Med-South Lifestyle Program for Pregnancy

NCT ID: NCT06374199

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-10
• Study Completion Date: 2025-07-05

Brief Summary

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

Detailed Description

For those taking part in this study, participation study will last from the enrollment visit (staring as early as possible during the 1st trimester, but < 15 weeks of pregnancy) to delivery-for most this will be about 24 weeks, but less for those who deliver early. There will be 10 counseling sessions throughout the study. Three sessions will be in-person and will include study measures. The other 7 sessions can be done over the phone or in person. Also, there are 4 optional phone counseling sessions. Each session will last approximately 10-45 minutes (except the first session, which may last an hour).

The risk of taking part in this study is minimal as the dietary pattern being tested is NOT experimental. This study is promoting a diet pattern that aligns with the United States Department of Agriculture (USDA) 2020-25 guidelines for people who are pregnant. A risk of all research studies is loss of confidentiality, but the study team will take all standard measures to reduce this risk.

In terms of benefits, if one takes part in this study and follows the dietary recommendations, pregnancy outcomes may be improved. Also, the food received as part of this study may be considered a benefit.

Both intervention groups will receive nuts and olive oil valued at $50 per month for up to 6 months (time of delivery). Participants in the group that only receives olive oil and nuts will also receive a grocery store gift card each month for up to 6 months (or time of delivery) while those in the group receiving medically tailored meals will receive 7 frozen meals a week for up to 6 months (or time of delivery).

Conditions

Pregnancy Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nuts and Extra Virgin Olive Oil

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

Group Type: ACTIVE_COMPARATOR

Med-South Lifestyle Intervention for Pregnancy--Arm 1

Intervention Type: BEHAVIORAL

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

Nuts, Extra Virgin Olive Oil, and Medically Tailored Meals

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

Group Type: EXPERIMENTAL

Med-South Lifestyle Intervention for Pregnancy--Arm 2

Intervention Type: BEHAVIORAL

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

Interventions

Med-South Lifestyle Intervention for Pregnancy--Arm 1

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

Intervention Type: BEHAVIORAL

Med-South Lifestyle Intervention for Pregnancy--Arm 2

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18 or older
• Patient plans to receive prenatal care at UNC OB/GYN at Weaver Crossing
• Patient deemed to have viable singleton pregnancy and approved for participation by OB clinician
• Gestational age < 15 weeks
• Patient able to consume nuts, EVOO, or both

Exclusion Criteria

• Patient is not fluent in English
• Patient does not have access to internet by web, tablet, or smart phone
• Type 1 diabetes
• Pregnant with twins or a greater number of fetuses

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Keyserling, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carollina at Chapel Hill

Locations

Center for Health Promotion and Disease Prevention/UNC-Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

24-0181

Identifier Type: -

Identifier Source: org_study_id