<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/NCT01713712</url>
  </required_header>
  <id_info>
    <org_study_id>11-070</org_study_id>
    <nct_id>NCT01713712</nct_id>
  </id_info>
  <brief_title>Access to Nutritional Services and the Effect on Maternal Weight Gain</brief_title>
  <official_title>Ease of Access to Nutritional Services and the Effect on Maternal Weight in an Obese Urban Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abington Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abington Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of access to nutrition services on&#xD;
      pregnancy outcomes in the obese urban population. There are many studies that have shown that&#xD;
      obesity has a negative impact on pregnancy. However, currently there are only a few small&#xD;
      studies that specifically look at ease of access to nutrition services in an obese urban&#xD;
      population and the effect this has on maternal weight gain and pregnancy outcomes. This study&#xD;
      will compare two groups of pregnant women with a BMI of 30 or greater. The investigators&#xD;
      hypothesize that access to nutritional services will lead to decreased weight gain during&#xD;
      pregnancy and improved pregnancy outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the effect of access to nutrition services on&#xD;
      pregnancy outcomes in the obese urban population. Approximately one fourth of women in the&#xD;
      United States are overweight and nearly one third are considered to be obese. Pregnancy&#xD;
      places obese women at increased risk for several adverse events in the antepartum,&#xD;
      intrapartum, and postpartum period. There are many studies that have shown that obesity in&#xD;
      pregnancy has a negative impact on pregnancy. However, currently there are few studies in the&#xD;
      United States that specifically look at ease of access to nutrition services in an obese&#xD;
      urban population and the effect this has on pregnancy outcomes. This study will be a&#xD;
      randomized controlled study that will compare two groups of pregnant women with a BMI of 30&#xD;
      or greater one of which has access to nutritional services along with routine prenatal care&#xD;
      while the other gets only routine prenatal care. The investigators hypothesize that the obese&#xD;
      parturient who has access to nutritional services will have decreased weight gain during&#xD;
      pregnancy and ultimately have improved pregnancy outcomes. This will help to guide future&#xD;
      care for the obese parturient in the urban population who may have limited access to&#xD;
      services.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">February 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight gain</measure>
    <time_frame>one year</time_frame>
    <description>change in weight from baseline prepregnancy weight</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Birth weight</measure>
    <time_frame>40 weeks</time_frame>
    <description>Weight of infant at the time of birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal anomalies</measure>
    <time_frame>40 weeks</time_frame>
    <description>Ultrasound findings of fetal anomalies or those detected at birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertensive disease of pregnancy</measure>
    <time_frame>40 weeks</time_frame>
    <description>Development of hypertensive disease during pregnancy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational diabetes</measure>
    <time_frame>40 weeks</time_frame>
    <description>Development of gestational diabetes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal intensive care admission</measure>
    <time_frame>28 days</time_frame>
    <description>Admission to neonatal intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APGAR scores</measure>
    <time_frame>At birth</time_frame>
    <description>Measurement at birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>40 weeks</time_frame>
    <description>vaginal delivery or cesarean section</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intrauterine Fetal Demise</measure>
    <time_frame>40 weeks</time_frame>
    <description>Death of fetus prior to delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Death</measure>
    <time_frame>28 days</time_frame>
    <description>Death of neonate from birth to 28 days of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Pregnancy</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Routine Obstetric Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutritional Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive an initial 90 minute nutritional consult followed by 60 minute follow up consults every 2 weeks to monitor weight gain and nutritional status.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutritional Counseling</intervention_name>
    <description>Patients will keep a daily diary of nutritional intake as well as physical activity. They will also follow up with the nutritional counselor six weeks postpartum.</description>
    <arm_group_label>Nutritional Counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primigravid women&#xD;
&#xD;
          -  age 19-40yrs&#xD;
&#xD;
          -  less than or equal to 18 weeks gestation at time of enrollment&#xD;
&#xD;
          -  body mass index (BMI) greater than or equal to 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiparous women&#xD;
&#xD;
          -  less than 19 yrs of age or older than 40&#xD;
&#xD;
          -  greater than 18 weeks gestation at time of enrollment&#xD;
&#xD;
          -  body mass index (BMI) less than 30&#xD;
&#xD;
          -  any significant past medical history including hypertension, diabetes, renal disease,&#xD;
             coagulopathy&#xD;
&#xD;
          -  past surgical history of gastric bypass/weight loss surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erin M Murphy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abington Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bethany Perry, MD</last_name>
    <role>Study Director</role>
    <affiliation>Abington Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Erin M Murphy, MD</last_name>
    <phone>215-481-4211</phone>
    <email>emmurphy@amh.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bethany Perry, MD</last_name>
    <phone>215-481-4211</phone>
    <email>bperry@amh.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Abington Memorial Hospital</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin M Murphy, MD</last_name>
      <phone>215-481-4020</phone>
      <email>emmurphy@amh.org</email>
    </contact>
    <contact_backup>
      <last_name>Bethany Perry, MD</last_name>
      <phone>215-481-4020</phone>
      <email>bperry@amh.org</email>
    </contact_backup>
    <investigator>
      <last_name>Erin M Murphy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bethany Perry, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Abington Memorial Hospital</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Erin M Murphy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bethany Perry, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>April 18, 2013</last_update_submitted>
  <last_update_submitted_qc>April 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 22, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Abington Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Erin M. Murphy, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Obesity</keyword>
  <keyword>Nutrition therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT01713712
org study id: 11-070
nct id: NCT01713712
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the effect of access to nutrition services on
      pregnancy outcomes in the obese urban population. There are many studies that have shown that
      obesity has a negative impact on pregnancy. However, currently there are only a few small
      studies that specifically look at ease of access to nutrition services in an obese urban
      population and the effect this has on maternal weight gain and pregnancy outcomes. This study
      will compare two groups of pregnant women with a BMI of 30 or greater. The investigators
      hypothesize that access to nutritional services will lead to decreased weight gain during
      pregnancy and improved pregnancy outcomes.
The purpose of this study is to evaluate the effect of access to nutrition services on
      pregnancy outcomes in the obese urban population. Approximately one fourth of women in the
      United States are overweight and nearly one third are considered to be obese. Pregnancy
      places obese women at increased risk for several adverse events in the antepartum,
      intrapartum, and postpartum period. There are many studies that have shown that obesity in
      pregnancy has a negative impact on pregnancy. However, currently there are few studies in the
      United States that specifically look at ease of access to nutrition services in an obese
      urban population and the effect this has on pregnancy outcomes. This study will be a
      randomized controlled study that will compare two groups of pregnant women with a BMI of 30
      or greater one of which has access to nutritional services along with routine prenatal care
      while the other gets only routine prenatal care. The investigators hypothesize that the obese
      parturient who has access to nutritional services will have decreased weight gain during
      pregnancy and ultimately have improved pregnancy outcomes. This will help to guide future
      care for the obese parturient in the urban population who may have limited access to
      services.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight gain
time frame: one year
description: change in weight from baseline prepregnancy weight
measure: Birth weight
time frame: 40 weeks
description: Weight of infant at the time of birth
measure: Fetal anomalies
time frame: 40 weeks
description: Ultrasound findings of fetal anomalies or those detected at birth
measure: Hypertensive disease of pregnancy
time frame: 40 weeks
description: Development of hypertensive disease during pregnancy
measure: Gestational diabetes
time frame: 40 weeks
description: Development of gestational diabetes
measure: Neonatal intensive care admission
time frame: 28 days
description: Admission to neonatal intensive care unit
measure: APGAR scores
time frame: At birth
description: Measurement at birth
measure: Mode of delivery
time frame: 40 weeks
description: vaginal delivery or cesarean section
measure: Intrauterine Fetal Demise
time frame: 40 weeks
description: Death of fetus prior to delivery
measure: Neonatal Death
time frame: 28 days
description: Death of neonate from birth to 28 days of life
arm group label: Routine Obstetric Care
arm group type: No Intervention
arm group label: Nutritional Counseling
arm group type: Experimental
description: Patients will receive an initial 90 minute nutritional consult followed by 60 minute follow up consults every 2 weeks to monitor weight gain and nutritional status.
intervention type: Behavioral
intervention name: Nutritional Counseling
description: Patients will keep a daily diary of nutritional intake as well as physical activity. They will also follow up with the nutritional counselor six weeks postpartum.
arm group label: Nutritional Counseling
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: No
last name: Erin M Murphy, MD
role: Principal Investigator
affiliation: Abington Memorial Hospital
last name: Bethany Perry, MD
role: Study Director
affiliation: Abington Memorial Hospital
last name: Erin M Murphy, MD
phone: 215-481-4211
email: emmurphy@amh.org
last name: Bethany Perry, MD
phone: 215-481-4211
email: bperry@amh.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Abington Memorial Hospital
investigator full name: Erin M. Murphy, MD
investigator title: Principal Investigator
mesh term: Obesity