Gaming Technology to Encourage Healthy Weight and Activity in Youth

Study Overview
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Brief Summary
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The goal of the proposed randomized controlled trial is to test the efficacy of exergaming (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and obese children.

Detailed Description
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The GAMESQUAD study is a 6-month, 2-arm randomized controlled trial among 46 overweight/obese children (aged 10 to 12 years) assigned to: 1) 3 hours/week of in-home exergaming or 2) a control group. An innovative aspect is the inclusion of a fitness trainer who will regularly video chat with the participant and virtually monitor gameplay. The study will advance the field by: 1) establishing the efficacy of exergaming to reduce BMIz among overweight and obese children and 2) demonstrating the potential of exergaming to reduce body fat and improve children's cardiovascular health.

Official Title
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Gaming Technology to Encourage Healthy Weight and Activity in Youth

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: Exergaming Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI percentile > or equal to 85 on the CDC growth chart Participating household has a high-speed internet connection At least 1 family member or friend who is willing to exergame in the home with the participant for 3 hours/week Exclusion Criteria: Pregnant Impairments that prevent normal ambulation Previous history, or current symptoms of, cardiovascular disease, musculoskeletal injury, or epileptic seizures

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Condition<br>Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff. | |
| Experimental: Exergaming Condition<br>Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention. | Behavioral: Exergaming Condition<br>* Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group | Height and weight will be collected at Screening, Week 0, and Week 24. Standing height will be measured in cm with a Harpenden stadiometer (Holtain Limited, Crymych, UK) with shoes removed while the participant holds breath and an assessor applies light traction to align the participant's head along the Frankfort Horizontal Plane. Weight will be measured in kg with a Michelli GSE 460 scale (G.T. Michelli Co., Baton Rouge, LA) while wearing a hospital gown and undergarments. Measures will be taken twice and recorded to the nearest 0.1 units, with a third if the initial 2 measures are greater than 0.5 units apart. BMIz will be calculated based on the child's age, sex, height, and weight using the 2000 Centers for Disease Control and Prevention (CDC) Growth Charts. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean | Change between Baseline (Week 0) and 6 months (Week 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Body Fat | A dual energy x-ray absorptiometry (DXA) scan will be completed at Week 0 and Week 24 with a GE iDXA whole-body scanner (GE Medical Systems, Milwaukee, WI) to measure adiposity, including total body fat mass and regional fat mass in the extremities and trunk. | Change between Baseline (Week 0) and 6 months (Week 24) | 
| Changes in Systolic Blood Pressure | Resting blood pressure will be assessed at Screening, Week 0, and Week 24 using standard clinical procedures on a standard mercury manometer. The participant's age-, sex-, and height-specific percentile will be calculated. | Change between Baseline (Week 0) and 6 months (Week 24) | 
| Changes in Diastolic Blood Pressure | Resting blood pressure will be assessed at Screening, Week 0, and Week 24 using standard clinical procedures on a standard mercury manometer. The participant's age-, sex-, and height-specific percentile will be calculated. | Change between Baseline (Week 0) and 6 months (Week 24) | 
| Changes in Total Cholesterol | A blood sample will be taken at Week 0 and Week 24 by a trained phlebotomist following standard clinic procedures after an 8-hour fast. Serum concentrations of total cholesterol will be assayed on a DXC600 from Trinity. | Change between Baseline (Week 0) and 6 months (Week 24) | 
| Changes in Fasting Glucose | A blood sample will be taken at Week 0 and Week 24 by a trained phlebotomist following standard clinic procedures after an 8-hour fast. Serum concentrations of glucose will be obtained from a DXC600 by Beckman Coulter. | Change between Baseline (Week 0) and 6 months (Week 24) | 
| Changes in Physical Activity | Physical activity will be assessed with an Actigraph GT3X+ accelerometer (ActiGraph, of Ft. Walton Beach, FL) to determine changes in habitual physical activity outside of the gaming intervention. Participants will wear the accelerometer for two bouts of 7-days following Week 0 baseline clinic visit and Week 24 clinic visit, but not during the gaming intervention. | Change between Baseline (Week 0) and 6 months (Week 24) | 
| Changes in Diet | Dietary information will be collected from the participant at Week 0 and Week 24. Healthy diet score will be determined by the NCI Self-administered 24-hour Dietary Recall (ASA24-Kids). This survey is administered on a computer through a web-based program. | Change between Baseline (Week 0) and 6 months (Week 24) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMIz, Exergaming, Cardiovascular Disease