<?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>IRCT20081205001488N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-03</date_registration>
      <primary_sponsor>National Institute for Medical Research Development (NIMAD)</primary_sponsor>
      <public_title>The impact of a results-based motivating system on population levels of the non-communicable diseases risk factors in Iran: A field trial study</public_title>
      <acronym>IRPONT</acronym>
      <scientific_title>The impact of a results-based motivating system on population levels of the non-communicable diseases risk factors in Iran: A field trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/774</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Other design features: This is a field trial. Interventions are performed at the first health level of the selected areas, and the final outcome is measured using population surveys, Randomization description: we use randomization to randomly assign centers for intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Risk factors of Non-communicable diseases.</hc_freetext>
      <i_freetext>Intervention 1: Group IV: Assessment of the main NCDs’ risk factors and setting time-bound targets, AND Finding and sharing evidence on effective/efficient interventions for controlling the risk factors AND Operational planning with contribution of local health authoriti. Intervention 2: Group I: Assessment of the main NCDs’ risk factors and setting time-bound targets. Intervention 3: Group II: Assessment of the main NCDs’ risk factors and setting time-bound targets AND  Finding and sharing evidence on effective/efficient interventions for controlling the risk factors. Intervention 4: Group III: Assessment of the main NCDs’ risk factors and setting time-bound targets AND  Finding and sharing evidence on effective/efficient interventions for controlling the risk factors AND Operational planning with contribution of local health authorit. Intervention 5: Control group: A county (Garmsar County) consisting of 4 health houses and 4 health center will not receive any intervention, and only three survey will be conducted.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Access to relevant files is possible one year after the publication, with correspondence email: mazmoradi@gmail.com.

When:
One year after publication

To whom:
Academic researchers

Conditions:
There is no limitation to the analysis

Where to obtain:
Contact with email: mazmoradi@gmail.com

How to obtain:
Study aims of the study, about 10 to 21 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maziar Moradi-Lakeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>IUMS, Crossroads of Hemmat-Chamran expressways, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8860 2225</telephone>
        <email>mazmoradi@yahoo.com</email>
        <affiliation>Preventive Medicine and Public Health Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Maziar Moradi-Lakeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Hemmat-Chamran crossroads</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8860 2225</telephone>
        <email>Mazmoradi@yahoo.com</email>
        <affiliation>Preventive Medicine and Public Health Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>In the first study, three medical universities will be selected randomly from three different climates, and they will be asked to submit a list of health and medical and health centers in their urban and rural areas, broken down by health centers and health homes. Then the list of networks that have the entry criteria (descriptions in the entry criteria) are prepared and then the selection is made randomly. From each University, four Urban health centers and four health home randomly selected . Four groups (each consisting of a health center and a health center) will be introduced.Of course, to control the likelihood of data contamination, one of the universities(ُSemnan), in addition to the intervention cluster city, will select another city(Garmsar) with 4 urban clusters and 4 rural clusters, which will receive no intervention.
Universities eligible for entry into the study: 1. Have the consent to cooperate in the study. Cities eligible for entry into the study are: 1. Cities with at least four urban health centers and four health-care homes. Eligible entry centers: 1. Health homes with at least two "Behvarz". 2. City bases Have at least 2 health care staff. And preferably have recruiting staff . 3. health homes that are preferable to the Very small village .eligible staff : Preferably, have fixed forces (recruitment) of health centers and  health homes At least 2 years into that center.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Disagreement with the text of the memorandum, by the relevant authorities of the universities</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group IV: Assessment of the main NCDs’ risk factors and setting time-bound targets, AND Finding and sharing evidence on effective/efficient interventions for controlling the risk factors AND Operational planning with contribution of local health authoriti</i_keyword>
      <i_keyword>Group I: Assessment of the main NCDs’ risk factors and setting time-bound targets.</i_keyword>
      <i_keyword>Group II: Assessment of the main NCDs’ risk factors and setting time-bound targets AND  Finding and sharing evidence on effective/efficient interventions for controlling the risk factors</i_keyword>
      <i_keyword>Group III: Assessment of the main NCDs’ risk factors and setting time-bound targets AND  Finding and sharing evidence on effective/efficient interventions for controlling the risk factors AND Operational planning with contribution of local health authorit</i_keyword>
      <i_keyword>Control group: A county (Garmsar County) consisting of 4 health houses and 4 health center will not receive any intervention, and only three survey will be conducted.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Population level of uncontrolled hypertension. Timepoint: At the beginning of intervention (Month 0), 12 months after starting of intervention, 24 month after starting of intervention. Method of measurement: Population Survey.</prim_outcome>
      <prim_outcome>Population level of Poorly controlled diabetes. Timepoint: At the beginning of intervention (Month 0), 12 months after starting of intervention, 24 month after starting of intervention. Method of measurement: Population Survey.</prim_outcome>
      <prim_outcome>Population level of insufficient physical activity. Timepoint: At the beginning of intervention (Month 0), 12 months after starting of intervention, 24 month after starting of intervention. Method of measurement: Population Survey.</prim_outcome>
      <prim_outcome>Population level of current tobacco smoking. Timepoint: At the beginning of intervention (Month 0), 12 months after starting of intervention, 24 month after starting of intervention. Method of measurement: Population Survey.</prim_outcome>
      <prim_outcome>Population level of  insufficient intake of fruits/vegetables. Timepoint: At the beginning of intervention (Month 0), 12 months after starting of intervention, 24 month after starting of intervention. Method of measurement: Population Survey.</prim_outcome>
      <prim_outcome>Population level of body mass index. Timepoint: At the beginning of intervention (Month 0), 12 months after starting of intervention, 24 month after starting of intervention. Method of measurement: Population Survey.</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>National Institute for Medical Research Development (NIMAD)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-31</approval_date>
        <contact_name>national institute for medical research development</contact_name>
        <contact_address>Tehran, West Fatemi St., Besat Street, No. 21 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
