Alternative Lifestyle Interventions in Vulnerable Ethnic Groups

Overview

Black obese mothers are vulnerable to pregnancy complications such as gestational diabetes mellitus (GDM). This ultimately elevates her risk of Type 2 diabetes mellitus (T2DM) which increases her cardiovascular risk. The post-partum period or "fourth trimester" may be an ideal time to employ preventative strategies to alter her lifetime health-course. Unfortunately, black mothers are less likely to follow up post-partum, less likely to be screened for T2DM and less likely to be informed of the connection between pregnancy complications and cardiovascular risk.

The Diabetes Prevention Program (DPP) is the "gold standard" for lifestyle intervention to prevent T2DM in at risk patients. However, the DPP underperformed in Black women and can be improved upon. The investigators propose a randomized controlled double blind trial entitled: Alternative Lifestyle Interventions for the Prevention of Vulnerable Ethnic groups or ALIVE. The ALIVE 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 to administer post-partum support via telehealth for the first 12 weeks post-partum. Participants will be randomized to (1. Doula only x 12 weeks. 2. DPP only x 1 year or 3. ALIVE=doula+DPP). In order to understand the biology that accompanies GDMtoT2DM transition, the investigators will conduct concomitant, longitudinal assessment of DNA methylation patterns to identify differentially methylated genes important in the pathogenesis of T2DM.

The investigators hypothesize that for Black participants with GDM, ALIVE will reduce incidence of T2DM at two years and give biological insight into the susceptibility of developing Type 2 DM using genome wide epigenomic profiling

The investigators propose this randomized double blind controlled clinical trial utilizing institution and community partnerships to increase the rates of post-partum screening of T2DM in Black women with a pregnancy complicated with GDM. The investigators also will implement the ALIVE, a precision based approach to reduce and T2DM in Black women. The investigators will gain biologic insights by linking the epigenome to the clinical phenotypes. 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.

Full Title of Study: “Alternative Lifestyle Interventions in Vulnerable Ethnic Groups, a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 2023

Detailed Description

SPECIFIC AIMS Black and White mothers have similar prevalence of Gestational Diabetes Mellitus (GDM). However, Black mothers are more likely to progress to Type 2 Diabetes Mellitus (T2DM) and are less likely to be screened post-partum. Since GDM is a significant risk factor for T2DM, the post-partum period is a window of opportunity to change a mother's health course using preventative lifestyle medicine. Unfortunately, traditional post-partum care has failed to engage, screen, and employ prevention measures against the development of T2DM in Black mothers. Moreover, the fact that prevalence of GDM is similar in Blacks and Whites but differs in progression to T2DM raises the question about the epigenetic underpinnings as a biologic basis for GDM progressing to T2DM in Black women. GDM has been linked to epigenetic modifications in obesity genes such as low-density lipoprotein receptor-related protein 1B and leptin of infants and is a causal link to metabolic syndrome in her offspring. In our preliminary data, maternal hyperglycemia in mice led to an increase in placental mRNA expression of Angpt1 (endothelial gene) and Nr4a3 (pancreatic beta cell gene). While it is well established that GDM leads to abnormal metabolic programming in her offspring, the investigators do not know how the epigenome forecasts cardio-metabolic risks to her.

To address the disparities in screening and prevention of T2DM in at risk Black mothers while understanding the biologic basis for GDM to T2DM progression, the investigators propose Alternative Lifestyle Interventions for Vulnerable Ethnic Groups (ALIVE): A randomized controlled clinical trial that compares our precision-based lifestyle intervention to that of the traditional Diabetes Prevention Program (DPP) in post-partum Black mothers with a history of GDM. ALIVE will expand on the DPP by providing specially trained community-based health care workers (i.e doulas) to administer post-partum tele-health support for 12 weeks before the start of the DPP. In order to understand the biology that accompanies GDMtoT2DM transition, the investigators will conduct concomitant, longitudinal assessment of DNA methylation patterns to identify differentially methylated genes important in the pathogenesis of T2DM. The investigators hypothesize that for Black participants with GDM, ALIVE will increase screening adherence, reduce incidence of T2DM and give biological insight into the susceptibility of developing T2DM using DNA methylation profiling.

Aim 1: Increase adherence to post-partum screening recommendations for T2DM in individuals with pregnancies complicated by GDM.

The investigators hypothesize that deployment of doulas using telehealth visits in at risk participants post-partum will result in adherence to post-partum screening for T2DM.

A. Using evidenced based community engagement stakeholder strategies, the investigators will recruit recently post-partum (<4 weeks) Black women who experienced GDM during their pregnancy.

B. Using telehealth, the investigators will deploy specially trained community doulas from Homeland Heart Nashville Birth Collective to perform post-partum assessments, build healthy habits, and ensure completion of screening for T2DM with a 2-hour 75gram GTT by 12 weeks.

Aim 2: Reduce incidence of T2DM at two years in participants with history of GDM The investigators hypothesize that the ALIVE program will be superior to the CDC DPP (online) in reducing the incidence of T2DM at two years in participants with history of GDM.

A. The investigators will execute this randomized controlled double masked trial comparing three interventions: Doula only x 12 weeks, DPP online only x 1 year, or ALIVE (doula x 12 weeks +DPP online x 1 year).

B. The investigators will determine the prevalence of T2 DM in each group at two years.

Aim 3: Determine the epigenetic modifications that are associated with the progression of GDM to T2DM after two years.

The investigators hypothesize the GDMtoT2DM progression has an epigenetic signature that is distinct from GDM that does not progress to T2DM at two years and will give biological insights regarding susceptibility to T2DM in black mothers.

A. Blood drawn at the beginning and end of study will be banked at Vanderbilt. The phenotypes of interest are:(GDM progressing to T2DM) and (GDM not progressing to T2DM). The investigators will perform bisulphite sequencing to identify metabolic genes that are differentially methylated between phenotypes.

Impact: ALIVE is a precision based intervention with the goal of reducing T2DM in at risk black mothers with a history of GDM. It uses a novel, team-work approach to deliver post-partum care to a vulnerable population by empowering the mother to implement practices that will decrease her risk of T2DM. The investigators believe this study will also uncover epigenetic modifications that predispose Black women with a history of GDM to develop T2DM.

Interventions

  • Behavioral: Alternative Lifestyle Interventions in Vulnerable Ethnic groups
    • Participation in the ALIVE intervention
  • Behavioral: Diabetes Prevention Program (DPP) online
    • Participation in the DPP online intervention
  • Behavioral: Standard of Care
    • Standard of care

Arms, Groups and Cohorts

  • Experimental: ALIVE Program
    • Post-partum doulas for in home support and BP/glucose screening via telehealth visits after hospital discharge Weekly community sponsored agriculture (CSA) boxes/ gardening lessons by a local farmer and virtual culturally sensitive recipe demonstrations. Assess DNA methylation to identify differentially methylated genes important in the pathogenesis of Type 2 DM and chronic hypertension (CHTN)
  • Active Comparator: Diabetes Prevention Program (DPP) online
    • Diabetes Prevention Program (DPP) curriculum as outlined by the Centers for Disease Control and Prevention (CDC) using an online platform. Enrolled participants randomized to DPP only will be enrolled into the Fruit street program at www.fruitstreet.com for one year. As a member of Fruit street, they are provided with a wireless scale, a Fitbit activity tracker and have access to a video chat with a licensed dietitian and online support from other Fruit street participants. They will also sign a medical release and be followed 12 weeks post-partum up to 2 years to assess if they have completed recommended screening and whether or not they developed Type 2 DM or CHTN as defined above.
  • Other: Standard of Care
    • 1 week post-partum followup for blood pressure check and 6 weeks post-partum follow-up and screening for Type 2 DM CHTN.

Clinical Trial Outcome Measures

Primary Measures

  • Participants with gestational diabetes that complete the recommended screening for Type 2 Diabetes Mellitus (T2DM)
    • Time Frame: Between 6 to 12 weeks post-partum
    • Participants diagnosed with Gestational Diabetes receive the T2DM screening is a 75 gram 2-hour glucose tolerance test

Secondary Measures

  • Participants with gestational diabetes who develop T2DM
    • Time Frame: 2 years post-partum
    • Participants diagnosed with Gestational Diabetes receive the T2DM screening is a 75 gram 2-hour glucose tolerance test

Participating in This Clinical Trial

Inclusion Criteria

  • Self-identified Black race
  • >18 years of age with English fluency
  • recently post-partum (<4 weeks)
  • clinical diagnosis of Gestational Diabetes Mellitus (GDM) using Carpenter Coustan criteria
  • Preeclampsia (PEC) (new onset elevated blood pressure >140/90 mmHg 4 hours apart after 20 weeks gestation +/- proteinuria) or both Gestational Diabetes Mellitus (GDM) and PEC
  • access to smart phone technology

Exclusion Criteria

  • Preexisting Chronic Hypertension (CHTN) or Type 2 Diabetes Mellitus (T2DM)
  • Non-Black race
  • BMI<30
  • Inability to follow up

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University Medical Center
  • Collaborator
    • National Heart, Lung, and Blood Institute (NHLBI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rolanda Lister, Assistant Professor, Obstetrics and Gynecology – Vanderbilt University Medical Center
  • Overall Official(s)
    • Rolanda Lister, Principal Investigator, Vanderbilt University Medical Center
  • Overall Contact(s)
    • Rolanda Lister, MD, 6153435700, rolanda.l.lister@vumc.org

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.