<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/NCT04406792</url>
  </required_header>
  <id_info>
    <org_study_id>201903</org_study_id>
    <secondary_id>5K01HL140278-02</secondary_id>
    <nct_id>NCT04406792</nct_id>
  </id_info>
  <brief_title>Mobilizing Doulas to Empower Black Women in Post-partum Diabetes Prevention</brief_title>
  <official_title>Mobilizing Doulas to Empower Black Women in Post-partum Diabetes Prevention, a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Black and White mothers have similar prevalence of gestational diabetes mellitus (GDM).&#xD;
      However Black mothers are more likely to develop Type 2 Diabetes Mellitus (T2DM) after a&#xD;
      diagnosis of GDM. Both GDM and Type 2 diabetes mellitus (T2DM) increase her cardiovascular&#xD;
      risk. The post-partum period is an ideal time to employ preventative strategies to alter her&#xD;
      lifetime health-course. Unfortunately, Black mothers are less likely to follow up post-partum&#xD;
      and less likely to be informed of the connection between pregnancy complications such as GDM&#xD;
      and cardiovascular risks.&#xD;
&#xD;
      The Diabetes Prevention Program (DPP) is the &quot;gold standard&quot; for lifestyle intervention to&#xD;
      prevent T2DM in at risk patients. From the original trial of over 1,000 racially heterogenous&#xD;
      participants, the DPP underperformed in Black women and can be improved upon. The&#xD;
      investigators propose a randomized controlled trial entitled: Mobilizing doulas to empower&#xD;
      black women in post-partum diabetes prevention. This program will follow the Diabetes&#xD;
      Prevention Program (DPP) curriculum as outlined by the CDC using an online platform. However,&#xD;
      this program will expand on the DPP's educational program and provide trained community-based&#xD;
      health care workers i.e., &quot;doulas divas&quot; to administer post-partum support while the&#xD;
      participants matriculate through the online DPP. Participants will be randomized to either&#xD;
      DPP only for one year or DPP + doula divas for one year).&#xD;
&#xD;
      The investigators hypothesize that for Black participants with GDM, DPP+ doula divas program&#xD;
      will have a completion rate superior to that of the DPP alone.&#xD;
&#xD;
      The investigators propose this randomized controlled clinical trial utilizing institution and&#xD;
      community partnerships to increase the rates of completion of post-partum diabetes prevention&#xD;
      program in at risk women: Black women with GDM. The investigators also will implement this&#xD;
      culturally responsive approach with the goal of reducing T2DM in Black women. Our discoveries&#xD;
      will be a forward leap in the quest to reduce cardiovascular risk contributed by GDM and T2DM&#xD;
      that lead to maternal morbidity and mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. SPECIFIC AIMS Racial disparities in progression to type 2 diabetes mellitus from&#xD;
      gestational diabetes Black and white mothers have a similar prevalence of Gestational&#xD;
      Diabetes Mellitus (GDM). However, Black women are more likely to progress to Type 2 Diabetes&#xD;
      Mellitus (T2DM) after a GDM compared to White women. The postpartum period is a window of&#xD;
      opportunity to transform the women's health trajectory. Unfortunately, Black women are less&#xD;
      likely to follow up postpartum due to perceived racism and deep mistrust of the medical&#xD;
      system. However, forming allies with professionals that are trusted members of the patient's&#xD;
      community and can serve as a liaison to build rapport and adherence to preventative health.&#xD;
      Community-based doulas generally live in the same area in which they serve. They provide&#xD;
      emotional and physical support for a family from pregnancy through the first few months of&#xD;
      the postpartum period. Doula support during pregnancy has been linked to reduced cesarean&#xD;
      births a reduction of preterm birth, and increased breastfeeding. Unfortunately, while Black&#xD;
      women prefer doula support, they do not have ready access to them as desired. Expanding doula&#xD;
      training to include motivational interviewing for at-risk patients will enable doulas to&#xD;
      provide mothers with postpartum mother/baby support and accountability as they navigate the&#xD;
      diabetes prevention program.&#xD;
&#xD;
      Diabetes Prevention Program (DPP) The DPP was a landmark multicenter randomized&#xD;
      placebo-controlled trial racially inclusive of 1,079 participants at risk of T2DM. It&#xD;
      investigated the effects of a lifestyle intervention in participants who had significant risk&#xD;
      factors for developing T2DM. The endpoint was a diagnosis of T2DM with a median follow-up of&#xD;
      2.8 years. Participants in the active arm had a 58% reduction in the diagnosis of T2DM. While&#xD;
      the DPP is an effective evidence-based intervention, it is underutilized in real-world&#xD;
      scenarios. For example, in a United States-based survey of 50,912 insured respondents who&#xD;
      either had a formal diagnosis of pre-diabetes or had an elevated American Diabetes&#xD;
      Association (ADA) risk score (&gt;5), less than one percent of respondents indicated that their&#xD;
      doctor referred them to a formal Diabetes Prevention Program. In addition, at Vanderbilt, the&#xD;
      postpartum workflow for patients who have been treated for GDM does not include referral to&#xD;
      any type of Diabetes Prevention Program post-delivery.&#xD;
&#xD;
      Telehealth visits are a viable option for the delivery of healthcare. The current pandemic of&#xD;
      Covid-19 has led to the rapid adoption of telehealth during pregnancy and the postpartum&#xD;
      period. At Vanderbilt, we successfully employed telehealth to deliver pre and postpartum&#xD;
      care, resulting in similar access to pregnancy and postpartum care as compared to in person&#xD;
      visits. We have an opportunity to apply a more personalized approach to delivering a&#xD;
      lifestyle intervention via telehealth that is tailored to recently postpartum Black women who&#xD;
      have a significantly higher risk of T2DM by having GDM. We hypothesize that the Healthiby&#xD;
      Diabetes Prevention Program + Doula Divas will result in a greater completion rate than women&#xD;
      who receive a Healthiby diabetes prevention program without doulas. We will test our&#xD;
      hypothesis using the following aims:&#xD;
&#xD;
      Aim 1: To train postpartum doulas from Homeland Heart Nashville Birth Collective (HH) with&#xD;
      aspects of motivational interviewing techniques sufficient to enable a new mother to navigate&#xD;
      the Healthiby DPP. To test the hypothesis that it is feasible to train community doulas from&#xD;
      HH, we will leverage our existing relationships with our community partner-Homeland Heart and&#xD;
      Healthiby, to train additional doulas (up to 20) in motivational interviewing necessary for&#xD;
      the Healthiby Diabetes Prevention Program platform. We hypothesize that it is feasible to&#xD;
      train doulas to become champions in guiding a recently postpartum black mother with&#xD;
      gestational diabetes through this year-long program.&#xD;
&#xD;
      Aim 2: To compare the CDC-approved Healthiby (DPP only) with a doula enhanced (DPP+doula&#xD;
      divas) guided diabetes prevention program. To test the hypothesis that Healthiby's DPP+doula&#xD;
      diva is more effective for program completion than Healthiby DPP alone, we will randomize 100&#xD;
      participants between the CDC-approved online DPP (Healthiby) program and DPP (Healthiby+doula&#xD;
      divas). We will measure rates of completion defined by the CDC whereby, participants must&#xD;
      attend at least eight sessions in months one through six and stay in the program for at least&#xD;
      nine months.&#xD;
&#xD;
      Our team is well situated to carry out this research and will build on the momentum from our&#xD;
      community-engaged research program pilot grant. We have relationships with HH, and Healthiby.&#xD;
      Our purpose is to partner with community-based doulas to coach new Black mothers with a&#xD;
      history of gestational diabetes through an online Diabetes Prevention Program. Our intended&#xD;
      impact is to reduce the long-term burden of T2DM in at-risk Black mothers. This proposal is&#xD;
      responsive in integrating community doulas in preventing maternal morbidity in this&#xD;
      vulnerable population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 31, 2024</start_date>
  <completion_date type="Anticipated">January 2028</completion_date>
  <primary_completion_date type="Anticipated">January 2025</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>Online DPP only: Participants will not be led by a &quot;doula diva;&quot; they will merely be in small groups led by the dietitian and lifestyle coach. Group members will consist of all people at risk for T2DM.&#xD;
Online DPP+ Doula divas: Online DPP where a doula diva leads the teams.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The participant and the outcome assessor will be masked to the allocation groups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Participants with gestational diabetes that complete the recommended screening for Type 2 Diabetes Mellitus (T2DM)</measure>
    <time_frame>Between 6 to 12 weeks post-partum</time_frame>
    <description>Participants diagnosed with Gestational Diabetes receive the T2DM screening is a 75 gram 2-hour glucose tolerance test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participants with gestational diabetes who develop T2DM</measure>
    <time_frame>2 years post-partum</time_frame>
    <description>Participants diagnosed with Gestational Diabetes receive the T2DM screening is a 75 gram 2-hour glucose tolerance test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Gestational Diabetes</condition>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>DPP+doula divas</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled participants will have access to an online DPP with other Black post-partum mothers who have had GDM. The teams will be led by doula divas trained in aspects of motivational interviewing and trained on the Healthiby platform.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DPP only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Online DPP only support without doula as team lead. The participants will be in groups with a diverse group of patients that are non-mothers but who are at risk of type 2 diabetes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DPP only</intervention_name>
    <description>Participation in the online DPP only with a mixed group of participants at risk for type 2 diabetes and doula divas are not the team leaders.</description>
    <arm_group_label>DPP only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diabetes Prevention Program (DPP) online + doula divas</intervention_name>
    <description>Participation in the DPP online intervention with doula divas as team leaders.</description>
    <arm_group_label>DPP+doula divas</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years of age with English fluency&#xD;
&#xD;
          -  recently post-partum&#xD;
&#xD;
          -  clinical diagnosis of Gestational Diabetes Mellitus (GDM) using Carpenter Coustan&#xD;
             criteria&#xD;
&#xD;
          -  access to smart phone technology Self identified Black race&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        &lt;18 years Preexisting type 2 diabetes&#xD;
&#xD;
        • Inability to follow up Non-black race&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rolanda Lister</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rolanda Lister, MD</last_name>
    <phone>6153435700</phone>
    <email>rolanda.l.lister@vumc.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Rolanda Lister</investigator_full_name>
    <investigator_title>Assistant Professor, Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <keyword>Black women</keyword>
  <keyword>Minority women</keyword>
  <keyword>Postpartum</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <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/NCT04406792
org study id: 201903
secondary id: 5K01HL140278-02
nct id: NCT04406792
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Black and White mothers have similar prevalence of gestational diabetes mellitus (GDM).
      However Black mothers are more likely to develop Type 2 Diabetes Mellitus (T2DM) after a
      diagnosis of GDM. Both GDM and Type 2 diabetes mellitus (T2DM) increase her cardiovascular
      risk. The post-partum period is an ideal time to employ preventative strategies to alter her
      lifetime health-course. Unfortunately, Black mothers are less likely to follow up post-partum
      and less likely to be informed of the connection between pregnancy complications such as GDM
      and cardiovascular risks.

      The Diabetes Prevention Program (DPP) is the "gold standard" for lifestyle intervention to
      prevent T2DM in at risk patients. From the original trial of over 1,000 racially heterogenous
      participants, the DPP underperformed in Black women and can be improved upon. The
      investigators propose a randomized controlled trial entitled: Mobilizing doulas to empower
      black women in post-partum diabetes prevention. This program will follow the Diabetes
      Prevention Program (DPP) curriculum as outlined by the CDC using an online platform. However,
      this program will expand on the DPP's educational program and provide trained community-based
      health care workers i.e., "doulas divas" to administer post-partum support while the
      participants matriculate through the online DPP. Participants will be randomized to either
      DPP only for one year or DPP + doula divas for one year).

      The investigators hypothesize that for Black participants with GDM, DPP+ doula divas program
      will have a completion rate superior to that of the DPP alone.

      The investigators propose this randomized controlled clinical trial utilizing institution and
      community partnerships to increase the rates of completion of post-partum diabetes prevention
      program in at risk women: Black women with GDM. The investigators also will implement this
      culturally responsive approach with the goal of reducing T2DM in Black women. Our discoveries
      will be a forward leap in the quest to reduce cardiovascular risk contributed by GDM and T2DM
      that lead to maternal morbidity and mortality.
1. SPECIFIC AIMS Racial disparities in progression to type 2 diabetes mellitus from
      gestational diabetes Black and white mothers have a similar prevalence of Gestational
      Diabetes Mellitus (GDM). However, Black women are more likely to progress to Type 2 Diabetes
      Mellitus (T2DM) after a GDM compared to White women. The postpartum period is a window of
      opportunity to transform the women's health trajectory. Unfortunately, Black women are less
      likely to follow up postpartum due to perceived racism and deep mistrust of the medical
      system. However, forming allies with professionals that are trusted members of the patient's
      community and can serve as a liaison to build rapport and adherence to preventative health.
      Community-based doulas generally live in the same area in which they serve. They provide
      emotional and physical support for a family from pregnancy through the first few months of
      the postpartum period. Doula support during pregnancy has been linked to reduced cesarean
      births a reduction of preterm birth, and increased breastfeeding. Unfortunately, while Black
      women prefer doula support, they do not have ready access to them as desired. Expanding doula
      training to include motivational interviewing for at-risk patients will enable doulas to
      provide mothers with postpartum mother/baby support and accountability as they navigate the
      diabetes prevention program.

      Diabetes Prevention Program (DPP) The DPP was a landmark multicenter randomized
      placebo-controlled trial racially inclusive of 1,079 participants at risk of T2DM. It
      investigated the effects of a lifestyle intervention in participants who had significant risk
      factors for developing T2DM. The endpoint was a diagnosis of T2DM with a median follow-up of
      2.8 years. Participants in the active arm had a 58% reduction in the diagnosis of T2DM. While
      the DPP is an effective evidence-based intervention, it is underutilized in real-world
      scenarios. For example, in a United States-based survey of 50,912 insured respondents who
      either had a formal diagnosis of pre-diabetes or had an elevated American Diabetes
      Association (ADA) risk score (>5), less than one percent of respondents indicated that their
      doctor referred them to a formal Diabetes Prevention Program. In addition, at Vanderbilt, the
      postpartum workflow for patients who have been treated for GDM does not include referral to
      any type of Diabetes Prevention Program post-delivery.

      Telehealth visits are a viable option for the delivery of healthcare. The current pandemic of
      Covid-19 has led to the rapid adoption of telehealth during pregnancy and the postpartum
      period. At Vanderbilt, we successfully employed telehealth to deliver pre and postpartum
      care, resulting in similar access to pregnancy and postpartum care as compared to in person
      visits. We have an opportunity to apply a more personalized approach to delivering a
      lifestyle intervention via telehealth that is tailored to recently postpartum Black women who
      have a significantly higher risk of T2DM by having GDM. We hypothesize that the Healthiby
      Diabetes Prevention Program + Doula Divas will result in a greater completion rate than women
      who receive a Healthiby diabetes prevention program without doulas. We will test our
      hypothesis using the following aims:

      Aim 1: To train postpartum doulas from Homeland Heart Nashville Birth Collective (HH) with
      aspects of motivational interviewing techniques sufficient to enable a new mother to navigate
      the Healthiby DPP. To test the hypothesis that it is feasible to train community doulas from
      HH, we will leverage our existing relationships with our community partner-Homeland Heart and
      Healthiby, to train additional doulas (up to 20) in motivational interviewing necessary for
      the Healthiby Diabetes Prevention Program platform. We hypothesize that it is feasible to
      train doulas to become champions in guiding a recently postpartum black mother with
      gestational diabetes through this year-long program.

      Aim 2: To compare the CDC-approved Healthiby (DPP only) with a doula enhanced (DPP+doula
      divas) guided diabetes prevention program. To test the hypothesis that Healthiby's DPP+doula
      diva is more effective for program completion than Healthiby DPP alone, we will randomize 100
      participants between the CDC-approved online DPP (Healthiby) program and DPP (Healthiby+doula
      divas). We will measure rates of completion defined by the CDC whereby, participants must
      attend at least eight sessions in months one through six and stay in the program for at least
      nine months.

      Our team is well situated to carry out this research and will build on the momentum from our
      community-engaged research program pilot grant. We have relationships with HH, and Healthiby.
      Our purpose is to partner with community-based doulas to coach new Black mothers with a
      history of gestational diabetes through an online Diabetes Prevention Program. Our intended
      impact is to reduce the long-term burden of T2DM in at-risk Black mothers. This proposal is
      responsive in integrating community doulas in preventing maternal morbidity in this
      vulnerable population.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Online DPP only: Participants will not be led by a "doula diva;" they will merely be in small groups led by the dietitian and lifestyle coach. Group members will consist of all people at risk for T2DM.
Online DPP+ Doula divas: Online DPP where a doula diva leads the teams.
primary purpose: Screening
masking: Double (Participant, Outcomes Assessor)
masking description: The participant and the outcome assessor will be masked to the allocation groups.
measure: Participants with gestational diabetes that complete the recommended screening for Type 2 Diabetes Mellitus (T2DM)
time frame: Between 6 to 12 weeks post-partum
description: Participants diagnosed with Gestational Diabetes receive the T2DM screening is a 75 gram 2-hour glucose tolerance test
measure: Participants with gestational diabetes who develop T2DM
time frame: 2 years post-partum
description: Participants diagnosed with Gestational Diabetes receive the T2DM screening is a 75 gram 2-hour glucose tolerance test
arm group label: DPP+doula divas
arm group type: Experimental
description: Enrolled participants will have access to an online DPP with other Black post-partum mothers who have had GDM. The teams will be led by doula divas trained in aspects of motivational interviewing and trained on the Healthiby platform.
arm group label: DPP only
arm group type: Active Comparator
description: Online DPP only support without doula as team lead. The participants will be in groups with a diverse group of patients that are non-mothers but who are at risk of type 2 diabetes.
intervention type: Behavioral
intervention name: DPP only
description: Participation in the online DPP only with a mixed group of participants at risk for type 2 diabetes and doula divas are not the team leaders.
arm group label: DPP only
intervention type: Behavioral
intervention name: Diabetes Prevention Program (DPP) online + doula divas
description: Participation in the DPP online intervention with doula divas as team leaders.
arm group label: DPP+doula divas
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rolanda Lister
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Rolanda Lister, MD
phone: 6153435700
email: rolanda.l.lister@vumc.org
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Rolanda Lister
investigator title: Assistant Professor, Obstetrics and Gynecology
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
sharing ipd: No