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

Kommour Prenatal Among Marshallese Pregnant Women Clinical Trial

Official title:

Exploring the Feasibility of a Group Prenatal Program, Kōmmour Prenatal, to Reduce Maternal and Infant Health Disparities Among Marshallese Pacific Islander Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04558619
• Other study ID #: 261186
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: University of Arkansas
• Contact: Catarina Young
• Phone: 479-644-1096
• Email: CYoung[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kommour Prenatal Among Marshallese Pregnant Women

Intervention

Behavioral:
• Kommour 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).

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences Northwest	Fayetteville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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