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 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.

Conditions

Type 2 Diabetes; Obesity & Overweight

Keywords

Pediatrics

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 (5)

• 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

• Change in Sedentary Time

  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 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

Interventions

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.

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 (Hemoglobin A1c \> 6.5%)
• 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: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)