- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02810834
Understanding the Impact of School-Based Physical Activity Programs
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The FLEX Study is a three-year, randomized control trial that seeks to understand how two different innovative school-based physical activity (PA) programs influence not only children's time spent in MVPA but also their cognitive and academic outcomes. The FLEX Study will be implemented and evaluated by researchers from Tufts University. The project is funded by the National Institutes of Health.
Schools participating in the study will be randomly assigned to receive a walking/running program, a classroom physical activity program, or no program (control) during first year and a half of the study. Third and fourth grade children will be enrolled in the study.
Physical activity will be assessed objectively using accelerometry. Additional measurements will include: BMI/BMI-z (measured height and weight), diet and physical activity questionnaires, cognitive functioning (tests of working memory and inhibitory control).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02111
- Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy, Tufts University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Children participants 3rd or 4th grade student in participating school (during first school year of study)
Exclusion Criteria:
Not a 3rd or 4th grade student
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Walking/Running Program
Walking/running/jogging program; school-based.
|
Participants will receive a behavioral intervention that consists of a school-based, walking/running/jogging program. Participants work to accumulate miles towards a goal of at least 100 miles, over the course of the school year. Program will be implemented through a "champion" in the school and structured/scheduled according to the schools resources (before, during, or after school). Miles are tracked at the school level, and incentives are provided for participants' completion of set milestones (25, 50, 75, and 100 miles). The intervention will run over two school years (approximately 16 months)
Andre navne:
|
|
Eksperimentel: Classroom activity break program
Classroom physical activity break program; school-based.
|
Participants will receive a behavioral intervention that consists of a classroom-based, physical activity break program. Classroom teachers, paraprofessionals, and other school staff will lead short (5-15 minute) activity breaks that include both higher intensity (ex. jumping jacks, squats) and low-intensity (ex. stretching, yoga) activities. Classrooms will be encouraged to integrate at least one short break per day. Activities are connected to national Common Core academic standards so that breaks can be integrated with academics. The intervention will run over two school years (approximately 16 months)
Andre navne:
|
|
Ingen indgriben: Control
Control/Delayed Intervention
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
School-time and total daily MVPA
Tidsramme: 5 months and 1.5 years
|
Changes in minutes of school-time and total daily moderate-to-vigorous physical activity (MVPA) among third-fifth graders participating in innovative school-based physical activity programs, compared to controls
|
5 months and 1.5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cognitive performance
Tidsramme: 5 months and 1.5 years
|
Changes in cognitive performance, as measured by standard tests of executive function, among third-fifth graders participating in innovative
|
5 months and 1.5 years
|
|
Academic achievement
Tidsramme: 5 months and 1.5 years
|
Changes in academic achievement, as measured by standardized tests (English language art and math), among third-fifth graders participating in innovative
|
5 months and 1.5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jennifer M Sacheck, PhD, Tufts University
Publikationer og nyttige links
Generelle publikationer
- Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
- Sacheck JM, Wright CM, Amin SA, Anzman-Frasca S, Chomitz VM, Chui KK, Duquesnay PJ, Nelson ME, Economos CD. The Fueling Learning Through Exercise Study Cluster RCT: Impact on Children's Moderate-to-Vigorous Physical Activity. Am J Prev Med. 2021 Jun;60(6):e239-e249. doi: 10.1016/j.amepre.2021.01.002. Epub 2021 Mar 26.
- Wright CM, Chomitz VR, Duquesnay PJ, Amin SA, Economos CD, Sacheck JM. The FLEX study school-based physical activity programs - measurement and evaluation of implementation. BMC Public Health. 2019 Jan 16;19(1):73. doi: 10.1186/s12889-018-6335-3.
- Amin SA, Duquesnay PJ, Wright CM, Chui K, Economos CD, Sacheck JM. The Association Between Perceived Athletic Competence and Physical Activity: Implications for Low-Income Schoolchildren. Pediatr Exerc Sci. 2018 Aug 1;30(3):433-440. doi: 10.1123/pes.2017-0242. Epub 2018 Mar 15.
- Wright CM, Duquesnay PJ, Anzman-Frasca S, Chomitz VR, Chui K, Economos CD, Langevin EG, Nelson ME, Sacheck JM. Study protocol: the Fueling Learning through Exercise (FLEX) study - a randomized controlled trial of the impact of school-based physical activity programs on children's physical activity, cognitive function, and academic achievement. BMC Public Health. 2016 Oct 13;16(1):1078. doi: 10.1186/s12889-016-3719-0.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
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
- R01HD080180 (U.S. NIH-bevilling/kontrakt)
- 1R01HD080180-01A1 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Fysisk aktivitet
-
NYU Langone HealthAfsluttetAttention Deficit Hyper ActivityForenede Stater
-
Texas Woman's UniversityAfsluttetIntellektuel handicap | Autismespektrumforstyrrelse | Motoriske lidelser | Motorforsinkelse | Sanseforstyrrelser | Attention Deficit Hyper Activity
-
University of ValenciaAfsluttetAutismespektrumforstyrrelse | Attention Deficit Hyper ActivitySpanien
-
Cingulate TherapeuticsPremier Research Group plcAfsluttetADHD | Attention Deficit Hyperactivity Disorder | ADHD - kombineret type | Attention Deficit Hyperactivity Disorder kombineret | Attention Deficit Hyper Activity | Opmærksomhedsunderskud hyperaktivitetForenede Stater
-
Cingulate TherapeuticsSuspenderetADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder med hyperaktivitet | ADHD - kombineret type | Attention Deficit Hyperactivity Disorder kombineret | Attention Deficit Hyper Activity | Opmærksomhedsunderskud hyperaktivitetForenede Stater
-
Affiliated Hospital to Academy of Military Medical...Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Peking...RekrutteringAldersinterval ≥16 år, køn ubegrænset | Histopatologi bekræftet diffust stort B-celle lymfom eller højgradigt B-celle lymfom | Modtaget tidligere førstelinjekemoterapi for DLBCL eller HGBL, kunne ikke nå CR i fire cyklusser eller tilbagefald | Mindst én positiv læsion ifølge 2014 Lugano-kriterierne... og andre forholdKina
Kliniske forsøg med Walking/Running program
-
St. Louis UniversityRekrutteringParkinsons sygdom | Parkinsons sygdom, idiopatiskForenede Stater
-
Oxford University Hospitals NHS TrustAfsluttetKnæ slidgigt | Hofteartrose | Knæarthroplastik | HofteproteserDet Forenede Kongerige
-
Cionic, Inc.RekrutteringMultipel sclerose | Multipel sklerose, kronisk progressiv | Multipel sklerose, recidiverende-remitterendeForenede Stater
-
Brian W. NoehrenU.S. Army Medical Research and Development CommandAfsluttetLårbensbrud | SkinnebensbrudForenede Stater
-
Marwa Gamal Abd El Ghany FathallaAfsluttet
-
McMaster UniversityYMCA Hamilton/Burlington/Brantford; City of HamiltonAktiv, ikke rekrutterendeMobilitetsbegrænsningCanada
-
Chi-Wen ChenIkke rekrutterer endnuHjertefejl, medfødtTaiwan
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Afsluttet
-
Odense University HospitalUniversity of Southern DenmarkRekrutteringLivskvalitet | Fysisk aktivitet | Fysisk handicap | Fysisk funktion | DeltagelseDanmark
-
University of British ColumbiaUkendtKirurgisk ar erytemCanada