICD-10 code description
Problem related to lifestyle, unspecified---Other specified counselling

Primary outcomes

1

Description
Frequency of tooth brushing
Timepoint
Before and one month after intervention
Method of measurement
Answering checklist (self-reported)

2

Description
Duration of tooth brushing
Timepoint
Before and one month after intervention
Method of measurement
Answering checklist (self-reported)

Secondary outcomes

empty

Intervention groups

1

Description
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)
Category
Prevention

2

Description
Intervention in the control city (Jafariye city): The use of traditional methods such as distributing pamphlets to increase the frequency and duration of brushing
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahhari2 school of Kahak city
Full name of responsible person
Mr Esmaeily
Street address
Zeynabieh St.
City
Kahak
Province
Ghoum
Postal code
3735114640
Phone
+98 25 3422 3424
Email
name@domian.com

2

Recruitment center
Name of recruitment center
Motahhari1 school of Kahak city
Full name of responsible person
Mr Abarghooyi
Street address
Zeynabieh St.
City
Kahak
Province
Ghoum
Postal code
3735114641
Phone
+98 25 3422 7676
Email
name@domian.com

3

Recruitment center
Name of recruitment center
Fatemiyeh school of Kahak city
Full name of responsible person
Mrs Moosayi
Street address
Hazrat Abalfazl Blvd.
City
Kahak
Province
Ghoum
Postal code
3735114159
Phone
+98 25 3422 5464
Email
name@domian.com

4

Recruitment center
Name of recruitment center
Ansarolhossein1 school of Jafariyeh
Full name of responsible person
Mr Moosavi
Street address
Imam Ali St.
City
Jafariyeh
Province
Ghoum
Postal code
3744118884
Phone
+98 25 3627 3223
Email
name@domian.com

5

Recruitment center
Name of recruitment center
Ansarolhosein2 school of Jafariyeh
Full name of responsible person
Mr Jokar
Street address
Farhang St.
City
Jafariyeh
Province
Ghoum
Postal code
3744118875
Phone
+98 25 3627 5433
Email
name@domian.com

6

Recruitment center
Name of recruitment center
Bahonar school of Kahak city
Full name of responsible person
Mr Rahnama
Street address
Khamenei Blvd.
City
Jafariyeh
Province
Ghoum
Postal code
3744118864
Phone
+98 25 3627 4312
Email
name@domian.com

7

Recruitment center
Name of recruitment center
Jahad school of Jafariyeh
Full name of responsible person
Mrs Jafari
Street address
Imam ALi St.
City
Jafariyeh
Province
Ghoum
Postal code
3744118891
Phone
+98 25 3627 7679
Email
name@domian.com

8

Recruitment center
Name of recruitment center
Bagher Rabbani school of Jafariyeh
Full name of responsible person
Mrs Karimi
Street address
Moradi St.
City
Jafariyeh
Province
Ghoum
Postal code
3744118721
Phone
+98 25 3627 4563
Email
name@domian.com

9

Recruitment center
Name of recruitment center
Kowsar school of Jafariyeh
Full name of responsible person
Mrs Mirzayi
Street address
Hakim St.
City
Jafariyeh
Province
Ghoum
Postal code
3744118731
Phone
+98 25 3627 4456
Email
name@domian.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Younesian
Street address
room No. 605, sixth floor, the Central Organization of Tehran University of Medical Sciences, St. Qods, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417713541
Phone
+98 21 8893 3766
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Dentistry School of Teharan University of Medical Sciences
Full name of responsible person
Dr. Mahdia Gholami
Position
Member of science committee of oral health and social dentistry department
Latest degree
Ph.D.
Other areas of specialty/work
Street address
School of Dentistry, after Energy-Atomi, North AmirAbad
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 8801 5960
Fax
Email
m_gholami@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dentistry School of Teharan University of Medical Sciences
Full name of responsible person
Dr. Mahdia Gholami
Position
PhD of oral health and social dentistry
Latest degree
Ph.D.
Other areas of specialty/work
Street address
School of Dentistry, after Energy-Atomi, North AmirAbad
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 8801 5960
Fax
Email
m_gholami@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dentistry faculty of Teharan University of Medical Sciences
Full name of responsible person
AliAsghar Habibi
Position
Dentistry student
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Kooy-e-Daneshgah, North AmirAbad
City
Tehran
Province
Tehran
Postal code
1439957181
Phone
+98 25 3423 4155
Fax
Email
dreamstar890@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifying people
When the data will become available and for how long
The start of access to data is 3 months after publishing the results
To whom data/document is available
Study data will be available to all individuals, including academic and industry researchers
Under which criteria data/document could be used
Access to data will be available for oral health promotion programs and any statistical analysis will be allowed.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
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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