Kōmmour Prenatal Among Marshallese Pregnant WomenNCT04558619
Exploring the Feasibility of Kōmmour Prenatal to Reduce Maternal and Infant Health Disparities
A study testing Kōmmour Prenatal in people with Kōmmour Prenatal Among Marshallese Pregnant Women, run by University of Arkansas at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Kōmmour Prenatal Among Marshallese Pregnant Women
- What is being tested?
- Kōmmour Prenatal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2022to 1 Mar 2026
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who self-identify as Marshallese
- 18 years of age or older
- And 8-20 weeks pregnant
Who cannot join
- Women who do not self-identify as Marshallese
- Not 18 years of age or older
- And not 8-20 weeks pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences Northwest
Fayetteville, Arkansas, 72703
About this study
Official title: Exploring the Feasibility of a Group Prenatal Program, Kōmmour Prenatal, to Reduce Maternal and Infant Health Disparities Among Marshallese Pacific Islander Women
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.
- Being tested
- Kōmmour Prenatal
- Keywords
- Kōmmour, Prenatal, Marshallese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kōmmour PrenatalBehavioural
Centering Pregnancy, a group prenatal care model, is a promising intervention that challenges the standard model of one-on-one counseling of prenatal care. The model, is currently implemented at the UAMS, but as of yet to be adapted for Pacific Islanders. Centering Pregnancy replaces the individual prenatal care visit with a group model for obstetrically low-risk women. This model provides substantially more health promotion content than the traditional one-on-one prenatal care model. The intervention occurs from week 14 of pregnancy through birth, following the same same schedule as individual care. Group visits are 90-120 minutes each and follow a unique structured curriculum that incorporates standards of care. In the group setting, credentialed prenatal providers conduct a one-on-one assessment with each patient (30 min) and then facilitate group discussions on the topics of pregnancy, using adult learning principles (60-90 min).
| Study group | Role | What they receive |
|---|---|---|
| Kōmmour Prenatal | Other | Not described Receives: Behavioral: Kōmmour Prenatal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Weight Gain
Gestational weight gain will be measured by weight of first and last group prenatal visit along with information from the birth record data. We will use independent samples tests for proportions to compare treatment groups. We will also use generalized linear models to examine treatment group differences including important covariates such as income, education, age and marital status. Further, data from the proposed study will be use the data from the Kommour treatment group to estimate intraclass correlations as an indicator of clustering due to the nesting of participants within groups.
Measured: 9 months
Secondary outcomes (1)
Breastfeeding initiation, birth weight of infant, preeclampsia, primary cesarean birth, and gestational diabetes mellitus
The research team will abstract medical record information about the mother and child.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start5 Apr 2022
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
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 Kōmmour Prenatal Among Marshallese Pregnant WomenStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Britni Ayers, PhD, Principal investigator, University of Arkansas for Medical Sciences Northwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558619
- Sponsor's protocol ID
- 261186
- Status last verified
- Aug 2025
- First submitted
- 16 Sep 2020
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ayers BL, Eswaran H, CarlLee S, Reece S, Manning N, McElfish PA. 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. Contemp Clin Trials Commun. 2023 Apr 3;33:101127. doi: 10.1016/j.conctc.2023.101127. eCollection 2023 Jun.
PubMed 37091509
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility of a Group Prenatal Program, Kōmmour Prenatal, to Reduce Maternal and Infant Health Disparities Among Marshallese Pacific Islander Women
- ClinicalTrials.gov ID
- NCT04558619
- Acronym / sponsor ID
- 261186
- Keywords
- Kōmmour, Prenatal, Marshallese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 22 Sep 2020 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kōmmour Prenatal | Other | Behavioral: Kōmmour Prenatal |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women who self-identify as Marshallese
- 18 years of age or older
- And 8-20 weeks pregnant
Key exclusion criteria (3 listed)
- Women who do not self-identify as Marshallese
- Not 18 years of age or older
- And not 8-20 weeks pregnant
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 |
|---|---|---|
| Kōmmour PrenatalCentering Pregnancy, a group prenatal care model, is a promising intervention that challenges the standard model of one-on-one counseling of prenatal care. The model, is currently implemented at the UAMS, but as of yet to be adapted for Pacific Islanders. Centering Pregnancy replaces the individual prenatal care visit with a group model for obstetrically low-risk women. This model provides substantially more health promotion content than the traditional one-on-one prenatal care model. The intervention occurs from week 14 of pregnancy through birth, following the same same schedule as individual care. Group visits are 90-120 minutes each and follow a unique structured curriculum that incorporates standards of care. In the group setting, credentialed prenatal providers conduct a one-on-one assessment with each patient (30 min) and then facilitate group discussions on the topics of pregnancy, using adult learning principles (60-90 min). | Behavioural | Kōmmour Prenatal |
Primary outcome
Gestational Weight Gain
Time frame: 9 months
Gestational weight gain will be measured by weight of first and last group prenatal visit along with information from the birth record data. We will use independent samples tests for proportions to compare treatment groups. We will also use generalized linear models to examine treatment group differences including important covariates such as income, education, age and marital status. Further, data from the proposed study will be use the data from the Kommour treatment group to estimate intraclass correlations as an indicator of clustering due to the nesting of participants within groups.
1 secondary outcome
Breastfeeding initiation, birth weight of infant, preeclampsia, primary cesarean birth, and gestational diabetes mellitus
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Derived from this study: PubMed 37091509Ayers BL, Eswaran H, CarlLee S, Reece S, Manning N, McElfish PA. 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. Contemp Clin Trials Commun. 2023 Apr 3;33:101127. doi: 10.1016/j.conctc.2023.101127. eCollection 2023 Jun.
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.
Britni Ayers, PhD principal investigator
University of Arkansas for Medical Sciences Northwest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kōmmour Prenatal in people with Kōmmour Prenatal Among Marshallese Pregnant Women, run by University of Arkansas 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 7 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational Weight Gain (time frame: 9 months). 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 NCT04558619, 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 7 Apr 2026.