MSC - OneBiome UX Pilot Study (OneBiome)

January 26, 2023 updated by: Danone Asia Pacific Holdings Pte, Ltd.

Evaluating the User Experience of the OneBiome Consumers Value Journey Service Offered to the 1000 Days and Young Children Consumers Market

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

Study Overview

Status

Completed

Detailed Description

The OneBiome service aims to empower consumers with microbiome science in a friendly/consumer centric manner. The investigators wants to show that microbiome data can be used as an estimate of consumer's health and can be translated into actionable insights. The investigators aim to pilot a consumers' insight study to measure the perception/sentiments of this service in the Singapore market by recruiting study subjects from local public/private hospitals.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 229899
        • KK Women's and Children's Hospital
      • Singapore, Singapore, 228510
        • Mount Elizabeth Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Pregnant women who are in the third trimester, or children from birth to 5 years of age
  2. Pregnant women or parents of children should have access to the internet and a smartphone or tablet to access the OneBiome mobile friendly website.
  3. 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.
  4. Pregnant women and parents of children should stay in Singapore and remain contactable should they decide to do two microbiome assessments within 8 weeks

Exclusion Criteria:

  1. Children born prematurely
  2. Incapability of the pregnant women or parents of children to access OneBiome mobile friendly website and complete the questionnaires in English.
  3. Any other family member is enrolled in the study
  4. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregnant women or children 0-5 years of age
Pregnant women in third trimester or children 0-5 years of age
participants will be asked to complete the user experience of the OneBiome service

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall user experience of the OneBiome microbiome profiling service
Time Frame: Approximately 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
User experience of different "steps/ phases" of the OneBiome consumers value journey service
Time Frame: Approximately 8 weeks
Pregnant women and parents of young children reported user experience of different "steps/ phases" of the OneBiome consumers value journey service, including 'kit discovery, 'kit usage', 'web platform', 'evaluation of report', 'evaluation of service' and ''evaluation of consumer's motivation and consumption behaviour habits'
Approximately 8 weeks
Healthcare professional (HCP) reported overall experience of the OneBiome consumers value journey service
Time Frame: Approximately 8 weeks
HCP reported overall user experience of the OneBiome microbiome profiling service
Approximately 8 weeks
HCP reported usefulness of microbiome data
Time Frame: Approximately 8 weeks
HCP reported usefulness of microbiome data for their general practice based on user experience interaction between HCP and pregnant women and parents of young children
Approximately 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome composition of the participants
Time Frame: Approximately 8 weeks
Microbiome composition in the stool sample of the subject which will be included in the microbiome analysis report to be shared with subject/ parent's subject.
Approximately 8 weeks
Association between microbiome composition and known factors that influence the microbiome
Time Frame: Approximately 8 weeks
Association between microbiome composition and known factors that influence the microbiome in early life including mode of delivery, antibiotic prophylaxis, infant feeding patterns and diet.
Approximately 8 weeks
Food frequency questionnaire translation into food groups
Time Frame: Approximately 8 weeks
FFQ data at the beginning and at the end of the study based on translation of FFQ into food groups according to the healthy plate guideline from the Health Promotion Board.
Approximately 8 weeks
Association between gut health parameters, stool images, microbiome composition and dietary patterns
Time Frame: Approximately 8 weeks
Association between gut health parameters (symptoms, stool consistency, frequency and color, gastrointestinal infection, antibiotic intake) and stool images from participants, and microbiome composition and dietary patterns
Approximately 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

March 19, 2022

Study Completion (Actual)

April 29, 2022

Study Registration Dates

First Submitted

August 1, 2021

First Submitted That Met QC Criteria

August 1, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SBB20R&33310

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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