Medically Tailored Groceries for Pregnancy

Recruiting at 2 trial locations

Overseen By Elaine A Borawski, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Under 18 years old

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 40 weeks of pregnancy and 6 months post-delivery

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how delivering medically tailored groceries (MTG) to pregnant women can improve their health and food security. It compares three approaches: clinic-based groceries, home-delivered groceries, and home-delivered groceries with added nutrition education. The goal is to assess how these methods affect pregnancy health outcomes and food habits. Pregnant women who are 10 to 22 weeks along, on Medicaid, and living in Cuyahoga County, Ohio, may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance maternal health and food security.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that medically tailored groceries (MTG) are generally safe and well-received. Nutrition experts select these groceries to meet specific health needs. The absence of direct information about negative effects or side effects in the sources suggests no major safety issues have been reported.

For example, a study on home-delivered MTG for pregnant women with diabetes found this approach practical and well-accepted, indicating participants used the groceries without major problems. While this isn't direct proof of safety, it suggests the groceries are easy to use and not harmful.

If this treatment were in the early stages of testing, safety might still be under evaluation. However, since this trial lacks a phase label, it likely focuses on effectiveness rather than initial safety testing. Overall, current findings suggest MTG is a safe option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about medically tailored groceries for pregnancy because they offer a personalized approach to nutrition during this critical time. Unlike traditional advice, which often involves generalized dietary guidelines, these groceries are specifically designed to meet the unique nutritional needs of each individual. The home-delivered option brings convenience, ensuring consistent access to healthy foods without the hassle of grocery shopping. Moreover, the PLUS version includes added nutrition and culinary education, empowering expectant mothers with knowledge and skills to maintain balanced diets, which could lead to better health outcomes for both mother and child.

What evidence suggests that this trial's treatments could be effective for improving pregnancy outcomes?

This trial will compare different methods of providing medically tailored groceries (MTG) to pregnant individuals. Research has shown that MTGs can significantly improve health by addressing food insecurity. Studies have found that these groceries ensure better nutrition, leading to healthier pregnancies and improved birth outcomes. In this trial, one group will receive clinic-based MTGs, while another group will have MTGs delivered to their homes. Early findings suggest home delivery is especially effective because it removes obstacles like transportation. A third group will receive home-delivered MTGs along with additional nutrition and culinary education, which can further enhance benefits by improving understanding of food and encouraging healthier eating habits. Overall, this approach appears promising for supporting better health in pregnant individuals. ^{1 2 6 7 8}

Who Is on the Research Team?

Elaine A Borawski, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for pregnant individuals facing food insecurity, which can lead to complications during pregnancy and at birth. It's designed to see if getting groceries chosen by nutrition experts helps improve their health outcomes.

Inclusion Criteria

I am pregnant, between 10 and 22 weeks along, and can consent by 20 weeks.

Eligible for Medicaid

Singleton pregnancy, confirmed by ultrasound

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored groceries, either clinic-based or home-delivered, with or without additional nutrition and culinary education, throughout pregnancy and up to 6 months post-delivery

Up to 40 weeks of pregnancy and 6 months post-delivery

Bi-weekly home deliveries

Follow-up

Participants are monitored for dietary quality, healthy eating index, and other health outcomes post-delivery

6 months post-delivery

What Are the Treatments Tested in This Trial?

Interventions

• Medically Tailored Groceries

Trial Overview The study tests three approaches: home delivery of medically tailored groceries (HD-MTG), clinic-based pickup of these groceries (CB-MTG), and home delivery with additional education on food preparation and nutrition (HD-MTG_PLUS).

How Is the Trial Designed?

Group I: Home Delivered Medically Tailored Groceries PLUS (HD-MTGPLUS) Experimental Treatment 1 Intervention

Same as Arm 2, receiving home delivered medically tailored groceries every two weeks during pregnancy and up to 6 months post-delivery, but receives additional nutrition and culinary education and support throughout the trial.

Group II: Home Delivered Medically Tailored Groceries (HD-MTG) Experimental Treatment 1 Intervention

Patient received home delivered medically tailored groceries every two weeks during pregnancy and up to 6 months post-delivery.

Group III: Clinic-Based Medically Tailored Groceries (CB-MTG) Active Control 1 Intervention

Standard of Care: Patients enrolled in the health systems clinic-based Food is Medicine Program.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

University Hospitals Cleveland Medical Center

Collaborator

Trials

348

Recruited

394,000+

MetroHealth Medical Center

Collaborator

Trials

125

Recruited

22,600+

Greater Cleveland Food Bank

Collaborator

Trials

1

Recruited

120+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06965530

Study Details | NCT06965530 | Nourishing Tomorrow: Role ... Patients receive home delivered medically tailored groceries every two weeks during pregnancy and up to 6 months post-delivery, plus also receives additional ...

2. reporter.nih.gov reporter.nih.gov/project-details/11190993

RePORT RePORTER - National Institutes of Health (NIH) | The Role of Medically Tailored Groceries in Mitigating Food Insecurity and Improving Pregnancy Outcomes through Clinic-Community Partnerships. Project Number ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06965530/nourishing-tomorrow-role-of-medically-tailored-groceries-in-addressing-food-insecurity-during-pregnancy?state=OH&city=Cleaveland

Role of Medically Tailored Groceries in Addressing Food ... Findings from this study will help to better understand how home delivery of MTGs, with and without supplemental education and support to ...

4. reporter.nih.gov reporter.nih.gov/search/gkBYlmPyeE-swDy72UkFdA/project-details/11059690

Project Details - NIH RePORTER The Role of Medically Tailored Groceries in Mitigating Food Insecurity and Improving Pregnancy Outcomes through Clinic-Community Partnerships. Project Number ...

5. mdpi.com mdpi.com/2227-9032/13/3/253

Medically Tailored Grocery Deliveries to Improve Food ... Food is medicine (FIM) interventions show promise in improving health outcomes by integrating food and nutrition into healthcare systems to enhance patients' ...

6. case.edu case.edu/medicine/about/newsroom/our-latest-news/food-medicine-program-awarded-38m-federal-grant-support-health-and-nutrition-low-income-high-risk-pregnant-women

'Food is Medicine' program awarded $3.8M federal grant to ... Funding will provide one of the first comprehensive, rigorous studies of 'medically tailored' groceries as an approach to reduce food insecurity ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/30/NCT06965530/ICF_000.pdf

The Role of Medically Tailored Groceries in Mitigating The Role of Medically Tailored Groceries ... ○ Data about your prenatal care visits, pregnancy complications and birth outcomes will be extracted.

8. ideastream.org ideastream.org/health/2025-01-16/case-western-to-study-effects-of-healthy-groceries-on-pregnant-women-with-3-8-million-grant

Case Western to study effects of healthy groceries on ... Researchers will study three different approaches of providing medically-tailored groceries — including delivering directly to homes, an option ...