Active Video Games on Physical Activity (Main Trial)

Not Applicable

Completed

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

• Registration Number: NCT04116515
• Lead Sponsor: Northeastern University

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.

Study Timeline

• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-04
• Study Start: 2019-12-25
• Primary Completion: 2022-05-22
• Study Completion: 2022-05-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Care Only	Standard clinical care	A third of the participants will have standard clinical care only.
Care + AVG + Narratives	Standard clinical care	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.
Care + AVG	Standard clinical care	A third of the participants will have the same standard clinical care plus an Xbox and active games.
Care + AVG + Narratives	Xbox / active video games	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.
Care + AVG	Xbox / active video games	A third of the participants will have the same standard clinical care plus an Xbox and active games.
Care + AVG + Narratives	Animated cartoon 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.

Primary Outcome Measures

Name	Time	Method
Changes in fat%	6 months	Measured through dual-energy X-ray absorptiometry (DEXA) scan by GE Lunar Prodigy (GE Healthcare, Chicago, IL).
Changes in objective child physical activity	6 months	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.
Changes in lean tissue%	6 months	Measured through dual-energy X-ray absorptiometry (DEXA) scan by GE Lunar Prodigy (GE Healthcare, Chicago, IL).

Secondary Outcome Measures

Name	Time	Method
BMI%	6 months	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.
Fasting Insulin	6 months	Analysis of the plasma samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.
Lipid	6 months	Analysis of the serum samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.
C-reactive protein (CRP)	6 months	Analysis of the serum samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.
Fasting Glucose	6 months	Analysis of the plasma samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.

Trial Locations

Locations (1)

Northeastern University; 🇺🇸 Boston, Massachusetts, United States