Physical ActivityInPACTNCT03256188
Interrupting Prolonged Sitting With Activity
A study testing Active classroom in people with Physical Activity, run by University of Michigan at 1 site in United States.
Trial summary
This study tested the feasibility of interrupting prolonged sitting with 10, 3-minute activity breaks in elementary school classrooms. Three elementary schools in Southeast Michigan (20 teachers, 500 students) participated in this study. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Active classroom
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2016to 31 Dec 2016
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3rd thru 6th grade students in participating InPACT classrooms
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Childhood Disparities Research Laboratory
Ann Arbor, Michigan, 48109
About this study
Official title: Interrupting Prolonged Sitting With Activity Feasibility Study
This study tested the feasibility of interrupting prolonged sitting with 10, 3-minute activity breaks in elementary school classrooms. Three elementary schools in Southeast Michigan (20 teachers, 500 students) participated in this study.
Read the detailed description
School environments have historically provided many opportunities for children to be physically active through comprehensive programs, including recess, intramural physical activity clubs, interscholastic sports and physical education. However, with recent cuts to public school funding and an increased emphasis on standardized test scores, schools districts across the country have reduced time allocated for structured physical activity in favor of additional academic instruction time. This is troubling as uninterrupted prolonged sitting time is associated with increased disruptive behavior, lower academic achievement and increased obesity risk in children. As such, developing low-cost, innovative physical activity interventions aimed at improving weight outcomes and cognitive function in children are warranted.
Researchers have targeted the school classroom, where students spend the majority of their time, as a potential intervention site. Classroom-based physical activity interventions have been largely successful at increasing physical activity, improving physical fitness and academic achievement among children. Yet, no intervention to date has been able to produce significant improvements in weight status, in part due to the intensity, duration and frequency of activities employed (i.e., low-to-moderate intensity; 10-30 minutes per session; 1-2 sessions per day). Preliminary evidence from our laboratory suggests intermittent activity breaks performed at a moderate-to-vigorous intensity elicits greater total daily physical activity energy expenditure without subsequent increases in food intake compared to lower intensity activities. Other researchers have confirmed greater reductions in weight and fat mass in response to higher rather than lower intensity physical activities. In addition, short bursts of activity rather than continuous movements more closely mimics children's natural activity patterns in free-living environments. Hence, incorporating intermittent activity breaks of moderate-to-vigorous intensity as an intervention component may increase the likelihood of classroom-based physical activity interventions improving weight outcomes in children.
Implementing intermittent activity breaks in a classroom will require adjustments to both teaching curricula and classroom design. Current teaching curricula promotes sedentary behaviors by requiring children to spend between 6 and 8 hours in seated academic instruction per day. Moreover, current classroom designs (i.e., size of the classroom and interior areas, type of furniture, flooring and room arrangement) optimize student learning and classroom management with little consideration given to physical activity and movement. Yet, simple adjustments to teaching curricula (i.e. coupling physical activity with teacher's existing lessons) and classroom design (e.g. using smart floor planning to restructure spaces in a classroom) can dramatically increase movement and subsequent learning within that space. In partnership with the School of Education and the Taubman College of Architecture \& Urban Planning, two traditionally non-health related fields, the overall objectives of this pilot study are to: 1) develop a classroom curriculum and floor plan that promotes movement, learning and positive behavioral outcomes; and 2) test the feasibility of implementing our classroom-based physical activity intervention (Interrupting Prolonged sitting with ACTivity or INPACT) in three elementary schools (20 classrooms) across the state of Michigan. Third thru fifth grade teachers and students from Columbia Elementary, Estabrook Elementary and Anderson Elementary will be recruited to participate in this pilot study with classroom teachers delivering the physical activity intervention.
- Conditions
- Physical Activity
- Being tested
- Active classroom
- Keywords
- classroom, prolonged sitting, sedentary time, time-on-task, children
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active classroomBehavioural
Also called InPACT classroom
30 minutes of moderate-to-vigorous physical activity
| Study group | Role | What they receive |
|---|---|---|
| Active classroom | Experimental | Twenty elementary school teachers implemented 10, 3-minute moderate-to-vigorous physical activity breaks (50-75% of heart rate maximum), 5 days per week in their classrooms over a 16-week period. Receives: Behavioral: Active classroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate-to-vigorous physical activity (student)
Direct observation via the System for Observing Play and Leisure Activity in Youth (SOPLAY) was used to assess student physical activity intensity and physical activity minutes completed in the classroom.
Measured: 16 weeks
Moderate-to-vigorous physical activity (teacher)
Direct observation via the System for Observing Play and Leisure Activity in Youth (SOPLAY) was used to assess teacher physical activity intensity and physical activity minutes completed in the classroom.
Measured: 16 weeks
Secondary outcomes (5)
Transition time
Transition time was assessed via direct observation and was calculated as the amount of time from when the teacher completed instructions to his/her class to prepare for an activity break to when students started engaging in the activity break.
Measured: 16 weeks
Time-on-task
Time-on-task was assessed via direct observation and was calculated as the percent of students following the directions of the teacher 30 seconds post activity break.
Measured: 16 weeks
Physical activity enjoyment
Teachers distributed the revised Physical Activity Enjoyment Scale (PACES) to their students to assess enjoyment of participating in the activity breaks.
Measured: 16 weeks
Physical activity confidence
Teachers distributed a single-item question from the Physical Activity Self-Efficacy Scale (PASES) to measure physical activity confidence.
Measured: 16 weeks
Physical activity heart rate
Heart rate during physical activity breaks in the classroom was assessed via heart rate monitoring.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start15 Aug 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Hasson, University of Michigan
- Investigators
- Rebecca E Hasson, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256188
- Sponsor's protocol ID
- HUM00117049
- Acronym
- InPACT
- Status last verified
- Aug 2017
- First submitted
- 15 Aug 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrupting Prolonged Sitting With Activity Feasibility Study
- ClinicalTrials.gov ID
- NCT03256188
- Acronym / sponsor ID
- InPACT / HUM00117049
- Conditions
- Physical Activity
- Keywords
- classroom, prolonged sitting, sedentary time, time-on-task, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 21 Aug 2017 (actual)
- 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 study tested the feasibility of interrupting prolonged sitting with 10, 3-minute activity breaks in elementary school classrooms. Three elementary schools in Southeast Michigan (20 teachers, 500 students) participated in this study.
Detailed description
School environments have historically provided many opportunities for children to be physically active through comprehensive programs, including recess, intramural physical activity clubs, interscholastic sports and physical education. However, with recent cuts to public school funding and an increased emphasis on standardized test scores, schools districts across the country have reduced time allocated for structured physical activity in favor of additional academic instruction time. This is troubling as uninterrupted prolonged sitting time is associated with increased disruptive behavior, lower academic achievement and increased obesity risk in children. As such, developing low-cost, innovative physical activity interventions aimed at improving weight outcomes and cognitive function in children are warranted.
Researchers have targeted the school classroom, where students spend the majority of their time, as a potential intervention site. Classroom-based physical activity interventions have been largely successful at increasing physical activity, improving physical fitness and academic achievement among children. Yet, no intervention to date has been able to produce significant improvements in weight status, in part due to the intensity, duration and frequency of activities employed (i.e., low-to-moderate intensity; 10-30 minutes per session; 1-2 sessions per day). Preliminary evidence from our laboratory suggests intermittent activity breaks performed at a moderate-to-vigorous intensity elicits greater total daily physical activity energy expenditure without subsequent increases in food intake compared to lower intensity activities. Other researchers have confirmed greater reductions in weight and fat mass in response to higher rather than lower intensity physical activities. In addition, short bursts of activity rather than continuous movements more closely mimics children's natural activity patterns in free-living environments. Hence, incorporating intermittent activity breaks of moderate-to-vigorous intensity as an intervention component may increase the likelihood of classroom-based physical activity interventions improving weight outcomes in children.
Implementing intermittent activity breaks in a classroom will require adjustments to both teaching curricula and classroom design. Current teaching curricula promotes sedentary behaviors by requiring children to spend between 6 and 8 hours in seated academic instruction per day. Moreover, current classroom designs (i.e., size of the classroom and interior areas, type of furniture, flooring and room arrangement) optimize student learning and classroom management with little consideration given to physical activity and movement. Yet, simple adjustments to teaching curricula (i.e. coupling physical activity with teacher's existing lessons) and classroom design (e.g. using smart floor planning to restructure spaces in a classroom) can dramatically increase movement and subsequent learning within that space. In partnership with the School of Education and the Taubman College of Architecture \& Urban Planning, two traditionally non-health related fields, the overall objectives of this pilot study are to: 1) develop a classroom curriculum and floor plan that promotes movement, learning and positive behavioral outcomes; and 2) test the feasibility of implementing our classroom-based physical activity intervention (Interrupting Prolonged sitting with ACTivity or INPACT) in three elementary schools (20 classrooms) across the state of Michigan. Third thru fifth grade teachers and students from Columbia Elementary, Estabrook Elementary and Anderson Elementary will be recruited to participate in this pilot study with classroom teachers delivering the physical activity intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active classroom | Experimental | Behavioral: Active classroomTwenty elementary school teachers implemented 10, 3-minute moderate-to-vigorous physical activity breaks (50-75% of heart rate maximum), 5 days per week in their classrooms over a 16-week period. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 3rd thru 6th grade students in participating InPACT classrooms
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Active classroomAlso: InPACT classroom30 minutes of moderate-to-vigorous physical activity | Behavioural | Active classroom |
Primary outcome
Moderate-to-vigorous physical activity (student)
Time frame: 16 weeks
Direct observation via the System for Observing Play and Leisure Activity in Youth (SOPLAY) was used to assess student physical activity intensity and physical activity minutes completed in the classroom.
Moderate-to-vigorous physical activity (teacher)
Time frame: 16 weeks
Direct observation via the System for Observing Play and Leisure Activity in Youth (SOPLAY) was used to assess teacher physical activity intensity and physical activity minutes completed in the classroom.
5 secondary outcomes
Transition time
Time frame: 16 weeks
Time-on-task
Time frame: 16 weeks
Physical activity enjoyment
Time frame: 16 weeks
Physical activity confidence
Time frame: 16 weeks
Physical activity heart rate
Time frame: 16 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 21 Aug 2017.
- Individual participant dataSharing planned: No
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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 E Hasson, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active classroom in people with Physical Activity, run by University of Michigan 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 21 Aug 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?
Moderate-to-vigorous physical activity (student) (time frame: 16 weeks). 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 21 Aug 2017.