<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/NCT03242174</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 2017-036</org_study_id>
    <nct_id>NCT03242174</nct_id>
  </id_info>
  <brief_title>Health Behaviors in Pregnancy</brief_title>
  <official_title>Health Behaviors in Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pennington Biomedical Research Center</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>
      To assess health and lifestyle behavior of pregnant women in Baton Rouge including women&#xD;
      receiving traditional obstetrical prenatal care and delivering in a hospital and those&#xD;
      receiving prenatal care from a midwife and delivering at the birth center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is of scientific interest to learn what the health and lifestyle behaviors are for women&#xD;
      receiving prenatal care in a non-traditional birth center and the impact of these behaviors&#xD;
      on pregnancy and birth outcomes.Participants will be offered a questionnaire packet to&#xD;
      complete at a prenatal appointment in the third trimester of pregnancy by their obstetrical&#xD;
      prenatal care provider. The questionnaire packet will take approximately 10-15 minutes to&#xD;
      complete.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Eating Habits</measure>
    <time_frame>1 Day</time_frame>
    <description>Eating Habits assessed by Eating Habits Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eating Habits</measure>
    <time_frame>1 Day</time_frame>
    <description>Eating Habits assessed by Rapid Eating Assessment for Participants-Shortened Version</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mindful Eating</measure>
    <time_frame>1 Day</time_frame>
    <description>Mindful Eating assessed by Mindful Eating Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>1 Day</time_frame>
    <description>Physical Activity assessed by Nurses Health Study II Physical Activity Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Weighing</measure>
    <time_frame>1 Day</time_frame>
    <description>Frequency of Weighing by Frequency of Weighing Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sedentary Behavior</measure>
    <time_frame>1 Day</time_frame>
    <description>Sedentary Behavior by Sedentary Behavior Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional health and well-being</measure>
    <time_frame>1 Day</time_frame>
    <description>Quality of life measure that assesses functional health and well-being from the participant's point of view by 12 Item Short Form Health Survey by RAND</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Habits</measure>
    <time_frame>1 Day</time_frame>
    <description>Sleep Habits by Sleep Questionnaire</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Prenatal Care Late</condition>
  <condition>Pregnancy Related</condition>
  <condition>Lifestyle</condition>
  <arm_group>
    <arm_group_label>Traditional Obstetrical Prenatal Care</arm_group_label>
    <description>Pregnant women receiving traditional obstetrical prenatal care and delivering in a hospital will be offered the Health Behavior questionnaire packet at third trimester prenatal appointment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prenatal Care from Midwife</arm_group_label>
    <description>Pregnant women receiving prenatal care from a midwife and delivering at the birth center will be offered the Health Behavior questionnaire packet at third trimester prenatal appointment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health Behavior Questionnaire Packet</intervention_name>
    <description>Any pregnant woman offered the questionnaire at her prenatal appointment in the third trimester can complete</description>
    <arm_group_label>Prenatal Care from Midwife</arm_group_label>
    <arm_group_label>Traditional Obstetrical Prenatal Care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women in the third trimester of pregnancy ≥ 28 weeks GA will be offered the&#xD;
        opportunity to participate in this study at the time of a prenatal appointment ≥ 28 weeks&#xD;
        GA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women in the third trimester of pregnancy ≥ 28 weeks GA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leanne M Redman, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Abby D. Altazan, M.S.</last_name>
    <phone>2257632801</phone>
    <email>abby.duhe@pbrc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abby D Altazan, M.S.</last_name>
      <phone>225-763-2801</phone>
      <email>abby.duhe@pbrc.edu</email>
    </contact>
    <investigator>
      <last_name>Leanne M Redman, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Leanne Redman</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03242174
org study id: PBRC 2017-036
nct id: NCT03242174
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess health and lifestyle behavior of pregnant women in Baton Rouge including women
      receiving traditional obstetrical prenatal care and delivering in a hospital and those
      receiving prenatal care from a midwife and delivering at the birth center.
It is of scientific interest to learn what the health and lifestyle behaviors are for women
      receiving prenatal care in a non-traditional birth center and the impact of these behaviors
      on pregnancy and birth outcomes.Participants will be offered a questionnaire packet to
      complete at a prenatal appointment in the third trimester of pregnancy by their obstetrical
      prenatal care provider. The questionnaire packet will take approximately 10-15 minutes to
      complete.
observational model: Ecologic or Community
time perspective: Retrospective
measure: Eating Habits
time frame: 1 Day
description: Eating Habits assessed by Eating Habits Questionnaire
measure: Eating Habits
time frame: 1 Day
description: Eating Habits assessed by Rapid Eating Assessment for Participants-Shortened Version
measure: Mindful Eating
time frame: 1 Day
description: Mindful Eating assessed by Mindful Eating Questionnaire
measure: Physical Activity
time frame: 1 Day
description: Physical Activity assessed by Nurses Health Study II Physical Activity Questionnaire
measure: Frequency of Weighing
time frame: 1 Day
description: Frequency of Weighing by Frequency of Weighing Questionnaire
measure: Sedentary Behavior
time frame: 1 Day
description: Sedentary Behavior by Sedentary Behavior Questionnaire
measure: Functional health and well-being
time frame: 1 Day
description: Quality of life measure that assesses functional health and well-being from the participant's point of view by 12 Item Short Form Health Survey by RAND
measure: Sleep Habits
time frame: 1 Day
description: Sleep Habits by Sleep Questionnaire
arm group label: Traditional Obstetrical Prenatal Care
description: Pregnant women receiving traditional obstetrical prenatal care and delivering in a hospital will be offered the Health Behavior questionnaire packet at third trimester prenatal appointment
arm group label: Prenatal Care from Midwife
description: Pregnant women receiving prenatal care from a midwife and delivering at the birth center will be offered the Health Behavior questionnaire packet at third trimester prenatal appointment
intervention type: Other
intervention name: Health Behavior Questionnaire Packet
description: Any pregnant woman offered the questionnaire at her prenatal appointment in the third trimester can complete
arm group label: Prenatal Care from Midwife
arm group label: Traditional Obstetrical Prenatal Care
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Leanne M Redman, Ph.D.
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
last name: Abby D. Altazan, M.S.
phone: 2257632801
email: abby.duhe@pbrc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Leanne Redman
investigator title: Principal Investigator
sharing ipd: No