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Completed

NCT Number: NCT06374199

Med-South Lifestyle Program for Pregnancy

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

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Key information

Conditions

Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Chapel Hill, North Carolina, 27599, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Med-South Lifestyle Intervention for Pregnancy--Arm 1

Behavioral

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

Med-South Lifestyle Intervention for Pregnancy--Arm 2

Behavioral

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

Primary outcomes

  1. Percent that would recommend this program to others who are pregnancy

    Time frame: Assessed at approximately 24 and 36 weeks of 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."

  2. Percent of participants who take part in the 10 study counseling sessions

    Time frame: from enrollment to delivery (approximately 40 weeks of pregnancy)

    Percentage of participants who attend at 8 of the 10 sessions

Secondary outcomes

  1. Maternal diet quality

    Time frame: Assessed at approximately 24 and 36 weeks of pregnancy

    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.

Other outcomes

  1. skin carotenoids

    Time frame: Assessed at approximately 24 and 36 weeks of pregnancy

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2024
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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