PLAY2CONTROL Study

NCT07556679 | Not Yet Recruiting

• 1 other identifier: 20260243
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 improvement in weight and Hemoglobin A1c, as well as other complications related to obesity that is monitored in clinic.

Conditions

Type 2 Diabetes; Obesity & Overweight

Outcome Measures

Primary Outcomes (2)

• Percent Weight Change

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

  Baseline to 12 months

• Change in HbA1c

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

  Baseline to 12 months

Secondary Outcomes (4)

• Change in Lipids Levels

  Baseline to 12 months

• Change in Liver Enzymes

  Baseline to 12 months

• Change in Oral Diabetes Medication Dose

  Baseline to 12 months

• Change in Insulin Dose

  Baseline to 12 months

Study Arms (1)

Nex Playground Activity Program

EXPERIMENTAL

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 approximately 45 minutes. Participants will scan the provided activity-tracking QR code during each play session to document gaming system use.

Behavioral: Nex Playground Activity Program

Interventions

Nex Playground Activity Program BEHAVIORAL

Participants are provided with a Nex Playground gaming console and asked to use it regularly at home for 45 minutes at a time, unless otherwise doing another physical activity or sport for this timeframe.

Nex Playground Activity Program

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients followed at the University of Miami Pediatric Endocrinology Clinic
• Must have a diagnosis of Obesity (BMI \>= 95th percentile) and Type 2 Diabetes Mellitus
• Children and teenagers, 5-18 years old
• Young adults 19-21 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Gomez, M.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Landau, D.O.

CONTACT

305-243-2920; jessica.landau@jhsmiami.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)