Mediterranean Diet for Obesity in Pregnancy

(MedDiet Trial)

Overseen By Sequoia Finney, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Diabetes, Hypertension, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

41 Participants Needed

What You Need to Know Before You Apply

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.

Is the Mediterranean Diet safe for pregnant women?

The Mediterranean Diet, which includes extra-virgin olive oil and nuts, has been shown to be safe for pregnant women and may reduce the risk of gestational diabetes and other adverse pregnancy outcomes. ^{1 2 3 4 5}

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. ^{2 3 5 6 7}

What data supports the effectiveness of the Mediterranean Diet for Obesity in Pregnancy treatment?

Research shows that following a Mediterranean diet during pregnancy can help reduce excessive weight gain and postpartum weight retention, which are important for the health of both the mother and baby. ^{2 5 8 9 10}

Who Is on the Research Team?

Julio Mateus Nino, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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)

Exclusion Criteria

I had high blood pressure before getting pregnant.

Inability to read or write in primary language

Non-viable pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dietary counseling and follow either the ACOG-based dietary program or the Mediterranean Diet program throughout their pregnancy

32 weeks

Regular prenatal visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ACOG-based Dietary Program
• MedDiet Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Mediterranean Diet (MedDiet) Program Experimental Treatment 1 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 Program Active Control 1 Intervention

Routine dietary counseling program

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

Obesity is a growing global health crisis, particularly among pregnant women, leading to poor obstetrical and neonatal outcomes, as well as long-term health issues for both mothers and their infants.

Current guidelines for managing obesity in pregnancy are inconsistent and confusing, lacking standard recommendations for weight gain, nutritional needs, and preventive health services, highlighting the need for clearer protocols and broader healthcare coverage for obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives in obesity and pregnancy. Mariona, FG.[2023]

Citations

1. Spain pubmed.ncbi.nlm.nih.gov

The influence of obesity and diet quality on fetal growth and perinatal outcome. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Mediterranean Diet with an Enhanced Consumption of Extra Virgin Olive Oil and Pistachios Improves Pregnancy Outcomes in Women Without Gestational Diabetes Mellitus: A Sub-Analysis of the St. Carlos Gestational Diabetes Mellitus Prevention Study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet during pregnancy is associated with lower odds of excessive gestational weight gain and postpartum weight retention: results of the Mother-Infant Study Cohort. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Perspectives in obesity and pregnancy. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

[Analytic evaluation of a "Mediterranean" diet in pregnancy]. [2010]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Following Mediterranean Diet Recommendations in the Real World in the Incidence of Gestational Diabetes Mellitus (GDM) and Adverse Maternal-Foetal Outcomes: A Prospective, Universal, Interventional Study with a Single Group. The St Carlos Study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

An Early, Universal Mediterranean Diet-Based Intervention in Pregnancy Reduces Cardiovascular Risk Factors in the "Fourth Trimester". [2020]

8. England pubmed.ncbi.nlm.nih.gov

May the Mediterranean diet attenuate the risk of type 2 diabetes associated with obesity: the Seguimiento Universidad de Navarra (SUN) cohort. [2017]

9. Spain pubmed.ncbi.nlm.nih.gov

Association between the adherence to the Mediterranean diet and overweight and obesity in pregnant women in Gran Canaria. [2015]

10. Italy pubmed.ncbi.nlm.nih.gov

[Evaluation of the effect of a "Mediterranean diet" and pre-pregnancy body mass on fetal growth]. [2016]