Childhood ObesityNCT02087774
Brief Physical Activity Program to Increase Physical Fitness in Elementary School Children
A study testing 6 minutes activity in people with Childhood Obesity, run by Marshall University at 1 site in United States.
Trial summary
The investigators hypothesized that the addition of 6 minutes of exercise during the school day would increase physical fitness in elementary school students as demonstrated by longer distances run in 2 minutes and a decrease in heart rate at the end of the exercise. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- 6 minutes activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All students were invited to participate.
Who cannot join
- Lack of parental consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Marshall University
Huntington, West Virginia, 25755
About this study
Official title: The Effects of a Brief Physical Activity Program on Elementary School Students' Physical Fitness
The investigators hypothesized that the addition of 6 minutes of exercise during the school day would increase physical fitness in elementary school students as demonstrated by longer distances run in 2 minutes and a decrease in heart rate at the end of the exercise.
Read the detailed description
Intervention group played music for 6 minutes each morning in addition to recess and physical activity classes. Baseline fitness data and after-intervention data were compared.
- Conditions
- Childhood Obesity
- Being tested
- 6 minutes activity
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minutes activityBehavioural
Group added 6 minutes of physical activity daily during school day.
| Study group | Role | What they receive |
|---|---|---|
| Control School | No intervention | Control School received no intervention. |
| 6 minutes activity | Experimental | Implementation of 6 minutes of physical activity daily into the school day routine. Children can jog in place, do jumping jacks or dance. Receives: Behavioral: 6 minutes activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to After Intervention in 75 Foot Laps Completed in 2 Minutes
Subjects run for 2 minutes around cone separated by 75ft. One lap was one 75 foot length completed.
Difference in laps completed from baseline was taken.
Measured: Baseline to 12 weeks later
Change From Baseline to After Intervention for After-Exercise Heart Rate
Immediate cool-down, after-exercise heart rate was taken.
Difference in heart rate from baseline measurements is reported
Measured: Baseline to 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Hayes, Marshall University
- Investigators
- Rebecca H Hayes, M.D., Principal investigator, Marshall University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087774
- Sponsor's protocol ID
- 498505-2
- Status last verified
- Jul 2014
- First submitted
- 12 Mar 2014
- Last updated
- 15 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Brief Physical Activity Program on Elementary School Students' Physical Fitness
- ClinicalTrials.gov ID
- NCT02087774
- Acronym / sponsor ID
- 498505-2
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesized that the addition of 6 minutes of exercise during the school day would increase physical fitness in elementary school students as demonstrated by longer distances run in 2 minutes and a decrease in heart rate at the end of the exercise.
Detailed description
Intervention group played music for 6 minutes each morning in addition to recess and physical activity classes. Baseline fitness data and after-intervention data were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control School | No intervention | –Control School received no intervention. |
| 6 minutes activity | Experimental | Behavioral: 6 minutes activityImplementation of 6 minutes of physical activity daily into the school day routine. Children can jog in place, do jumping jacks or dance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All students were invited to participate.
Key exclusion criteria (1 listed)
- Lack of parental consent
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 |
|---|---|---|
| 6 minutes activityGroup added 6 minutes of physical activity daily during school day. | Behavioural | 6 minutes activity |
Primary outcome
Change From Baseline to After Intervention in 75 Foot Laps Completed in 2 Minutes
Time frame: Baseline to 12 weeks later
Subjects run for 2 minutes around cone separated by 75ft. One lap was one 75 foot length completed. Difference in laps completed from baseline was taken.
Change From Baseline to After Intervention for After-Exercise Heart Rate
Time frame: Baseline to 12 weeks later
Immediate cool-down, after-exercise heart rate was taken. Difference in heart rate from baseline measurements is reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Rebecca H Hayes, M.D. principal investigator
Marshall University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 minutes activity in people with Childhood Obesity, run by Marshall University 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 15 Aug 2014. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to After Intervention in 75 Foot Laps Completed in 2 Minutes (time frame: Baseline to 12 weeks later). The study lists 2 primary outcomes in all. 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 15 Aug 2014.