Prenatal CareNCT07011121
Determine the Clinical Effectiveness of Mobile CenteringPregnancy to Improve Maternal and Infant Health Outcomes of Marshallese in Arkansas
A study testing CenteringPregnancy in people with Prenatal Care, run by University of Arkansas at 1 site in United States.
Trial summary
Pacific Islanders bear a disproportionate burden of obesity compared to other racial/ethnic minorities and the United States (US) population. Pacific Islanders residing in the US also have high maternal and infant health disparities with disproportionally high rates of preterm birth (<37 weeks) and low birthweight… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prenatal Care
- What is being tested?
- CenteringPregnancy
- 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
- 1 May 2024to 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) women who self-report as Marshallese
- (2) 18 years of age or older
- (3) pregnant (12-14 weeks gestation; confirmed with ultrasound).
Who cannot join
- (1) conception with the use of fertility treatments
- (2) high-risk pregnancy that requires a transfer to a high-risk clinic
- (3) multiple gestations (i.e. pregnant with more than one infant)
- (4) use of medications known to influence fetal growth (e.g., glucocorticoids, insulin, thyroid, hormones).
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Community Health Innovation
Springdale, Arkansas, 72762
About this study
Pacific Islanders bear a disproportionate burden of obesity compared to other racial/ethnic minorities and the United States (US) population. Pacific Islanders residing in the US also have high maternal and infant health disparities with disproportionally high rates of preterm birth (<37 weeks) and low birthweight infants (<2,500 grams). They are also more likely to experience preeclampsia, primary cesarean birth, excessive gestational weight gain, gestational diabetes mellitus, and low exclusive breastfeeding rates compared to other racial/ethnic minorities and the US population in general. These unique health circumstances increase medical complications and are associated with impaired glucose intolerance, delivery complications, and higher incidence of obesity and metabolic disease risk later in life for infants. Early and consistent supportive care throughout the pregnancy continuum is strongly associated with positive birth outcomes that can mitigate childhood obesity.
However, Pacific Islanders are less likely to receive adequate prenatal care compared to other racial and/or ethnic minorities. Our preliminary studies using Arkansas birth records (n=2,488; 2019) have shown that Marshallese experience exceptionally poor perinatal outcomes, even compared to other US Pacific Islanders. Specifically, 15% of Marshallese women received no prenatal care (compared to 1.6% women nationally); more than 50% do not attend the recommended number of prenatal care visits; 19% of Marshallese infants were born preterm (compared to 9.6% nationally); and 15% of Marshallese infants were low birthweight (compared to 8.3% nationally). These poor health outcomes are highly associated with childhood obesity risk through increased odds of rapid infant weight gain and sub-optimal infant feeding practices. Thus, our foundational work demonstrates an urgent need for culturally adapted interventions to engage the Marshallese community in Arkansas in prenatal care that optimize birth outcomes that can mitigate childhood obesity.
CenteringPregnancy, an evidenced-based group prenatal care model, challenges the standard model of one- on-one prenatal counseling and has demonstrated effectiveness in other populations in lowering the risk of preterm birth, low birthweight infants, and increasing exclusive breastfeeding initiation compared to women receiving individualized care. Our prior work has demonstrated how challenging delivering group care is to the Marshallese community because of transportation barriers. Mobile health clinics are transforming the US healthcare system by delivering services directly to communities of need. However, mobile health clinics have not yet been implemented with group prenatal programs like CenteringPregnancy in the US. The proposed study will determine the preliminary effectiveness of an innovative Mobile CenteringPregnancy program for Marshallese women while also evaluating implementation determinants and outcomes to inform sustainable scaling of the program.
Read the detailed description
Overview. Using a Hybrid Type 1 effectiveness-implementation trial; the proposed study will establish approaches to determine the preliminary effectiveness of an innovative, culturally adapted, Mobile CenteringPregnancy program to improve prenatal care attendance and the early-stage impact on improved knowledge, attitudes, and behaviors. Additionally, the investigators will establish approaches to determine the effectiveness of Mobile CenteringPregnnacy to improve preterm birth (primary outcome) and maternal outcomes (secondary outcomes): low-birth weight and breastfeeding initiation for Marshallese women. Investigators will also assess implementation outcomes and identify key implementation determinants, which will inform the design of strategies to support wider implementation of the program. A Hybrid Type 1 is the correct study design because the investigators do not yet have robust data on the effectiveness of delivery Mobile CenteringPregnancy to Marshallese women, and both implementation outcomes and determinants are unknown. Our chosen approach also balances scientific rigor and community needs. Investigators will use an external control approach with a propensity score matched comparison group. Investigators considered a two-arm randomized controlled trial, but our community advisors did not feel it was ethical given the stark needs.
In Aim 1, investigators will use a mixed-methods approach to examine adherence to prenatal care appointments and the early-stage impact on knowledge, attitudes, and behaviors at pre-intervention and post-intervention. In Aim 2, investigators will establish key statistical approaches to determine the effectiveness of Mobile CenteringPregnancy to improve preterm birth (primary outcome) and maternal health outcomes (secondary outcome) that promote healthy development and mitigate childhood obesity in infants. A birth certificate data review will be used to document preterm birth, low-birth weight infants, and breastfeeding initiation in the intervention arm and the matched control group. In Aim 3, investigators will assess implementation outcomes and multilevel determinants of implementation and sustainability of Mobile CenteringPregnancy. Using a mixed methods design, investigators will assess implementation of the intervention using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework. This study will demonstrate the preliminary effectiveness of a culturally adapted Mobile CenteringPregnancy intervention. Further, these aims are in direct response to reviewer comments from a scored NIH RO1 on Mobile CenteringPregnnacy. The data collected from this proposed study will provide the necessary preliminary results to design a larger trail.
- Conditions
- Prenatal Care
- Being tested
- CenteringPregnancy
- Keywords
- Marshallese, CenteringPregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenteringPregnancyBehavioural
. CenteringPregnancy, a group prenatal care model, is a promising alternative that challenges the standard model of one-on-one prenatal counseling. Previous research has documented that group prenatal care is associated with a lower prevalence of preterm birth and low birth weight infants. 18,39 Group prenatal care also has been associated with improved maternal mental health, breastfeeding, optimal pregnancy weight gain, improved postpartum weight loss, better birth spacing, and higher patient satisfaction. 18,39 All participants will attend routine one-on-one prenatal appointments prior to the intervention. The sessions occur from week 14 of pregnancy through birth with women of similar gestational age, following the same schedule as standard care. Once the groups of women are formed (5 per group), the participants attend all appointments together for the duration of their pregnancies. Mobile health clinic located at FBOs will provide a location for providers to provide brief one-on-
| Study group | Role | What they receive |
|---|---|---|
| Group prenatal care | Experimental | . CenteringPregnancy, a group prenatal care model, is a promising alternative that challenges the standard model of one-on-one prenatal counseling. Previous research has documented that group prenatal care is associated with a lower prevalence of preterm birth and low birth weight infants. 18,39 Group prenatal care also has been associated with improved maternal mental health, breastfeeding, optimal pregnancy weight gain, improved postpartum weight loss, better birth spacing, and higher patient satisfaction. 18,39 All participants will attend routine one-on-one prenatal appointments prior to the intervention. The sessions occur from week 14 of pregnancy through birth with women of similar gestational age, following the same schedule as standard care. Once the groups of women are formed (5 per group), the participants attend all appointments together for the duration of their pregnancies. Mobile health clinic located at FBOs will provide a location for providers to provide brief one-on Receives: Behavioral: CenteringPregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-term birth
birth prior to 36 weeks gestation
Measured: three months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 May 2024
- 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.
- Other trials for Prenatal CareStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- . Using a Hybrid Type 1 effectiveness-implementation trial; the proposed study will establish approaches to determine the preliminary effectiveness of an innovative, culturally adapted, Mobile CenteringPregnancy program to improve prenatal care attendance and the early-stage impact on improved knowledge, attitudes, and behaviors. Additionally, we will establish approaches to determine the effectiveness of Mobile CenteringPregnnacy to improve preterm birth (primary outcome) and maternal outcomes (secondary outcomes): low-birth weight and breastfeeding initiation for Marshallese women. We will also assess implementation outcomes and identify key implementation determinants, which will inform the design of strategies to support wider implementation of the program. A Hybrid Type 1 is the correct study design because we do not yet have robust data on the effectiveness of delivery Mobile CenteringPregnancy to Marshallese women, and both implementation outcomes and determinants are unknown. O
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011121
- Sponsor's protocol ID
- 2P20GM109096-06
- Other IDs
- 2P20GM109096-06
- Status last verified
- Apr 2026
- First submitted
- 30 May 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be aggregated when disseminated to provide confidentiality to all participants.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Clinical Effectiveness of Mobile CenteringPregnancy to Improve Maternal and Infant Health Outcomes of Marshallese in Arkansas
- ClinicalTrials.gov ID
- NCT07011121
- Acronym / sponsor ID
- 2P20GM109096-06
- Conditions
- Prenatal Care
- Keywords
- Marshallese, CenteringPregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 8 Jun 2025 (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.
Pacific Islanders bear a disproportionate burden of obesity compared to other racial/ethnic minorities and the United States (US) population. Pacific Islanders residing in the US also have high maternal and infant health disparities with disproportionally high rates of preterm birth (<37 weeks) and low birthweight infants (<2,500 grams). They are also more likely to experience preeclampsia, primary cesarean birth, excessive gestational weight gain, gestational diabetes mellitus, and low exclusive breastfeeding rates compared to other racial/ethnic minorities and the US population in general. These unique health circumstances increase medical complications and are associated with impaired glucose intolerance, delivery complications, and higher incidence of obesity and metabolic disease risk later in life for infants. Early and consistent supportive care throughout the pregnancy continuum is strongly associated with positive birth outcomes that can mitigate childhood obesity.
However, Pacific Islanders are less likely to receive adequate prenatal care compared to other racial and/or ethnic minorities. Our preliminary studies using Arkansas birth records (n=2,488; 2019) have shown that Marshallese experience exceptionally poor perinatal outcomes, even compared to other US Pacific Islanders. Specifically, 15% of Marshallese women received no prenatal care (compared to 1.6% women nationally); more than 50% do not attend the recommended number of prenatal care visits; 19% of Marshallese infants were born preterm (compared to 9.6% nationally); and 15% of Marshallese infants were low birthweight (compared to 8.3% nationally). These poor health outcomes are highly associated with childhood obesity risk through increased odds of rapid infant weight gain and sub-optimal infant feeding practices. Thus, our foundational work demonstrates an urgent need for culturally adapted interventions to engage the Marshallese community in Arkansas in prenatal care that optimize birth outcomes that can mitigate childhood obesity.
CenteringPregnancy, an evidenced-based group prenatal care model, challenges the standard model of one- on-one prenatal counseling and has demonstrated effectiveness in other populations in lowering the risk of preterm birth, low birthweight infants, and increasing exclusive breastfeeding initiation compared to women receiving individualized care. Our prior work has demonstrated how challenging delivering group care is to the Marshallese community because of transportation barriers. Mobile health clinics are transforming the US healthcare system by delivering services directly to communities of need. However, mobile health clinics have not yet been implemented with group prenatal programs like CenteringPregnancy in the US. The proposed study will determine the preliminary effectiveness of an innovative Mobile CenteringPregnancy program for Marshallese women while also evaluating implementation determinants and outcomes to inform sustainable scaling of the program.
Detailed description
Overview. Using a Hybrid Type 1 effectiveness-implementation trial; the proposed study will establish approaches to determine the preliminary effectiveness of an innovative, culturally adapted, Mobile CenteringPregnancy program to improve prenatal care attendance and the early-stage impact on improved knowledge, attitudes, and behaviors. Additionally, the investigators will establish approaches to determine the effectiveness of Mobile CenteringPregnnacy to improve preterm birth (primary outcome) and maternal outcomes (secondary outcomes): low-birth weight and breastfeeding initiation for Marshallese women. Investigators will also assess implementation outcomes and identify key implementation determinants, which will inform the design of strategies to support wider implementation of the program. A Hybrid Type 1 is the correct study design because the investigators do not yet have robust data on the effectiveness of delivery Mobile CenteringPregnancy to Marshallese women, and both implementation outcomes and determinants are unknown. Our chosen approach also balances scientific rigor and community needs. Investigators will use an external control approach with a propensity score matched comparison group. Investigators considered a two-arm randomized controlled trial, but our community advisors did not feel it was ethical given the stark needs.
In Aim 1, investigators will use a mixed-methods approach to examine adherence to prenatal care appointments and the early-stage impact on knowledge, attitudes, and behaviors at pre-intervention and post-intervention. In Aim 2, investigators will establish key statistical approaches to determine the effectiveness of Mobile CenteringPregnancy to improve preterm birth (primary outcome) and maternal health outcomes (secondary outcome) that promote healthy development and mitigate childhood obesity in infants. A birth certificate data review will be used to document preterm birth, low-birth weight infants, and breastfeeding initiation in the intervention arm and the matched control group. In Aim 3, investigators will assess implementation outcomes and multilevel determinants of implementation and sustainability of Mobile CenteringPregnancy. Using a mixed methods design, investigators will assess implementation of the intervention using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework. This study will demonstrate the preliminary effectiveness of a culturally adapted Mobile CenteringPregnancy intervention. Further, these aims are in direct response to reviewer comments from a scored NIH RO1 on Mobile CenteringPregnnacy. The data collected from this proposed study will provide the necessary preliminary results to design a larger trail.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- . Using a Hybrid Type 1 effectiveness-implementation trial; the proposed study will establish approaches to determine the preliminary effectiveness of an innovative, culturally adapted, Mobile CenteringPregnancy program to improve prenatal care attendance and the early-stage impact on improved knowledge, attitudes, and behaviors. Additionally, we will establish approaches to determine the effectiveness of Mobile CenteringPregnnacy to improve preterm birth (primary outcome) and maternal outcomes (secondary outcomes): low-birth weight and breastfeeding initiation for Marshallese women. We will also assess implementation outcomes and identify key implementation determinants, which will inform the design of strategies to support wider implementation of the program. A Hybrid Type 1 is the correct study design because we do not yet have robust data on the effectiveness of delivery Mobile CenteringPregnancy to Marshallese women, and both implementation outcomes and determinants are unknown. O
| Arm | Type | Receives |
|---|---|---|
| Group prenatal care | Experimental | Behavioral: CenteringPregnancy. CenteringPregnancy, a group prenatal care model, is a promising alternative that challenges the standard model of one-on-one prenatal counseling. Previous research has documented that group prenatal care is associated with a lower prevalence of preterm birth and low birth weight infants. 18,39 Group prenatal care also has been associated with improved maternal mental health, breastfeeding, optimal pregnancy weight gain, improved postpartum weight loss, better birth spacing, and higher patient satisfaction. 18,39 All participants will attend routine one-on-one prenatal appointments prior to the intervention. The sessions occur from week 14 of pregnancy through birth with women of similar gestational age, following the same schedule as standard care. Once the groups of women are formed (5 per group), the participants attend all appointments together for the duration of their pregnancies. Mobile health clinic located at FBOs will provide a location for providers to provide brief one-on |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) women who self-report as Marshallese
- (2) 18 years of age or older
- (3) pregnant (12-14 weeks gestation; confirmed with ultrasound).
Key exclusion criteria (4 listed)
- (1) conception with the use of fertility treatments
- (2) high-risk pregnancy that requires a transfer to a high-risk clinic
- (3) multiple gestations (i.e. pregnant with more than one infant)
- (4) use of medications known to influence fetal growth (e.g., glucocorticoids, insulin, thyroid, hormones).
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 |
|---|---|---|
| CenteringPregnancy. CenteringPregnancy, a group prenatal care model, is a promising alternative that challenges the standard model of one-on-one prenatal counseling. Previous research has documented that group prenatal care is associated with a lower prevalence of preterm birth and low birth weight infants. 18,39 Group prenatal care also has been associated with improved maternal mental health, breastfeeding, optimal pregnancy weight gain, improved postpartum weight loss, better birth spacing, and higher patient satisfaction. 18,39 All participants will attend routine one-on-one prenatal appointments prior to the intervention. The sessions occur from week 14 of pregnancy through birth with women of similar gestational age, following the same schedule as standard care. Once the groups of women are formed (5 per group), the participants attend all appointments together for the duration of their pregnancies. Mobile health clinic located at FBOs will provide a location for providers to provide brief one-on- | Behavioural | Group prenatal care |
Primary outcome
pre-term birth
Time frame: three months postpartum
birth prior to 36 weeks gestation
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 13 Apr 2026.
- Individual participant dataSharing planned: No. All data will be aggregated when disseminated to provide confidentiality to all participants.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CenteringPregnancy in people with Prenatal Care, 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 4 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 13 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?
pre-term birth (time frame: three months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.