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Completed

NCT Number: NCT05868954

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

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.

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Key information

Conditions

Gestational Weight Gain Body Weight Body Weight Changes Diet, Healthy Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Myers Park OB/GYN

Charlotte, North Carolina, 28207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Diet Adherence Assessment Scores Continuous

    Time frame: week 38

    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.

Secondary outcomes

  1. Gestational Weight Gain (GWG)

    Time frame: week 40

    Total GWG will be calculated by subtracting the participant's weight (lbs.) at the initial prenatal visit from the weight (lbs.) at time of the delivery or at the last prenatal visit. GWG in the first trimester (6-13 weeks), second trimester (14-26 weeks), and third trimester (27-40 weeks) will also be calculated. Calibrated weight scales will be used at our clinic and at the hospital. Compliance rate of GWG based on Institute of Medicine (IOM) guidelines for overweight and obese women will be compared between the MedDiet and the control group.

  2. Cardiometabolic Biomarkers - Hemoglobin A1C Levels

    Time frame: Week 30

    Hypothesize that consuming the Mediterranean diet (MedDiet) may be associated with improved cardiometabolic biomarkers during pregnancy. Specifically, MedDiet might help reduce the physiological rise in lipids, enhance insulin sensitivity, and lower markers of subclinical inflammation, such as C-reactive protein (CRP). Pregnancy is usually marked by increased levels of total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides, especially in the second and third trimesters, along with increased insulin resistance. This study aims to determine whether MedDiet influences these biomarkers. Maternal lipid profiles, random glucose levels, hemoglobin A1C, and CRP will be measured at baseline (first or second trimester) and between 26-30 weeks of gestation among participants in both the intervention and control groups. Lab samples will be collected during routine blood draws for prenatal care.

  3. Cardiometabolic Biomarkers - C-reactive Protein (CRP) Levels

    Time frame: Week 30

    Consumption of MedDiet is associated with lower levels of total cholesterol, reduces insulin resistance preventing type 2 diabetes and Gestational diabetes mellitus (GDM), and reduces markers of subclinical inflammation such as C-reactive protein (CRP). Pregnancy is characterized by increased levels of total cholesterol, low-density lipoprotein (LDP), high-density lipoprotein (HDL), and triglycerides, especially in the second and third trimester, and pregnancy is a state of increased insulin resistance. There is limited knowledge about the effect of MedDiet on cardiometabolic biomarkers during pregnancy. Maternal lipid profile, random glucose level, hemoglobin A1C, and CRP levels will be compared at baseline (first or early second trimester) and at 26-30 weeks of gestation among participants in the intervention and the control groups. The labs will be obtained at the same time of scheduled blood draws for routine prenatal labs.

  4. Cardiometabolic Biomarkers - Triglycerides

    Time frame: Week 30

    Consumption of MedDiet is associated with lower levels of total cholesterol, reduces insulin resistance preventing type 2 diabetes and Gestational diabetes mellitus (GDM), and reduces markers of subclinical inflammation such as C-reactive protein (CRP). Pregnancy is characterized by increased levels of total cholesterol, low-density lipoprotein (LDP), high-density lipoprotein (HDL), and triglycerides, especially in the second and third trimester, and pregnancy is a state of increased insulin resistance. There is limited knowledge about the effect of MedDiet on cardiometabolic biomarkers during pregnancy. Maternal lipid profile, random glucose level, hemoglobin A1C, and CRP levels will be compared at baseline (first or early second trimester) and at 26-30 weeks of gestation among participants in the intervention and the control groups. The labs will be obtained at the same time of scheduled blood draws for routine prenatal labs.

  5. Cardiometabolic Biomarkers - Glucose Level

    Time frame: Week 30

    Consumption of MedDiet is associated with lower levels of total cholesterol, reduces insulin resistance preventing type 2 diabetes and Gestational diabetes mellitus (GDM), and reduces markers of subclinical inflammation such as C-reactive protein (CRP). Pregnancy is characterized by increased levels of total cholesterol, low-density lipoprotein (LDP), high-density lipoprotein (HDL), and triglycerides, especially in the second and third trimester, and pregnancy is a state of increased insulin resistance. There is limited knowledge about the effect of MedDiet on cardiometabolic biomarkers during pregnancy. Maternal lipid profile, random glucose level, hemoglobin A1C, and CRP levels will be compared at baseline (first or early second trimester) and at 26-30 weeks of gestation among participants in the intervention and the control groups. The labs will be obtained at the same time of scheduled blood draws for routine prenatal labs.

  6. Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic)

    Time frame: Week 16

    MedDiet is associated with reduction of blood pressure (BP) in non-pregnant adult overweight or obese women. Physiological changes of blood pressure (BP) during pregnancy are characterized by reduction of BP in the second trimester with return to the pre-pregnancy level late in the third trimester and postpartum period. Heart rate (HR) increases by 20% to 25% over baseline during gestation. Maternal BP and HR will be obtained by a calibrated automated oscillometric device during prenatal visits from the first to the third trimesters following the standardized technique established in our clinic. Trends of BP and HR throughout gestation will be compared among women allocated in the intervention and the control groups.

  7. Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic)

    Time frame: Week 24

    MedDiet is associated with reduction of blood pressure (BP) in non-pregnant adult overweight or obese women. Physiological changes of blood pressure (BP) during pregnancy are characterized by reduction of BP in the second trimester with return to the pre-pregnancy level late in the third trimester and postpartum period. Heart rate (HR) increases by 20% to 25% over baseline during gestation. Maternal BP and HR will be obtained by a calibrated automated oscillometric device during prenatal visits from the first to the third trimesters following the standardized technique established in our clinic. Trends of BP and HR throughout gestation will be compared among women allocated in the intervention and the control groups.

  8. Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic)

    Time frame: Week 30

    MedDiet is associated with reduction of blood pressure (BP) in non-pregnant adult overweight or obese women. Physiological changes of blood pressure (BP) during pregnancy are characterized by reduction of BP in the second trimester with return to the pre-pregnancy level late in the third trimester and postpartum period. Heart rate (HR) increases by 20% to 25% over baseline during gestation. Maternal BP and HR will be obtained by a calibrated automated oscillometric device during prenatal visits from the first to the third trimesters following the standardized technique established in our clinic. Trends of BP and HR throughout gestation will be compared among women allocated in the intervention and the control groups.

  9. Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic)

    Time frame: Week 38

    MedDiet is associated with reduction of blood pressure (BP) in non-pregnant adult overweight or obese women. Physiological changes of blood pressure (BP) during pregnancy are characterized by reduction of BP in the second trimester with return to the pre-pregnancy level late in the third trimester and postpartum period. Heart rate (HR) increases by 20% to 25% over baseline during gestation. Maternal BP and HR will be obtained by a calibrated automated oscillometric device during prenatal visits from the first to the third trimesters following the standardized technique established in our clinic. Trends of BP and HR throughout gestation will be compared among women allocated in the intervention and the control groups.

  10. Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic)

    Time frame: Week 16

    MedDiet is associated with reduction of blood pressure (BP) in non-pregnant adult overweight or obese women. Physiological changes of blood pressure (BP) during pregnancy are characterized by reduction of BP in the second trimester with return to the pre-pregnancy level late in the third trimester and postpartum period. Heart rate (HR) increases by 20% to 25% over baseline during gestation. Maternal BP and HR will be obtained by a calibrated automated oscillometric device during prenatal visits from the first to the third trimesters following the standardized technique established in our clinic. Trends of BP and HR throughout gestation will be compared among women allocated in the intervention and the control groups.

  11. Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic)

    Time frame: Week 24

    MedDiet is associated with reduction of blood pressure (BP) in non-pregnant adult overweight or obese women. Physiological changes of blood pressure (BP) during pregnancy are characterized by reduction of BP in the second trimester with return to the pre-pregnancy level late in the third trimester and postpartum period. Heart rate (HR) increases by 20% to 25% over baseline during gestation. Maternal BP and HR will be obtained by a calibrated automated oscillometric device during prenatal visits from the first to the third trimesters following the standardized technique established in our clinic. Trends of BP and HR throughout gestation will be compared among women allocated in the intervention and the control groups.

  12. Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic)

    Time frame: Week 30

    MedDiet is associated with reduction of blood pressure (BP) in non-pregnant adult overweight or obese women. Physiological changes of blood pressure (BP) during pregnancy are characterized by reduction of BP in the second trimester with return to the pre-pregnancy level late in the third trimester and postpartum period. Heart rate (HR) increases by 20% to 25% over baseline during gestation. Maternal BP and HR will be obtained by a calibrated automated oscillometric device during prenatal visits from the first to the third trimesters following the standardized technique established in our clinic. Trends of BP and HR throughout gestation will be compared among women allocated in the intervention and the control groups.

  13. Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic)

    Time frame: Week 38

    MedDiet is associated with reduction of blood pressure (BP) in non-pregnant adult overweight or obese women. Physiological changes of blood pressure (BP) during pregnancy are characterized by reduction of BP in the second trimester with return to the pre-pregnancy level late in the third trimester and postpartum period. Heart rate (HR) increases by 20% to 25% over baseline during gestation. Maternal BP and HR will be obtained by a calibrated automated oscillometric device during prenatal visits from the first to the third trimesters following the standardized technique established in our clinic. Trends of BP and HR throughout gestation will be compared among women allocated in the intervention and the control groups.

Other outcomes

  1. Initial Heartrate

    Time frame: Week 16

    MedDiet is associated with reduction of blood pressure (BP) in non-pregnant adult overweight or obese women.

    Physiological changes of blood pressure (BP) during pregnancy are characterized by reduction of BP in the second trimester with return to the pre-pregnancy level late in the third trimester and postpartum period. Heart rate (HR) increases by 20% to 25% over baseline during gestation. Maternal BP and HR will be obtained by a calibrated automated oscillometric device during prenatal visits from the first to the third trimesters following the standardized technique established in our clinic. Trends of BP and HR throughout gestation will be compared among women allocated in the intervention and the control groups.

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

    Time frame: week 40

    examine the most common Adverse Pregnancy Outcomes (APO) associated with overweight and obesity: preeclampsia, eclampsia, gestational hypertension, gestational diabetes mellitus, preterm birth, cesarean delivery, large for gestational age infant.

  3. Number of Adverse Pregnancy Outcomes (APO) Gestational Diabetes Mellitus

    Time frame: week 40

    examine the most common Adverse Pregnancy Outcomes (APO) associated with overweight and obesity: preeclampsia, eclampsia, gestational hypertension, gestational diabetes mellitus, preterm birth, cesarean delivery, large for gestational age infant.

  4. Number of Adverse Pregnancy Outcomes (APO) Preterm Birth

    Time frame: week 36

    examine the most common Adverse Pregnancy Outcomes (APO) associated with overweight and obesity: preeclampsia, eclampsia, gestational hypertension, gestational diabetes mellitus, preterm birth, cesarean delivery, large for gestational age infant.

  5. Number of Adverse Pregnancy Outcomes (APO) Cesarean Delivery

    Time frame: week 40

    examine the most common Adverse Pregnancy Outcomes (APO) associated with overweight and obesity: preeclampsia, eclampsia, gestational hypertension, gestational diabetes mellitus, preterm birth, cesarean delivery, large for gestational age infant.

  6. Number of Adverse Pregnancy Outcomes (APO) Large for Gestational Age Infant

    Time frame: week 40

    examine the most common Adverse Pregnancy Outcomes (APO) associated with overweight and obesity: preeclampsia, eclampsia, gestational hypertension, gestational diabetes mellitus, preterm birth, cesarean delivery, large for gestational age infant.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Acronym: MedDiet

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 22, 2023
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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