<?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>IRCT20201222049800N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-03</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Skill Training Intervention Based on the Healthy Lifestyle Counselling Module(5As model)</public_title>
      <acronym></acronym>
      <scientific_title>Designing, Implementation and Evaluation of Skill Training Intervention Based on the Healthy Lifestyle Counselling Module (5As model) in the Ira PEN Program among Health Workers: A Methodological and Interventional Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>184</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53205</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: n this study, for the first time in Iran, using a healthy lifestyle module that is recommended in 2018 by the World Health Organization for the training of health workers and is based on the 5As model, a training intervention, be designed, implemented and evaluated and its results presented to the managers and decision makers of the IraPEN program. One of the innovative aspects of this research is the design and psychometrics of the counseling skills training checklist and the innovation of educational intervention in the form of electronic content and its sharing through the virtual education system and social network. In this study, the intervention is performed only for the intervention group and includes a healthy lifestyle counseling training program. And no intervention is performed on the control group, Randomization description: For sampling between 3 health networks under coverage of Tehran University of Medical Sciences, 2 networks were selected by simple randomization and lottery method, then 2 networks were again, assigned to the intervention and control groups  by simple randomization and lottery method. Since each network covers 45 or more health centers and there are 3 health workers in each health centers, sampling at this stage will be done in a stratified. randomization manner. That is, in each network, according to the sample size (92 people), 31 health centers will be randomly selected from the list according to the table of random numbers, and in each center, all 3 health providers will be included in the study, Blinding description: In this study, health providers did not know whether they were in the intervention or control group. Counseling service is provided routinely and the checklist is completed by an observer imperceptibly during routine monitoring of the health system.
2. Observers complete the counseling checklist imperceptibly at the same time as monitoring other health services. However, they do not know in which intervention or control group health care providers are.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Healthy Life Style Counsseling.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 1. Participate in a healthy lifestyle counseling workshop for 2 days and 16 hours with a role-playing teamwork 2. Watch a healthy lifestyle counseling training video for 45 minutes. Watch a healthy lifestyle training motion graph for 10 minutes  3. Participate in a virtual training course and online exam and receive a course certificate. Intervention 2: Control group: They do not participate in any training course and have received only the relevant instructions, and when providing the service, the electronic system provides general recommendations for training to the clients.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the privacy of participants' personal information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najmolmolook Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First Floor, Ministry of Health Building, Hafez St., Jomhouri Intersection,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1134845764</zip>
        <telephone>+98 21 6345 3342</telephone>
        <email>namini@farabi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohtasham Ghaffari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Health and Safety, Velenjak St., Daneshjoo Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983535511</zip>
        <telephone>00982122432040-41</telephone>
        <email>mohtashamghaffari@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Health workers working in health centers
People between the ages of 30 and 70 who receive cardiovascular risk assessment services from health centers</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to cooperate in the study</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>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 1. Participate in a healthy lifestyle counseling workshop for 2 days and 16 hours with a role-playing teamwork 2. Watch a healthy lifestyle counseling training video for 45 minutes. Watch a healthy lifestyle training motion graph for 10 minutes  3. Participate in a virtual training course and online exam and receive a course certificate</i_keyword>
      <i_keyword>Control group: They do not participate in any training course and have received only the relevant instructions, and when providing the service, the electronic system provides general recommendations for training to the clients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Healthy lifestyle counseling skill. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Observation with checklist.</prim_outcome>
      <prim_outcome>Healthy lifestyle behaviors based on SIB system. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Data recorded in the SIB system.</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>2020-02-04</approval_date>
        <contact_name>Ethics committee of School of Health and Neuroscience Research Center, Shahid Beheshti University</contact_name>
        <contact_address>School of Health and Safety, Daneshjoo Blvd, Velenjak St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
