NCT03382951

Brief Summary

Children's screen media use has been identified as a prominent cause for sedentary time that has been linked to obesity and metabolic syndrome, as well as other unwanted physiologic, psychosocial, and academic outcomes in children. However, no system that is automatic, accurate and unobtrusive has been developed to assess children's screen use on different platforms. Advances in technology, such as person detection, accurate facial recognition based on images, and imaging, computer vision and signal processing algorithms now offer novel and promising solutions to objectively and automatically measure people's screen viewing behaviors. Investigators will leverage these recent advances and integrate them to develop a first of its kind, in-home, unobtrusive, automatic, privacy preserving screen use monitoring system: Family Level Assessment of Screen use in the Home (FLASH) that uses an embedded computing platform connected to a video camera on larger, stationary screens (FLASH-TV); or functions as a background app using a front facing camera (FLASH-Mobile). The trans-disciplinary group, consisting of behavioral researchers at Baylor College of Medicine (BCM) and electrical engineers at Rice University, will develop and asses the validity of the FLASH to accurately identify whether and for how long a child is using screen media devices. In this multiple-PI study, the development of FLASH is led by engineers at Rice. Once a final system has been developed, alpha and beta tested, a validation study will take place in observation labs by the BCM behavioral researchers with 6-11 year old children for FLASH-TV and FLASH-Mobile (n=43). Comparisons of FLASH output will be made to staff observations of children participating in a set of structured predefined activities. Next FLASH will be assessed for feasibility and accuracy for identifying children's screen use across platforms in a naturalistic home setting (n=46), compared to direct observation and screen use diaries. FLASH has the potential of having a significant impact on public health and clinical research regarding screen media use by improving scientist's ability to assess the children's screen use. This can lead to better methodology to understand the impact of screen use on children's health outcomes or intervention effects of screen media reduction programs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

6.1 years

First QC Date

November 29, 2017

Last Update Submit

March 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Screen media use/viewing

    Assessment of participant's screen media use as detected by the FLASH system. This will be assessed once per family triad during a task based protocol in the observational labs at the research center compared to staff coding of video/audio recordings of the same time period.

    once, upon enrollment

Secondary Outcomes (4)

  • The feasibility to recruit families to test the of the FLASH devices their home

    9 months

  • The feasibility of the FLASH devices to be used in the family's home

    9 months

  • The feasibility of the FLASH devices in children's homes to measure the amount of time a child spends viewing TV or other screens

    three days

  • The feasibility of the FLASH devices in children's homes for future studies

    three days

Study Arms (1)

Healthy children

Each study is an observational study with no group assignments and no control/placebo.

Eligibility Criteria

Age5 Years - 65 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy children living in the greater metropolitan area around the research center

You may qualify if:

  • index child 5-11 year old child along with parent (adult 18-65)
  • and for some studies a 6-14 years old sibling
  • family is fluent in English
  • parent willing to allow their children to watch age-appropriate TV or movies and play age-appropriate digital/video games.

You may not qualify if:

  • Parent or child with a developmental, medical, mental or physical diagnosis (such as Down's syndrome, Autism, psychosis, wheel-chair reliant) that would prevent him/her from following the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Teresia O'Connor, MD, MPH

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 26, 2017

Study Start

October 19, 2017

Primary Completion

November 27, 2023

Study Completion

November 27, 2023

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations