Physical ActivityPhase 2NCT03524183
Virtual Fitness Buddy Ecosystem
A Phase 2 study testing Virtual Fitness Buddy Ecosystem in people with Physical Activity, run by University of Georgia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Virtual Fitness Buddy Ecosystem
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 964 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2018to 30 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
YMCA of Metropolitan Atlanta
Atlanta, Georgia, 30303
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Virtual Fitness Buddy Ecosystem
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Fitness Buddy EcosystemBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Virtual Fitness Buddy Ecosystem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Physical activity of participating children will be assessed with Fitbits and validated with Actigraphs.
Measured: 12 months
Height
Height in meters
Measured: 12 months
Weight
Weight in kilograms
Measured: 12 months
Waist circumference
Waist circumference in centimeters
Measured: 12 months
Body fat percentage
Body fat percentage in percentile
Measured: 12 months
Self-efficacy
Self-reported perceived efficacy for physical activity
Measured: 12 months
Motivation
Self-reported motivation for physical activity
Measured: 12 months
Parent-child relationship
Self-reported parent-child relationship
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start27 Aug 2018
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 964 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- YMCA of Metropolitan Atlanta
- Responsible party
- Principal investigator, Sun Joo (Grace) Ahn, PHD, University of Georgia
- Investigators
- Sun Joo (Grace) Ahn, Ph.D., Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524183
- Sponsor's protocol ID
- 00004611
- Status last verified
- Dec 2024
- First submitted
- 1 May 2018
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The overriding aim of this project is to help tackle the childhood obesity epidemic, which of national importance. As such, all of the investigators are committed to ensuring widespread dissemination of our findings and to making the technologies developed freely available to other researchers. This will include publishing not just our evaluation results through appropriate scholarly journals and presentations at national meetings, but also our experiences and lessons learned during the design and development process. For example, our design documents will evolve on password-protected website that, upon completion of the project, will be made public (with teacher names removed) with contact details for the investigators included, and will be detailed in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Virtual Fitness Buddy Ecosystem: Using Digital Technology to Promote and Sustain Moderate-to-Vigorous Intensity Physical Activity in Children
- ClinicalTrials.gov ID
- NCT03524183
- Acronym / sponsor ID
- 00004611
- Conditions
- Physical Activity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 964 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- YMCA of Metropolitan Atlanta
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Virtual Fitness Buddy EcosystemThe 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. |
| Treatment | Experimental | Behavioral: Virtual Fitness Buddy EcosystemThe 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Fitness Buddy EcosystemThe 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. | Behavioural | Control, Treatment |
Primary outcome
Physical Activity
Time frame: 12 months
Physical activity of participating children will be assessed with Fitbits and validated with Actigraphs.
Height
Time frame: 12 months
Height in meters
Weight
Time frame: 12 months
Weight in kilograms
Waist circumference
Time frame: 12 months
Waist circumference in centimeters
Body fat percentage
Time frame: 12 months
Body fat percentage in percentile
Self-efficacy
Time frame: 12 months
Self-reported perceived efficacy for physical activity
Motivation
Time frame: 12 months
Self-reported motivation for physical activity
Parent-child relationship
Time frame: 12 months
Self-reported parent-child relationship
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Yes. The overriding aim of this project is to help tackle the childhood obesity epidemic, which of national importance. As such, all of the investigators are committed to ensuring widespread dissemination of our findings and to making the technologies developed freely available to other researchers. This will include publishing not just our evaluation results through appropriate scholarly journals and presentations at national meetings, but also our experiences and lessons learned during the design and development process. For example, our design documents will evolve on password-protected website that, upon completion of the project, will be made public (with teacher names removed) with contact details for the investigators included, and will be detailed in publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Joo (Grace) Ahn, Ph.D. principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Virtual Fitness Buddy Ecosystem in people with Physical Activity, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024; AzTrials last refreshed its copy on 31 Oct 2026.