Protocol summary

Study aim
General Objective: Determine the effect of education based on the theory of planned behavior on couples' fertility intentions Specific Objectives: 1- Determine and compare the distribution of demographic variables of couples in the experimental and control groups 2- Determine and compare the average scores of knowledge, perceived behavioral control, abstract norms, attitude, and behavioral intention of couples regarding fertility intentions before and 3 months after the educational intervention in the experimental and control groups.
Design
controlled, multi-stage, single-blind, randomized, parallel-group clinical trial on 80 subjects.
Settings and conduct
The study was conducted in the city of Khomein and the people studied did not know which group they were in.
Participants/Inclusion and exclusion criteria
Participants, including married women and men of childbearing age with children one year old and older, will be excluded from the program if they do not attend the training sessions.
Intervention groups
Holding educational and counseling sessions on the importance and benefits of having children based on model structures and sending educational content and media in cyberspace to the test group.
Main outcome variables
Demographic characteristics of the participants in the study were measured separately in two experimental and control groups, and the effect of education on the constructs of attitude, abstract norms, and perceived behavioral control on fertility intention was measured through a questionnaire before the educational intervention and 3 months after the intervention.

General information

Reason for update
Acronym
IHCS
IRCT registration information
IRCT registration number: IRCT20240215061011N1
Registration date: 2025-12-17, 1404/09/26
Registration timing: retrospective

Last update: 2025-12-17, 1404/09/26
Update count: 0
Registration date
2025-12-17, 1404/09/26
Registrant information
Name
Hadi Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4633 4046
Email address
h.mohammadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-22, 1404/03/01
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
2025-05-22, 1404/03/01
Actual recruitment end date
2025-09-23, 1404/07/01
Trial completion date
2025-09-23, 1404/07/01
Scientific title
Investigating the effect of training based on the theory of planned behavior on the intention to have children of single-child couples
Public title
Investigating the effect of training based on the theory of planned behavior on the intention to have children of single-child couples
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Do not have any contraindications for pregnancy and fertility Be literate in reading and writing Women of reproductive age and not pregnant Their child's age is one year or older be married
Exclusion criteria:
illiterate people single people
Age
From 10 years old to 54 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 90
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Multi-step method: dividing the city of Khomein into 8 regions and each region into several blocks - selecting one block from each region - random sampling of a class from each block (no children/one child/two or more children)
Blinding (investigator's opinion)
Single blinded
Blinding description
Because individuals enter the study with informed consent and must be aware of their assignment to the case and control groups, the data analyst, who is a statistical consultant, is not aware of the group assignment and only codes groups one and two, and the data is collected by interviewers who are unaware of the group assignment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Arak University of Medical Sciences
Street address
No. 34, Shahid Hashemi Alley, Shahid Sadoqi Boulevard
City
Khomein
Province
Markazi
Postal code
3881933783
Approval date
2024-05-26, 1403/03/06
Ethics committee reference number
IR.ARAKMU.REC.1403.077

Health conditions studied

1

Description of health condition studied
The effect of education based on the theory of planned behavior on the fertility intention of single-child couples
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fertility intention score in single-child couples
Timepoint
Conducting the test before the intervention and 3 months after the intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Increased childbearing in single-child couples
Timepoint
2 years after intervention
Method of measurement
Statistical information of level one health center systems

Intervention groups

1

Description
Intervention group: Educational intervention for the test group based on the results of the needs assessment and pre-test in the form of lectures, group discussions, educational videos and presentation of pamphlets and educational books (focusing on the structures of the theory of planned behavior) regarding the child, the importance and position of the child from the perspective of religion Explaining Islam and verses of the Quran, the benefits of children, the disadvantages of having fewer children, and solutions to deal with problems related to children by midwives and psychologists, as well as regarding the formation of groups in virtual space and the provision of media and educational content for the participants in the study based on theoretical structures. The programmed behavior is carried out. The questionnaire should be completed again by two groups 3 months after the educational intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
پایگاه های سلامت خمین
Full name of responsible person
هادی محمدی
Street address
No. 34, Shahid Hashemi Alley, Shahid Sadoughi Boulevard
City
Khomein
Province
Markazi
Postal code
3881933783
Phone
+98 86 4633 4046
Email
hady_1361@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Daud Hekmat Po
Street address
University Complex of the Prophet (PBUH), Basij Square, Sardasht.
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3532
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hadi Mohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 34, Shahid Hashemi Alley, Shahid Sadoqi Boulevard
City
Khomein
Province
Markazi
Postal code
3881933783
Phone
+98 86 4633 4046
Email
hady_1361@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Mohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
No. 34, Shahid Hashemi Alley, Shahid Sadoughi Blvd
City
Khomein
Province
Markazi
Postal code
3881933783
Phone
+98 86 4633 4046
Email
hady_1361@ yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
hadi mohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 34, Shahid Hashemi Alley, Shahid Sadoqi Boulevard
City
khomein
Province
Markazi
Postal code
3881933783
Phone
+98 86 4633 4046
Email
hady_1361@yahoo.com

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
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
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
Information about the scores of the model constructs can be shared.
When the data will become available and for how long
One year after results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Master's and doctoral students for use in their dissertations
From where data/document is obtainable
Email: hady_1361@yahoo.com Mobile number: 09183661997
What processes are involved for a request to access data/document
Personal request via email or phone number
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