Clinical trial NCT05436119: Select Nutrient and Gene Variant Analysis in a Targeted Diet and Lifestyle Intervention Reduces Preterm Birth
Official title: Select Nutrient and Gene Variant Analysis in a Targeted Diet and Lifestyle Intervention Reduces Preterm Birth (SNGLI-PTB)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Birth
Pre-Eclampsia
Small for Gestational Age Infant
Keywords: Nutrition
Lifestyle
Probiotics
Gene variants
Medicaid
Lead sponsor: GrowBaby Life Project
Sponsor class: OTHER
Collaborators: name: Metagenics, Inc.
name: OmegaQuant, LLC
First posted: 2022-06-28
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is derived from pregnant women managed at OB/GYN Clinics in Southern Nevada whose health care is covered by Molina Health Nevada MCO.

Brief summary: Preterm birth (PTB) rates in the US are among the highest in wealthy nations across the globe, and they are particularly high in our most socio-economically disadvantaged populations. PTB increases lifelong morbidity and mortality at significant economic cost. In addition to neonates born too early, small for gestational infants predict the greatest risk for chronic disease in the neonate (F1 generation) through adulthood. Single lifestyle, nutrient, or medical interventions intended to reduce PTB have produced mixed results, but combined micronutrient interventions appear more successful. The investigators experienced a reduced preterm birth rate and combined preeclampsia, gestational diabetes and small for gestational age rate in a 50% Medicaid population by providing targeted micro/macronutrient, genomic and lifestyle evaluation with personalized intervention in a trimester-by-trimester group educational setting (1). The model requires validation in more diverse populations.

This study will be applied in a 100% Medicaid population with greater ethnic diversity. Participation will be voluntary, offered to all pregnant participants enrolling at 18 weeks gestation or earlier with the comparator group being those participants who decline the intervention. The study population will receive targeted biomarker evaluation including serum 25-OH D, zinc and carnitine levels, dried blood spot omega 3 fatty acids and select gene variant analysis. Virtual group nutrition and lifestyle education visits conducted by the nutritionist cluster participants in the same trimester allowing for personalization of the nutrition and lifestyle plan based on the data collected and adapted to the specific needs of the trimester. Each study participant will receive individualized nutrient supplementation and probiotic supplementation. Anticipated performance improvement endpoints are significant reduction of preterm birth and combined incidence of preeclampsia, gestational diabetes, small for gestational age, neonatal morbidities and related health care expenses. The investigators will explore gene variants' role in directing nutrition, lifestyle and toxic exposure interventions and in predicting adverse maternal and neonatal outcomes.

Detailed description: Hypothesis:

• Diet and lifestyle education with diet and lifestyle modification will significantly decrease the incidence of preterm birth (PTB).

Secondary Hypothesis:

• Diet and lifestyle education and modification refined by limited genomics and nutrient biomarkers will significantly decrease the incidence of preeclampsia (preE), gestational diabetes mellitus (GDM), small for gestational age (SGA) and large for gestational age (LGA) neonates, and neonatal hospitalizations within the first 2 weeks of life.

Exploratory Hypotheses:

* A gene variant pattern will emerge that predicts PTB.
* A gene variant pattern will emerge that predicts preE, GDM, SGA, and LGA.

Goals:

* Ascertain PTB rates for both intervention and non-intervention groups.
* Ascertain preE, GDM, SGA, LGA, and neonatal hospitalization rates for both groups.
* Correlate diet and lifestyle education and modification refined by limited genomics and micronutrient biomarkers with reduced primary and secondary outcomes.
* Reduce related net healthcare costs.

Methods:

• Prospective longitudinal observational cohort with nested case-control study.

Relevance:

* Determine whether diet and lifestyle education and modification refined by trimester and by limited genomics and micronutrient biomarkers applied to a 100% Medicaid population is associated with reduced rates of PTB, preE, GDM, SGA, LGA, and neonatal hospitalizations.
* Determine whether the reduction in pregnancy and neonatal morbidities is associated with a reduction in related net health care costs.
* Explore predictive capability of limited genomics panel in a 100% Medicaid population.

Eligibility criteria: Inclusion Criteria:

* pregnant
* gestational age \< 19 weeks at time of enrollment
* Health care coverage through Molina Health of Nevada MCO
* Residing in the state of Nevada
* Signed consent

Exclusion Criteria:

* Not pregnant
* Gestational age \> 19 weeks at time of enrollment
* Health care coverage not through Molina
* Living outside the state of Nevada
* No signed consent or unable to give informed consent

Primary outcomes:
measure: Preterm Birth < 37 weeks EGA
timeFrame: At conclusion of pregnancy
Secondary outcomes:
measure: Preeclampsia
timeFrame: At conclusion of pregnancy
measure: Gestational diabetes mellitus(GDM)
timeFrame: At conclusion of pregnancy
measure: Small for gestational age infant (SGA)
timeFrame: At conclusion of pregnancy
measure: Large for gestational age infant (LGA)
timeFrame: At conclusion of pregnancy
measure: Neonatal hospitalization within 2 weeks of delivery
timeFrame: 8 weeks postpartum
Other outcomes:
measure: Gene variant pattern analysis
timeFrame: At 20 weeks EGA
Locations:
city: Las Vegas
country: United States
facility: Women's Health Associates of Nevada (WHAsN)
state: Nevada
Study officials:
name: Michael Stone, MD
role: STUDY_CHAIR
name: Leslie P Stone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.