Protocol summary

Study aim
Effect of education based on planned behavior theory on receiving prenatal care
Design
The study is an experimental randomized clinical trial that aims to investigate the effect of educational intervention based on the theory of planned behavior on receiving prenatal care. The data collection tool is a researcher-made questionnaire. The research environment is the study of the Center for Comprehensive Health Care Services No. 1 in Takestan. Samples will be selected among women participating in premarriage classes. Selection of samples will be done by random assignment. The pre-test questionnaire will be provided to the two test and control groups for the overall assessment of the audiences that affect the behavior.
Settings and conduct
Municipal Health Center No. 1 vineyard.
Participants/Inclusion and exclusion criteria
1. Have the consent to participate in the study. 2. It is in the age range of 18 to 40 years. 3. Lack of underlying illness that is an absolute prohibition for pregnancy. 4. The desire to have a pregnancy within a maximum of one year from the start of the study. 5. Reading and writing skill
Intervention groups
The intervention group includes 75 women who take part in marriage training classes, which will receive four sessions based on the theory of planned behavior. The control group also includes 75 women attending marriage classes, which will receive only one session of marriage training.
Main outcome variables
preconception care

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171019036878N3
Registration date: 2018-03-21, 1397/01/01
Registration timing: prospective

Last update: 2018-03-21, 1397/01/01
Update count: 0
Registration date
2018-03-21, 1397/01/01
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3524 1969
Email address
o.ghafoori@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-26, 1397/01/06
Expected recruitment end date
2018-04-26, 1397/02/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of health education based on theory of Planned Behavior on preconception care
Public title
Effect of health education based on theory of Planned Behavior on preconception care
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The age range is 18 to 40 years old. Planned for pregnancy within one year from the start of the study. Have reading and writing skills. Not having an underlying condition that has an absolute contraction of pregnancy.
Exclusion criteria:
Exit from the research site.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be randomly assigned. The green card for the intervention group and the yellow card will be used for the control group.
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 in Biomedical Research
Street address
Bahonar Blvd., Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2018-02-07, 1396/11/18
Ethics committee reference number
IR.QUMS.REC.1396.436

Health conditions studied

1

Description of health condition studied
preconception care
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Percentage of people who receive prenatal care
Timepoint
Three months after the intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group will receive educational intervention based on the theory of planned behavior in the form of four 90-minute training sessions on a weekly basis on prenatal care. Control group: This group will not receive any educational intervention and will receive only one session of marriage training as an intervention group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Marriage Training Center
Full name of responsible person
Ozra Ghafouri
Street address
Marriage Training Center،Fakouri Street, Health Center،Imam Khomeini Street
City
Takestan
Province
Qazvin
Postal code
3481657743
Phone
+98 28 3524 7106
Email
zjourabchi@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peimani
Street address
Qazvin University of Medical Sciences،Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
apeymani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Ozra Ghafouri
Position
Midvife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Andisheh 22،Teacher Street،Takestan - Imam Street،Qazvin
City
Takestan
Province
Qazvin
Postal code
34841
Phone
+98 28 3524 1969
Email
ozra_ghafoori1969@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Zinat Jorabchi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Family Health
Street address
University of Medical Sciences،Boulevar shahid bahonar
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
zjourabchi@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ozra Gafouri
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Andisheh 22،Teachers' Street،Imam Street
City
Takestan
Province
Qazvin
Postal code
34841
Phone
+98 28 3524 1969
Email
ozra_ghafoori1969@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
No more information
When the data will become available and for how long
Get started six months after printing results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
No more information
From where data/document is obtainable
email address
What processes are involved for a request to access data/document
Six months after printing results
Comments
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