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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post-partum
Awards & highlights
ALIVE Trial 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.Check my eligibility
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.See study design
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.
ALIVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with gestational diabetes.
Select...
I am 18 or older and speak English fluently.
ALIVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years post-partum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post-partum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Participants with gestational diabetes that complete the recommended screening for Type 2 Diabetes Mellitus (T2DM)
Secondary outcome measures
Participants with gestational diabetes who develop T2DM
ALIVE 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.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,132 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,832 Previous Clinical Trials
47,306,246 Total Patients Enrolled
Rolanda ListerPrincipal InvestigatorVanderbilt University Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not able to attend follow-up appointments.I have been diagnosed with gestational diabetes.I am 18 or older and speak English fluently.You have given birth recently.You have a smartphone.You identify as Black.You are not of black race.I have type 2 diabetes.I am younger than 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: DPP only
- Group 2: DPP+doula divas
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are medical professionals currently inviting individuals to join this research endeavor?
"Clinicaltrials.gov reveals that this medical study is no longer recruiting patients, with the initial post dated on January 31st 2023 and the most recent update from April 13th 2022. However, 2881 other trials are still actively looking for participants."
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