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临床试验/NCT06615791
NCT06615791招募中不适用

FIT FIRST Teen Effectiveness and School Implementation Study - a Cluster Randomised Mixed Methods Trial.

University of Southern Denmark2 个研究点 分布在 1 个国家目标入组 912 人开始时间: 2024年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
912
试验地点
2
主要终点
Cardiometabolic Fitness

研究概览

简要总结

The goal of this cluster randomised controlled trial is to investigate the effects of the FIT FIRST Teen program on adolescents' physical fitness, motivation, and well-being, as well as the implementation of such a program within schools. The main questions it aims to answer are:

Research Question 1: Does the FIT FIRST Teen program improve cardiorespiratory fitness, body composition, and muscle strength among adolescents?

Research Question 2: Does the FIT FIRST Teen program improve well-being, motivation towards physical activity, and body image among adolescents?

Research Question 3: What are the challenges that teachers and schools will face regarding the implementation of the FIT FIRST Teen program?

The research team will compare the FIT FIRST Teen program to a control (usual physical education curricula) to see if such a program improves adolescents' physical fitness, motivation, and well-being. Participating schools will:

  • Participate in a training course, where the core principles of the FIT FIRST Teen program will be delivered.
  • Implement the FIT FIRST Teen program for a full school year (three 45-minute lessons a week).
  • Keep a logbook where the weekly practised activities will be reported.

详细描述

Background. Physical activity (PA) is an important part of a healthy lifestyle for children and youth, as it improves physical fitness, motor competencies, and well-being, and reduces the risk of developing overweight and non-communicable diseases later in life. Current recommendations from the Danish Health Authorities are that young people should participate in at least 60 minutes of moderate-to-vigorous physical activity (MVPA) per day, of which at least 3 times per week should involve muscle strengthening training, however, currently only about one-quarter of the Danish 11-15-year-olds meet these recommendations.

Given that children and adolescents, irrespective of socio-economic background, spend a substantial portion of their waking hours in school, schools serve as pivotal settings for the widespread promotion of PA. However, current school-based PA interventions have shown limited effects. Often the poor results of interventions can be ascribed to implementation challenges, encompassing deficiencies in program fidelity, suboptimal attendance rates, or lack of access to intended resources, time, or space. Details about the contextual environment and how to implement interventions are typically derived from implementation evaluations. Nonetheless, such evaluations are rarely undertaken.

The FIT FIRST program was developed to address these limitations. FIT FIRST was originally an acronym for a 40-week intervention study for 8- to 9-year-olds with Frequent Intense Training through Football, Interval Running, and Circuit Strength Training. In 2018, the FIT FIRST 10 concept was developed for 6-9-yr-olds that covered 10 sports. In 2020, the FIT FIRST 20 concept for 10-12-year-olds was developed to include 20 sports. In brief, all versions of the FIT FIRST concept are built on the principles of using multiple sporting activities modified for the school setting, with a focus on high intensity, high involvement, fun, and inclusion. The use of multiple sporting activities modified for the school setting may also recess activities and leisure-time sports. Therefore, it will be investigated whether the developed abilities and motivation for FIT FIRST sporting activities can result in recruitment or re-recruitment of members to the local sports clubs.

The implementation of the FIT FIRST Teen project is based on training teachers to deliver such a program, which has been developed by experienced staff from SDU (University of Southern Denmark (SDU), The DIF (Danish Sports Confederation (DIF), and Team Denmark. These partners have developed 3-6 lessons for each of the sports, all using pair-based exercises and small-sided game drills and activities. All the lessons included in the FIT FIRST Teen program have been developed to (1) provide high-intensity strength and cardiovascular training and (2) motivate children to participate, according to the self-determination theory.

FIT FIRST Teen will run over a full school year with physical fitness, motivation, and well-being as primary outcomes, and project implementation as co-primary outcome. In this study, the research team will be testing the effects of the FIT FIRST Teen program by randomizing schools into two groups. Hence, this will be a cluster RCT with a 1:1 randomization of schools into an intervention arm, which will implement the FIT FIRST Teen program 3 times a week weekly (three 40-minute lessons a week), and a control arm, which will provide the usual physical education curricula.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • part of the enrolled classes

排除标准

  • 未提供

结局指标

主要结局

Cardiometabolic Fitness

时间窗: Change from baseline to 40 weeks

The cardiometabolic fitness profile will be evaluated by using the Yo-Yo test measured as the total distance in meters as an indicator for the participants\' ability to perform intermittent exercise and their cardiometabolic fitness. The longer the distance, the better the cardiometabolic fitness of the participants.

Implementation

时间窗: From baseline to 40 weeks

Implementation of the FIT FIRST Teen Program will be evaluated.

次要结局

  • Health-Related Quality of Life(Change from baseline to 40 weeks)
  • Body Functionality Appreciation(Change from baseline to 40 weeks)
  • Body Image(Change from baseline to 40 weeks)
  • Motivation towards Physical Education(Change from baseline to 40 weeks)
  • Body Self-perception(Change from baseline to 40 weeks)
  • Resting Heart Rate(Change from baseline to 40 weeks)
  • Blood Pressure(Change from baseline to 40 weeks)
  • Body Composition(Change from baseline to 40 weeks)
  • Height(Change from baseline to 40 weeks)
  • Muscular Fitness(Change from baseline to 40 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Krustrup

Professor

University of Southern Denmark

研究点 (2)

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