ObesityNCT02411552
Systematic Initiative to Increase Activity in Schools
An observational study of Obesity and Cardiovascular Fitness, run by University of Wisconsin, Madison.
Trial summary
This initiative is a prospective study evaluating the effects of implementing physical activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Fitness
- What is being tested?
- physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,894 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to May 2014
- Phase
- Observational
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Wisconsin schools with low socio-economic status (grades 3-8)
Who may be able to join
- all children between 3rd and 8th grade
Who cannot join
- children who could not perform PACER (exercise)
About this study
This initiative is a prospective study evaluating the effects of implementing physical activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness.
Read the detailed description
This initiative is a prospective study evaluating the effects of implementing physical activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness. Forty-nine schools participated in the study providing de-identified fitness data for students for 3 consecutive years. Twenty-five schools initiated physical activity interventions in year one and 24 schools initiating physical activity interventions in year two.
- Conditions
- Obesity, Cardiovascular Fitness
- Being tested
- physical activity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityBehavioural
4 strategies are: (1) increased activity time during physical education class, (2) active recess, (3) opportunities for activity before and after school, and (4) active classroom breaks
| Study group | Role | What they receive |
|---|---|---|
| Intervention schools | These schools were promoting 4 strategies to increase physical activity in students. Receives: Behavioral: physical activity | |
| Control schools | These schools continued with standard programming for activity during year 1, and implemented intervention during years 2 and 3. Receives: Behavioral: physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
PACER fitness test
PACER is a 20 meter shuttle run in PE class
Measured: performed every 6 months each school year for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startSep 2011
- Primary completionMay 2014
- Study completionMay 2014
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.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,894 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Wisconsin Department of Public Instruction
- Responsible party
- Sponsor
- Investigators
- Aaron L Carrel, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411552
- Sponsor's protocol ID
- Wisconsin Active Schools
- Status last verified
- Apr 2015
- First submitted
- 31 Mar 2015
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Initiative to Increase Activity in Schools
- ClinicalTrials.gov ID
- NCT02411552
- Acronym / sponsor ID
- Wisconsin Active Schools
- Conditions
- Obesity, Cardiovascular Fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,894 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Wisconsin Department of Public Instruction
- Study start
- Sep 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Apr 2015 (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.
This initiative is a prospective study evaluating the effects of implementing physical activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness.
Detailed description
This initiative is a prospective study evaluating the effects of implementing physical activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness. Forty-nine schools participated in the study providing de-identified fitness data for students for 3 consecutive years. Twenty-five schools initiated physical activity interventions in year one and 24 schools initiating physical activity interventions in year two.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention schools | – | Behavioral: physical activityThese schools were promoting 4 strategies to increase physical activity in students. |
| Control schools | – | Behavioral: physical activityThese schools continued with standard programming for activity during year 1, and implemented intervention during years 2 and 3. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Wisconsin schools with low socio-economic status (grades 3-8)
Key inclusion criteria (1 listed)
- all children between 3rd and 8th grade
Key exclusion criteria (1 listed)
- children who could not perform PACER (exercise)
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 activity4 strategies are: (1) increased activity time during physical education class, (2) active recess, (3) opportunities for activity before and after school, and (4) active classroom breaks | Behavioural | Control schools, Intervention schools |
Primary outcome
PACER fitness test
Time frame: performed every 6 months each school year for 3 years
PACER is a 20 meter shuttle run in PE class
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 8 Apr 2015.
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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.
Aaron L Carrel principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Cardiovascular Fitness, run by University of Wisconsin, Madison.
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 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
PACER fitness test (time frame: performed every 6 months each school year for 3 years). 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 8 Apr 2015.