NCT07005674

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable healthy

Timeline
9mo left

Started May 2025

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
May 2025Feb 2027

First Submitted

Initial submission to the registry

May 22, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

May 27, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

1.5 years

First QC Date

May 22, 2025

Last Update Submit

October 2, 2025

Conditions

Keywords

CyclingBicycleCommunitiesRandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants cycling (for any purpose)

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

    From baseline to 12 months follow-up

Secondary Outcomes (24)

  • 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

  • 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

  • +19 more secondary outcomes

Study Arms (2)

Cycle Nation intervention

EXPERIMENTAL
Behavioral: Cycle Nation

Cycling Scotland standard cycling session

ACTIVE COMPARATOR
Behavioral: Cycling Scotland standard cycling session

Interventions

Cycle NationBEHAVIORAL

Participants will be asked to attend nine weekly 90-minute face-to-face sessions, delivered by trained facilitators at community cycling organisations. Sessions include off road cycling skills and on-road group rides, behaviour change techniques (e.g. goal setting), and bicycle maintenance training. Two extra group rides will be offered during the programme for additional practice, along with two catch-up sessions at the end for those who missed any content. Participants will be added to a WhatsApp group to encourage peer communication. Bicycles, helmets, and locks will be loaned to participants for 10-12 weeks to support participation.

Cycle Nation intervention

Participants will be asked to participate in Cycling Scotland's 'Introduction to On-Road Cycling' a single 2-2.5-hour session that is offered as standard. The session covers key cycling skills such as hazard awareness, road positioning, and communicating with other road users. Activities are tailored to participants' needs and may include navigating junctions, using shared infrastructure, and performing U-turns. Bicycles and helmets will be provided for the session.

Cycling Scotland standard cycling session

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Glasgow

Glasgow, United Kingdom

RECRUITING

Related Publications (2)

  • 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.

    PMID: 36385778BACKGROUND
  • 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.

    PMID: 32269057BACKGROUND

Study Officials

  • Jason Gill, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR
  • Cindy Gray, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda Gabler Trisotti, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Members of the research team that perform measurements are blinded to group allocation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomised controlled trial with two groups, Cycle Nation programme and Cycling Scotland single standard cycling session
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2025

First Posted

June 5, 2025

Study Start

May 27, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

October 7, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

At the end of the project, anonymised/pseudonymised/de-identified research data will be deposited with the UK Data Service ReShare Repository.

Locations