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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Preterm Birth

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• 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
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Preterm; born at <37 weeks of gestation
Full term Term; born at >/= 37 weeks of gestation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
• Collaborators: KK Women's and Children's Hospital
• Investigators: Principal Investigator: Mei Chien Chua, MBBS, KK Women's and Children's Hospital

Publications and helpful links

General Publications

• Wong J, Foussat AC, Ting S, Acerbi E, van Elburg RM, Mei Chien C. A Chatbot to Engage Parents of Preterm and Term Infants on Parental Stress, Parental Sleep, and Infant Feeding: Usability and Feasibility Study. JMIR Pediatr Parent. 2021 Oct 26;4(4):e30169. doi: 10.2196/30169.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): May 9, 2019

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 2, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: OBVIO-DAN-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No