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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT03256188
Study groupRoleWhat they receive
Active classroomExperimentalTwenty 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted21 Aug 2017
  2. Study start15 Aug 2016
  3. Primary completion31 Dec 2016
  4. Study completion31 Dec 2016

Resources

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)
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

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.

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