Family Exergaming: A Research Study Testing a Videogame I... | NCT00889122

Studies
Family Exergaming: A Research Study Testing a Videogame Intervention to Increase Physical Activity for Families

NCT00889122

Sponsor

MaineHealth

Status

Completed

Last Update Posted

Aug 4, 2010Estimated

Enrollment

213Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Exergame (DDR)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Apr 27, 2009

First Submission Date that Met QC Criteria

Apr 27, 2009

First Posted Date

Apr 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2010

Last Update Posted Date

Aug 4, 2010Estimated

Name	Class
Robert Wood Johnson Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine if an interactive game (Dance Dance Revolution/DDR) can promote healthy physical activity for the health of all family members

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

213Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifestyle Counseling	Experimental		Behavioral: Exergame (DDR)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exergame (DDR)	Behavioral	Use of an active videogame vs. pedometers given to entire families to promote physical activity.	Lifestyle Counseling

Measure	Description	Time Frame
Amount of physical activity		14 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 9-17
Overweight status (BMI of 85% and above)
Willing to come to two (2 hour) visits to MMCRI for measurements and complete surveys
Family participation

Exclusion Criteria:

Serious heart condition
Photo-sensitive seizures
Previous extensive history using DDR

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ann Maloney, MD	MaineHealth	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maine Medical Center Research Institute		Scarborough	Maine	04074	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000088544	Exergaming

Ancestor Terms

ID	Term
D015444	Exercise
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided