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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Eating a Mediterranean-style diet during pregnancy improves pregnancy outcomes, yet most Americans who are pregnant do not follow this type of dietary pattern. There is increasing interest in Food is Medicine programs, which provides foods to patients to improve health outcomes - food provided in this context is called medically tailored meals. The research team at the UNC Center for Health Promotion and Disease Prevention is developing a Food is Medicine program to improve pregnancy outcomes and at this point the team is ready to test the program. The purpose of this study is to assess the feasibility and acceptability of a Food is Medicine intervention when started during the first trimester of pregnancy. The eating pattern to be evaluated in this study is a Mediterranean-style dietary pattern adapted for the southern United States - thus, the program is called "Med-South." All who take part will receive Med-South dietary counseling. In addition, to help participants follow a Med-style dietary pattern, one group of study participants will receive extra virgin olive oil and nuts. The other group will receive extra virgin olive oil, nuts, and frozen meals (medically tailored meals) that align with the Med-South dietary pattern. Participants will be assigned at random (like flipping a coin) to one of these groups

Research Team

Thomas Keyserling, MD

Principal Investigator

University of North Carollina at Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+