Clinical trial NCT04116515: Active Video Games on Physical Activity (Main Trial)
Official title: The Narrative Effect of Active Video Games on Long-term Moderate-to-Vigorous Physical Activity (Main Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity in Children
Keywords: Active Video Game
Physical Activity
Narrative
Child Obesity
Lead sponsor: Northeastern University
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 135
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in objective child physical activity
timeFrame: 6 months
measure: Changes in fat%
timeFrame: 6 months
measure: Changes in lean tissue%
timeFrame: 6 months
Secondary outcomes:
measure: BMI%
timeFrame: 6 months
measure: Fasting Insulin
timeFrame: 6 months
measure: Fasting Glucose
timeFrame: 6 months
measure: Lipid
timeFrame: 6 months
measure: C-reactive protein (CRP)
timeFrame: 6 months
Other outcomes:
measure: Sustained Attention
timeFrame: 6 months
measure: Working Memory
timeFrame: 6 months
measure: Working Memory
timeFrame: 6 months
measure: Inhibitory Control
timeFrame: 6 months
measure: Inhibitory Control
timeFrame: 6 months
measure: Physical Activity Motivation
timeFrame: 6 months
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
Study officials:
References: