Exergaming to Increase Physical Activity in Overweight/Obese Children and Adolescents

Study Overview
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Brief Summary
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The primary purpose of this study is to examine the effects of regular exergaming for 8 weeks in 24 overweight/obese children and adolescents (10-17 years) on maximal aerobic fitness (VO2max) and physical activity levels measured before and after (8 weeks) intervention period, and in addition at follow-up (12 weeks). We also wish to investigate the effects on markers of cardio metabolic health and body composition, measured at baseline, 8 weeks and 12 weeks follow-up. Also, the participants gaming frequency will be registered throughout the 8 week period, as well as during the follow-up between 8 and 12 weeks. Aim of this study is to investigate if access to this game can provide health benefits for overweight/obese children and adolescents.

Official Title
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Exergaming to Increase Physical Activity in Overweight/Obese Children and Adolescents

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Exergaming


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Defined as overweight/obese for age and sex Able to ride a bike for up to 60 minutes Exclusion Criteria: Known cardiovascular disease Taking beta-blockers or anti-arrhythmic drugs Other diseases that restrict them from doing High-Intensity Training

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 24 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exergaming<br>The participants in the Exergaming group will use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks. Between 8 and 12 weeks the exergaming group will be provided with free access to the exergame but without the two mandatory exergaming sessions | Behavioral: Exergaming<br>* The participants in the Exergaming group will use the PlayPulse exergame for 45 minutes a minimum of three times per week for 8 weeks. Between 8 and 12 weeks the exergaming group will be provided with free access to the exergame but without the two mandatory exergaming sessions<br>|
| No Intervention: Control<br>Continue with normal daily routine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily time physical activity (moderate, vigorous and very vigorous) | Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and at 12 weeks. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily average energy expenditure | Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks. | 8 and 12 weeks | 
| Daily average number of steps | Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks. | 8 and 12 weeks | 
| Daily time in sedentary activity (< 3.0 metabolic equivalents = METs) | Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks. | 8 and 12 weeks | 
| Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs) | Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks. | 8 and 12 weeks | 
| Daily time in vigorous intensity activity | Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks. | 8 and 12 weeks | 
| Daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs) | Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks. | 8 and 12 weeks | 
| Daily average total physical activity duration | Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks. | 8 and 12 weeks | 
| Bioelectrical impedance | Body composition assessed using bioelectrical impedance analysis (InBody 720) | 8 and 12 weeks | 
| Blood Pressure |  | 8 and 12 weeks | 
| Fasting circulating glucose, as blood marker of cardiometabolic health |  | 8 and 12 weeks | 
| Fasting triglycerides, LDL-, HDL- and Total cholesterol, as blood marker of cardiometabolic health |  | 8 and 12 weeks | 
| Circulating insulin concentration, as blood marker of cardiometabolic health |  | 8 and 12 weeks | 
| glucose response to a 2 hour glucose tolerance test, as blood marker of cardiometabolic health |  | 8 and 12 weeks | 
| VO2max | Maximal Aerobic Capacity | 8 and 12 weeks | 
| Daily time physical activity (moderate, vigorous and very vigorous) | Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and at 8 weeks | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gaming, Exercise therapy, Physical fitness, Child, Healthy lifestyle, Fitness testing