Sponsor study identifier
Secondary identifiers
NIH
interventional
360
1 country
2
Study Start
November 12, 2025
Actual (reported)Primary Completion
November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 11, 2025
Actual (reported)May 11, 2025
Actual (reported)November 12, 2025
Actual (reported)November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Birth Complications
Perioperative/periprocedural
Prenatal Health Care
From first documented prenatal visit until the baby's delivery date, assessed up to 9 months
Pregnancy Complications
Perioperative/periprocedural
Gestational Diabetes Mellitus (GDM)
Assessed up to 40 weeks of pregnancy
Attitudes toward Cooking and Food Preparation
Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Standard of Care: Patients enrolled in the health systems clinic-based Food is Medicine Program.
Patient received home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery.
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.
Patient receive home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery.
MetroHealth Medical Center
Cleveland, Ohio, 44106, United States
University Hospitals Rainbow Ahuja Women and Children's Center
Cleveland, Ohio, 44106, United States
Elaine A Borawski, PhD
Case Western Reserve University
First Submitted
April 11, 2025
First Posted
May 11, 2025
Study Start
November 12, 2025
Actual (reported)Primary Completion
November 1, 2028
EstimatedMyo-inositol During Pregnancy to Prevent Gestational Diabetes
Nourishing Beginnings: Addressing Food Insecurity During Pregnancy
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 20, 2026
Record last verified: 2026-04
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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