Active Video Games and Their Effect on Weight Loss and HgbA1c in Patients With Obesity and Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percent Weight Change
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Nex Playground Activity Program (Behavioral)
结局指标
主要结局
Percent Weight Change
时间窗: Baseline to 12 months
Percent change in body weight (percentage points) from baseline, measured using clinic calibrated scales during routine visits
Change in HbA1c
时间窗: Baseline to 12 months
Absolute change in HbA1c (percentage points) from baseline, measured through standard laboratory blood tests performed during routine clinic visits
次要结局
- 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)
研究者
Patricia Gomez
Assistant Professor
University of Miami