Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374199
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Med-South Lifestyle Program for Pregnancy
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
A Pilot Study of a Food is Medicine Intervention to Improve Pregnancy Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None