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Completed

NCT Number: NCT04116515

Active Video Games on 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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeastern University

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xbox / active video games

Behavioral

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

Behavioral

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

Behavioral

Each clinic will provide standard clinical care to the participants.

Primary outcomes

  1. Changes in objective child physical activity

    Time frame: 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.

  2. Changes in fat%

    Time frame: 6 months

    Measured through dual-energy X-ray absorptiometry (DEXA) scan by GE Lunar Prodigy (GE Healthcare, Chicago, IL).

  3. Changes in lean tissue%

    Time frame: 6 months

    Measured through dual-energy X-ray absorptiometry (DEXA) scan by GE Lunar Prodigy (GE Healthcare, Chicago, IL).

Secondary outcomes

  1. BMI%

    Time frame: 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.

  2. Fasting Insulin

    Time frame: 6 months

    Analysis of the plasma samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.

  3. Fasting Glucose

    Time frame: 6 months

    Analysis of the plasma samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.

  4. Lipid

    Time frame: 6 months

    Analysis of the serum samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.

  5. C-reactive protein (CRP)

    Time frame: 6 months

    Analysis of the serum samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.

Other outcomes

  1. Sustained Attention

    Time frame: 6 months

    Response time will be measured by the Psychomotor Vigilance Task

  2. Working Memory

    Time frame: 6 months

    Response time will be measured by the Delayed Match-to-Sample Task

  3. Working Memory

    Time frame: 6 months

    Response accuracy will be measured by the Delayed Match-to-Sample Task

  4. Inhibitory Control

    Time frame: 6 months

    Response time will be measured by the Stroop Test

  5. Inhibitory Control

    Time frame: 6 months

    Response accuracy will be measured by the Stroop Test

  6. Physical Activity Motivation

    Time frame: 6 months

    Physical Activity Motivation will be measured by the Physical Activity Motivation scale through self-report

Sponsors and collaborators

Lead sponsor

Northeastern University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 4, 2019
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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