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

Sponsor
GrowBaby Life Project
Study ID
NCT07559773
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • '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.

Study Details

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.

Key Dates

First listed
Apr 30, 2026
Start date
Aug 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2033

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Other: 'Standard of Care Plus' ('PLUS')
    The 'Standard of care Plus' ('PLUS') model arm provides targeted nutritional and lifestyle interventions based on select gene variant and micronutrient analysis collaboratively with standard obstetric care. The comparators are historical regional and national standard obstetric care control groups.

Primary Outcome Measure

Preterm birth [ Time Frame: The 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. ]

Central Contacts

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