Gestational Weight GainMedDietNCT05868954
Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting
A study testing MedDiet Program and ACOG-based Dietary Program in people with Gestational Weight Gain and Diet, Healthy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Weight Gain, Diet, Healthy
- What is being tested?
- MedDiet Program and ACOG-based Dietary Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Myers Park OB/GYN
Charlotte, North Carolina, 28207
About this study
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.
Read the 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.
- Conditions
- Gestational Weight Gain, Diet, Healthy
- Being tested
- MedDiet Program, ACOG-based Dietary Program
- Keywords
- Mediterranean Diet, Overweight, Pregnant Women, Obese
- Medical subject headings
- Gestational Weight Gain, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedDiet ProgramBehavioural
Subjects allocated to the MedDiet Program group will receive counseling based on the principles of the traditional MedDiet with a focus on a general change in diet instead of micronutrients or macronutrients. Diet adherence will be assessed using a 14 question questionnaire. Participants will receive 6, free traditional MedDiet meals every 3 weeks between enrollment and until the subject is approximately 38 weeks pregnant. In addition, participants will receive olive oil and nuts during their enrollment visit and during their routine 26-30 week prenatal visit.
ACOG-based Dietary ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-based Dietary Program | Active comparator | Routine dietary counseling program Receives: Behavioral: ACOG-based Dietary Program |
| Mediterranean Diet (MedDiet) Program | Experimental | 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. Receives: Behavioral: MedDiet Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 38
Secondary outcomes (13)
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.
Measured: week 40
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.
Measured: Week 30
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.
Measured: Week 30
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.
Measured: Week 30
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.
Measured: Week 30
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.
Measured: Week 16
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.
Measured: Week 24
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.
Measured: Week 30
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.
Measured: Week 38
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.
Measured: Week 16
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.
Measured: Week 24
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.
Measured: Week 30
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.
Measured: Week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start31 Aug 2023
- Primary completion30 Nov 2024
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gestational Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Julio Mateus Nino, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868954
- Sponsor's protocol ID
- IRB00096969
- Other IDs
- UL1TR001420
- Acronym
- MedDiet
- Status last verified
- Mar 2025
- First submitted
- 11 May 2023
- Last updated
- 8 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting
- ClinicalTrials.gov ID
- NCT05868954
- Acronym / sponsor ID
- MedDiet / IRB00096969
- Conditions
- Gestational Weight Gain, Diet, Healthy
- Keywords
- Mediterranean Diet, Overweight, Pregnant Women, Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Posted 8 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| American College of Obstetricians and Gynecologists (ACOG)-based Dietary Program | Active comparator | Behavioral: ACOG-based Dietary ProgramRoutine dietary counseling program |
| Mediterranean Diet (MedDiet) Program | Experimental | Behavioral: MedDiet ProgramWell-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedDiet ProgramSubjects 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. | Behavioural | Mediterranean Diet (MedDiet) Program |
| ACOG-based Dietary ProgramFollowing 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. | Behavioural | American College of Obstetricians and Gynecologists (ACOG)-based Dietary Program |
Primary outcome
Diet Adherence Assessment Scores Continuous
Time frame: week 38
The Routine Healthy Diet Assessment Questionnaire consists of 15 items. Each item is scored as 1 for adherence and 0 for non-adherence, with some items having trimester-specific scoring. The total score is the sum of all items, ranging from 0 (no adherence) to 15 (full adherence). Higher scores indicate better adherence to the routine healthy diet .The MedDiet Assessment Questionnaire consists of 17 items. Each item is scored as 1 for adherence and 0 for non-adherence. The total score is the sum of all items, ranging from 0 (no adherence) to 17 (full adherence). Higher scores indicate better adherence to the Mediterranean diet.
13 secondary outcomes
Gestational Weight Gain (GWG)
Time frame: week 40
Cardiometabolic Biomarkers - Hemoglobin A1C Levels
Time frame: Week 30
Cardiometabolic Biomarkers - C-reactive Protein (CRP) Levels
Time frame: Week 30
Cardiometabolic Biomarkers - Triglycerides
Time frame: Week 30
Cardiometabolic Biomarkers - Glucose Level
Time frame: Week 30
Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic)
Time frame: Week 16
Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic)
Time frame: Week 24
Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic)
Time frame: Week 30
Cardiovascular Parameters - Blood Pressure (BP) Values (Diastolic)
Time frame: Week 38
Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic)
Time frame: Week 16
Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic)
Time frame: Week 24
Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic)
Time frame: Week 30
Cardiovascular Parameters - Blood Pressure (BP) Values (Systolic)
Time frame: Week 38
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Mateus Nino, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedDiet Program and ACOG-based Dietary Program in people with Gestational Weight Gain and Diet, Healthy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Adherence Assessment Scores Continuous (time frame: week 38). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.