Protocol summary
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Study aim
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Determining the effect of Design, implementation, and evaluation of childbearing intention program based on multi -theory model in women of reproductive age referring to comprehensive health centers;Yazd
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Design
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A clinical trial with a control group, parallel groups, randomized, on 100 patients( 50 people in each group). Random Allocation software will be used for randomization.
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Settings and conduct
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The pre-test involves women completing a self-reported questionnaire via an internal messaging network. The educational intervention includes at least four sessions: (three sessions, 45-60 minutes each, twice a week for women at the Comprehensive Health Center and a joint session with their husbands.) These sessions, led by Ph.D student under professor supervision, are based on pre-test results and interviews, following the Multi-Theory Model. Participants will receive updates, materials, and session reminders via the messaging network and SMS, with opportunities to ask questions through voice or private chat.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Be literate in reading and writing and reproductive age; Not planning pregnancy before the study; First marriage of the woman; Has one child; having an active sexual and marital relationship; At least 18 months since the previous pregnancy; Access to cell phones and virtual social networks; No medical contraindications for pregnancy; The only wife of her husband
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Intervention groups
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The research population consists of women of reproductive age with one child who refer to comprehensive health centers in Yazd. The intervention consists of at least 4 sessions, and the control group receives routine care at the health center
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Main outcome variables
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Changing the behavior of pregnancy intention and the mean scores of the constructs of the beginning and Sustaining pregnancy behavior change.
General information
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Reason for update
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-Modify "assess" to "evaluation" in the title.
-Renaming one of the Inclusion criteria for entering the study from "To have a common bed with her husband" to "having an active sexual and marital relationship."
-Insert the full name of the research committee, the Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd.
- Change the target group from "Women with one and two children" to "Women with one child"
- Modify the overall aim of the study to "Determine the effect of the childbearing intention program based on a multi-theory model in women of reproductive age referring to comprehensive health centers in Yazd city
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170802035446N3
Registration date:
2024-10-18, 1403/07/27
Registration timing:
prospective
Last update:
2025-04-02, 1404/01/13
Update count:
1
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Registration date
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2024-10-18, 1403/07/27
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2025-04-09, 1404/01/20
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Expected recruitment end date
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2025-07-23, 1404/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Design, implementation, and evaluation of childbearing intention program based on Multi -theory model in women of reproductive age referring to comprehensive health centers in Yazd
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Public title
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evaluation of childbearing intention program based on Multi - theory model in women of reproductive age referring to comprehensive health centers in Yazd
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Be literate in reading and writing.
Be of reproductive age.
Not intending to get pregnant before starting the study
Be The first marriage of the woman
At least 18 months have passed since her previous pregnancy
Access cell phones and virtual social networks
Participants do not have medical contraindications for pregnancy (class 4 heart disease, patients using Teratogenic drugs for epilepsy or rheumatoid arthritis, and malignancies).
Be the only wife of her husband.
having an active sexual and marital relationship
have one children
Exclusion criteria:
Occurrence of pregnancy (during and before the intervention)
The unwillingness of the wife or her husband to continue participating in the plan
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Age
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From 15 years old to 49 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At first, for the greater diversity of participants, among the 23 comprehensive health centers of Yazd city, in each of the north, south, east, and west parts of Yazd city, a total of four comprehensive health centers will be selected by cluster sampling method and Simple randomization, two centers will be selected for intervention and two centers for control.
Sampling centers for the intervention and control groups are selected in such a way that they are similar in economic, social, and cultural terms. In the intervention phase, 100 women will be included in the study, using random allocation software, in a simple random manner. They are divided into two intervention groups (50 participants) and control group (50 participants).
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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The present study will be of a combined exploratory type that will be conducted in three phases and stages.
Ethics committees
1
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Ethics committee
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Approval date
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2024-06-24, 1403/04/04
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Ethics committee reference number
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IR.SSU.SPH.REC.1403.069
Health conditions studied
1
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Description of health condition studied
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Childbearing behavior
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Changing the behavior of pregnancy intention. Behavioral intention means starting the behavior of having children, performing pre-pregnancy care behaviors in the health center by completing the pre-pregnancy care form, starting to take folic acid, and not using contraceptive methods.
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Timepoint
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Before the intervention based on the Multi-theory model in two groups. One month later and three months after the completion of the intervention based on the Multi-theory model in two groups. before, one month after, and three months after the completion of the intervention based on the multi-theoretical model in each group.
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Method of measurement
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Questionnaire
2
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Description
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Change in the mean scores of the constructs of the beginning of pregnancy behavior change (participatory dialogue, behavioral confidence, change in the physical environment)
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Timepoint
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Before the intervention based on the Multi-theory model in two groups. One month later and three months after the completion of the intervention based on the Multi-theory model in two groups. before, one month after, and three months after the completion of the intervention based on the multi-theoretical model in each group.
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Method of measurement
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Questionnaire
3
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Description
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Change in the mean scores of the constructs of maintaining and Sustaining pregnancy behavior change (emotional transformation, change in the social environment, practicing for change)
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Timepoint
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Before the intervention based on the Multi-theory model in two groups. One month later and three months after the completion of the intervention based on the Multi-theory model in two groups. before, one month after, and three months after the completion of the intervention based on the multi-theoretical model in each group.
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Method of measurement
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Questionnaire
Secondary outcomes
1
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Description
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Pregnancy rate
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Timepoint
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Three, six, and nine months after the intervention based on the Multi-theory model l
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Method of measurement
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Phone interview
Intervention groups
1
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Description
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Intervention Group: To participate in the pre-test, the questionnaire link will be provided to all participating women via the authorized internal messaging network, where they will complete it in a self-reported format. The educational intervention will consist of at least four sessions (including three 45-60 minute in-person sessions for women, held twice a week, and a joint session with their husbands). These sessions will be conducted by students under the supervision of esteemed professors and will involve lectures, group discussions, educational videos, pamphlets, recommendations of educational books, and training based on insights from pre-test results and interviews, aligned with the structures of the Multi-Theory Model (MTM). The topics will cover:• Having children• The importance and position of children from the Islamic perspective and Quranic teachings• Benefits of having children• The ideal age for having children• The drawbacks of having few or only one child• Strategies to address challenges related to raising and caring for childrenIf necessary, based on pre-test results and the research team's judgment, the number of sessions will be increased. Through the internal messaging network, participants will receive updates on meetings and educational materials, and they will have the opportunity to ask questions via voice or private chat with the researcher. Session assignments will also be sent via SMS as reminders. Since the participation and support of husbands are crucial for having children, husbands will also receive training and counseling on the significance of childbearing, the appropriate timing and age, and additional related topics. A joint session with spouses (in the intervention group) will be invited at the Yazd Municipality Cultural Center, where they will receive necessary training during a group session conducted by experts trusted and approved by them.
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Category
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N/A
2
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Description
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Control Group: During this period, the control group will receive routine care from the comprehensive health center. All participating women in both groups will complete the questionnaire again one month and three months after the intervention. Pregnancy occurrence will be followed up by telephone calls to the women (in both groups) at three, six, and nine months after the intervention. Upon completing the follow-ups, and per ethical principles, the educational materials and package will be made available to the women and their spouses in the control group through a virtual network, where their questions will be answered.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All potential data can be shared after making people unidentifiable, for example, in a qualitative study, how to code and themes obtained, and the psychometrics of the final questionnaire and the result of the intervention phase.
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When the data will become available and for how long
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The access period starts 6 months after the results are published
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To whom data/document is available
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Researchers working in academic and scientific institutions and policy makers of the Ministry of Health, Treatment and Medical Education
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Under which criteria data/document could be used
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The results of the study can be used in other provinces with the permission of the researchers
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From where data/document is obtainable
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Tayebeh Mokhtari Sorkhani
00989138417584
arianmokhtari2@gmail.com
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What processes are involved for a request to access data/document
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After receiving the email, the files will be sent in less than a week
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Comments
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