<?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>IRCT20181002041201N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-25</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of physical activity labeling and traffic light labeling on food choice</public_title>
      <acronym></acronym>
      <scientific_title>The effect of physical activity labeling which indicates the amount of physical activity needed to burn energy of chosen food, and traffic light labeling on food choice</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>500</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34182</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Randomization description: To evaluate the effect of physical activity labeling, schools from Tehran will be assigned.  Block randomization will be considered. Tehran will be divided into five regions: north, south, east, west and center. two schools from each region will be randomly selected. Preschool and elementary schools (girls or boys) will be included.  Fifty mothers will be randomly enrolled from each school, Then selected mothers will be divided into five groups. A total of 500 mothers will be included, Blinding description: Mothers will  be not aware of the aim of the study, so their food choices will be not affected.
The divisions will be done by an expert and the researcher will not aware of it.</study_design>
      <phase>N/A</phase>
      <hc_freetext>prevention of non-communicable diseases.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group number1: physical activity labeling: After designing physical activity label in the first step, it will be produced by a printing office and will be fixed on products (dairy products- beverages- cakes and biscuits). It will be asked from mothers to assume that they are a supermarket and choose from the products that are available. This label will compare with the traffic light label which is currently in use. Mothers will only encounter this label once. one hundred mothers will participate in this group. Intervention 2: Intervention group  number 2: physical activity labeling via brochure: Physical activity label with brochure: In this group, an educational brochure for choosing healthy food will be given to one hundred mothers, so the effect of education on choice is taken into account. The results of this group will be compared with the traffic light label group via brochure. Intervention 3: Intervention group number 3: traffic light labeling: In this group, 100 mothers will be included and they will select once from the products with a traffic light labels. Intervention 4: Intervention group  number 4: traffic light labeling via brochure: An educational brochure with healthy food choice information will be provided for the 100 mothers in this group to determine its impact on food choice. Intervention 5: Control group: without nutrition labeling: 100 mothers will enter to this group, and will make their choices among products that do not have any nutritional labels so we can determine the impact of nutritional labels.</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:
All information will be shared documented without the identity of the participants.

When:
Starting in 2021

To whom:
Researchers

Conditions:
Results will be useful for policy makers.

Where to obtain:
dorostim@tums.ac.ir

How to obtain:
After confirming the applicant, by Dr Dorosty the information will be provided.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shirin Seyedhamzeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 44, Hojjat-dost Alley, Naderi Street, Keshavarz Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416643931</zip>
        <telephone>+98 21 8898 4837</telephone>
        <email>sh-seyedhamzeh@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shirin Seyedhamzeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>44No, Hojjatdost Ave, Naderi St, Keshavarz boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416643931</zip>
        <telephone>+98 21 8898 4837</telephone>
        <email>sh-seyedhamzeh@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants are mothers who can read and write and want to participate  in  the study.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Those individuals who are pregnant, lactating, or have diseases such as diabetes, allergies, etc., and those with diets will be  excluded.</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group number1: physical activity labeling: After designing physical activity label in the first step, it will be produced by a printing office and will be fixed on products (dairy products- beverages- cakes and biscuits). It will be asked from mothers to assume that they are a supermarket and choose from the products that are available. This label will compare with the traffic light label which is currently in use. Mothers will only encounter this label once. one hundred mothers will participate in this group.</i_keyword>
      <i_keyword>Intervention group  number 2: physical activity labeling via brochure: Physical activity label with brochure: In this group, an educational brochure for choosing healthy food will be given to one hundred mothers, so the effect of education on choice is taken into account. The results of this group will be compared with the traffic light label group via brochure.</i_keyword>
      <i_keyword>Intervention group number 3: traffic light labeling: In this group, 100 mothers will be included and they will select once from the products with a traffic light labels.</i_keyword>
      <i_keyword>Intervention group  number 4: traffic light labeling via brochure: An educational brochure with healthy food choice information will be provided for the 100 mothers in this group to determine its impact on food choice.</i_keyword>
      <i_keyword>Control group: without nutrition labeling: 100 mothers will enter to this group, and will make their choices among products that do not have any nutritional labels so we can determine the impact of nutritional labels.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The total calories of selected products in each groups are considered as the final result. Timepoint: Immediately after food choice. Method of measurement: observation and record.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-08</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz boulevard, Ghods St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
