The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Model to Optimize Maternal and Infant Health (ROOT)
The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Integrated Model to Optimize Maternal and Infant Health: a Prospective Interventional Study: Resilient Outcomes Through OB-Nutrition Team Care (ROOT)
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Over a consecutive 2-year period, all pregnant females >17 years old presenting to Novant Health (NH) Triad Obstetrics/Gynecology (OB/GYN) at <20 weeks' gestation will be offered the cost-free virtual digital nutrition platform standard of care 'Plus' ('PLUS') model in addition to the in-person standard of care (SOC) routinely provided at the clinic. The 'PLUS' model will be offered to all eligible females regardless of payor source. After instruction and consent by 'PLUS'-trained clinic personnel, each participant will be on-boarded via a digital nutrition and health intake. Based on health information disclosed by the participant, body weight and height collected by the clinic, and select micronutrient and genomic evaluation, customized nutrition and lifestyle education and recommendations will be created through the digital nutrition platform with direct oversight by a 'PLUS'-trained board-certified nutrition professional. Virtual contact time allotment for the participant with the nutritionist is 60 minutes per trimester for customization of the nutrition and lifestyle plan, with unlimited text or digital follow-up.
The 'PLUS' diet is based on a pregnancy-adapted Mediterranean Diet modified by a low glycemic index with a 40% carbohydrate / 30% fat / 30% protein ratio that is seasonally, geographically, and socio-economically sensitive. Macronutrients will be calculated, and adjustments to the core food plan will be made each trimester based on nationally accepted pregnancy-specific Mifflin St. Jeor standards, with further refinement based on pre-pregnancy body mass index (BMI), gestational weight gain, activity, and dietary preferences.
Nutrition education will be personalized by trimester-specific physiologic demand, and by select gene variant analysis and micronutrient analysis. Gene variant analysis will include 42 gene variants used in the prior study associated with adverse maternal and neonatal outcomes, and non-communicable disease risk in the offspring. Micronutrient analysis will occur at intake, at each subsequent trimester, and at postpartum. It will include a complete blood count, serum zinc, carnitine (total and free), vitamin D (25(OH)D), ferritin, homocysteine, ionized calcium, vitamin B12, folate, glycosylated hemoglobin, and a lipid panel (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides).
Sleep quality, movement, exogenous stress and mood will be assessed at intake, at 24-28 weeks gestation, and at 6-8 weeks postpartum. Other common pregnancy-related concerns will be addressed at each visit.
'PLUS' participants will receive a multi-nutrient prenatal supplement and iron separate from the multivitamin, a probiotic, and an Omega 3 fatty acid supplement or its vegan algal oil alternative. Because protein intake commonly remains insufficient, a protein supplement will be added. Collagen is selected because of its tolerability and ease of intake. Vitamin D3, acetyl l-carnitine, choline, and myo-inositol supplementation will occur if identified needs cannot be met with diet/lifestyle modification and base nutrient support alone. Other identified micronutrient insufficiencies will be managed with nutrient-rich food incorporation in the diet.
All participant-facing materials are created at 8th grade reading level and will be translated into Spanish, as needed. Nutrition and lifestyle communication will be transferred through the digital health platform which is Health Insurance Portability and Accountability Act (HIPAA) & Systems and Organization Controls 2 (SOC2) compliant. Clinic staff will receive a 30-minute virtual training and an in-clinic logistical visit. Further OB provider communication regarding intervention changes, clinical condition, or persistent nutrient insufficiencies obtained through real-time chart review by the board-certified MD investigator will occur via secure e-mail to the OB provider or designee.
Consent for pediatric longitudinal follow-up of neonatal participants under the 'PLUS' model will occur at maternal participant intake. All neonatal participants remaining in the Novant Health system will be followed by chart review at 2 weeks for neonatal intensive care admission, and at 1, 3, and 5 years of life for occurrence of atopic dermatitis and eczema, asthma and allergy, otitis media, obesity, and autism spectrum disorder.
The investigators will examine the usability of the digital nutrition and lifestyle health platform that interfaces with NH Triad OB/GYN's electronic medical record to accomplish collaborative virtual personalized nutrition and lifestyle evaluation, education, and recommendations. The outcomes assessed will include participant and nutritionist access, compliance, and user experience during each trimester of use, and during the postpartum time period. Additionally, the investigators will evaluate the cost-efficiency of the 'PLUS' model compared to standard of care alone within the NH system by comparing frequency of and assigned reimbursement for the adverse maternal, neonatal, and childhood diagnoses and ICD-10 codes under study.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Leslie P Stone, MD
- Puhelinnumero: 541-301-8446
- Sähköposti: lstonemd@gmail.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Emily S Rydbom, MS
- Puhelinnumero: 541-840-1503
- Sähköposti: emilyrydbom@yahoo.com
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Muut: '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.
|
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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Preterm birth
Aikaikkuna: 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.
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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.
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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.
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Hypertensive disorders of pregnancy (HDP)
Aikaikkuna: 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.
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Hypertensive disorders of pregnancy (HDP) including gestational hypertension, preeclampsia, and eclampsia, diagnosis per ACOG guidelines.
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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.
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Gestational Diabetes Mellitus (GDM)
Aikaikkuna: 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.
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GDM defined by ACOG guidelines
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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.
|
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Small for gestational age (SGA)
Aikaikkuna: At time of birth
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SGA neonates defined as < 10th percentile weight per gestational age at birth using Fenton criteria, based on American Academy of Pediatrics (AAP) standards.
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At time of birth
|
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Large for Gestational Age (LGA)
Aikaikkuna: At time of birth
|
LGA defined as > 10th percentile weight per gestational age at birth based on Fenton criteria, per AAP standards.
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At time of birth
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Pediatric Longitudinal Outcomes: NICU admission within the first 2 weeks of life
Aikaikkuna: 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.
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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.
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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.
|
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Pediatric Longitudinal Outcomes: Atopic dermatitis
Aikaikkuna: 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.
|
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.
|
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
Aikaikkuna: 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.
|
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.
|
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: Asthma and Reactive Airway Disease
Aikaikkuna: 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.
|
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.
|
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: Allergic Rhinitis
Aikaikkuna: 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.
|
Diagnosis and inclusion of allergic rhinitis 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 allergic rhinitis will be calculated at 1, 3, and 5 years of age.
|
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: Otitis Media and Recurrent Otitis Media
Aikaikkuna: 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.
|
Diagnosis and inclusion of otitis media (OM) and recurrent otitis media (ROM) 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 OM and ROM will be calculated at 1, 3, and 5 years of age.
|
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: Autism Spectrum Disorder, Levels 1, 2, and 3
Aikaikkuna: 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.
|
Diagnosis and inclusion of autism spectrum disorder (ASD), levels 1, 2, and 3 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 ASD levels 1, 2, and 3 will be calculated at 1, 3, and 5 years of age.
|
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.
|
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Pediatric Longitudinal Outcomes: Obesity
Aikaikkuna: 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.
|
Obesity will be defined as BMI at or above the 95th percentile for children at the same age and sex for ages 2-19 years.
Diagnosis and inclusion of obesity 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 obesity will be calculated at 2, 3, and 5 years of age.
|
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.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Leslie P Stone, MD, GrowBaby Health
- Opintojohtaja: Lewis Lipscomb, MD, Novant Health Triad OB/Gyn Clinic
- Opintojen puheenjohtaja: Emily S Rydbom, MS, GrowBaby Health, GrowBaby Life Project
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Autismispektrihäiriö
- Urogenitaaliset sairaudet
- Endokriinisen järjestelmän sairaudet
- Mielenterveyshäiriöt
- Ravitsemushäiriöt
- Naisten virtsa- ja sukupuolielinten sairaudet ja raskauden komplikaatiot
- Geneettiset sairaudet, synnynnäiset
- Metaboliset sairaudet
- Yliravitsemus
- Kehon paino
- Immuunijärjestelmän sairaudet
- Synnytystyö, ennenaikainen
- Synnytystyön komplikaatiot
- Raskauden komplikaatiot
- Glukoosiaineenvaihduntahäiriöt
- Diabetes mellitus
- Yliherkkyys, välitön
- Yliherkkyys
- Ihosairaudet
- Hypertensio, raskauden aiheuttama
- Otorinolaryngologiset sairaudet
- Neurokehityshäiriöt
- Lapsen kehityshäiriöt, leviävät
- Ylipainoinen
- Korvan sairaudet
- Otitis
- Ihosairaudet, geneettiset
- Ihosairaudet, eksematoottiset
- Dermatiitti
- Synnynnäiset, perinnölliset ja vastasyntyneiden sairaudet ja poikkeavuudet
- Patologiset tilat, merkit ja oireet
- Ravitsemukselliset ja aineenvaihduntataudit
- Iho- ja sidekudostaudit
- Merkit ja oireet
- Ennenaikainen Synnytys
- Lihavuus
- Diabetes, raskausaika
- Pre-eklampsia
- Autistinen häiriö
- Dermatiitti, atooppinen
- Lasten liikalihavuus
- Välikorvatulehdus
- Terveyspalveluiden hallinto
- Terveydenhuollon laatu, saatavuus ja arviointi
- Terveydenhuollon laatu
- Laatuindikaattorit, terveydenhuolto
- Hoidon taso
Muut tutkimustunnusnumerot
- The ROOT Study
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