Mediterranean Diet for Obesity in Pregnancy
(MedDiet Trial)
Trial Summary
What is the purpose of this trial?
The purpose of this research is to compare two healthy diet styles during pregnancy. Sixty pregnant women between 8 and 16 weeks will participate. Participates will be randomly assigned (like flipping a coin) to either receive routine healthy diet advice and counseling, or to receive advice and counseling for the Mediterranean style diet. Our current routine healthy diet program follows the recommendations provided by the American College of Obstetricians and Gynecologists (ACOG). It recommends the consumption of grains, fruits, vegetables, protein foods, and dairy foods during pregnancy. The Mediterranean diet (MedDiet) is a well-known healthy diet that consists of a large amount of plant-based foods such as fruits, vegetables, beans, and nuts with olive oil as the principal source of fat. Dairy, fish, and poultry are consumed in moderation and red meat only eaten occasionally. Throughout their pregnancy, participants will receive free food and be assessed to determine how will they are following to the diet plan they were randomized to.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the Mediterranean Diet for Obesity in Pregnancy treatment?
Is the Mediterranean Diet safe for pregnant women?
How does the Mediterranean Diet treatment differ from other treatments for obesity in pregnancy?
The Mediterranean Diet treatment for obesity in pregnancy is unique because it emphasizes the consumption of extra virgin olive oil and nuts, which are known to improve pregnancy outcomes and reduce cardiovascular risk factors postpartum. This approach focuses on dietary quality rather than calorie restriction, which is different from many other weight management strategies.127910
Research Team
Julio Mateus Nino, MD, PhD
Principal Investigator
Wake Forest University Health Sciences
Eligibility Criteria
This trial is for overweight or obese pregnant women in their first trimester, with a BMI of 25.0 kg/m2 or higher. They must be at least 18 years old and speak English or Spanish. Women with multiple pregnancies except those reduced to a singleton are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dietary counseling and follow either the ACOG-based dietary program or the Mediterranean Diet program throughout their pregnancy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ACOG-based Dietary Program
- MedDiet Program
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator