<?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>IRCT20251129068147N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-11</date_registration>
      <primary_sponsor>Khoy University of Medical Sciences</primary_sponsor>
      <public_title>The Impact of Teach-Back Educational Interventions on Childbearing Intentions: Evaluating Attitudes and Perceived Behavioral Control</public_title>
      <acronym></acronym>
      <scientific_title>Promoting Childbearing Intention WithTeach-Back Method: The Role of Attitudes and Perceived Behavioral Control Among Married Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/93469</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization was conducted using a multistage cluster-randomized design. Khoy city was initially divided into two geographic zones based on municipal divisions. From each zone, four urban comprehensive health service centers were randomly selected (total of 8 centers). Within each zone, two centers were randomly allocated to the intervention group and two centers to the control group (resulting in 4 intervention clusters and 4 control clusters). In the final stage, 20 eligible women from each health center were selected using simple random sampling from the center’s registry list. The primary unit of randomization for group allocation was at the cluster level (comprehensive health service centers) to prevent contamination and information exchange between groups, while the secondary selection of participants was at the individual level. Stratified randomization was applied based on the two municipal geographical regions of Khoy city as strata to ensure socioeconomic and geographical balance across study arms. The random allocation sequence for both cluster assignment and individual participant sampling was generated using a random number table. Cluster allocation was determined prior to participant enrollment. Eligible participants were unaware of the alternative group allocation across other centers during recruitment and consent, and geographical separation between health centers ensured effective concealment and prevented contamination across study arms.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fertility Intention,Reproductive Health,Health Education,Reproductive Behavior.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The educational intervention consisted of four 45-minute training sessions (one session per week) conducted for the intervention group. Each session included 25 minutes of structured education based on the constructs of the Theory of Planned Behavior (TPB) (including attitudes, subjective norms, and perceived behavioral control regarding childbearing) and 20 minutes of practice and feedback using the Teach-Back method to ensure comprehension. Intervention 2: Control group: .The control group received routine health center care and no educational intervention during the study period (3-month follow-up). The educational content was provided to the control group after the completion of the 3-month follow-up period.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the sensitivity of the study topic and the potential risk of re-identification of participants within a small-scale sample, we are unable to share individual participant data in order to strictly protect participant confidentiality and privacy.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Morad Ali Zareipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ostad Shahriar St., Shahid Fahmideh Sq., 15th of Khordad Blvd</address>
        <city>Khoy</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4334358147</zip>
        <telephone>+98 44 3646 7036</telephone>
        <email>z.morad@yahoo.com</email>
        <affiliation>Khoy University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Morad Ali Zareipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ostad Shahriar St., Shahid Fahmideh Sq., 15th of Khordad Blvd</address>
        <city>Khoy</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4334358147</zip>
        <telephone>+98 44 3646 7036</telephone>
        <email>z.morad@yahoo.com</email>
        <affiliation>Khoy University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>being within reproductive age (15–49 years)
having no medical contraindication for pregnancy
having an active health record at a comprehensive health service center</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>pregnancy during the study period and infertility in either partner</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The educational intervention consisted of four 45-minute training sessions (one session per week) conducted for the intervention group. Each session included 25 minutes of structured education based on the constructs of the Theory of Planned Behavior (TPB) (including attitudes, subjective norms, and perceived behavioral control regarding childbearing) and 20 minutes of practice and feedback using the Teach-Back method to ensure comprehension.</i_keyword>
      <i_keyword>Control group: .The control group received routine health center care and no educational intervention during the study period (3-month follow-up). The educational content was provided to the control group after the completion of the 3-month follow-up period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fertility Intention. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Data were collected using a structured questionnaire consisting of three main sections: (1) demographic characteristics, (2) knowledge related to childbearing, and (3) constructs of the Theory of Planned Behavior (TPB) associated with fertility intention.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Khoy University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-24</approval_date>
        <contact_name>Research Ethics Committees of Khoy University of Medical Sciences</contact_name>
        <contact_address>15th of Khordad Blvd., Shahid Fahmideh Sq., Ostad Shahriar St. Khoy West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
