<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20170802035446N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-10-18</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>evaluation of childbearing intention program based on Multi - theory model in women of reproductive age referring to comprehensive health centers in Yazd</public_title>
      <acronym></acronym>
      <scientific_title>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</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26784</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The present study will be of a combined exploratory type that will be conducted in three phases and stages, Randomization description: 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).</study_design>
      <phase>3</phase>
      <hc_freetext>Childbearing behavior.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
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.

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions and policy makers of the Ministry of Health, Treatment and Medical Education

Conditions:
The results of the study can be used in other provinces with the permission of the researchers

Where to obtain:
Tayebeh Mokhtari Sorkhani
00989138417584
arianmokhtari2@gmail.com

How to obtain:
After receiving the email, the files will be sent in less than a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebeh Mokhtari Sorkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mohabbateh Alley., Imam Reza Street., Modares Blvd., Yazd</address>
        <city>یزد</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۹۱۵۴۵۷۳۴۵</zip>
        <telephone>+98 35 3834 4099</telephone>
        <email>arianmokhtari2@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Saeid Mazloomi Mahmodabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alem Square., Faculty of Health., Yazd.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۹۱۵۱۷۳۱۶۰</zip>
        <telephone>+98 35 3820 9100</telephone>
        <email>Mazloomy.mm@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <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</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Occurrence of pregnancy (during and before the intervention)
The unwillingness of the wife or her husband to continue participating in the plan</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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. Timepoint: 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. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Change in the mean scores of the constructs of the beginning of pregnancy behavior change (participatory dialogue, behavioral confidence, change in the physical environment). Timepoint: 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. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>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). Timepoint: 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. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pregnancy rate. Timepoint: Three, six, and nine months after the intervention based on the Multi-theory model l. Method of measurement: Phone interview.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-24</approval_date>
        <contact_name>Ethics Committee of the Shahid Sadoughi University of Medical Sciences in Yazd, Iran.</contact_name>
        <contact_address>Imam Hossein (AS) square., Vice-chancellor for Research of Yazd University of Medical Sciences., Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
