NCT01757925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 31, 2012

Completed
Last Updated

December 31, 2012

Status Verified

December 1, 2012

Enrollment Period

1.1 years

First QC Date

December 21, 2012

Last Update Submit

December 28, 2012

Conditions

Childhood Obesity

Keywords

activitygamingobesityActive GamingControl

Outcome Measures

Primary Outcomes (1)

  • MVPA

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

    16 weeks

Secondary Outcomes (2)

  • relative weight

    16 weeks

  • quality of life

    16 weeks

Study Arms (2)

Active Gaming

EXPERIMENTAL

Participants will receivce a weight management program plus active gaming device

Behavioral: weight managment programOther: Active Gaming

Control Group

ACTIVE COMPARATOR

Participants will receive a weight management program without active gaming

Behavioral: weight managment program

Interventions

weight managment programBEHAVIORAL

a comprehensive peditric weight management program consisting of 16 weekly group sessions

Active GamingControl Group
Active GamingOTHER

partcipants will be given a gaming device and 2 games (1 at baseline and 1 at week 8)

Also known as: Hands free Kinect gaming device plus 2 games
Active Gaming

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • English Speaking Participants only

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

YMCA Andvore

Andover, Massachusetts, 01810, United States

Location

YMCA Lawrence

Lawrence, Massachusetts, 01840, United States

Location

YMCA Merrimack Valley of MAss

Methuen, Massachusetts, 01844, United States

Location

YMCA Boroughs

Westborough, Massachusetts, 01580, United States

Location

Barrinton YMCA

Barrington, Rhode Island, 02806, United States

Location

Newman YMCA

Seakonk, Rhode Island, 02771, United States

Location

YMCA Kent

Warwick, Rhode Island, 02886, United States

Location

Jones Elementary

Missouri City, Texas, 77498, United States

Location

Barabara Jordan Elementary

Richmond, Texas, 77407, United States

Location

Oyster Creek Elementary

Sugarland, Texas, 77498, United States

Location

Townwest Elementary

Sugraland, Texas, 77498, United States

Location

Related Publications (1)

  • 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.

    PMID: 24589566DERIVED

MeSH Terms

Conditions

Pediatric ObesityMotor ActivityObesity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Deneen Vojta Vice President of Center for Health Reform and Modernization

Study Record Dates

First Submitted

December 21, 2012

First Posted

December 31, 2012

Study Start

August 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 31, 2012

Record last verified: 2012-12

Locations

US(11)