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Mediterranean Diet for Obesity in Pregnancy (MedDiet Trial)

N/A

Waitlist Available

Led By Julio Mateus Nino, MD, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks, 16, 24, 30 and 40

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two healthy diets in pregnant women to see which one is most beneficial. Participants randomly receive either ACOG program or MedDiet. Both diets focus on eating plants, with MedDiet emphasizing olive oil and limiting red meat. Participants get free food and assessments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves healthy eating programs rather than medications, side effects are minimal but may include changes in digestion due to dietary adjustments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks, 16, 24, 30 and 40

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks, 16, 24, 30 and 40

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks, 16, 24, 30 and 40 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Diet Adherence Assessment Scores

Secondary study objectives

Cardiometabolic biomarkers - C-reactive protein (CRP) levels

Cardiometabolic biomarkers - glucose level

Cardiometabolic biomarkers - hemoglobin A1C levels

+4 more

Other study objectives

Number of Adverse Pregnancy Outcomes (APO)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

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