PLAY2CONTROL Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-21
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Patients who have conditions preventing physical activity (such as physical limitations)
Patients without Televisions at home
Pregnant females
Patients in juvenile detention or prison
Trial design
Treatments tested in this trial
- Nex Playground Activity Program
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov