Diet, Healthy, Gestational Weight Gain
Conditions
Keywords
Mediterranean Diet, Overweight, Pregnant Women, Obese
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.
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.
Interventions
BEHAVIORALMedDiet Program
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.
BEHAVIORALACOG-based Dietary Program
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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diet Adherence Assessment Scores Continuous | 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiometabolic Biomarkers - Hemoglobin A1C Levels | 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. |
| Gestational Weight Gain (GWG) | 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. |
| Cardiometabolic Biomarkers - C-reactive Protein (CRP) Levels | 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. |
| Cardiometabolic Biomarkers - Triglycerides | 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. |
| Cardiometabolic Biomarkers - Glucose Level | 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. |
| Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic) | 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. |
| Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Pregnancy Outcomes - Gestational Hypertension, Pre-eclampsia, Eclampsia | 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. |
| Number of Adverse Pregnancy Outcomes (APO) Preterm Birth | 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. |
| Number of Adverse Pregnancy Outcomes (APO) Cesarean Delivery | 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. |
| Number of Adverse Pregnancy Outcomes (APO) Large for Gestational Age Infant | 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. |
| Initial Heartrate | 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. |
| Number of Adverse Pregnancy Outcomes (APO) Gestational Diabetes Mellitus | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program Routine dietary counseling program
ACOG-based Dietary Program: 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 a 14 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. | 21 |
| Mediterranean Diet (MedDiet) Program 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.
MedDiet Program: 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 an 18 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. | 20 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Miscarriage | 0 | 1 |
| Overall Study | Participant delivered | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Mediterranean Diet (MedDiet) Program | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 20 Participants | 41 Participants |
| Age, Continuous | 30.24 years STANDARD_DEVIATION 5.36 | 26.86 years STANDARD_DEVIATION 5.32 | 28.59 years STANDARD_DEVIATION 5.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 20 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 15 Participants | 30 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 9 Participants |
| Region of Enrollment United States | 21 participants | 20 participants | 41 participants |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 8 / 21 | 7 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
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.
Time frame: week 38
| Arm | Measure | Value (MEAN) |
|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Diet Adherence Assessment Scores Continuous | 9.0 score on a scale |
| Mediterranean Diet (MedDiet) Program | Diet Adherence Assessment Scores Continuous | 11 score on a scale |
Secondary
Cardiometabolic Biomarkers - C-reactive Protein (CRP) Levels
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.
Time frame: Week 30
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Cardiometabolic Biomarkers - C-reactive Protein (CRP) Levels | 1.00 mg/dL |
| Mediterranean Diet (MedDiet) Program | Cardiometabolic Biomarkers - C-reactive Protein (CRP) Levels | 0.90 mg/dL |
Secondary
Cardiometabolic Biomarkers - Glucose Level
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.
Time frame: Week 30
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Cardiometabolic Biomarkers - Glucose Level | 86 mg/dL |
| Mediterranean Diet (MedDiet) Program | Cardiometabolic Biomarkers - Glucose Level | 98 mg/dL |
Secondary
Cardiometabolic Biomarkers - Hemoglobin A1C Levels
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.
Time frame: Week 30
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Cardiometabolic Biomarkers - Hemoglobin A1C Levels | 5.10 percentage |
| Mediterranean Diet (MedDiet) Program | Cardiometabolic Biomarkers - Hemoglobin A1C Levels | 4.90 percentage |
Secondary
Cardiometabolic Biomarkers - Triglycerides
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.
Time frame: Week 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Cardiometabolic Biomarkers - Triglycerides | 217.66 mg/dL | Standard Deviation 14.21 |
| Mediterranean Diet (MedDiet) Program | Cardiometabolic Biomarkers - Triglycerides | 261.23 mg/dL | Standard Deviation 36.27 |
Secondary
Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic)
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.
Time frame: Week 38
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic) | 73.93 mmHg | Standard Deviation 5.43 |
| Mediterranean Diet (MedDiet) Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic) | 67.80 mmHg | Standard Deviation 10.06 |
Secondary
Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic)
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.
Time frame: Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic) | 69.87 mmHg | Standard Deviation 8.34 |
| Mediterranean Diet (MedDiet) Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic) | 70.80 mmHg | Standard Deviation 9.9 |
Secondary
Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic)
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.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic) | 67.20 mmHg | Standard Deviation 6.49 |
| Mediterranean Diet (MedDiet) Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic) | 67.80 mmHg | Standard Deviation 11.91 |
Secondary
Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic)
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.
Time frame: Week 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic) | 67.20 mmHg | Standard Deviation 6.09 |
| Mediterranean Diet (MedDiet) Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic) | 66.60 mmHg | Standard Deviation 8.53 |
Secondary
Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic)
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.
Time frame: Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic) | 116.33 mmHg | Standard Deviation 9.34 |
| Mediterranean Diet (MedDiet) Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic) | 116.27 mmHg | Standard Deviation 9.91 |
Secondary
Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic)
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.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic) | 113.13 mmHg | Standard Deviation 10.14 |
| Mediterranean Diet (MedDiet) Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic) | 109.73 mmHg | Standard Deviation 12.4 |
Secondary
Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic)
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.
Time frame: Week 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic) | 114.00 mmHg | Standard Deviation 17.39 |
| Mediterranean Diet (MedDiet) Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic) | 109.53 mmHg | Standard Deviation 12.21 |
Secondary
Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic)
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.
Time frame: Week 38
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic) | 118.13 mmHg | Standard Deviation 7.91 |
| Mediterranean Diet (MedDiet) Program | Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic) | 109.80 mmHg | Standard Deviation 10.44 |
Secondary
Gestational Weight Gain (GWG)
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.
Time frame: week 40
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Gestational Weight Gain (GWG) | 24.07 pounds | Standard Deviation 10.47 |
| Mediterranean Diet (MedDiet) Program | Gestational Weight Gain (GWG) | 19.54 pounds | Standard Deviation 8.51 |
Other Pre-specified
Initial Heartrate
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.
Time frame: Week 16
Population: Data not collected
Other Pre-specified
Number of Adverse Pregnancy Outcomes (APO) Cesarean Delivery
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.
Time frame: week 40
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Number of Adverse Pregnancy Outcomes (APO) Cesarean Delivery | 7 Number of events |
| Mediterranean Diet (MedDiet) Program | Number of Adverse Pregnancy Outcomes (APO) Cesarean Delivery | 6 Number of events |
Other Pre-specified
Number of Adverse Pregnancy Outcomes (APO) Gestational Diabetes Mellitus
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.
Time frame: week 40
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Number of Adverse Pregnancy Outcomes (APO) Gestational Diabetes Mellitus | 3 Number of events |
| Mediterranean Diet (MedDiet) Program | Number of Adverse Pregnancy Outcomes (APO) Gestational Diabetes Mellitus | 5 Number of events |
Other Pre-specified
Number of Adverse Pregnancy Outcomes (APO) Large for Gestational Age Infant
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.
Time frame: week 40
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Number of Adverse Pregnancy Outcomes (APO) Large for Gestational Age Infant | 0 Number of events |
| Mediterranean Diet (MedDiet) Program | Number of Adverse Pregnancy Outcomes (APO) Large for Gestational Age Infant | 0 Number of events |
Other Pre-specified
Number of Adverse Pregnancy Outcomes (APO) Preterm Birth
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.
Time frame: week 36
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Number of Adverse Pregnancy Outcomes (APO) Preterm Birth | 2 Number of events |
| Mediterranean Diet (MedDiet) Program | Number of Adverse Pregnancy Outcomes (APO) Preterm Birth | 2 Number of events |
Other Pre-specified
Number of Adverse Pregnancy Outcomes - Gestational Hypertension, Pre-eclampsia, Eclampsia
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.
Time frame: week 40
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-Based Dietary Program | Number of Adverse Pregnancy Outcomes - Gestational Hypertension, Pre-eclampsia, Eclampsia | 5 Number of events |
| Mediterranean Diet (MedDiet) Program | Number of Adverse Pregnancy Outcomes - Gestational Hypertension, Pre-eclampsia, Eclampsia | 2 Number of events |