IntelligenceA+PAACNCT01699295
Physical Activity and Academic Achievement Across the Curriculum (A+PAAC)
A study testing A+PAAC and CON in people with Intelligence and Obesity, run by Joseph Donnelly at 1 site in United States.
Trial summary
There is currently considerable interest in both improving academic achievement (No Child Left Behind) and reducing the rates of obesity and its associated negative health consequences in elementary school students. Increased physical activity (PA) offers a potential intervention to address both issues. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Intelligence, Obesity
- What is being tested?
- A+PAAC and CON
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jun 2015
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Grade 2 or 3 Student at one of the randomly selected elementary schools
- Students that agree to complete assessments
- Signed parental consent form
- Signed child assent form
Who cannot join
- Students that do not agree to complete assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
There is currently considerable interest in both improving academic achievement (No Child Left Behind) and reducing the rates of obesity and its associated negative health consequences in elementary school students. Increased physical activity (PA) offers a potential intervention to address both issues. Evidence is available which suggests an association of PA with both academic achievement and obesity, and an association between obesity and academic achievement.
To provide increased PA while maintaining academic instruction time, we developed a program we call "Physical Activity Across the Curriculum" (PAAC) in which regular classroom teachers were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA) for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between students in elementary schools that participate in academic lessons taught through MVPA (PAAC) to students that do not (CON).
- Conditions
- Intelligence, Obesity
- Being tested
- A+PAAC, CON
- Keywords
- academic achievement, elementary school, physical activity, exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A+PAACBehavioural
academic lessons delivered by regular classroom teachers using moderate to vigorous physical activity (MVPA) for 20 minutes/day, 5 days/week.
CONBehavioural
lessons taught by regular classroom teachers using traditional/regular sedentary lessons
| Study group | Role | What they receive |
|---|---|---|
| A+PAAC | Experimental | Lessons delivered using A+PAAC Receives: Behavioral: A+PAAC |
| CON | Active comparator | Regular sedentary lessons Receives: Behavioral: CON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Academic Achievement in Elementary Students
Changes in academic achievement between students in elementary schools that participate in a program that delivers academic lessons taught through MVPA (A+PAAC) to students in elementary schools that do not receive academic lessons taught through MVPA (CON)
Measured: Baseline to 3 Years
Secondary outcomes (4)
Assessment of Cognitive Function
Changes in attentional control and academic achievement
Measured: Baseline to 3 Years
Body Mass Index (BMI)
Change in the BMI over course of the study.
Measured: Baseline to 3 Years
Cardiovascular (CV) Fitness and Daily Physical Activity (PA)
Changes in CV Fitness and PA and its impact on cognitive control of attention and academic achievement
Measured: Baseline to 3 Years
Change in Attention-to-Task
Measured: Baseline to 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startSep 2011
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for IntelligenceStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Donnelly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph Donnelly, University of Kansas Medical Center
- Investigators
- Joseph Donnelly, EDD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699295
- Sponsor's protocol ID
- 13460
- Acronym
- A+PAAC
- Status last verified
- Jan 2016
- First submitted
- 1 Oct 2012
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Honas JJ, Willis EA, Herrmann SD, Greene JL, Washburn RA, Donnelly JE. Energy Expenditure and Intensity of Classroom Physical Activity in Elementary School Children. J Phys Act Health. 2016 Jun;13(6 Suppl 1):S53-6. doi: 10.1123/jpah.2015-0717.
PubMed 27392380Willis EA, Ptomey LT, Szabo-Reed AN, Honas JJ, Lee J, Washburn RA, Donnelly JE. Length of moderate-to-vigorous physical activity bouts and cardio-metabolic risk factors in elementary school children. Prev Med. 2015 Apr;73:76-80. doi: 10.1016/j.ypmed.2015.01.022. Epub 2015 Jan 31.
PubMed 25647532Hansen DM, Herrmann SD, Lambourne K, Lee J, Donnelly JE. Linear/nonlinear relations of activity and fitness with children's academic achievement. Med Sci Sports Exerc. 2014 Dec;46(12):2279-85. doi: 10.1249/MSS.0000000000000362.
PubMed 24781896Donnelly JE, Greene JL, Gibson CA, Sullivan DK, Hansen DM, Hillman CH, Poggio J, Mayo MS, Smith BK, Lambourne K, Herrmann SD, Scudder M, Betts JL, Honas JJ, Washburn RA. Physical activity and academic achievement across the curriculum (A + PAAC): rationale and design of a 3-year, cluster-randomized trial. BMC Public Health. 2013 Apr 8;13:307. doi: 10.1186/1471-2458-13-307.
PubMed 23565969
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Academic Achievement Across the Curriculum (A+PAAC)
- ClinicalTrials.gov ID
- NCT01699295
- Acronym / sponsor ID
- A+PAAC / 13460
- Conditions
- Intelligence, Obesity
- Keywords
- academic achievement, elementary school, physical activity, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Joseph DonnellyUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Oct 2012 (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.
There is currently considerable interest in both improving academic achievement (No Child Left Behind) and reducing the rates of obesity and its associated negative health consequences in elementary school students. Increased physical activity (PA) offers a potential intervention to address both issues. Evidence is available which suggests an association of PA with both academic achievement and obesity, and an association between obesity and academic achievement.
To provide increased PA while maintaining academic instruction time, we developed a program we call "Physical Activity Across the Curriculum" (PAAC) in which regular classroom teachers were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA) for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between students in elementary schools that participate in academic lessons taught through MVPA (PAAC) to students that do not (CON).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A+PAAC | Experimental | Behavioral: A+PAACLessons delivered using A+PAAC |
| CON | Active comparator | Behavioral: CONRegular sedentary lessons |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Grade 2 or 3 Student at one of the randomly selected elementary schools
- Students that agree to complete assessments
- Signed parental consent form
- Signed child assent form
Key exclusion criteria (1 listed)
- Students that do not agree to complete assessments
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 |
|---|---|---|
| A+PAACacademic lessons delivered by regular classroom teachers using moderate to vigorous physical activity (MVPA) for 20 minutes/day, 5 days/week. | Behavioural | A+PAAC |
| CONlessons taught by regular classroom teachers using traditional/regular sedentary lessons | Behavioural | CON |
Primary outcome
Changes in Academic Achievement in Elementary Students
Time frame: Baseline to 3 Years
Changes in academic achievement between students in elementary schools that participate in a program that delivers academic lessons taught through MVPA (A+PAAC) to students in elementary schools that do not receive academic lessons taught through MVPA (CON)
4 secondary outcomes
Assessment of Cognitive Function
Time frame: Baseline to 3 Years
Body Mass Index (BMI)
Time frame: Baseline to 3 Years
Cardiovascular (CV) Fitness and Daily Physical Activity (PA)
Time frame: Baseline to 3 Years
Change in Attention-to-Task
Time frame: Baseline to 3 Years
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 12 Jan 2016.
- Derived from this study: PubMed 27392380Honas JJ, Willis EA, Herrmann SD, Greene JL, Washburn RA, Donnelly JE. Energy Expenditure and Intensity of Classroom Physical Activity in Elementary School Children. J Phys Act Health. 2016 Jun;13(6 Suppl 1):S53-6. doi: 10.1123/jpah.2015-0717.
- Derived from this study: PubMed 25647532Willis EA, Ptomey LT, Szabo-Reed AN, Honas JJ, Lee J, Washburn RA, Donnelly JE. Length of moderate-to-vigorous physical activity bouts and cardio-metabolic risk factors in elementary school children. Prev Med. 2015 Apr;73:76-80. doi: 10.1016/j.ypmed.2015.01.022. Epub 2015 Jan 31.
- Derived from this study: PubMed 24781896Hansen DM, Herrmann SD, Lambourne K, Lee J, Donnelly JE. Linear/nonlinear relations of activity and fitness with children's academic achievement. Med Sci Sports Exerc. 2014 Dec;46(12):2279-85. doi: 10.1249/MSS.0000000000000362.
- Derived from this study: PubMed 23565969Donnelly JE, Greene JL, Gibson CA, Sullivan DK, Hansen DM, Hillman CH, Poggio J, Mayo MS, Smith BK, Lambourne K, Herrmann SD, Scudder M, Betts JL, Honas JJ, Washburn RA. Physical activity and academic achievement across the curriculum (A + PAAC): rationale and design of a 3-year, cluster-randomized trial. BMC Public Health. 2013 Apr 8;13:307. doi: 10.1186/1471-2458-13-307.
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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.
Joseph Donnelly, EDD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A+PAAC and CON in people with Intelligence and Obesity, run by Joseph Donnelly 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 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 12 Jan 2016. 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?
Changes in Academic Achievement in Elementary Students (time frame: Baseline to 3 Years). 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 NCT01699295, which also lists 4 linked publications.
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 12 Jan 2016.