What side effects are associated with this type of intervention?

Digital feedback and parental support interventions to enhance physical activity, such as those studied in the VFB Ecosystem trial, generally have minimal side effects. Common issues include screen fatigue, technical difficulties, and data privacy concerns. Psychological effects like frustration or anxiety may occur if goals are not met or if there is excessive pressure to perform. Despite these potential side effects, the benefits of increased physical activity and improved self-efficacy typically outweigh the drawbacks.

What prior FDA approvals exist?

The FDA has approved various digital health tools and mobile applications aimed at promoting physical activity and self-efficacy. These include wearable fitness trackers that monitor physical activity and provide real-time feedback, as well as mobile apps that offer personalized exercise plans and motivational support. While specific FDA approvals for systems exactly like the VFB Ecosystem are not detailed, the general trend towards integrating digital feedback and parental support in health interventions is well-supported. These tools often aim to increase user engagement and adherence to physical activity regimens through interactive and personalized feedback mechanisms.

What other types of research exist?

Promising alternatives to the VFB Ecosystem for enhancing physical activity and self-efficacy in 2024 include: 1) Mobile health applications with real-time monitoring and feedback, such as those that track physical activity and provide personalized recommendations and encouragement. 2) Wearable fitness trackers integrated with AI-driven coaching platforms that offer tailored exercise plans and motivational messages. 3) Virtual reality (VR) fitness programs that create immersive and engaging exercise experiences. 4) Online community platforms that connect users with similar goals for peer support and accountability. 5) Telehealth services that provide remote consultations with fitness and health professionals to create and monitor personalized exercise regimens.

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Virtual Fitness Buddy for Physical Activity

Phase 2

Waitlist Available

Led By Sun Joo (Grace) Ahn, Ph.D.

Research Sponsored by University of Georgia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participating parent must be the caregiver for the child for the majority of the week

Children must be between the ages of 6-10

Must not have

Child has impairments that prevent unassisted physical activity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the Virtual Fitness Buddy Ecosystem, which uses a virtual pet and Fitbits to encourage children to be more active. It targets children who need more support in staying active. The system tracks their activity, provides encouragement, and keeps parents involved through text messages. The concept of using virtual pets to promote physical activity in children has been previously explored, showing potential in increasing activity levels and self-efficacy.

Who is the study for?

This trial is for children aged 6-10 who attend a specific afterschool program daily. Only the oldest child and one caregiver, who must be the primary guardian during the week, can join. It's not for families planning to move soon or if the child has disabilities that limit independent physical activity.

What is being tested?

The study tests a Virtual Fitness Buddy (VFB) Ecosystem—a kiosk with a virtual dog that interacts with kids wearing Fitbits to encourage them to meet exercise goals. Parents receive updates via text and can send encouragement back, aiming to boost kids' motivation and parent-child communication about fitness.

What are the potential side effects?

Since this intervention involves digital technology and physical activity rather than medication, traditional side effects are not expected. However, there may be risks of overexertion or injury from increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am the main caregiver for my child most of the week.

Select...

My child is between 6 and 10 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child cannot move around without help due to their condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body fat percentage

Height

Motivation

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

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.

Group II: ControlActive Control1 Intervention

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The VFB Ecosystem trial leverages digital feedback and parental support to enhance physical activity in children. The digital feedback mechanism involves using wearable devices like Fitbits to track physical activity and provide real-time evaluations and encouragement through a virtual pet. This personalized feedback helps children set and achieve self-determined physical activity goals, promoting self-efficacy. Parental support is facilitated through text messages that keep parents informed of their child's progress and allow them to send motivational messages. These mechanisms are crucial as they create a supportive environment that encourages consistent physical activity, which is essential for improving overall health and well-being in patients.