<?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>IRCT20200718048132N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-04</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The effect of an educational intervention based on the TransTheoretical Model on dairy consumption of girl students</public_title>
      <acronym></acronym>
      <scientific_title>The effect of an educational intervention based on the TransTheoretical Model  on dairy consumption of girl students of  10th and 11th grade</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>98</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50003</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of an educational intervention based on the TransTheoretical Modelon dairy consumption of  students.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the case of educational intervention, the training program will be held once a week for 30-45 minutes. In this intervention, all of the constructs, based on the research requirements and low scores regarding them, will be taught directly through employing lecture method, appropriate participatory methods such as question and answer activation, group discussion. The educational content of each session will include general and specific training according to the stages of students' change in dairy consumption. General training strategies in the program include: Drawing attention to the program through informing participants regarding the recommended amount of milk and its products, the importance of its consumption during adolescence and the side effects resulting from lack of its consumption. Specific training is based on improving the constructs of trans-theoretical model regarding self-efficacy, change processes (cognitive and behavioral) and decisional balance (perceived barriers and benefits), and the stages of subjects' change. General topics of educational materials include: The importance of nutrition during adolescence, the food pyramid and the role of each group in body health, the importance and role of milk and its products in body health, the role of calcium in the body, the side effects of insufficient calcium intake, the role of dairy in preventing osteoporosis, diseases related to low consumption of dairy products, benefits of dairy consumption on body health, perceived barriers regarding dairy consumption, ways of overcoming barriers considering dairy consumption and increasing self-awareness, environmental reevaluation, self-reappraisal, self-liberation, counterconditioning, reinforcement management, stimulus control, helping relationships, social liberation, and perceived ways to enhance perceived self-efficacy for increasing dairy consumption. Intervention 2: Control group:  During the intervention and one month of follow-up, the control group will not receive training and after the intervention, educational booklets will be provided to them.</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:
Information on the frequency distribution of students in the stages of changing dairy consumption, student awareness, change process, decision balance and self-efficacy

When:
6 months after printing the results

To whom:
University professors and students

Conditions:
For similar studies

Where to obtain:
By contacting the email nrouhani@gums.ac.ir

How to obtain:
By contacting the email nrouhani@gums.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Noushin Rouhani Tonekaboni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Former building of Azad University - Rasht School of Health (new building)-Behind the building of the Radio and Television Organization-Resalat St</address>
        <city>rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4185733411</zip>
        <telephone>+98 13 3384 9411</telephone>
        <email>nrouani@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Noushin Rouhani Tonekaboni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Former building of Azad University - Rasht School of Health (new building)-Behind the building of the Radio and Television Organization-Resalat St</address>
        <city>rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4185733411</zip>
        <telephone>+98 13 3384 9411</telephone>
        <email>nrouhani@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Study in the tenth and eleventh grades
Having the consent to participate in the study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a special diet related to the consumption of dairy products prescribed by a specialist, according to the student statement</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the case of educational intervention, the training program will be held once a week for 30-45 minutes. In this intervention, all of the constructs, based on the research requirements and low scores regarding them, will be taught directly through employing lecture method, appropriate participatory methods such as question and answer activation, group discussion. The educational content of each session will include general and specific training according to the stages of students' change in dairy consumption. General training strategies in the program include: Drawing attention to the program through informing participants regarding the recommended amount of milk and its products, the importance of its consumption during adolescence and the side effects resulting from lack of its consumption. Specific training is based on improving the constructs of trans-theoretical model regarding self-efficacy, change processes (cognitive and behavioral) and decisional balance (perceived barriers and benefits), and the stages of subjects' change. General topics of educational materials include: The importance of nutrition during adolescence, the food pyramid and the role of each group in body health, the importance and role of milk and its products in body health, the role of calcium in the body, the side effects of insufficient calcium intake, the role of dairy in preventing osteoporosis, diseases related to low consumption of dairy products, benefits of dairy consumption on body health, perceived barriers regarding dairy consumption, ways of overcoming barriers considering dairy consumption and increasing self-awareness, environmental reevaluation, self-reappraisal, self-liberation, counterconditioning, reinforcement management, stimulus control, helping relationships, social liberation, and perceived ways to enhance perceived self-efficacy for increasing dairy consumption.</i_keyword>
      <i_keyword>Control group:  During the intervention and one month of follow-up, the control group will not receive training and after the intervention, educational booklets will be provided to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dairy consumption status. Timepoint: Before the intervention and one month after the intervention. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Student Awareness Score. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Using a researcher-made questionnaire (12 questions).</sec_outcome>
      <sec_outcome>Student change process score. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Using a researcher-made questionnaire (20 questions).</sec_outcome>
      <sec_outcome>Student decision balance score. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Using a researcher-made questionnaire (17 questions).</sec_outcome>
      <sec_outcome>Students' self-efficacy score. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Using a researcher-made questionnaire (10 questions).</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-01</approval_date>
        <contact_name>Research Ethics Committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Former building of the Azad University - Rasht School of Health (new building)- – Behind of the building of the Radio and Television Organization-- Resalat St- Rasht-Islamic Republic of Iran. rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
