ObesityNCT00424918
"Generation Fit and Exerlearning With In the Groove"
A study testing Physical Activity, reduced sedentary behavior in people with Obesity, run by MaineHealth at 1 site in United States.
Trial summary
In middle schools participating in a statewide program called "Take Time", we are randomizing youth to a 10-12 week intervention using the dance mat games on the Playstation2 (like Dance Dance Revolution). This program is testing feasibility of using the dance mats as a way to increase activity during the school day. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Physical Activity, reduced sedentary behavior
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2009
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Take Time middle school in Maine with consent/assent
Who cannot join
- Any condition that prevents a child from doing physical activity on the dance mat like photic seizures, broken leg, blindness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Generation-Fit, a Pilot Study of Youth in Maine Middle Schools Using an "Exerlearning" Dance Video Game to Promote Physical Activity During School
In middle schools participating in a statewide program called "Take Time", we are randomizing youth to a 10-12 week intervention using the dance mat games on the Playstation2 (like Dance Dance Revolution). This program is testing feasibility of using the dance mats as a way to increase activity during the school day. We are using "Groove Masters" as a peer-mentored mechanism to keep track of the activity of youth in the intervention compared to the control group. Our main objective is increase in activity time.
Read the detailed description
We met with administrators and teachers and obtained consent and assent for this study. After assessing baseline measures (end-of-grade test scores, absenteeism, Pediatric Quality of Life, physical fitness, GEMS Activity Rating Scale, Dennison's measure of sedentary screen time, Physical Activity Enjoyment Scale, BMI%ile, (with a small subset assayed for fasting lipids and glucose, with a smaller subset wearing ActiGraphs for objective measures of activity) we randomized to the intervention or control group.
In our intervention, youth play a dance game at school called "In the Groove", with the goal of 40 additional minutes each week of physical activity during the school hours.
We will obtain change scores and compare the groups to find an effect size for future studies, this this proves acceptable and feasible in Maine schools.
- Conditions
- Obesity
- Being tested
- Physical Activity, reduced sedentary behavior
- Keywords
- Dance, Peers, middle school-based, feasibility
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity, reduced sedentary behaviorBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes of activity added in school day.
Secondary outcomes (5)
Quality of Life change scores
Relation to test scores, absenteeism
Fitness change scores
Change in biological endpoints
Others
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startSep 2006
- Primary completionSep 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Investigators
- Ann E Maloney, MD, Principal investigator, Research Attending
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424918
- Sponsor's protocol ID
- MMCRI-3000
- Status last verified
- May 2017
- First submitted
- 18 Jan 2007
- Last updated
- 18 May 2017
- Results posted
- No
Publications
Lanningham-Foster L, Jensen TB, Foster RC, Redmond AB, Walker BA, Heinz D, Levine JA. Energy expenditure of sedentary screen time compared with active screen time for children. Pediatrics. 2006 Dec;118(6):e1831-5. doi: 10.1542/peds.2006-1087.
PubMed 17142504
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation-Fit, a Pilot Study of Youth in Maine Middle Schools Using an "Exerlearning" Dance Video Game to Promote Physical Activity During School
- ClinicalTrials.gov ID
- NCT00424918
- Acronym / sponsor ID
- MMCRI-3000
- Conditions
- Obesity
- Keywords
- Dance, Peers, middle school-based, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Study start
- Sep 2006 (actual)
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Jan 2007 (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.
In middle schools participating in a statewide program called "Take Time", we are randomizing youth to a 10-12 week intervention using the dance mat games on the Playstation2 (like Dance Dance Revolution). This program is testing feasibility of using the dance mats as a way to increase activity during the school day. We are using "Groove Masters" as a peer-mentored mechanism to keep track of the activity of youth in the intervention compared to the control group. Our main objective is increase in activity time.
Detailed description
We met with administrators and teachers and obtained consent and assent for this study. After assessing baseline measures (end-of-grade test scores, absenteeism, Pediatric Quality of Life, physical fitness, GEMS Activity Rating Scale, Dennison's measure of sedentary screen time, Physical Activity Enjoyment Scale, BMI%ile, (with a small subset assayed for fasting lipids and glucose, with a smaller subset wearing ActiGraphs for objective measures of activity) we randomized to the intervention or control group.
In our intervention, youth play a dance game at school called "In the Groove", with the goal of 40 additional minutes each week of physical activity during the school hours.
We will obtain change scores and compare the groups to find an effect size for future studies, this this proves acceptable and feasible in Maine schools.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Take Time middle school in Maine with consent/assent
Key exclusion criteria (1 listed)
- Any condition that prevents a child from doing physical activity on the dance mat like photic seizures, broken leg, blindness.
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 |
|---|---|---|
| Physical Activity, reduced sedentary behavior | Behavioural | – |
Primary outcome
Minutes of activity added in school day.
5 secondary outcomes
Quality of Life change scores
Relation to test scores, absenteeism
Fitness change scores
Change in biological endpoints
Others
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 18 May 2017.
- Background: PubMed 17142504Lanningham-Foster L, Jensen TB, Foster RC, Redmond AB, Walker BA, Heinz D, Levine JA. Energy expenditure of sedentary screen time compared with active screen time for children. Pediatrics. 2006 Dec;118(6):e1831-5. doi: 10.1542/peds.2006-1087.
- Take TimeLink 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 E Maloney, MD principal investigator
Research Attending
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity, reduced sedentary behavior 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 1 inclusion and 1 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 18 May 2017. 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?
Minutes of activity added in school day.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00424918, which also lists 1 linked publication.
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 18 May 2017.