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NCT05868954Completed

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

Source: ClinicalTrials.gov · Last updated 8 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
41 (actual)
First submitted
11 May 2023
Start date
31 Aug 2023
Primary completion date
30 Nov 2024
Lead sponsor
Wake Forest University Health Sciences
Diseases
Obesity
NCT number
NCT05868954

What you commit to

  • Study type: Interventional
  • Participants enrolled: 41
  • From 31 Aug 2023 to the primary completion date, 30 Nov 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known pre-pregnancy diabetes
  • Pre-pregnancy hypertensive disease
  • Known allergies to an essential component(s) of MedDiet

Lab values

  • Hemoglobin glycosylated (A1C) \> 5.7% at first prenatal visit

Other

  • BMI \< 25.0 kg/m2
  • Non-viable pregnancy
  • Inability to read or write in primary language
  • Mental incapacity to make medical decisions

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Atrium Health Myers Park OB/GYN
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.