<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/NCT01719406</url>
  </required_header>
  <id_info>
    <org_study_id>eIRB # 8895</org_study_id>
    <nct_id>NCT01719406</nct_id>
  </id_info>
  <brief_title>The OHSU Pregnancy Exercise &amp; Nutrition (PEN) Program</brief_title>
  <acronym>PEN</acronym>
  <official_title>Randomized Control Pilot of a Behavior-based Exercise and Diet Intervention to Reduce Risk Factors for Gestational Diabetes Among Otherwise Healthy Pregnant Women.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Personal behaviors can influence development of Gestational Diabetes Mellitus (GDM), a&#xD;
      condition that can adversely affect the pregnant woman, her developing fetus and future&#xD;
      events for both. To reduce GDM risk, we will develop and implement an in-person team and&#xD;
      web-based nutrition and exercise program for women, beginning in their first trimester. A&#xD;
      scripted, peer-led, 20-week educational program, tailored for pregnant women working in teams&#xD;
      (5 women/team), will be developed and implemented among pregnant employees and/or their&#xD;
      spouses. Each weekly thirty minute session will focus on achieving 30-minutes of moderate&#xD;
      daily physical activity with nutrition targets of five servings of fruits and vegetables, 3&#xD;
      servings of whole grains and lower fat food choices. Diet, exercise and lab assessments will&#xD;
      occur before enrollment during the first trimester, each subsequent trimester and 12 weeks&#xD;
      after delivery. In addition to exercise and diet survey results, we will assess fasting&#xD;
      glucose, insulin, hemoglobin A1C levels, pregnancy weight gain, blood pressure, lipid and&#xD;
      lipoprotein levels, pedometer records, weekly accelerometer data, each trimester and at 12&#xD;
      weeks post delivery, as well as gestational birth age, Apgar score, delivery mode and infant&#xD;
      birth weight, and weekly health thermometer self-ratings during the assessment period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Achieving 30 minutes of daily exercise, four or more times each week</measure>
    <time_frame>32 weeks</time_frame>
    <description>Assessment of daily exercise (in minutes) during pregnancy and 12 weeks post pregnancy for the duration of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eating 5 or more servings of vegetables and/or fruits each day</measure>
    <time_frame>32 weeks of the study</time_frame>
    <description>Women will self-assess the number of servings of vegetables and fruits each day throughout the study.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pregnancy weight gain</measure>
    <time_frame>20 weeks</time_frame>
    <description>Assess pregnancy weight gain, in which excessive weight gain is a risk factor for gestational diabetes.</description>
  </other_outcome>
  <other_outcome>
    <measure>HemoglobinA1C</measure>
    <time_frame>Each trimester and 12-weeks post delivery</time_frame>
    <description>Assessing the average plasma glucose concentration over longer time periods.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>Intervention, behavioral lifestyle education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pregnant women will participate in 20 educational sessions designed to promote daily exercise, vegetable and fruit intake, maintain a diet that is relatively lower in fat and rich in whole grains.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard medical care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention, behavioral lifestyle education</intervention_name>
    <description>Twenty interactive weekly sessions that are scripted curriculum and peer led.</description>
    <arm_group_label>Intervention, behavioral lifestyle education</arm_group_label>
    <other_name>Lifestyle</other_name>
    <other_name>Nutrition</other_name>
    <other_name>Exercise</other_name>
    <other_name>Stress management</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Healthy first trimester pregnant women -&#xD;
&#xD;
        Exclusion Criteria: hypertension, diabetes, known cardiopulmonary disease; orthopedic&#xD;
        problems or other conditions that would prevent regular physical activity.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Linn Goldberg</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Gestational diabetes</keyword>
  <keyword>Exercise</keyword>
  <keyword>Diet</keyword>
  <keyword>Fruits</keyword>
  <keyword>Vegetables</keyword>
  <keyword>Whole grains</keyword>
  <keyword>pregnancy weight</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
  </condition_browse>
  <!-- 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/NCT01719406
org study id: eIRB # 8895
nct id: NCT01719406
lead sponsor: 
has dmc: No
Personal behaviors can influence development of Gestational Diabetes Mellitus (GDM), a
      condition that can adversely affect the pregnant woman, her developing fetus and future
      events for both. To reduce GDM risk, we will develop and implement an in-person team and
      web-based nutrition and exercise program for women, beginning in their first trimester. A
      scripted, peer-led, 20-week educational program, tailored for pregnant women working in teams
      (5 women/team), will be developed and implemented among pregnant employees and/or their
      spouses. Each weekly thirty minute session will focus on achieving 30-minutes of moderate
      daily physical activity with nutrition targets of five servings of fruits and vegetables, 3
      servings of whole grains and lower fat food choices. Diet, exercise and lab assessments will
      occur before enrollment during the first trimester, each subsequent trimester and 12 weeks
      after delivery. In addition to exercise and diet survey results, we will assess fasting
      glucose, insulin, hemoglobin A1C levels, pregnancy weight gain, blood pressure, lipid and
      lipoprotein levels, pedometer records, weekly accelerometer data, each trimester and at 12
      weeks post delivery, as well as gestational birth age, Apgar score, delivery mode and infant
      birth weight, and weekly health thermometer self-ratings during the assessment period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Achieving 30 minutes of daily exercise, four or more times each week
time frame: 32 weeks
description: Assessment of daily exercise (in minutes) during pregnancy and 12 weeks post pregnancy for the duration of the study.
measure: Eating 5 or more servings of vegetables and/or fruits each day
time frame: 32 weeks of the study
description: Women will self-assess the number of servings of vegetables and fruits each day throughout the study.
measure: Pregnancy weight gain
time frame: 20 weeks
description: Assess pregnancy weight gain, in which excessive weight gain is a risk factor for gestational diabetes.
measure: HemoglobinA1C
time frame: Each trimester and 12-weeks post delivery
description: Assessing the average plasma glucose concentration over longer time periods.
arm group label: Intervention, behavioral lifestyle education
arm group type: Experimental
description: Pregnant women will participate in 20 educational sessions designed to promote daily exercise, vegetable and fruit intake, maintain a diet that is relatively lower in fat and rich in whole grains.
arm group label: Control
arm group type: No Intervention
description: Standard medical care
intervention type: Behavioral
intervention name: Intervention, behavioral lifestyle education
description: Twenty interactive weekly sessions that are scripted curriculum and peer led.
arm group label: Intervention, behavioral lifestyle education
other name: Lifestyle
other name: Nutrition
other name: Exercise
other name: Stress management
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Linn Goldberg
investigator title: Professor of Medicine
mesh term: Diabetes, Gestational