<?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>IRCT20201128049514N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-30</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>A comparative study of the effect of lecture-based learning and problem-based learning on menstrual hygiene behaviors and food habits in adolescent girls</public_title>
      <acronym></acronym>
      <scientific_title>Effects of a two-week lecture-based versus problem-based learning on menstrual hygiene behaviors and food habits of adolescent girls: A community-based three-arm study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52622</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: َMulti-stage cluster sampling method by a random number table.
First, District 7 was selected from five education districts located in the central areas of Tehran using a random number table. Then, from 13 government girls’ high-schools in this district, three were randomly selected by a random number table. Each of the selected school was considered as each study’s arm. For this purpose, we allocated first, second, and third selected school to three groups of PBL, LBL and control by lottery method. The ninth-grade classes in each school were serially numbered and one class was randomly selected using a table of random numbers; then, all students of the selected class were invited to participate in the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Menstrual Hygiene Behaviors. Condition 2: Food Habits.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group (LBL group): ninth grade female students in one of the three selected government girls’ high-schools located in the seven education district of Tehran. The educational program in LBL group was performed in four 60-minute training sessions by lecture and the question-and-answer methods using teaching media (i.e., whiteboard, pictures). The educational contents for LBL and PBL groups were similar and were adapted from valid books and articles and it was validated by a gynecologist and two nursing and nutrition faculty members of SBMU. The educational content included these items: the definition of healthy diet, macronutrients needs during adolescence, introducing of healthy snacks, disadvantages of fast foods and the risks of obesity in adolescence, as well as the definition of menstruation and premenstrual syndrome, menstrual pain management, the principles of personal hygiene during menstruation, consisting of cleanliness and bath methods, underwear hygiene and vaginal hygiene. Intervention 2: Second intervention group (PBL group): ninth grade female students in one of the three selected government girls’ high-schools located in the seven education district of Tehran. The educational program in PBL group was performed in four 60-minute training sessions using teaching media (i.e., whiteboard, pictures). In the PBL group, five small groups were established, and then four scenarios were presented (two for menstrual hygiene and two for a healthy diet). The PBL steps were as follow: 1) presenting situation and scenario and clarifying the concepts, 2) defining the problem and reviewing scenario, 3) discussing and analyzing the problem with brain storming technique, 4) finding the possible solutions, 5) identifying learning needs, 6) seeking information, and 7) reporting, assessing, and using of new information. The educational contents for LBL and PBL groups were similar and were adapted from valid books and articles and it was validated by a gynecologist and two nursing and nutrition faculty members of SBMU. The educational content included these items: the definition of healthy diet, macronutrients needs during adolescence, introducing of healthy snacks, disadvantages of fast foods and the risks of obesity in adolescence, as well as the definition of menstruation and premenstrual syndrome, menstrual pain management, the principles of personal hygiene during menstruation, consisting of cleanliness and bath methods, underwear hygiene and vaginal hygiene. Intervention 3: Control group: ninth grade female students in one of the three selected government girls’ high-schools located in the seven education district of Tehran. At the end of study, students of control group received a 1-hour education session by a designed booklet about menstrual hygiene and a healthy diet in order to observe the ethical issues of the research.</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:
-

When:
-

To whom:
-

Conditions:
-

Where to obtain:
-

How to obtain:
-

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parvaneh Vasli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>0098 21 88655366-9</telephone>
        <email>p-vasli@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvaneh Vasli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>0098 21 88655367-9</telephone>
        <email>p-vasli@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>An age range of 14-15 years
Students’ verbal assent
A written informed consent from the students’ parents</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Missed more than one learning session
Filling out the questionnaires incompletely
No history of menstruation
Had not passed at least one year since her menarche</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group (LBL group): ninth grade female students in one of the three selected government girls’ high-schools located in the seven education district of Tehran. The educational program in LBL group was performed in four 60-minute training sessions by lecture and the question-and-answer methods using teaching media (i.e., whiteboard, pictures). The educational contents for LBL and PBL groups were similar and were adapted from valid books and articles and it was validated by a gynecologist and two nursing and nutrition faculty members of SBMU. The educational content included these items: the definition of healthy diet, macronutrients needs during adolescence, introducing of healthy snacks, disadvantages of fast foods and the risks of obesity in adolescence, as well as the definition of menstruation and premenstrual syndrome, menstrual pain management, the principles of personal hygiene during menstruation, consisting of cleanliness and bath methods, underwear hygiene and vaginal hygiene.</i_keyword>
      <i_keyword>Second intervention group (PBL group): ninth grade female students in one of the three selected government girls’ high-schools located in the seven education district of Tehran. The educational program in PBL group was performed in four 60-minute training sessions using teaching media (i.e., whiteboard, pictures). In the PBL group, five small groups were established, and then four scenarios were presented (two for menstrual hygiene and two for a healthy diet). The PBL steps were as follow: 1) presenting situation and scenario and clarifying the concepts, 2) defining the problem and reviewing scenario, 3) discussing and analyzing the problem with brain storming technique, 4) finding the possible solutions, 5) identifying learning needs, 6) seeking information, and 7) reporting, assessing, and using of new information. The educational contents for LBL and PBL groups were similar and were adapted from valid books and articles and it was validated by a gynecologist and two nursing and nutrition faculty members of SBMU. The educational content included these items: the definition of healthy diet, macronutrients needs during adolescence, introducing of healthy snacks, disadvantages of fast foods and the risks of obesity in adolescence, as well as the definition of menstruation and premenstrual syndrome, menstrual pain management, the principles of personal hygiene during menstruation, consisting of cleanliness and bath methods, underwear hygiene and vaginal hygiene.</i_keyword>
      <i_keyword>Control group: ninth grade female students in one of the three selected government girls’ high-schools located in the seven education district of Tehran. At the end of study, students of control group received a 1-hour education session by a designed booklet about menstrual hygiene and a healthy diet in order to observe the ethical issues of the research.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Menstrual Hygiene Behaviors - Food Habits. Timepoint: Before, immediately and three months after the last learning session by lecture-based and problem-based methods. Method of measurement: Information about menstrual hygiene behaviors (MHBs) was collected by the 16-item researcher-made questionnaire (MHBsQ) and information about food habits (FHs) was collected by presenting the Persian version of Adolescent Food Habits Checklist (AFHC) with 23 items.</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>2019-07-15</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>ValiAsr Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
