Examining the Effect of Hyper-personalized Nutrition Advice for OBGYN Patients on Health and Wellbeing Outcomes During and After Pregnancy
Phase: NA
Conditions: Nutrition, Healthy, Nutrition Poor, Pregnancy Related
Sponsor: Olivia Sher

Title: Examining the effect of hyper-personalized 
nutrition advice for OBGYN patients on health and 
wellbeing outcomes during and after pregnancy
Unique Protocol ID: 2022-03-15
Document Date: December 15,  2022 

 
 
 
Summary and Significance: Dietary quality and total energy intake during pregnancy 
significantly influences the mother’s health during pregnancy and that of the fetus as well as 
decade long influences on the health outcomes of the child. However, a one size fits all approach 
to nutritional guidance is far from ideal given the unique biological, lifestyle, demographic, and 
health condition differences of expecting mothers. This research proposal will examine the effect 
of precision nutrition on the health and wellbeing outcomes of mothers during pregnancy, at the 
time of delivery, and post-delivery. Personal nutritional guidance is  based on personal 
biological, behavioral, and health data. 
Hypothesis. Personalized nutrition advice, monitoring, and feedback provided during prenatal 
care will result in improved cardiometabolic profiles during pregnancy, gestational weight gain 
within targeted goals, improved wellbeing as reported by the mother and greater satisfaction with 
prenatal care as well as birthweight for gestational age in the optimal range. 
Target Population and exclusions: Pregnant patients of Maimonides Medical Center less than 20 
weeks gestation at the time of randomization. Exclusions are: High-risk patients with severe 
obesity (BMI >35), existing pre-conditions such as diabetes, hypertension, cardiac abnormalities, 
and need for special medical attention 
Population power required: A minimum of 75 participants per group (total 150) will be required 
for a continuous endpoint measure for independent outcome measures for an expected 20% 
reduction in complications expected in the intervention group with a 25% of mean standard 
deviation, alpha=0.05, beta=0.1, and power of 80%. 
Intervention and control group assignments: Patients consenting to participation will be 
randomly assigned with the control group receiving the usual nutrition consultation process in 
the hospital whenever available. The intervention group will go through a personalized nutrition 
assessment including DNA-based predisposition analysis for micronutrient, macronutrient, and 
metabolic needs as well as a baseline health-based lifestyle screening questionnaire. Intervention 
group participants will then receive personalized nutrition advice during regular OBGYN visits. 
All participants will be asked the same health questionnaires during their regular OBGYN visits 
and in post-delivery follow-ups. 
Data Collection 

Data collection will include the standard clinical and patient intake form data, as well as data 
collection done at regular OBGYN visits for both groups. For the intervention group, DNA test 
data and nutrition-focused health questionnaire data will   be collected. For both groups 
additional data on energy and mood levels, pregnancy-related symptoms, activity levels and 
nutritional intake data will be collected. Additionally, clinical outcome data on birth and post-
birth complications for both groups will be used in the final analysis. 
STUDY OBJECTIVES 
Research Question. What is the impact of continuous personalized nutrition advice, 
monitoring, and feedback on objective and self-reported health and wellbeing measures and 
outcomes for healthy women during pregnancy, at childbirth, and post-delivery? 
HYPOTHESIS 
Hypothesis. Personalized nutrition advice, monitoring, and feedback provided during prenatal 
care will result in improved cardiometabolic profiles during pregnancy, gestational weight gain 
within targeted goals, improved wellbeing as reported by the mother and greater satisfaction 
with prenatal care as well as birthweight for gestational age in the optimal range. 
Background / Significance: 
INTRODUCTION 
Dietary quality and total energy intake during pregnancy significantly influences the mother’s 
health during pregnancy and that of the fetus as well as decade long influences on the health 
outcomes of the child . However, a one size fits all approach to nutritional guidance is far from 
ideal given the unique biological, lifestyle, demographic, and health condition differences of 
expecting mothers. This research proposal will examine the effect of precision nutrition on the 
health and wellbeing outcomes of mothers during pregnancy, at the time of delivery, and post-
delivery. Personal nutritional guidance is based on personal biological, behavioral, and health pre-
condition data. 
BACKGROUND AND SIGNIFICANCE 
According to the CDC, between 1993 and 2014 the number of pregnant women with hypertensive 
disorders increased by 100%. A significant portion of that comes with obesity and BMI issues 
before and during pregnancy. 
And postpartum hemorrhage rates have increased 6 folds in the same timeframe, and there is a 
strong linkage with antenatal iron−folic acid use. Therefore, there is little doubt that healthy and 
targeted nutrition can help reduce many of these complications. However, the actual influence of 

personalized nutrition, i.e., nutritional advice that is customized and tailored to the individual’s 
biology, preexisting health conditions, physiology, and lifestyle has not been adequately studied. 
Source: Center for Disease Control, Pregnancy Complications Bulletin 
https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pregnancy-complications.html 
Source: Center for Disease Control, Pregnancy Complications Bulletin 
https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pregnancy-complications.html 
STUDY DESIGN 
The proposed study design is a randomized controlled trial (RCT) with  a one arm treatment 
group compared to  a control group. Pregnant women visiting the hospital (subject to exclusion 
criteria) will be assigned randomly to an intervention group receiving personalized nutrition 
guidance and a control group receiving the standard nutrition advice during their visits. 
Subjects/Target Population: Pregnant patients of Maimonides Medical Center less than 20 
weeks gestation at the time of randomization. 
Eligibility Requirements/Exclusions: High-risk patients with severe obesity (BMI >35), 
existing pre-conditions such as diabetes, hypertension, cardiac abnormalities, , and need for 
special medical attention 
Sample Size/Population power required: A minimum of 75 participants per group (total 150) 
will be required for a continuous endpoint measures for independent outcome measures for an 
expected 20% reduction in complications expected in the intervention group with a 25% of 
mean standard deviation, alpha=0.05, beta=0.1, and power of 80%. 
Intervention and control group assignments: Patients consenting to participation will be 
randomly assigned to either  control group or an intervention group. All participants will be 
asked the same health and wellbeing outcome questionnaires during their regular OBGYN 
visits and in post-delivery follow-ups. 
Control group treatment: The control group will receive the usual nutrition consultation process 
in the hospital whenever available. This includes basic nutrition guidance provided by the 
OBGYN during the first visit as well as any referrals to the hospital nutritionist due to gestational 
diabetes, excessive weight gain, or other nutrition-related complications that may arise during 
the pregnancy and identified at regular OBGYN visits. 

Intervention group treatment: The intervention group will be provided with DNA swab kits to 
collect samples that combined with and a baseline health and lifestyle screening questionnaire 
can provide an assessment of the patient’s micronutrient, macronutrient, and metabolic needs 
Intervention group participants will then receive personalized nutrition advice, recipes, and meal 
plans during regular OBGYN visits and provide information on food intake and adherence in 
between visits. 
Data collection: Data collection will include the standard clinical and patient intake form data, 
as well as data collection done at regular OBGYN visits for both groups. For the intervention 
group, DNA test data and nutrition-focused health questionnaire data will be collected. For both 
groups additional data on energy and mood levels, pregnancy-related symptoms, activity levels 
and nutritional intake data will be collected. Additionally, clinical outcome data on birth and post-
birth complications for both groups will be used in the final analysis. 
Data collected for intervention outcome assessment 
 
1. 
ICD-9 CM Maternal Morbidity Indicators 
Maternal Morbidity Indicator 
ICD-9-CM Codes 
Chronic hypertension 
642.0x, 642.1x, 642.2x, 642.7x, 401.x, 
402.x, 403.x, 404.x, 405.x 
Hypertensive disorder in pregnancy ( 
Pre-eclampsia, Eclampsia and Gestational 
Hypertension) 
642.3x, 642.4x, 642.5x, 642.6x, 642.9x 
Blood transfusion 
99.0x 
Cesarean Hysterectomy 
‘683’, ‘6831’, ‘6839’, ‘684’, ‘6841’, ‘6849’, 
‘685’, ‘6851’, ‘6859’, ‘686’, ‘6861’, ‘6869’, 
‘687’, ‘6871’, ‘6879’, ‘689’ 
Obstetric tamponade of uterus or vagina 
‘758’ 

Repair of current obstetric laceration of 
uterus 
‘7550’, ‘7552’ 
Uterine artery ligation/embolization 
‘3979’*, ‘9929’*, ‘6825’**, ‘6824’** 
 
Pulmonary embolism 
415.1x, 673.2 
 
 
Deep venous thrombosis 
4534, 453.5x, 453.7x, 453.8x, 453.9x, 
 
Gestational Diabetes 
671.3x, 671.4x, 9972 
Asthma, Renal Disease Sepsis, and Stroke 
2. 
Delivery Outcomes 
 
· 
Preterm Birth 
 
· 
Miscarriages 
 
· 
Full-term Vaginal Birth 
 
· 
Cesarean Section 
 
· 
Shoulder Dystocia 
 
· 
Vacuum Assisted Vaginal Delivery 
 
· 
Intrauterine Fetal Demise 
 
· 
Low APGAR scores or NICU admission 
3. 
Symptoms during pregnancy 
Review of systems form on the SCM 
 
· 
General 
 
· 
Neurological 
 
· 
Breast 
 
· 
Respiratory 
 
· 
Gastrointestinal 
 
· 
Genitourinary 
 
· 
Musculoskeletal 
 
· 
Endocrinological 
 
· 
Gestational Age 
 
· 
Fundal Height 
 
· 
Fetal presentation 

 
· 
Fetal heart rate 
 
· 
Fetal movement 
 
· 
Preterm labor 
 
· 
Blood pressure 
 
· 
Edema 
 
· 
Urine protein glucose 
 
· 
Weight and nutritional screening 
 
· 
Depression 
 
· 
COVID-19 status 
4. 
Self-reported pregnancy experience 
 
· 
Mood measures (Likert scale) 
 
· 
Fatigue 
 
· 
Mental health wellbeing (stress, depression, etc.) 
 
· 
Joyousness 
 
· 
Satisfaction with prenatal care 
5. Social Determinants of Health 
While it is not expected that personalized nutrition advice will impact social determinants of 
health, tracking the actual conditions of the patients will allow for a better understanding of the 
social environment of the trial. 
 
· 
Interpersonal Violence 
 
· 
Barriers to Appointments 
 
· 
Substance Use 
 
· 
Unstable housing 
 
· 
Access to food resources 
 
· 
Financial Instability 
 

Data Analysis 
Data inclusion/exclusion 
The table below identifies the data inclusion/exclusion criteria for data analysis. 
Statistical Analysis methodology 
For each continuous measure of interest, two sample t-test will be performed. For Likert-scale 
data a non-parametric Mann-Whitney test will be used. For categorical type data, a chi-square 
test will be employed. A null hypothesis for each measure of interest is that there is no 
difference between control and precision nutrition (intervention) group at the significance level 
0.05. Additionally, we will construct scores for each category: maternal morbidity indicator 
score, delivery score, symptoms during pregnancy and emotional score. Each score will 
integrate objective or self-reported measures from each category. The scores will be compared 
between the intervention and control groups using statistical tests. 
10. 
Expected Outcomes: Describe specific outcomes or results you expect to see as a 
result of this study (e.g., treatment group will be higher on outcome measure X than 
control group). 
It is expected that individuals within the intervention/treatment group will exhibit at least 20% 
improved outcomes (statistically significant change of group average) in the form of risk 
reduction for risky outcomes, and score improvement for positive outcomes in one or more of the 
following outcome categories over a 9-month period following the start of the intervention: 
Outcome Category A) ICD-9 Maternal Morbidity Indicators (See data collection) (Composite 
Mortality Index based on all mortality metrics) 
Outcome Category B) Pregnancy Symptoms (within the pregnancy period) (Composite Score of 
Individual Metrics) (See collection data for detailed) 
11. 
Timetable: Provide an approximate timetable for your study including 
achievement of key milestones. Include in your timetable any preparatory work needed to 
carry out the study. 

 
· 
IRB Approval Completed (Day 0) 
 
· 
Protocol refinement (Days 1-14) 
 
· 
Subject recruitment and consent management (Days 14-74) 
· 
Nutritional needs assessment (DNA testing) for treatment group (Days 15-75) 
· 
Study start date for participants (Days 30-90) (Individuals start the protocol at 
different times following recruitment) 
· 
Interventions (Physician visit and guidance) (Days 30-334) (Every 4 weeks after 
starting for those recruited by day 30 for 9 months) 
 
· 
Year 1 data analysis and hypothesis validation (Days 334-355) 
 
· 
Start of year 2 study cohort