Virtual Fitness Buddy Ecosystem

NCT03524183 | Completed Phase 2

• 1 other identifier: 00004611
• Study Type: interventional
• Target: 964
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (8)

• Physical Activity

  Physical activity of participating children will be assessed with Fitbits and validated with Actigraphs.

  12 months

• Height

  Height in meters

  12 months

• Weight

  Weight in kilograms

  12 months

• Waist circumference

  Waist circumference in centimeters

  12 months

• Body fat percentage

  Body fat percentage in percentile

  12 months

• Self-efficacy

  Self-reported perceived efficacy for physical activity

  12 months

• Motivation

  Self-reported motivation for physical activity

  12 months

• Parent-child relationship

  Self-reported parent-child relationship

  12 months

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Behavioral: Virtual Fitness Buddy Ecosystem

Treatment

EXPERIMENTAL

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.

Behavioral: Virtual Fitness Buddy Ecosystem

Interventions

Virtual Fitness Buddy Ecosystem BEHAVIORAL

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.

Control; Treatment

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: lead
• YMCA of Metropolitan Atlanta: collaborator

Study Sites (1)

YMCA of Metropolitan Atlanta

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sun Joo (Grace) Ahn, Ph.D.

  University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The unit of randomization (control vs. treatment) is at the school level. Participants at each school will be masked of the other schools' assigned condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The efficacy of the VFB Ecosystem will be tested using a cluster randomized trial with repeated measures at baseline, posttest (immediately after 3-month intervention), mid-term follow up (6 months post intervention), and a long-term follow up (12 months post intervention). A 3-month intervention period was selected to observe variance in engagement over the course of an academic semester in the afterschool programs. A cluster randomized design is indicated when outcomes are tracked at a group level (afterschool programs) instead of at the individual level (children) and is the preferred method to reduce the impact of dependency in the data. From a pool of 24 demographically matched afterschool programs, we will randomly assign pairs to either receive the Ecosystem or physical activity as usual. Outcomes will be modeled and expressed as changes occurring at the afterschool program level--the unit of randomization.

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: August 27, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: Data files will be compiled as data collection progresses. After completion of the study, data analysis, and manuscript publication, the PI will share de-identified data with researchers who can verify certification to (a) work with Human Subjects and (b) complete an agreement with the host institution, the University of Georgia. Thus, following study completion, all data will be accessible to qualified researchers. Additionally, surveys created for the study will be hosted on university websites to be used free of charge by interested researchers. Treatment manuals and other materials will be made available upon request.

Locations

US (1)