Pregnancy RelatedNCT06965530
Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy
A study testing Clinic-Based Medically Tailored Groceries (CB-MTG), Home Delivered Medically Tailored Groceries (HD-MTG) and Home Delivered Medically Tailored Groceries plus Education (HD-MTG_PLUS) in people with Pregnancy Related and Prematurity, run by Case Western Reserve University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Prematurity, Birth Outcome, Adverse
- What is being tested?
- Clinic-Based Medically Tailored Groceries (CB-MTG), Home Delivered Medically Tailored Groceries (HD-MTG) and Home Delivered Medically Tailored Groceries plus Education (HD-MTG_PLUS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Nov 2025to 31 May 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Under 18 years old
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44106
Kelly Gibson, MD, 216-778-7076, kgibson@metrohealth.org
- Recruiting
University Hospitals Rainbow Ahuja Women and Children's Center
Cleveland, Ohio, 44106
Christopher Nau, MD, 216-844-1000, Christopher.Nau@uhhospitals.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Related, Prematurity, Birth Outcome, Adverse
- Being tested
- Clinic-Based Medically Tailored Groceries (CB-MTG), Home Delivered Medically Tailored Groceries (HD-MTG), Home Delivered Medically Tailored Groceries plus Education (HD-MTG_PLUS)
- Keywords
- Randomized trial, Behavioral intervention
- Medical subject headings
- Premature Birth, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic-Based Medically Tailored Groceries (CB-MTG)Dietary supplement
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.
Home Delivered Medically Tailored Groceries (HD-MTG)Dietary supplement
Patient 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 supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinic-Based Medically Tailored Groceries (CB-MTG) | Active comparator | Standard of Care: Patients enrolled in the health systems clinic-based Food is Medicine Program. Receives: Dietary Supplement: Clinic-Based Medically Tailored Groceries (CB-MTG) |
| Home Delivered Medically Tailored Groceries (HD-MTG) | Experimental | Patient received home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery. Receives: Dietary Supplement: Home Delivered Medically Tailored Groceries (HD-MTG) |
| Home Delivered Medically Tailored Groceries PLUS (HD-MTGPLUS) | Experimental | 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. Receives: Dietary Supplement: Home Delivered Medically Tailored Groceries plus Education (HD-MTG_PLUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Insecurity
6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome
Measured: Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Food Insecurity
6 item, USDA measure; dichotomous outcome
Measured: Change from baseline to 6-months post delivery
Baby Gestational Age
Measured in weeks and classified as preterm (<37 weeks) vs. term (37+ weeks)
Measured: 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)
Measured: At birth
Days Hospitalized (Baby)
Number of days baby was hospitalized following birth
Measured: 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
Measured: From admission date to the NICU/SCN until the date of discharge from NICU/SCN, assessed up to 100 months
Secondary outcomes (24)
Birth Complications
List of poor maternal and fetal health conditions or outcomes at time of delivery
Measured: Perioperative/periprocedural
Prenatal Health Care
Number / Frequency of prenatal health care visits, extracted from medical record (chart review)
Measured: 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
Measured: Perioperative/periprocedural
Gestational Diabetes Mellitus (GDM)
Diagnosis of GDM during pregnancy
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Change from Baseline to 6 months post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start12 Nov 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University Hospitals Cleveland Medical Center, MetroHealth Medical Center, Greater Cleveland Food Bank
- Responsible party
- Principal investigator, Elaine Borawski, Case Western Reserve University
- Investigators
- Elaine A Borawski, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965530
- Sponsor's protocol ID
- STUDY20241029
- Other IDs
- R01NR021490
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.