A Sleep Hygiene-based Intervention Program for Infants and Toddlers
1 other identifier
interventional
247
1 country
1
Brief Summary
Sleep problems during infancy are associated with behavior and emotional problems, poor language development , parental distress and mood disturbances, and overweight and obese children. The investigators proposed that children who receive the light, activity, and sleep training (LAST) intervention program in this study will have less parent report of problem sleep behaviors and longer duration of nighttime sleep compared to children with no intervention provided.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 8, 2015
CompletedFirst Posted
Study publicly available on registry
March 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 18, 2017
October 1, 2016
4.1 years
March 8, 2015
April 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Actigraphic assessed sleep quantity variables
Total nighttime, daytime, and 24 hour sleep duration
Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up
Secondary Outcomes (1)
Actigraphic assessed sleep quality variables
Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up
Study Arms (2)
Sleep hygiene & standard care
EXPERIMENTALParticipants receive a light, activity, and sleep training (LAST) intervention consists of behavioral and educational strategies for increasing light exposure and physical activity to minimize sleep disturbance.
Standard care
NO INTERVENTIONParticipants receive usual care.
Interventions
LAST intervention (light, activity, and sleep training) consists of behavioral and educational strategies for increasing light exposure and physical activity, minimizing television viewing and reducing television viewing time to \< 2 hours per day, and engaging activities suitable to the child's motor development to minimize sleep disturbance.
Eligibility Criteria
You may qualify if:
- Healthy singleton infant born at gestational age \>= 37 weeks
You may not qualify if:
- Infants born before 37 weeks gestation
- Infants born with a congenital abnormality or a genetic disorder
- Parents with insufficient Chinese
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taipei, 10048, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Shao-Yu Tsai, PhD
National Taiwan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2015
First Posted
March 25, 2015
Study Start
November 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
April 18, 2017
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share