<?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>IRCT2016071428927N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-04</date_registration>
      <primary_sponsor>Vice chancellor for research, Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Effect of family-centered empowerment pattern on nutrition style and physical activity in patients with asthma</public_title>
      <acronym></acronym>
      <scientific_title>Effect of family-centered empowerment pattern on nutrition style and physical activity in patients with asthma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23359</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Asthma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention will implement as a discussion group of 6-8 people over 3-5 meetings (maximum 45 minutes) as follows: The first step in Family-Centered Empowerment Model is increasing the threat perceived by the patient in relation to the nature of the disease and the potential side effects of the disease and treatment using discussion groups. The second phase is to use problem-solving skills in groups of 6-8 persons in which the patients are faced with problems and problem-solving process. Patients express their problems in this phase and discuss on how to solve them according to their viewpoints and subsequently participate in selecting the best solution. In the third phase, patients are required to transfer the contents discussed in training sessions to their active family member through flash cards using educational participation to promote self-esteem. In the fourth stage, process evaluation will be done with special tools to measure empowerment and the patients’ empowerment and their active family member are studied in about 7-10 days after the intervention. Intervention 2: In the control group did not perform certain actions.</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>Fatemeh Khajemahmoud</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaffari Street, Birjand  University of Medical Sciences, Birjand</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 3238 1400</telephone>
        <email>fatemekhaje34@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholamhossein Mahmoudirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaffari Street, Birjand University of Medical Sciences, Birjand</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 3238 1400</telephone>
        <email>mahmoudirad@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Suffering from asthma; experiencing asthma attack at least once in the last six months; literacy; lack of other chronic diseases; patients aged 18-60 years. Exclusion Criteria: Suffering with known physical and mental illnesses; lack of participation in all meetings of the intervention.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mixed asthma Combination of conditions listed in J45.0 and J45.1</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention will implement as a discussion group of 6-8 people over 3-5 meetings (maximum 45 minutes) as follows: The first step in Family-Centered Empowerment Model is increasing the threat perceived by the patient in relation to the nature of the disease and the potential side effects of the disease and treatment using discussion groups. The second phase is to use problem-solving skills in groups of 6-8 persons in which the patients are faced with problems and problem-solving process. Patients express their problems in this phase and discuss on how to solve them according to their viewpoints and subsequently participate in selecting the best solution. In the third phase, patients are required to transfer the contents discussed in training sessions to their active family member through flash cards using educational participation to promote self-esteem. In the fourth stage, process evaluation will be done with special tools to measure empowerment and the patients’ empowerment and their active family member are studied in about 7-10 days after the intervention.</i_keyword>
      <i_keyword>In the control group did not perform certain actions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nutrition Style. Timepoint: Before the intervention and one week, one month, and three months after the intervention. Method of measurement: questionaire.</prim_outcome>
      <prim_outcome>Physical Activity. Timepoint: Before the intervention and one week, one month, and three months after the intervention. Method of measurement: questionaire.</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, Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-12</approval_date>
        <contact_name>Birjand University of Medical Sciences</contact_name>
        <contact_address>Ghaffari Street, Birjand  University of Medical Sciences, Birjand Birjand  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
