Type 2 DiabetesNCT07556679
PLAY2CONTROL Study
A study testing Nex Playground Activity Program in people with Type 2 Diabetes and Obesity & Overweight, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of active video gaming participation in otherwise sedentary patients with obesity and Type 2 diabetes mellitus. The study will assess changes in sedentary time, activity level and changes in weight and Hemoglobin A1c, as well as other complications related to obesity… Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Type 2 Diabetes, Obesity & Overweight
- What is being tested?
- Nex Playground Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients followed at the University of Miami Pediatric Endocrinology Clinic
- Must have a diagnosis of Obesity (BMI >= 95th percentile) and Type 2 Diabetes Mellitus (Hemoglobin A1c > 6.5%)
- Children and teenagers, 5-18 years old
- Young adults 19-21 years old
Who cannot join
- Patients who have conditions preventing physical activity (such as physical limitations)
- Patients without Televisions at home
- Pregnant females
- Patients in juvenile detention or prison
- Adults unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Active Video Games and Their Effect on Weight Loss and HgbA1c in Patients With Obesity and Type 2 Diabetes Mellitus
The purpose of this study is to assess the impact of active video gaming participation in otherwise sedentary patients with obesity and Type 2 diabetes mellitus. The study will assess changes in sedentary time, activity level and changes in weight and Hemoglobin A1c, as well as other complications related to obesity that is monitored in clinic.
- Conditions
- Type 2 Diabetes, Obesity & Overweight
- Being tested
- Nex Playground Activity Program
- Keywords
- Pediatrics
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nex Playground Activity ProgramBehavioural
Participants are provided with a Nex Playground gaming console and asked to use it regularly at home for no less than 20 minutes at a time, unless otherwise doing another physical activity or sport for this timeframe.
| Study group | Role | What they receive |
|---|---|---|
| Nex Playground Activity Program | Experimental | Participants assigned to this arm will receive a Nex Playground gaming console. Over a 12-month period, participants will be asked to use the gaming system several times per week, with each play session lasting no less than 20 minutes. Participants will scan the provided activity-tracking QR code during each play session to document gaming system use. Receives: Behavioral: Nex Playground Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Weight Change
Percent change in body weight (percentage points) from baseline, measured using clinic calibrated scales during routine visits
Measured: Baseline to 12 months
Change in HbA1c
Absolute change in HbA1c (percentage points) from baseline, measured through standard laboratory blood tests performed during routine clinic visits
Measured: Baseline to 12 months
Secondary outcomes (5)
Change in Lipids Levels
Change in lipids levels (milligrams per deciliter) from baseline, measured through fasting lipid panels obtained during routine clinic blood work
Measured: Baseline to 12 months
Change in Liver Enzymes
Change in liver enzymes (units per liter) measured through standard liver function tests obtained during routine clinic blood work
Measured: Baseline to 12 months
Change in Oral Diabetes Medication Dose
Change in doses of oral antihyperglycemic medications (milligrams), as recorded in the medical record and summarized using the prescribed daily or weekly doses.
Measured: Baseline to 12 months
Change in Insulin Dose
Change in insulin dose (units), as recorded in the medical record and summarized as the total prescribed daily insulin units
Measured: Baseline to 12 months
Change in Sedentary Time
Absolute change in daily sedentary time (hours), assessed via a clinic-administered sedentary behavior questionnaire. Sedentary time will be reported as total hours per day.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start8 Oct 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Gomez, University of Miami
- Investigators
- Patricia Gomez, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556679
- Sponsor's protocol ID
- 20260243
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Video Games and Their Effect on Weight Loss and HgbA1c in Patients With Obesity and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07556679
- Acronym / sponsor ID
- 20260243
- Conditions
- Type 2 Diabetes, Obesity & Overweight
- Keywords
- Pediatrics
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Apr 2026 (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 purpose of this study is to assess the impact of active video gaming participation in otherwise sedentary patients with obesity and Type 2 diabetes mellitus. The study will assess changes in sedentary time, activity level and changes in weight and Hemoglobin A1c, as well as other complications related to obesity that is monitored in clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nex Playground Activity Program | Experimental | Behavioral: Nex Playground Activity ProgramParticipants assigned to this arm will receive a Nex Playground gaming console. Over a 12-month period, participants will be asked to use the gaming system several times per week, with each play session lasting no less than 20 minutes. Participants will scan the provided activity-tracking QR code during each play session to document gaming system use. |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients followed at the University of Miami Pediatric Endocrinology Clinic
- Must have a diagnosis of Obesity (BMI >= 95th percentile) and Type 2 Diabetes Mellitus (Hemoglobin A1c > 6.5%)
- Children and teenagers, 5-18 years old
- Young adults 19-21 years old
Key exclusion criteria (5 listed)
- Patients who have conditions preventing physical activity (such as physical limitations)
- Patients without Televisions at home
- Pregnant females
- Patients in juvenile detention or prison
- Adults unable to consent
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 |
|---|---|---|
| Nex Playground Activity ProgramParticipants are provided with a Nex Playground gaming console and asked to use it regularly at home for no less than 20 minutes at a time, unless otherwise doing another physical activity or sport for this timeframe. | Behavioural | Nex Playground Activity Program |
Primary outcome
Percent Weight Change
Time frame: Baseline to 12 months
Percent change in body weight (percentage points) from baseline, measured using clinic calibrated scales during routine visits
Change in HbA1c
Time frame: Baseline to 12 months
Absolute change in HbA1c (percentage points) from baseline, measured through standard laboratory blood tests performed during routine clinic visits
5 secondary outcomes
Change in Lipids Levels
Time frame: Baseline to 12 months
Change in Liver Enzymes
Time frame: Baseline to 12 months
Change in Oral Diabetes Medication Dose
Time frame: Baseline to 12 months
Change in Insulin Dose
Time frame: Baseline to 12 months
Change in Sedentary Time
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Patricia Gomez, M.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nex Playground Activity Program in people with Type 2 Diabetes and Obesity & Overweight, run by University of Miami 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 5 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: enrolling by invitation, as of the sponsor's last update on 16 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Percent Weight Change (time frame: Baseline to 12 months). 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 16 Oct 2026.