Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07446205

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

Led by University of Hawaii · Updated on 2026-04-23

50

Participants Needed

3

Research Sites

41 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Be at least 10 weeks into their pregnancy
  • Have no pre-existing health conditions
  • Be able to read and write in English
  • Be at least 18 years of age
  • Own a smartphone
  • Live on the windward side of O'ahu
  • Be able to complete study activities
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University of Hawai'i Cancer Center

Honolulu, Hawaii, United States, 96813

Actively Recruiting

2

Hawaii Pacific Health

Honolulu, Hawaii, United States, 96826

Actively Recruiting

3

Waimanalo Health Center

Waimanalo, Hawaii, United States, 96795

Actively Recruiting

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Research Team

M

Marie Kainoa Fialkowski Revilla

CONTACT

T

Tomomi Otaki

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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