<?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>IRCT20230419057966N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-19</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of education on the nutritional behaviors of the elderly with non-alcoholic fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of an educational intervention based on the Health Belief Model on the nutritional behaviors of the older people with non-alcoholic fatty liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>156</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69813</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random allocation of centers to control and intervention groups is done by generating random numbers in Excel. For example, for 4 centers in the first column of Excel, we write 2 zeros to indicate the two control centers and 2 ones to indicate the two intervention centers. In the next column, we generate random numbers with the rand command and then sort the first column based on the generated random numbers column. The order of two zeros and two ones is arranged randomly, for example, as 0, 1, 1, 0. Then the first center is assigned to group 0, the second  is intervention center, the third is intervention center and the fourth is control center.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-alcoholic fatty liver.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group consists of 5 groups. After completing the questionnaire, the educational intervention will be conducted in the form of 5 educational sessions of 40-60 minutes in a period of 2 months. The intervention will be conducted once a week in the form of lectures, questions and answers, and using pamphlets. The educational content has been collected from authentic books about getting to know the disease, educational programs of the country, ways to improve and prevent the disease from worsening, the role of nutrition in the disease process. From the collected content, 2 educational pamphlets have been prepared, one with the title of healthy nutrition in old age and the other with the title of nutrition and non-alcoholic fatty liver, the content of which is presented in 5 sessions. Intervention 2: The control group, which consists of 4 groups, did not receive any intervention during the intervention and only completed the questionnaire twice with a time interval of one month, without receiving training. After completing the training in the intervention group, training will be provided to them. The training will be conducted by lectures, questions and answers and by using pamphlets. The educational content has been collected from authentic books about getting to know the disease, educational programs of the country, ways to improve and prevent the disease from worsening, the role of nutrition in the disease process. From the collected content, 2 educational pamphlets, one with the title of healthy nutrition in old age and the other with the title of nutrition and non-alcoholic fatty liver, have been prepared and will be presented to the elderly in a compact form of 1-2 sessions lasting 30-60 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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Ravaghi Ardebili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Rahimi Alley, after Chaman park, South Homayunshahr St, Soroush 1st St.Deriano St, Sattarkhan St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1455764186</zip>
        <telephone>+98 21 6655 3646</telephone>
        <email>f77.ravaghi@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Ramezankhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Health and Safety, Daneshjou Blvd, Shahid Shahriari square, Shahid Chamran Highway.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717444</zip>
        <telephone>+98 21 2243 2040</telephone>
        <email>aramezankhani@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti 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>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No cognitive impairment
No history of regular alcohol consumption
Elderly with non-alcoholic fatty liver disease
Minimum education at the sixth elementary level
Elderly covered by designated health centers</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fatty (change of) liver, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group consists of 5 groups. After completing the questionnaire, the educational intervention will be conducted in the form of 5 educational sessions of 40-60 minutes in a period of 2 months. The intervention will be conducted once a week in the form of lectures, questions and answers, and using pamphlets. The educational content has been collected from authentic books about getting to know the disease, educational programs of the country, ways to improve and prevent the disease from worsening, the role of nutrition in the disease process. From the collected content, 2 educational pamphlets have been prepared, one with the title of healthy nutrition in old age and the other with the title of nutrition and non-alcoholic fatty liver, the content of which is presented in 5 sessions.</i_keyword>
      <i_keyword>The control group, which consists of 4 groups, did not receive any intervention during the intervention and only completed the questionnaire twice with a time interval of one month, without receiving training. After completing the training in the intervention group, training will be provided to them. The training will be conducted by lectures, questions and answers and by using pamphlets. The educational content has been collected from authentic books about getting to know the disease, educational programs of the country, ways to improve and prevent the disease from worsening, the role of nutrition in the disease process. From the collected content, 2 educational pamphlets, one with the title of healthy nutrition in old age and the other with the title of nutrition and non-alcoholic fatty liver, have been prepared and will be presented to the elderly in a compact form of 1-2 sessions lasting 30-60 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean nutritional behavior scores. Timepoint: before the intervention and one month after the intervention. Method of measurement: Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr).</prim_outcome>
      <prim_outcome>Knowledge. Timepoint: before the intervention and one month after the intervention. Method of measurement: Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr).</prim_outcome>
      <prim_outcome>Average perceived susceptibility scores. Timepoint: before the intervention and one month after the intervention. Method of measurement: Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr).</prim_outcome>
      <prim_outcome>Mean perceived intensity scores. Timepoint: before the intervention and one month after the intervention. Method of measurement: Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr).</prim_outcome>
      <prim_outcome>Mean perceived threat scores. Timepoint: before the intervention and one month after the intervention. Method of measurement: Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr).</prim_outcome>
      <prim_outcome>Average scores of perceived benefits. Timepoint: before the intervention and one month after the intervention. Method of measurement: Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr).</prim_outcome>
      <prim_outcome>Mean scores of perceived barriers. Timepoint: before the intervention and one month after the intervention. Method of measurement: Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr).</prim_outcome>
      <prim_outcome>Mean self-efficacy scores. Timepoint: before the intervention and one month after the intervention. Method of measurement: Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr).</prim_outcome>
      <prim_outcome>Average practice guide scores. Timepoint: before the intervention and one month after the intervention. Method of measurement: Compiled questionnaire (based on the researcher's questionnaire for a thesis entitled "Investigation of the effect of education based on the health belief model on the promotion of nutritional behaviors in elderly women covered by health care centers in Ahvaz in 2013" written by Maryam Erfani mehr).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-29</approval_date>
        <contact_name>Ethics Committee of Health Faculty and Neuroscience Research Center of Shahid Beheshti University of</contact_name>
        <contact_address>Faculty of Health and Safety, Shahid Beheshti University of Medical Sciences, Daneshju Blvd, Shahid Shahriari Square, Shahid Chamran Highway. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
