Active Video Games on Physical Activity (Main Trial)

NCT04116515 | Completed DMC

• 1 other identifier: R01DK109316
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity in Children

Keywords

Active Video Game; Physical Activity; Narrative; Child Obesity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• BMI%

  6 months

• Fasting Insulin

  6 months

• Fasting Glucose

  6 months

• Lipid

  6 months

• C-reactive protein (CRP)

  6 months

Other Outcomes (6)

• Sustained Attention

  6 months

• Working Memory

  6 months

• Working Memory

  6 months

Study Arms (3)

Care Only

ACTIVE COMPARATOR

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

Behavioral: Standard clinical care

Care + AVG

EXPERIMENTAL

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

Behavioral: Xbox / active video games; Behavioral: Standard clinical care

Care + AVG + Narratives

EXPERIMENTAL

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: Xbox / active video games; Behavioral: Animated cartoon narratives; Behavioral: Standard clinical care

Interventions

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.

Care + AVG; Care + AVG + Narratives

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.

Care + AVG + Narratives

Standard clinical care BEHAVIORAL

Each clinic will provide standard clinical care to the participants.

Care + AVG; Care + AVG + Narratives; Care Only

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northeastern University: lead

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 40420195 DERIVED

MeSH Terms

Conditions

Motor Activity; Narration; Pediatric Obesity

Condition Hierarchy (Ancestors)

Behavior; Communication; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be informed of their group at the conclusion of the study.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: December 25, 2019
• Primary Completion: May 22, 2022
• Study Completion: May 22, 2022
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

US (1)