PLAY2CONTROL Study

August 26, 2026 updated by: Patricia Gomez, University of Miami

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nex Playground Activity Program
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Weight Change
Time Frame: Baseline to 12 months
Percent change in body weight (percentage points) from baseline, measured using clinic calibrated scales during routine visits
Baseline to 12 months
Change in HbA1c
Time Frame: Baseline to 12 months
Absolute change in HbA1c (percentage points) from baseline, measured through standard laboratory blood tests performed during routine clinic visits
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lipids Levels
Time Frame: Baseline to 12 months
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
Time Frame: Baseline to 12 months
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
Time Frame: 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.
Baseline to 12 months
Change in Insulin Dose
Time Frame: Baseline to 12 months
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
Time Frame: 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.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Patricia Gomez, M.D., University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20260243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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