<?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>IRCT20170316033099N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-01</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Effect of peer counseling on breastfeeding behavior</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial comparing the effect of peer counseling and routine training delivered by health centers on breastfeeding behavior in primipara mothers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35420</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A total of 80 mothers with inclusion criteria were selected through multi-stage random sampling from among mothers referring to Birjand health centers. To select the samples, the city of Birjand was classified into northern and southern regions. From each region, two health bases were randomly selected from the bases covered by the health centers of that area, and one base was placed in the intervention group and one base in the control group. Then, in each base, based on the Integrated Health System, the list of eligible primipara women was extracted, and 20 individuals were subsequently randomly selected from each base. Accordingly, 40 women were in the intervention group and 40 women in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breastfeeding behavior.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (Peer counseling): the intervention group completed B-R-E-A-S-T-Feeding Observation Form before intervention. They were trained and supported by the peer counselors during two 3-hour sessions. The contents of the sessions included anatomy, principles and skills of breastfeeding, problems and incorrect beliefs about breastfeeding and infant nutrition, and proper breastfeeding techniques, etc. according to the guidelines and syllabuses provided by the Ministry of Health and the World Health Organization. The mothers could contact the sponsor at any time, via telephone or in person, and raise problems concerning their baby's breastfeeding and nutrition. The counselor also had a weekly phone call with mothers to encourage them to continue and perform proper breastfeeding skills. Immediately after the intervention, at the end of the first, second and third months after intervention, the standard B-R-E-A-S-T-Feeding Observation Form was completed. Intervention 2: Control group (Routine training): the control group completed B-R-E-A-S-T-Feeding Observation Form before intervention. They received the routine face-to-face training at the health bases at the time of referral. Immediately after the intervention, at the end of the first, second and third months after intervention, the standard B-R-E-A-S-T-Feeding Observation Form was completed.</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:
Deidentified Individual Participant Data Set

When:
when the extracted paper from the project will be published and for 6 months

To whom:
all readers of the paper

Conditions:
research purposes

Where to obtain:
personal correspondence with the corresponding author

How to obtain:
email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasimeh Azimi Tabas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Meghdad Ave.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 56 3239 1514</telephone>
        <email>na.azimi1395@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ahmad Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaffari Ave.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 56 3239 1415</telephone>
        <email>A.nasiri@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to collaborate in the study
Residence in Birjand
Having reading and writing literacy
The newborn being a single child
The first pregnancy or childbirth of the mother</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Disabling disease and  breast problems in the mother
Congenital anomalies and oral abnormalities in the newborn
Presence of prohibitions for breastfeeding
Hospitalization of the newborn</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P92.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Feeding problem of newborn, unspecified</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 (Peer counseling): the intervention group completed B-R-E-A-S-T-Feeding Observation Form before intervention. They were trained and supported by the peer counselors during two 3-hour sessions. The contents of the sessions included anatomy, principles and skills of breastfeeding, problems and incorrect beliefs about breastfeeding and infant nutrition, and proper breastfeeding techniques, etc. according to the guidelines and syllabuses provided by the Ministry of Health and the World Health Organization. The mothers could contact the sponsor at any time, via telephone or in person, and raise problems concerning their baby's breastfeeding and nutrition. The counselor also had a weekly phone call with mothers to encourage them to continue and perform proper breastfeeding skills. Immediately after the intervention, at the end of the first, second and third months after intervention, the standard B-R-E-A-S-T-Feeding Observation Form was completed.</i_keyword>
      <i_keyword>Control group (Routine training): the control group completed B-R-E-A-S-T-Feeding Observation Form before intervention. They received the routine face-to-face training at the health bases at the time of referral. Immediately after the intervention, at the end of the first, second and third months after intervention, the standard B-R-E-A-S-T-Feeding Observation Form was completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Breastfeeding behavior. Timepoint: Before intervention; immediately after the intervention; at the end of the first, second and third months after intervention. Method of measurement: B-R-E-A-S-T-Feeding Observation Form.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complementary milk consumption. Timepoint: Immediately after the intervention, at the end of the first, second and third months after intervention. Method of measurement: Asking the mother.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-12</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Ghaffari Ave. Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
