Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03382951 |
| Other study ID # |
H-40556 |
| Secondary ID |
R01DK113269 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 19, 2017 |
| Est. completion date |
November 27, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Baylor College of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Screen media use and TV viewing has been linked to child obesity through epidemiologic and
randomized controlled intervention studies, resulting in excess TV viewing becoming a public
health concern. Higher amounts of TV viewing among children have also been associated with
decreased fitness and higher risk of metabolic syndrome. While TV viewing has often been used
as a marker of sedentary behavior, it has been distinguished from inactivity (or lack of
physical activity (PA)), by a meta-analyses that found only a small negative (-0.13) effect
size between children's TV viewing and PA. A major limitation of the meta-analyses was most
included studies relied on parent or self-report of screen viewing behaviors, potentially
introducing errors and under or overestimating the true effect size. Screen media use and TV
viewing is a common sedentary behavior among children, and accurate assessment of screen use
is important to characterize the role it plays in children's overall sedentary behaviors.
Accurate assessment of screen media use and TV viewing is also needed to delineate the causal
pathways that screen use plays in children's physical activity, development of obesity, and
other health outcomes.
Substantial problems and limitations have been identified in the current available measures
of TV viewing, which reduces the likelihood of "high quality exposure assessment" of screen
use. The most commonly used measure, child self-report or parent-report to estimate the
minutes of TV viewing in a typical day has low correlation (0.27) with home
video-observations. The current gold standard method to measure children's TV viewing, direct
or video recorded observation, is too expensive and intrusive for most field studies. In
addition, it may cause privacy concerns for participants and requires additional costs of
coding the video recordings at a later time. TV diaries had higher correlations with home
video recording (r=0.84) than parent estimates, but are very burdensome requiring
documentation of child activity every 15 min for several days, which may introduce systematic
errors. Lastly, children's TV viewing behaviors are quickly changing and many children now
view TV shows and movies on other screen devices, such as smartphones and mobile tablets
(e.g. iPads or Kindles). In summary, the current ability to measure and monitor how much TV a
child watches is intrusive (observations), burdensome (TV diaries) or crude and fraught with
error and bias (general estimates). This limits researcher's ability to identify causal
associations with health outcomes. While automatic and objective measures of PA, such as
accelerometers, have shown validity and reliability for quantifying children's PA, no system
that is automatic, accurate and unobtrusive has been developed to assess children's screen
use on traditional TV screens or tablets.
Imaging, computer vision and signal processing algorithms have made tremendous progress in
the last decade, resulting in high-performance, reliable algorithms for many tasks such as
face detection, face recognition, gaze tracking, human activity recognition, and 3D sensing.
In collaboration with electrical engineers at Rice University, investigators at Baylor
College of Medicine are leveraging these recent advances to build a first-of-its-kind 'Family
Level Assessment of Screen use in the Home" (FLASH), a fully integrated, unobtrusive system
for accurate, privacy preserving and reliable monitoring of TV and other screen usage by
children and adults in their homes. In this study, investigators will focus on (a)
Integrating the vision and signal processing algorithms and the imaging hardware required to
develop FLASH (Rice investigators); (b) Refining the FLASH hardware and the software pipeline
for TVs and mobile devices via alpha and beta laboratory studies (Rice and BCM
investigators); (c) Validating the FLASH TV and mobile device against the gold standard
(observations) among 6-11 year old children who are old enough to follow instructions in a
controlled observation laboratory to ensure fidelity to the protocol (BCM investigators), and
(d) Performing a preliminary investigation of the challenges for in-home use and adoption
(home feasibility study) (BCM investigators).
The ultimate goal of this project is to develop a highly accurate system to measure the
screen use by the index child, across diverse screens, including TVs, smartphones and
tablets. Since smartphones and tablets are similar in software and hardware, investigators
only need to develop two systems: FLASH-TV and FLASH-Mobile. Both systems will take a three
step approach: 1) use detection, 2) index user identification, and 3) usage logging, to
assess an index child's screen use. The goal is to merge a child's use across screen
platforms into one database to be able to track their screen use across devices along with
simultaneous use of devices.
FLASH will be developed collaboratively with electrical engineers at Rice University and
behavioral researchers at Baylor College of Medicine in a series of four studies:
STUDY 1: Iterative alpha-tests with small samples of family diads or triads (n=3-5 families
per trial) of the individual FLASH components and integrated FLASH systems in the CNRC
Metabolic Research Unit (MRU) Observational Lab. Investigators plan for these alpha-tests to
occur approximately every 3 months to assess the most recent advances of the FLASH
technology. Approximately 3-4 separate alpha test with 3-5 triads per test, resulting in an
anticipated sample of 42-60 participants (12-20 triads). The experiences from pilot studies
we have conducted, identified that iterative testing of new components with a small sample,
followed by refinement and retesting, allows for the ideal tight-loop feedback with input
from both teams to capitalize on human subject data collection and allow advancement of the
technology development.
STUDY 2: One to six beta tests (depending on results) of the integrated prototype FLASH
system with 10 family dyads or triads per test will be conducted also in the CNRC MRU
Observational Lab, with a maximum on 240 participants (80 triads or dyads). The experience
from the pilot study suggests that data from 10 triads or dyads per beta test will allow
adequate assessment of the functionality of the FLASH prototype.
STUDY 3: Lab based validation of the final FLASH-TV and FLASH-Mobile devices in the CNRC MRU
Observational Lab with 32 parent-child triads. This number has been revised from our initial
estimation based on our experiences in alpha and beta tests. Investigators will recruit 32
parent-sibling triads (96 participants) to complete the validation study. Three of the
parent-sibling triads (9 participants) will participate in a pilot study prior to starting
data collection on the remaining sample to refine the final validation protocol, if needed.
To be conservative, we account for ICC of 0.6 in calculating a sample size required for this
validation study. A random sample of 29 subjects who are each measured at least 100 times
yields a two-sided 95% confidence interval with a width of 0.25 (margin of error = 0.25/2 =
0.125 = 12.5%) when the estimated ICC is 0.6 as assessed using a two-way mixed-effects ANOVA
model.
STUDY 4: Home feasibility study to assess families' willingness to have devices installed in
their home for a limited time study period and the ability of the FLASH devices to capture
children's screen use across an entire day. With a power of 80% and an alpha of 0.05, to
detect a moderate-to large effect (0.4) with bivariate correlation between minutes of TV
viewing as measured by FLASH compared to TV diaries a final sample size of 37 families will
be needed. A moderate-to-large effect size will help ensure high accuracy for FLASH to
measure TV viewing in the home. Investigators anticipate having complete data on 80% of
participating families and will therefore recruit 46 families (184 participants, estimating 4
family members per family) to achieve the final sample of 37 families.
Across the four studies, investigators therefore anticipate a total sample size of 448
participants (88 triads in studies 1-3 and 46 families in study 4). Each study is an
observational study with no group assignments and no control/placebo.
