<?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>IRCT20180427039436N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-31</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Program for improving physical activity among women</public_title>
      <acronym></acronym>
      <scientific_title>Implementation and evaluation of a program for improving physical activity among women: mixed method action research</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40493</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>improving physical activity among healthy women.</hc_freetext>
      <i_freetext>Intervention group: The intervention group received one of the three programs. Sport assistances program: The purpose of the program was to influence the role of sport assistances in encouraging women to increase their PA. Of the women who were attending the PA at the sports club, they were asked to work as sport assistance. A booklet entitled "Educational content for sports assistants" was compiled to increase their awareness of PA. This contained information on the importance of sport from the point of view of Islam, the Quran and hadiths, benefits of exercise, strategies for increasing PA, barriers to PA and the way to overcome them, the type, intensity and amount of PA. Sports assistants began to advertise participation in sports events in crowded places of the city, mosques, etc. Program of information plan: The goal was to increase people’s information about sports facilities in the district. Text messages, banner, and trakets were used for informing women in women's gathering places such as Quran interpreting sessions and religious ceremonies, Husayniyah and Fatimah and the health center. The cognitive-behavioral therapy program. Behavior therapy was co-sponsored by a sports psychologist that used a ten-part protocol. It was consisted of sessions weekly for 90 minutes with 13 participants in the first course and 12 participants in the second course at the health center. The protocol was endorsed by a psychologist and a psychiatrist and was consisted of: (1) Attracting members'  trust and  collaboration,  as  well  as  reducing  stress;  2) Training  to  detect  unpleasant emotions and detecting when these occur; 3) Teaching the relationship between thoughts,  emotions,  and  behaviors,  as  well  as  familiarity  with  a  variety  of  cognitive  errors; 4)  Learning  to  discover  and  challenge  irrational  thoughts;  5) Teaching  the method  of  science  to better  understand  and  counteract  irrational thoughts; 6) Teaching how to determine and prioritize goals; 7) Learning how to plan  and  how  to  increase  the  level  of  activity;  8)  Reviewing  the  previous sessions and practice exercises, obtaining feedback and answering  questions; 9) Training  the  group  on  relaxation  techniques  and     application;  10)  Providing feedback  to members  and  emphasizing  the  continued  use  of  what  they  have learned..</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:
it is not available

When:
it is not available

To whom:
it is not available

Conditions:
it is not available

Where to obtain:
it is not available

How to obtain:
it is not available

Comments:
---</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Amiri Farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>•	School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>141973317</zip>
        <telephone>+98 21 4365 1139</telephone>
        <email>l.amirifarahani@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Amiri Farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>•	School of Nursing Midwifery ,Tehran University of Medical Sciences •	Nosrat st. Tohid sq. Tehran I.IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>141973317</zip>
        <telephone>+98 21 4365 1139</telephone>
        <email>l.amirifarahani@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>- Women at the age 18-65 years have inadequate PA
Entered the study based on at least one of the three strategies: assisting by the other athletes (sport assistants), improving their knowledge about the sports facilities available in the district, and participating in the cognitive behavioral therapy classes.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a motion sickness requires no physical activity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z72.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problem related to lifestyle, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group received one of the three programs. Sport assistances program: The purpose of the program was to influence the role of sport assistances in encouraging women to increase their PA. Of the women who were attending the PA at the sports club, they were asked to work as sport assistance. A booklet entitled "Educational content for sports assistants" was compiled to increase their awareness of PA. This contained information on the importance of sport from the point of view of Islam, the Quran and hadiths, benefits of exercise, strategies for increasing PA, barriers to PA and the way to overcome them, the type, intensity and amount of PA. Sports assistants began to advertise participation in sports events in crowded places of the city, mosques, etc. Program of information plan: The goal was to increase people’s information about sports facilities in the district. Text messages, banner, and trakets were used for informing women in women's gathering places such as Quran interpreting sessions and religious ceremonies, Husayniyah and Fatimah and the health center. The cognitive-behavioral therapy program. Behavior therapy was co-sponsored by a sports psychologist that used a ten-part protocol. It was consisted of sessions weekly for 90 minutes with 13 participants in the first course and 12 participants in the second course at the health center. The protocol was endorsed by a psychologist and a psychiatrist and was consisted of: (1) Attracting members'  trust and  collaboration,  as  well  as  reducing  stress;  2) Training  to  detect  unpleasant emotions and detecting when these occur; 3) Teaching the relationship between thoughts,  emotions,  and  behaviors,  as  well  as  familiarity  with  a  variety  of  cognitive  errors; 4)  Learning  to  discover  and  challenge  irrational  thoughts;  5) Teaching  the method  of  science  to better  understand  and  counteract  irrational thoughts; 6) Teaching how to determine and prioritize goals; 7) Learning how to plan  and  how  to  increase  the  level  of  activity;  8)  Reviewing  the  previous sessions and practice exercises, obtaining feedback and answering  questions; 9) Training  the  group  on  relaxation  techniques  and     application;  10)  Providing feedback  to members  and  emphasizing  the  continued  use  of  what  they  have learned.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amount of Physical activity on the basis of minute per week. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: International physical activity questionnaire (IPAQ).</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>2013-08-16</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tohid Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
