<?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>IRCT2015040411691N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-06-21</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of nurses telephone follow-up  on the self-efficacy of dietary behavior and physical activity in patients with nonalcoholic fatty liver disease</public_title>
      <acronym>NAFLD</acronym>
      <scientific_title>The Effect of nurses telephone follow-up (Telenursing) on the self-efficacy of dietary behavior and physical activity in patients with nonalcoholic fatty liver disease referred to subspeciality gastrointestinal Clinics of Shiraz</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11868</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nonalcoholic Fatty Liver.</hc_freetext>
      <i_freetext>Intervention 1: Intervention  group : Before and after intervention, Questionnaires related to the self-efficacy of dietary behavior and physical activity were completed by study participants .The patients  received dietary advice from a nutritionist individually and were trained to perform physical activity. Telephone intervention in the Intervention group lasted for 12 weeks for following up the recommended diet and physical activity. Before and after intervention, measurements of weight, height and BMI of the patients was done by the researcher and all the patients to assess serum levels of AST, ALT, TG, LDL, HDL, Cholesterol and FBS and to determine the size of the liver by ultrasound were referred. Intervention 2: Control  group : Before and after intervention, Questionnaires related to the self-efficacy of dietary behavior and physical activity were completed by study participants .The patients  received dietary advice from a nutritionist individually and were trained to perform physical activity. the case group did not receive any intervention by the researcher and were only followed up as usual by a specialist. Before and after intervention, measurements of weight, height and BMI of the patients was done by the researcher and all the patients to assess serum levels of AST, ALT, TG, LDL, HDL, Cholesterol and FBS and to determine the size of the liver by ultrasound were referred.</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>Fariba Ghodsbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh(P.B.U.H) School of Nursing and Midwifery, Namazi Square, Zand Street, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71348-14336</zip>
        <telephone>+98 71 3230 5410</telephone>
        <email>vcrdep@sums.ac.irghodsbin@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Ghodsbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh(P.B.U.H) School of Nursing and Midwifery, Namazi Square, Zand Street, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71348-14336</zip>
        <telephone>+98 71 3230 5410</telephone>
        <email>vcrdep@sums.ac.irghodsbin@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:19 years and over; the incidence of overweight or obesity; capability to perform moderate physical activity confirmed by medical professionals; accessibility to a telephone at home; lack of any speech and hearing problems.&#13;
Exclusion criteria: history of chronic liver disease such as viral or drug hepatitis; confirmed diagnosis of Wilson diseases; primary hemochromatosis; hyperthyroidism or hypothyroidism; bile duct cancer; diabetes mellitus; obesity due to excessive use of corticosteroid; Cushing's syndrome; Addison syndrome; chronic infections such as tuberculosis; use of hepatotoxic drugs within the past 6 months; incidence of gall stones in the gallbladder having exposure to petrochemicals; alcohol consumption; drug abuse;genetic diseases related to lipid disorders.</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k75.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified inflammatory liver diseases</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 : Before and after intervention, Questionnaires related to the self-efficacy of dietary behavior and physical activity were completed by study participants .The patients  received dietary advice from a nutritionist individually and were trained to perform physical activity. Telephone intervention in the Intervention group lasted for 12 weeks for following up the recommended diet and physical activity. Before and after intervention, measurements of weight, height and BMI of the patients was done by the researcher and all the patients to assess serum levels of AST, ALT, TG, LDL, HDL, Cholesterol and FBS and to determine the size of the liver by ultrasound were referred.</i_keyword>
      <i_keyword>Control  group : Before and after intervention, Questionnaires related to the self-efficacy of dietary behavior and physical activity were completed by study participants .The patients  received dietary advice from a nutritionist individually and were trained to perform physical activity. the case group did not receive any intervention by the researcher and were only followed up as usual by a specialist. Before and after intervention, measurements of weight, height and BMI of the patients was done by the researcher and all the patients to assess serum levels of AST, ALT, TG, LDL, HDL, Cholesterol and FBS and to determine the size of the liver by ultrasound were referred.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dietary behavior self efficacy. Timepoint: Before and three months after intervention. Method of measurement: dietary behavior self-efficacy  Questionnaire ( sherer &amp;madox).</prim_outcome>
      <prim_outcome>Physical activity self-efficacy. Timepoint: Before and three months after intervention. Method of measurement: Exercise Self-Efficacy Questionnaire( pender).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight average. Timepoint: Before and three months after intervention. Method of measurement: scale.</sec_outcome>
      <sec_outcome>Lipid average. Timepoint: Before and three months after intervention. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>Liver Enzymes Average. Timepoint: Before and three months after intervention. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>Liver size average. Timepoint: Before and three months after intervention. Method of measurement: Ultrasound.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-04-21</approval_date>
        <contact_name>Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand street Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
