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

NCT03630679 | Completed Results

• 1 other identifier: OBVIO-DAN-003
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preterm Birth; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Ratings by Parents of Quality of Their Sleep

  8 weeks

• Particular Reasons for Stress Caused by the Baby

  8 weeks

• Number of Chats on Feedings Among Parents Who Give Their Infants Formula

  8 weeks

Other Outcomes (1)

• Satisfaction Scale Scores for Chatbot and ClaimIt

  8 weeks

Study Arms (2)

Preterm

born at \<37 weeks of gestation

Full term Term

born at \>/= 37 weeks of gestation

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danone Asia Pacific Holdings Pte, Ltd.: lead
• KK Women's and Children's Hospital: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

Location

Related Publications (1)

• 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.

  PMID: 34544679 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Digital Project Manager
• Organization: Danone Asia Pacific Holdings

jill.wong@danone.com

82281172

Study Officials

• Mei Chien Chua, MBBS

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 15, 2018
• Study Start: November 7, 2018
• Primary Completion: March 1, 2019
• Study Completion: May 9, 2019
• Last Updated: August 13, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)