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N/A N=41 Randomized Prevention

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

Gestational Weight Gain · Diet, Healthy

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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