Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting

NACompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

August 31, 2023

Primary Completion Date

November 30, 2024

Study Completion Date

July 10, 2025

Conditions
Gestational Weight GainDiet, Healthy
Interventions
BEHAVIORAL

MedDiet Program

Subjects allocated to the MedDiet Program group will receive counseling based on the principles of the traditional MedDiet with a focus on a general change in diet instead of micronutrients or macronutrients. Diet adherence will be assessed using a questionnaire. Participants will receive 6, free traditional MedDiet meals every 3 weeks between enrollment and until the subject is approximately 38 weeks pregnant. In addition, participants will receive olive oil and nuts during their enrollment visit and during their routine 26-30 week prenatal visit.

BEHAVIORAL

ACOG-based Dietary Program

Following ACOG recommendation, subjects allocated to the ACOG-based Dietary Program group, will receive routine counseling on healthy eating. This will include advice on the consumption of grains, fruits, vegetables, protein, and dairy foods recommended during pregnancy. Diet adherence will be assessed using a questionnaire. Participants will receive 6, free traditional healthy meals every 3 weeks between enrollment and until the subject is approximately 38 weeks pregnant. In addition, participants will receive canola oil and healthy snacks during their enrollment visit and during their routine 26-30 week prenatal visit.

Trial Locations (1)

28207

Atrium Health Myers Park OB/GYN, Charlotte

All Listed Sponsors
collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

lead

Wake Forest University Health Sciences

OTHER

NCT05868954 - Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting | Biotech Hunter | Biotech Hunter