<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03767699</url>
  </required_header>
  <id_info>
    <org_study_id>2013-12-239</org_study_id>
    <secondary_id>D43TW009135</secondary_id>
    <nct_id>NCT03767699</nct_id>
  </id_info>
  <brief_title>Medical Nutrition Therapy Program and Eating Behavior Questionnaires on Gestational Weight Gain</brief_title>
  <official_title>Medical Nutrition Therapy Program and Eating Behavior Questionnaires on Gestational Weight Gain in Mexican Women With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hugo Mendieta Zeron</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fogarty International Center of the National Institute of Health</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Nacional de Salud Publica, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Materno-Perinatal Hospital of the State of Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Type 2 Diabetes Mellitus (T2DM) and Gestational Diabetes Mellitus (GDM) create complications&#xD;
      during pregnancy, particularly in women with gestational weight gain (GWG) that falls over&#xD;
      the recommended limit. On the other hand Medical nutrition therapy (MNT) has been shown to&#xD;
      reduce some complications in women with T2DM and GDM. The aim of this project was to assess&#xD;
      the association of MNT consultations and eating behavior with GWG in Mexican women with T2DM&#xD;
      and GDM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This cross-sectional study conducted at from 2013 to 2014. Fifty seven patients with T2DM or&#xD;
      GDM were invited to participate. The dependent variable was GWG and the main independent&#xD;
      variables were MNT and eating behaviors. Data were obtained from medical records or&#xD;
      interviews. Multiple linear regression models were used to assess associations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2013</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Gestational Weight Gain</measure>
    <time_frame>Nine months</time_frame>
    <description>Weight (kg) was measured using a weight scale (SECA 711). GWG was calculated by subtracting the prepregnancy weight from the weight at the end of the third trimester (kg). Recommended GWG was based on U.S. Institute of Medicine guidelines.</description>
  </primary_outcome>
  <enrollment type="Actual">57</enrollment>
  <condition>Gestational Weight Gain</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Medical Nutrition Therapy</intervention_name>
    <description>MNT was offered every 2-4 weeks to all pregnant women with T2DM and GDM. Women. MNT is offered as a mandatory part of their prenatal visit and/or hospital stay. The MNT provides an individual food plan with the following recommendations: total calories should be calculated as 30 kcal/kg based on pregestational BMI for an ideal weight. Of the total energy intake 40-45% is provided by carbohydrates, a maximum of 40% is provided by lipids and the remaining percentage by proteins providing moderate-to-low glycemic index foods and fiber consumption, glucose self-monitoring, participating in 15-30 min of daily physical activity after prior authorization of the treating physician, and meeting the minimal energy requirements of pregnancy (never &lt; 1,500 kcal).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women with T2DM or GDM who received as a routine management the Medical Nutrition&#xD;
        Therapy. The characteristics of the pregnant women usually attended at the&#xD;
        Maternal-Perinatal Hospital &quot;Mónica Pretelini Sáenz&quot; are: low socioecomic status and&#xD;
        education, they all receive free medical attention.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who had given birth and with known T2DM.&#xD;
&#xD;
          -  Women who had given birth and with GDM diagnosed during pregnancy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with multiple pregnancies.&#xD;
&#xD;
          -  Women with type 1 diabetes mellitus.&#xD;
&#xD;
          -  Women with glucose intolerance.&#xD;
&#xD;
          -  Women with chronic diseases.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adriana Garduño Alanís, PhD.</last_name>
    <role>Study Chair</role>
    <affiliation>Independent researcher.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Materno-Perinatal Hospital &quot;Mónica Pretelini&quot;</name>
      <address>
        <city>Toluca</city>
        <zip>50130</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Horosz E, Bomba-Opon DA, Szymanska M, Wielgos M. Maternal weight gain in women with gestational diabetes mellitus. J Perinat Med. 2013 Sep 1;41(5):523-8. doi: 10.1515/jpm-2012-0254.</citation>
    <PMID>23492551</PMID>
  </reference>
  <reference>
    <citation>Perichart-Perera O, Balas-Nakash M, Parra-Covarrubias A, Rodriguez-Cano A, Ramirez-Torres A, Ortega-Gonzalez C, Vadillo-Ortega F. A medical nutrition therapy program improves perinatal outcomes in Mexican pregnant women with gestational diabetes and type 2 diabetes mellitus. Diabetes Educ. 2009 Nov-Dec;35(6):1004-13. doi: 10.1177/0145721709343125. Epub 2009 Aug 20.</citation>
    <PMID>19696205</PMID>
  </reference>
  <reference>
    <citation>Balas-Nakash M, Rodriguez-Cano A, Munoz-Manrique C, Vasquez-Pena P, Perichart-Perera O. [Adherence to a medical nutrition therapy program in pregnant women with diabetes, measured by three methods, and its association with glycemic control]. Rev Invest Clin. 2010 May-Jun;62(3):235-43. Spanish.</citation>
    <PMID>20815129</PMID>
  </reference>
  <reference>
    <citation>Jaakkola J, Hakala P, Isolauri E, Poussa T, Laitinen K. Eating behavior influences diet, weight, and central obesity in women after pregnancy. Nutrition. 2013 Oct;29(10):1209-13. doi: 10.1016/j.nut.2013.03.008. Epub 2013 Jun 22.</citation>
    <PMID>23800568</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Materno-Perinatal Hospital of the State of Mexico</investigator_affiliation>
    <investigator_full_name>Hugo Mendieta Zeron</investigator_full_name>
    <investigator_title>Chief of the Research Department</investigator_title>
  </responsible_party>
  <keyword>Medical nutrition therapy</keyword>
  <keyword>Eating behavior</keyword>
  <keyword>Type 2 diabetes mellitus</keyword>
  <keyword>Gestational Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Gain</mesh_term>
    <mesh_term>Gestational Weight Gain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Information will be available upon request.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03767699
org study id: 2013-12-239
secondary id: D43TW009135
nct id: NCT03767699
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Type 2 Diabetes Mellitus (T2DM) and Gestational Diabetes Mellitus (GDM) create complications
      during pregnancy, particularly in women with gestational weight gain (GWG) that falls over
      the recommended limit. On the other hand Medical nutrition therapy (MNT) has been shown to
      reduce some complications in women with T2DM and GDM. The aim of this project was to assess
      the association of MNT consultations and eating behavior with GWG in Mexican women with T2DM
      and GDM.
This cross-sectional study conducted at from 2013 to 2014. Fifty seven patients with T2DM or
      GDM were invited to participate. The dependent variable was GWG and the main independent
      variables were MNT and eating behaviors. Data were obtained from medical records or
      interviews. Multiple linear regression models were used to assess associations.
observational model: Cohort
time perspective: Prospective
measure: Gestational Weight Gain
time frame: Nine months
description: Weight (kg) was measured using a weight scale (SECA 711). GWG was calculated by subtracting the prepregnancy weight from the weight at the end of the third trimester (kg). Recommended GWG was based on U.S. Institute of Medicine guidelines.
intervention type: Behavioral
intervention name: Medical Nutrition Therapy
description: MNT was offered every 2-4 weeks to all pregnant women with T2DM and GDM. Women. MNT is offered as a mandatory part of their prenatal visit and/or hospital stay. The MNT provides an individual food plan with the following recommendations: total calories should be calculated as 30 kcal/kg based on pregestational BMI for an ideal weight. Of the total energy intake 40-45% is provided by carbohydrates, a maximum of 40% is provided by lipids and the remaining percentage by proteins providing moderate-to-low glycemic index foods and fiber consumption, glucose self-monitoring, participating in 15-30 min of daily physical activity after prior authorization of the treating physician, and meeting the minimal energy requirements of pregnancy (never < 1,500 kcal).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adriana Garduño Alanís, PhD.
role: Study Chair
affiliation: Independent researcher.
facility: 
country: Mexico
citation: Horosz E, Bomba-Opon DA, Szymanska M, Wielgos M. Maternal weight gain in women with gestational diabetes mellitus. J Perinat Med. 2013 Sep 1;41(5):523-8. doi: 10.1515/jpm-2012-0254.
PMID: 23492551
citation: Perichart-Perera O, Balas-Nakash M, Parra-Covarrubias A, Rodriguez-Cano A, Ramirez-Torres A, Ortega-Gonzalez C, Vadillo-Ortega F. A medical nutrition therapy program improves perinatal outcomes in Mexican pregnant women with gestational diabetes and type 2 diabetes mellitus. Diabetes Educ. 2009 Nov-Dec;35(6):1004-13. doi: 10.1177/0145721709343125. Epub 2009 Aug 20.
PMID: 19696205
citation: Balas-Nakash M, Rodriguez-Cano A, Munoz-Manrique C, Vasquez-Pena P, Perichart-Perera O. [Adherence to a medical nutrition therapy program in pregnant women with diabetes, measured by three methods, and its association with glycemic control]. Rev Invest Clin. 2010 May-Jun;62(3):235-43. Spanish.
PMID: 20815129
citation: Jaakkola J, Hakala P, Isolauri E, Poussa T, Laitinen K. Eating behavior influences diet, weight, and central obesity in women after pregnancy. Nutrition. 2013 Oct;29(10):1209-13. doi: 10.1016/j.nut.2013.03.008. Epub 2013 Jun 22.
PMID: 23800568
responsible party type: Sponsor-Investigator
investigator affiliation: Materno-Perinatal Hospital of the State of Mexico
investigator full name: Hugo Mendieta Zeron
investigator title: Chief of the Research Department
mesh term: Body Weight
mesh term: Weight Gain
mesh term: Gestational Weight Gain
sharing ipd: Undecided
ipd description: Information will be available upon request.