| 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. | | Posted | | Mean | Full Range | score on a scale | | week 38 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0009.0(7.5 to 10.0)
- OG00111(10.0 to 13.0)
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| |
| 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. | | Posted | | Mean | Standard Deviation | pounds | | week 40 | | | | ID | Title | Description |
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| OG000 | 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 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. | | OG001 | 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 a 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. |
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| 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. | | Posted | | Median | Inter-Quartile Range | percentage | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. |
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| 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. | | Posted | | Median | Inter-Quartile Range | mg/dL | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. |
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| 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. | | Posted | | Mean | Standard Deviation | mg/dL | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. |
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| 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. | | Posted | | Median | Inter-Quartile Range | mg/dL | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. |
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| 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. | | Posted | | Mean | Standard Deviation | mmHg | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 |
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| 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. | | Posted | | Mean | Standard Deviation | mmHg | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 |
|
| 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. | | Posted | | Mean | Standard Deviation | mmHg | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 |
|
| 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. | | Posted | | Mean | Standard Deviation | mmHg | | Week 38 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 |
|
| 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. | | Posted | | Mean | Standard Deviation | mmHg | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 |
|
| 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. | | Posted | | Mean | Standard Deviation | mmHg | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 |
|
| 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. | | Posted | | Mean | Standard Deviation | mmHg | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 |
|
| 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. | | Posted | | Mean | Standard Deviation | mmHg | | Week 38 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 |
|
| 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. | | Posted | | | | | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 |
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| 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. | | Posted | | Number | | Number of events | | week 40 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 | 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 a 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. |
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| 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. | | Posted | | Number | | Number of events | | week 40 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 | 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 a 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. |
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| 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. | | Posted | | Number | | Number of events | | week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 | 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 a 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. |
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| 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. | | Posted | | Number | | Number of events | | week 40 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 | 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 a 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. |
|
| 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. | | Posted | | Number | | Number of events | | week 40 | | | | ID | Title | Description |
|---|
| OG000 | 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 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. | | OG001 | 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 a 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. |
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