- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05868954
Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting (MedDiet)
September 26, 2023 updated by: Wake Forest University Health Sciences
The purpose of this research is to compare two healthy diet styles during pregnancy.
Sixty pregnant women between 8 and 16 weeks will participate.
Participates will be randomly assigned (like flipping a coin) to either receive routine healthy diet advice and counseling, or to receive advice and counseling for the Mediterranean style diet.
Our current routine healthy diet program follows the recommendations provided by the American College of Obstetricians and Gynecologists (ACOG).
It recommends the consumption of grains, fruits, vegetables, protein foods, and dairy foods during pregnancy.
The Mediterranean diet (MedDiet) is a well-known healthy diet that consists of a large amount of plant-based foods such as fruits, vegetables, beans, and nuts with olive oil as the principal source of fat.
Dairy, fish, and poultry are consumed in moderation and red meat only eaten occasionally.
Throughout their pregnancy, participants will receive free food and be assessed to determine how will they are following to the diet plan they were randomized to.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
The Mediterranean diet (MedDiet) is a well-known healthy diet that consists of a large amount of plant-based foods such as fruits, vegetables, beans, and nuts with extra virgin olive oil (EVOO) as the principal source of fat.
Dairy, fish, and poultry are consumed in moderation and red meat only eaten occasionally.
A growing body of evidence demonstrates that outside of pregnancy, the MedDiet is associated with a reduction of cardiovascular disease, diabetes, metabolic syndrome, and certain cancers.
However, the potential clinical benefits of MedDiet in pregnancy are understudied with most data originating from clinical trials in Europe.
Proper nutrition during pregnancy has multiple health benefits.
A mother eating a healthy diet has a higher probability of meeting the demands required for a normal fetal development.
In addition, she is more likely to achieve the recommended gestational weight gain thereby reducing the risk of pregnancy-related complications.
Finally, a healthy diet is associated with a reduction of chronic conditions such as cardiovascular disease and diabetes later in life for both the mother and the infant.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sequoia Finney, BS
- Phone Number: 704-355-8248
- Email: sequoia.finney@atriumhealth.org
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28207
- Atrium Health Myers Park OB/GYN
-
Contact:
- Julio Mateus Nino, MD, PhD
- Phone Number: 704-355-3149
- Email: Julio.MateusNino@atriumhealth.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: American College of Obstetricians and Gynecologists (ACOG)-based Dietary Program
Routine dietary counseling 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.
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Diet Adherence Assessment Scores
Time Frame: week 38
|
Adherence of both groups will be assessed with a questionnaire based on a validated diet adherence questionnaire during counseling sessions as described above.
Questionnaires will be scored with a "1" assigned to all responses corresponding to the recommended guidelines and a "0" assigned to all responses which do not correspond to the recommended guidelines.
The level of adherence will be defined based on the scale score as: ≤4 low adherence, 5-11 moderate adherence, and ≥ 12 high adherence.
|
week 38
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 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.
|
week 40
|
Cardiovascular parameters - blood pressure (BP) Values
Time Frame: Weeks, 16, 24, 30 and 40
|
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.
|
Weeks, 16, 24, 30 and 40
|
Cardiovascular parameters - Heart rate (HR) Values
Time Frame: Weeks, 16, 24, 30 and 40
|
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.
|
Weeks, 16, 24, 30 and 40
|
Cardiometabolic biomarkers - lipid profile
Time Frame: Baseline and 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.
|
Baseline and Week 30
|
Cardiometabolic biomarkers - glucose level
Time Frame: Baseline and 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.
|
Baseline and Week 30
|
Cardiometabolic biomarkers - hemoglobin A1C levels
Time Frame: Baseline and 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.
|
Baseline and Week 30
|
Cardiometabolic biomarkers - C-reactive protein (CRP) levels
Time Frame: Baseline and 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.
|
Baseline and Week 30
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Adverse Pregnancy Outcomes (APO)
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.
|
week 40
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Julio Mateus Nino, MD, PhD, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2023
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
May 11, 2023
First Submitted That Met QC Criteria
May 11, 2023
First Posted (Actual)
May 22, 2023
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00096969
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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