Active Video Games on Physical Activity (Main Trial)

NCT ID: NCT04116515

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-25

Study Completion Date

2022-05-22

Brief Summary

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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

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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.

Conditions

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Physical Inactivity in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be informed of their group at the conclusion of the study.

Study Groups

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Care Only

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

Group Type ACTIVE_COMPARATOR

Standard clinical care

Intervention Type BEHAVIORAL

Each clinic will provide standard clinical care to the participants.

Care + AVG

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

Group Type EXPERIMENTAL

Xbox / active video games

Intervention Type 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.

Standard clinical care

Intervention Type BEHAVIORAL

Each clinic will provide standard clinical care to the participants.

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.

Group Type EXPERIMENTAL

Xbox / active video games

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

Each clinic will provide standard clinical care to the participants.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Standard clinical care

Each clinic will provide standard clinical care to the participants.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northeastern University

OTHER

Sponsor Role lead

Responsible Party

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Amy Lu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northeastern University

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Lu AS, Baranowski T, Barreira TV, Fleischman A, Green MC, Huang SY, Lee IM, Levitsky LL, Noubary F, Thompson D. The impact of narratives and active video games among black and hispanic children with overweight and obesity: a randomized controlled trial. Int J Behav Nutr Phys Act. 2025 May 26;22(1):60. doi: 10.1186/s12966-025-01756-1.

Reference Type DERIVED
PMID: 40420195 (View on PubMed)

Other Identifiers

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R01DK109316

Identifier Type: NIH

Identifier Source: org_study_id

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