Active Video Games on Physical Activity (Main Trial)

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Inactivity in Children
• Intervention / Treatment: Behavioral: Standard clinical care; Behavioral: Xbox / active video games; Behavioral: Animated cartoon narratives

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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Northeastern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Care Only; A third of the participants will have standard clinical care only.	Behavioral: Standard clinical care; Each clinic will provide standard clinical care to the participants.
Experimental: Care + AVG; A third of the participants will have the same standard clinical care plus an Xbox and active games.	Behavioral: Standard clinical care; Each clinic will provide standard clinical care to the participants.; 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.
Experimental: Care + AVG + Narratives; 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: Standard clinical care; Each clinic will provide standard clinical care to the participants.; 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.; Behavioral: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained Attention	Response time will be measured by the Psychomotor Vigilance Task	6 months
Working Memory	Response time will be measured by the Delayed Match-to-Sample Task	6 months
Working Memory	Response accuracy will be measured by the Delayed Match-to-Sample Task	6 months
Inhibitory Control	Response time will be measured by the Stroop Test	6 months
Inhibitory Control	Response accuracy will be measured by the Stroop Test	6 months
Physical Activity Motivation	Physical Activity Motivation will be measured by the Physical Activity Motivation scale through self-report	6 months

Collaborators and Investigators

• Sponsor: Northeastern University

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2019
• Primary Completion (Actual): May 22, 2022
• Study Completion (Actual): May 22, 2022

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Physical Activity; Narrative; Child Obesity; Active Video Game
• Other Study ID Numbers: R01DK109316 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No