Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting (MedDiet)

Wake Forest University (WFU)

Status: Completed

Conditions: Gestational Weight Gain; Diet, Healthy

Treatments: Behavioral: MedDiet Program; Behavioral: ACOG-based Dietary Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05868954

IRB00096969

UL1TR001420 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this Pilot randomized clinical Trial is to compare two healthy diet styles during pregnancy. Patients between 8 and 16 weeks of gestation who agree to participate 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 adherence to the diet and receive counseling to reinforce diet recommendations.

Full description

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 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. A growing body of evidence demonstrates that outside of pregnancy, the MedDiet is associated with a reduction of cardiovascular disease, diabetes, metabolic syndrome, and certain cancers. However, the potential clinical benefits of MedDiet in pregnancy are understudied with most data originating from clinical trials in Europe. Proper nutrition during pregnancy has multiple health benefits. A mother eating a healthy diet has a higher probability of meeting the demands required for a normal fetal development. In addition, she is more likely to achieve the recommended gestational weight gain thereby reducing the risk of pregnancy-related complications. Finally, a healthy diet is associated with a reduction of chronic conditions such as cardiovascular disease and diabetes later in life for both the mother and the infant.

Enrollment: 41 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)
• Age 18 years or older
• Primary language of English or Spanish

Exclusion criteria

• BMI < 25.0 kg/m2
• Known pre-pregnancy diabetes
• Hemoglobin glycosylated (A1C) > 5.7% at first prenatal visit
• Pre-pregnancy hypertensive disease
• Non-viable pregnancy
• Known allergies to an essential component(s) of MedDiet
• Inability to read or write in primary language
• Mental incapacity to make medical decisions

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

41 participants in 2 patient groups

American College of Obstetricians and Gynecologists (ACOG)-based Dietary Program

Active Comparator group

Description:

Routine dietary counseling program

Treatment:

Behavioral: ACOG-based Dietary Program

Mediterranean Diet (MedDiet) Program

Experimental group

Description:

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.

Treatment:

Behavioral: MedDiet Program