Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention

December 28, 2012 updated by: Dr. Deneen Vojta, UnitedHealth Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MVPA
Time Frame: 16 weeks
difference between groups in MVPA at week 16 as assess by accelerometry
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relative weight
Time Frame: 16 weeks
difference in % overweight, bmi z-score between groups at week 16
16 weeks
quality of life
Time Frame: 16 weeks
Differences between groups in pediatric qulaitry of life as assessed by parents and children
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UnitedHealth Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 21, 2012

First Submitted That Met QC Criteria

December 28, 2012

First Posted (Estimate)

December 31, 2012

Study Record Updates

Last Update Posted (Estimate)

December 31, 2012

Last Update Submitted That Met QC Criteria

December 28, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JXBX 2012 11-214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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