Kōmmour Prenatal for Prenatal Health Disparities among Marshallese Pregnant Women

Overseen By Pearl A McElfish, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Non-Marshallese, Under 18, Not pregnant

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on improving the health of Marshallese Pacific Islander pregnant women and their babies. It tests a program called Kōmmour Prenatal, which provides group prenatal care tailored to the cultural needs of the Marshallese community. The goal is to determine if this program can reduce health disparities and improve outcomes for mothers and infants. Women who identify as Marshallese, are between 8 to 20 weeks pregnant, and are interested in culturally specific prenatal care may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to culturally tailored healthcare solutions.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Kōmmour Prenatal program is safe for Marshallese pregnant women?

Research has shown that the Kōmmour Prenatal program is being studied to improve the health of Marshallese pregnant women. Although specific studies on its safety are lacking, this program employs a group prenatal care approach. It provides support and information in a group setting, rather than introducing a new drug or medical device.

Programs like this generally aim to enhance health through education and support, which are typically safe. The study focuses on evaluating the program's effectiveness, suggesting it is expected to be well-received. No reports of negative effects linked to the Kōmmour Prenatal program appear in the sources provided, indicating that the program is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Kōmmour Prenatal is unique because it specifically targets prenatal health disparities among Marshallese pregnant women, a group often underserved by typical prenatal care options like standard prenatal vitamins and routine check-ups. Researchers are excited about Kōmmour Prenatal because it is designed to address cultural and genetic factors unique to the Marshallese population, potentially leading to more effective and personalized prenatal care. Unlike conventional treatments that take a one-size-fits-all approach, Kōmmour Prenatal aims to offer a tailored solution, which could lead to better health outcomes for both mothers and their babies.

What evidence suggests that Kōmmour Prenatal is effective for reducing health disparities among Marshallese pregnant women?

Research shows that the Kōmmour Prenatal program is specially designed for Marshallese pregnant women to help reduce health disparities. Early findings suggest that over half of Marshallese women miss important prenatal check-ups, potentially leading to health problems. Kōmmour Prenatal, based on the CenteringPregnancy model, aims to improve health by offering group care that respects their culture. This method has succeeded in other communities in improving the health of mothers and babies. While specific data on its effectiveness for Marshallese women is still being collected, the program builds on proven methods used in similar group prenatal care settings. ^{1 2 6 7 8}

Who Is on the Research Team?

Britni Ayers, PhD

Principal Investigator

University of Arkansas for Medical Sciences Northwest

Are You a Good Fit for This Trial?

This trial is for Marshallese women who are at least 18 years old and between 8-20 weeks pregnant. It aims to help reduce health issues for mothers and babies by adapting a group prenatal program specifically for their community.

Inclusion Criteria

I am a Marshallese woman, over 18, and 8-20 weeks pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Kōmmour Prenatal program to reduce maternal and infant health disparities

9 months

Follow-up

Participants are monitored for outcomes such as gestational weight gain, breastfeeding initiation, and birth weight of infant

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Kōmmour Prenatal

Trial Overview

The study is testing the Kōmmour Prenatal program, which has been culturally tailored for Marshallese Pacific Islander women in the US. The focus is on its feasibility and effectiveness in improving maternal and infant health outcomes.

How Is the Trial Designed?

Group I: Kōmmour Prenatal Experimental Treatment 1 Intervention

Kōmmour Prenatal is already approved in United States for the following indications:

Approved in United States as Kōmmour Prenatal for:

• Reducing maternal and infant health disparities among Marshallese Pacific Islander women

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Published Research Related to This Trial

Marshallese women experienced significantly higher rates of adverse perinatal outcomes, including medical risk factors, precipitous labor, and fetal distress, compared to non-Hispanic White women, based on a study of 2488 births from 1997 to 2013.

Marshallese infants had increased rates of conditions such as anemia, birth injury, and preterm birth, indicating a need for targeted healthcare interventions for this population to improve perinatal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Pregnancy and Neonatal Outcomes Among Marshallese Women Living in the United States. Nembhard, WN., Ayers, BL., Collins, RT., et al.[2022]

A significant 74% of migrant Marshallese Islanders reported forgoing medical care due to cost, compared to only 15% of the general US diabetic population, highlighting severe healthcare access inequities.

Among Marshallese Islanders, the lack of health insurance was the primary factor associated with both forgoing care and not having a usual source of care, indicating a critical need for policies to improve access to health insurance and healthcare resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inequities in Access to Medical Care Among Adults Diagnosed with Diabetes: Comparisons Between the US Population and a Sample of US-Residing Marshallese Islanders. Towne, SD., Yeary, KHK., Narcisse, MR., et al.[2023]

A study involving 33 pregnant Marshallese women identified key dietary practices, revealing that traditional beliefs about diet during pregnancy are significant, including what foods are considered healthy or unhealthy and the influence of spiritual customs.

The research highlighted a shift towards individual dietary choices, particularly concerning the consumption of sugar-sweetened beverages, indicating that acculturation affects dietary practices and should be addressed in maternal health education and interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Practices during Pregnancy in a Marshallese Community: A Mixed Methods Analysis. Ayers, BL., Bogulski, CA., Bennett-Milburn, A., et al.[2022]

A study involving 33 Marshallese participants identified key influences on gestational weight gain, including strong impacts from church and family, as well as a lack of guidance from healthcare providers.

Participants expressed concerns about excessive gestational weight gain and its potential effects on pregnancy and labor, highlighting the need for culturally tailored interventions to address these issues and improve maternal and infant health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gestational weight gain influences, beliefs, and goals among Marshallese pregnant women in Arkansas: a mixed-methods analysis. Ayers, BL., Bogulski, CA., Andersen, JA., et al.[2022]

The study highlights significant language and cultural barriers faced by the growing Marshallese population in the U.S. when accessing medical care, which can hinder effective communication and treatment.

Effective communication strategies tailored for Marshallese patients are essential for healthcare providers, especially genetic counselors, to improve accessibility and relevance of genetic services for this community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eliciting culturally and medically informative family health histories from Marshallese patients living in the United States. Blocker, K., Hallford, HG., McElfish, P., et al.[2021]

Marshallese mothers in Arkansas face significant barriers to prenatal care, including health insurance issues, transportation difficulties, and language barriers, which hinder their access to necessary services.

Social and cultural factors, such as a lack of understanding of the importance of early prenatal care, feelings of shame regarding their circumstances, and perceived discrimination from healthcare providers, further complicate their experiences and discourage them from seeking care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structural and Socio-cultural Barriers to Prenatal Care in a US Marshallese Community. Ayers, BL., Purvis, RS., Bing, WI., et al.[2021]

The study aims to implement and evaluate the CenteringPregnancy model for Marshallese Pacific Islander women in the U.S., addressing their higher rates of adverse perinatal outcomes and barriers to prenatal care.

This research will be the first to culturally adapt CenteringPregnancy for this population, assessing its feasibility, acceptability, and preliminary effectiveness, which could lead to improved prenatal care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the feasibility, acceptability, and preliminary effectiveness of a culturally adapted group prenatal program, CenteringPregnancy, to reduce maternal and infant health disparities among Marshallese Pacific Islanders: A study protocol. Ayers, BL., Eswaran, H., CarlLee, S., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10999336/

Providers' Perspectives of a Culturally Adapted ...

Specifically, 15% of Marshallese women received no prenatal care (compared to 1.6% of women nationally); more than 50% do not attend the ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1751485124000333

Providers' Perspectives of a Culturally Adapted ...

Exploring CenteringPregnancy: The feasibility of a group prenatal program, Kōmmour Prenatal, to reduce maternal and infant health disparities among Marshallese ...

3.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/49/NCT05645549/Prot_SAP_000.pdf

Determine the Preliminary Effectiveness of Mobile ...

effectiveness of Kōmmour Prenatal among pregnant Marshallese women. Potential participants may be recruited from UAMS centering programs ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37091509/

Exploring the feasibility, acceptability, and preliminary ...

This will be the first study to culturally adapt and implement CenteringPregnancy with Marshallese pregnant women in the United States.

5.

nwhjournal.org

nwhjournal.org/article/S1751-4851(24)00033-3/abstract

Providers' Perspectives of a Culturally Adapted ...

Marshallese Pacific Islanders residing in the United States have disproportionally high rates of poor maternal and infant health outcomes, even ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10120290/

Exploring the feasibility, acceptability, and preliminary ...

Marshallese Pacific Islanders residing in the United States have higher rates of adverse perinatal outcomes than the general population and experience ...

7.

tri.uams.edu

tri.uams.edu/people/britini-ayers-phd/

Britini Ayers, PhD

The purpose of the proposed study is to adapt and examine the feasibility and preliminary effectiveness of a group prenatal program (Kōmmour Prenatal) to reduce ...

8.

sciencedirect.com

sciencedirect.com/science/article/am/pii/S1751485124000333

Providers' Perspectives of a Culturally Adapted ...

Prenatal Program, Kōmmour Prenatal, to Reduce Maternal and Infant Health Disparities among Marshallese Women (summary of results under review).