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NCT Number: NCT07556679

PLAY2CONTROL Study

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Landau, D.O.

CONTACT

[email protected]

305-243-2920

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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