Clinical trial NCT05868954: Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting
Official title: Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gestational Weight Gain
Diet, Healthy
Keywords: Mediterranean Diet
Overweight
Pregnant Women
Obese
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-05-22
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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 \< 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

Primary outcomes:
measure: Change in Diet Adherence Assessment Scores
timeFrame: week 38
Secondary outcomes:
measure: Change in Gestational weight gain (GWG)
timeFrame: week 40
measure: Cardiovascular parameters - blood pressure (BP) Values
timeFrame: Weeks, 16, 24, 30 and 40
measure: Cardiovascular parameters - Heart rate (HR) Values
timeFrame: Weeks, 16, 24, 30 and 40
measure: Cardiometabolic biomarkers - lipid profile
timeFrame: Baseline and Week 30
measure: Cardiometabolic biomarkers - glucose level
timeFrame: Baseline and Week 30
measure: Cardiometabolic biomarkers - hemoglobin A1C levels
timeFrame: Baseline and Week 30
measure: Cardiometabolic biomarkers - C-reactive protein (CRP) levels
timeFrame: Baseline and Week 30
Other outcomes:
measure: Number of Adverse Pregnancy Outcomes (APO)
timeFrame: week 40
Locations:
city: Charlotte
country: United States
facility: Atrium Health Myers Park OB/GYN
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Julio Mateus Nino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: