A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot

Healthy Clinical Trial

Official title:

A Pilot Study Evaluating Sleep, Stress, and Infant Nutrition Using a Chatbot With Parents of Preterm and Full-term Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630679
• Other study ID #: OBVIO-DAN-003
• Status: Completed
• Start date: November 7, 2018
• Est. completion date: May 9, 2019

Study information

• Verified date: August 2020
• Source: Danone Asia Pacific Holdings Pte, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

20 parents with healthy preterm infants (born at <37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment will be enrolled to obtain records of sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot.

Description:

20 parents with healthy preterm infants (born at <37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment will be enrolled to obtain records of sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot.

Data obtained from parents of preterm infants and parents of full-term infants on sleep, stress, and infant nutrition will be compared.

An evaluation of the usability of the mobile app hosting the chatbot, the study chatbot and its functionality in general among this population will also be conducted

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 9, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

Subjects (parent and infant) must meet the following criteria:

• Healthy infants (preterm and full-term) must be 0-6 months of age at time of enrollment

• Infants must be at home (discharged from the hospital) at time of enrollment

• Informed consent from parent whose age is =21 years

• Parent must be proficient in the English language

• Parent must be able to comply with the required study tasks, as per PI's judgment

• In-home access to reliable internet connections; a mobile device suitable for electronic communication

Exclusion Criteria:

Infant must not meet any of the following criteria:

• Known to have current or previous illnesses/conditions which could interfere with the study outcome (per PI's clinical judgment)

• Must not be currently participating in any other clinical study

Parent must not meet any of the following criteria:

• Must not be known to have a significant medical condition that might interfere with the study (per PI's clinical judgment) that meets one of the following criteria:

• Presence of current mental illness or history of mental illness

• Any acute or chronic illness that makes the parent unsuitable for the study based on the PI's judgment

• Must not be a single parent

• Inability of the parent to comply with the study protocol or PI's uncertainty about the willingness or ability of the parent to comply with the protocol requirements

Related Conditions & MeSH terms

• Healthy
• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Danone Asia Pacific Holdings Pte, Ltd.	KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction Scale Scores for Chatbot and ClaimIt	Satisfaction scale scores for Chatbot and ClaimIt based on a scale score of 1 (very dissatisfied) to 5 (very satisfied) on the Usability of Chatbot and ClaimIt eQuestionnaire	8 weeks
Primary	Number of Chats on Sleep, Stress and Infant Nutrition	Obtaining number of chats for sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot	8 weeks
Secondary	Ratings by Parents of Quality of Their Sleep	Comparison on ratings for quality of their (parent) sleep from parents of preterm infants and parents of full-term infants	8 weeks
Secondary	Particular Reasons for Stress Caused by the Baby	Comparison of particular reasons for stress caused by the baby from parents of preterm infants and parents of full-term infants	8 weeks
Secondary	Number of Chats on Feedings Among Parents Who Give Their Infants Formula	Comparison of number of chats on the feeding from parents of preterm infants and parents of full-term infants who give their infants formula	8 weeks