<?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>IRCT20160824029508N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-17</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of two types of lifestyle intervention on health measures</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of counseling on diet quality and physical activity enhancement with or without behavior counseling on body mass index, body composition and lipid profile of obese and overweight women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>61</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41744</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After recognition of 61 eligible participants, due to the small sample size of the population (&lt;200), in order to have two groups with equal sizes, restricted randomization, random allocation rule, was applied to randomize the participants into two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Overweight. Condition 2: Obesity.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: 31 overweight or obese women received counseling on diet quality improvement, increasing physical activity and psychological counseling for behavior change. Demographic characteristics of the participants were recorded at baseline. Health measures including physical activity level, body composition, weight, Body mass index, lipid profile, eating behavior, Healthy Eating Index and calorie intake were assessed at baseline and after 3 months of follow up. Intervention 2: Second intervention group: 30 overweight or obese women received counseling on diet quality improvement and increasing physical activity. Demographic characteristics of the participants were recorded at baseline. Health measures including physical activity level, body composition, weight, Body mass index, lipid profile, eating behavior, Healthy Eating Index and calorie intake were assessed at baseline and after 3 months of follow up.</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 The file including IPD will be submitted to the university.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rasoul Zarrin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of nutrition, Faculty of Medicine, Pardis Nazlou, 11th km of Nazlou Road,Urmia,Iran</address>
        <city>Umia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3346 9935</telephone>
        <email>rasoul.zarrin@uqconnect.edu.au</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rasoul Zarrin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of nutrition, Medicine Faculty, Nazlou Pardis , 11th km of Nazlou Road,Urmia,IranDepartment of nutrition, Medicine Faculty, Nazlou Pardis , 11th km of Nazlou Road, Urmia, Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3346 9935</telephone>
        <email>rasoul.zarrin@uqconnect.edu.au</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being female
BMI=25-40
Being within the age of 18 to 65 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lactation or being pregnant
Planning to become pregnant from beginning of the study until the next 4 months
Having cancer or kidney diseases
Taking corticosteroid drugs (like prednisolone) or psychothrapic medications including tricyclic drugs (like amitriptyline, imipramine, nortriptyline)
Getting scores from 61 to 84 on the General Health Questionnaire</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: 31 overweight or obese women received counseling on diet quality improvement, increasing physical activity and psychological counseling for behavior change. Demographic characteristics of the participants were recorded at baseline. Health measures including physical activity level, body composition, weight, Body mass index, lipid profile, eating behavior, Healthy Eating Index and calorie intake were assessed at baseline and after 3 months of follow up.</i_keyword>
      <i_keyword>Second intervention group: 30 overweight or obese women received counseling on diet quality improvement and increasing physical activity. Demographic characteristics of the participants were recorded at baseline. Health measures including physical activity level, body composition, weight, Body mass index, lipid profile, eating behavior, Healthy Eating Index and calorie intake were assessed at baseline and after 3 months of follow up.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: At baseline and after 3 months. Method of measurement: Measured in kg using digital Scale.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: At baseline and after 3 months. Method of measurement: kg/m2, using formula.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: At baseline and after 3 months. Method of measurement: Measured in milligram per deciliter, using auto-analyzer BT1500.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: At baseline and after 3 months. Method of measurement: Measured in milligram per deciliter using auto-analyzer BT1500.</prim_outcome>
      <prim_outcome>Low density lipoprotein (LDL-C). Timepoint: At baseline and after 3 months. Method of measurement: Measured in milligram per deciliter, using auto-analyzer BT1500.</prim_outcome>
      <prim_outcome>High density lipoprotein (HDL-C). Timepoint: At baseline and after 3 months. Method of measurement: Measured in milligram per deciliter using auto-analyzer BT1500.</prim_outcome>
      <prim_outcome>Fat free mass. Timepoint: At baseline and after 3 months. Method of measurement: Measured in kg, using InBody770.</prim_outcome>
      <prim_outcome>Fat mass. Timepoint: At baseline and after 3 months. Method of measurement: Measured in kg, using InBody770.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical activity level. Timepoint: At baseline and after 3 months. Method of measurement: International physical activity questionnaire short form (IPAQ-SF).</sec_outcome>
      <sec_outcome>Eating behavior. Timepoint: At baseline and after 3 months. Method of measurement: Three Factor Eating Questionnaire-R18 (TFEQ-R18).</sec_outcome>
      <sec_outcome>Calorie intake. Timepoint: At baseline and after 3 months. Method of measurement: Measured in Kcal, using 24 hour diet recall.</sec_outcome>
      <sec_outcome>Healthy eating index. Timepoint: At baseline and after 3 months. Method of measurement: Scores measured using 24 hour diet recall.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-30</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Umia University of Medical Sciences, Oorjans Alley, Resalat Blvd, URMIA, IRAN Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
