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NCT Number: NCT07446205

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

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.

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Adnexal Diseases Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Metabolic Diseases Nutritional and Metabolic Diseases Ovarian Diseases Pregnancy Pregnancy Complications Primary Ovarian Insufficiency Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hawaii Pacific Health, Honolulu, Hawaii, United States

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About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fermented Poi

Other

Participants consume one pound of fermented poi daily for 28 days.

Primary outcomes

  1. Maternal microbial composition at the end of the intervention

    Time frame: Baseline and 4 weeks

    Assessment of changes in maternal microbial composition, including the relative abundance of beneficial species such as Lactobacilli crispatus, by the end of the 4-week poi intervention.

Secondary outcomes

  1. Maternal microbial composition and its association with the bacterial taxonomic profile of fermented poi

    Time frame: 4 weeks

    Identification of whether maternal microbial composition is associated with the bacterial taxonomic profile of the fermented poi provided during the study.

Other outcomes

  1. Diet quality score (Food Frequency Questionnaire)

    Time frame: Baseline and 4 weeks

    Change in diet quality score as measured by the Food Frequency Questionnaire, comparing participants who completed the poi intervention with matched controls.

  2. Gestational weight gain

    Time frame: Baseline and 4 weeks

    Change in maternal weight (kg) from baseline to post-intervention, comparing participants who received the poi intervention with matched controls

  3. Blood pressure

    Time frame: Baseline and 4 weeks

    Change in systolic and diastolic blood pressure (mmHg) from baseline to post-intervention, comparing participants who received the poi intervention with matched controls

  4. Gestational diabetes mellitus (GDM) diagnosis

    Time frame: By post-intervention (no later than 27 weeks gestation)

    Proportion of participants with a Gestational diabetes mellitus (GDM) diagnosis (yes/no) by post-intervention, comparing participants who received the poi intervention with matched controls

  5. Acceptability score (Theoretical Framework of Acceptability [TFA] questionnaire)

    Time frame: 4 weeks

    Acceptability score as measured by the Theoretical Framework of Acceptability (TFA) questionnaire (e.g., mean score), assessed at post-intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Kainoa Fialkowski Revilla

CONTACT

[email protected]

808-564-5915

Tomomi Otaki

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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