Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
University of Hawaii
Study ID
NCT07446205
Status
Recruiting
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Conditions

  • Gestational Diabetes Mellitus (GDM)
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fermented Poi — OTHER
    Participants consume one pound of fermented poi daily for 28 days.

Study Details

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.

Key Dates

Start date
Apr 16, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Poi Intervention
    Daily consumption of fermented poi for 4 weeks during the second trimester.

Primary Outcome Measure

Maternal microbial composition at the end of the intervention [ Time Frame: Baseline and 4 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Hawaii Pacific HealthHonoluluHawaii96826-
University of Hawai'i Cancer CenterHonoluluHawaii96813
Marie Kainoa Fialkowski Revilla
[email protected]
808-564-5915
Waimanalo Health CenterWaimanaloHawaii96795-

Find similar trials in Honolulu, HI

By research site
Hawaii Pacific Health· Honolulu, HIUniversity of Hawai'i Cancer Center· Honolulu, HIWaimanalo Health Center· Waimanalo, HI

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