Med-South Lifestyle Program for Pregnancy

A Pilot Study of a Food is Medicine Intervention to Improve Pregnancy Outcomes

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Complications
• Intervention / Treatment: Behavioral: Med-South Lifestyle Intervention for Pregnancy--Arm 1; Behavioral: Med-South Lifestyle Intervention for Pregnancy--Arm 2

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).

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Center for Health Promotion and Disease Prevention/UNC-Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nuts and Extra Virgin Olive Oil; Intervention includes lifestyle counseling and food provisions including extra virgin olive oil (EVOO) and nuts	Behavioral: Med-South Lifestyle Intervention for Pregnancy--Arm 1; Intervention includes lifestyle counseling and food provisions including extra virgin olive oil and nuts
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent that would recommend this program to others who are pregnancy	Percent who report they strongly agree or agree (other options on scale -- neither, agree, strongly disagree) with the statement: "I would recommend this program to others who are pregnant."	Assessed at approximately 24 and 36 weeks of pregnancy
Percent of participants who take part in the 10 study counseling sessions	Percentage of participants who attend at 8 of the 10 sessions	from enrollment to delivery (approximately 40 weeks of pregnancy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal diet quality	Quality of diet during pregnancy assessed with modified Prevención con Dieta Mediterránea (PREDIMED) study screener. The modified PREDIMED screener consists of 12 items, each scored as healthful or not (1 for healthful and 0 for not healthful), with items summed for a total score.	Assessed at approximately 24 and 36 weeks of pregnancy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
skin carotenoids	Assessed by Reflection Spectroscopy Device ("Veggie Meter"™). Results is a score that reflects skin carotenoid content with is correlated with fruit and vegetable intake. The score is assessed 3 times and averaged.	Assessed at approximately 24 and 36 weeks of pregnancy

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Thomas Keyserling, MD, University of North Carollina at Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Actual): July 5, 2025
• Study Completion (Actual): July 5, 2025

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications
• Other Study ID Numbers: 24-0181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No