- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03256188
Interrupting Prolonged Sitting With Activity (InPACT)
Interrupting Prolonged Sitting With Activity Feasibility Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- Childhood Disparities Research Laboratory
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 3rd thru 6th grade students in participating InPACT classrooms
Exclusion Criteria:
- N/A
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Active classroom
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.
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30 minutes of moderate-to-vigorous physical activity
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Moderate-to-vigorous physical activity (student)
Lasso di tempo: 16 weeks
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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.
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16 weeks
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Moderate-to-vigorous physical activity (teacher)
Lasso di tempo: 16 weeks
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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.
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16 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Transition time
Lasso di tempo: 16 weeks
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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.
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16 weeks
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Time-on-task
Lasso di tempo: 16 weeks
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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.
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16 weeks
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Physical activity enjoyment
Lasso di tempo: 16 weeks
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Teachers distributed the revised Physical Activity Enjoyment Scale (PACES) to their students to assess enjoyment of participating in the activity breaks.
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16 weeks
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Physical activity confidence
Lasso di tempo: 16 weeks
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Teachers distributed a single-item question from the Physical Activity Self-Efficacy Scale (PASES) to measure physical activity confidence.
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16 weeks
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Physical activity heart rate
Lasso di tempo: 16 weeks
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Heart rate during physical activity breaks in the classroom was assessed via heart rate monitoring.
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16 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Rebecca E Hasson, PhD, University of Michigan
Studiare le date dei record
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- HUM00117049
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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