NCT06965530 · Case Western Reserve University
Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy
What this study is about
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.
View original scientific description
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.
Interventions
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.
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.
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.
Primary outcome measures
Food Insecurity
Time frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome
Food Insecurity
Time frame: Change from baseline to 6-months post delivery
6 item, USDA measure; dichotomous outcome
Baby Gestational Age
Time frame: At birth
Measured in weeks and classified as preterm (\<37 weeks) vs. term (37+ weeks)
Baby Birthweight
Time frame: 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)
Time frame: 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
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Cleveland, Ohio
Collaborators
National Institute of Nursing Research (NINR), University Hospitals Cleveland Medical Center, MetroHealth Medical Center, Greater Cleveland Food Bank
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations