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NCT05868954 | ACTIVE NOT RECRUITING | Gestational Weight Gain


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

Wake Forest University Health Sciences

Brief Summary:

The purpose of this research is to compare two healthy diet styles during pregnancy. Sixty pregnant women between 8 and 16 weeks will participate. Participates 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 how will they are following to the diet plan they were randomized to.

Condition or disease

Gestational Weight Gain

Diet, Healthy

Intervention/treatment

MedDiet Program

ACOG-based Dietary Program

Phase

NA

Detailed Description:

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 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. A growing body of evidence demonstrates that outside of pregnancy, the MedDiet is associated with a reduction of cardiovascular disease, diabetes, metabolic syndrome, and certain cancers. However, the potential clinical benefits of MedDiet in pregnancy are understudied with most data originating from clinical trials in Europe. Proper nutrition during pregnancy has multiple health benefits. A mother eating a healthy diet has a higher probability of meeting the demands required for a normal fetal development. In addition, she is more likely to achieve the recommended gestational weight gain thereby reducing the risk of pregnancy-related complications. Finally, a healthy diet is associated with a reduction of chronic conditions such as cardiovascular disease and diabetes later in life for both the mother and the infant.

Study Type : INTERVENTIONAL
Estimated Enrollment : 41 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting
Actual Study Start Date : 2023-08-31
Estimated Primary Completion Date : 2024-11-30
Estimated Study Completion Date : 2025-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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 \< 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

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

Location Details

NCT05868954


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Locations


Not yet recruiting

United States, North Carolina

Atrium Health Myers Park OB/GYN

Charlotte, North Carolina, United States, 28207

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