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

NCT04406792 | Withdrawn DMC

• 2 other identifiers: 2019035K01HL140278-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Black women; Minority women; Postpartum

Outcome Measures

Primary Outcomes (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

  Between 6 to 12 weeks post-partum

Secondary Outcomes (1)

• Participants with gestational diabetes who develop T2DM

  2 years post-partum

Study Arms (2)

DPP+doula divas

EXPERIMENTAL

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.

Behavioral: Diabetes Prevention Program (DPP) online + doula divas

DPP only

ACTIVE COMPARATOR

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.

Behavioral: DPP only

Interventions

DPP only BEHAVIORAL

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.

DPP only

Diabetes Prevention Program (DPP) online + doula divas BEHAVIORAL

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

DPP+doula divas

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

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Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rolanda Lister

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and the outcome assessor will be masked to the allocation groups.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Obstetrics and Gynecology

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: January 31, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)