A pre-conception clinical trial to reduce intergenerational obesity and diabetes risks: The NDPP-NextGen trial protocol.

BACKGROUND: Intrauterine exposure to maternal overweight/obesity or diabetes transmits risks to offspring, perpetuating a disease cycle across generations. Prenatal interventions to reduce maternal weight or dysglycemia have limited impact, while postpartum interventions can alter the intrauterine environment only if child-bearing continues. Efficacious preconception interventions are needed, especially for underserved populations, and with the potential to be scaled up sustainably. Research is also needed to assess intervention effects at conception, throughout pregnancy, and among offspring. METHODS: This two-arm, parallel randomized clinical trial will include 360 biological females with overweight/obesity and moderate-to-high likelihood of pregnancy within 24 months. Participants will be randomized 1:1 to a yearlong pre-conception lifestyle intervention based on the National Diabetes Prevention Program (NDPP-NextGen) or usual care. Data collection will occur at enrollment (before conception), post-conception (<8 weeks gestation), late pregnancy (28-32 weeks gestation), and delivery (before discharge) for participants who become pregnant within 24 months of enrollment. Main outcomes are post-conception body mass index (<8 weeks gestation; primary outcome), post-conception fasting glucose (<8 weeks gestation; secondary outcome), and neonatal adiposity (<2 days post-birth). Additional clinical, behavioral, perinatal and offspring data will be collected, and biospecimens (blood, urine, stool, cord blood) will be banked for future ancillary studies. CONCLUSION: This clinical trial will evaluate an intervention model (NDPP-NextGen) with potential to improve maternal health among the >50% of US females with overweight/obesity or diabetes risks in pregnancy. If successful, it can be scaled among >1800 organizations delivering NDPP in the United States to benefit the health of future generations.

Reach and Effectiveness of Diabetes Self-Management Education and Support in a Network of Federally Qualified Health Centers.

Diabetes self-management education and support (DSMES) is an evidence-based intervention to improve diabetes-related outcomes. Access to DSMES is limited for diverse and low-income groups, despite greater need for services to address health disparities. Providing DSMES in federally qualified health centers (FQHCs) may increase reach for priority populations, and further study is needed to evaluate this delivery model. This report examines program effectiveness, including outcomes by race/ethnicity and Medicaid status, among 1,247 enrollees in FQHC-based DSMES. There was substantial glycated hemoglobin (A1c) improvement overall (-0.98%) among a diverse, majority-Medicaid population. However, Medicaid beneficiaries were approximately half as likely to attend as other enrollees (p<.001), while Latinx and non-Latinx Black participants attended fewer sessions (p=.008 and p=.040, respectively). Additionally, Medicaid beneficiaries experienced less A1c improvement than others (p=.040). Findings are promising that FQHC-based delivery can increase access to high-quality DSMES, although further effort appears needed to ensure optimal outcomes for all.