NCT04991818

Brief Summary

Evaluating the user (pregnant women and parents of young children) experience of the OneBiome consumers value journey service offered to the 1000 days and young children consumers market

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

August 1, 2021

Last Update Submit

January 26, 2023

Conditions

Microbial Colonization

Keywords

OneBiomeConsumer insightsUser experience

Outcome Measures

Primary Outcomes (1)

  • Overall user experience of the OneBiome microbiome profiling service

    Pregnant women and parents of young children reported overall user experience of the OneBiome microbiome profiling service, i.e. average rating of the four following UX surveys1) overall experience of kit discovery (from unboxing to shipment); 2) ease of use of the stool collection kit; 3) overall user experience of the OneBiome web platform; 4) overall user experience of reading and understanding the microbiome analysis report.

    Approximately 8 weeks

Secondary Outcomes (3)

  • User experience of different "steps/ phases" of the OneBiome consumers value journey service

    Approximately 8 weeks

  • Healthcare professional (HCP) reported overall experience of the OneBiome consumers value journey service

    Approximately 8 weeks

  • HCP reported usefulness of microbiome data

    Approximately 8 weeks

Other Outcomes (4)

  • Microbiome composition of the participants

    Approximately 8 weeks

  • Association between microbiome composition and known factors that influence the microbiome

    Approximately 8 weeks

  • Food frequency questionnaire translation into food groups

    Approximately 8 weeks

  • +1 more other outcomes

Study Arms (1)

Pregnant women or children 0-5 years of age

EXPERIMENTAL

Pregnant women in third trimester or children 0-5 years of age

Other: OneBiome microbiome profiling service

Interventions

OneBiome microbiome profiling serviceOTHER

participants will be asked to complete the user experience of the OneBiome service

Pregnant women or children 0-5 years of age

Eligibility Criteria

Age0 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women who are in the third trimester, or children from birth to 5 years of age
  • Pregnant women or parents of children should have access to the internet and a smartphone or tablet to access the OneBiome mobile friendly website.
  • Pregnant women or parents of children should be able to comprehend the content in the OneBiome mobile friendly website and complete the questionnaires in English.
  • Pregnant women and parents of children should stay in Singapore and remain contactable should they decide to do two microbiome assessments within 8 weeks

You may not qualify if:

  • Children born prematurely
  • Incapability of the pregnant women or parents of children to access OneBiome mobile friendly website and complete the questionnaires in English.
  • Any other family member is enrolled in the study
  • Incapability of the pregnant women or parents of children to comply with study protocol or Investigator's uncertainty about the willingness or ability of the pregnant women or parents of children to comply with the protocol requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Elizabeth Medical Centre

Singapore, 228510, Singapore

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bee Wah Lee, MD

    The Child and Allergy Clinic

    PRINCIPAL INVESTIGATOR

  • Wen Chin Chiang, MD

    Chiang Children's Allergy and Asthma Clinic

    PRINCIPAL INVESTIGATOR

  • Anne Goh, MD

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2021

First Posted

August 5, 2021

Study Start

September 1, 2021

Primary Completion

March 19, 2022

Study Completion

April 29, 2022

Last Updated

January 27, 2023

Record last verified: 2023-01

Locations

SG(2)