Protocol summary

Study aim
Evaluation of the effect of educational interventions on preventive behaviors of oral cancer based on the Theory of Planned Behavior
Design
Cluster randomized controlled trial, with parallel groups, single blind, people aged 15 years and more living in Tehran, two intervention groups, simple randomization using Excel software, 400 people, participated in study in 2022
Settings and conduct
The health centers in two low-advantaged and very low-advantaged areas of Tehran located in five districts covered by Tehran University of Medical Sciences, which have the necessary criteria for better implementation of study will be selected, and from these centers, 20 centers will be randomly selected, and in each center, 20 people will be selected by simple random sampling. Data will be collected using structured interviewer-administered questionnaire of Theory of Planned Behavior, which will be again completed one and three months after the intervention. The data will be entered into STATA software with special codes, so that the analyzer is not informed about the clusters and groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 15 years and more; Living in low-advantaged or very low-advantaged area of Tehran; Absence of physical and mental disabling diseases; Agreement to sign the informed consent form Exclusion criteria: Non-Iranian citizens; Unwillingness to participate in face-to-face educational sessions; Unwillingness to work with virtual social networks; Inability to use smartphone applications
Intervention groups
Intervention group 1 (control group): Education on oral cancer prevention using lecture presentation and pamphlet based on the Theory of Planned Behavior, Intervention group 2: Education on oral cancer prevention using smartphone based on the Theory of Planned Behavior
Main outcome variables
Preventive behaviors of oral cancer; Knowledge about oral cancer

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220221054086N1
Registration date: 2022-03-04, 1400/12/13
Registration timing: prospective

Last update: 2022-03-04, 1400/12/13
Update count: 0
Registration date
2022-03-04, 1400/12/13
Registrant information
Name
Anoosheh Ghasemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5950
Email address
a-ghasemian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of educational interventions on preventive behaviors of oral cancer based on the Theory of Planned Behavior among people aged 15 years and more: A cluster randomized controlled trial
Public title
Evaluation of the effect of educational interventions on prevention of oral cancer based on the behavior change model
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 15 years and more Living in low-advantaged or very low-advantaged area of Tehran Absence of physical and mental disabling diseases Minimum literacy of reading and writing Having a smartphone and installed applications Willingness to participate in the study and agreement to sign the informed consent form
Exclusion criteria:
Non-Iranian citizens Unwillingness to participate in face-to-face educational sessions Unwillingness to work with virtual social networks Inability to use smartphone applications
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 400
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be performed using simple cluster random sampling. Based on the socio-economic development index, the city of Tehran is divided into five areas of advantaged, relatively-advantaged, semi-advantaged, low-advantaged, and very low-advantaged. The city of Tehran has 22 districts, of which the advantaged area includes four districts (1, 2, 3, 6), the relatively-advantaged area includes two districts (5, 7), the semi-advantaged area includes six districts (4, 8, 11, 13, 21, 22), the low-advantaged area includes five districts (9, 10, 12, 14, 20), and the very low-advantaged area includes five districts (15, 16, 17, 18, 19). Two areas of low- and very low-advantaged will be selected according to the research goal. Then, the list of health centers in these two areas will be extracted based on their locations in the districts covered by Tehran University of Medical Sciences, including districts 10, 15, 16, 17, and 19, which include 100 centers. Next, among the health centers located in these districts, the centers which have capability to implement study better will be selected based on the criteria such as activeness of the center, cooperation of the center, sufficient number of clients, amount of participation of covered people, and facilities of the center including appropriate space and place for education. The list of selected health centers that are considered as clusters will be prepared, and from these selected centers, 20 centers will be randomly selected, of which 10 centers will be allocated to intervention group 1 (control) and 10 centers to intervention group 2 by simple randomization using Excel software. Then, according to the sample size of 400 people, in each of the 20 health centers, 20 people will be selected, in such a way that the list of people covered by these centers will be prepared, and 20 of them will be selected by simple random sampling and invited to participate in the study, and if people do not have willing to participate in the study, alternative people from the prepared list will be also selected by simple random sampling.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data will be entered into STATA software with special codes, so that the analyzer is not informed about the clusters and groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of School of Dentistry, Tehran University of Medical Sciences
Street address
Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, North Kargar Ave
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2022-02-21, 1400/12/02
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1400.189

Health conditions studied

1

Description of health condition studied
Prevention of oral cancer
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Preventive behaviors of oral cancer
Timepoint
At the beginning of study, one and three months after intervention
Method of measurement
Structured interviewer-administered questionnaire of Theory of Planned Behavior

2

Description
Knowledge about oral cancer
Timepoint
َAt the beginning of study, one and three months after intervention
Method of measurement
Structured interviewer-administered questionnaire of Theory of Planned Behavior

Secondary outcomes

1

Description
Behavioral intention about preventive behaviors of oral cancer
Timepoint
At the beginning of study, one and three months after intervention
Method of measurement
Structured interviewer-administered questionnaire of Theory of Planned Behavior

2

Description
Attitude toward preventive behaviors of oral cancer
Timepoint
At the beginning of study, one and three months after intervention
Method of measurement
Structured interviewer-administered questionnaire of Theory of Planned Behavior

3

Description
Subjective norm about preventive behaviors of oral cancer
Timepoint
At the beginning of study, one and three months after intervention
Method of measurement
Structured interviewer-administered questionnaire of Theory of Planned Behavior

4

Description
Perceived behavioral control about preventive behaviors of oral cancer
Timepoint
At the beginning of study, one and three months after intervention
Method of measurement
Structured interviewer-administered questionnaire of Theory of Planned Behavior

Intervention groups

1

Description
Control group: Education on oral cancer prevention by educated health volunteers using two sessions of 10-15 minutes lecture presentation in form of PowerPoint slides, and presentation of pamphlet based on the structures of the Theory of Planned Behavior, with interactive group discussions, and questions and answers to questions
Category
Prevention

2

Description
Intervention group: Education on oral cancer prevention by educated health volunteers using information presentation on smartphone in form of educational and motivational messages, pictures, and videos in WhatsApp groups based on the structures of the Theory of Planned Behavior, with interactive group discussions, and questions and answers to questions
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
District 10, South Tehran Health Center
Full name of responsible person
Mohammad Reza Salmani
Street address
Shafiei Alley, Vesal Shirazi St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1311754339
Phone
+98 21 6695 0069
Email
Behdasht-Jonoob-Tehran@sina.tums.ac.ir

2

Recruitment center
Name of recruitment center
District 15, South Tehran Health Center
Full name of responsible person
Mohammad Reza Salmani
Street address
Shafiei Alley, Vesal Shirazi St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1311754339
Phone
+98 21 6695 0069
Email
Behdasht-Jonoob-Tehran@sina.tums.ac.ir

3

Recruitment center
Name of recruitment center
District 16, South Tehran Health Center
Full name of responsible person
Mohammad Reza Salmani
Street address
Shafiei Alley, Vesal Shirazi St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1311754339
Phone
+98 21 6695 0069
Email
Behdasht-Jonoob-Tehran@sina.tums.ac.ir

4

Recruitment center
Name of recruitment center
District 17, South Tehran Health Center
Full name of responsible person
Mohammad Reza Salmani
Street address
Shafiei Alley, Vesal Shirazi St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1311754339
Phone
+98 21 6695 0069
Email
Behdasht-Jonoob-Tehran@sina.tums.ac.ir

5

Recruitment center
Name of recruitment center
District 19, South Tehran Health Center
Full name of responsible person
Mohammad Reza Salmani
Street address
Shafiei Alley, Vesal Shirazi St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1311754339
Phone
+98 21 6695 0069
Email
Behdasht-Jonoob-Tehran@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
6th floor, Vice Chancellor for Research and Technology, Central Organization of Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tehran University of Medical Sciences
Full name of responsible person
Anoosheh Ghasemian
Position
PhD student of Community Oral Health
Latest degree
Medical doctor
Other areas of specialty/work
Community Oral Health
Street address
Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, North Kargar Ave
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
a-ghasemian@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Katayoun Sargeran
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Community Oral Health
Street address
Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, North Kargar Ave
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Email
k-sargeran@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Anoosheh Ghasemian
Position
PhD student of Community Oral Health
Latest degree
Medical doctor
Other areas of specialty/work
Community Oral Health
Street address
Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, North Kargar Ave
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
a-ghasemian@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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