<?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>IRCT20210612051546N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-12</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education based on health belief model on physical activity and dietary intake in nonalcoholic fatty liver disease patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of education based on health belief model on physical activity and dietary intake in nonalcoholic fatty liver disease patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56848</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Candidates who were eligible for participation in the study were randomly chosen and were assigned to the groups according to the random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nonalcoholic fatty liver(NAFLD).</hc_freetext>
      <i_freetext>Intervention 1: After referral of the patient from the physician, all patients are examined based on criteria for entering the study and are described the goals of the plan to patients. If the patient wishes to participate in plan, the consent form will be given to sign it after the study. Candidates who were eligible for participation in the study were randomly chosen and were assigned to the groups according to the random number table. Health Belief Model questionnaire, International Physical Activity Questionnaire (IPAQ), 3-day food record will be completed before and after the intervention (2 months after the start of the intervention). also Liver enzymes (ALT, AST) and weight of patients will be measured before and after the intervention. The intervention group will receive messages via Whats App for 2 months, including clips, photos and podcasts about the severity of fatty liver disease, benefits and barriers to regular physical activity and healthy eating, intervention group will receive a self-care book on fatty liver disease, which includes a healthy lifestyle in fatty liver disease and self-assessment tables and the patient will be complete the book tables at the end of each week and send a photo for researcher. Intervention 2: Control group:  Control group were follow their routine life for 2 months.</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:
Study protocol and  informed consent form will be shared.

When:
The access period starts 12 months after the results are published.

To whom:
Researchers interested in liver disease , as well as researchers working in academic and scientific institutions, can apply to receive the mentioned data and documents.

Conditions:
There are no other special conditions for using the mentioned and send able documents.

Where to obtain:
1-email:nafisehtamadonpoor@yahoo.com
2-email:as_pirzadeh@hlth.mui.ac.ir
3-Department of Health Education and Health Promotion, school of Health, Isfahan University of Medical Sciences

How to obtain:
The applicant for the mentioned documents can receive the requested documents after a few days after submitting his / her application in the ways mentioned in the previous section, such as sending an email .

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nafiseh Tamadonpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.41, Dadsetan Allay, Bozorgmehr Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8154843911</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>nafisehtamadonpoor@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Asiyeh Pirzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dept.of Health Education and promotion ; Faculty of Health ; Isfahan University of Medical Sciences ; Hezarjerib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 3340</telephone>
        <email>as_pirzadeh@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of non alcoholic fatty liver disease by physician
20 to 50 years’ old
Patients who agree to participate in the study
Ability to use smartphones and social media (Whats App)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Medical prohibition for physical activity or have special diet
Using alcohol
Diagnosis of other diseases, including Liver disease, Biliary Disease, Autoimmune disease and Cancers
Pregnancy, lactation and menopause in women</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After referral of the patient from the physician, all patients are examined based on criteria for entering the study and are described the goals of the plan to patients. If the patient wishes to participate in plan, the consent form will be given to sign it after the study. Candidates who were eligible for participation in the study were randomly chosen and were assigned to the groups according to the random number table. Health Belief Model questionnaire, International Physical Activity Questionnaire (IPAQ), 3-day food record will be completed before and after the intervention (2 months after the start of the intervention). also Liver enzymes (ALT, AST) and weight of patients will be measured before and after the intervention. The intervention group will receive messages via Whats App for 2 months, including clips, photos and podcasts about the severity of fatty liver disease, benefits and barriers to regular physical activity and healthy eating, intervention group will receive a self-care book on fatty liver disease, which includes a healthy lifestyle in fatty liver disease and self-assessment tables and the patient will be complete the book tables at the end of each week and send a photo for researcher.</i_keyword>
      <i_keyword>Control group:  Control group were follow their routine life for 2 months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dietary intake. Timepoint: At the beginning and end of intervention. Method of measurement: 3-day food record.</prim_outcome>
      <prim_outcome>Physical activity. Timepoint: At the beginning and end of intervention. Method of measurement: The International Physical Activity Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>AST and ALT. Timepoint: At the beginning and end of intervention. Method of measurement: Blood sample.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-09</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی  اصفهان</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar-Jerib Ave, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
