<?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>IRCT20221228056969N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-21</date_registration>
      <primary_sponsor>WHO Eastern Mediterranean Regional Office</primary_sponsor>
      <public_title>Evaluation of the effectiveness of women's empowerment in predicting infected COVID-19 outcomes.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a web-based education strategy on immunoglobulin G and M in the prevention of covid-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>303</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67679</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The participants were randomized to the intervention group (n = 152) and the control group (n = 151) were assigned randomly, and random numbers were generated using Random Allocation Software (RAS), using block. Allocations were communicated to the groups by people other than the trial coordinator. The study groups were matched in terms of age and weight variables during a random assignment, Blinding description: Because of the nature of this study, only the analysts and evaluators were masked in group allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The current study aimed to provide four education sessions on mental health behavior and four training sessions on personal health behaviors, Physical activity, and healthy diet within 4 weeks (8 sessions). Each training session lasted one hour. Both local psychologists and university professors provided training strategy programs in the fields of mental health behavior and personal health, healthy diet, and physical activity education. The training sessions were conducted online using multimedia via the big blue button, and questions and answers were conducted during the sessions to ensure the attendance of the participants. A WhatsApp group was created for the intervention group, and they were informed of the class times. A training site was created to make educational content available to the intervention group, including a home page, instructions, and offline classes. Access codes protected offline classes and instructions. On the site's offline classes section, the educational content of online classes was uploaded. Codes were given to the intervention group. After the training strategy, the intervention group was evaluated in terms of educational content. The contents of the sessions were developed based on a review literature search. Intervention 2: Control group: The control group received routine training via mass and social media. After follow-up, the control group was provided with address training sites.</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 The dataset analyzed during the current study is not publicly available due to legal and ethical constraints. Public sharing of participant data was not included in the informed consent of the study. All inquiries about access to data should be sent to the corresponding author. All requests to access data will be handled in accordance with the Ethics Committee of the Faculty of Ardabil University of Medical Sciences.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah Street</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>56189-85991</zip>
        <telephone>+98 45 3352 2247</telephone>
        <email>zaremaryam119@gmail.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah Street</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>56189-85991</zip>
        <telephone>+98 45 3352 2247</telephone>
        <email>zaremaryam119@gmail.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Housewives with an age range of 30-60years
No renal disease or diabetes, mental and learning problems, vision, and hearing problems
Has literacy
Internet access
Having a computer or smartphone</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnant women / intention to conceive or breastfeed
Subjects with COVID-19 disease
Subjects who are recovering of COVID-19</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B97.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronavirus as the cause of diseases classified elsewhere</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The current study aimed to provide four education sessions on mental health behavior and four training sessions on personal health behaviors, Physical activity, and healthy diet within 4 weeks (8 sessions). Each training session lasted one hour. Both local psychologists and university professors provided training strategy programs in the fields of mental health behavior and personal health, healthy diet, and physical activity education. The training sessions were conducted online using multimedia via the big blue button, and questions and answers were conducted during the sessions to ensure the attendance of the participants. A WhatsApp group was created for the intervention group, and they were informed of the class times. A training site was created to make educational content available to the intervention group, including a home page, instructions, and offline classes. Access codes protected offline classes and instructions. On the site's offline classes section, the educational content of online classes was uploaded. Codes were given to the intervention group. After the training strategy, the intervention group was evaluated in terms of educational content. The contents of the sessions were developed based on a review literature search.</i_keyword>
      <i_keyword>Control group: The control group received routine training via mass and social media. After follow-up, the control group was provided with address training sites.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Immunoglobulin G (IgG) and Immunoglobulin M (Ig M) antibodies titers. Timepoint: This study was conducted at three time points: baseline, post-intervention (4 weeks), and follow-up (12 weeks). Method of measurement: enzyme-linked immunosorbent assay, using kits (ELISA; Pishtaz, Iran).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Symptoms of COVID-19 Diseases. Timepoint: baseline, post-intervention (4 weeks), and follow-up (12 weeks). Method of measurement: the physician examined the participants' physical condition during the study and diagnosed symptoms of COVID-19 diseases.</sec_outcome>
      <sec_outcome>Mental Health Behavior score. Timepoint: baseline, post-intervention (4 weeks), and follow-up (12 weeks). Method of measurement: the lifestyle for prevention of infectious diseases questionnaire (LSPIDQ).</sec_outcome>
      <sec_outcome>Stress and Anxiety score. Timepoint: baseline, post-intervention (4 weeks), and follow-up (12 weeks). Method of measurement: the lifestyle for prevention of infectious diseases questionnaire (LSPIDQ).</sec_outcome>
      <sec_outcome>Personal and Public Health Behavior score. Timepoint: baseline, post-intervention (4 weeks), and follow-up (12 weeks). Method of measurement: the lifestyle for prevention of infectious diseases questionnaire (LSPIDQ).</sec_outcome>
      <sec_outcome>Physical activity behavior score. Timepoint: baseline, post-intervention (4 weeks), and follow-up (12 weeks). Method of measurement: the lifestyle for prevention of infectious diseases questionnaire (LSPIDQ).</sec_outcome>
      <sec_outcome>Healthy eating behavior score. Timepoint: baseline, post-intervention (4 weeks), and follow-up (12 weeks). Method of measurement: the lifestyle for prevention of infectious diseases questionnaire (LSPIDQ).</sec_outcome>
      <sec_outcome>Average intake of macronutrients. Timepoint: baseline, post-intervention (4 weeks), and follow-up (12 weeks). Method of measurement: 24-hour dietary recall.</sec_outcome>
      <sec_outcome>Physical activity score. Timepoint: baseline, post-intervention (4 weeks), and follow-up (12 weeks). Method of measurement: the International Physical Activity Questionnaire (IPAQ).</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>WHO Eastern Mediterranean Regional Office</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-11</approval_date>
        <contact_name>Ardabil University of Medical Sciences</contact_name>
        <contact_address>Daneshgah street Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
