Med-South Lifestyle Program for Pregnancy Complications

Overseen By Lauren M Kruse, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Type 1 diabetes, Twins, others

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

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a Mediterranean-style diet might improve pregnancy outcomes. Participants will receive guidance on following this diet, adjusted to fit southern U.S. food preferences. Some participants will receive extra virgin olive oil and nuts, while others will also receive frozen meals designed to match the diet's guidelines. This trial suits those in their first trimester, receiving prenatal care at UNC, and comfortable with eating nuts and olive oil.

As an unphased trial, this study offers a unique opportunity to contribute to understanding how dietary changes can enhance pregnancy health.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Med-South Lifestyle Program is safe for pregnancy?

Research has shown that following a Mediterranean diet during pregnancy can be beneficial. Studies have found that this diet does not increase common pregnancy issues such as nausea, vomiting, or constipation. In Japan, women who followed this diet had children with a lower risk of developing asthma. Additionally, evidence suggests that the Mediterranean diet might help prevent children from becoming overweight by age two.

The Med-South Lifestyle Program combines the traditional Mediterranean diet with Southern U.S. food habits to promote healthier eating. Participants in this study will receive extra virgin olive oil, nuts, and possibly meals tailored to their medical needs. This plan is not a medicine and therefore lacks the usual side effects of drugs. It focuses on dietary changes to improve health during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Med-South Lifestyle Program for pregnancy complications because it offers a holistic approach that combines lifestyle counseling with specific dietary changes, like adding extra virgin olive oil and nuts. These components are known for their heart-healthy benefits and could provide a natural way to address pregnancy complications, unlike standard medical treatments which may focus on medications or supplements. Another unique aspect of this program is the inclusion of medically tailored meals in one of the treatment arms, which is personalized to meet the nutritional needs of pregnant individuals. This comprehensive approach could offer a safer and more sustainable option for managing pregnancy complications.

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

Research has shown that following a Mediterranean-style diet during pregnancy can improve health for both mothers and babies. Studies indicate that this diet reduces the risk of having a baby smaller than expected for their age. In this trial, participants will join different treatment arms. One arm of the Med-South Lifestyle Program includes extra virgin olive oil and nuts, which have already improved health. Another arm adds specially prepared meals, making the diet easier to follow and potentially increasing its benefits. Overall, the Mediterranean diet is linked to positive pregnancy outcomes, and this program aims to make it easier and more effective to follow. ^{6 7 8 9 10}

Who Is on the Research Team?

Thomas Keyserling, MD

Principal Investigator

University of North Carollina at Chapel Hill

Are You a Good Fit for This Trial?

This trial is for pregnant individuals in their first trimester who are interested in improving their pregnancy outcomes through diet. Participants will receive dietary counseling to follow a Mediterranean-style diet adapted for the southern U.S., known as 'Med-South.'

Inclusion Criteria

Patient able to consume nuts, EVOO, or both

Patient plans to receive prenatal care at UNC OB/GYN at Weaver Crossing

Gestational age < 15 weeks

Exclusion Criteria

Pregnant with twins or a greater number of fetuses

Patient does not have access to internet by web, tablet, or smart phone

I am not fluent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Counseling

Participants are enrolled and receive dietary counseling sessions starting in the first trimester

Up to 24 weeks

10 counseling sessions (3 in-person, 7 phone or in-person)

Intervention

Participants receive Med-South dietary counseling and food provisions including extra virgin olive oil, nuts, and optionally medically tailored meals

Up to 24 weeks

4 optional phone counseling sessions

Follow-up

Participants are monitored for dietary adherence and pregnancy outcomes

Up to 36 weeks of pregnancy

What Are the Treatments Tested in This Trial?

Interventions

• Med-South Lifestyle Program for Pregnancy

Trial Overview The study tests the feasibility and acceptability of a 'Food is Medicine' program during early pregnancy. There are two groups: one receives extra virgin olive oil and nuts, while the other gets these plus frozen meals tailored to the Med-South diet.

How Is the Trial Designed?

Group I: Nuts, Extra Virgin Olive Oil, and Medically Tailored Meals Experimental Treatment 1 Intervention

Intervention includes lifestyle counseling and food provisions including extra virgin olive oil (EVOO), nuts, and medically tailored meals

Group II: Nuts and Extra Virgin Olive Oil Active Control 1 Intervention

Intervention includes lifestyle counseling and food provisions including extra virgin olive oil (EVOO) and nuts

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6566342/

The Impact of Mediterranean Dietary Patterns During ... Results show that being on a Mediterranean Diet during pregnancy is associated with favourable outcomes for both maternal and offspring health.

2. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1564567/full

Scaling up the Med-South Lifestyle Program in public ... We measured both implementation and effectiveness outcomes as described below. Study data were collected and managed using REDCap (Research ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8227784/

Mediterranean Diet and Lifestyle Habits during Pregnancy The Mediterranean diet (MD) is related to lower odds of being SGA. The study explored retrospectively the association between SGA, maternal MD ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900725002278

Effect of Mediterranean diet adherence during the third ... The aim of this study was to explore the impact of Mediterranean diet (MD) adherence during the third trimester of pregnancy on both maternal and newborn health ...

5. hpdp.unc.edu hpdp.unc.edu/completed-research/scaling-up-the-med-south-lifestyle-program-to-reduce-chronic-disease-in-partnership-with-rural-communities/

Scaling up the Med-South Lifestyle Program to Reduce ... This project is studying the most efficient and effective ways to scale up a previously proven lifestyle intervention, the Med-South Lifestyle Program, for use ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10096633/

Relationship between the Mediterranean Diet Score in ... In Japan, a high adherence to the Mediterranean diet during pregnancy was associated with a lower incidence of asthma in the offspring.

7. hpdp.unc.edu hpdp.unc.edu/med-south-lifestyle-program/

Med-South Lifestyle Program The Med-South Lifestyle Program blends a Mediterranean style of eating with traditional Southern food culture to help people eat healthier and become more ...

8. nature.com nature.com/articles/s41366-024-01626-z

Effects of Mediterranean diet during pregnancy on the ... MD during pregnancy could be an effective strategy for preventing pediatric overweight or obesity at 24 months.

9. link.springer.com link.springer.com/article/10.1007/s10995-025-04078-7

Impact of Mediterranean Diet Adherence in Early ... Baseline adherence to the MedDiet was not proven to influence nausea, vomiting, and constipation during pregnancy.

10. mdpi.com mdpi.com/2075-1729/13/1/241

Mediterranean Dietary Pattern and Cardiovascular Risk in ... Our data suggest that the MedDiet could be improved in relation to the consumption of cereals, vegetables, and fish during pregnancy in order to reduce CV risk.