NCT07446205 Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk
| NCT ID | NCT07446205 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Hawaii |
| Condition | Gestational Diabetes Mellitus (GDM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-06-12 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-06-12 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This investigator-initiated, non-randomized pilot study evaluates the effect of daily consumption of fermented poi on the maternal microbiome and gestational diabetes risk during pregnancy. Fifty pregnant participants between approximately 12 and 24 weeks of gestation will receive one pound of poi daily for four weeks, accompanied by culturally tailored nutrition education delivered via secure text messaging. Changes in vaginal, oral, and rectal microbiome composition, diet quality, gestational diabetes diagnosis, and pregnancy-related outcomes will be assessed and compared with matched controls derived from an existing cohort. This study aims to inform the feasibility and design of a larger culturally grounded dietary intervention for gestational diabetes prevention.
Eligibility Criteria
Inclusion Criteria: * Be at least 10 weeks into their pregnancy * have no pre-existing health conditions * Be able to read and write in English * be at least18 years of age * Own a smartphone * Live on the windward side of O'ahu * Be able to complete study activities Exclusion Criteria: * Less than 10 weeks pregnant or already in third trimester * Have pre-existing health conditions * Not able to read and write in English * Under 18 years of age * Do not own a smartphone * Do not live on the windward side of O'ahu * Unable to complete study activities
Contact & Investigator
Marie Kainoa Fialkowski Revilla
PRINCIPAL INVESTIGATOR
University of Hawaii
Frequently Asked Questions
Who can join the NCT07446205 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gestational Diabetes Mellitus (GDM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07446205 currently recruiting?
Yes, NCT07446205 is actively recruiting participants. Contact the research team at mariekf@hawaii.edu for enrollment information.
Where is the NCT07446205 trial being conducted?
This trial is being conducted at Honolulu, United States, Honolulu, United States, Waimanalo, United States.
Who is sponsoring the NCT07446205 clinical trial?
NCT07446205 is sponsored by University of Hawaii. The principal investigator is Marie Kainoa Fialkowski Revilla at University of Hawaii. The trial plans to enroll 50 participants.
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