<?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>IRCT20170611034452N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-28</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of breastfeeding counseling on the quality and continuity of breastfeeding and the health of mothers and babies</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of breastfeeding counseling based on the information – motivation – behavior skills (IMB) model on the some of maternal and newborn’s health indicators among referees to the breastfeeding counseling  center</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67108</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Mothers and their babies who are eligible will continue to be selected by available sampling method until reaching the sample size (at least 21 people in each group). Using the software (https://www.sealedenvelope.com/simple- randomiser/v1/lists) People are placed in two groups of routine care and intervention with simple randomization method (double blocks).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breastfeeding counseling in mothers with breastfeeding problems.</hc_freetext>
      <i_freetext>Intervention group: Breastfeeding counseling based on correct breastfeeding teaching based on the model of information, motivation, and behavior to improve some maternal and child health indicators, which is the first face-to-face session immediately after sampling. In the second session if the problem is not resolved the mother will visit face to face the next day. If the mother does not come, the consultant will make a phone call on the 1st-3rd day via WhatsApp or Rubika. the consultant Coordinates with the mother to contact WhatsApp or Rubika. If not possible, a phone call will be made. Follow-ups determin on the 7th, 14th and 21st days from the time of the mother's visit (the second day after giving birth does not include, for example a mother who visited on the 16th day after giving birth, the follow-up date of the mother is determined 7 days later from the time of the visit). the first counseling session (referral day): 1.to state goals and rules 2.to define latch and position trainingthe importance of their correct performance in maternal and newborn outcomes. to state the difference of maternal and newborn outcomes in correct and incorrect breastfeeding. task: performing correct breastfeeding (to the mother). if The mother’s breastfeeding problem does not solve, she can come back the next day or she can give number to call him. If person does not refer or call, counselor call with him on day 1-3. The second counselling session of day 1 to 3: (face to face or by phone) if mother come back counselor revision remaining problem and then following step will be performed and then the following steps will be performed:1. check the correctness of the mother's breastfeeding 2.state the process of correct breastfeeding and its continue based on the relationship between information and motivation and breastfeeding skills3. mention the benefits of proper breastfeeding in the child (based on the indicators examined in this study, if the mother does not come back, counselor will call him). Follow-up on day 7: (phone call)1.check the correctness of mother's breastfeeding2.state maternal benefits of correct breastfeeding (based on the indicators examined in this study). Follow-up on day 14: (phone call) 1.check the correctness of mother's breastfeeding2. motivate the mother to continue correct breastfeeding. Follow-up on day 21: (phone call)1. check the correctness of mother's breastfeeding2.creating self-care and guidance to remove personal, family and environmental obstacles to proper breastfeeding. The third counseling session, the end of the third month: (telephone call)check the correctness of mother's breastfeeding2.creat self-efficacy and guidance to remove personal, family and environmental obstacles to correct breastfeeding. The fourth counseling session, the end of the fifth month: (telephone call)1.check the correctness of the mother's breastfeeding2.creating self-efficacy and guidance to remove personal, family and environmental obstacles to proper breastfeeding. The third counseling session, the end of the third month: (telephone call)1. check the correctness of mother's breastfeeding2. creat self-efficacy and guidance to remove personal, family and environmental obstacles to correct breastfeeding. The fourth counseling session, the end of the fifth month: (telephone call)1.check the correctness of the mother's breastfeeding2. creat self-efficacy and guidance to remove personal, family and environmental obstacles to correct breastfeeding..</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 collected deidentified IPD

When:
starting 6 months after publication

To whom:
people working in academic institutions

Conditions:
with previous agreement with the corresponding author

Where to obtain:
email address

How to obtain:
email address

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Sciences, Medical University Campus,    Haft-Bagh Highway, Kerman, Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5220</telephone>
        <email>a.ahmadi@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefeh Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Sciences, Medical University Campus,    Haft-Bagh Highway, Kerman, Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5220</telephone>
        <email>a.ahmadi@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infancy period
mother hasn't  prohibition for breastfeeding
mother hasn't an untreated psychiatric
mother doesn't take medicine that prohibit breastfeeding
mother should be Iranian / Afgan people who spease persian</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Stopping exclusive breastfeeding and then , starting bottle feeding
Non cooperation in comple the questionnaiers and checke the study indicators after intervention at 2 , 4 and 6 months
If mother use a special diet / exercise in order to decrease weight but it doesn’t cause decrease breastfeeding, it isnot important
Diseases disrupt on breastfeeding , such as Sheehan's syndrome</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Breastfeeding counseling based on correct breastfeeding teaching based on the model of information, motivation, and behavior to improve some maternal and child health indicators, which is the first face-to-face session immediately after sampling. In the second session if the problem is not resolved the mother will visit face to face the next day. If the mother does not come, the consultant will make a phone call on the 1st-3rd day via WhatsApp or Rubika. the consultant Coordinates with the mother to contact WhatsApp or Rubika. If not possible, a phone call will be made. Follow-ups determin on the 7th, 14th and 21st days from the time of the mother's visit (the second day after giving birth does not include, for example a mother who visited on the 16th day after giving birth, the follow-up date of the mother is determined 7 days later from the time of the visit). the first counseling session (referral day): 1.to state goals and rules 2.to define latch and position trainingthe importance of their correct performance in maternal and newborn outcomes. to state the difference of maternal and newborn outcomes in correct and incorrect breastfeeding. task: performing correct breastfeeding (to the mother). if The mother’s breastfeeding problem does not solve, she can come back the next day or she can give number to call him. If person does not refer or call, counselor call with him on day 1-3. The second counselling session of day 1 to 3: (face to face or by phone) if mother come back counselor revision remaining problem and then following step will be performed and then the following steps will be performed:1. check the correctness of the mother's breastfeeding 2.state the process of correct breastfeeding and its continue based on the relationship between information and motivation and breastfeeding skills3. mention the benefits of proper breastfeeding in the child (based on the indicators examined in this study, if the mother does not come back, counselor will call him). Follow-up on day 7: (phone call)1.check the correctness of mother's breastfeeding2.state maternal benefits of correct breastfeeding (based on the indicators examined in this study). Follow-up on day 14: (phone call) 1.check the correctness of mother's breastfeeding2. motivate the mother to continue correct breastfeeding. Follow-up on day 21: (phone call)1. check the correctness of mother's breastfeeding2.creating self-care and guidance to remove personal, family and environmental obstacles to proper breastfeeding. The third counseling session, the end of the third month: (telephone call)check the correctness of mother's breastfeeding2.creat self-efficacy and guidance to remove personal, family and environmental obstacles to correct breastfeeding. The fourth counseling session, the end of the fifth month: (telephone call)1.check the correctness of the mother's breastfeeding2.creating self-efficacy and guidance to remove personal, family and environmental obstacles to proper breastfeeding. The third counseling session, the end of the third month: (telephone call)1. check the correctness of mother's breastfeeding2. creat self-efficacy and guidance to remove personal, family and environmental obstacles to correct breastfeeding. The fourth counseling session, the end of the fifth month: (telephone call)1.check the correctness of the mother's breastfeeding2. creat self-efficacy and guidance to remove personal, family and environmental obstacles to correct breastfeeding.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Breastfeeding counseling based on the IMB model. Timepoint: before the intervention and after the intervention at 2, 4 and 6 months. Method of measurement: WHO breastfeeding observation form checklist, Latch questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Newborn weight. Timepoint: The first day of visit, then at 2, 4 and 6 months. Method of measurement: It is measured using a digital flat scale (874 seca, Germany).</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-15</approval_date>
        <contact_name>Research Ethics Committees of Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman University of Medical Sciences, Medical University campus. Haft. Bagh Highway,Kerman ,Iran Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
