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Gestational DiabetesNCT04406792

Mobilizing Doulas to Empower Black Women in Post-partum Diabetes Prevention

A study testing DPP only and Diabetes Prevention Program (DPP) online + doula divas in people with Gestational Diabetes and Type2 Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Gestational Diabetes, Type2 Diabetes
What is being tested?
DPP only and Diabetes Prevention Program (DPP) online + doula divas
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
31 Jan 2025to Jan 2028
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >18 years of age with English fluency
  • recently post-partum
  • clinical diagnosis of Gestational Diabetes Mellitus (GDM) using Carpenter Coustan criteria
  • access to smart phone technology Self identified Black race

Who cannot join

  • <18 years Preexisting type 2 diabetes
  • Inability to follow up Non-black race

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Mobilizing Doulas to Empower Black Women in Post-partum Diabetes Prevention, a Randomized Controlled Trial

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).

Read more

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.

Read the detailed description
  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.

Being tested
DPP only, Diabetes Prevention Program (DPP) online + doula divas
Keywords
Black women, Minority women, Postpartum
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DPP onlyBehavioural

    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.

  • Diabetes Prevention Program (DPP) online + doula divasBehavioural

    Participation in the DPP online intervention with doula divas as team leaders.

Study groups in NCT04406792
Study groupRoleWhat they receive
DPP+doula divasExperimentalEnrolled 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.
Receives: Behavioral: Diabetes Prevention Program (DPP) online + doula divas
DPP onlyActive comparatorOnline 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.
Receives: Behavioral: DPP only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants with gestational diabetes that complete the recommended screening for Type 2 Diabetes Mellitus (T2DM)

    Participants diagnosed with Gestational Diabetes receive the T2DM screening is a 75 gram 2-hour glucose tolerance test

    Measured: Between 6 to 12 weeks post-partum

Secondary outcomes (1)
  1. Participants with gestational diabetes who develop T2DM

    Participants diagnosed with Gestational Diabetes receive the T2DM screening is a 75 gram 2-hour glucose tolerance test

    Measured: 2 years post-partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2020
  2. Study start31 Jan 2025 (estimated)
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completionJan 2028 (estimated)

Why it stopped: Feasibility limitations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
1. 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. 2. Online DPP+ Doula divas: Online DPP where a doula diva leads the teams.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04406792
Sponsor's protocol ID
201903
Other IDs
5K01HL140278-02
Status last verified
Aug 2025
First submitted
22 May 2020
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing DPP only and Diabetes Prevention Program (DPP) online + doula divas in people with Gestational Diabetes and Type2 Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.

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