| Registry | NCT07446205 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, prevention |
| Enrollment | 50 (Estimated) |
| Sponsor | University of Hawaii (Other) |
| Conditions | Gestational Diabetes Mellitus (GDM), Pregnancy |
| Interventions | Fermented Poi (Other) |
| Dates | start 2026-06-12, primary completion 2027-01-31 (estimated), completion 2027-01-31 (estimated), first posted 2026-03-03, last updated 2026-07-02 |
| Locations | 3 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Gestational Diabetes Mellitus (GDM) All trials for Pregnancy All trials of Fermented Poi
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.
This investigator-initiated, non-randomized pilot study evaluates whether daily consumption of fermented poi during pregnancy can improve maternal microbiome composition and reduce risk factors related to gestational diabetes mellitus (GDM). The intervention will be implemented during the second trimester. After a brief dietary washout period (avoiding poi and other fermented foods/beverages as specified in the protocol), eligible participants will receive fermented poi from a single source meeting food safety standards and will be instructed to consume one pound per day for 28 consecutive days. Participants will also receive culturally tailored nutrition education delivered via secure text messaging throughout the intervention period.
Participants will complete study assessments at enrollment, baseline, mid-point, end of intervention, long term follow-up in third trimester. Maternal microbiome outcomes will be assessed using self-collected vaginal swabs (with optional self-collection of oral and rectal swabs, if applicable). Samples will be labeled with a study identification code and returned to the study team using approved procedures. Study staff will collect anthropometrics and blood pressure at scheduled visits. Participants will complete questionnaires related to pregnancy characteristics, psychosocial and cultural factors, and intervention acceptability and feasibility. Dietary intake will also be assessed using a mobile food record and questionnaire-based measures during the study period. With participant authorization, information on GDM diagnosis and labor and delivery outcomes will be obtained from the participant's health care provider.
Study outcomes will be compared with matched controls derived from an existing cohort with similar characteristics and no or low poi consumption. Findings from this pilot study will inform feasibility, procedures, and effect-size estimates to support the design of a larger culturally grounded dietary intervention for GDM prevention.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Poi Intervention | Experimental | Other: Fermented Poi | Daily consumption of fermented poi for 4 weeks during the second trimester. |
Sex: Female, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |