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Not yet recruiting NCT07556679

PLAY2CONTROL Study

No phase Interventional Type 2 Diabetes Obesity & Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nex Playground Activity Program.
Who it may be relevant to
Registry conditions: Type 2 Diabetes, Obesity & Overweight. Basic parameters: 5 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Active Video Games and Their Effect on Weight Loss and HgbA1c in Patients With Obesity and Type 2 Diabetes Mellitus

Overview

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

  • Behavioral Nex 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.

Primary outcome measures

  • Percent Weight Change [Time frame: Baseline to 12 months]
  • Change in HbA1c [Time frame: Baseline to 12 months]
Secondary outcome measures (5)
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT07556679 · 20260243

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗