Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03524183 |
| Other study ID # |
00004611 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
August 27, 2018 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
University of Georgia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The VFB Ecosystem capitalizes on digital technologies' ability to connect parents and
children, allowing parents to actively support their child's physical activity, even when
parents cannot be present. The VFB is a kiosk-based system that houses a virtual dog
programmed to allow children to set self-determined physical activity goals. The children
wear Fitbits while performing physical activity. Using the unique data embedded in the
Fitbit, the kiosk is able to detect each individual child and automatically connect him or
her to a unique, personalized virtual dog. Physical activity data is transmitted
automatically from the Fitbit to the kiosk when the child approaches, and the virtual dog
provides accurate evaluations of whether the child met the self-determined physical activity
goal, offering words of encouragement and physical activity support. The virtual pet
functions as a personalized fitness buddy to encourage children to set and meet physical
activity goals, promote physical activity self-efficacy, and foster mutually supportive
relationships among children, parents, and the virtual pet. This will be particularly helpful
for children who receive insufficient amounts of social support in their current environment.
Concurrently, the kiosk sends a text message to parents on the child's physical activity
progress. Parents are then able to send words of encouragement and communicate with their
children via the kiosk, using the text messaging feature of their mobile phones. Thus, even
when the parent is not with the child, the virtual pet is designed to serve as a coordinating
focus for facilitating parent-child communication. Parents will also receive text messages
from the kiosk with a security code to access a website that provides detailed records of the
child's physical activity over time.
Description:
Childhood obesity poses a critical public health concern and chronically remains as one of
the strongest predictors of obesity as an adult. Scientific evidence has demonstrated that
daily physical activity (PA) is imperative in preventing the onset of obesity. The outpour of
academic and professional interest has increased the public awareness of the risks related to
obesity (e.g., type 2 diabetes, cardiovascular diseases, cancers) as well as the importance
of PA. However, studies show that the rising prevalence of childhood obesity has not faltered
since 1999. Many existing PA interventions show short-term impact, but have failed to
demonstrate longer-term efficacy in sustaining the changes in PA over time-a gap this project
aims to address.
One important, yet commonly overlooked, limitation of existing PA interventions is the
negative impact of extrinsic rewards, such as points, grades, and badges, which are often
used in health promotion interventions to incentivize children for engaging with the program.
Children become motivated to excel in obtaining the extrinsic rewards rather than learning
the intrinsic benefits of the intervention. Consequently, these types of interventions have
limited effects that may disappear altogether when they stop receiving extrinsic rewards.
Another critical limitation of existing PA interventions related to the use of extrinsic
rewards is that the focus on "beating the system" by obtaining extrinsic rewards
decontextualizes the intervention from the child's everyday life. This is an isolating
experience for the child, taking him or her away from existing social support (e.g., parents)
and left to his or her devices to engage in PA, based solely on the motivation from extrinsic
rewards.
Guided by the frameworks of social ecological theory and self-determination theory, we
propose a paradigm-shifting intervention through an engaging, game-like platform that
incorporates intrinsic reward systems by harnessing the power of technology to connect people
and devices to promote PA in children. The Virtual Fitness Buddy (VFB) Ecosystem was designed
to encourage children to embrace PA as a lifestyle change that can be sustained over time
rather than a means to gain points. The Ecosystem meets this goal by leveraging one of the
most influential existing social relationships in children's lives, the parent-child
relationship. Using consumer-grade technological devices, such as mobile phones, the
Ecosystem allows parents to stay involved in the intervention and support their children's PA
efforts even when they cannot be with their children. In addition, a virtual pet, designed to
mimic human-pet relationships in the physical world, will guide children to set and meet PA
goals and offer tailored support.
Using technology to amplify the power of existing social relationships, children will learn
to embrace PA as a lifestyle change while supported by their parents and the virtual pet
within the Ecosystem. Because the intervention is embedded in the context of children's
everyday lives, our preliminary findings demonstrated the potential of the Ecosystem to
elicit high levels of engagement and excitement from both children and parents over a 3-day
intervention period. The next critical question is whether the Ecosystem can maintain
children and parents' engagement over longer periods of time, yielding sustainable changes in
health behavior and lifestyle choices that were initiated by the Ecosystem.
In collaboration with YMCA, 480 children and 480 parents in 24 afterschool programs will be
randomly assigned to treatment and control groups in a cluster-randomized controlled trial.
Afterschool programs in the treatment group will receive the Ecosystem intervention for
3-months; afterschool programs in the control group will not experience the Ecosystem (but
will receive the standard of care). All children will complete baseline assessments, a
3-month posttest, and a 6-month and 12-month follow up. Parents and children will provide
self-report data on their perceived social support, motivation, and PA self-efficacy. PA will
be assessed with activity monitors, which children will wear throughout the project.
Our specific aims are:
Aim 1. Test the hypothesis that at the 3-month, 6 month, and 12-month assessments, children
assigned to the Ecosystem will evince higher levels of moderate-to-vigorous intensity PA than
children in the control group.
Auxiliary Aim 1. For the treatment group only, test the engagement of parents and children
over the 3-month intervention through tracking the usage frequency and duration of their
interactions through the Ecosystem.
Aim 2. Test the parent and child mechanisms of change. Specifically, we hypothesize that
children and parents in the treatment group will report higher levels of motivation, PA
self-efficacy, and perceived social support at the 3-month, 6 month, and 12-month follow up
compared to control children. Moderators of change, such as the child's age and gender will
also be analyzed.
The Virtual Fitness Buddy Ecosystem represents a new generation of technology-mediated health
interventions for children, which integrates fun and engaging technology into existing social
systems, to promote sustainable lifestyle changes through the intrinsic reward of social
support. Because the Ecosystem is a cost- and labor-effective solution that integrates
consumer-grade technology with low barriers for continued use, it has the potential for rapid
diffusion and widespread public health impact.
