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

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. 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.

Conditions

• Gestational Diabetes
• Type2 Diabetes

Interventions

BEHAVIORAL

DPP only

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.

BEHAVIORAL

Diabetes Prevention Program (DPP) online + doula divas

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Rolanda Lister · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-31

Primary Completion

2026-01-01

Completion

2028-01-31

Countries

• United States

Study Locations