Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting
Phase: NA
Conditions: Gestational Weight Gain, Diet, Healthy
Sponsor: Wake Forest University Health Sciences

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Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women 
in a Low-resource Clinical Setting 
 
 
 
 
 
NCT05868954 
 
IRB Approval Date:  23JUL2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women 
in a Low-resource Clinical Setting 
 
 
Principle Investigator: 
Julio Mateus Nino, MD, PhD 
 
Co-investigators: 
 
Gretchen Hoelscher, MS 
 
 
 
 
Silvia Triana, BS, RD, LDN 
 
 
 
 
Leah Ledford, MSN, WHNP-BC 
 
 
 
 
Sequoia Finney, BS 
Nicole El Helou, MD  
 
 
 
 
 
 
 
Ada Ventura Braswell, MD, MBA 
Mara Vitolins, DrPD 
 
Funding Source: CTSI Pilot Award - July 2023-June 2024 
 
Background, Rational, and Context 
Maternal overweight and obesity are the most common medical conditions diagnosed in the 
United States1-4 and are associated with serious adverse maternal and infant health 
outcomes.2,4,5-7 The burden of the disease is stressing our health care system due to the 
increasing prevalence of obesity and related chronic conditions.8,9 There is a linear association 
between increasing maternal body mass index (BMI) and pregnancy complications including 
gestational diabetes mellitus (GDM), hypertensive disorders of pregnancy (HDP), preterm birth 
(PTB), and cesarean delivery.2,4,5-7 Gestational weight gain (GWG) that exceeds the Institute of 
Medicine (IOM) recommendations10 occurs in approximately 50% of overweight or obese 
women11 further increasing the risk of obstetrical complications.5,6,12Western-style diet is a 
major contributor to the obesity epidemic in the United States.13,14  
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.15,16 In 
addition, she is more likely to achieve the recommended gestational weight gain thereby 
reducing the risk of pregnancy-related complications.15-19 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.16,20  
Behavioral lifestyle interventions aimed to optimize health and improve clinical outcomes of 
overweight [body mass index (BMI) 25.0-29.9 kg/m2] or obese [BMI ≥30.0 kg/m2] pregnant 
women are essential given the dramatic increasing prevalence of these conditions in the United 

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States.1-4 Although several lifestyle dietary-based intervention programs evaluated in clinical 
trials demonstrated overall good efficacy controlling gestational weight gain in obese women,17-
19 the impact of these interventions on pregnancy and neonatal outcomes has been 
inconsistent.21-23 Diet components,21 quality of the nutritional program,21 degree of diet 
adherence,24 and duration of intervention25,26 are factors that influence positively or negatively 
the clinical efficacy of a dietary intervention 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 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.27 A growing body of evidence demonstrates that outside of pregnancy, 
the MedDiet is associated with a reduction of cardiovascular disease,28,29 diabetes,30,31 metabolic 
syndrome,32 and certain cancers.33 However, the potential clinical benefits of MedDiet in 
pregnancy are understudied with most data originating from clinical trials in Europe.34,35 For 
example, a recent European randomized trial found that the consumption of the MedDiet 
during pregnancy reduced GWG,36 GDM,34,36 and increased birth weight in pregnancies which 
were at risk of low birth weight.35 However, in the United States which has a pregnant 
population consuming predominantly the Western-style diet,13 data are more limited and 
constricted to cohort studies.37,38  
We propose to examine the feasibility of implementing a structured MedDiet program 
beginning in the first or early second trimester maximizing dietary intervention exposure 
throughout gestation for overweight or obese pregnant women in a low-resource setting. Our 
investigation will help to address health disparities by offering a unique opportunity to 
investigate this program in a socially vulnerable and highly racial/ethnic diverse pregnant 
population in the United States. We provide care to women living in zip codes areas (i.e., 28212, 
28215, and 28217) characterized by elevated levels of unemployment (28%-32%), around 15% 
of the adult population did not complete high school, and the median annual income is between 
$33,781 and $45,983 (www.unitedstateszipcodes.org). Approximately 51% of our patients are 
uninsured with 6-10% requiring financial assistance for medical visits. The race/ethnic 
distribution consists of 10% White non-Hispanic, 25% Black non-Hispanic, and 59% Hispanic 
women. Approximately 50% of our pregnant population is overweight or obese. 
We expect our investigation will provide new insights on the implementation process, the 
factors that facilitate or prevent adherence and sustainability, and preliminary data on the 
clinical efficacy of this healthy diet style. Our findings will serve as the foundation of larger 
clinical trials powered to evaluate pregnancy and neonatal outcomes, clinical studies designed 
to investigate predictive, risk, diagnostic, and prognostic novel biomarkers, and prospective 
cohort studies that examine long-term maternal and neonatal health effects. We plan to apply 
to grants offered by the National Institutes of Health (NIH) in the maternal health and nutrition-
related research sections, to the Maternal and Child Health Nutrition Training Program, and 
Maternal and Child Health-Initiated Innovative Research Studies. We plan to translate the 
findings of our study into clinical practice as the screening tools, educational material, and meal 
guides in English and Spanish developed in this study will be optimal for use in routine 
obstetrical practice. We are committed to work with the leadership and administration of our 
organization to restructure the prenatal nutritional program. 
Therefore, if our study is successful in implementing a sustainable evidence-based dietary 
program, the next step will be to establish a specialized nutritional prenatal care service 
designed to prevent clinical complications and improve pregnancy outcomes. This will involve 

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increasing the dedicated time and frequency of comprehensive dietary counseling sessions 
during gestation. These sessions will be independent from routine prenatal care visits. In 
addition, we plan to work with local government and private healthy diet organizations to help 
socially vulnerable pregnant women overcome nutritional challenges.  
Objectives and Hypothesis  
Primary Objective 
To examine the feasibility and adherence to a MedDiet program initiated in the first or early 
second trimester of gestation (6-16 weeks) among overweight and obese women. 
Hypothesis: Overweight and obese pregnant women enrolled in the MedDiet program have an 
elevated level of adherence facilitated by the design of a comprehensive dietary program with 
free home-delivered meals, nuts, and EVOO bottles. This hypothesis will be tested by examining 
adherence to the MedDiet program using a validated screening tool.39 
Secondary Objectives 
1. To estimate the preliminary efficacy of a MedDiet intervention controlling gestational 
weight gain and reducing adverse pregnancy outcomes (APO).  
Hypothesis: Overweight or obese pregnant women consuming MedDiet have low rates of 
excessive gestational weight gain and adverse pregnancy outcomes. This hypothesis will be 
tested by comparing gestational weight gain and pre-selected pregnancy outcomes between 
women allocated in each dietary group.  
2. To estimate the preliminary impact of MedDiet intervention on maternal cardiometabolic 
profile. 
Hypothesis:  MedDiet leads to favorable effects on cardiovascular clinical parameters and 
cardiometabolic biomarkers in pregnancy. This hypothesis will be tested by comparing 
maternal cardiovascular parameters trends and cardiometabolic biomarkers during 
pregnancy among the studied groups.  
 
Methods and Measures 
Study Design 
Type of study 
This is a prospective, randomized, pilot study with a behavioral intervention. Sixty 
participants diagnosed as overweight (BMI 25.0-29.9 kg/m2) or obese (BMI ≥ 30.0 kg/m2) 
in the first or early second trimester of gestation will be invited to participate. 
Participants will be randomized to a MedDiet program or the currently offered 
American College of Obstetricians and Gynecologists (ACOG)-based dietary counseling 
program at Myers Park and North Park OBGYN Clinic(s) in Charlotte, North Carolina. 
Duration of Study and Participating Site 
This will be a multi-center study including Myers Park OB/GYN Clinic and North Park 
OB/GYN Clinic which are academic obstetrical practices providing prenatal care to a 
socially vulnerable and highly racial/ethnic diverse population. All new scheduled 
prenatal visits will be screened in Epic for eligibility by our research team. 

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We anticipate full completion of the study by July 2025. 
 
Study population (Table 1) 
Inclusion Criteria 
Exclusion 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 (BMI calculator available at 
www.cdc.gov)  
• Confirmed intrauterine pregnancy by 
ultrasound exam (6-16 weeks) 
• Age 18 years or older 
• Primary language of English or Spanish 
• 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 
• Food insecurity 
 
Sample Size 
Since this is a pilot study, we aim to enroll 60 participants with 30 per study arm. Based 
on the patient population at Myers Park, we anticipate the following racial/ethnic 
breakdown of subjects. 
Table 2 Anticipated Enrollment (all subjects will be female) 
Race 
Non-Hispanic Hispanic 
Total 
Asian 
1 
0 
1 
Black or African American 
15 
0 
15 
White 
6 
36 
42 
More than One Race 
2 
0 
2 
Total 
24 
36 
60 
 
 

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Methods and Intervention 
• 
Fig 1 and Table 3 provide a detailed view of the study activities. 
• 
With the purpose of overcoming language barriers, the dietary program was developed in 
English and Spanish. Multiple aids were created including practical educational tools, recipes, 
shopping list, and meal portion guidance to improve engagement and enhance sustainability.  
 
Randomization and Study Groups: 
• 
Following informed consent and eligibility confirmation, subjects will be randomized in blocks of 
4 using a single sequence computer-generated random number40 to balance for baseline BMI 
category (overweight or obese Random allocation number assigned to MedDiet program 
(intervention group) or ACOG-based nutritional counseling (control group) will be in a sealed 
opaque envelope.  
o Subjects allocated to the ACOG-based Dietary Program (Control Group) will receive:  
▪ 
Following ACOG recommendation, routine counseling on healthy eating will be 
provided. This will include advice on the consumption of grains, fruits, 
vegetables, protein, and dairy foods recommended during pregnancy (Nutrition 
During Pregnancy | ACOG ) 41  (www.myplate.gov). (Appendix A-F 
(English)/Appendix G-L (Spanish)) 
▪ 
Diet adherence will be assessed using a Routine Diet Adherence Questionnaire 
(Appendix M (English)/Appendix N (Spanish)). 
▪ 
Six traditional healthy meals will be shipped by ModifyHealth LLC directly to the 
participant’s home every 3 weeks between enrollment and until the subject is 
approximately 38 weeks pregnant.   
▪ 
Participants will receive canola oil and a healthy snack during their enrollment 
visit and during their routine 26-30 week prenatal visit  
o Subjects allocated to the MedDiet Program (Intervention Group) group will receive: 
▪ 
Counseling based on the principles of the traditional MedDiet27 with a focus on 
a general change in diet instead of micronutrients or macronutrients. (Appendix 
O-P;SS-UU (English)/Appendix Q-R; VV-XX (Spanish) 
▪ 
Diet adherence will be assessed using a modified version of the validated 
MedDiet Adherence Questionnaire.39 (Appendix S (English)/Appendix T 
(Spanish)) 
▪ 
Six traditional MedDiet meals will be shipped by ModifyHealth LLC directly to 
the participant’s home every 3 weeks between enrollment and until the subject 
is approximately 38 weeks pregnant.   
▪ 
Participants will receive olive oil and nuts during their enrollment visit and 
during their routine 26-30 week prenatal visit. 
 
 

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Baseline Visit: 
• 
All subjects will participate in a 30-minute baseline Nutritional Assessment and Diet Counseling 
Session regardless of the arm they are randomized to. This will occur during their initial prenatal 
visit at 6-16 weeks of pregnancy. The following items will be covered in this visit: 
o Subjects will complete an enrollment questionnaire to obtain demographic and baseline 
diet/physical activity information (Appendix U (English)/Appendix V (Spanish))  
o Subjects will complete a form for ModifyHealth so their free meals will be delivered to 
their home (Appendix VV (Spanish)/ Appendix WW (English))  
o Additional subject enrollment data will be collected by the enrolling research teammate 
regarding a history of eating disorders, tobacco/alcohol/substance use, insurance 
coverage, phone number, and email (Appendix W(Spanish)/Appendix SS (English)). 
o 
Subjects will complete the Federation of Gynecology and Obstetrics (FIGO)42 Nutrition 
Checklist (Appendix X (English)/Appendix Y (Spanish)). This is a validated tool used to 
assess the subject’s quality of diet.  It consists of six yes/no questions (www.figo.org) 
and at least one “no” response will be classified as a suboptimal diet.42 
o All subjects will have a total of 8 ml of blood drawn for the following tests: 
▪ 
C-reactive protein (CRP) panel 
▪ 
metabolic panel that includes glucose level 
▪ 
the lipid panel 
▪ 
hemoglobin A1c 
The blood sample collection form will be completed at each timepoint (Appendix Z) 
o All subjects will receive dietary advice for the diet they have been randomized to by a 
registered dietitian with expertise in nutrition during pregnancy (ST, Co-I). (Appendix A-
C; F (English)/Appendix G-;-L (Spanish) or Appendix O-P (English)/Appendix Q-R 
(Spanish)) 
▪ 
Educational materials for each diet program such as recipes, shopping lists, and 
meal plans will be discussed, and the material will be printed for the 
participant’s use at home. (Appendix A-F (English)/Appendix G-L (Spanish) or 
Appendix O-P; SS (English)/Appendix Q-R; VV (Spanish)) 
▪ 
Routine counseling of physical activity and exercise based on ACOG 
recommendations (ACOG Committee Opinion No 804) will be provided. If there 
are no clinical contraindications, women will be encouraged to start with low 
intensity, short periods of exercise at least 4 times a week. (Appendix A-F 
(English)/Appendix G-L (Spanish) or Appendix O-P (English)/Appendix Q-R 
(Spanish)) 
o All subjects will be screened for household food insecurity, as well as, reliable 
transportation, housing, and a support system using the standard OB Social Worker 
Assessment  questionnaire which all patients complete as part of their routine care 
(Appendix AA (English)/Appendix BB (Spanish)).43 Women who screen positive for 
household food insecurity will be excluded from the study and referred to our clinic 

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social worker or registered dietitian for information on community resource assistance 
such as Loaves and Fishes, a Charlotte-based food bank. 
o Participants will be counseled to control gestational weight gain (GWG) following the 
Institute of Medicine (IOM) recommendations: 
▪ 
Total GWG of 15-25 lb. for overweight women (BMI 25.0-29.9 kg/m2)  
▪ 
Total GWG 0f 11-20 lb. for obese women (BMI ≥ 30.0 kg/m2).10 
Trimester Visits: 
• 
An additional ~20-minute in-person, virtual, or phone call dietary counseling sessions will be 
scheduled at the following time points (Figure 1). 
o Between 20-24 weeks of pregnancy 
o Between 26-30 weeks of pregnancy 
o Between 34-38 weeks of pregnancy 
These sessions will include the following: 
o The following questionnaires will be completed: 
▪ 
Routine Healthy Diet Assessment Questionnaire ((Appendix M 
(English)/Appendix N (Spanish)) or the MedDiet Assessment Questionnaire 
(Appendix S (English)/Appendix T (Spanish)) 
▪ 
Diet and Physical Activity Recall (Appendix CC (English)/Appendix DD (Spanish)) 
▪ 
Trimester Collection Form (Appendix EE-GG) 
o Education and reinforcement of diet recommendations will be provided by addressing 
the subjects’ questions and issues. 
o Subjects will receive recipes specific for the ACOG Routine Healthy Diet ((Appendix D-E 
(Engligh)/Appendix J-K (Spanish)) or the MedDiet ((Appendix TT-UU (English)/ Appendix 
WW-XX (Spanish)). Recipes will either be printed for the subjects or sent via EPIC  
o If no clinical contraindications were established during the baseline visit, subjects will be 
encouraged to gradually increase their length and intensity of physical activity and 
exercise as tolerated from the first trimester until delivery. This will be based on ACOG 
recommendations.44  
o Participants will continue to be counseled to control gestational weight gain following 
the IOM recommendations: 
▪ 
Total GWG of 15-25 lbs for overweight women (BMI 25.0-29.9 kg/m2)  
▪ 
Total GWG of 11-20 lb. for obese women (BMI ≥ 30.0 kg/m2).10 
o The time length for all sessions will be recorded. 
o Between 26-30 weeks, all subjects will have a total of 8 ml of blood drawn for the 
following tests: 
▪ 
C-reactive protein (CRP) 
▪ 
metabolic panel that includes glucose level 
▪ 
the lipid panel (total cholesterol, triglycerides, high-density lipoprotein 
(HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol) 
▪ 
hemoglobin A1c 
The blood sample collection form will be completed at each timepoint (Appendix Z) 
• 
For each meal received from ModifyHealth, subjects will be asked to take share a photo (via 
REDCap using the subject's cell phone number or email, EPIC, or in-person) of the uneaten food. 

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Data on subjects’ history and pregnancy/neonatal outcomes will be collected via EPIC: 
• 
The following data will be collected from EPIC for all subjects  
o Medical history (Appendix HH (Spanish)/Appendix TT(English))) 
o Reproductive, and obstetric history including all prior pregnancy 
complications/outcomes and neonate outcomes (Appendix II (Spanish)/Appendix 
UU(English))) 
o Current pregnancy labs (Appendix JJ) 
o Current pregnancy, scans, complications, progress reports, clinic reports, hospital 
reports  
o Current pregnancy outcomes (Appendix KK) 
o Neonatal outcomes will be collected up to 6-weeks post-delivery including all birth 
data and complications (Appendix LL) 
 
 
 
• 
Data regarding any adverse events will be collected on the Adverse Event form. (Appendix MM).  
• 
Data collected on data collection forms (Appendix HH-LL) and then transferred to REDCap. 
 
 
 

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Table 3 
 
Screening/ 
Enrollment/ 
Randomization 
Between 20-24 
weeks of pregnancy 
Between 26-30 
weeks of pregnancy 
Between 34-38 
weeks of pregnancy 
Routine 
Diet 
MedDiet 
  
Routine 
Diet 
MedDiet 
  
Routine 
Diet 
MedDiet 
  
Routine 
Diet 
MedDiet 
  
Informed 
consent  
X 
X 
  
  
  
  
  
  
Inclusion/ 
Exclusion 
criteria  
X 
X 
  
  
  
  
  
  
Medical record 
release  
X 
X 
  
  
  
  
  
  
Medical, 
reproductive, 
& obstetric 
history*  
X 
X 
  
  
  
  
  
  

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Nutrition 
(FIGO) 
checklist 
X 
X 
  
  
  
  
  
  
Food 
insecurity 
screening 
X 
X 
  
  
  
  
  
  
Diet 
information & 
handouts 
provided 
X 
X 
  
  
  
  
  
  
Diet and 
physical 
activity 
counseling 
X 
X 
X 
X 
X 
X 
X 
X 
Blood draw 
for: 
1. CRP 
2. metabolic 
panel 
3. Lipid panel 
4. A1C  
X 
X 
  
  
X 
X 
 
 
MedDiet 
adherence 
screening 
  
  
  
X 
  
X 
  
X 
Routine Diet 
adherence 
screening 
 
 
X 
 
X 
 
X 
 
6 meals 
delivered every 
3 weeks 
 X 
X 
 X 
X 
X  
X 
X  
X 
Olive oil and 
nuts provided 
  
X 
  
 
  
X 
  
 
Canola oil and 
healthy snack 
provided 
X 
 
 
 
X 
 
 
 
 Exercise/food 
recall and 
general 
assessment 
questionnaire  
  
  
X 
X 
X 
X 
X 
X 
Pregnancy 
data collected* 
X 
X 
X 
X 
X 
X 
X 
X 
Delivery data 
collected** 
  
  
  
  
  
  
  
  
Neonatal data 
collected** 
  
  
  
  
  
  
  
  
*Data will be collected through medical records 
**Data will be collected at 6 weeks post-delivery through medical records. 
 
 
Outcomes 

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• 
Diet Adherence Assessment: Adherence of both groups will be assessed with a questionnaire 
based on a validated diet adherence questionnaire39 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. 
• 
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 IOM guidelines for overweight and obese women10 
will be compared between the MedDiet and the control group.  
• 
Adverse Pregnancy Outcomes (APO): We will examine the most common Adverse Pregnancy 
Outcomes (APO) associated with overweight and obesity (Table 3).2,4,5-7,45-51 Definition and 
management of all APO will follow the standardized guidelines at Myers Park OBGYN clinic. 
• 
Cardiovascular parameters:  MedDiet is associated with reduction of blood pressure (BP) in non-
pregnant adult overweight or obese women.52 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.53 Heart rate (HR) 
increases by 20% to 25% over baseline during gestation.54 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. 
• 
Cardiometabolic biomarkers:  Consumption of MedDiet is associated with lower levels of total 
cholesterol,53 reduces insulin resistance preventing type 2 diabetes30,31 and GDM,34,36 and 
reduces markers of subclinical inflammation such as C-reactive protein (CRP).55 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,56 and 
pregnancy is a state of increased insulin resistance.57 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 (6-16 
Table 3 Adverse Pregnancy Outcomes (APO) 
APO 
Prevalence in Pregnant Women 
HDP (preeclampsia, eclampsia, or 
gestational hypertension) 
4-6% of overweight/obese women BMI ≥3045 
12% in women with a BMI ≥4046 
GDM 
6-14% in overweight/obese women47 
PTB 
10.2% in US in 2021 was 10.2% (www.cdc.gov); data 
suggest increased risk among overweight/obese women 
48-50 
Cesarean Delivery 
29.9% in NC in 2020 (www.cdc.gov); There is a dose-
response relationship between pre-pregnancy BMI and 
cesarean delivery rate.4,7,51 
Large for Gestational Age (LGA) 
infant 
Data suggestion relationship between LGA (birth weight 
>90th percentile) and overweight /obese women7,51 

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weeks) 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.             
 
Analytical Plan 
This is prospective randomized pilot study of sixty participants who will be randomly allocated in 
the MedDiet group or in the control group. Because this is a pilot study, a sample size was not 
calculated. Results will be analyzed initially using descriptive statistics. Comparison between 
groups will be done using chi square tests for proportions, and t-tests or ANOVA procedures for 
continuous variables. Regression analysis will be performed to identify independent outcome 
predictors. Other inferential statistical analysis will be conducted as appropriate. 
    
Human Subjects Protection 
Screening and Recruitment 
Approximately 30 new prenatal visits are scheduled in our clinic weekly and we anticipate 10 of 
those patients will be eligible. All pregnancy confirmation visits will be screened by a research 
member (PI, Co-PI, study coordinator) in Epic to establish eligibility. The following PHI will be 
collected for screening purposes: 
• 
Name 
• 
MRN 
• 
Age 
• 
BMI  
• 
Diagnosis of pre-pregnancy diabetes 
• 
Hemoglobin glycosylated (A1C) value at pregnancy confirmation visit 
• 
Diagnosis of pre-pregnancy hypertensive disease 
• 
Confirmation of viable singleton pregnancy 
• 
Gestational age of pregnancy 
• 
Primary language of English or Spanish 
• 
Food allergies 
Screening data will be entered into an Excel spreadsheet stored on a secure drive which only the 
research team will have access to.  
At the first prenatal visit, women who meet inclusion/exclusion criteria will be presented a flyer 
(Appendix NN (English)/ Appendix OO (Spanish)) and invited to participate in the study. Eligibility 
will be confirmed following informed consent and the Eligibility Form will be completed 
(Appendix PP). 
 
 
Informed Consent  
At the first prenatal visit, women who meet inclusion/exclusion criteria will be invited to 
participate in the study. Signed informed consent (Appendix QQ (English)/Appendix RR 
(Spanish))) will be obtained from each subject by a member of the research team. If the 

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research member obtaining consent is not fluent in Spanish, an interpreter will be used. Consent 
will be obtained in a private room with a closed door in the clinic during the subject’s initial 
prenatal visit. Participants will be fully informed about the nature of the study and the potential 
risks of the dietary intervention, anticipated to be minimal as this is a behavioral intervention. 
 
Spanish Speaking Subjects 
All study related materials will be available in both English and Spanish. Qualified and trained 
 
Spanish language medical interpreters will be used to communicate with Spanish language 
 
participants if the investigators are not proficient in speaking Spanish. 
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that could 
directly identify subjects, and maintaining all study information in a secure manner. To help 
ensure subject privacy and confidentiality, only a unique study identifier will remain on the data 
collection forms. Any identifiable information collected on the forms will be blacked out after 
data has been entered into RedCap or the Excel linkage file. Any collected patient identifying 
information corresponding to the unique study identifier will be maintained on a linkage file, 
stored separately from the data. The linkage file will be kept secure, with access limited to 
designated study personnel. Following data collection subject identifying information will be 
destroyed (three years after closure of the study), consistent with data validation and study 
design, producing an anonymous analytical data set. Data access will be limited to study staff. 
Data and records will be kept locked and secured, with any computer data password protected. 
No reference to any individual participant will appear in reports, presentations, or publications 
that may arise from the study. 
 
 
 
Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of 
study participants. The principal investigator will be assisted by other members of the study 
staff. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol 
changes will be promptly reported by the principal investigator or designated member of the 
research team to the IRB and sponsor or appropriate government agency if appropriate.(Appendix 
MM) 
 
References 

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3. Driscoll AK, Gregory EC. Increases in Prepregnancy Obesity: United States, 2016-2019. 
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Appendix 
1. Appendix A-F: ACOG-based Dietary Program - English  
2. Appendix G-L: ACOG-based Dietary Program - Spanish 
3. Appendix M: Routine Diet Adherence Questionnaire - English 
4. Appendix N: Routine Diet Adherence Questionnaire - Spanish 
5. Appendix O-P; SS-UU: MedDiet Program - English 
6. Appendix Q-R; VV-XX: MedDiet Program - Spanish 
7. Appendix S: MedDiet Adherence Questionnaire - English 
8. Appendix T: MedDiet Adherence Questionnaire - Spanish 
9. Appendix U: Enrollment Questionnaire - English 
10. Appendix V: Enrollment Questionnaire - Spanish 
11. Appendix W: Enrollment Data -Spanish 
12. Appendix X: Federation of Gynecology and Obstetrics (FIGO)42 Nutrition Checklist - English 
13. Appendix Y: Federation of Gynecology and Obstetrics (FIGO)42 Nutrition Checklist – Spanish 
14. Appendix Z: Blood Sample Collection Form  
15. Appendix AA: OB Social Worker Assessment Questionnaire – 
16. Appendix BB: OB Social Worker Assessment Questionnaire -Spanish Data collection form 
17. Appendix CC: Diet and Physical Activity Recall - English 
18. Appendix DD: Diet and Physical Activity Recall - Spanish  
19. Appendix EE: 1st Trimester Collection Form 
20. Appendix FF: 2nd Trimester Collection Form 
21. Appendix GG: 3rd Trimester Collection Form 
22. Appendix HH: Medical History Form - Spanish 
23. Appendix II: Reproductive, and Obstetric History Form -Spanish 
24. Appendix JJ: Current Pregnancy Labs Form  
25. Appendix KK: Current Pregnancy Outcomes Form  
26. Appendix LL: Neonatal Outcomes Form  
27. Appendix MM: Adverse Event Form 

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28. Appendix NN: Study Flyer – English 
29. Appendix OO: Study Flyer - Spanish 
30. Appendix PP: Eligibility Confirmation Form 
31. Appendix QQ: Informed Consent - English  
32. Appendix RR: Informed Consent – Spanish 
33. Appendix SS Enrollment Data – English 
34. Appendix TT Medical History Form – English 
35. Appendix UU: Reproductive, and Obstetric History Form – English 
36. Appendix VV _Information for ModifyHealth – Spanish 
37. Appendix WW _Information for ModifyHealth –English