Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention
NCT ID: NCT01757925
Last Updated: 2012-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
77 participants
INTERVENTIONAL
2011-08-31
2012-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active Gaming
Participants will receivce a weight management program plus active gaming device
weight managment program
a comprehensive peditric weight management program consisting of 16 weekly group sessions
Active Gaming
partcipants will be given a gaming device and 2 games (1 at baseline and 1 at week 8)
Control Group
Participants will receive a weight management program without active gaming
weight managment program
a comprehensive peditric weight management program consisting of 16 weekly group sessions
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
weight managment program
a comprehensive peditric weight management program consisting of 16 weekly group sessions
Active Gaming
partcipants will be given a gaming device and 2 games (1 at baseline and 1 at week 8)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Child must be enroll in JOIN Program,
* Child must have a BMI in the 85th percentile
Exclusion Criteria
6 Years
12 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UnitedHealth Group
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Deneen Vojta
Dr. Deneen Vojta Vice President of Center for Health Reform and Modernization
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
YMCA Andvore
Andover, Massachusetts, United States
YMCA Lawrence
Lawrence, Massachusetts, United States
YMCA Merrimack Valley of MAss
Methuen, Massachusetts, United States
YMCA Boroughs
Westborough, Massachusetts, United States
Barrinton YMCA
Barrington, Rhode Island, United States
Newman YMCA
Seakonk, Rhode Island, United States
YMCA Kent
Warwick, Rhode Island, United States
Jones Elementary
Missouri City, Texas, United States
Barabara Jordan Elementary
Richmond, Texas, United States
Oyster Creek Elementary
Sugarland, Texas, United States
Townwest Elementary
Sugraland, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JXBX 2012 11-214
Identifier Type: -
Identifier Source: org_study_id