- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04675658
Stay Active Physical Activity Program
Stay Active Physical Activity Program for Teachers, Students, and Families
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Classrooms
- Teacher of a 4th or 5th grade class in the Kansas City area.
- English speaking only
Students
- Any student in the selected classrooms
- A parent or guardian of the student
- English speaking only
Exclusion Criteria:
- Does not meet the required criteria above.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Classroom Intervention
Physical activity support is provided by integrating daily structured activities in the classroom delivered by physical activity leaders through a video conferencing platform in partnership with the classroom teacher. Activities last about 10 minutes or less and have the flexibility of being integrated with academic lessons or serving as a break from academics. The activities are simple and get kids moving in place. The activities will be delivered by a research staff member via video conferencing (using the schools preferred platform). A combination of live activities led by the research team and pre-recorded videos will be used (see example below). If live videos do not work for the teacher, they will have the option to only use the pre-recorded videos or receive a list of resources to promote CBPA in their classrooms. |
Classroom Based Physical Activity
|
|
Eksperimentel: Classroom Intervention plus family support
Same components as the Classroom Intervention Arm plus the following: Family Component: A newsletter will be sent to parents or guardians once every two weeks over the semester and posted on the study website. The newsletters include physical activity information related to safety/protection, skills building, motivation, overcoming barriers, and goal setting and monitoring (all newsletters are included as an appendix). As part of the program, children also receive a Garmin wearable physical activity monitor. Parents or guardians will receive text messages with behavior change messages based on the Garmin data (text message content is included as an appendix). Text messages also contain links to website materials. Texts will be sent out using the Twilio platform. |
Classroom Based Physical Activity + family support as described in the Arm
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Daily minutes of PA (physical activity)
Tidsramme: 3 months
|
Measured by Garmin device
|
3 months
|
|
Daily step count
Tidsramme: 3 months
|
Measured by Garmin device
|
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Parent perceptions of interventions
Tidsramme: 3 months
|
Measured via satisfaction surveys
|
3 months
|
|
Teacher perceptions of interventions
Tidsramme: 3 months
|
Measured via satisfaction interviews
|
3 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jordan Carlson, PhD, Research Faculty
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- STUDY00001495
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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