NOURISH - A Healthcare-community Partnership to Improve Nutrition for Optimal Glycemic Control and Pregnancy Outcomes With Pregestational Diabetes

Overview

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.

Detailed description

Nutrition insecurity (inclusive of food insecurity + poor diet quality) is a fundamental non-medical, health-related social need that impacts \>20% of pregnant women and up to 50% of individuals with pregestational diabetes in the United States. Nutrition insecurity has devastating health consequences for the \>100,000 pregnant women with pregestational diabetes (type 1 or 2) and their exposed infants every year for whom a healthy diet is critical. Pregnant women with pregestational diabetes and nutrition insecurity are more likely to experience poor glycemic control, and as a result, adverse pregnancy outcomes. The risk of these adverse health outcomes increases when glycemic control is not achieved and social needs go unaddressed. Enhancing healthy food access and providing nutrition education-i.e., building "nutrition security"-is critical to improving outcomes for pregnant women with diabetes and poor glycemic control.

Our transdisciplinary team designed NOURISH: a theory- and evidence-based and collaborative healthcare-community partnership to enhance healthy food access, provide nutrition education and support, and address unmet social needs to improve glycemic control and pregnancy outcomes for high-risk pregnant women with pregestational diabetes, poor glycemic control, and food insecurity. The investigators propose the tripartite sustainable NOURISH intervention: 1) weekly nutritious produce home delivery by the Mid-Ohio Farmacy (MOF+), 2) monthly clinic-integrated diabetes, nutrition, and culinary group education by the OSU Cooperative Extension's Dining with Diabetes Program (DWD), and 3) continuous community health worker-led social needs assessment and support by the Health Impact Ohio Central Ohio Pathways Hub (Hub). Our central hypothesis is the combined NOURISH intervention (MOF + DWD + Hub) versus standard care will achieve glycemic control (hemoglobin A1c \<6.5% by delivery), prevent adverse pregnancy outcomes (gestational weight gain and neonatal morbidity), and improve diet quality and nutrition security. The investigators will randomize 174 eligible pregnant women (87 NOURISH, 87 standard care) with pregestational diabetes, poor glycemic control, and food insecurity.

The investigators will accomplish three specific aims: 1: use a pragmatic randomized controlled trial to test the effect of NOURISH-enhanced nutrition provision (MOF+), nutrition and diabetes education (DWD), and social needs referrals (Hub)-on improving glycemic control by delivery and secondarily, pregnancy outcomes (maternal gestational weight gain, neonatal morbidity), nutrition quality, and nutrition security.; 2: use cost- effectiveness analysis to assess the NOURISH intervention's value relative to standard care; and 3: use process evaluation to characterize intervention and contextual factors influencing uptake, effectiveness, and sustainability of the NOURISH intervention. NOURISH is a scalable and mutually beneficial healthcare-community partnership to improve nutrition security, glycemic control, and outcomes for pregnant women living with diabetes.

Interventions

• Dietary supplement Mid-Ohio Food Farmacy (MOF+) produce delivery
  The 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
• Behavioral Nutrition education with Dining with Diabetes (DWD)
  The 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
• Behavioral Health Impact Ohio Central Ohio Pathways Hub to address unmet social needs
  Health 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

Primary outcome measures

• The primary clinical outcome is the proportion of participants with an A1c <6.5% before delivery. [Time frame: Approximately once per trimester every 12-14 weeks betwee trial enrollment through 6-12 weeks postpartum.]

Secondary outcome measures (3)

• Gestational weight gain (GWG) z-score [Time frame: Time from randomization in the first or second trimester of pregnancy through date of delivery, assessed up to 9 months]
• Composite neonatal outcome [Time frame: Time from delivery or birth of infant to discharge from the hospital, assessed up to 100 weeks]
• Nutrition security [Time frame: pproximately once per trimester every 12-14 weeks betwee trial enrollment through 6-12 weeks postpartum.]

Eligibility criteria

Inclusion criteria

• 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.
• Screen positive for food insecurity based on answering "Often" or "Sometimes" true to either of the two questions on the USDA Hunger Vital Sign screening questions (within 12 months of enrolling in prenatal care).
• English or Spanish speaking.
• Willing to participate in Mid-Ohio Farmacy program and able to provide a home address to which food delivery can be provided by the Mid-Ohio Food Collective.
• Hemoglobin A1c criteria:

• If not taking glucagon-line peptide-1 (GLP-1) or sodium-glucose co-transporter 2 (SGLT2) medication within 12 months of enrolling in prenatal care, A1c ≥6.5% during this time period.
• If taking GLP-1 or SGLT2 medication within 12 months of enrolling in prenatal care, A1c≥6.5% during the 12 months prior to initiation of these medications.

Exclusion criteria

• Involuntarily confined or detained.
• Considered as having a diminished decision-making capacity.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus

Identifiers

NCT: NCT07560813 · STUDY20260307

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗