<?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>IRCT2016091029769N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-11-27</date_registration>
      <primary_sponsor>Vice chancellor for research, Qom University of Medical Sciences and health service</primary_sponsor>
      <public_title>The effect of educational program on the promotion of sports activities in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational intervention based on health belief model on promotion of particular sports activities in nulliparous pregnant women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23838</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: A total of 88 nulliparous women who referred to the two selected health centers in Qom&#13;
were selected based on the specified inclusion and exclusion criteria and then divided into two groups of 44 subjects (intervention group and control group).</study_design>
      <phase>2-3</phase>
      <hc_freetext>Pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Interventions 1:&#13;
The intervention group included 44 nulliparous women referred to the selective medical centers in Qom.&#13;
The self-made questionnaires were distributed to intervention group and so the information was collected before the intervention.  &#13;
Then three one-hour training sessions were held for the intervention group according to the Health Belief Model and with lecture method, group discussion, questions and answers and by using PowerPoint, pamphlets and role playing method.  &#13;
The questionnaires were completed by the participants in this group after the last training session and two months after it. Then the obtained data were analyzed. Intervention 2: Interventions 2:&#13;
The control group included 44 nulliparous women referred to the selective medical centers in Qom.&#13;
The self-made questionnaires were also distributed to the control group before the educational intervention  for the intervention group and so the information was collected before the intervention.  &#13;
The control group did not receive any educational intervention during this study. The questionnaires were completed by the participants in control group after the last training session and two months after it. Then the obtained data were analyzed.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Jafari Behbahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.83, 1/1 Alley, No.4 Alley, Safashahr St.</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 25 3783 3595</telephone>
        <email>Nazi.jafari81@gmail.com</email>
        <affiliation>Qom University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Gholamreza Sharifirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.83, 1/1 Alley, No.4 Alley, Safashahr St.</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 25 3721 1301</telephone>
        <email>sharifirad@hlth.mui.ac.ir</email>
        <affiliation>Qom University of Medical Sciences and Health Services-Faculty of Health</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1. Lack of physical disability and medical contraindications for exercise &#13;
2. Lack of any pregnancy complications during the intervention period&#13;
3. Gestational age between 16 weeks and 24 weeks &#13;
&#13;
Exclusion criteria:&#13;
1. Termination pregnancy for any reason&#13;
2. Failure to attend more than two classes</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>48 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O20-O29</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other maternal disorders predominantly related to pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventions 1:&#13;
The intervention group included 44 nulliparous women referred to the selective medical centers in Qom.&#13;
The self-made questionnaires were distributed to intervention group and so the information was collected before the intervention.  &#13;
Then three one-hour training sessions were held for the intervention group according to the Health Belief Model and with lecture method, group discussion, questions and answers and by using PowerPoint, pamphlets and role playing method.  &#13;
The questionnaires were completed by the participants in this group after the last training session and two months after it. Then the obtained data were analyzed.</i_keyword>
      <i_keyword>Interventions 2:&#13;
The control group included 44 nulliparous women referred to the selective medical centers in Qom.&#13;
The self-made questionnaires were also distributed to the control group before the educational intervention  for the intervention group and so the information was collected before the intervention.  &#13;
The control group did not receive any educational intervention during this study. The questionnaires were completed by the participants in control group after the last training session and two months after it. Then the obtained data were analyzed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge. Timepoint: Immediately after intervention-2 Months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Perceived susceptibility. Timepoint: Immediately after intervention-2 Months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Perceived severity. Timepoint: Immediately after intervention-2 Months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Perceived benefits. Timepoint: Immediately after intervention-2 Months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Perceived barriers. Timepoint: Immediately after intervention-2 Months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Performance. Timepoint: Immediately after intervention-2 Months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Percieved self-efficacy. Timepoint: Immediately after intervention-2 Months after the intervention. Method of measurement: Questionnaire.</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>Vice chancellor for research, Qom University of Medical Sciences and health service</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-22</approval_date>
        <contact_name>Ethics committee of Qom University of Medical Sciences and Health Services</contact_name>
        <contact_address>No.83, 1/1 Alley, No.4 Alley, Safashahr St. Qom  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
