Clinical trial

The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Model to Optimize Maternal and Infant Health

Opening soon · Not applicable · 0 countries · Registry ID NCT07559773

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersNot accepted

ConditionPreterm Birth, Preeclampsia, Gestational Diabetes Mellitus (GDM), Small for Gestational Age (SGA), Large for Gestational Age (LGA), Asthma Childhood, Atopic Dermatitis, Autism, Otitis Media Recurrent, Obesity

Full registry criteria

Inclusion Criteria: * 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 * Access to smart phone/internet for digital platform use Exclusion Criteria: * \> 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

Treatments and study arms

'Standard of Care PLUS'

Other

All 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.

Primary outcomes

Preterm birthThe time period of study will be up to 31 weeks, beginning with entry into the study between 6 weeks gestation up to 19 6/7 weeks gestation, and will be completed at preterm birth or 36 6/7 weeks gestation.

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.

Study locations

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No public site location was included in this record. Check the original registry for updates.