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

Trial Summary

What is the purpose of this trial?

The purpose of the study is to culturally adapt and examine the feasibility of a group prenatal program (Kōmmour Prenatal) to reduce maternal and infant health disparities among Marshallese Pacific Islander women in the US. The study will also gather information from providers of Kōmmour Prenatal and stakeholders in the Marshallese community familiar with the program to learn of their experience with the program.

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 data supports the effectiveness of the treatment Kōmmour Prenatal for improving prenatal health among Marshallese pregnant women?

The CenteringPregnancy program, a group prenatal care model similar to Kōmmour Prenatal, has shown potential in reducing adverse perinatal outcomes among Marshallese Pacific Islanders by addressing cultural and community-specific needs. ^{1 2 3 4 5}

How is the Kōmmour Prenatal treatment different from other prenatal care options for Marshallese women?

Kōmmour Prenatal is unique because it is a culturally adapted group prenatal care program specifically designed to address the health disparities faced by Marshallese pregnant women, incorporating their traditional beliefs and practices into the care process. ^{1 2 4 6 7}

Research Team

Britni Ayers, PhD

Principal Investigator

University of Arkansas for Medical Sciences Northwest

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Gestational weight gain influences, beliefs, and goals among Marshallese pregnant women in Arkansas: a mixed-methods analysis. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Practices during Pregnancy in a Marshallese Community: A Mixed Methods Analysis. [2022]

3. Netherlands 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Structural and Socio-cultural Barriers to Prenatal Care in a US Marshallese Community. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Eliciting culturally and medically informative family health histories from Marshallese patients living in the United States. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse Pregnancy and Neonatal Outcomes Among Marshallese Women Living in the United States. [2022]

7. Switzerland 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. [2023]