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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two healthy diets for pregnant women to determine which better manages obesity. Participants will follow either the standard diet advice recommended by health experts (ACOG-based Dietary Program) or a Mediterranean diet (MedDiet Program), rich in fruits, vegetables, beans, and nuts. The trial provides free food and monitors participants' adherence to their assigned diet. It suits women in their first trimester with a body mass index (BMI) of 25 or higher who speak English or Spanish. As an unphased trial, this study offers a unique opportunity to contribute to valuable research on diet and pregnancy health.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Mediterranean diet is safe for pregnant women and offers several health benefits. Studies have found that following this diet during pregnancy can reduce the risk of developing gestational diabetes by 35%. This type of diabetes can occur during pregnancy and affect both the mother and baby. Additionally, adhering to the Mediterranean diet is linked to a 24% lower chance of becoming overweight or obese during pregnancy.

Women who follow this diet often gain less extra weight during pregnancy, which is beneficial because excessive weight gain can cause problems. The diet also appears to lower risks related to heart health. In summary, the Mediterranean diet is well-tolerated and may lead to better pregnancy outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mediterranean Diet (MedDiet) Program for obesity in pregnancy because it emphasizes a diet rich in plant-based foods and healthy fats, which could offer a natural and sustainable way to manage weight gain during pregnancy. Unlike many standard treatment options that focus on general dietary guidelines, the MedDiet specifically includes extra virgin olive oil as the main fat source and limits red meat, which may improve overall health for both the mother and baby. This approach not only aims to control weight but also potentially enhances heart health and reduces inflammation, offering multiple benefits beyond traditional dietary counseling.

What evidence suggests that this trial's dietary programs could be effective for obesity in pregnancy?

This trial will compare the Mediterranean Diet (MedDiet) Program with the American College of Obstetricians and Gynecologists (ACOG)-based Dietary Program. Research has shown that following the MedDiet during pregnancy might help prevent children from becoming overweight or obese by age two. Some studies suggest that closely adhering to this diet can lower the risk of a child being overweight by age four. The MedDiet is rich in fruits, vegetables, beans, and nuts, with olive oil as the main fat source. Additionally, this diet has been linked to a lower chance of pregnancy complications like preeclampsia (a condition with high blood pressure) and gestational diabetes (a type of diabetes that starts during pregnancy). These findings suggest that the MedDiet can be a healthy choice during pregnancy. ^{2 6 7 8 9}

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. nature.com nature.com/articles/s41366-024-01626-z

Effects of Mediterranean diet during pregnancy on the ... MD during pregnancy could be an effective strategy for preventing pediatric overweight or obesity at 24 months.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12114062/

Impact of Mediterranean Diet Adherence During ... Of the three study outcomes, incidence of preeclampsia ranged from 1% to 10%, GDM from 5% to 43%, and eGWG from 18.2% to 43.4%. Of the three ...

3. mdpi.com mdpi.com/2072-6643/16/4/532

Close Adherence to a Mediterranean Diet during ... Our findings suggest that closer adherence to the MedDiet during pregnancy may protect against the risk of offspring overweight/obesity at 4 years.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03337802?tab=table

Effect of Mediterranean Diet During Pregnancy on the ... The PREMEDI study has been designed to evaluate the effects of Mediterranean Diet during pregnancy on the occurrence of overweight/obesity at 24 months in the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325001267

Dietary Patterns and Diet Quality before and/or during ... Limited consistent evidence exists on how diet quality before and during pregnancy influences preterm birth and low birthweight risk.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6650045/

Mediterranean-style diet in pregnant women with metabolic ... Of the individual outcomes, the risk of gestational diabetes apparently decreased by 35% with the intervention.

7. nature.com nature.com/articles/s41598-025-21443-2

Association between mediterranean diet during pregnancy ... Radwan, H. et al. Adherence to the mediterranean diet during pregnancy is associated with lower odds of excessive gestational weight gain and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9860628/

Mediterranean Dietary Pattern and Cardiovascular Risk in ... Adequate adherence to the MedDiet was found for 54.2% of women who were considered to be without CV risk and 45.8% of women with CV risk. Our data suggest that ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323014461

Association between the Maternal Mediterranean Diet and ... Another meta-analysis, based on 113 publications from 51 cohort studies concluded that Mediterranean dietary patterns were linked to a reduced risk of SGA [57].