Active Video Games on Physical Activity (Main Trial)

Physical Inactivity in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04116515
• Other study ID #: R01DK109316
• Status: Completed
• Phase: N/A
• Start date: December 25, 2019
• Est. completion date: May 22, 2022

Study information

• Verified date: March 2023
• Source: Northeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: May 22, 2022
• Est. primary completion date: May 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Inactivity in Children

Intervention

Behavioral:
• Xbox / active video games
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.
• Animated cartoon narratives
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.
• Standard clinical care
Each clinic will provide standard clinical care to the participants.

Locations

Country	Name	City	State
United States	Northeastern University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sustained Attention	Response time will be measured by the Psychomotor Vigilance Task	6 months
Other	Working Memory	Response time will be measured by the Delayed Match-to-Sample Task	6 months
Other	Working Memory	Response accuracy will be measured by the Delayed Match-to-Sample Task	6 months
Other	Inhibitory Control	Response time will be measured by the Stroop Test	6 months
Other	Inhibitory Control	Response accuracy will be measured by the Stroop Test	6 months
Other	Physical Activity Motivation	Physical Activity Motivation will be measured by the Physical Activity Motivation scale through self-report	6 months
Primary	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
Primary	Changes in fat%	Measured through dual-energy X-ray absorptiometry (DEXA) scan by GE Lunar Prodigy (GE Healthcare, Chicago, IL).	6 months
Primary	Changes in lean tissue%	Measured through dual-energy X-ray absorptiometry (DEXA) scan by GE Lunar Prodigy (GE Healthcare, Chicago, IL).	6 months
Secondary	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
Secondary	Fasting Insulin	Analysis of the plasma samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.	6 months
Secondary	Fasting Glucose	Analysis of the plasma samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.	6 months
Secondary	Lipid	Analysis of the serum samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.	6 months
Secondary	C-reactive protein (CRP)	Analysis of the serum samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.	6 months