<?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>IRCT20200621047858N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-25</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Impact of educational intervention based on the integrated social marketing approach  for regular physical activity among female students</public_title>
      <acronym></acronym>
      <scientific_title>Design, implementation and evaluation of the Impact of educational intervention based on the integrated social marketing approach  for regular physical activity among female students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>216</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49064</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: To select intervention and control groups, first Kermanshah city is divided into north and south, then the covered schools in these areas are divided into control and intervention group in order to prevent the dissemination of information in a simple random way. In each area (north and south of the city) using the division of the school education department into three categories (rich, low-income and low-income) and a simple random method is selected from each category of one school (3 intervention schools And 3 control schools) and in the next stage, 3 classes from each grade (seventh, eighth, ninth) are selected after each school. The sample size required for the intervention and control group is calculated as 108 people, which requires 36 students for each school and 12 students from each grade.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sedentary lifestyle and lack of regular physical activity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Social Marketing Planning + FITT Protocol + ACSM Protocol(Educational interventions are designed based on the results of the first and second phases of the study (qualitative and quantitative study) and the placement of people in different stages of pre-operation (pre-thinking and thinking) and operational (readiness-action and maintenance). The educational package contains theory and Practical educational CD, motion graphics, posters and banners and pedometers. The educational content will be based on the following axes:1. Providing information about diseases caused by inactivity and the role of physical activity in reducing the complications of diseases 2. The benefits of regular physical activity in improving academic and physical performance 3. Appropriate amount and time of regular physical activity 4. Increase students' self-efficacy and emphasize existing benefits and barriers A total of 4 training sessions are planned for those who will be held in the pre-operational phase and two sessions for those who are in the operational phase. Each training session lasts 45 to 60 minutes. Practical training sessions for each class are provided by the physical education instructor in the presence of the researcher in coordination with the school principal in the school gym or prayer hall. According to the ACSM protocol, practical movement training in small groups to learn warm-up exercises, aerobic exercises, Flexibility movements, and muscle strength and cooling will be performed.). Intervention 2: Control group:They will not receive any intervention from the research team and will be covered by the usual school curriculum.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the confidentiality of the participants' information, the data file will not be published</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Geravandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan, Shahid Fahmideh St., Hamadan University of Medical Sciences</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3838 1646</telephone>
        <email>geravandi_a88@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Geravandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan, Shahid Fahmideh St., Hamadan University of Medical Sciences</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3838 1646</telephone>
        <email>geravandi_a88@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Conscious consent of high school students in Kermanshah to participate and continue their studies
Student parental consent for their participation in the study
Kermanshah high school female high school students (seventh, eighth, ninth grade)
Students in the age group of 10 to 19 years</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>19 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1) Transfer from the sample school during the study
Lack of desire to continue participating in the study
3) Having an incurable disease and physical and mental condition related to physical activity to participate in the study</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Social Marketing Planning + FITT Protocol + ACSM Protocol(Educational interventions are designed based on the results of the first and second phases of the study (qualitative and quantitative study) and the placement of people in different stages of pre-operation (pre-thinking and thinking) and operational (readiness-action and maintenance). The educational package contains theory and Practical educational CD, motion graphics, posters and banners and pedometers. The educational content will be based on the following axes:1. Providing information about diseases caused by inactivity and the role of physical activity in reducing the complications of diseases 2. The benefits of regular physical activity in improving academic and physical performance 3. Appropriate amount and time of regular physical activity 4. Increase students' self-efficacy and emphasize existing benefits and barriers A total of 4 training sessions are planned for those who will be held in the pre-operational phase and two sessions for those who are in the operational phase. Each training session lasts 45 to 60 minutes. Practical training sessions for each class are provided by the physical education instructor in the presence of the researcher in coordination with the school principal in the school gym or prayer hall. According to the ACSM protocol, practical movement training in small groups to learn warm-up exercises, aerobic exercises, Flexibility movements, and muscle strength and cooling will be performed.)</i_keyword>
      <i_keyword>Control group:They will not receive any intervention from the research team and will be covered by the usual school curriculum.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of intervention in the stages of behavior change and passing from the pre-operational stage to the operational stage And increase self-efficacy in individuals. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Standard questionnaire:The method of data collection will be in the form of a questionnaire and through self-report. Due to the fact that this study uses a transtheoretical model, the data collection tool follows this model. The Marcus et al. Scale is used to measure the stages of change. This scale includes a 5-choice question in which a person chooses only one option according to their physical activity conditions. According to this scale, people in terms of physical activity behavior are in one of the 5 stages of pre-thinking, thinking, preparation, action and maintenance. The criterion for physical activity in this study is activity that is performed at least 3-5 times a week for at least 30 minutes each time; In such a way that it increases the heart rate and respiration and the person sweats, such as brisk walking and cycling. The Norman test will be used to measure change (cognitive-behavioral) processes. Also, Nig et al.'s questionnaire will be used to prepare a questionnaire related to measuring students' self-efficacy, and a questionnaire prepared by Blanchard et al. Will be used to measure decision-making balance.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Regular physical activity and changes in body mass index. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Standard questionnaire:The questions related to this section will be related to the International Physical Activity Questionnaire (IPAQ) which examines the status of physical activity in the research sample. This questionnaire is asked in the mode of moderate to severe physical activity and walking during the week. Also, the FITT protocol is used to determine the level of physical activity, which stands for frequency, intensity, time and type. F number of repetitions of physical activity per week, I degree of activity intensity, T is the length of time spent on physical activity, T is the type of physical activity.</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>Vice -Chancellor for Research, Hamadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-25</approval_date>
        <contact_name>Ethics Committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Hamedan, Shahid Fahmideh St., in front of People's Park, Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
