Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorCase Western Reserve University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Under 18 years old
Trial design
Design model
Parallel
Treatments tested in this trial
Clinic-Based Medically Tailored Groceries (CB-MTG)
Dietary supplementPatients have the opportunity to pick up medically tailored groceries every other week at the Food Is Medicine Clinic or Market associated with their provider.
Home Delivered Medically Tailored Groceries (HD-MTG)
Dietary supplementPatient receive home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery.
Home Delivered Medically Tailored Groceries plus Education (HD-MTG_PLUS)
Dietary supplementPatients 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.
Treatment groups
360 Participants
are divided into 3 treatment groupsGroup A: Clinic-Based Medically Tailored Groceries (CB-MTG)Active comparator 1 intervention
Group B: Home Delivered Medically Tailored Groceries (HD-MTG)Experimental treatment 1 intervention
Group C: Home Delivered Medically Tailored Groceries PLUS (HD-MTGPLUS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Food Insecurity
6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome
Time frame
Change from baseline to delivery (assessed up to 40 weeks of pregnancy)2
Food Insecurity
6 item, USDA measure; dichotomous outcome
Time frame
Change from baseline to 6-months post delivery3
Baby Gestational Age
Measured in weeks and classified as preterm (\<37 weeks) vs. term (37+ weeks)
Time frame
At birth4
Baby Birthweight
Measured in grams and classified as normal (\> or = 2500g), low birth weight (\<2500g), very low birthweight (\<1500g), extremely low birth weight (\<1000g)
Time frame
At birthSecondary outcomes
1
Birth Complications
List of poor maternal and fetal health conditions or outcomes at time of delivery
Time frame
Perioperative/periprocedural2
Prenatal Health Care
Number / Frequency of prenatal health care visits, extracted from medical record (chart review)
Time frame
From first documented prenatal visit until the baby's delivery date, assessed up to 9 months3
Pregnancy Complications
Yes / No for any of the following: (1) gestational diabetes; (2)preeclampsia; (3) poor weight gain or loss during pregnancy
Time frame
Perioperative/periprocedural4
Gestational Diabetes Mellitus (GDM)
Diagnosis of GDM during pregnancy
Time frame
Assessed up to 40 weeks of pregnancySponsors and contacts
Click on the lead sponsor to view all of their trials.
Case Western Reserve University
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
University Hospitals Cleveland Medical Center
Collaborator
MetroHealth Medical Center
Collaborator
Greater Cleveland Food Bank
Collaborator
Source ClinicalTrials.gov