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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment DPP + Doula Support for Gestational Diabetes?

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 been adapted for various conditions, suggesting potential benefits for gestational diabetes when combined with additional support like doula services. ^{1 2 3 4 5}

Is the Diabetes Prevention Program (DPP) safe for humans?

The Diabetes Prevention Program (DPP) is a well-established lifestyle intervention that has been used safely in various studies to reduce the risk of type 2 diabetes and improve health outcomes in conditions like non-alcoholic fatty liver disease. ^{1 2 4 5 6}

How does the DPP + Doula Support treatment for gestational diabetes differ from other treatments?

The DPP + Doula Support treatment is unique because it combines an online Diabetes Prevention Program (DPP) with support from doulas, who provide emotional and educational support during pregnancy. This approach is different from standard treatments that typically focus solely on medical management without the added personal support component. ^{7 8 9 10 11}

Research Team

Rolanda Lister

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: an update to the study protocol for a randomized controlled trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. England 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). [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Text Message Support for Weight Loss in Patients With Prediabetes: A Randomized Clinical Trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A systematic review with expert opinion on the role of gepants for the preventive and abortive treatment of migraine. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Topiramate vs divalproex sodium in the preventive treatment of migraine: a prospective "real-world" study. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of monoclonal antibodies targeting the CGRP pathway and gepants in migraine prevention: A systematic review and network meta-analysis. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Divalproex sodium in migraine prophylaxis: a dose-controlled study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Preventive pharmacologic treatments for episodic migraine in adults. [2023]