- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03524183
Virtual Fitness Buddy Ecosystem
The Virtual Fitness Buddy Ecosystem: Using Digital Technology to Promote and Sustain Moderate-to-Vigorous Intensity Physical Activity in Children
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- YMCA of Metropolitan Atlanta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children must be between the ages of 6-10
- Children must be daily participants in the specified afterschool program
- Only one child (oldest) and one caregiver from each family can participate
- Participating parent must be the caregiver for the child for the majority of the week
Exclusion Criteria:
- Family has imminent plans for moving
- Child has impairments that prevent unassisted physical activity
- A non-residential parent who has little interaction with the child
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
The children will receive the standard of care at their respective afterschool programs.
As with the treatment group, all children will be asked to wear their Fitbits for one year following the intervention period, for the mid- and long-term follow up.
Fitbit data will be recorded tracked year-round through the automated Fitbit data syncing stations at the afterschool program site.
All participants will be assessed for PA and psychosocial variables at the same four measurement points for the treatment group.
|
The Virtual Fitness Buddy Ecosystem allows parents to stay involved in the intervention and support their children's PA efforts even when they cannot be with their children.
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.
In collaboration with YMCA, 480 children and 480 parents in 24 afterschool programs will be randomly assigned to treatment and control groups.
Afterschool programs in the treatment group will receive the Ecosystem intervention for 6-months; afterschool programs in the control group will not experience the Ecosystem.
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.
|
Experimental: Treatment
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.
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.
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.
Participants will be assessed for post-treatment measurements immediately after 3 months, 6 months after, and 12 months after the intervention.
|
The Virtual Fitness Buddy Ecosystem allows parents to stay involved in the intervention and support their children's PA efforts even when they cannot be with their children.
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.
In collaboration with YMCA, 480 children and 480 parents in 24 afterschool programs will be randomly assigned to treatment and control groups.
Afterschool programs in the treatment group will receive the Ecosystem intervention for 6-months; afterschool programs in the control group will not experience the Ecosystem.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: 12 months
|
Weight in kilograms
|
12 months
|
Physical Activity
Time Frame: 12 months
|
Physical activity of participating children will be assessed with Fitbits and validated with Actigraphs.
|
12 months
|
Height
Time Frame: 12 months
|
Height in meters
|
12 months
|
Waist circumference
Time Frame: 12 months
|
Waist circumference in centimeters
|
12 months
|
Body fat percentage
Time Frame: 12 months
|
Body fat percentage in percentile
|
12 months
|
Self-efficacy
Time Frame: 12 months
|
Self-reported perceived efficacy for physical activity
|
12 months
|
Motivation
Time Frame: 12 months
|
Self-reported motivation for physical activity
|
12 months
|
Parent-child relationship
Time Frame: 12 months
|
Self-reported parent-child relationship
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sun Joo (Grace) Ahn, Ph.D., University of Georgia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 00004611
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Activity
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
-
University of Colorado, DenverCompletedPhysical Activity | Physical ImpairmentUnited States
-
PXL University CollegeHasselt UniversityNot yet recruitingPhysical Activity - Digital Phenotyping - Activity Tracking
-
University of ExtremaduraThe Spanish Ministry of Science, Innovation and UniversitiesRecruitingPhysical Activity | Cognition | Physical Fitness | AdolescentsSpain
-
AdventHealth Translational Research InstituteWake Forest UniversityRecruiting
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruitingPhysical ActivityUnited States
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruiting
Clinical Trials on Virtual Fitness Buddy Ecosystem
-
Chinese University of Hong KongNot yet recruitingPhysical Competence | Daily Behaviour
-
University of British ColumbiaUniversity of Victoria; Social Sciences and Humanities Research Council of...CompletedPhysical Activity | Well-being | Identity, SocialCanada
-
University of Alabama at BirminghamLakeshore FoundationActive, not recruitingAging | Disability Physical | Chronic Conditions, MultipleUnited States