Pilot testing daily fermented poi to improve the maternal microbiome and lower gestational diabetes risk
Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk
This pilot will test whether eating one pound of fermented poi daily for four weeks can change the maternal microbiome and lower gestational diabetes risk for pregnant people in mid-pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Hawaii Academic / other |
| Locations | 3 sites (Honolulu, Hawaii and 2 other locations) |
| Trial ID | NCT07446205 on ClinicalTrials.gov |
What this trial studies
This non-randomized pilot will enroll 50 pregnant participants in the second trimester to consume one pound of fermented poi daily for 28 days while receiving culturally tailored nutrition education via secure text messaging. Participants will complete baseline, mid-point, end-of-intervention, and third-trimester follow-up visits with collection of self-collected vaginal swabs and optional oral and rectal swabs, plus anthropometrics, blood pressure, dietary records, and questionnaires. Outcomes will include changes in vaginal, oral, and rectal microbiome composition, diet quality, gestational diabetes diagnosis, and pregnancy-related outcomes compared with matched controls from an existing cohort. The study is designed to test feasibility and generate data to inform a larger, culturally grounded dietary intervention for gestational diabetes prevention.
Who should consider this trial
Good fit: Ideal candidates are pregnant people at least 10 weeks into pregnancy but not yet in the third trimester (roughly early-to-mid second trimester), age 18 or older, with no major pre-existing health conditions, who live on the windward side of Oʻahu, can read and write English, own a smartphone, and can complete study activities.
Not a fit: People with pre-existing health conditions (including pregestational diabetes), those already in the third trimester, or those unable or unwilling to eat poi, use a smartphone, or attend local visits are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this could provide a simple, culturally grounded dietary option to improve maternal microbiome health and reduce risk factors for gestational diabetes.
How similar studies have performed: Prior research on fermented foods and probiotics shows some microbiome and metabolic effects but pregnancy-specific evidence is limited and mixed, making this culturally specific poi intervention largely novel and exploratory.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Honolulu, Hawaii and 2 other locations
- University of Hawai'i Cancer Center — Honolulu, Hawaii, United States (Recruiting)
- Hawaii Pacific Health — Honolulu, Hawaii, United States (Recruiting)
- Waimanalo Health Center — Waimanalo, Hawaii, United States (Recruiting)
Study contacts
- Principal investigator: Marie Kainoa Fialkowski Revilla — University of Hawaii
- Study coordinator: Marie Kainoa Fialkowski Revilla
- Email: mariekf@hawaii.edu
- Phone: 808-564-5915
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.