Med-South Lifestyle Program for Pregnancy

Pregnancy Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06374199
• Other study ID #: 24-0181
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Thomas C. Keyserling, MD, MPH
• Phone: 9192596791
• Email: jato[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

Behavioral:
• Med-South Lifestyle Intervention for Pregnancy--Arm 1
Intervention includes lifestyle counseling and food provisions including extra virgin olive oil and nuts
• 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

Locations

Country	Name	City	State
United States	Center for Health Promotion and Disease Prevention/UNC-Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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