Mediterranean Diet for Obesity in Pregnancy
(MedDiet Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJulio Mateus Nino, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

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.

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

Viable singleton pregnancy in the first trimester (6 0/7- 16 6/7 weeks); includes twins reduced to singleton spontaneously or vanishing twin syndrome

BMI ≥ 25.0 kg/m2; calculated by dividing maternal weight in kilograms by height in meters squared using a calibrated scale and standard metric measure

Confirmed intrauterine pregnancy by ultrasound exam (6-16 weeks)

+2 more

Exclusion Criteria

I had high blood pressure before getting pregnant.

Inability to read or write in primary language

Non-viable pregnancy

+5 more

Participant Groups

The study compares two diet programs during pregnancy: the routine ACOG-based dietary advice versus the Mediterranean Diet (MedDiet) program, which emphasizes plant-based foods and olive oil as the main fat source. Participants will receive free food and guidance according to their assigned diet plan.

2Treatment groups

Experimental Treatment

Active Control

Group I: Mediterranean Diet (MedDiet) ProgramExperimental Treatment1 Intervention

Well-known healthy diet that consists of a large amount of plant-based foods such as fruits, vegetables, beans, and nuts with extra virgin olive oil (EVOO) as the principal source of fat. Dairy, fish, and poultry are consumed in moderation and red meat only eaten occasionally.

Group II: American College of Obstetricians and Gynecologists (ACOG)-based Dietary ProgramActive Control1 Intervention

Routine dietary counseling program