Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Deneen Vojta, UnitedHealth Group
ClinicalTrials.gov Identifier:
NCT01757925
First received: December 21, 2012
Last updated: December 28, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Childhood Obesity
Behavioral: weight managment program
Other: Active Gaming
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention

Resource links provided by NLM:


Further study details as provided by UnitedHealth Group:

Primary Outcome Measures:
  • MVPA [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    difference between groups in MVPA at week 16 as assess by accelerometry


Secondary Outcome Measures:
  • relative weight [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    difference in % overweight, bmi z-score between groups at week 16

  • quality of life [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Differences between groups in pediatric qulaitry of life as assessed by parents and children


Enrollment: 77
Study Start Date: August 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Gaming
Participants will receivce a weight management program plus active gaming device
Behavioral: weight managment program
a comprehensive peditric weight management program consisting of 16 weekly group sessions
Other: Active Gaming
partcipants will be given a gaming device and 2 games (1 at baseline and 1 at week 8)
Other Name: Hands free Kinect gaming device plus 2 games
Active Comparator: Control Group
Participants will receive a weight management program without active gaming
Behavioral: weight managment program
a comprehensive peditric weight management program consisting of 16 weekly group sessions

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children ages 6 - 12 with Parent or Gaurdian.
  • Child must be enroll in JOIN Program,
  • Child must have a BMI in the 85th percentile

Exclusion Criteria:

  • English Speaking Participants only
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757925

Locations
United States, Massachusetts
YMCA Andvore
Andover, Massachusetts, United States, 01810
YMCA Lawrence
Lawrence, Massachusetts, United States, 01840
YMCA Merrimack Valley of MAss
Methuen, Massachusetts, United States, 01844
YMCA Boroughs
Westborough, Massachusetts, United States, 01580
United States, Rhode Island
Barrinton YMCA
Barrington, Rhode Island, United States, 02806
Newman YMCA
Seakonk, Rhode Island, United States, 02771
YMCA Kent
Warwick, Rhode Island, United States, 02886
United States, Texas
Jones Elementary
Missouri City, Texas, United States, 77498
Barabara Jordan Elementary
Richmond, Texas, United States, 77407
Oyster Creek Elementary
Sugarland, Texas, United States, 77498
Townwest Elementary
Sugraland, Texas, United States, 77498
Sponsors and Collaborators
UnitedHealth Group
  More Information

No publications provided by UnitedHealth Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Deneen Vojta, Dr. Deneen Vojta Vice President of Center for Health Reform and Modernization, UnitedHealth Group
ClinicalTrials.gov Identifier: NCT01757925     History of Changes
Other Study ID Numbers: JXBX 2012 11-214
Study First Received: December 21, 2012
Last Updated: December 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by UnitedHealth Group:
activity
gaming
obesity
Active Gaming
Control

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014