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Mediterranean Diet for Obesity in Pregnancy (MedDiet Trial)

N/A

Waitlist Available

Led By Julio Mateus Nino, MD, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks, 16, 24, 30 and 40

Awards & highlights

MedDiet Trial Summary

This trial compares two healthy diets in pregnant women to see which one is most beneficial. Participants randomly receive either ACOG program or MedDiet. Both diets focus on eating plants, with MedDiet emphasizing olive oil and limiting red meat. Participants get free food and assessments.

Who is the study for?

This trial is for overweight or obese pregnant women in their first trimester, with a BMI of 25.0 kg/m2 or higher. They must be at least 18 years old and speak English or Spanish. Women with multiple pregnancies except those reduced to a singleton are not eligible.Check my eligibility

What is being tested?

The study compares two diet programs during pregnancy: the routine ACOG-based dietary advice versus the Mediterranean Diet (MedDiet) program, which emphasizes plant-based foods and olive oil as the main fat source. Participants will receive free food and guidance according to their assigned diet plan.See study design

What are the potential side effects?

Since this trial involves healthy eating programs rather than medications, side effects are minimal but may include changes in digestion due to dietary adjustments.

MedDiet Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks, 16, 24, 30 and 40

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks, 16, 24, 30 and 40

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks, 16, 24, 30 and 40 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Diet Adherence Assessment Scores

Secondary outcome measures

Cardiometabolic biomarkers - C-reactive protein (CRP) levels

Cardiometabolic biomarkers - glucose level

Cardiometabolic biomarkers - hemoglobin A1C levels

+4 more

Other outcome measures

Number of Adverse Pregnancy Outcomes (APO)

MedDiet Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mediterranean Diet (MedDiet) ProgramExperimental Treatment1 Intervention

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.

Group II: American College of Obstetricians and Gynecologists (ACOG)-based Dietary ProgramActive Control1 Intervention

Routine dietary counseling program

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,240 Previous Clinical Trials

1,004,147 Total Patients Enrolled

Julio Mateus Nino, MD, PhDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

ACOG-based Dietary Program Clinical Trial Eligibility Overview. Trial Name: NCT05868954 — N/A

Pregnancy Weight Gain Research Study Groups: American College of Obstetricians and Gynecologists (ACOG)-based Dietary Program, Mediterranean Diet (MedDiet) Program

Pregnancy Weight Gain Clinical Trial 2023: ACOG-based Dietary Program Highlights & Side Effects. Trial Name: NCT05868954 — N/A

ACOG-based Dietary Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05868954 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for participants of this trial?

"According to the clinicaltrials.gov database, this research protocol is not presently in need of new enrollees. The study was first listed on July 1st 2023 and last updated May 11th 2023. However, there are currently 495 other studies that are actively recruiting participants for their trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05868954.

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