Behavior Change InterventionsNCT06950528
Monocular-Camera-Based Mobile Exergame for Type 2 Diabetes Prevention
A study testing Kinect group and Monocular group in people with Behavior Change Interventions, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Exergames have demonstrated potential as effective interventions for promoting physical activity and preventing type 2 diabetes (T2D), particularly among older adults. Kinect-based exergames, in particular, have been associated with improved adherence to exercise regimens and positive health outcomes. Read more about this study
- Who is it for?
- Ages 60 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior Change Interventions
- What is being tested?
- Kinect group and Monocular group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Aug 2024
- Phase
- Interventional
- 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 60 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 60-74;
- a score of 25 or higher on the Chinese Diabetes Risk Score;
- community-dwelling individuals, not reside in assisted living or long-term care facilities;
- physically capable of engaging in light to moderate exercise, as determined by self-report and/or physician clearance;
- normal cognitive function that enable the participant to complete the experiment independently or with minimal assistance;
- Written informed consent provided by participants or their families.
Who cannot join
- diagnosis of type 1 or type 2 diabetes;
- current participation in another exercise intervention study;
- severe cognitive impairment with MMSE < 24;
- major mobility limitations such as severe osteoarthritis and recent orthopedic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of a Monocular-Camera-Based Mobile Exergame for At-Home Intervention in Individuals at High Risk of Type 2 Diabetes
Exergames have demonstrated potential as effective interventions for promoting physical activity and preventing type 2 diabetes (T2D), particularly among older adults. Kinect-based exergames, in particular, have been associated with improved adherence to exercise regimens and positive health outcomes. However, widespread implementation is limited by the high cost and reduced accessibility of the required hardware, restricting their use in home-based settings. Recent advances in computer vision have enabled the development of exergames using monocular camera systems, which may represent a cost-effective and scalable alternative. This study investigates the feasibility of monocular-camera-based exergames as a cost-effective and convenient alternative for home-dwelling individuals.
A total of 45 community-dwelling older adults aged 60-74 years, identified as high risk for T2D were recruited through local community health centers. Participants were randomly assigned to one of three groups (n = 15 per group): (1) Control group (traditional offline exercise with printed instructions), (2) Kinect group (Kinect-based exergames targeting aerobic capacity, balance, and strength), and (3) Monocular group (monocular-camera-based exergames using real-time 2D pose estimation). The intervention lasted six weeks, with participants completing three 30-minute sessions per week at home. Primary outcomes included exercise performance (completion rate and movement accuracy) and intrinsic motivation. Secondary outcomes included perceived enjoyment, challenge, and usability. Data were analyzed using one-way ANOVA.
- Conditions
- Behavior Change Interventions
- Being tested
- Control group, Kinect group, Monocular group
- Keywords
- Exergame, Individuals at High Risk of Type 2 Diabetes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupBehavioural
Control Group consists of six motion videos, including: crossover steps, high knees, lateral raises, punching movements, downward leg punches from a standing position, and elbow-to-chest expansions
Kinect groupBehavioural
Kinect Group features the same software functionality and design as the application based on bullet-screen cameras, but the hardware is built using a Kinect sensor. The gamified platform is primarily developed and presented using Unity software. The Kinect 3D motion-sensing camera incorporates real-time dynamic capture and image recognition capabilities, offering new possibilities for interactive approaches to motion therapy
Monocular groupBehavioural
The game employs a virtual avatar to replicate users' movements, thereby fostering an immersive and engaging experience. A monocular camera captures users' movements in real time, which are analyzed through pose estimation algorithms and subsequently mapped onto the virtual avatar. Users interact with the game by following on-screen visual demonstrations, presented as either static images or animations, to perform the prescribed exercises. Movement accuracy is evaluated by the system, with scores awarded based on performance. To enhance user motivation and adherence, the game incorporates a reward system, where points earned through accurate execution can be redeemed for in-game rewards, such as unlocking background music, avatar customization options, and new virtual environments.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Receive traditional offline exercise with printed instructions Receives: Behavioral: Control group |
| Kinect group | Active comparator | Use Kinect based mobile exergame Receives: Behavioral: Kinect group |
| Monocular group | Experimental | Used monocular-camera-based exergame Receives: Behavioral: Monocular group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
The post-intervention heart rate was collected during the first 10 seconds post-exercise to estimate physiological responses. Considering the general physical condition of individuals at high risk of diabetes, the study used 50%-80% of the maximum heart rate as the target exercise intensity. The maximum heart rate was calculated using the formula: 208 - (age × 0.7).
Measured: Baseline, Immediately after the intervention
Perceived fatigue
perceived fatigue, a widely accepted parameter in exercise assessments for diabetes-related fields, was employed to supplement the evaluation of physical activity. The Borg RPE (Rating of Perceived Exertion) scale[18], ranging from 6 to 20, was utilized to assess subjective fatigue and compare perceived exercise intensity across groups.
Measured: Baseline, Immediately after the intervention
Secondary outcomes (3)
Game experience
At the first session of intervention, participants in the Kinect and monocular groups completed the Game Experience Questionnaire (GEQ) to assess their user experience[19]. The GEQ was used to evaluate and compare the impact of different technologies on immersion and the overall experience of exergames.
Measured: Immediately after the intervention
Intrinsic motivation
Furthermore, the Interest/Enjoyment Subscale of the Intrinsic Motivation Inventory (IMI) was administered to participants in the control group, Kinect group, and monocular group[20]. This subscale evaluated and compared intrinsic motivation and enjoyment associated with physical activity across the three groups.
Measured: Immediately after the intervention
User engagement
At the end of one-week experiment period, user engagement was further quantified by tracking the frequency of intervention use over the one-week period, based on participants' video-recorded usage logs.
Measured: Follow-up (one week after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior Change InterventionsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianan Zhao, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950528
- Sponsor's protocol ID
- SRSY202504100034
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The information might be shared after the research group finished the data analysis process.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Monocular-Camera-Based Mobile Exergame for At-Home Intervention in Individuals at High Risk of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06950528
- Acronym / sponsor ID
- SRSY202504100034
- Conditions
- Behavior Change Interventions
- Keywords
- Exergame, Individuals at High Risk of Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 30 Apr 2025 (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.
Exergames have demonstrated potential as effective interventions for promoting physical activity and preventing type 2 diabetes (T2D), particularly among older adults. Kinect-based exergames, in particular, have been associated with improved adherence to exercise regimens and positive health outcomes. However, widespread implementation is limited by the high cost and reduced accessibility of the required hardware, restricting their use in home-based settings. Recent advances in computer vision have enabled the development of exergames using monocular camera systems, which may represent a cost-effective and scalable alternative. This study investigates the feasibility of monocular-camera-based exergames as a cost-effective and convenient alternative for home-dwelling individuals.
A total of 45 community-dwelling older adults aged 60-74 years, identified as high risk for T2D were recruited through local community health centers. Participants were randomly assigned to one of three groups (n = 15 per group): (1) Control group (traditional offline exercise with printed instructions), (2) Kinect group (Kinect-based exergames targeting aerobic capacity, balance, and strength), and (3) Monocular group (monocular-camera-based exergames using real-time 2D pose estimation). The intervention lasted six weeks, with participants completing three 30-minute sessions per week at home. Primary outcomes included exercise performance (completion rate and movement accuracy) and intrinsic motivation. Secondary outcomes included perceived enjoyment, challenge, and usability. Data were analyzed using one-way ANOVA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Control groupReceive traditional offline exercise with printed instructions |
| Kinect group | Active comparator | Behavioral: Kinect groupUse Kinect based mobile exergame |
| Monocular group | Experimental | Behavioral: Monocular groupUsed monocular-camera-based exergame |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age between 60-74;
- a score of 25 or higher on the Chinese Diabetes Risk Score;
- community-dwelling individuals, not reside in assisted living or long-term care facilities;
- physically capable of engaging in light to moderate exercise, as determined by self-report and/or physician clearance;
- normal cognitive function that enable the participant to complete the experiment independently or with minimal assistance;
Key exclusion criteria (4 listed)
- diagnosis of type 1 or type 2 diabetes;
- current participation in another exercise intervention study;
- severe cognitive impairment with MMSE < 24;
- major mobility limitations such as severe osteoarthritis and recent orthopedic surgery.
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 |
|---|---|---|
| Control groupControl Group consists of six motion videos, including: crossover steps, high knees, lateral raises, punching movements, downward leg punches from a standing position, and elbow-to-chest expansions | Behavioural | Control group |
| Kinect groupKinect Group features the same software functionality and design as the application based on bullet-screen cameras, but the hardware is built using a Kinect sensor. The gamified platform is primarily developed and presented using Unity software. The Kinect 3D motion-sensing camera incorporates real-time dynamic capture and image recognition capabilities, offering new possibilities for interactive approaches to motion therapy | Behavioural | Kinect group |
| Monocular groupThe game employs a virtual avatar to replicate users' movements, thereby fostering an immersive and engaging experience. A monocular camera captures users' movements in real time, which are analyzed through pose estimation algorithms and subsequently mapped onto the virtual avatar. Users interact with the game by following on-screen visual demonstrations, presented as either static images or animations, to perform the prescribed exercises. Movement accuracy is evaluated by the system, with scores awarded based on performance. To enhance user motivation and adherence, the game incorporates a reward system, where points earned through accurate execution can be redeemed for in-game rewards, such as unlocking background music, avatar customization options, and new virtual environments. | Behavioural | Monocular group |
Primary outcome
Heart rate
Time frame: Baseline, Immediately after the intervention
The post-intervention heart rate was collected during the first 10 seconds post-exercise to estimate physiological responses. Considering the general physical condition of individuals at high risk of diabetes, the study used 50%-80% of the maximum heart rate as the target exercise intensity. The maximum heart rate was calculated using the formula: 208 - (age × 0.7).
Perceived fatigue
Time frame: Baseline, Immediately after the intervention
perceived fatigue, a widely accepted parameter in exercise assessments for diabetes-related fields, was employed to supplement the evaluation of physical activity. The Borg RPE (Rating of Perceived Exertion) scale[18], ranging from 6 to 20, was utilized to assess subjective fatigue and compare perceived exercise intensity across groups.
3 secondary outcomes
Game experience
Time frame: Immediately after the intervention
Intrinsic motivation
Time frame: Immediately after the intervention
User engagement
Time frame: Follow-up (one week after the intervention)
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 30 Apr 2025.
- Individual participant dataSharing planned: Undecided. The information might be shared after the research group finished the data analysis process.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinect group and Monocular group in people with Behavior Change Interventions, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 6 inclusion and 4 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 30 Apr 2025. 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 China. 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.
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?
Heart rate (time frame: Baseline, Immediately after the intervention). The study lists 2 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 30 Apr 2025.