The effect of educational intervention based on the behavioral theory on the encouragement to oral health of mothers with children under the age of three years referring to Khaf health centers
This study will be done to determine the effect of educational intervention based on on the theory of planned behavior to encourage mothers with children under the age of three to observe the oral health of their young children
Design
98 people will be selected from the Health centers under study. The assignment of the groups was non-random, the Health centers of Khaf are listed and 2 Health centers will be randomly selected as the intervention group. Then two Health centers will be selected as control group that are culturally and socially similar to the two intervention Health centers, but they are not geographically close.then 24 people are randomly selected from each village.
Settings and conduct
Educational intervention will be implemented with an emphasis on theory of planned behavior, for a maximum of 2 months on intervention group. Educational intervention will take place in 5 one-hour training sessions. The training sessions will be held in a group discussion. In this study, considering the characteristics of the target group and the objectives of the curriculum will be used various oral, written and combination methods such as lectures with questions and answers, providing and presenting suggestions, group discussion, practical presentation and role play.
Participants/Inclusion and exclusion criteria
Inclusion criteria: residence for at least 6 months in the research setting; having a child under three years of age.
Exclusion criteria: employ in a profession related to dentistry.
Intervention groups
Intervention group: educational intervention is done with an emphasis on theory of planned behavior.
Control Group: no intervention.
Main outcome variables
Oral care behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180910040991N1
Registration date:2020-06-02, 1399/03/13
Registration timing:registered_while_recruiting
Last update:2020-06-02, 1399/03/13
Update count:0
Registration date
2020-06-02, 1399/03/13
Registrant information
Name
Mahdi Gholian-aval
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3189 2207
Email address
gholianam@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on the behavioral theory on the encouragement to oral health of mothers with children under the age of three years referring to Khaf health centers
Public title
The effect of educational intervention based on the behavioral theory on the encouragement to oral health of mothers with children under the age of three years referring to Khaf health centers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Residence for at least 6 months in the research setting
Having a child under three years of age
Exclusion criteria:
Employ in a profession related to dentistry
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
N/A
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Qoreishi Building, Daneshgah 18, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-09-06, 1397/06/15
Ethics committee reference number
IR.MUMS.REC.1397.156
Health conditions studied
1
Description of health condition studied
Oral and dental diseases
ICD-10 code
K08.54
ICD-10 code description
Contour of existing restoration of tooth biologically incompatible with oral health
Primary outcomes
1
Description
Oral Health Behavior
Timepoint
Before the intervention, immediately and, tow months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Educational intervention will be implemented with an emphasis on theory of planned behavior, for a maximum of 2 months on intervention group. Educational intervention will take place in 5 one-hour training sessions. The training sessions will be held in a group discussion. In this study, considering the characteristics of the target group and the objectives of the curriculum will be used various oral, written and combination methods such as lectures with questions and answers, providing and presenting suggestions, group discussion, practical presentation and role play
Category
Behavior
2
Description
Control group: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khaf County Health Centers
Full name of responsible person
Mahin Osmani-roudi
Street address
School of Public Health, between 16th and 18th Daneshgah, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2210
Email
Osmanim1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice President of Research, Qoreishi Building, Daneshgah 18, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 1538
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mahdi Gholian-aval
Position
Vice Chancellor for Health of Mashhad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion. School of Public Health, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2207
Email
gholianam@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Gholian-aval
Position
Assisstance Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion. School of Public Health, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2204
Email
gholianam@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Gholian-aval
Position
Assisstance Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion. School of Public Health, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2204
Email
gholianam@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Not applicable
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
Title and more details about the data/document
Potential data is sharable after distinguishing people
When the data will become available and for how long
Start the access period one month after the publication of result
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data is sent through an official request and by email
From where data/document is obtainable
ِDr Mahdi Gholian-aval: gholianam@mums.ac.ir
What processes are involved for a request to access data/document
Data is sent through an official request and by email