Health TrialsbyHealthPanel

PLAY2CONTROL Study

ConditionsType 2 DiabetesObesity & Overweight
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-21
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients who have conditions preventing physical activity (such as physical limitations)

Patients without Televisions at home

Pregnant females

Patients in juvenile detention or prison

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Nex Playground Activity ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent Weight Change

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

Time frame
Baseline to 12 months
2

Change in HbA1c

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

Time frame
Baseline to 12 months

Secondary outcomes

1

Change in Lipids Levels

Change in lipids levels (milligrams per deciliter) from baseline, measured through fasting lipid panels obtained during routine clinic blood work

Time frame
Baseline to 12 months
2

Change in Liver Enzymes

Change in liver enzymes (units per liter) measured through standard liver function tests obtained during routine clinic blood work

Time frame
Baseline to 12 months
3

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.

Time frame
Baseline to 12 months
4

Change in Insulin Dose

Change in insulin dose (units), as recorded in the medical record and summarized as the total prescribed daily insulin units

Time frame
Baseline to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: