Clinical trial NCT04991818: MSC - OneBiome UX Pilot Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Microbial Colonization
Keywords: OneBiome
Consumer insights
User experience
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chiang Children's Allergy and Asthma Clinic
name: The Child and Allergic Clinic
name: KK Women's and Children's Hospital
First posted: 2021-08-05
Enrollment: 90
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall user experience of the OneBiome microbiome profiling service
timeFrame: Approximately 8 weeks
Secondary outcomes:
measure: User experience of different "steps/ phases" of the OneBiome consumers value journey service
timeFrame: Approximately 8 weeks
measure: Healthcare professional (HCP) reported overall experience of the OneBiome consumers value journey service
timeFrame: Approximately 8 weeks
measure: HCP reported usefulness of microbiome data
timeFrame: Approximately 8 weeks
Other outcomes:
measure: Microbiome composition of the participants
timeFrame: Approximately 8 weeks
measure: Association between microbiome composition and known factors that influence the microbiome
timeFrame: Approximately 8 weeks
measure: Food frequency questionnaire translation into food groups
timeFrame: Approximately 8 weeks
measure: Association between gut health parameters, stool images, microbiome composition and dietary patterns
timeFrame: Approximately 8 weeks
Locations:
city: Singapore
country: Singapore
facility: Mount Elizabeth Medical Centre
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: The Child and Allergy Clinic
name: Bee Wah Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chiang Children's Allergy and Asthma Clinic
name: Wen Chin Chiang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: KK Women's and Children's Hospital
name: Anne Goh, MD
role: PRINCIPAL_INVESTIGATOR
References: