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DPP + Doula Support for Gestational Diabetes (ALIVE Trial)

N/A

Waitlist Available

Led By Rolanda Lister

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

clinical diagnosis of Gestational Diabetes Mellitus (GDM) using Carpenter Coustan criteria

18 years of age with English fluency

Must not have

Preexisting type 2 diabetes

Under 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post-partum

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of the Diabetes Prevention Program (DPP) with and without the addition of "doula divas" (community health workers) in reducing the rate of Type 2 Diabetes Mellitus (T2DM) in Black women with Gestational Diabetes Mellitus (GDM).

Who is the study for?

This trial is for Black women who are recently post-partum, diagnosed with gestational diabetes using Carpenter Coustan criteria, over 18 years old, fluent in English, and have access to smart phone technology. It excludes those under 18, non-Black race individuals, anyone unable to follow up or with preexisting type 2 diabetes.

What is being tested?

The study tests a standard Diabetes Prevention Program (DPP) online course against the same DPP course supplemented with support from 'doula divas'—trained community health workers—for one year. The goal is to see if adding doulas improves program completion rates and helps prevent Type 2 Diabetes in Black mothers after gestational diabetes.

What are the potential side effects?

Since this trial involves educational programs and support services rather than medical treatments or drugs, there are no direct side effects associated with the interventions being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with gestational diabetes.

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I am 18 or older and speak English fluently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have type 2 diabetes.

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I am younger than 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post-partum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post-partum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-partum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Participants with gestational diabetes who develop T2DM

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DPP+doula divasExperimental Treatment1 Intervention

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.

Group II: DPP onlyActive Control1 Intervention

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.

0 / 4Eligibility criteria met