跳至主要内容
临床试验/NCT07005674
NCT07005674招募中不适用

Effectiveness and Cost-effectiveness of a Community-based Nine-week Multi-component Group-based Cycling Intervention Versus a Single Cycle Training Session to Increase Cycling Participation: the Cycle Nation Communities Randomised Controlled Trial

University of Glasgow1 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2025年5月27日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
268
试验地点
1
主要终点
Proportion of participants cycling (for any purpose)

研究概览

简要总结

This randomised controlled trial will evaluate the effects of a 9-week multi-component group-based cycling programme (Cycle Nation) versus a standard single cycle training session on self-reported cycling, health and wellbeing outcomes. Participants are adults that do not regularly cycle, who will be randomly allocated to each arm of the study. Outcomes will be assessed at baseline, post-programme, and at 12 months from baseline. Cost effectiveness will be assessed, and a process evaluation will be conducted.

详细描述

Cycling improves physical and mental health, lowering risks of major diseases and reducing stress while enhancing wellbeing and fitness. It is a time-efficient way to increase physical activity and, when replacing motorised transport, reduces air pollution, carbon emissions, and traffic congestion. However, cycling participation in the UK remains low; only 10% of adults cycle at least weekly. This is a missed opportunity to enhance population health, lower health service costs, reduce environmental impact, and improve health related quality of life. Evidence suggests that over 50% of UK adults are interested in cycling more, therefore the potential to increase cycling is substantial.

Non-cyclists report numerous barriers, spanning the individual, social, and environmental factors of the socio-ecological model. While improvements to cycling infrastructure can address some environmental barriers, they alone are insufficient to drive substantial increases in cycling. While many organisations offer standard single or short-term cycling sessions, these often address isolated components rather than taking an integrated approach. In contrast, Cycle Nation is an integrated group-based 9-week multi-component intervention, targeting multiple individual and social barriers over a sustained period to maximise effectiveness.

Initially co-developed and piloted in collaboration with British Cycling and HSBC-UK as a workplace programme for employees, it has since been adapted for community settings in Manchester and Glasgow. Findings of these studies have demonstrated feasibility, acceptability, and short-term effectiveness. However, Cycle Nation has not yet been rigorously tested in a powered randomised controlled trial (RCT), nor had its long-term effectiveness or cost-effectiveness evaluated.

This is a pragmatic, two-arm RCT to assess the effect of the Cycle Nation programme in comparison to a single cycling training session. The interventions will be delivered by community-based cycling delivery partners across Glasgow, UK, with up to six organisations delivering the Cycle Nation programme (intervention) and one delivering the standard single introduction to road cycling session offered by Cycling Scotland (comparison).

The primary objective is to evaluate the effect of the Cycle Nation programme versus a standard single session on the proportion of participants cycling at least weekly at 12 months. Secondary objectives are to a) to evaluate the effect of the Cycle Nation programme versus a standard cycling session on self-reported health and wellbeing at 12 months, b) to evaluate the within-trial cost-effectiveness of the Cycle Nation programme at 12 months (and longer pending within trial findings), c) to assess how (well) Cycle Nation is delivered and examine how the core causal mechanisms function, and d) to determine how contextual factors contribute to variations in outcome and engagement with the Cycle Nation intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Members of the research team that perform measurements are blinded to group allocation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Can ride a bicycle Self-identified infrequent cyclists (currently cycle less than once per month) Aged 18 years or over Willing to provide informed consent Willing to partake in measurements Willing to be randomised to intervention or control arm Have a good understanding of the English language Not have a contraindication to moderate intensity physical activity as assessed by the adapted Physical Activity Readiness Questionnaire-Plus (PAR-Q+) Able to attend in-person sessions (at least 6 out of 9 sessions) Intend to still be in the UK by November 2026

排除标准

  • Cannot cycle (i.e. cannot balance and/or have never learnt to cycle) Frequent or regular cyclists (i.e. currently cycle at least once a month, confident riding on roads) Less than 18 years old Not willing to provide informed consent Not willing to partake in measurements Not willing to be randomised to the intervention or control arm Cannot speak basic English Have a contraindication to moderate intensity physical activity as assessed by the adapted Physical Activity Readiness Questionnaire-Plus (PAR-Q+) Not able to attend in-person sessions (less than 6 out of 9 sessions) Not intending to still be in the UK by November 2026

结局指标

主要结局

Proportion of participants cycling (for any purpose)

时间窗: From baseline to 12 months follow-up

Change in number (proportion) of participants cycling (for any purpose) over past four weeks at 12 months

次要结局

  • Proportion of participants cycling (for any purpose)(From baseline to 12 weeks follow-up)
  • Number of cycling journeys (for any purpose)(From baseline to 12-weeks and 12-months follow-up)
  • Total duration of weekly cycling (for any purpose)(From baseline to 12 weeks and 12 months follow-up)
  • Number of cycling journeys (leisure)(From baseline to 12 weeks and 12 months follow-up)
  • Number of cycling journeys (commuting)(From baseline to 12 weeks and 12 months follow-up)
  • Number of cycling journeys (errands)(From baseline to 12 weeks and 12 months follow-up)
  • Total duration of weekly cycling (leisure)(From baseline to 12 weeks and 12 months follow-up)
  • Total duration of weekly cycling (commuting)(From baseline to 12 weeks and 12 months follow-up)
  • Total duration of weekly cycling (errands)(From baseline to 12 weeks and 12 months follow-up)
  • Number of private car journeys(From baseline to 12 weeks and 12 months follow-up)
  • Number of taxi journeys(From baseline to 12 weeks and 12 months follow-up)
  • Total duration of taxi journeys(From baseline to 12 weeks and 12 months follow-up)
  • Number of public transport journeys(From baseline to 12 weeks and 12 months follow-up)
  • Total duration of public transport journeys(From baseline to 12 weeks and 12 months follow-up)
  • Number of walking journeys(From baseline to 12 weeks and 12 months follow-up)
  • Total duration of walking journeys(From baseline to 12 weeks and 12 months follow-up)
  • Perception of cycling safety(From baseline to 12 weeks and 12 months follow-up)
  • Perceptions of environment(From baseline to 12 weeks and 12 months follow-up)
  • Confidence to cycle(From baseline to 12 weeks and 12 months follow-up)
  • Motivation for cycling(From baseline to 12 weeks and 12 months follow-up)
  • Self-esteem(From baseline to 12 weeks and 12 months follow-up)
  • Vitality(From baseline to 12 weeks and 12 months follow-up)
  • Health related quality of life(From baseline to 12 weeks and 12 months follow-up)
  • Capability wellbeing(From baseline to 12 weeks and 12 months follow-up)

研究者

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

Professor Jason Gill

Professor

University of Glasgow

研究点 (1)

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