Childhood ObesityPhase 4NCT01757925
Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention
A Phase 4 study testing weight managment program and Active Gaming in people with Childhood Obesity, run by UnitedHealth Group at 11 sites in United States.
Trial summary
Recently, researchers have been interested in the use of game play, mechanics and psychology for health-related engagement and behavior change. While initial studies have shown some increases in health knowledge and/or behavior through gaming, there remains concern that the vehicle for change is associated with a… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- weight managment program and Active Gaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 11 sitesUnited States
- Study dates
- Aug 2011to Sep 2012
- Phase
- Phase 4
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ages 6 - 12 with Parent or Gaurdian.
- Child must be enroll in JOIN Program,
- Child must have a BMI in the 85th percentile
Who cannot join
- English Speaking Participants only
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
YMCA Andvore
Andover, Massachusetts, 01810
Barrinton YMCA
Barrington, Rhode Island, 02806
YMCA Lawrence
Lawrence, Massachusetts, 01840
YMCA Merrimack Valley of MAss
Methuen, Massachusetts, 01844
Jones Elementary
Missouri City, Texas, 77498
Barabara Jordan Elementary
Richmond, Texas, 77407
Newman YMCA
Seakonk, Rhode Island, 02771
Oyster Creek Elementary
Sugarland, Texas, 77498
Townwest Elementary
Sugraland, Texas, 77498
YMCA Kent
Warwick, Rhode Island, 02886
YMCA Boroughs
Westborough, Massachusetts, 01580
About this study
Recently, researchers have been interested in the use of game play, mechanics and psychology for health-related engagement and behavior change. While initial studies have shown some increases in health knowledge and/or behavior through gaming, there remains concern that the vehicle for change is associated with a perceived sedentary behavior (6).
More recently, commercially available gaming devices are able to directly promote physical activity through a new set of "kinetic controllers" added to the gaming experience. UHG plans to evaluate the most recent of these kinetic controller technologies in the context of a second iteration of JOIN (described above) to be implemented among a pilot group of overweight and/or obese children whose BMI percentile is above the 85th.
This study will evaluate the effect of a commercial controller-free Exercise Gaming and Entertainment Experience (EGEE) on physical activity levels in the context of a weight management program in approximately 70 children ages 6 to12. The study will compare the differences in physical activity levels over 16 weeks in two groups of children.
Read the detailed description
The Center for Health Reform and Modernization at UHG will compare levels of physical activity, assessed by accelerometry, among children randomly assigned to WMA or WM+E groups. Specific aims of this evaluation are:
- Compare the two groups on changes in the daily minutes of physical activity (mild, moderate and vigorous) after sessions 1, 8 and 15, respectively (Sessions are typically one week a part. Due to holiday schedules, there may be a lapse of two weeks between sessions).
- Compare the two groups on changes in the daily minutes of sedentary behavior after sessions 1, 8 and 15, respectively
- Compare the two groups on changes in relative weight (weight, BMI percentile, BMI z-score) at sessions 1, 8, and 16 weeks, respectively
- Compare the two groups on measures of program satisfaction at 1, 8, and 16 weeks, respectively
Participation in the post session one session is required in order to be eligible for the study requirements include:
- A signed consent/ assent from the parent and child.
- The child must be able to participate in physical activity similar to exercise gaming
- The family must have a TV/monitor that supports Microsoft Kinect
- The family must have internet connection in the home
The family's decision to participate in the study does not affect the child's'/ parent's overall ability to fully participate in the JOIN Program. All JOIN program materials will be the same whether or not JOIN participants agree to be in the study. All aspects of the study will be conducted outside of the standard class time. Interested and eligible participants will be scheduled to attend a study visit immediately after their first JOIN class. During that study visit, written informed consent/assent from the parent/child will be obtained.
Once a participant has agreed to enroll and have been consented/assented he/she will be informed of study group to which he/she has been randomly assigned. There are two options: 1) weight management alone or 2) weight management plus exercise gaming and entertainment experience. Randomization will occur at the group level (i.e., all consented/assented children in the Wed at 5 p group). Classes will be randomized in pairs of 2 and based on enrollment.
Treatment JOIN consists of 16 weekly Core in-person group sessions followed by 8 monthly mastery group sessions. While the JOIN Program continues for one year, the study will only occur over the first 16 weeks. YMCA sessions last 75 minutes and include a weight assessment of the child prior to each session. The groups are led by a YMCA facilitator. The topics for the first 16 sessions are listed below.
Child Activity Monitor. At sessions 1, 8, and 15 an actigraph will be distributed to each participating child in group 1 and 2. Each child will wear it for 1 week (7 days) during waking hours, and return it at the next session. An activity monitor provides no feedback to participants and provides an objective measure of physical activity (mild, moderate, vigorous) as well as sedentary behavior through downloaded data. The GT3XE Triaxial Activity Monitor w/Extended Memory® (produced by Actigraph) is a small, omni-directional accelerometer (Actigraph), which has already been approved by the FDA for measuring subject's physical activity, and energy expenditure level. The activity monitor (Actigraph) is a small, 1 inch by 1 inch, device that is worn at the hip level attached to an adjustable belt (also provided by the study). The belt can be worn below or above clothing.
- Conditions
- Childhood Obesity
- Being tested
- weight managment program, Active Gaming
- Keywords
- activity, gaming, obesity, Active Gaming, Control
- Medical subject headings
- Pediatric Obesity, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight managment programBehavioural
a comprehensive peditric weight management program consisting of 16 weekly group sessions
Active GamingOther
Also called Hands free Kinect gaming device plus 2 games
partcipants will be given a gaming device and 2 games (1 at baseline and 1 at week 8)
| Study group | Role | What they receive |
|---|---|---|
| Active Gaming | Experimental | Participants will receivce a weight management program plus active gaming device Receives: Behavioral: weight managment program; Other: Active Gaming |
| Control Group | Active comparator | Participants will receive a weight management program without active gaming Receives: Behavioral: weight managment program |
What is being measured
The primary outcome is the main question the study is designed to answer.
MVPA
difference between groups in MVPA at week 16 as assess by accelerometry
Measured: 16 weeks
Secondary outcomes (2)
relative weight
difference in % overweight, bmi z-score between groups at week 16
Measured: 16 weeks
quality of life
Differences between groups in pediatric qulaitry of life as assessed by parents and children
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startAug 2011
- Primary completionSep 2012
- Study completionSep 2012
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- UnitedHealth Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Deneen Vojta, UnitedHealth Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757925
- Sponsor's protocol ID
- JXBX 2012 11-214
- Status last verified
- Dec 2012
- First submitted
- 21 Dec 2012
- Last updated
- 31 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Trost SG, Sundal D, Foster GD, Lent MR, Vojta D. Effects of a pediatric weight management program with and without active video games a randomized trial. JAMA Pediatr. 2014 May;168(5):407-13. doi: 10.1001/jamapediatrics.2013.3436.
PubMed 24589566
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention
- ClinicalTrials.gov ID
- NCT01757925
- Acronym / sponsor ID
- JXBX 2012 11-214
- Conditions
- Childhood Obesity
- Keywords
- activity, gaming, obesity, Active Gaming, Control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- UnitedHealth GroupIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 31 Dec 2012 (estimated)
- 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.
Recently, researchers have been interested in the use of game play, mechanics and psychology for health-related engagement and behavior change. While initial studies have shown some increases in health knowledge and/or behavior through gaming, there remains concern that the vehicle for change is associated with a perceived sedentary behavior (6).
More recently, commercially available gaming devices are able to directly promote physical activity through a new set of "kinetic controllers" added to the gaming experience. UHG plans to evaluate the most recent of these kinetic controller technologies in the context of a second iteration of JOIN (described above) to be implemented among a pilot group of overweight and/or obese children whose BMI percentile is above the 85th.
This study will evaluate the effect of a commercial controller-free Exercise Gaming and Entertainment Experience (EGEE) on physical activity levels in the context of a weight management program in approximately 70 children ages 6 to12. The study will compare the differences in physical activity levels over 16 weeks in two groups of children.
Detailed description
The Center for Health Reform and Modernization at UHG will compare levels of physical activity, assessed by accelerometry, among children randomly assigned to WMA or WM+E groups. Specific aims of this evaluation are:
- Compare the two groups on changes in the daily minutes of physical activity (mild, moderate and vigorous) after sessions 1, 8 and 15, respectively (Sessions are typically one week a part. Due to holiday schedules, there may be a lapse of two weeks between sessions).
- Compare the two groups on changes in the daily minutes of sedentary behavior after sessions 1, 8 and 15, respectively
- Compare the two groups on changes in relative weight (weight, BMI percentile, BMI z-score) at sessions 1, 8, and 16 weeks, respectively
- Compare the two groups on measures of program satisfaction at 1, 8, and 16 weeks, respectively
Participation in the post session one session is required in order to be eligible for the study requirements include:
- A signed consent/ assent from the parent and child.
- The child must be able to participate in physical activity similar to exercise gaming
- The family must have a TV/monitor that supports Microsoft Kinect
- The family must have internet connection in the home
The family's decision to participate in the study does not affect the child's'/ parent's overall ability to fully participate in the JOIN Program. All JOIN program materials will be the same whether or not JOIN participants agree to be in the study. All aspects of the study will be conducted outside of the standard class time. Interested and eligible participants will be scheduled to attend a study visit immediately after their first JOIN class. During that study visit, written informed consent/assent from the parent/child will be obtained.
Once a participant has agreed to enroll and have been consented/assented he/she will be informed of study group to which he/she has been randomly assigned. There are two options: 1) weight management alone or 2) weight management plus exercise gaming and entertainment experience. Randomization will occur at the group level (i.e., all consented/assented children in the Wed at 5 p group). Classes will be randomized in pairs of 2 and based on enrollment.
Treatment JOIN consists of 16 weekly Core in-person group sessions followed by 8 monthly mastery group sessions. While the JOIN Program continues for one year, the study will only occur over the first 16 weeks. YMCA sessions last 75 minutes and include a weight assessment of the child prior to each session. The groups are led by a YMCA facilitator. The topics for the first 16 sessions are listed below.
Child Activity Monitor. At sessions 1, 8, and 15 an actigraph will be distributed to each participating child in group 1 and 2. Each child will wear it for 1 week (7 days) during waking hours, and return it at the next session. An activity monitor provides no feedback to participants and provides an objective measure of physical activity (mild, moderate, vigorous) as well as sedentary behavior through downloaded data. The GT3XE Triaxial Activity Monitor w/Extended Memory® (produced by Actigraph) is a small, omni-directional accelerometer (Actigraph), which has already been approved by the FDA for measuring subject's physical activity, and energy expenditure level. The activity monitor (Actigraph) is a small, 1 inch by 1 inch, device that is worn at the hip level attached to an adjustable belt (also provided by the study). The belt can be worn below or above clothing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Gaming | Experimental | Behavioral: weight managment program, Other: Active GamingParticipants will receivce a weight management program plus active gaming device |
| Control Group | Active comparator | Behavioral: weight managment programParticipants will receive a weight management program without active gaming |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children ages 6 - 12 with Parent or Gaurdian.
- Child must be enroll in JOIN Program,
- Child must have a BMI in the 85th percentile
Key exclusion criteria (1 listed)
- English Speaking Participants only
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 |
|---|---|---|
| weight managment programa comprehensive peditric weight management program consisting of 16 weekly group sessions | Behavioural | Active Gaming, Control Group |
| Active GamingAlso: Hands free Kinect gaming device plus 2 gamespartcipants will be given a gaming device and 2 games (1 at baseline and 1 at week 8) | Other | Active Gaming |
Primary outcome
MVPA
Time frame: 16 weeks
difference between groups in MVPA at week 16 as assess by accelerometry
2 secondary outcomes
relative weight
Time frame: 16 weeks
quality of life
Time frame: 16 weeks
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 Dec 2012.
- Derived from this study: PubMed 24589566Trost SG, Sundal D, Foster GD, Lent MR, Vojta D. Effects of a pediatric weight management program with and without active video games a randomized trial. JAMA Pediatr. 2014 May;168(5):407-13. doi: 10.1001/jamapediatrics.2013.3436.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing weight managment program and Active Gaming in people with Childhood Obesity, run by UnitedHealth Group at 11 sites 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 1 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 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
MVPA (time frame: 16 weeks). 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 NCT01757925, 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 Dec 2012.