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

NCT07560813 | Not Yet Recruiting

• 1 other identifier: STUDY20260307
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Type 1 Diabetes; Pregnancy, High Risk

Keywords

Pregnancy; Type 1 Diabetes; Type 2 Diabetes; food insecurity; nutrition insecurity; social determinants of health

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately once per trimester every 12-14 weeks betwee trial enrollment through 6-12 weeks postpartum.

Secondary Outcomes (3)

• Gestational weight gain (GWG) z-score

  Time from randomization in the first or second trimester of pregnancy through date of delivery, assessed up to 9 months

• Composite neonatal outcome

  Time from delivery or birth of infant to discharge from the hospital, assessed up to 100 weeks

• Nutrition security

  pproximately once per trimester every 12-14 weeks betwee trial enrollment through 6-12 weeks postpartum.

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the NOURISH intervention group will be enrolled in the Mid-Ohio Farmacy program to receive home delivery of healthy food and produce from the Mid-Ohio Food Collective up to once a week and access to nutrition education and community resources. They may be invited to participate in an optional interview about their experience. Participants will be asked to complete surveys about their diet and nutrition and experiences living with diabetes and pregnancy.

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

Standard of care

NO INTERVENTION

Participants in the standard of care group will receive access to community resources to support their diet during pregnancy, be asked to complete surveys about their diet and nutrition and experiences living with diabetes and pregnancy. They may be invited to participate in an optional interview about their experience. Participants will be given access to community resources about nutrition for which they may qualify. At the completion of the study, participants will be encouraged to enroll and utilize the Mid-Ohio Farmacy program.

Interventions

Mid-Ohio Food Farmacy (MOF+) produce delivery DIETARY_SUPPLEMENT

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 9 clinics, including an integrated diabetes and prenatal care clinic for pregnant individuals with pregestational diabetes. The goal of the MOF is to establish a systematic screening and referral process 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 Thrifty Food Plan.

Intervention group

Nutrition education with Dining with Diabetes (DWD) BEHAVIORAL

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. The investigators have tailored this program to target the specific needs of pregnant women with pregestational diabetes. This includes primarily virtual education sessions with interactive cooking sessions. 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 current guidance for pregnant women with diabetes

Intervention group

Health Impact Ohio Central Ohio Pathways Hub to address unmet social needs BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is restricted to pregnant women with type 1 and 2 diabetes.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Daniel Walker, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Kartik K Venkatesh, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Christine Field, MD, MPH

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessment of the primary outcome of glycemic control (Hemoglobin A1c) will assessed blinded to study arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The NOURISH tripartite intervention will consist of 1) nutritious produce home delivery (MOF+), 2) clinic-integrated diabetes, nutrition, and culinary group education (DWD), and 3) CHW-led social needs assessment and support (Hub).

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): June 25, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)