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

NCT05436119 | Unknown

• 1 other identifier: GrowBaby/Molina PIP 2022
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Nutrition; Lifestyle; Probiotics; Gene variants; Medicaid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Preeclampsia

  At conclusion of pregnancy

• Gestational diabetes mellitus(GDM)

  At conclusion of pregnancy

• Small for gestational age infant (SGA)

  At conclusion of pregnancy

• Large for gestational age infant (LGA)

  At conclusion of pregnancy

• Neonatal hospitalization within 2 weeks of delivery

  8 weeks postpartum

Other Outcomes (1)

• Gene variant pattern analysis

  At 20 weeks EGA

Study Arms (1)

GrowBaby

All pregnant women presenting at \< 19 weeks EGA for prenatal care covered by Molina Health of Nevada MCO will be offered the GrowBaby group nutrition and lifestyle program. Primary and secondary outcomes of those who opt out of the program will be compared to those who opt in. Additionally, all women who develop primary or secondary outcomes in the GrowBaby arm will be compared to those who do not develop primary or secondary outcomes (nested case-control). Outcomes will be compared locally, regionally and nationally within the Medicaid population, as well.

Dietary Supplement: GrowBaby

Interventions

GrowBaby DIETARY_SUPPLEMENT

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.

Also known as: Dietary, Probiotic, Behavioral

GrowBaby

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GrowBaby Life Project: lead
• Metagenics, Inc.: collaborator
• OmegaQuant, LLC: collaborator

Study Sites (1)

Women's Health Associates of Nevada (WHAsN)

Las Vegas, Nevada, 89149, United States

Location

Related 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.

  PMID: 25568832 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

dried blood spot analyzed for 44 relevant gene variants

MeSH Terms

Conditions

Premature Birth; Pre-Eclampsia

Interventions

Diet; Probiotics

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food; Food and Beverages

Study Officials

• Michael Stone, MD

  STUDY CHAIR

• Leslie P Stone, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie P Stone, MD

CONTACT

541-414-5146; lstonemd@growbabyhealth.com

Emily Rydbom, BCHN

CONTACT

541-414-5146; emily@growbabyhealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 28, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: October 1, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)