<?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>IRCT2016030225127N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-03-25</date_registration>
      <primary_sponsor>Vice chancellor for research, Yasouj University of Medical Sciences .</primary_sponsor>
      <public_title>The Effect of education on The indexes of growth and development of  6-12 months infants</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effect of tele health– nursing and multimedia education of mothers on the growth and developmental indexes of infants, Compared with mothers who received training of health care workers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>129</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21065</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Health service research, Other design features: Blindness is not carried out due to educational interventions.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infants  growth &amp; developement.</hc_freetext>
      <i_freetext>Intervention 1: In the first intervention group (long distance-tele- health nursing education method), procedures of surveying, education, orientation and suggestion were performed and used. For 6-8 months age children, phone connections were performed once a week regarding to Nutrition Education Protocol suggested by the Health Ministry of Iran according to items mentioned in children development profiles, assigned at 6, 7, 9 and 12 months of children age. Necessary educations were presented as weekly phone calls and the questions of parents were answered and were consulted if required. Contents of the next week were educated in each phone call and previous efforts were also checked and emphasized if were not obeyed. Two phone calls were performed for children with age of 9 months and more per week and the mother were referred to reserved physician if medical intervention was required. They were also given a phone number for further and necessary consults. Intervention 2: In the second intervention group (multi media education method), the education process was based on lectures in group sessions according to an educational program. These educational sessions were formed at 6,8,10 and 12 moths of children ages regarding to the time of َAges and Stages questionnaire filling. Because of the dissipation of children ages and large number of people in a group, children born at the first half of month were educated at the beginning of the corresponding month and children born at the second half of month were educated at the last days of month by multimedia method. Also an educational film containing items about supplementary nutrition, use of iron supplementary droplets, emotional relations performance with the suckle, quality and modality of games at different ages and protection of the baby against accidents was shown to the mothers. Duration of each session was an hour. Educational pamphlets containing the issues of next 2 months according to the phone educations were given to the participants at the end of each session and they were asked to read the contents of each next week at corresponding week time. All educational contents and concepts were similar in both intervention groups. These educations were presented besides and apart of educations and recommendations offered by health personnel of mentioned health and medical centers. Intervention 3: In the control group, only educations through the health care personnel were presented. ages and stages questionnaires were filled at the end of 6, 8, 10 and 12 months during interviews by the mothers.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Farahnak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Univercity of Medical Science, Dr.Jalil street, Yasouj</address>
        <city>yasouj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 74 3223 5138</telephone>
        <email>farahnake@sums.ac.ir</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nazafarin Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Univercity of Medical Science, Dr.Jalil street, Yasouj</address>
        <city>Yasouj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 74 2332 3411</telephone>
        <email>hosseinichenar@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: mother is willing to cooperate in this project; mother has direct responsible for child's feeding; the father and mother be literate (at least secondary education is completed); the mother does not express certain mental problem; no graduates or studying in sciences or psychology or medicine; children at the time of the study not have defects, acute illness or not systematic; children have normal growth at baseline (is not Under 3 percentile ); parents are both still alive; having a home phone or mobile phone. Exclusion criteria: at the time of the study children go to kindergarten; children become ill or chronic disease; the child get single parent; the child's father become unemployed; the child's mother begin studying the medical sciences or psychology; parents cancel to continue working with more than two absences researcher training sessions or care.</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>12 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first intervention group (long distance-tele- health nursing education method), procedures of surveying, education, orientation and suggestion were performed and used. For 6-8 months age children, phone connections were performed once a week regarding to Nutrition Education Protocol suggested by the Health Ministry of Iran according to items mentioned in children development profiles, assigned at 6, 7, 9 and 12 months of children age. Necessary educations were presented as weekly phone calls and the questions of parents were answered and were consulted if required. Contents of the next week were educated in each phone call and previous efforts were also checked and emphasized if were not obeyed. Two phone calls were performed for children with age of 9 months and more per week and the mother were referred to reserved physician if medical intervention was required. They were also given a phone number for further and necessary consults.</i_keyword>
      <i_keyword>In the second intervention group (multi media education method), the education process was based on lectures in group sessions according to an educational program. These educational sessions were formed at 6,8,10 and 12 moths of children ages regarding to the time of َAges and Stages questionnaire filling. Because of the dissipation of children ages and large number of people in a group, children born at the first half of month were educated at the beginning of the corresponding month and children born at the second half of month were educated at the last days of month by multimedia method. Also an educational film containing items about supplementary nutrition, use of iron supplementary droplets, emotional relations performance with the suckle, quality and modality of games at different ages and protection of the baby against accidents was shown to the mothers. Duration of each session was an hour. Educational pamphlets containing the issues of next 2 months according to the phone educations were given to the participants at the end of each session and they were asked to read the contents of each next week at corresponding week time. All educational contents and concepts were similar in both intervention groups. These educations were presented besides and apart of educations and recommendations offered by health personnel of mentioned health and medical centers.</i_keyword>
      <i_keyword>In the control group, only educations through the health care personnel were presented. ages and stages questionnaires were filled at the end of 6, 8, 10 and 12 months during interviews by the mothers</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: At the end of 6, 7, 9 and 12 months. Method of measurement: By Scale.</prim_outcome>
      <prim_outcome>Length. Timepoint: At the end of 6, 7, 9 and 12 months. Method of measurement: Length measured with meters.</prim_outcome>
      <prim_outcome>Head circumference. Timepoint: At the end of 6, 7, 9 and 12 months. Method of measurement: Head circumference measured with meters.</prim_outcome>
      <prim_outcome>Development. Timepoint: At the end of 6, 8, 10 and 12 months. Method of measurement: By using Ages and Stages Questionnaire.</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>Vice chancellor for research, Yasouj University of Medical Sciences .</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-22</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj Univercity of Medical Science, Shahid Motahari street Yasuj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
