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

Sponsor
University of Arkansas (Other)
Overall Status
Recruiting
CT.gov ID
NCT04558619
Collaborator
(none)
40
1
1
10.8
3.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Kōmmour Prenatal
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Exploring the Feasibility of a Group Prenatal Program, Kōmmour Prenatal, to Reduce Maternal and Infant Health Disparities Among Marshallese Pacific Islander Women
Actual Study Start Date :
Apr 5, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Gestational Weight Gain [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.

Secondary Outcome Measures

  1. Breastfeeding initiation, birth weight of infant, preeclampsia, primary cesarean birth, and gestational diabetes mellitus [9 months]

    The research team will abstract medical record information about the mother and child.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Arkansas for Medical Sciences Northwest Fayetteville Arkansas United States 72703

Sponsors and Collaborators

  • University of Arkansas

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT04558619
Other Study ID Numbers:
  • 261186
First Posted:
Sep 22, 2020
Last Update Posted:
May 11, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Arkansas

Study Results

No Results Posted as of May 11, 2022