ObesityNCT00889122
Family Exergaming: A Research Study Testing a Videogame Intervention to Increase Physical Activity for Families
A study testing Exergame (DDR) in people with Obesity, run by MaineHealth at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exergame (DDR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Serious heart condition
- Photo-sensitive seizures
- Previous extensive history using DDR
Trial locations and contacts
1 site in 1 country.
United States1 site
Maine Medical Center Research Institute
Scarborough, Maine, 04074
About this study
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
- Conditions
- Obesity
- Being tested
- Exergame (DDR)
- Keywords
- Obesity, Exergames, Videogames, Prevention, Family, Dance Dance Revolution, Pedometer
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame (DDR)Behavioural
Use of an active videogame vs. pedometers given to entire families to promote physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Counseling | Experimental | Not described Receives: Behavioral: Exergame (DDR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of physical activity
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Investigators
- Ann Maloney, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889122
- Sponsor's protocol ID
- 3459
- Status last verified
- Jul 2010
- First submitted
- 27 Apr 2009
- Last updated
- 4 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Exergaming: A Research Study Testing a Videogame Intervention to Increase Physical Activity for Families
- ClinicalTrials.gov ID
- NCT00889122
- Acronym / sponsor ID
- 3459
- Conditions
- Obesity
- Keywords
- Obesity, Exergames, Videogames, Prevention, Family, Dance Dance Revolution, Pedometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Counseling | Experimental | Behavioral: Exergame (DDR) |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Serious heart condition
- Photo-sensitive seizures
- Previous extensive history using DDR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergame (DDR)Use of an active videogame vs. pedometers given to entire families to promote physical activity. | Behavioural | Lifestyle Counseling |
Primary outcome
Amount of physical activity
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2010.
- Family Exergaming web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Maloney, MD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame (DDR) in people with Obesity, run by MaineHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of physical activity (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2010.