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

Not Applicable

Not yet recruiting

• Conditions: Pregnancy Related; Prematurity; Birth Outcome, Adverse

• Registration Number: NCT06965530
• Lead Sponsor: Case Western Reserve University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-05-02
• Study First Posted: 2025-05-11
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-08
• Study Start: 2025-07-01
• Primary Completion: 2028-11-01
• Study Completion: 2029-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

• 18 years of age and older
• Pregnant patients >10 weeks and <22 weeks gestation at randomization (must be consented by 20 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cooking Frequency	Change from baseline to 6-months post delivery	3 items; from NHNES; # of times a week cooking breakfast, lunch and dinner
Perceived Stress	Change from baseline to 6-months post delivery	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)
Decision Fatigue	Change from baseline to 6-months post delivery	Decisional Fatigue Scale (DFS) (range 0 to 30; higher total scores are posited to correlate with the intensity of perceived decisional fatigue)
Social Support	Change from Baseline to 6 months post-delivery	Multidimensional Scale of Perceived Social Support; 6-item questionnaire, each answer scored 1-5 with higher scores indicating strong social support
Birth Complications	Perioperative/periprocedural	List of poor maternal and fetal health conditions or outcomes at time of delivery
Prenatal Health Care	From first documented prenatal visit until the baby's delivery date, assessed up to 9 months	Number / Frequency of prenatal health care visits, extracted from medical record (chart review)
Pregnancy Complications	Perioperative/periprocedural	Yes / No for any of the following: (1) gestational diabetes; (2)preeclampsia; (3) poor weight gain or loss during pregnancy
Gestational Diabetes Mellitus (GDM)	Assessed up to 40 weeks of pregnancy	Diagnosis of GDM during pregnancy
Attitudes toward Cooking and Food Preparation	Change from baseline to 6-months post delivery	Mean of 6 items, range 1-5, higher scores indicate more positive attitudes toward cooking
Cooking Efficacy	Change from baseline to 6-months post delivery	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).
Dietary Quality	Change from baseline to 6-months post delivery	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
Healthy Eating Index (HEI)	Change from Baseline to 6 months post-delivery	Total Healthy Eating Index score, ranging from 1-100, with higher scores indicating higher nutritional quality of diet
Healthy Eating Self Efficacy (HESE)	Change from baseline to delivery (assessed up to 40 weeks of pregnancy)	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
Healthy Eating Self-Efficacy (HESE)	Change from Baseline to 6 months post-delivery	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
Depressive Symptoms	Change from baseline to 6-months post delivery	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

Trial Locations

Locations (3)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

University Hospitals Rainbow Ahuja Women and Children's Center; 🇺🇸 Cleveland, Ohio, United States

Greater Cleveland Food Bank; 🇺🇸 Cleveland, Ohio, United States