Clinical trial NCT07005674: Cycle Nation Communities: Increasing Cycling in Glasgow
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Cycling
Bicycle
Communities
Randomised controlled trial
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial with two groups, Cycle Nation programme and Cycling Scotland single standard cycling session
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of participants cycling (for any purpose)
timeFrame: From baseline to 12 months follow-up
Secondary outcomes:
measure: Proportion of participants cycling (for any purpose)
timeFrame: From baseline to post-programme (9-11 weeks)
measure: Number of cycling journeys (for any purpose)
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Number of cycling journeys (leisure)
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Number of cycling journeys (commuting)
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Number of cycling journeys (errands)
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Duration (time) of cycling journeys (for any purpose)
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Duration (time) of cycling journeys (leisure)
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Duration (time) of cycling journeys (commuting)
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Duration (time) of cycling journeys (errands)
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Number of private car journeys
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Number of taxi journeys
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Duration (time) of taxi journeys
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Number of public transport journeys
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Duration (time) of public transport journeys
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Number of walking journeys
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Duration (time) of walking journeys
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Perception of cycling safety
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Perceptions of environment
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Confidence to cycle
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Motivation for cycling
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Self-esteem
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Vitality
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Health related quality of life
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
measure: Capability wellbeing
timeFrame: From baseline to post-programme (9-11 weeks) and 12 months follow-up
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow
Study officials:
affiliation: University of Glasgow
name: Jason Gill, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Cindy Gray, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Connell H, Logan G, Somers C, Baker G, Broadfield S, Bunn C, Harper LD, Kelly P, McIntosh E, Pell JP, Puttnam J, Robson S, Gill JMR, Gray CM. Development and optimisation of a multi-component workplace intervention to increase cycling for the Cycle Nation Project. Front Sports Act Living. 2022 Oct 26;4:857554. doi: 10.3389/fspor.2022.857554. eCollection 2022.
citation: Kelly P, Williamson C, Baker G, Davis A, Broadfield S, Coles A, Connell H, Logan G, Pell JP, Gray CM, Gill JM; Cycle Nation Project. Beyond cycle lanes and large-scale infrastructure: a scoping review of initiatives that groups and organisations can implement to promote cycling for the Cycle Nation Project. Br J Sports Med. 2020 Dec;54(23):1405-1415. doi: 10.1136/bjsports-2019-101447. Epub 2020 Apr 8.