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

NCT05868954 | Completed Results

• 2 other identifiers: IRB00096969UL1TR001420
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Weight Gain; Diet, Healthy

Keywords

Mediterranean Diet; Overweight; Pregnant Women; Obese

Outcome Measures

Primary Outcomes (1)

• Diet Adherence Assessment Scores Continuous

  The Routine Healthy Diet Assessment Questionnaire consists of 15 items. Each item is scored as 1 for adherence and 0 for non-adherence, with some items having trimester-specific scoring. The total score is the sum of all items, ranging from 0 (no adherence) to 15 (full adherence). Higher scores indicate better adherence to the routine healthy diet .The MedDiet Assessment Questionnaire consists of 17 items. Each item is scored as 1 for adherence and 0 for non-adherence. The total score is the sum of all items, ranging from 0 (no adherence) to 17 (full adherence). Higher scores indicate better adherence to the Mediterranean diet.

  week 38

Secondary Outcomes (13)

• Gestational Weight Gain (GWG)

  week 40

• Cardiometabolic Biomarkers - Hemoglobin A1C Levels

  Week 30

• Cardiometabolic Biomarkers - C-reactive Protein (CRP) Levels

  Week 30

• Cardiometabolic Biomarkers - Triglycerides

  Week 30

• Cardiometabolic Biomarkers - Glucose Level

  Week 30

Other Outcomes (6)

• Initial Heartrate

  Week 16

• Number of Adverse Pregnancy Outcomes - Gestational Hypertension, Pre-eclampsia, Eclampsia

  week 40

• Number of Adverse Pregnancy Outcomes (APO) Gestational Diabetes Mellitus

  week 40

Study Arms (2)

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

ACTIVE COMPARATOR

Routine dietary counseling program

Behavioral: ACOG-based Dietary Program

Mediterranean Diet (MedDiet) Program

EXPERIMENTAL

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.

Behavioral: MedDiet Program

Interventions

MedDiet Program BEHAVIORAL

Subjects allocated to the MedDiet Program group will receive counseling based on the principles of the traditional MedDiet with a focus on a general change in diet instead of micronutrients or macronutrients. Diet adherence will be assessed using a 14 question questionnaire. Participants will receive 6, free traditional MedDiet meals every 3 weeks between enrollment and until the subject is approximately 38 weeks pregnant. In addition, participants will receive olive oil and nuts during their enrollment visit and during their routine 26-30 week prenatal visit.

Mediterranean Diet (MedDiet) Program

ACOG-based Dietary Program BEHAVIORAL

Following ACOG recommendation, subjects allocated to the ACOG-based Dietary Program group, will receive routine counseling on healthy eating. This will include advice on the consumption of grains, fruits, vegetables, protein, and dairy foods recommended during pregnancy. Diet adherence will be assessed using an 18 question questionnaire. Participants will receive 6, free traditional healthy meals every 3 weeks between enrollment and until the subject is approximately 38 weeks pregnant. In addition, participants will receive canola oil and healthy snacks during their enrollment visit and during their routine 26-30 week prenatal visit.

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Viable singleton pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Atrium Health Myers Park OB/GYN

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Gestational Weight Gain; Overweight; Obesity

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Julio Mateus Nino, MD, PhD
• Organization: Wake Forest University Health Sciences

julio.mateusnino@advocatehealth.org

704-355-8248

Study Officials

• Julio Mateus Nino, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: August 31, 2023
• Primary Completion: November 30, 2024
• Study Completion: July 10, 2025
• Last Updated: December 8, 2025
• Results First Posted: December 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)