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

NCT07559773 | Not Yet Recruiting

• 1 other identifier: The ROOT Study
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

adverse pregnancy outcomes; prevention; personalized nutrition; nutrigenomics; adverse neonatal outcomes; childhood asthma; childhood allergy; autism; childhood obesity; recurrent otitis media

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (4)

• Hypertensive disorders of pregnancy (HDP)

  The time period of study will be up to 44 weeks, beginning at study entry between 6 weeks gestation up to 19 6/7 weeks gestation, and will be measured at time of diagnosis up to 6 weeks postpartum.

• Gestational Diabetes Mellitus (GDM)

  The time period of study will be up to 36 weeks, beginning at study entry between 6 weeks gestation up to 19 6/7 weeks gestation, and will be measured at time of diagnosis during gestation.

• Small for gestational age (SGA)

  At time of birth

• Large for Gestational Age (LGA)

  At time of birth

Other Outcomes (8)

• Pediatric Longitudinal Outcomes: NICU admission within the first 2 weeks of life

  Chart review for NICU admissions within 2 weeks of age will begin no later than 6 weeks of age and repeat at one year of age, for a duration of approximately one year.

• Pediatric Longitudinal Outcomes: Atopic dermatitis

  Chart review will recur annually up to five years after the birth of individual pediatric participants, with full review duration time up to seven years from ROOT study onset for the entire population.

• Pediatric Longitudinal Outcomes: Eczema

  Chart review will recur annually up to five years after the birth of individual pediatric participants, with full review duration time up to seven years from ROOT study onset for the entire population.

Study Arms (1)

'Standard of Care Plus' ('PLUS')

OTHER

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.

Other: 'Standard of Care PLUS'

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.

Also known as: 'PLUS'

'Standard of Care Plus' ('PLUS')

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \> 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

Sponsors & Collaborators

• GrowBaby Life Project: lead

Related Publications (2)

• Stone LP, Rydbom ES, Stone PM, Kim D. A 'Standard of Care PLUS' Model for Preterm Birth Prevention: Integrating Nutrient and Gene Variant Analysis with Targeted Interventions. J Pers Med. 2026 Feb 28;16(3):134. doi: 10.3390/jpm16030134.

  PMID: 41893003 BACKGROUND

• Stone LP, Stone PM, Rydbom EA, Stone LA, Stone TE, Wilkens LE, Reynolds K. Customized nutritional enhancement for pregnant women appears to lower incidence of certain common maternal and neonatal complications: an observational study. Glob Adv Health Med. 2014 Nov;3(6):50-5. doi: 10.7453/gahmj.2014.053.

  PMID: 25568832 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Pre-Eclampsia; Diabetes, Gestational; Dermatitis, Atopic; Autistic Disorder; Obesity; Pediatric Obesity; Otitis Media

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Leslie P Stone, MD

  GrowBaby Health

  PRINCIPAL INVESTIGATOR

• Lewis Lipscomb, MD

  Novant Health Triad OB/Gyn Clinic

  STUDY DIRECTOR

• Emily S Rydbom, MS

  GrowBaby Health, GrowBaby Life Project

  STUDY CHAIR

Central Study Contacts

Leslie P Stone, MD

CONTACT

541-301-8446; lstonemd@gmail.com

Emily S Rydbom, MS

CONTACT

541-840-1503; emilyrydbom@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients presenting to Novant Health Triad OB/GYN Clinic who are pregnant at less than 20 weeks gestation will be consented for participation in the study. Comparators will be historical, regional and national.

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2033
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share