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Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
weight managment program
Active Gaming
Sponsored by
UnitedHealth Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring activity, gaming, obesity, Active Gaming, Control

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • YMCA Andvore
  • YMCA Lawrence
  • YMCA Merrimack Valley of MAss
  • YMCA Boroughs
  • Barrinton YMCA
  • Newman YMCA
  • YMCA Kent
  • Jones Elementary
  • Barabara Jordan Elementary
  • Oyster Creek Elementary
  • Townwest Elementary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active Gaming

Control Group

Arm Description

Participants will receivce a weight management program plus active gaming device

Participants will receive a weight management program without active gaming

Outcomes

Primary Outcome Measures

MVPA
difference between groups in MVPA at week 16 as assess by accelerometry

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2012
Last Updated
December 28, 2012
Sponsor
UnitedHealth Group
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1. Study Identification

Unique Protocol Identification Number
NCT01757925
Brief Title
Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention
Official Title
Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UnitedHealth Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
activity, gaming, obesity, Active Gaming, Control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Gaming
Arm Type
Experimental
Arm Description
Participants will receivce a weight management program plus active gaming device
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants will receive a weight management program without active gaming
Intervention Type
Behavioral
Intervention Name(s)
weight managment program
Intervention Description
a comprehensive peditric weight management program consisting of 16 weekly group sessions
Intervention Type
Other
Intervention Name(s)
Active Gaming
Other Intervention Name(s)
Hands free Kinect gaming device plus 2 games
Intervention Description
partcipants will be given a gaming device and 2 games (1 at baseline and 1 at week 8)
Primary Outcome Measure Information:
Title
MVPA
Description
difference between groups in MVPA at week 16 as assess by accelerometry
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
relative weight
Description
difference in % overweight, bmi z-score between groups at week 16
Time Frame
16 weeks
Title
quality of life
Description
Differences between groups in pediatric qulaitry of life as assessed by parents and children
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
YMCA Andvore
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
YMCA Lawrence
City
Lawrence
State/Province
Massachusetts
ZIP/Postal Code
01840
Country
United States
Facility Name
YMCA Merrimack Valley of MAss
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
YMCA Boroughs
City
Westborough
State/Province
Massachusetts
ZIP/Postal Code
01580
Country
United States
Facility Name
Barrinton YMCA
City
Barrington
State/Province
Rhode Island
ZIP/Postal Code
02806
Country
United States
Facility Name
Newman YMCA
City
Seakonk
State/Province
Rhode Island
ZIP/Postal Code
02771
Country
United States
Facility Name
YMCA Kent
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Jones Elementary
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77498
Country
United States
Facility Name
Barabara Jordan Elementary
City
Richmond
State/Province
Texas
ZIP/Postal Code
77407
Country
United States
Facility Name
Oyster Creek Elementary
City
Sugarland
State/Province
Texas
ZIP/Postal Code
77498
Country
United States
Facility Name
Townwest Elementary
City
Sugraland
State/Province
Texas
ZIP/Postal Code
77498
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24589566
Citation
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. Erratum In: JAMA Pediatr. 2018 Apr 1;172(4):395.
Results Reference
derived

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Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention

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