<?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>IRCT20180626040243N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-12</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>physical activity among  middle-aged women</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of empowerment program based on Health Action Process Approach model on promoting physical activity among  middle-aged women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32451</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: Multi-stage sampling will be done. In this way, two centers are randomly selected from among the five health centers covered by the city. At the next stage, between the bases and the home of the covered health centers, centers of two bases or health houses were selected randomly, then By contacting the Midwife Care Office, people will be randomly selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>physical activity.</hc_freetext>
      <i_freetext>Intervention groupAfter collecting and analyzing the data of the first stage and identifying the factors associated with impulsivity, 160 women were randomly divided into intervention and control groups. Data collection in an interventional phase of the study is done using a self-made questionnaire based on the HAPA approach. This questionnaire is designed and validated by the researcher. The two groups first complete the completed questionnaires (pre-test). Then, the individuals in the intervention group will be assigned an empowerment training program designed to carry out physical activity. It should be noted that intervention is done in two stages. The first phase of the intervention is intended to form the intention, during which the educational planning and preparation of the appropriate training package to increase outcome expectation, task self-efficacy, perception of the concepts of risk, and ultimately the intention to perform physical activity are carried out. The type, content, teaching method and the number and time of conducting the training classes will be performed according to the analysis of the results in the pre-test phase and the required teaching materials will be designed. The training method is likely to include lecture sessions, brain storming thoughts, modeling modeling, and distribution of educational package. Immediately after the intervention and one month later, a post-test is performed to measure the formation of the intent. After a month from the intervention of the first stage, intervention of the second stage is performed. In this stage, behavior planning, coping planning, coping self-efficacy, self-efficacy of returning to people is taught. It should be noted that the barriers and resources available for physical activity from the start of its activity or its sustainability are considered. Immediately and 3 months later, post-test is measured to measure behavior and 6 months after the maintenance of the behavior is measured.سابقهذخیره‌شده‌ها:.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Masomeh Hashemian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Hossein Square, Qamar Bani Hashem Street</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9647165716</zip>
        <telephone>+98 51 4401 8300</telephone>
        <email>hashemianm@medsab.ac.ir</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masomeh Hashemian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Education and Health Promotion, School of Health, Sabzevar University of Medical Sciences, Sabzevar, Iran.</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9647165716</zip>
        <telephone>+98 51 4401 8300</telephone>
        <email>hashemianm@medsab.ac.ir</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>In the age range of 30 to 59 (middle aged)
Not having the recommended physical activity recommended by the World Health Organization</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>59 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not in middle age
Not having recommended daily physical activity</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>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention groupAfter collecting and analyzing the data of the first stage and identifying the factors associated with impulsivity, 160 women were randomly divided into intervention and control groups. Data collection in an interventional phase of the study is done using a self-made questionnaire based on the HAPA approach. This questionnaire is designed and validated by the researcher. The two groups first complete the completed questionnaires (pre-test). Then, the individuals in the intervention group will be assigned an empowerment training program designed to carry out physical activity. It should be noted that intervention is done in two stages. The first phase of the intervention is intended to form the intention, during which the educational planning and preparation of the appropriate training package to increase outcome expectation, task self-efficacy, perception of the concepts of risk, and ultimately the intention to perform physical activity are carried out. The type, content, teaching method and the number and time of conducting the training classes will be performed according to the analysis of the results in the pre-test phase and the required teaching materials will be designed. The training method is likely to include lecture sessions, brain storming thoughts, modeling modeling, and distribution of educational package. Immediately after the intervention and one month later, a post-test is performed to measure the formation of the intent. After a month from the intervention of the first stage, intervention of the second stage is performed. In this stage, behavior planning, coping planning, coping self-efficacy, self-efficacy of returning to people is taught. It should be noted that the barriers and resources available for physical activity from the start of its activity or its sustainability are considered. Immediately and 3 months later, post-test is measured to measure behavior and 6 months after the maintenance of the behavior is measured.سابقهذخیره‌شده‌ها:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physical activity. Timepoint: Measuring the amount of physical activity. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reduce noncommunicable diseases. Timepoint: Before the intervention, immediately, one month, three months, six months after the intervention. Method of measurement: 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>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-01</approval_date>
        <contact_name>Ethics Committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Neghab , Imam Hossein Square , Qamar Bani Hashem Street Sabzvar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
