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
NCT number | NCT04558619 |
Other study ID # | 261186 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 5, 2022 |
Est. completion date | July 2024 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas for Medical Sciences Northwest | Fayetteville | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas |
United States,
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 |