<?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>IRCT20161122031023N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-15</date_registration>
      <primary_sponsor>Vice Chancellor for research Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of health promotion interventions on outcomes of pregnancy and childbirth</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of health promoting interventions on pregnancy outcomes in overweight women in Tabriz</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24477</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In the random sampling process of pregnant women in two groups of intervention and control, random allocation software for clinical trails was used. Using this software, data about the number of samples, the number and names of the groups were given to Excel software, and the output was taken from the random list of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Overweight. Condition 2: Pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group received 4 sessions of training and counseling for regulating physical activity and balanced diet In weeks 16 to 20 of pregnancy. Intervention 2: Control group: The control group received only routine prenatal care.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azita Fathnezhad Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 58, second Ave, Azari Ave, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5167635361</zip>
        <telephone>+98 41 3327 1080</telephone>
        <email>afnkazemi@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sepideh Hajian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School, Crossroads Valieaser with Niaiesh, Valieaser St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>hajian74@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranians
Body mass index between 29.9-25
First pregnancy
single pregnancy
Being in weeks 16 to 20 of pregnancy
Lack of specific physical and mental illness
lack of midwifery risk factors
18 to 40 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Non-cooperation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z68.54</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Body mass index (BMI) pediatric, greater than or equal to 95th percentile for age</hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group received 4 sessions of training and counseling for regulating physical activity and balanced diet In weeks 16 to 20 of pregnancy.</i_keyword>
      <i_keyword>Control group: The control group received only routine prenatal care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight gain. Timepoint: Weeks 16 to 20, 24 to 28, 30 to 34, and 36 to 40 pregnancies. Method of measurement: Scale.</prim_outcome>
      <prim_outcome>Physical activity. Timepoint: Weeks 16 to 20, 24 to 28, 30 to 34, and 36 to 40 pregnancies. Method of measurement: International Physical Activity Questionnaire.</prim_outcome>
      <prim_outcome>Amount of calories. Timepoint: Weeks 16 to 20, 24 to 28, 30 to 34, and 36 to 40 pregnancies. Method of measurement: Food Frequency Questionnaire.</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 Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-15</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Nursing and Midwifery School, Crossroads Valieaser with Niaiesh, Valieaser St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
