DPP + Doula Support for Gestational Diabetes

(ALIVE Trial)

Overseen By Rolanda Lister, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Preexisting type 2 diabetes, Non-black race, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Black mothers who experienced gestational diabetes (GDM) during pregnancy reduce their risk of developing Type 2 diabetes (T2DM) after childbirth. It compares two groups: one follows an online Diabetes Prevention Program (DPP), while the other follows the same program with additional support from trained doulas, who are supportive companions during childbirth and postpartum. The researchers aim to determine if the extra support increases program completion, potentially lowering the risk of diabetes and related heart problems. The trial seeks recently postpartum Black women who had GDM and can use a smartphone. As an unphased trial, it offers participants a unique opportunity to contribute to research that could improve postpartum care and diabetes prevention for Black mothers.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Diabetes Prevention Program (DPP) is generally safe for people at risk of type 2 diabetes. Studies have found that this program, which emphasizes lifestyle changes like diet and exercise, can reduce the risk of developing type 2 diabetes by 58% over three years. No major safety concerns have been reported.

Specific safety data for the version of the program that includes doula support is not yet available. However, doulas are trained community workers who provide support, and this is not typically associated with safety risks. Adding doulas aims to enhance support and outcomes, particularly for Black mothers who have experienced gestational diabetes (a type of diabetes that can occur during pregnancy).

Overall, both versions of the DPP—online with or without doula support—are expected to be well-tolerated based on previous experiences with the DPP alone. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for gestational diabetes because they offer a unique approach by combining the Diabetes Prevention Program (DPP) with specialized support from doula divas. Unlike traditional treatments that might focus solely on medication or generalized lifestyle changes, this approach provides online support specifically tailored for Black post-partum mothers who have experienced gestational diabetes. The involvement of doula divas, trained in motivational interviewing and using the Healthiby platform, offers personalized guidance and peer support, which is not typically part of standard diabetes care. This personalized, culturally relevant support could offer more effective and sustainable diabetes prevention for this group.

What evidence suggests that the DPP + doula divas program could be effective for Black mothers with gestational diabetes?

Research has shown that the Diabetes Prevention Program (DPP) can reduce the risk of developing type 2 diabetes by 58% over three years for at-risk individuals. This includes those with a history of gestational diabetes, who can greatly benefit from the lifestyle changes encouraged by the program. In this trial, participants will be assigned to different treatment arms. One arm will receive the DPP only, focusing on younger women from diverse backgrounds who have had gestational diabetes, which has resulted in better attendance and more weight loss compared to other groups. Another arm will include the "DPP+doula divas," where Black mothers receive extra support from doula divas. This personalized help aims to enhance the program's effectiveness, as studies suggest it can improve participation and outcomes in health programs. ^{1 4 6 7 8}

Who Is on the Research Team?

Rolanda Lister

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with gestational diabetes.

You have given birth recently.

You have a smartphone.

Exclusion Criteria

You are not able to attend follow-up appointments.

You are not of black race.

I have type 2 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are enrolled in the Diabetes Prevention Program (DPP) with or without doula support for one year

12 months

Telehealth visits as needed

Follow-up

Participants are monitored for completion of the DPP and screened for Type 2 Diabetes Mellitus (T2DM)

6 to 12 weeks post-partum

Screening visit for T2DM

Long-term Follow-up

Participants are monitored for the development of T2DM

2 years post-partum

What Are the Treatments Tested in This Trial?

Interventions

• Alternative Lifestyle Interventions in Vulnerable Ethnic groups
• Diabetes Prevention Program (DPP) online
• Diabetes Prevention Program (DPP) online + doula divas
• DPP only
• Standard of Care

Trial Overview 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.

How Is the Trial Designed?

Group I: DPP+doula divas Experimental Treatment 1 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 only Active Control 1 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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The Diabetes Prevention Program (DPP) can reduce the incidence of diabetes by 58% over three years for individuals with prediabetes, yet most patients are unaware of their condition.

With Medicare coverage starting in 2018, the DPP has become more accessible for patients over 65, highlighting the need for healthcare providers to implement screening and referral processes for prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. Jasik, CB., Joy, E., Brunisholz, KD., et al.[2019]

In a modified Diabetes Prevention Program (DPP) for patients with non-alcoholic fatty liver disease (NAFLD), 79% of participants completed the program, leading to significant weight loss and improvements in liver health indicators over 12 months.

Key improvements included reduced hepatic steatosis and liver enzymes, indicating enhanced liver function, although there was a noted increase in low-density lipoprotein levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. Hershman, M., Torbjornsen, K., Pang, D., et al.[2023]

The Diabetes Prevention Program (DPP) effectively identified high-risk adults for type 2 diabetes, with 27% of participants showing impaired glucose tolerance and 13% having previously undiagnosed diabetes based on oral glucose tolerance tests (OGTT).

Fasting capillary glucose levels, along with age and BMI, significantly improved the screening process for high-risk individuals across various ethnic groups, suggesting it can enhance the efficiency of diabetes prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to identify adults at high risk for type 2 diabetes: the Diabetes Prevention Program. [2021]

The Veterans Affairs Diabetes Prevention Program (VA-DPP) showed higher fidelity in delivery compared to the usual MOVE! program, indicating it may be more effectively implemented in clinical settings.

Participant satisfaction was generally higher in the VA-DPP, suggesting that this program not only has better implementation but also resonates more positively with participants, which is crucial for long-term success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation findings from a hybrid III implementation-effectiveness trial of the Diabetes Prevention Program (DPP) in the Veterans Health Administration (VHA). Damschroder, LJ., Reardon, CM., AuYoung, M., et al.[2022]

In a study of 163 patients with prediabetes, those who received text message support alongside invitations to Diabetes Prevention Program (DPP) classes lost an average of 2.6 pounds, compared to only 0.6 pounds in the control group, indicating that text support can enhance weight loss efforts.

The intervention group also had a higher percentage of participants achieving a 3% weight loss (38.5%) compared to the control group (21.5%), suggesting that text message support is effective in promoting weight loss in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Message Support for Weight Loss in Patients With Prediabetes: A Randomized Clinical Trial. Fischer, HH., Fischer, IP., Pereira, RI., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04406792

Mobilizing Doulas to Empower Black Women in Post ... 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 ...

2. withpower.com withpower.com/trial/dpp-doula-support-for-gestational-diabetes-3618b

DPP + Doula Support for Gestational Diabetes (ALIVE Trial) The Diabetes Prevention Program (DPP) is a proven lifestyle change program that reduces the risk of developing type 2 diabetes by 58% over three years. It has ...

3. coveragetoolkit.org coveragetoolkit.org/health-equity/gestational-diabetes/

People with Gestational Diabetes The National DPP lifestyle change program can benefit individuals with a history of gestational diabetes by greatly reducing the risk of developing type 2 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36918133/

Effectiveness of the National Diabetes Prevention Program ... Conclusions: Diverse younger women with previous gestational diabetes attending the NDPP had one third greater attendance and twice as much weight loss as other ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4399293/

The Diabetes Prevention Program Outcomes Study 10 ... In the initial 3-year intervention period of the DPP, women with a history of GDM had a 71% higher risk of development of diabetes compared with parous women ...

6. diabetesjournals.org diabetesjournals.org/care/article/48/7/1101/158195/The-Diabetes-Prevention-Program-and-Its-Outcomes

NIDDK's Journey Into the Prevention of Type 2 Diabetes and ... After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379723001307

Effectiveness of the National Diabetes Prevention Program ... Younger women with previous gestational diabetes represented <4% (n=107) of participants. There was no significant difference in the frequency ...

8. diabetes.org diabetes.org/newsroom/new-data-from-diabetes-prevention-program-outcomes-study-shows-persistent-reduction-of-t2d-development-over-22-year-average-follow-up

New Data from Diabetes Prevention Program Outcomes ... The DPP demonstrated lifestyle intervention, aimed at achieving weight loss, and metformin treatment reduced the risk of T2D development by 58% and 31%, ...