Active Video Games on Physical Activity (Main Trial)

Northeastern University

Status: Completed

Conditions: Physical Inactivity in Children

Treatments: Behavioral: Animated cartoon narratives; Behavioral: Standard clinical care; Behavioral: Xbox / active video games

Study type: Interventional

Funder types: Other

Identifiers

NCT04116515

R01DK109316

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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135 participants in 3 patient groups

Care Only

Active Comparator group

Description:

A third of the participants will have standard clinical care only.

Treatment:

Behavioral: Standard clinical care

Care + AVG

Experimental group

Description:

A third of the participants will have the same standard clinical care plus an Xbox and active games.

Treatment:

Behavioral: Standard clinical care

Behavioral: Xbox / active video games

Care + AVG + Narratives

Experimental group

Description:

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.

Treatment:

Behavioral: Standard clinical care

Behavioral: Xbox / active video games

Behavioral: Animated cartoon narratives