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Recruiting Not applicable NCT07446205

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

No applicable phase (e.g. observational)
Conditions: Gestational Diabetes Mellitus (GDM) Pregnancy

Sponsor: University of Hawaii

trial.available_in: БГ
Overview
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.
Description
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.
Who can participate
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
Interventions
Fermented Poi
OTHER
Locations 3
United States (3)
University of Hawai'i Cancer Center
Honolulu , Hawaii
Marie Kainoa Fialkowski Revilla
Hawaii Pacific Health
Honolulu , Hawaii
Waimanalo Health Center
Waimanalo , Hawaii
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
16.04.2026
Completion date
31.01.2027
Registry ID
NCT07446205
Source
clinicaltrials.gov
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