N/A
N=41
Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting
Gestational Weight Gain · Diet, Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05868954 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Diet Adherence Assessment Scores Continuous — 9.0; 11 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MedDiet Program (Behavioral); ACOG-based Dietary Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diet Adherence Assessment Scores Continuous |
9.0; 11 | — |
| SECONDARY Gestational Weight Gain (GWG) |
24.07; 19.54 | — |
| SECONDARY Cardiometabolic Biomarkers - Hemoglobin A1C Levels |
5.10; 4.90 | — |
| SECONDARY Cardiometabolic Biomarkers - C-reactive Protein (CRP) Levels |
1.00; 0.90 | — |
| SECONDARY Cardiometabolic Biomarkers - Triglycerides |
217.66; 261.23 | — |
| SECONDARY Cardiometabolic Biomarkers - Glucose Level |
86; 98 | — |
| SECONDARY Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic) |
73.93; 67.80 | — |
| SECONDARY Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic) |
73.93; 67.80 | — |
| SECONDARY Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic) |
73.93; 67.80 | — |
| SECONDARY Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic) |
73.93; 67.80 | — |
| SECONDARY Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic) |
118.13; 109.80 | — |
| SECONDARY Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic) |
118.13; 109.80 | — |
| SECONDARY Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic) |
118.13; 109.80 | — |
| SECONDARY Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic) |
118.13; 109.80 | — |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT05868954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.