Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Hawaii
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Fermented Poi
Other interventionParticipants consume one pound of fermented poi daily for 28 days.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Poi InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maternal microbial composition at the end of the intervention
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.
Time frame
Baseline and 4 weeksSecondary outcomes
1
Maternal microbial composition and its association with the bacterial taxonomic profile of fermented poi
Identification of whether maternal microbial composition is associated with the bacterial taxonomic profile of the fermented poi provided during the study.
Time frame
4 weeksOther outcomes
1
Diet quality score (Food Frequency Questionnaire)
Change in diet quality score as measured by the Food Frequency Questionnaire, comparing participants who completed the poi intervention with matched controls.
Time frame
Baseline and 4 weeks2
Gestational weight gain
Change in maternal weight (kg) from baseline to post-intervention, comparing participants who received the poi intervention with matched controls
Time frame
Baseline and 4 weeks3
Blood pressure
Change in systolic and diastolic blood pressure (mmHg) from baseline to post-intervention, comparing participants who received the poi intervention with matched controls
Time frame
Baseline and 4 weeks4
Gestational diabetes mellitus (GDM) diagnosis
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
Time frame
By post-intervention (no later than 27 weeks gestation)Sponsors and contacts
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Source ClinicalTrials.gov