<?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>IRCT20180613040088N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-12</date_registration>
      <primary_sponsor>Mashhad University of Nursing and Midwifery</primary_sponsor>
      <public_title>Comparison of the effect of combined counseling and face-to-face on mothers self-efficacy in complementary nutrition and growth index of 6-10 month infants</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of combined counseling and face-to-face on mothers self-efficacy in complementary nutrition and growth index of 6-10 month infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32174</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, the randomization method is simple and draw Use the random numbers table. First, a center is selected from the five centers of Mashhad and then by drawing the centers covered by the center, two centers for intervention group 1 and 2 Selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Infant Growth Index. Condition 2: Self-efficacy of mothers.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1:  In face-to-face group, 4 supplementary nutritional counseling sessions will be held during 4 weeks from 6 months to 7 months, each session including counseling, question and answer, and exchange of views, the content of the sessions will be based on the results of the required measurement. The preparation will consist mainly of erroneous false beliefs and nutritional behaviors, as well as creativity in the mother to prepare new, tasty and tasty foods for the infant. The duration of each session is 40 to 60 minutes. Intervention 2: Intervention group 2: In the consolidated group, we will have four counseling sessions from sixth to seventh for four weeks, with a face-to-face consultation and question-and-answer session, and three sessions for submitting podcast files, the content of the sessions will be prepared based on the results of the need assessment and will include the refinement Nutrition beliefs and nutritional behaviors, along with creativity in the mother to cook new and tasty and tasty foods for the infant, will be discussed at the first session (in person) and in the next sessions through the podcast link provided to mothers as well as Q &amp; A and chat through an internet messenger program, the duration of each session 40 Or 60 minutes.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elahe Moghadasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.38 , Imahat52 , Imamat Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188796789</zip>
        <telephone>+98 51 3604 3299</telephone>
        <email>Moghadasie1@Mums.Ac.Ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elahe Moghadasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.38, Floor 3, Imamate 52, Imamate Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188796789</zip>
        <telephone>+98 51 3604 3299</telephone>
        <email>Moghadasie1@Mums.Ac.Ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have written informed consent to participate in the research.
Iranian and resident of Mashhad.
Do not have spoken, audible or dialectal problems that prevent communication with the researcher.
The age of the mother is between 18 and 45 years old.
Have at least fifth grade elementary education.
The mother has no medical condition. (medical illness includes diabetes, cardiovascular disease, hypertension, epilepsy, migraine, history of head trauma, thyroid disease, connective tissue disease, asthma, respiratory disorders, kidney disease, anemia and stroke Brain)
Mother is prenatal.
Moms have access to Android and the Internet in a combination group.
The age of the infant is 6 months, the growth curve between the 15th and the 85th percentile, has no metabolic and medical problems, low birth weight and hospitalization history.</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwilling to continue studying.
In the compilation group, they did not follow the tutorials and podcast files in a meeting, nor would they attend a face-to-face meeting in a counseling session, they would be excluded from the research process.
Medical problems have occurred during the study for infants (listed in clause 6 of entry requirements).
Do things like travel and change during the study, which leads to lack of follow up counseling sessions and missed infant formula.
The infant has a history of hospitalization during the study period.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1:  In face-to-face group, 4 supplementary nutritional counseling sessions will be held during 4 weeks from 6 months to 7 months, each session including counseling, question and answer, and exchange of views, the content of the sessions will be based on the results of the required measurement. The preparation will consist mainly of erroneous false beliefs and nutritional behaviors, as well as creativity in the mother to prepare new, tasty and tasty foods for the infant. The duration of each session is 40 to 60 minutes.</i_keyword>
      <i_keyword>Intervention group 2: In the consolidated group, we will have four counseling sessions from sixth to seventh for four weeks, with a face-to-face consultation and question-and-answer session, and three sessions for submitting podcast files, the content of the sessions will be prepared based on the results of the need assessment and will include the refinement Nutrition beliefs and nutritional behaviors, along with creativity in the mother to cook new and tasty and tasty foods for the infant, will be discussed at the first session (in person) and in the next sessions through the podcast link provided to mothers as well as Q &amp; A and chat through an internet messenger program, the duration of each session 40 Or 60 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mothers self-efficacy in complementary nutrition. Timepoint: Before intervention and 1 and 3 months after intervention. Method of measurement: Researcher-made questionnaire on maternal nutritional self-efficacy.</prim_outcome>
      <prim_outcome>Infant growth index of 6 to 10 months. Timepoint: Before the intervention, 1, 2 and 3 months after the intervention. Method of measurement: Balance and meter.</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>Mashhad University of Nursing and Midwifery</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-24</approval_date>
        <contact_name>Ethics committee of Mashhad University of Nursing and Midwifery</contact_name>
        <contact_address>Doktora Crossroads Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
