The 'Standard of Care Plus' ('PLUS') model in the ROOT Study consists of analyzing select micronutrient and gene variants of pregnant females to construct trimester-specific and personalized nutrition and lifestyle recommendations in collaboration with in-person standard obstetric care (SOC).
In 2014, the investigators demonstrated statistically significant reductions in adverse maternal and infant outcomes using the 'PLUS' model compared to SOC alone. Further study in a 50% Medicaid Oregon 'PLUS' cohort (N=387) demonstrated association with highly significant risk reductions in all primary outcomes (p-value \<0.001): preterm birth: relative risk (RR) = 0.238 (4.2x less likely), hypertensive disorders of pregnancy: RR = 0.229 (4.4x less likely), gestational diabetes: RR = 0.071 (14x less likely), small for gestational age: RR = 0.252 (4x less likely), and large for gestational age: RR = 0.357 (2.8x less likely). A 100% Medicaid and ethnically diverse Nevada 'PLUS' cohort showed similar trends in all outcomes that were not statistically significant because of small sample size.
Structured as a prospective interventional study, the study evaluates whether the 'PLUS' model can achieve similar outcome improvements within the Novant Health (NH) system in North Carolina. The study will assess both clinical outcomes and digital nutrition platform performance within the existing healthcare infrastructure.
The primary hypothesis of the ROOT study is that collaborative implementation of the 'PLUS' nutritional care model at NH Triad Obstetrics/Gynecology (OB/GYN) Clinic will be associated with reduced maternal and infant adverse outcome rates when compared to historical regional and NH system outcomes in those who received SOC alone.
The secondary hypothesis of the ROOT Study is that the 'PLUS' model applied during pregnancy will be associated with reduced pediatric adverse outcomes. The 'PLUS' offspring that remain in the NH system will be observed longitudinally over 5 years with chart review at birth through 2 weeks of age, and at 1, 3, and 5 years of life. The outcomes assessed include neonatal intensive care unit (NICU) admission in the first two weeks of life, atopic dermatitis, eczema, asthma, allergies, otitis media, obesity, and autism. The 'PLUS' adverse outcome rates will be compared to adverse outcome rates in children born regionally and nationally under SOC alone.
Participant compliance with the 'PLUS' model, and participant and nutritionist access to the digital health platform will be studied during each trimester of use, as well as in the postpartum time period. The exploratory hypothesis is that the digital platform will not affect access, compliance, and rates of maternal and neonatal adverse outcomes.
Pregnant women receiving care at NH Triad OB/GYN
≤20 weeks gestational age at enrollment
Age ≥ 18 years (<18 years requires parental consent)
Ability to provide informed consent
> 20 weeks gestational age
High-risk pregnancies requiring specialized care beyond study scope
Inability to participate in digital health platform
Cognitive impairment preventing informed consent
Single group
'Standard of Care PLUS'
Other interventionAll pregnant patients presenting to the sponsoring clinic will receive standard obstetric care. Those patients who meet inclusion criteria and agree to participate will receive standard obstetric care 'PLUS' select micronutrient and gene variant evaluation allowing creation of customized nutrition and lifestyle plans with targeted micronutrient supplementation. The plans will be modified in each trimester and postpartum to meet the physiologic demands specific to the time period. Serum micronutrient levels, nutrition/lifestyle plan adherence, and micronutrient supplementation adherence will be re-evaluated in each subsequent trimester and in the postpartum time period allowing individual adjustment. The 'PLUS' model will be delivered virtually via a digital nutrition health platform.
Preterm birth
Preterm birth defined as delivery \< 37 weeks gestation, further analysis stratified by delivery \< 28 weeks, 28 to \< 32 weeks, 32 to \< 36 weeks, and 36 to \< 37 weeks gestation per American College of Obstetricians and Gynecologists (ACOG) guidelines.
Hypertensive disorders of pregnancy (HDP)
Hypertensive disorders of pregnancy (HDP) including gestational hypertension, preeclampsia, and eclampsia, diagnosis per ACOG guidelines.
Gestational Diabetes Mellitus (GDM)
GDM defined by ACOG guidelines
Small for gestational age (SGA)
SGA neonates defined as \< 10th percentile weight per gestational age at birth using Fenton criteria, based on American Academy of Pediatrics (AAP) standards.
Large for Gestational Age (LGA)
LGA defined as \> 10th percentile weight per gestational age at birth based on Fenton criteria, per AAP standards.
Pediatric Longitudinal Outcomes: NICU admission within the first 2 weeks of life
Neonatal Intensive Care Unit (NICU) admission within the first 2 weeks of life, through chart review of documented NICU admission and associated diagnoses based on International Classification of Diseases', Tenth Revision, Clinical Modification (ICD-10) codes assigned by the treating provider.
Pediatric Longitudinal Outcomes: Atopic dermatitis
Diagnosis and inclusion of atopic dermatitis will be obtained by chart review and based on associated ICD-10 codes assigned by the treating physician. Chart review will begin at one year of onset of the ROOT study and recur annually up to 5 years of age for each participant. Occurrence rate for atopic dermatitis will be calculated at 1, 3, and 5 years of age.
Pediatric Longitudinal Outcomes: Eczema
Diagnosis and inclusion of eczema will be obtained by chart review and based on associated ICD-10 codes assigned by the treating physician. Chart review will begin at one year of onset of the ROOT study and recur annually up to 5 years of age for each participant. Occurrence rate for eczema will be calculated at 1, 3, and 5 years of age.
Pediatric Longitudinal Outcomes: Asthma and Reactive Airway Disease
Diagnosis and inclusion of asthma and reactive airways disease (RAD) will be obtained by chart review and based on associated ICD-10 codes assigned by the treating physician. Chart review will begin at one year of onset of the ROOT study and recur annually up to 5 years of age for each participant. Occurrence rate for asthma and RAD will be calculated at 1, 3, and 5 years of age.
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