Premature BirthSNGLI-PTBNCT05436119
Select Nutrient and Gene Variant Analysis in a Targeted Diet and Lifestyle Intervention Reduces Preterm Birth
An observational study of Premature Birth and Pre-Eclampsia, run by GrowBaby Life Project at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Premature Birth, Pre-Eclampsia, Small for Gestational Age Infant
- What is being tested?
- GrowBaby
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2022to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Health Associates of Nevada (WHAsN)
Las Vegas, Nevada, 89149
About this study
Official title: Select Nutrient and Gene Variant Analysis in a Targeted Diet and Lifestyle Intervention Reduces Preterm Birth (SNGLI-PTB)
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.
Read the 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.
- Being tested
- GrowBaby
- Keywords
- Nutrition, Lifestyle, Probiotics, Gene variants, Medicaid
- Medical subject headings
- Premature Birth, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrowBabyDietary supplement
Also called Dietary, Probiotic, Behavioral
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: GrowBaby |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At conclusion of pregnancy
Secondary outcomes (5)
Preeclampsia
Evaluating the percentage of preeclampsia, condition defined by ACOG standards
Measured: At conclusion of pregnancy
Gestational diabetes mellitus(GDM)
Evaluating the percentage of GDM in each group, condition defined by ACOG standards
Measured: At conclusion of pregnancy
Small for gestational age infant (SGA)
Evaluating the percentage of SGA in each group, condition defined by APP standards.
Measured: At conclusion of pregnancy
Large for gestational age infant (LGA)
Evaluating the percentage of LGA in each group, condition defined by APP standards.
Measured: At conclusion of pregnancy
Neonatal hospitalization within 2 weeks of delivery
Evaluating the percentage of neonatal hospitalization within 2 weeks of delivery in each group
Measured: 8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GrowBaby Life Project
- Sponsor type
- University, hospital or other
- Collaborators
- Metagenics, Inc., OmegaQuant, LLC
- Responsible party
- Sponsor
- Investigators
- Michael Stone, MD, Study chairLeslie P Stone, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436119
- Sponsor's protocol ID
- GrowBaby/Molina PIP 2022
- Acronym
- SNGLI-PTB
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. At completion of the study all the data will be de-identified and grouped for purposes of analysis and publication.
Publications
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.
PubMed 25568832
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Select Nutrient and Gene Variant Analysis in a Targeted Diet and Lifestyle Intervention Reduces Preterm Birth (SNGLI-PTB)
- ClinicalTrials.gov ID
- NCT05436119
- Acronym / sponsor ID
- SNGLI-PTB / GrowBaby/Molina PIP 2022
- Keywords
- Nutrition, Lifestyle, Probiotics, Gene variants, Medicaid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- GrowBaby Life ProjectUniversity, hospital or other
- Collaborators
- Metagenics, Inc., OmegaQuant, LLC
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GrowBaby | – | Dietary Supplement: GrowBabyAll 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. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GrowBabyAlso: Dietary, Probiotic, BehavioralVirtual 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. | Dietary supplement | GrowBaby |
Primary outcome
Preterm Birth < 37 weeks EGA
Time frame: At conclusion of pregnancy
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.
5 secondary outcomes
Preeclampsia
Time frame: At conclusion of pregnancy
Gestational diabetes mellitus(GDM)
Time frame: At conclusion of pregnancy
Small for gestational age infant (SGA)
Time frame: At conclusion of pregnancy
Large for gestational age infant (LGA)
Time frame: At conclusion of pregnancy
Neonatal hospitalization within 2 weeks of delivery
Time frame: 8 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Background: PubMed 25568832Stone 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.
- Individual participant dataSharing planned: No. No individual participant data will be shared. At completion of the study all the data will be de-identified and grouped for purposes of analysis and publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Stone, MD study chair
Leslie P Stone, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Pre-Eclampsia, run by GrowBaby Life Project at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leslie P Stone, MD (541-414-5146, lstonemd@growbabyhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm Birth < 37 weeks EGA (time frame: At conclusion of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05436119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.