<?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>IRCT20211211053351N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-20</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educating nulliparous mothers based on Precede model on mothers self-efficacy in complementary nutrition and growth index infants</public_title>
      <acronym>no</acronym>
      <scientific_title>The effect of educating nulliparous mothers based on Precede model on mothers self-efficacy in complementary nutrition and growth index infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72659</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the block method will be used to allocate the sample in two groups.Randomization will be by block method. In this study, four blocks (AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)- BAAB(6)) will be the sampling guide. Then the list of blocks will be written and numbers will be assigned to them, then choosing random numbers between 1 to 6 (for example 1 4 5 and ...) using the site http://www.graphpad.com/quickcalcs/index. cfm numbers will be selected, finally specifying the treatment allocation list will be based on the previous random numbers (...AABB-BBAA-BABA-) and to generate a random sequence from http://www.graphpad.com/quickcalcs/index. cfm is used, Blinding description: Blinding (evaluator, analysts, allocation of sample data to groups)
in the study child evaluator of weight, height and outcome and the health care workers who allocation of sample data to groups  and also tantalizer are blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The subject of study is not a disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Educational intervention based on PERESED model structures, especially predisposing structures, enabling factors and strengthening factors will be provided during 4 sessions of 60 minutes (one session per week). The educational content will be taught in the form of group training of 5-7 people. In order to educate and gain the support of the family, an educational booklet will be prepared for the training of fathers and will be presented to the intervention group. Educational content will be provided using the teaching methods of lectures, group discussions, questions and answers, role playing, and individual counseling. Three months after the intervention, the mother will be met in health centers to evaluate and complete the questionnaire again. Intervention 2: Control group: The control group will receive only the routine training provided in health centers. The routine training in health centers is in this way that when the mother visits at the end of the fourth month, the necessary training on individual nutrition is provided to the mother.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahereh Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate o Ferdowsi University of Mashhad, Azadi Square , Mashhad, Razavi Khorasan, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 7313</telephone>
        <email>tahereh.sadeghi@yahoo.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahereh Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate o Ferdowsi University of Mashhad, Azadi Square , Mashhad, Razavi Khorasan, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 7313</telephone>
        <email>tahereh.sadeghi@yahoo.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Complete the informed consent of parents to participate in the research
Be Iranian and a resident of Mashhad
Mother's age should be between 18 and 45 years.
be the first delivery
The age of pregnancy was between 38 and 40
The age of the infant should be between 4 and 5 months
The infant does not have a history of hospitalization during infancy.
Not IUGR
Do not have medical and metabolic problems and FTT.</inclusion_criteria>
      <agemin>4 months</agemin>
      <agemax>10 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not wanting to continue participating in the study.
Failure to participate in more than two training sessions
Medical problems occurred during the study for infants
Carry out actions such as travel and change of location during the study period, which lead to non-follow-up of counseling sessions and messing up the infant's meal plan..
The infant has a history of hospitalization during the study period.</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Educational intervention based on PERESED model structures, especially predisposing structures, enabling factors and strengthening factors will be provided during 4 sessions of 60 minutes (one session per week). The educational content will be taught in the form of group training of 5-7 people. In order to educate and gain the support of the family, an educational booklet will be prepared for the training of fathers and will be presented to the intervention group. Educational content will be provided using the teaching methods of lectures, group discussions, questions and answers, role playing, and individual counseling. Three months after the intervention, the mother will be met in health centers to evaluate and complete the questionnaire again.</i_keyword>
      <i_keyword>Control group: The control group will receive only the routine training provided in health centers. The routine training in health centers is in this way that when the mother visits at the end of the fourth month, the necessary training on individual nutrition is provided to the mother.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mother's self-efficacy in the field of complementary feeding. Timepoint: Measuring the self-efficacy of the mother at the beginning of the study (before the start of the intervention) and at the end of the intervention three months later. Method of measurement: In this study, the meaning of self-efficacy is the feeling of competence, sufficiency, self-control and belief in abilities in the field of complementary feeding behaviors of breast-fed infants and will be investigated by a self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Infant growth index: according to head circumference, height and weight. Timepoint: Measuring the self-efficacy of the mother at the beginning of the study (before the start of the intervention) and at the end of the intervention three months later. Method of measurement: The growth indices of the normal range of height, weight and head circumference are based on the growth index of breast-fed infants under 24 months of the Ministry of Health and Medicine of Iran.</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 Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-30</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square , Mashhad, Razavi Khorasan, Iran. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
