Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional
Phase: Phase 4

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 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.
    

Intervention name(s): weight managment program; Active Gaming
Intervention type(s): Behavioral; Other
Intervention description(s): a comprehensive peditric weight management program consisting of 16 weekly group sessions; partcipants will be given a gaming device and 2 games (1 at baseline and 1 at week 8)
Other intervention name(s): Hands free Kinect gaming device plus 2 games
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: activity; gaming; obesity; Active Gaming; Control