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MSC - OneBiome UX Pilot Study (OneBiome)

Primary Purpose

Microbial Colonization

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
OneBiome microbiome profiling service
Sponsored by
Danone Asia Pacific Holdings Pte, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Microbial Colonization focused on measuring OneBiome, Consumer insights, User experience

Eligibility Criteria

0 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mount Elizabeth Medical Centre
  • KK Women's and Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pregnant women or children 0-5 years of age

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

User experience of different "steps/ phases" of the OneBiome consumers value journey service
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'
Healthcare professional (HCP) reported overall experience of the OneBiome consumers value journey service
HCP reported overall user experience of the OneBiome microbiome profiling service
HCP reported usefulness of microbiome data
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

Full Information

First Posted
August 1, 2021
Last Updated
January 26, 2023
Sponsor
Danone Asia Pacific Holdings Pte, Ltd.
Collaborators
Chiang Children's Allergy and Asthma Clinic, The Child and Allergic Clinic, KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04991818
Brief Title
MSC - OneBiome UX Pilot Study
Acronym
OneBiome
Official Title
Evaluating the User Experience of the OneBiome Consumers Value Journey Service Offered to the 1000 Days and Young Children Consumers Market
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 19, 2022 (Actual)
Study Completion Date
April 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danone Asia Pacific Holdings Pte, Ltd.
Collaborators
Chiang Children's Allergy and Asthma Clinic, The Child and Allergic Clinic, KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization
Keywords
OneBiome, Consumer insights, User experience

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregnant women or children 0-5 years of age
Arm Type
Experimental
Arm Description
Pregnant women in third trimester or children 0-5 years of age
Intervention Type
Other
Intervention Name(s)
OneBiome microbiome profiling service
Intervention Description
participants will be asked to complete the user experience of the OneBiome service
Primary Outcome Measure Information:
Title
Overall user experience of the OneBiome microbiome profiling service
Description
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.
Time Frame
Approximately 8 weeks
Secondary Outcome Measure Information:
Title
User experience of different "steps/ phases" of the OneBiome consumers value journey service
Description
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'
Time Frame
Approximately 8 weeks
Title
Healthcare professional (HCP) reported overall experience of the OneBiome consumers value journey service
Description
HCP reported overall user experience of the OneBiome microbiome profiling service
Time Frame
Approximately 8 weeks
Title
HCP reported usefulness of microbiome data
Description
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
Time Frame
Approximately 8 weeks
Other Pre-specified Outcome Measures:
Title
Microbiome composition of the participants
Description
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.
Time Frame
Approximately 8 weeks
Title
Association between microbiome composition and known factors that influence the microbiome
Description
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.
Time Frame
Approximately 8 weeks
Title
Food frequency questionnaire translation into food groups
Description
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.
Time Frame
Approximately 8 weeks
Title
Association between gut health parameters, stool images, microbiome composition and dietary patterns
Description
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
Time Frame
Approximately 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bee Wah Lee, MD
Organizational Affiliation
The Child and Allergy Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wen Chin Chiang, MD
Organizational Affiliation
Chiang Children's Allergy and Asthma Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Goh, MD
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Elizabeth Medical Centre
City
Singapore
ZIP/Postal Code
228510
Country
Singapore
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore

12. IPD Sharing Statement

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MSC - OneBiome UX Pilot Study

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