Nutrition insecurity (inclusive of food insecurity + poor diet quality) is a fundamental social need that must be addressed to improve treatment and health outcomes for high-risk pregnant women with pregestational type 1 and 2 diabetes, poor glucose control, and food insecurity for whom a healthy diet is critical. The NOURISH trial will provide evidence of a scalable, integrated, and theory-based healthcare-community partnership that includes weekly nutritious produce home delivery, monthly clinic-integrated diabetes, nutrition, and culinary group education, and continuous social needs assessment and support to improve glucose control and pregnancy outcomes. Given the increasing burden and devasting consequences of nutrition insecurity among high-risk pregnant women with diabetes and unmet social needs, NOURISH-an innovative and sustainable healthcare-community partnership-will have significant public health benefit.
Pregnant with singleton or twin pregnancy
Gestational age >8+0 to ≤22+6 weeks at enrollment by project EDD
Age ≥ 18 years.
Type 1 or 2 diabetes.
Involuntarily confined or detained.
Considered as having a diminished decision-making capacity.
Parallel
Mid-Ohio Food Farmacy (MOF+) produce delivery
Dietary supplementThe Mid-Ohio Food Collective (MOFC) is a regional foodbank that delivers \>170,000 meals daily through 680 agency partnerships and is ranked as one of the 10 largest in the U.S. Both OSUWMC and MOFC are located in a large metropolitan region in Ohio. OSUWMC offers the Mid-Ohio Farmacy (MOF) referral in nine clinics, including an integrated diabetes and prenatal care clinic for pregnant individuals with pregestational diabetes, with OSUWMC funding secured to continue this program. The goal of the MOF is to establish a systematic screening and referral process aimed at addressing food insecurity that connects patients to fresh produce through a food pantry near their home. In NOURISH: The investigators will extend the existing MOF program to weekly home delivery of produce coordinated by the Food Collective. Weekly MOF+ deliveries will include 15 to 20 pounds per week of low to medium glycemic index fruits and vegetables from available inventory, as recommended by the USDA.
Nutrition education with Dining with Diabetes (DWD)
BehavioralThe investigators will deploy OSU Extension's community-based education program, DWD, with live programming focused on cooking instruction from the OSU-based Cooking Matters (CM) program, which actively engages participants to develop skills for healthy eating. Working with our diabetes education team from DWD, the investigators have tailored this program to target the specific needs of pregnant individuals with pregestational diabetes. This includes in-person 1 hour group sessions every 4 weeks (monthly) at the time of clinic visits with alternating education sessions provided by DWD with interactive hands-on cooking sessions provided by CM. The nutrition portion focuses on healthy eating and blood glucose management, and the cooking portion provides education on food safety, knife techniques, nutrition facts and ingredients label reading, meal planning, budgeting, and shopping. Content will be adapted from state-approved curricula for pregnancy and the American Diabetes Association.
Health Impact Ohio Central Ohio Pathways Hub to address unmet social needs
BehavioralHealth Impact Ohio Central Ohio Pathways Hub. The Pathways Community Hub ('Hub') model consists of three features: (1) the Hub is a regional coordination entity that employs CHWs to assess the medical and social needs of vulnerable patients and connect them to community resources; (2) the CHWs initiate a "care pathway," a defined action plan that describes how patient needs will be addressed, which is then recorded and tracked in an electronic database; and (3) completion of each care pathway is linked to payment from insurance companies (Medicaid-managed care plans and other community partners) based on specific performance benchmarks. Specifically, a financial contract is attached to each standardized care pathway: When a care pathway is completed, a CHW must confirm that a measurable outcome (e.g., patient is assigned to a medical home) is obtained in order to receive an insurance payment.
The primary clinical outcome is the proportion of participants with an A1c <6.5% before delivery.
The primary outcome of A1c \<6.5% versus A1c ≥6.5% will be assessed according to the A1c most proximate to the time of delivery, and is consistent with current clinical guidelines to prevent adverse pregnancy outcomes for the mother and infant. The frequencies of adverse pregnancy outcomes are significantly decreased with an A1c \<6%. A1c typically will be assessed once per trimester, consistent with guidelines for the management of pregestational diabetes, and at delivery. The value closest to delivery will be used for participants with \>1 A1c value in the third trimester. The investigators will evaluate A1c using a standard assay and as an absolute percentage of total hemoglobin.
Gestational weight gain (GWG) z-score
The secondary outcome of maternal GWG will be defined as the GWG z-score within versus above or below pregnancy recommendations per the Institute of Medicine guidelines. The Institute of Medicine guidelines for GWG include recommendations specific to pre-pregnancy body mass index (BMI) to optimize maternal and infant outcomes. The investigators will assess GWG with z-scores (PMID: 34839478). The investigators will convert absolute weight gain to z-scores using established charts specific to the 4 pre-pregnancy BMI groups and gestational age at delivery. This GWG z-score is not confounded by duration of pregnancy.
Composite neonatal outcome
The secondary composite neonatal outcome includes one (or more) of the following: large-for-gestational-age at birth, hypoglycemia, hyperbilirubinemia, preterm birth \<37 weeks, and neonatal intensive care unit admission. The individual components will be defined as: 1) Large-for-gestational age: birthweight ≥90th percentile per infant-sex standardized 2017 U.S. reference for singleton birthweight %tile; 2) Hypoglycemia: Capillary glucose \<35 mg/dL requiring glucose supplementation \<24 hours of birth; 3) Hyperbilirubinemia: Phototherapy without another cause of jaundice; 4) Preterm birth \<37 weeks, either spontaneous or medically-indicated; and 5) Neonatal intensive care unit admission for any indication.
Nutrition security
The newly developed Gretchen Swanson Center for Nutrition Household Nutrition Security measure consists of 4 questions and is measured on a continuous measure. This measure aims to determine a household's ability to acquire nutritious foods that meet their health needs without resource challenges or worry. The measure includes 4 questions, which were scored from 0 to 4, where 4 corresponds to "Always" and 0 corresponds to "Never." Per the scoring protocol, the investigators will assess this outcome as a continuous measure from 0 to 4 and as a binary variable classifying individuals as "nutrition secure" (average score \>2) or "nutrition insecure" (average score ≤2).
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Ohio State University
Lead sponsor
University of Michigan
Collaborator
