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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nex Playground Activity Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Change | Percent change in body weight (percentage points) from baseline, measured using clinic calibrated scales during routine visits | 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 | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lipids Levels | Change in lipids levels (milligrams per deciliter) from baseline, measured through fasting lipid panels obtained during routine clinic blood work | Baseline to 12 months |
| Change in Liver Enzymes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Landau, D.O. | Contact | 305-243-2920 | jessica.landau@jhsmiami.org |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Gomez, M.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Change in liver enzymes (units per liter) measured through standard liver function tests obtained during routine clinic blood work
| 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. | 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 | 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. | Baseline to 12 months |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |