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

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ClinicalTrials.gov Identifier: NCT03630679
Recruitment Status : Completed
First Posted : August 15, 2018
Results First Posted : August 3, 2020
Last Update Posted : August 13, 2020
Sponsor:
Collaborator:
KK Women's and Children's Hospital
Information provided by (Responsible Party):
Danone Asia Pacific Holdings Pte, Ltd.

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.

Condition or disease
Preterm Birth Healthy

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

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study Evaluating Sleep, Stress, and Infant Nutrition Using a Chatbot With Parents of Preterm and Full-term Infants
Actual Study Start Date : November 7, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : May 9, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Number of Chats on Sleep, Stress and Infant Nutrition [ Time Frame: 8 weeks ]
    Obtaining number of chats for sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot


Secondary Outcome Measures :
  1. Ratings by Parents of Quality of Their Sleep [ Time Frame: 8 weeks ]
    Comparison on ratings for quality of their (parent) sleep from parents of preterm infants and parents of full-term infants

  2. Particular Reasons for Stress Caused by the Baby [ Time Frame: 8 weeks ]
    Comparison of particular reasons for stress caused by the baby from parents of preterm infants and parents of full-term infants

  3. Number of Chats on Feedings Among Parents Who Give Their Infants Formula [ Time Frame: 8 weeks ]
    Comparison of number of chats on the feeding from parents of preterm infants and parents of full-term infants who give their infants formula


Other Outcome Measures:
  1. Satisfaction Scale Scores for Chatbot and ClaimIt [ Time Frame: 8 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630679


Locations
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Singapore
KK Women's and Children's Hospital
Singapore, Singapore
Sponsors and Collaborators
Danone Asia Pacific Holdings Pte, Ltd.
KK Women's and Children's Hospital
Investigators
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Principal Investigator: Mei Chien Chua, MBBS KK Women's and Children's Hospital
  Study Documents (Full-Text)

Documents provided by Danone Asia Pacific Holdings Pte, Ltd.:
Study Protocol  [PDF] August 31, 2018
Statistical Analysis Plan  [PDF] April 11, 2019

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Responsible Party: Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier: NCT03630679    
Other Study ID Numbers: OBVIO-DAN-003
First Posted: August 15, 2018    Key Record Dates
Results First Posted: August 3, 2020
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications