<?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>IRCT201706236261N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-19</date_registration>
      <primary_sponsor>Vice chancellor for research of  Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational program on physical activity in women overweight 30 to 54 years old</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the theory-centered curriculum on the application of the health belief model and social support on physical activity in women aged 30-54 with overweight</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6710</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Physical activity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In each intervention and comparison group, 40 patients and 80 subjects participated in the study:After the random allocation of the subjects in the intervention and comparison groups, the questionnaires were distributed to the subjects at the first session by the researcher. After completing them (pre-test), the data were analyzed and based on the results, needs Educational intervention group and determine the content of the training program and the number of sessions will be set. It is anticipated that educational intervention will be implemented in 4 weeks and the intervention group will be divided into four groups. It is estimated that the training program for each intervention group consists of 6 sessions of 60 minutes each with 2 times a weekly frequency and using direct methods such as interactive lectures, group discussions, role play and practical training and indirect methods with educational materials such as pamphlets, Poster and educational pamphlets will be delivered by a health education researcher and a physical education expert. Alternatively, the duration of the training sessions may be increased based on the capacity, the willingness, the conditions and the views of the participants in the classroom and other factors. During the intervention period, coordination centers were established so that the intervention group, other than the training, did not receive comparative training in the form of this study and the group. Intervention 2: Control group: In the control group, educational intervention does not take place. These group will participate in the pre-test and post-test.</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>Masoomeh Faghih</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Health education and health promotion,School of Public Health , Shiraz University of Medical sciences</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>stud3501107943@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hosein Kaveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Health education and health promotion,School of Public Health , Shiraz University of Medical sciences</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>kaveh@sums.ac.ir</email>
        <affiliation>Shiraz University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: female sex; age range 30 to 54 years old; 30 ≥BMI≥ 25 in overweight; fourth grade primary and higher. Non-inclusion criteria: pregnant women; any underlying disease with limited musculoskeletal, skeletal, normal and bodybuilding degree of obesity grade one, two and three; unwillingness to participate. Exit criteria: pregnancy occurrence in women with a history of previous abortions or early delivery; no attendance at training sessions; more than one session or tests; withdrawal from the study for any reason; including illness or withdrawal of the subject during the intervention.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>54 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XXI</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Factors influencing health status and contact with health services</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: In each intervention and comparison group, 40 patients and 80 subjects participated in the study:After the random allocation of the subjects in the intervention and comparison groups, the questionnaires were distributed to the subjects at the first session by the researcher. After completing them (pre-test), the data were analyzed and based on the results, needs Educational intervention group and determine the content of the training program and the number of sessions will be set. It is anticipated that educational intervention will be implemented in 4 weeks and the intervention group will be divided into four groups. It is estimated that the training program for each intervention group consists of 6 sessions of 60 minutes each with 2 times a weekly frequency and using direct methods such as interactive lectures, group discussions, role play and practical training and indirect methods with educational materials such as pamphlets, Poster and educational pamphlets will be delivered by a health education researcher and a physical education expert. Alternatively, the duration of the training sessions may be increased based on the capacity, the willingness, the conditions and the views of the participants in the classroom and other factors. During the intervention period, coordination centers were established so that the intervention group, other than the training, did not receive comparative training in the form of this study and the group.</i_keyword>
      <i_keyword>Control group: In the control group, educational intervention does not take place. These group will participate in the pre-test and post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physical activity behavior. Timepoint: Before the intervention and one month after intervention. Method of measurement: International Physical Activity questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knowledge. Timepoint: Before the intervention and one month after intervention. Method of measurement: Researcher-made standardized questionnaire.</sec_outcome>
      <sec_outcome>Perceived severity. Timepoint: Before the intervention and one month after intervention. Method of measurement: Researcher-made standardized questionnaire.</sec_outcome>
      <sec_outcome>Perceived vulnerability. Timepoint: Before the intervention and one month after intervention. Method of measurement: Researcher-made standardized questionnaire.</sec_outcome>
      <sec_outcome>Perceived benefit. Timepoint: Before the intervention and one month after intervention. Method of measurement: Researcher-made standardized questionnaire.</sec_outcome>
      <sec_outcome>Perceived barriers. Timepoint: Before the intervention and one month after intervention. Method of measurement: Researcher-made standardized questionnaire.</sec_outcome>
      <sec_outcome>Cues to Action. Timepoint: Before the intervention and one month after intervention. Method of measurement: Researcher-made standardized questionnaire.</sec_outcome>
      <sec_outcome>Self-efficacy. Timepoint: Before the intervention and one month after intervention. Method of measurement: Researcher-made standardized questionnaire.</sec_outcome>
      <sec_outcome>Perceived social support. Timepoint: Before the intervention and one month after intervention. Method of measurement: Researcher-made standardized questionnaire.</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 of  Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-08</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, seventh floor, Shiraz University Center Building, Zand Avenue Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
