Obesity & Overweight, Type 2 Diabetes
Conditions
Keywords
Pediatrics
Brief 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 that is monitored in clinic.
Interventions
BEHAVIORALNex Playground Activity Program
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.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Weight Change | Baseline to 12 months | Percent change in body weight (percentage points) from baseline, measured using clinic calibrated scales during routine visits |
| Change in HbA1c | Baseline to 12 months | Absolute change in HbA1c (percentage points) from baseline, measured through standard laboratory blood tests performed during routine clinic visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lipids Levels | Baseline to 12 months | Change in lipids levels (milligrams per deciliter) from baseline, measured through fasting lipid panels obtained during routine clinic blood work |
| Change in Liver Enzymes | Baseline to 12 months | Change in liver enzymes (units per liter) measured through standard liver function tests obtained during routine clinic blood work |
| Change in Oral Diabetes Medication Dose | Baseline to 12 months | Change in doses of oral antihyperglycemic medications (milligrams), as recorded in the medical record and summarized using the prescribed daily or weekly doses. |
| Change in Insulin Dose | Baseline to 12 months | Change in insulin dose (units), as recorded in the medical record and summarized as the total prescribed daily insulin units |
| Change in Sedentary Time | Baseline to 12 months | 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. |
Countries
United States
Contacts
CONTACTJessica Landau, D.O.
PRINCIPAL_INVESTIGATORPatricia Gomez, M.D.
University of Miami
Outcome results
None listed