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临床试验/NCT06409793
NCT06409793尚未招募不适用

Motivating Adolescent Fitness

University of British Columbia2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
2
主要终点
Eligibility to participate in the intervention

研究概览

简要总结

The researchers are investigating whether adding mobile technology to a home-based exercise counselling program makes it easier for youth to begin and maintain regular exercise. Participants who joins the study will receive exercise counselling from an exercise specialist, but half of all participants will receive mobile technology - a fitness watch - that links to a mobile phone App. The mobile App allows the exercise specialist to provide personalized feedback throughout the program via the fitness watch. The investigators are interested to know whether the fitness watch and mobile App will make it easier for youth to achieve their exercise goals. Both groups will be compared to an active control group, who will receive no exercise program.

详细描述

Purpose:

The investigators aim to undertake an experimental trial using exercise training in adolescents, evaluating a theoretical model where mHealth technology, allowing biometric informed feedback and coaching, is incorporated into a structured home-based exercise and physical activity (PA) intervention. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future randomised controlled trial (RCT).

Hypothesis:

It is hypothesized that this approach will increase both habitual PA and adherence to structured exercise of the appropriate intensity to promote improvements in cardiorespiratory fitness and vascular function.

Justification:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
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

  • Male or Female
  • Aged 13-16 years
  • Be comfortable communicating in English

排除标准

  • Aged <13 or >16
  • Inability to increase level of activity or exercise
  • Not owning a smartphone/ or having no data plan or access to Wi-Fi
  • Currently meeting the recommended exercise guidelines
  • Have congenital cardiac abnormalities (e.g., tetralogy of Fallot)
  • Have a known respiratory disease (e.g., asthma)
  • Have a known metabolic disease (e.g., Type 1 diabetes)
  • Are pregnant

结局指标

主要结局

Eligibility to participate in the intervention

时间窗: Baseline, and follow up at weeks 4,8,12

1. The number of adolescents approached and reasons for not joining the study 2. Number of participants approached to participate, percentage attending/ dropout throughout the intervention

Enrolment in the intervention

时间窗: Baseline, week 12

Percentage of adolescents attending at 3-month post and 6-month follow up and reasons for drop-out.

次要结局

  • Precision of potential outcome measures of cardiorespiratory fitness(Baseline, week 12, week 24)
  • Acceptability of the exercise training program(baseline, week 6 and week 12)
  • Adherence(12 weeks)
  • Precision of potential outcome measures of peripheral vascular function(Baseline, week 12, week 24)
  • Precision of potential outcome measures of cerebrovascular function(Baseline, week 12, week 24)

研究者

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

Ai McManus

Professor

University of British Columbia

研究点 (2)

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