- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02810834
Understanding the Impact of School-Based Physical Activity Programs
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy, Tufts University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Walking/Running Program
Walking/running/jogging program; school-based.
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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)
Outros nomes:
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Experimental: Classroom activity break program
Classroom physical activity break program; school-based.
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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)
Outros nomes:
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Sem intervenção: Control
Control/Delayed Intervention
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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School-time and total daily MVPA
Prazo: 5 months and 1.5 years
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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
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5 months and 1.5 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Cognitive performance
Prazo: 5 months and 1.5 years
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Changes in cognitive performance, as measured by standard tests of executive function, among third-fifth graders participating in innovative
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5 months and 1.5 years
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Academic achievement
Prazo: 5 months and 1.5 years
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Changes in academic achievement, as measured by standardized tests (English language art and math), among third-fifth graders participating in innovative
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5 months and 1.5 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jennifer M Sacheck, PhD, Tufts University
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- R01HD080180 (Concessão/Contrato do NIH dos EUA)
- 1R01HD080180-01A1 (Concessão/Contrato do NIH dos EUA)
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