Med-South Lifestyle Program for Pregnancy

NCT06374199 | Completed

• 1 other identifier: 24-0181
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Pregnancy Complications

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Maternal diet quality

  Assessed at approximately 24 and 36 weeks of pregnancy

Other Outcomes (1)

• skin carotenoids

  Assessed at approximately 24 and 36 weeks of pregnancy

Study Arms (2)

Nuts and Extra Virgin Olive Oil

ACTIVE COMPARATOR

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

Behavioral: Med-South Lifestyle Intervention for Pregnancy--Arm 1

Nuts, Extra Virgin Olive Oil, and Medically Tailored Meals

EXPERIMENTAL

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

Interventions

Med-South Lifestyle Intervention for Pregnancy--Arm 1 BEHAVIORAL

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

Nuts and Extra Virgin Olive Oil

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

Nuts, Extra Virgin Olive Oil, and Medically Tailored Meals

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: The study will enroll participants who are pregnant whatever their gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Thomas Keyserling, MD

  University of North Carollina at Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Standard 2 group parallel randomized trial study design.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: May 10, 2024
• Primary Completion: July 5, 2025
• Study Completion: July 5, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)