<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/NCT03239054</url>
  </required_header>
  <id_info>
    <org_study_id>28028</org_study_id>
    <nct_id>NCT03239054</nct_id>
  </id_info>
  <brief_title>Prescribing Exercise as Medicine in Pregnancy</brief_title>
  <official_title>Prescribing Exercise as Medicine in Pregnancy: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</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>
      This study is a randomized controlled parallel arms trial. The purpose of this study is to&#xD;
      evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized controlled parallel arms trial. The purpose of this study is to&#xD;
      evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.&#xD;
      Once screened and consented, participants will be randomized to either the intervention or&#xD;
      control group in a 1:1 fashion. The intervention group will receive the PARMED-X prescription&#xD;
      and the control group will receive routine care as usual. Physical activity will be monitored&#xD;
      with a Polar fitness tracking device.&#xD;
&#xD;
      Maternal and neonatal outcomes will be collected from the electronic medical record. Maternal&#xD;
      outcomes include demographics, total gestational weight gain, pre-pregnancy body mass index&#xD;
      (BMI), BMI at the time of delivery, mode of delivery, glucose screen value, presence or&#xD;
      absence of gestational diabetes and presence or absence of hypertensive disorders of&#xD;
      pregnancy. Neonatal outcomes include gestational age at delivery, birth weight, Apgar scores,&#xD;
      arterial cord blood gases.&#xD;
&#xD;
      Psychological outcomes will also be assessed using several validated scales in pregnancy&#xD;
      including The Edinburgh Postnatal Depression Scale (EPDS) and The State Trait Anxiety&#xD;
      Inventory (STAI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    IRB issues&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2020</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>
    <intervention_model_description>participants will be randomized in a 1:1 fashion into the study group or the control group.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PARmed-X: Change in number of steps (physical activity level)</measure>
    <time_frame>1 year</time_frame>
    <description>change in number of steps (physical activity level)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PARMed-X: Gestational Weight Gain</measure>
    <time_frame>1 year</time_frame>
    <description>Gestational Weight Gain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the study group will complete the Parmed-X Pregnancy form and be provided with a prescription for exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control group will be provided with the ACOG Pamphlet entitled &quot;Exercise during pregnancy&quot; and will be encouraged to become physically active during their pregnancy. They will receive routine care as scheduled.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical activity</intervention_name>
    <description>pregnancy prescription for physical activity as part of prenatal care can increase healthy exercise behaviors during pregnancy</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Information will be given as part of standard care</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 45 years of age&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Gestational age at or less than 20 0/7 weeks at the time of enrollment&#xD;
&#xD;
          -  Low risk pregnancy&#xD;
&#xD;
          -  Willing and able to participate in a more active lifestyle/exercise program&#xD;
&#xD;
          -  Smart phone able to add the &quot;Flow mobile app&quot;.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Twins or higher order multiple gestations&#xD;
&#xD;
          -  Known congenital anomaly&#xD;
&#xD;
          -  Underweight BMI ( BMI less than 18.50)&#xD;
&#xD;
          -  High risk pregnancy - ie. hypertension, pre-existing diabetes&#xD;
&#xD;
          -  Women with a known contraindication to exercise&#xD;
&#xD;
          -  Persistent 2nd or 3rd trimester vaginal bleeding&#xD;
&#xD;
          -  Hemodynamically significant heart disease&#xD;
&#xD;
          -  Restrictive lung disease&#xD;
&#xD;
          -  Incompetent cervix or cerclage&#xD;
&#xD;
          -  Placenta previa&#xD;
&#xD;
          -  Premature labor or rupture of membranes&#xD;
&#xD;
          -  Preeclampsia&#xD;
&#xD;
          -  Severe anemia&#xD;
&#xD;
          -  Poorly controlled hypertension, seizure disorder, or hyperthyroidism&#xD;
&#xD;
          -  Known intrauterine growth restriction&#xD;
&#xD;
          -  Not cleared for exercise by the &quot;Contraindications to Exercise from PARMED-X&quot; form&#xD;
&#xD;
          -  PAVS score greater than or equal to 150 minutes/week&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shilpa Babbar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Mary's Health Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>July 31, 2018</last_update_submitted>
  <last_update_submitted_qc>July 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Shilpa Babbar, MD</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/NCT03239054
org study id: 28028
nct id: NCT03239054
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a randomized controlled parallel arms trial. The purpose of this study is to
      evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.
This study is a randomized controlled parallel arms trial. The purpose of this study is to
      evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.
      Once screened and consented, participants will be randomized to either the intervention or
      control group in a 1:1 fashion. The intervention group will receive the PARMED-X prescription
      and the control group will receive routine care as usual. Physical activity will be monitored
      with a Polar fitness tracking device.

      Maternal and neonatal outcomes will be collected from the electronic medical record. Maternal
      outcomes include demographics, total gestational weight gain, pre-pregnancy body mass index
      (BMI), BMI at the time of delivery, mode of delivery, glucose screen value, presence or
      absence of gestational diabetes and presence or absence of hypertensive disorders of
      pregnancy. Neonatal outcomes include gestational age at delivery, birth weight, Apgar scores,
      arterial cord blood gases.

      Psychological outcomes will also be assessed using several validated scales in pregnancy
      including The Edinburgh Postnatal Depression Scale (EPDS) and The State Trait Anxiety
      Inventory (STAI).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: participants will be randomized in a 1:1 fashion into the study group or the control group.
primary purpose: Prevention
masking: None (Open Label)
measure: PARmed-X: Change in number of steps (physical activity level)
time frame: 1 year
description: change in number of steps (physical activity level)
measure: PARMed-X: Gestational Weight Gain
time frame: 1 year
description: Gestational Weight Gain
arm group label: Study Group
arm group type: Experimental
description: Participants in the study group will complete the Parmed-X Pregnancy form and be provided with a prescription for exercise.
arm group label: Control Group
arm group type: Other
description: The control group will be provided with the ACOG Pamphlet entitled "Exercise during pregnancy" and will be encouraged to become physically active during their pregnancy. They will receive routine care as scheduled.
intervention type: Behavioral
intervention name: Physical activity
description: pregnancy prescription for physical activity as part of prenatal care can increase healthy exercise behaviors during pregnancy
arm group label: Study Group
intervention type: Behavioral
intervention name: Control group
description: Information will be given as part of standard care
arm group label: Control Group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Shilpa Babbar, MD
role: Principal Investigator
affiliation: St. Louis University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Shilpa Babbar, MD
investigator title: Principal Investigator
sharing ipd: No