Gaming Technology to Encourage Healthy Weight and Activity in Youth

Not Applicable

Completed

Conditions: Childhood Obesity

Interventions: Behavioral: Exergaming Condition

Registration Number: NCT02560493

Lead Sponsor: Pennington Biomedical Research Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exergaming Condition	Exergaming Condition	Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.

Primary Outcome Measures

Name	Time	Method
Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group	Change between Baseline (Week 0) and 6 months (Week 24)	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

Secondary Outcome Measures

Name	Time	Method
Changes in Fasting Glucose	Change between Baseline (Week 0) and 6 months (Week 24)	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.
Changes in Body Fat	Change between Baseline (Week 0) and 6 months (Week 24)	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.
Changes in Systolic Blood Pressure	Change between Baseline (Week 0) and 6 months (Week 24)	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.
Changes in Diastolic Blood Pressure	Change between Baseline (Week 0) and 6 months (Week 24)	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.
Changes in Total Cholesterol	Change between Baseline (Week 0) and 6 months (Week 24)	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.
Changes in Physical Activity	Change between Baseline (Week 0) and 6 months (Week 24)	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.
Changes in Diet	Change between Baseline (Week 0) and 6 months (Week 24)	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.