Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy

The Role of Medically Tailored Groceries in Mitigating Food Insecurity and Improving Pregnancy Outcomes Through Clinic-Community Partnerships

Medically tailored groceries (MTG), involving grocery items to be prepared at home, selected by a nutritional professional based on a treatment plan, is a growing approach adopted by healthcare systems to address food insecurity in their patient populations, a leading contribution to health disparities such as poor birth outcomes within pregnant populations. However, transportation and other social needs can often hinder patient uptake of clinic-based approaches. Findings from this study will help to better understand how home delivery of MTGs, with and without supplemental education and support to improve food literacy, behavioral and health outcomes.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Prematurity; Birth Outcome, Adverse
• Intervention / Treatment: Dietary supplement: Clinic-Based Medically Tailored Groceries (CB-MTG); Dietary supplement: Home Delivered Medically Tailored Groceries (HD-MTG); Dietary supplement: Home Delivered Medically Tailored Groceries plus Education (HD-MTG_PLUS)

Detailed Description

Medically tailored groceries (MTG) generally involve fresh and shelf-stable grocery items to be prepared at home, selected by a nutritional professional based on a treatment plan and are typically picked up at a clinic, market, or pantry. This clinic-based market or pantry model (CB-MTG) is a growing approach adopted by health care systems in their effort to address food insecurity in their patient population, including University Hospitals of Cleveland (UH) and MetroHealth Medical Center (Metro), two of the three largest health systems in Cleveland, Ohio. Often offered to patients with food-related chronic conditions, CB-MTGs have shown to improve medication adherence, increase fruits and vegetable consumption and decrease HbA1c in people with diabetes. However, less evidence is available on the impact of CB-MTGs with food insecure pregnant individuals, where food insecurity has been strongly associated with prematurity and other negative birth outcomes.

While promising, the CB-MTG approach requires transportation, having the tools and equipment to prepare meals at home and some basic food preparation skills, all potential barriers for low-income pregnant individuals, especially younger parents-to-be or those already with children. The Greater Cleveland Food Bank and partners, seeking to address these barriers, recently developed a home delivered version of MTG (HD-MTG), offered to Medicaid-eligible pregnant individuals across the county, with promising results. The investigators seek to integrate these approaches into patient care for food insecure, pregnant women and test the effectiveness of these two approaches, alongside an additional intervention arm that adds supplemental nutrition and culinary education and support to the home-delivered approach (HD-MTG PLUS). These three approaches will be offered (via randomization) to 360 pregnant individuals (120 per arm) with food insecurity who are patients within UH and Metro's largest urban obstetric practices, each with direct electronic health record (EHR) referral systems to their "food as medicine" clinics/markets. Data are collected at baseline, near/at delivery and 6 months post-delivery. This study seeks to understand the unique contribution of each approach, as well as implementation and intervention uptake barriers, with the goal of building the evidence base of MTG interventions and making recommendations to providers and health systems seeking to address food insecurity and nutrient deficiencies during pregnancy.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elaine A Borawski, PhD; Phone Number: 216-368-1024; Email: exb11@case.edu
• Study Contact Backup: Name: Samantha Bentley, MPH; Phone Number: 216-368-1024; Email: sxb1213@case.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • MetroHealth Medical Center
      • Contact: Kelly Gibson, MD; Phone Number: 216-778-7076; Email: kgibson@metrohealth.org
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Rainbow Ahuja Women and Children's Center
      • Contact: Christopher Nau, MD; Phone Number: 216-844-1000; Email: Christopher.Nau@uhhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years of age and older
• Pregnant patients >10 weeks and <22 weeks gestation at randomization (must be consented by 18 weeks)
• Eligible for Medicaid
• Singleton pregnancy, confirmed by ultrasound
• An established patient of the UH or Metro pregnancy clinic
• English speaking
• Lives in Cuyahoga County, Ohio

Exclusion Criteria:

• Under 18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinic-Based Medically Tailored Groceries (CB-MTG); Standard of Care: Patients enrolled in the health systems clinic-based Food is Medicine Program.	Dietary supplement: Clinic-Based Medically Tailored Groceries (CB-MTG); Patients have the opportunity to pick up medically tailored groceries every other week at the Food Is Medicine Clinic or Market associated with their provider.
Experimental: Home Delivered Medically Tailored Groceries (HD-MTG); Patient received home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery.	Dietary supplement: Home Delivered Medically Tailored Groceries (HD-MTG); Patient receive home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery.
Experimental: Home Delivered Medically Tailored Groceries PLUS (HD-MTGPLUS); Same as Arm 2, receiving home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery, but receives additional nutrition and culinary education and support throughout the trial.	Dietary supplement: Home Delivered Medically Tailored Groceries plus Education (HD-MTG_PLUS); Patients receive home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery, plus also receives additional nutrition and culinary education and support throughout the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Insecurity	6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome	Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Food Insecurity	6 item, USDA measure; dichotomous outcome	Change from baseline to 6-months post delivery
Baby Gestational Age	Measured in weeks and classified as preterm (<37 weeks) vs. term (37+ weeks)	At birth
Baby Birthweight	Measured in grams and classified as normal (> or = 2500g), low birth weight (<2500g), very low birthweight (<1500g), extremely low birth weight (<1000g)	At birth
Days Hospitalized (Baby)	Number of days baby was hospitalized following birth	From date of birth until the date of discharge from the hospital, assessed up to 100 months
Neonatal Intensive Care Unit (NICU)/Special Care Nursery (SCN) Utilization	Number of days baby was admitted to NICU or SCN	From admission date to the NICU/SCN until the date of discharge from NICU/SCN, assessed up to 100 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth Complications	List of poor maternal and fetal health conditions or outcomes at time of delivery	Perioperative/periprocedural
Prenatal Health Care	Number / Frequency of prenatal health care visits, extracted from medical record (chart review)	From first documented prenatal visit until the baby's delivery date, assessed up to 9 months
Pregnancy Complications	Yes / No for any of the following: (1) gestational diabetes; (2)preeclampsia; (3) poor weight gain or loss during pregnancy	Perioperative/periprocedural
Gestational Diabetes Mellitus (GDM)	Diagnosis of GDM during pregnancy	Assessed up to 40 weeks of pregnancy
Attitudes toward Cooking and Food Preparation	Mean of 6 items, range 1-5, higher scores indicate more positive attitudes toward cooking	Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Attitudes toward Cooking and Food Preparation	Mean of 6 items, range 1-5, higher scores indicate more positive attitudes toward cooking	Change from baseline to 6-months post delivery
Cooking Efficacy	Mean of 4 items, range 1-5 (not all at confident to extremely confident); higher number indicates higher efficacy; e.g. I can cook nutritious meal; I can cook a meal in a short amount of time; I can cook a nutritious meal without spending a lot of money; I can follow a recipe).	Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Cooking Efficacy	Mean of 4 items, range 1-5 (not all at confident to extremely confident); higher number indicates higher efficacy; e.g. I can cook nutritious meal; I can cook a meal in a short amount of time; I can cook a nutritious meal without spending a lot of money; I can follow a recipe).	Change from baseline to 6-months post delivery
Cooking Frequency	3 items; from National Health and Nutrition Examination Survey (NHNES); # of times a week cooking breakfast, lunch and dinner	Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Cooking Frequency	3 items; from NHNES; # of times a week cooking breakfast, lunch and dinner	Change from baseline to 6-months post delivery
Dietary Quality	Derived from diet recalls collected with the Nutrition Data System for Research. Includes: total calories, energy density, macronutrient intake, micronutrients, dietary fiber, sugar sweetened beverages, food group intake, and fast food intake	Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Dietary Quality	Derived from diet recalls collected with the Nutrition Data System for Research. Includes: total calories, energy density, macronutrient intake, micronutrients, dietary fiber, sugar sweetened beverages, food group intake, and fast food intake	Change from baseline to 6-months post delivery
Healthy Eating Index (HEI)	Total Healthy Eating Index score, ranging from 1-100, with higher scores indicating higher nutritional quality of diet	Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Healthy Eating Index (HEI)	Total Healthy Eating Index score, ranging from 1-100, with higher scores indicating higher nutritional quality of diet	Change from Baseline to 6 months post-delivery
Healthy Eating Self Efficacy (HESE)	Subscale of the Healthy Eating and Weight Self-Efficacy Scale: Mean of 6 items, range 1-5, higher scores indicate higher level of confidence to choose, prepare and consume healthy food options	Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Healthy Eating Self-Efficacy (HESE)	Subscale of the Healthy Eating and Weight Self-Efficacy Scale: Mean of 6 items, range 1-5, higher scores indicate higher level of confidence to choose, prepare and consume healthy food options	Change from Baseline to 6 months post-delivery
Depressive Symptoms	Edinburgh Perinatal / Postnatal Depression Scale (EDPS); a 10-question survey with each answer given a score of 0-3; higher scores suggest minor or major depression may be present	Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Depressive Symptoms	Edinburgh Perinatal / Postnatal Depression Scale (EDPS); a 10-question survey with each answer given a score of 0-3; higher scores suggest minor or major depression may be present	Change from baseline to 6-months post delivery
Perceived Stress	Mother's stress index score (10-item standardized index, with each answer given a score of 1-5 and higher scores indicating stress is present)	Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Perceived Stress	Mother's stress index score (10-item standardized index, with each answer given a score of 1-5 and higher scores indicating stress is present)	Change from baseline to 6-months post delivery
Decision Fatigue	Decisional Fatigue Scale (DFS) (range 0 to 30; higher total scores are posited to correlate with the intensity of perceived decisional fatigue)	Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Decision Fatigue	Decisional Fatigue Scale (DFS) (range 0 to 30; higher total scores are posited to correlate with the intensity of perceived decisional fatigue)	Change from baseline to 6-months post delivery
Social Support	Multidimensional Scale of Perceived Social Support; 6-item questionnaire, each answer scored 1-5 with higher scores indicating strong social support	Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Social Support	Multidimensional Scale of Perceived Social Support; 6-item questionnaire, each answer scored 1-5 with higher scores indicating strong social support	Change from Baseline to 6 months post-delivery

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: National Institute of Nursing Research (NINR); University Hospitals Cleveland Medical Center; MetroHealth Medical Center; Greater Cleveland Food Bank
• Investigators: Principal Investigator: Elaine A Borawski, PhD, Case Western Reserve University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: May 2, 2025
• First Posted (Actual): May 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Randomized trial; Behavioral intervention
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Premature Birth; Pregnancy Complications; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: STUDY20241029; R01NR021490 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As required by our National Institute of Nursing Research grant award, please see the required Data Management and Sharing Plan (uploaded as separate document). In brief, at the of the study, de-identified questionnaire, clinical and implementation data will be deposited into the Inter-university Consortium for Political and Social Research (ICPSR) and designated as controlled access. Case Western Reserve University (CWRU) is a member of ICPSR which permits the deposit of data at no charge.
• IPD Sharing Time Frame: Within 6 months of the primary outcomes paper being published.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No