Physical Inactivity in ChildrenNCT04116515
Active Video Games on Physical Activity (Main Trial)
A study testing Xbox / active video games, Animated cartoon narratives and Standard clinical care in people with Physical Inactivity in Children, run by Northeastern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Physical Inactivity in Children
- What is being tested?
- Xbox / active video games, Animated cartoon narratives and Standard clinical care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Dec 2019to 22 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeastern University
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Inactivity in Children
- Being tested
- Xbox / active video games, Animated cartoon narratives, Standard clinical care
- Keywords
- Active Video Game, Physical Activity, Narrative, Child Obesity
- Medical subject headings
- Motor Activity, Narration, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xbox / active video gamesBehavioural
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 narrativesBehavioural
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 careBehavioural
Each clinic will provide standard clinical care to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Care Only | Active comparator | A third of the participants will have standard clinical care only. Receives: 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. Receives: 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. Receives: Behavioral: Xbox / active video games; Behavioral: Animated cartoon narratives; Behavioral: Standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Changes in fat%
Measured through dual-energy X-ray absorptiometry (DEXA) scan by GE Lunar Prodigy (GE Healthcare, Chicago, IL).
Measured: 6 months
Changes in lean tissue%
Measured through dual-energy X-ray absorptiometry (DEXA) scan by GE Lunar Prodigy (GE Healthcare, Chicago, IL).
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 6 months
Fasting Insulin
Analysis of the plasma samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.
Measured: 6 months
Fasting Glucose
Analysis of the plasma samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.
Measured: 6 months
Lipid
Analysis of the serum samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.
Measured: 6 months
C-reactive protein (CRP)
Analysis of the serum samples will be performed using dedicated Enzyme-Linked Immunosorbent Assay (ELISA) kits.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start25 Dec 2019
- Primary completion22 May 2022
- Study completion22 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical Inactivity in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Lu, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116515
- Sponsor's protocol ID
- R01DK109316
- Status last verified
- Mar 2023
- First submitted
- 2 Oct 2019
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40420195
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Narrative Effect of Active Video Games on Long-term Moderate-to-Vigorous Physical Activity (Main Trial)
- ClinicalTrials.gov ID
- NCT04116515
- Acronym / sponsor ID
- R01DK109316
- Conditions
- Physical Inactivity in Children
- Keywords
- Active Video Game, Physical Activity, Narrative, Child Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- 22 May 2022 (actual)
- Study completion
- 22 May 2022 (actual)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Care Only | Active comparator | Behavioral: Standard clinical careA third of the participants will have standard clinical care only. |
| Care + AVG | Experimental | Behavioral: Xbox / active video games, Behavioral: Standard clinical careA third of the participants will have the same standard clinical care plus an Xbox and active games. |
| Care + AVG + Narratives | Experimental | Behavioral: Xbox / active video games, Behavioral: Animated cartoon narratives, Behavioral: Standard clinical careA third of the participants will have the same standard clinical care, an Xbox and active games, plus the stories delivered to their Xbox consoles. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xbox / active video gamesThe 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. | Behavioural | Care + AVG, Care + AVG + Narratives |
| Animated cartoon narrativesThe 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. | Behavioural | Care + AVG + Narratives |
| Standard clinical careEach clinic will provide standard clinical care to the participants. | Behavioural | Care + AVG, Care + AVG + Narratives, Care Only |
Primary outcome
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.
Changes in fat%
Time frame: 6 months
Measured through dual-energy X-ray absorptiometry (DEXA) scan by GE Lunar Prodigy (GE Healthcare, Chicago, IL).
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).
5 secondary outcomes
BMI%
Time frame: 6 months
Fasting Insulin
Time frame: 6 months
Fasting Glucose
Time frame: 6 months
Lipid
Time frame: 6 months
C-reactive protein (CRP)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Derived from this study: PubMed 40420195Lu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xbox / active video games, Animated cartoon narratives and Standard clinical care in people with Physical Inactivity in Children, run by Northeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in objective child physical activity (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04116515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.