<?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>IRCT20230912059412N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-14</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Examining the impact of a program that promotes pregnancy health literacy on self-care, maternal infant attachment, and some pregnancy outcomes in pregnant teenagers.</public_title>
      <acronym></acronym>
      <scientific_title>Design, implementation, and evaluation of a program to improve adolescent pregnancy health literacy through a social messenger and investigating its impact on self-care, maternal infant attachment and some pregnancy outcome.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72561</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: By being present in the research environment and providing information about the pregnancy health literacy promotion program, the researcher invites pregnant adolescents who are willing to participate in the program and meet the criteria for entering the study, and by randomly assigning people to the intervention and non-intervention groups. intervention are divided. (There are 55 people in each group). For random allocation, the six block method will be used. For this purpose, all possible modes of placement of letters A (intervention) and B (non-intervention) will be considered in blocks of 6 with an allocation ratio of 1:1. It is a sequential stage. In the first stage, the researcher examines the health literacy needs of pregnant adolescents from the perspective of pregnant adolescents and key informants with a qualitative approach. In the second stage of the study, the researcher determines the priority needs of the adolescent pregnancy health literacy promotion program by using the nominal group technique and based on the opinions of key people, then in the third stage of the study of the promotion program Pregnancy health literacy will be designed using the ADDIE educational model. In the fourth stage, the researcher, by being present in the research environment and providing information about the educational program, invites pregnant teenagers who wish to participate in the program, and after obtaining written consent, the intervention group, which includes a total of 55 people, It divides 5 groups consisting of eleven pregnant teenagers and distributes the educational content through the internal messenger of ITA in an easy and understandable media format (Powerpoint with sound, video, poster, booklet, audio file) on a weekly basis within each group. In addition, the researcher will be responsible for supporting and answering possible questions. The non-intervention group also receives the usual pregnancy care and education. Then, in the fourth stage, the evaluation of pregnancy outcomes in the postpartum period (between 6 and 8 weeks after delivery) will be done in two intervention groups and non-intervention groups that received routine care and training, Randomization description: Six block method will be used for random allocation. For this purpose, all possible modes of placement of letters A (intervention) and B (non-intervention) will be considered in blocks of 6 with an allocation ratio of 1:1, and the number of required blocks will be determined based on the number of studied samples. Then, according to the number of required blocks and based on the table of random numbers, the blocks corresponding to each table number will be listed in order. Finally, when the samples are entered into the study, each person will acquire a certain letter according to the obtained order. are written, they are allocated in closed and non-transparent envelopes by a person outside the study who has no knowledge of the research objectives, and when choosing the envelopes, a person who has no knowledge of the research objectives is asked to choose an envelope slow After obtaining informed consent and randomly assigning people in each group, the educational program will be implemented by the researcher.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pregnancy health literacy in adolescent pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group is pregnant teenagers who meet the inclusion criteria. They will receive routine pregnancy care according to Iran's national guidelines. In addition, they will receive health literacy promotion program based on ITA's internal messenger in  the manner described below.  The educational content of the adolescent pregnancy health literacy promotion program will be designed based on first and second stages of the study.  The researcher puts the educational content in an Comprehensible and easy way in the form of media (power point with sound, video, poster, booklet, audio file) through the internal messenger of ITA every week inside intervention  group.  Due to the unknown content of the program, the number of times and weeks that the program is uploaded in the internal messenger group is not known, It should be noted that the pregnancy health literacy promotion program for adolescents will be designed based on the needs of pregnant adolescents that identified through the first and second stages of the study. Intervention 2: The control group is pregnant adolescents who meet the inclusion criteria. They will receive routine pregnancy care and training according to Iran's national guidelines.</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 completed data and questionnaires will be provided to the Ahvaz University of Medical Sciences

When:
It will be possible to access the research documents six months after the statistical analysis and at the end of the fourth phase of the study

To whom:
The data will be available only for the use of researchers in academic institutions.

Conditions:
This research will be done with the aim of improving pregnancy health literacy in pregnant teenagers, and the use of its documents is allowed only in this direction with the knowledge and permission of the responsible author.

Where to obtain:
In order to receive the data, people can refer to the main execution of the project, Dr. Mojgan Javad Nouri, a member of the academic staff of Jundishapur University of Medical Sciences, Ahvaz.

How to obtain:
The applicant obtaining the necessary permission from the Jundishapur University of Medical Sciences and Vice The research and technology of this university can take action to receive documents.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Mirzababaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 20, Gouy abadi Street, Zafar Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1916736613</zip>
        <telephone>+98 21 2227 7218</telephone>
        <email>mirzababaei.m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojgan Javadnoori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Ahvaz University of Medical Sciences, Golestan Blvd, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135733337</zip>
        <telephone>+98 61 3373 8331</telephone>
        <email>mojganjadnoori@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1) Ability to read and write in Farsi
2) Mothers under 19 years old
3) Being in the gestational age of 6 to 30 weeks of pregnancy
4) Access to the Internet and internal messengers</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>19 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1) Medical and background problems such as major or life-threatening disabilities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z35.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Supervision of very young primigravida</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group is pregnant teenagers who meet the inclusion criteria. They will receive routine pregnancy care according to Iran's national guidelines. In addition, they will receive health literacy promotion program based on ITA's internal messenger in  the manner described below.  The educational content of the adolescent pregnancy health literacy promotion program will be designed based on first and second stages of the study.  The researcher puts the educational content in an Comprehensible and easy way in the form of media (power point with sound, video, poster, booklet, audio file) through the internal messenger of ITA every week inside intervention  group.  Due to the unknown content of the program, the number of times and weeks that the program is uploaded in the internal messenger group is not known, It should be noted that the pregnancy health literacy promotion program for adolescents will be designed based on the needs of pregnant adolescents that identified through the first and second stages of the study.</i_keyword>
      <i_keyword>The control group is pregnant adolescents who meet the inclusion criteria. They will receive routine pregnancy care and training according to Iran's national guidelines.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>To improve adolescent pregnancy health literacy. Timepoint: Evaluation of maternal health literacy outcomes in the postpartum period (between 6 and 8 weeks after delivery) in intervention and non-intervention groups. Method of measurement: Specific questionnaire for measuring maternal health literacy.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maternal- infant attachment. Timepoint: Measurement of mother-infant attachment in the postpartum period (between 6 and 8 weeks after delivery) in two interventions and non-intervention groups. Method of measurement: Condon and corkindale's postnatal attachment questionnaire.</sec_outcome>
      <sec_outcome>Postpartum self-care. Timepoint: Measuring the performance of women in the field of postpartum self-care in the postpartum period (between 6 and 8 weeks after delivery) in two interventions and non-intervention groups. Method of measurement: Questionnaire on women's performance in the field of self-care after childbirth.</sec_outcome>
      <sec_outcome>Breastfeeding self-efficacy. Timepoint: Measurement of breastfeeding self-efficacy in the postpartum period (between 6 and 8 weeks after delivery) in two interventions and non-intervention groups. Method of measurement: Dennis Short Breastfeeding Self-Efficacy Questionnaire (2003).</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-22</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>No 20, Gouy ababi Street, Zafar Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
