Clinical trial

PLAY2CONTROL Study

Opening soon · Not applicable · 1 countries · Registry ID NCT07556679

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age5 Years to 21 Years

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes, Obesity & Overweight

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments and study arms

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.

Primary outcomes

Percent Weight ChangeBaseline to 12 months

Percent change in body weight (percentage points) from baseline, measured using clinic calibrated scales during routine visits

Change in HbA1cBaseline to 12 months

Absolute change in HbA1c (percentage points) from baseline, measured through standard laboratory blood tests performed during routine clinic visits

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Miami🇺🇸 Miami, Florida, United States

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Jessica Landau, D.O.Contact

Email · Call 305-243-2920