Exploring the Feasibility of Kōmmour Prenatal to Reduce Maternal and Infant Health Disparities

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.

Study Overview

• Status: Recruiting
• Conditions: Kōmmour Prenatal Among Marshallese Pregnant Women
• Intervention / Treatment: Behavioral: Kōmmour Prenatal

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pearl A McElfish, PhD; Phone Number: 479-713-8680; Email: pamcelfish@uams.edu
• Study Contact Backup: Name: Catarina Young; Phone Number: 479-644-1096; Email: CYoung@uams.edu

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Recruiting
      • University of Arkansas for Medical Sciences Northwest
      • Contact: Britni L Ayers, PhD; Phone Number: 479-713-8000; Email: BLAyers@uams.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

The inclusion criteria are: (1) women who self-report as Marshallese, and (2) 18 years of age or older, and (3) 8-20 weeks pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Kōmmour Prenatal

Behavioral: Kōmmour Prenatal; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Britni Ayers, PhD, University of Arkansas for Medical Sciences Northwest

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Prenatal; Marshallese; Kōmmour
• Other Study ID Numbers: 261186

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No