<?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>IRCT20190227042858N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-18</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother referring to health center, Omidiyeh.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37835</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: open label, Parallel - controlled randomized trial, Randomization description: using block randomization , two groups of intervention and control (using random numbers table).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gestational Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A general questionnaire and a physical activity questionnaire, a three-days food record and a researcher-made questionnaire based on the HBM model with subscales of; awareness,  perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy and guidance for action before and after three-months  will be collected .The education sessions is based on the dietary glycemic index of food items and their glycemic load and its effect on the maternal blood glucose, prevalence of gestational diabetes mellitus and its complications for mother and fetus, and prevention of gestational diabetes. At the end of the three-months intervention period, a face-to-face session,  the HBM questionnaire, three-day food record  and physical activity questionnaire will be collected. Intervention 2: Control group: Pregnant women in the control group receive routine pregnancy training and 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 No more info.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shirin Alipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Highway, Faculty of Paramedicine, Jundishapur University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 613738319</telephone>
        <email>alipour.sh@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fatemeh Borazjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Highway, Faculty of Paramedicine ،  Ahwaz University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 613738319</telephone>
        <email>borazjani-f@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Interested in participating in the study
Gestational age 12-16 weeks
Having reading and writing skills
Single pregnancy
over weight pre-BMI&gt; 25 or obese pre-BMI&gt; 30
Age ≥ 25 years
Having a family history of type 2 diabetes in first-degree relatives
Having a history of gestational diabetes or glucose intolerance in previous pregnancies
Having a neonatal birth weight &gt; 4000 grams
Having a baby prematurely or losing a baby during the previous pregnancy</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having Type 2 Diabetes / Thyroid Disease / Cardiovascular Disease / Respiratory Disease
Having a history of taking drugs that affect blood sugar level, such as corticosteroid medications
Absence of active participation in class / training sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O24.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus arising in pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: A general questionnaire and a physical activity questionnaire, a three-days food record and a researcher-made questionnaire based on the HBM model with subscales of; awareness,  perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy and guidance for action before and after three-months  will be collected .The education sessions is based on the dietary glycemic index of food items and their glycemic load and its effect on the maternal blood glucose, prevalence of gestational diabetes mellitus and its complications for mother and fetus, and prevention of gestational diabetes. At the end of the three-months intervention period, a face-to-face session,  the HBM questionnaire, three-day food record  and physical activity questionnaire will be collected.</i_keyword>
      <i_keyword>Control group: Pregnant women in the control group receive routine pregnancy training and care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood glucose. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Serum sample.</prim_outcome>
      <prim_outcome>Blood Glucose Level One hour, two hours after giving 75 grams of glucose. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Serum sample.</prim_outcome>
      <prim_outcome>Fasting Insulin serum. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Serum sample.</prim_outcome>
      <prim_outcome>Hs CRP measurement. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Serum sample.</prim_outcome>
      <prim_outcome>Health belief model variables (awareness, sensitivity, severity, perceived benefits and barriers and self-efficacy). Timepoint: Before the intervention and three months after the intervention. Method of measurement: Health Belief Model Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body Mass Index (BMI) measurements. Timepoint: Before intervention and three months after the intervention. Method of measurement: weight in kilograms (kg) by their height in meters (m) squared.</sec_outcome>
      <sec_outcome>Measuring maternal weight gain. Timepoint: Before intervention and three months after the intervention. Method of measurement: digital scale.</sec_outcome>
      <sec_outcome>Measure physical activity. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Physical activity questionnaire.</sec_outcome>
      <sec_outcome>Measurement of triglyceride levels. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Serum sample.</sec_outcome>
      <sec_outcome>Total cholesterol level measurements. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Serum sample.</sec_outcome>
      <sec_outcome>Measuring LDL and HDL cholesterol. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Serum sample.</sec_outcome>
      <sec_outcome>Insulin Sensitivity. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Formula based.</sec_outcome>
      <sec_outcome>Insulin resistance. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Formula based.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-10</approval_date>
        <contact_name>Ethics committee of Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Golestan Highway, Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
