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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atrium Health Myers Park OB/GYN Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.