Childhood ObesityGameSquadNCT02560493
Gaming Technology to Encourage Healthy Weight and Activity in Youth
A study testing Exergaming Condition in people with Childhood Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The goal of the proposed randomized controlled trial is to test the efficacy of exergaming (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and obese children. Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Exergaming Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI percentile > or equal to 85 on the CDC growth chart
- Participating household has a high-speed internet connection
- At least 1 family member or friend who is willing to exergame in the home with the participant for 3 hours/week
Who cannot join
- Pregnant
- Impairments that prevent normal ambulation
- Previous history, or current symptoms of, cardiovascular disease, musculoskeletal injury, or epileptic seizures
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
The goal of the proposed randomized controlled trial is to test the efficacy of exergaming (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and obese children.
Read the detailed description
The GAMESQUAD study is a 6-month, 2-arm randomized controlled trial among 46 overweight/obese children (aged 10 to 12 years) assigned to: 1) 3 hours/week of in-home exergaming or 2) a control group. An innovative aspect is the inclusion of a fitness trainer who will regularly video chat with the participant and virtually monitor gameplay. The study will advance the field by: 1) establishing the efficacy of exergaming to reduce BMIz among overweight and obese children and 2) demonstrating the potential of exergaming to reduce body fat and improve children's cardiovascular health.
- Conditions
- Childhood Obesity
- Being tested
- Exergaming Condition
- Keywords
- BMIz, Exergaming, Cardiovascular Disease
- Medical subject headings
- Pediatric Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergaming ConditionBehavioural
Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | No intervention | Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff. |
| Exergaming Condition | Experimental | Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention. Receives: Behavioral: Exergaming Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group
Height and weight will be collected at Screening, Week 0, and Week 24. Standing height will be measured in cm with a Harpenden stadiometer (Holtain Limited, Crymych, UK) with shoes removed while the participant holds breath and an assessor applies light traction to align the participant's head along the Frankfort Horizontal Plane. Weight will be measured in kg with a Michelli GSE 460 scale (G.T. Michelli Co., Baton Rouge, LA) while wearing a hospital gown and undergarments. Measures will be taken twice and recorded to the nearest 0.1 units, with a third if the initial 2 measures are greater than 0.5 units apart. BMIz will be calculated based on the child's age, sex, height, and weight using the 2000 Centers for Disease Control and Prevention (CDC) Growth Charts. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean
Measured: Change between Baseline (Week 0) and 6 months (Week 24)
Secondary outcomes (7)
Changes in Body Fat
A dual energy x-ray absorptiometry (DXA) scan will be completed at Week 0 and Week 24 with a GE iDXA whole-body scanner (GE Medical Systems, Milwaukee, WI) to measure adiposity, including total body fat mass and regional fat mass in the extremities and trunk.
Measured: Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Systolic Blood Pressure
Resting blood pressure will be assessed at Screening, Week 0, and Week 24 using standard clinical procedures on a standard mercury manometer. The participant's age-, sex-, and height-specific percentile will be calculated.
Measured: Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Diastolic Blood Pressure
Resting blood pressure will be assessed at Screening, Week 0, and Week 24 using standard clinical procedures on a standard mercury manometer. The participant's age-, sex-, and height-specific percentile will be calculated.
Measured: Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Total Cholesterol
A blood sample will be taken at Week 0 and Week 24 by a trained phlebotomist following standard clinic procedures after an 8-hour fast. Serum concentrations of total cholesterol will be assayed on a DXC600 from Trinity.
Measured: Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Fasting Glucose
A blood sample will be taken at Week 0 and Week 24 by a trained phlebotomist following standard clinic procedures after an 8-hour fast. Serum concentrations of glucose will be obtained from a DXC600 by Beckman Coulter.
Measured: Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Physical Activity
Physical activity will be assessed with an Actigraph GT3X+ accelerometer (ActiGraph, of Ft. Walton Beach, FL) to determine changes in habitual physical activity outside of the gaming intervention. Participants will wear the accelerometer for two bouts of 7-days following Week 0 baseline clinic visit and Week 24 clinic visit, but not during the gaming intervention.
Measured: Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Diet
Dietary information will be collected from the participant at Week 0 and Week 24. Healthy diet score will be determined by the NCI Self-administered 24-hour Dietary Recall (ASA24-Kids). This survey is administered on a computer through a web-based program.
Measured: Change between Baseline (Week 0) and 6 months (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Amanda Staiano, Pennington Biomedical Research Center
- Investigators
- Amanda E Staiano, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560493
- Sponsor's protocol ID
- PBRC 2015-037
- Acronym
- GameSquad
- Status last verified
- Mar 2024
- First submitted
- 18 Sep 2015
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Staiano AE, Beyl RA, Guan W, Hendrick CA, Hsia DS, Newton RL Jr. Home-based exergaming among children with overweight and obesity: a randomized clinical trial. Pediatr Obes. 2018 Nov;13(11):724-733. doi: 10.1111/ijpo.12438. Epub 2018 Jul 20.
PubMed 30027607
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaming Technology to Encourage Healthy Weight and Activity in Youth
- ClinicalTrials.gov ID
- NCT02560493
- Acronym / sponsor ID
- GameSquad / PBRC 2015-037
- Conditions
- Childhood Obesity
- Keywords
- BMIz, Exergaming, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Posted 19 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed randomized controlled trial is to test the efficacy of exergaming (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and obese children.
Detailed description
The GAMESQUAD study is a 6-month, 2-arm randomized controlled trial among 46 overweight/obese children (aged 10 to 12 years) assigned to: 1) 3 hours/week of in-home exergaming or 2) a control group. An innovative aspect is the inclusion of a fitness trainer who will regularly video chat with the participant and virtually monitor gameplay. The study will advance the field by: 1) establishing the efficacy of exergaming to reduce BMIz among overweight and obese children and 2) demonstrating the potential of exergaming to reduce body fat and improve children's cardiovascular health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Condition | No intervention | –Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff. |
| Exergaming Condition | Experimental | Behavioral: Exergaming ConditionParticipants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- BMI percentile > or equal to 85 on the CDC growth chart
- Participating household has a high-speed internet connection
- At least 1 family member or friend who is willing to exergame in the home with the participant for 3 hours/week
Key exclusion criteria (3 listed)
- Pregnant
- Impairments that prevent normal ambulation
- Previous history, or current symptoms of, cardiovascular disease, musculoskeletal injury, or epileptic seizures
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 |
|---|---|---|
| Exergaming ConditionParticipants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines. | Behavioural | Exergaming Condition |
Primary outcome
Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Height and weight will be collected at Screening, Week 0, and Week 24. Standing height will be measured in cm with a Harpenden stadiometer (Holtain Limited, Crymych, UK) with shoes removed while the participant holds breath and an assessor applies light traction to align the participant's head along the Frankfort Horizontal Plane. Weight will be measured in kg with a Michelli GSE 460 scale (G.T. Michelli Co., Baton Rouge, LA) while wearing a hospital gown and undergarments. Measures will be taken twice and recorded to the nearest 0.1 units, with a third if the initial 2 measures are greater than 0.5 units apart. BMIz will be calculated based on the child's age, sex, height, and weight using the 2000 Centers for Disease Control and Prevention (CDC) Growth Charts. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean
7 secondary outcomes
Changes in Body Fat
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Systolic Blood Pressure
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Diastolic Blood Pressure
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Total Cholesterol
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Fasting Glucose
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Physical Activity
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Diet
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30027607Staiano AE, Beyl RA, Guan W, Hendrick CA, Hsia DS, Newton RL Jr. Home-based exergaming among children with overweight and obesity: a randomized clinical trial. Pediatr Obes. 2018 Nov;13(11):724-733. doi: 10.1111/ijpo.12438. Epub 2018 Jul 20.
- Individual participant dataSharing planned: No
Related trials for Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
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.
Amanda E Staiano, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming Condition in people with Childhood Obesity, run by Pennington Biomedical Research Center 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 3 inclusion and 3 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 29 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Body Mass Index Z-score (BMIz) Compared to a Control Group (time frame: Change between Baseline (Week 0) and 6 months (Week 24)). 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 NCT02560493, 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 29 Mar 2024.