Select Nutrient and Gene Variant Analysis in a Targeted Diet and Lifestyle Intervention Reduces Preterm Birth

Premature Birth Clinical Trial

— SNGLI-PTB  

Official title:

Select Nutrient and Gene Variant Analysis in a Targeted Diet and Lifestyle Intervention Reduces Preterm Birth (SNGLI-PTB)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05436119
• Other study ID #: GrowBaby/Molina PIP 2022
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: October 2023

Study information

• Verified date: June 2022
• Source: GrowBaby Life Project
• Contact: Leslie P Stone, MD
• Phone: 541-414-5146
• Email: lstonemd[@]growbabyhealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 2023
• Est. primary completion date: July 2023
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Premature Birth
• Small for Gestational Age Infant

Intervention

Dietary Supplement:
• GrowBaby
Virtual group educational visits will cluster women in the same trimester of pregnancy teaching trimester-specific diet and lifestyle modification, further customized to the individual using limited micronutrient and gene variant analysis. Each woman will receive base multi-nutrient and probiotic supplementation with customization if identified needs cannot be met with diet and lifestyle modification alone.

Locations

Country	Name	City	State
United States	Women's Health Associates of Nevada (WHAsN)	Las Vegas	Nevada

Sponsors (3)

Lead Sponsor	Collaborator
GrowBaby Life Project	Metagenics, Inc., OmegaQuant, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gene variant pattern analysis	Evaluating association of gene variant patterns with primary and secondary outcomes in each group, and in the nested case control subset	At 20 weeks EGA
Primary	Preterm Birth < 37 weeks EGA	Evaluating the percentage of preterm birth in each group, further divided by delivery < 28 weeks, 28 to <= 32 weeks, 32 to <= 36 weeks, and 36 to <= 37 weeks.	At conclusion of pregnancy
Secondary	Preeclampsia	Evaluating the percentage of preeclampsia, condition defined by ACOG standards	At conclusion of pregnancy
Secondary	Gestational diabetes mellitus(GDM)	Evaluating the percentage of GDM in each group, condition defined by ACOG standards	At conclusion of pregnancy
Secondary	Small for gestational age infant (SGA)	Evaluating the percentage of SGA in each group, condition defined by APP standards.	At conclusion of pregnancy
Secondary	Large for gestational age infant (LGA)	Evaluating the percentage of LGA in each group, condition defined by APP standards.	At conclusion of pregnancy
Secondary	Neonatal hospitalization within 2 weeks of delivery	Evaluating the percentage of neonatal hospitalization within 2 weeks of delivery in each group	8 weeks postpartum