<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/NCT02233673</url>
  </required_header>
  <id_info>
    <org_study_id>13-276</org_study_id>
    <nct_id>NCT02233673</nct_id>
  </id_info>
  <brief_title>Incentives Targeting Gestational Weight Gain in Overweight/Obese Low Income Women</brief_title>
  <official_title>Incentives Targeting Gestational Weight Gain in Overweight/Obese Low Income Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of General Medical Sciences (NIGMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Vermont</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Excessive weight gain during pregnancy, particularly in overweight and obese women,&#xD;
      predisposes to adverse perinatal outcomes and has long term effects on maternal and neonatal&#xD;
      health. With an inverse relationship between socioeconomic status and obesity, significant&#xD;
      health disparities exist between obese and normal weight women. The Institute of Medicine&#xD;
      (IOM) recently revised its gestational weight gain recommendations, targeted to pregravid&#xD;
      body mass index (BMI), to minimize pregnancy complications. However, these recommendations&#xD;
      are based on cross sectional observational studies and neither the ideal method to achieve&#xD;
      weight gain goals nor whether perinatal outcome is optimized with active management of weight&#xD;
      gain is known. The investigators propose to investigate a behavioral incentive-based&#xD;
      intervention to improve compliance with IOM weight gain recommendations during pregnancy in&#xD;
      low-income overweight and obese women. The investigators will evaluate if 1) gestational&#xD;
      weight gain can be reliably targeted to the IOM recommendations and 2) active weight gain&#xD;
      management during pregnancy improves perinatal outcomes. Two study groups will be compared in&#xD;
      a prospective randomized trial; 1) those receiving standard obstetrical care and 2) those&#xD;
      receiving behavioral weight management counseling plus financial incentives for achieving&#xD;
      weight gain goals. The main outcome measure will be the percentage of women gaining within&#xD;
      the IOM recommendations based on prepregnancy BMI. Secondary outcomes evaluated will include&#xD;
      fetal growth and body composition changes, birth weight and the rate of cesarean delivery.&#xD;
      The investigators hypothesize that 1) the behavioral intervention with incentives will result&#xD;
      in greater compliance to IOM guidelines for gestational weight gain than standard care and 2)&#xD;
      targeting weight gain to the IOM guidelines will lead to a reduction in the rates of fetal&#xD;
      macrosomia and cesarean delivery. Finally, cost effectiveness of treatment conditions will be&#xD;
      examined. This intervention, if efficacious and cost-effective, has the potential to improve&#xD;
      compliance with gestational weight gain guidelines, optimize perinatal outcomes, and reduce&#xD;
      health disparities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">August 28, 2017</completion_date>
  <primary_completion_date type="Actual">August 28, 2017</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>Gestational weight gain within the Institute of Medicine guidelines</measure>
    <time_frame>At time of delivery</time_frame>
    <description>Total gestational weight gain at time of last prenatal visit. For participants in the intervention arm, gestational weight gain at 2 week intervals will also be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cesarean delivery rate</measure>
    <time_frame>Time of delivery</time_frame>
    <description>Cesarean delivery rate (as a percent of total deliveries) will be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal macrosomia</measure>
    <time_frame>At delivery</time_frame>
    <description>Fetal weight at delivery will be recorded. Percent fetal macrosomia (birthweight &gt;4000g) will be assessed.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost of intervention</measure>
    <time_frame>Intake to 6 weeks postpartum</time_frame>
    <description>Costs to the patient attending the intervention (transportation, childcare, missed wages) will be calculated against cost differences in outcomes.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Behavioral, incentives</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive behavioral intervention and financial incentives for meeting gestational weight gain goals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants receive standard obstetrical care from their provider</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Financial incentives</intervention_name>
    <description>Participants receive a behavioral intervention and financial incentives for meeting gestational weight gain goals.</description>
    <arm_group_label>Behavioral, incentives</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -≥18 years of age and ≤ 45 years of age&#xD;
&#xD;
        -≤16 weeks gestation&#xD;
&#xD;
          -  BMI ≥25&#xD;
&#xD;
          -  Ultrasound documented viable singleton intrauterine pregnancy&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Planning to deliver at Fletcher Allen Health Care&#xD;
&#xD;
          -  Willing to be randomized to one of the study groups&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major fetal congenital or chromosomal anomaly&#xD;
&#xD;
          -  Women with a restricted diet (i.e., celiac disease, prior bariatric surgery,&#xD;
             Phenylketonuria, or other metabolic disorder)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Vermont</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont</investigator_affiliation>
    <investigator_full_name>Julie Phillips</investigator_full_name>
    <investigator_title>Project Director</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Weight Gain</mesh_term>
    <mesh_term>Gestational Weight Gain</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/NCT02233673
org study id: 13-276
nct id: NCT02233673
lead sponsor: 
collaborator: 
has dmc: No
Excessive weight gain during pregnancy, particularly in overweight and obese women,
      predisposes to adverse perinatal outcomes and has long term effects on maternal and neonatal
      health. With an inverse relationship between socioeconomic status and obesity, significant
      health disparities exist between obese and normal weight women. The Institute of Medicine
      (IOM) recently revised its gestational weight gain recommendations, targeted to pregravid
      body mass index (BMI), to minimize pregnancy complications. However, these recommendations
      are based on cross sectional observational studies and neither the ideal method to achieve
      weight gain goals nor whether perinatal outcome is optimized with active management of weight
      gain is known. The investigators propose to investigate a behavioral incentive-based
      intervention to improve compliance with IOM weight gain recommendations during pregnancy in
      low-income overweight and obese women. The investigators will evaluate if 1) gestational
      weight gain can be reliably targeted to the IOM recommendations and 2) active weight gain
      management during pregnancy improves perinatal outcomes. Two study groups will be compared in
      a prospective randomized trial; 1) those receiving standard obstetrical care and 2) those
      receiving behavioral weight management counseling plus financial incentives for achieving
      weight gain goals. The main outcome measure will be the percentage of women gaining within
      the IOM recommendations based on prepregnancy BMI. Secondary outcomes evaluated will include
      fetal growth and body composition changes, birth weight and the rate of cesarean delivery.
      The investigators hypothesize that 1) the behavioral intervention with incentives will result
      in greater compliance to IOM guidelines for gestational weight gain than standard care and 2)
      targeting weight gain to the IOM guidelines will lead to a reduction in the rates of fetal
      macrosomia and cesarean delivery. Finally, cost effectiveness of treatment conditions will be
      examined. This intervention, if efficacious and cost-effective, has the potential to improve
      compliance with gestational weight gain guidelines, optimize perinatal outcomes, and reduce
      health disparities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Gestational weight gain within the Institute of Medicine guidelines
time frame: At time of delivery
description: Total gestational weight gain at time of last prenatal visit. For participants in the intervention arm, gestational weight gain at 2 week intervals will also be assessed.
measure: Cesarean delivery rate
time frame: Time of delivery
description: Cesarean delivery rate (as a percent of total deliveries) will be assessed
measure: Fetal macrosomia
time frame: At delivery
description: Fetal weight at delivery will be recorded. Percent fetal macrosomia (birthweight >4000g) will be assessed.
measure: Cost of intervention
time frame: Intake to 6 weeks postpartum
description: Costs to the patient attending the intervention (transportation, childcare, missed wages) will be calculated against cost differences in outcomes.
arm group label: Behavioral, incentives
arm group type: Experimental
description: Participants receive behavioral intervention and financial incentives for meeting gestational weight gain goals
arm group label: Standard care
arm group type: No Intervention
description: Participants receive standard obstetrical care from their provider
intervention type: Behavioral
intervention name: Financial incentives
description: Participants receive a behavioral intervention and financial incentives for meeting gestational weight gain goals.
arm group label: Behavioral, incentives
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Vermont
investigator full name: Julie Phillips
investigator title: Project Director
mesh term: Overweight
mesh term: Weight Gain
mesh term: Gestational Weight Gain