Alternative Lifestyle Interventions for Vulnerable Ethnic Groups

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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...

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.

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