Mobilizing Doulas to Empower Black Women in Post-partum Diabetes Prevention
Key facts
- Who runs it
- Vanderbilt University Medical Center
- Where
- Nashville, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- 31 Jan 2025
- Expected to end
- Jan 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- DPP only
- Diabetes Prevention Program (DPP) online + doula divas
- Record updated
- 15 August 2025
- Why it stopped
- Feasibility limitations
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- >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 take part
- <18 years Preexisting type 2 diabetes
- Inability to follow up Non-black race
Where in United States
- Vanderbilt University Medical CenterNashville, United States
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- DPP+doula divasTreatment being tested
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.
Treatment: Diabetes Prevention Program (DPP) online + doula divas
- DPP onlyExisting treatment, for comparison
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Mobilizing Doulas to Empower Black Women in Post-partum Diabetes Prevention, a Randomized Controlled Trial
- Record updated
- 15 August 2025