Active Video Games on Physical Activity (Main Trial)

Study Overview
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Brief Summary
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The purpose of the study is to test the effects of different versions of active video games (AVGs) on body composition, cardiometabolic risks, and cognitive functions among overweight/obese children over 6 months.

Detailed Description
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The study aims to explore the effects of narrative-enhanced AVG on (1) body composition, (2) cardiometabolic risks, and (3) cognitive functioning among overweight/obese 8-12 years old children over 6 months. A total of 210 children will be recruited from Tufts Floating Hospital, Boston Children's Hospital, and Martha Eliot Health Center. The investigators divided the participants into three groups to evaluate the effect of using active game consoles and stories to motivate children to exercise: A third of them have standard clinical care only; a third of them have the same standard clinical care plus an Xbox and active games; the remaining third of them have the same standard clinical care, an Xbox and active games, plus the stories delivered to their Xbox consoles. Each child, accompanied by their guardian, will be asked to visit the Northeastern University Exercise Science Laboratory over the 6-month period. Blood samples, body composition (using Dual-energy X-ray absorptiometry, or DEXA Scan), and cognitive and affective evaluations of the active video games (AVGs) will be collected. Additionally, parents will be asked to fill out questionnaires related to their child's physical activity behaviors. Children would also be required to wear two accelerometers (essentially, a smart watch or activity tracker) on their wrist and waist for 7 consecutive days after the three visits within the 6 months.

Official Title
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The Narrative Effect of Active Video Games on Long-term Moderate-to-Vigorous Physical Activity (Main Trial)

Conditions
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Physical Inactivity in Children

Intervention / Treatment
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* Behavioral: Xbox / active video games
* Behavioral: Animated cartoon narratives
* Behavioral: Standard clinical care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 8-to-12-year-old Being overweight or obese (BMI% >=85) Speak and understand English Are willing and able to complete all measures Equal numbers of both genders will be recruited One child per household will be eligible to participate Exclusion Criteria: Not between 8 and 12 Not being overweight or obese Do not speak and understand English Have medical or physical problems that prevent them from playing AVGs, such as epilepsy Use orthopedic devices

Ages Eligible for Study
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Minimum Age: 8 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Care Only<br>A third of the participants will have standard clinical care only. | Behavioral: Standard clinical care<br>* Each clinic will provide standard clinical care to the participants.<br>|
| Experimental: Care + AVG<br>A third of the participants will have the same standard clinical care plus an Xbox and active games. | Behavioral: Xbox / active video games<br>* The investigators would expect children to play active video games as a way to reduce their sedentary activities and increase their moderate and vigorous physical activities.<br>Behavioral: Standard clinical care<br>* Each clinic will provide standard clinical care to the participants.<br>|
| Experimental: Care + AVG + Narratives<br>A third of the participants will have the same standard clinical care, an Xbox and active games, plus the stories delivered to their Xbox consoles. | Behavioral: Xbox / active video games<br>* The investigators would expect children to play active video games as a way to reduce their sedentary activities and increase their moderate and vigorous physical activities.<br>Behavioral: Animated cartoon narratives<br>* The investigators would expect the animated cartoon narratives to motivate children to play more active video games as a way to reduce their sedentary activities and increase their moderate and vigorous physical activities.<br>Behavioral: Standard clinical care<br>* Each clinic will provide standard clinical care to the participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in objective child physical activity | Physical activity will be measured with two 7-day accelerometer worn on the wrist and hip after three visits over 4-6 weeks, including minutes/day MVPA total. Physical activity and time spent in moderate to vigorous physical activity will be measured by two triaxial accelerometer (Actigraph Link and Actigraph GT3X+, Actigraph, Ft. Walton Beach, FL). Children will be asked to wear them for 7 full days during periods. | 6 months | 
| Changes in fat% | Measured through dual-energy X-ray absorptiometry (DEXA) scan by GE Lunar Prodigy (GE Healthcare, Chicago, IL). | 6 months | 
| Changes in lean tissue% | Measured through dual-energy X-ray absorptiometry (DEXA) scan by GE Lunar Prodigy (GE Healthcare, Chicago, IL). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI% | The investigators plan to use the weight in kilograms and height in meters from the DEXA scan and children's birthdays and sex to calculate their BMI% using the CDC Calculator. | 6 months | 
| Fasting Insulin | Analysis of the plasma samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits. | 6 months | 
| Fasting Glucose | Analysis of the plasma samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits. | 6 months | 
| Lipid | Analysis of the serum samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits. | 6 months | 
| C-reactive protein (CRP) | Analysis of the serum samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Active Video Game, Physical Activity, Narrative, Child Obesity