Interventions to increase the number of people cycling regularly are likely to induce a range of health and societal benefits, including reduced incidence of heart disease, cancer and obesity, improved mental health and well-being, and reduced road congestion and air pollution. They are also likely to provide tangible financial and in-kind benefits to employers and society, through reduced workforce absenteeism, increased productivity and decreased use of NHS resources. However, increasing the number of people cycling regularly is complex and interventions undertaken to date have only been modestly successful. Thus, to induce a step-change in the number of people cycling in the United Kingdom (UK), in line with British Cycling and HSBC UK's stated aim of getting two million more people on bikes, new approaches are needed.

The research team have been working with staff and management at British Cycling and HSBC to co-develop a novel, multi-component intervention for delivery at HSBC offices to increase the number of employees cycling regularly. The intervention has four main components: 1) a six (intermediate) or nine (foundation) week practical skills programme; 2) cycle provision (tune-up/loan/subsidised purchase) schemes; 3) establishment of a cycle-friendly workplace culture; 4) a cycle app. The purpose of this study is to test the feasibility of this intervention in a before-and-after study in four HSBC offices around the UK.

Read the detailed description

Objective: To assess the feasibility of the novel multicomponent workplace cycling intervention that aims to support more employees to cycle regularly. There are eight related research questions:

Can sufficient (~20-30) employees per HSBC office be recruited to take part in the intervention?
Can participants be retained in the study for up to three months?
To what extent do participants receive the intervention as intended (exposure)?
To what extent is the intervention acceptable to participants, those leading the intervention (local cycle champions), local HSBC office management and local bike providers?
How feasible and acceptable is it to conduct a suite of measurements, including self-report questionnaires, objective physical activity and blood biomarkers of cardiovascular disease, in this setting?
Does the intervention have potential to increase cycling and cycle journeys (likely primary outcomes in a future RCT)?
To what extent do participants improve on a range of behavioural, psychological, clinical and work-related outcomes?
Does the intervention have potential to be cost-effective, and what are the range of cost and benefit outcomes that are to be considered?

Setting and Participants: The study will be conducted at four HSBC offices across the UK, which have some degree of on-site cycle infrastructure (e.g. secure bike racks, showers, lockers). At each office, up to 40 participants will be recruited to either the foundation (nine-week) or intermediate (six-week) practical skills programme (up to 160 participants in total across the four sites). Participants will be self-identified infrequent cyclists (currently cycle less than once per month or not at all) aged 18 years or over who are current HSBC employees.

Interventions:

The intervention has four main components.

Practical skills programme: this has two versions - a core six-week programme (intermediate), with an additional three weeks (nine weeks in total - foundation) covering basic cycling skills. It is designed to be delivered at HSBC offices by trained 'cycle champions' - ideally HSBC staff members. Each session includes group-based learning activities and in-saddle, off- and on-road practical cycle training. Participants will receive information delivered simply in handbook format with a "toolkit" of skills and behaviour change techniques (e.g. goal setting) participants can apply to increase their cycling and maintain this long-term.
Cycle provision scheme: participants will have the opportunity to have their own bicycles serviced or obtain a loaned bike or e-bike from local bike shops before the start of the programme. At the end of the programme, participants will be given support and advice to take part in the HSBC subsidised cycle purchase bike to work scheme.
Cycle-friendly workplace culture: all of the HSBC offices taking part in the study will have a minimum of secure bike locks as part of an ongoing roll-out of cycle infrastructure across HSBC UK offices. During training, the cycle champion will be asked to identify (and subsequently implement) other cycle-friendly features (e.g. availability of cycle tools and spares, flexible hours to avoid peak commuter traffic, flexible dress code, altruistic reward scheme for cycling).
Our Cycle Hub app: an adapted version of an existing HSBC app including route planning, goal setting and practical skills videos, as well as supportive social interaction among participants.

Outcomes:

The feasibility study will assess: recruitment, retention, adherence, feasibility of delivery of all components, fidelity to intervention protocol, acceptability (to participants and cycle champions, other staff in the office who are not doing the practical skills programme but are exposed to the cycle-friendly culture, HSBC office managers and bike providers), and likely primary outcomes of any future randomised controlled trial (RCT) - number of people cycling regularly (both monthly and weekly) and number of cycling journeys for transport or leisure in the last month, both self-reported. The investigators will also assess likely secondary outcomes in a future RCT at baseline, 9 weeks, and 13 weeks.

behavioural - objectively-measured cycling and other physical activity (using the activPAL device and a new algorithm specifically-developed to detect cycling) and self-reported cycling activity, modes of transport, physical activity, sedentary behaviour, sleep, dietary intake.
psychological - self-reported motivation, autonomy, competence, relatedness and perceptions of safety in relation to cycling, wellbeing, self-esteem, vitality, quality of life and perceived general physical health.
work-related - productivity, job satisfaction, occupational stress, absenteeism and presenteeism.
clinical - objectively-measured weight, height, BMI, waist circumference, diastolic and systolic blood pressure. Cardio-metabolic disease risk biomarkers related to glucose, insulin, HbA1c, lipids and liver function will be assessed at baseline and 13 weeks only (opt in).

Participant characteristics (e.g. date of birth, gender, postcode of residence, marital status, education, smoking status, alcohol consumption, job description) will be recorded at baseline only. Extent of delivery, acceptability and perceived utility of programme components (practical skills programme components, bike provision, cycle-friendly culture and cycle app), and acceptability of the study procedures will be assessed at follow up only. Adverse events and injury will be assessed at all time points. Health economists will work with HSBC head office staff to identify available sources of cost and benefit data throughout the study.

Conditions: Health Behavior
Being tested: Cycle Nation Multicomponent Intervention
Keywords: physical activity, cycling
Medical subject headings: Health Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cycle Nation Multicomponent InterventionBehavioural
This intervention group will receive 4 elements:
1. Practical skills programme: a workplace-based programme covering basic cycling skills, delivered by trained 'cycle champions' - HSBC staff members.
2. Cycle provision scheme: participants will have the opportunity to have their own bicycles serviced or obtain a loaned bike or e-bike from local bike shops before the start of the programme.
3. Cycle-friendly workplace culture: all offices taking part will have a minimum of secure bike parking facilities as part of an ongoing roll-out of cycle infrastructure across HSBC UK offices.
4. Our Cycle Hub app: an adapted version of an existing HSBC app including route planning, goal setting and practical skills videos, as well as supportive social interaction among participants.

Study groups in NCT04035941
Study group	Role	What they receive
Feasibility	Experimental	The cycle training intervention group Receives: Behavioral: Cycle Nation Multicomponent Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of intervention delivery: Investigator conducted session observations
To measure the feasibility of delivery of all cycle training components by investigator conducted session observations.
Measured: 9 weeks
Feasibility of intervention delivery: Investigator conducted interviews
To measure the feasibility of delivery of all cycle training components by investigator conducted interviews with cycle champions.
Measured: 9 weeks
Cycling behaviour
Self reported number of people cycling regularly (both monthly and weekly) and number of cycling journeys for transport or leisure in the last month.
Measured: Change from baseline to 13 weeks
Participant and Cycle Champion recruitment
Measeurement of the recruitment of participants and cycle champions.
Measured: Conducted pre baseline
Participant and Cycle Champion retention
Measurement of the number of participants and cycle champions who undertake the training course to completion, as well as participant drop-out
Measured: Change from baseline to 9 weeks
Participant adherence to the cycle training course
Measurement of participant attendance to training sessions
Measured: Through study completion to 9 weeks
Cycle Champion interviews: acceptability of cycle training course delivery
Interview measured acceptability of all elements of intervention delivery (cycle champions)
Measured: 9 weeks
Participant questionnaire: Likert scale of training course acceptability
Self-reported questionnaire measured acceptability of all elements of intervention delivery
Measured: 9 weeks

Secondary outcomes (19)

Objectively-measured incidental physical activity
Minutes spent in activity per day measured using the activPAL device.
Measured: Change from baseline to 13 weeks
Participant questionnaire reported motivation: 15 item Likert scale
15 item scale adapted from Markland, D. \& Tobin, V. (2004). Journal of Sport and Exercise Psychology, 26, 191-196 (BREQ-2 for PA)
Measured: Change from baseline to 13 weeks
Participant questionnaire measured work-related productivity: Likert scale
Likert scale of productivity adapted from Kessler et al's World Health Organisation Health and Work Performance Questionnaire (HPQ)
Measured: Change from baseline to 13 weeks
Participant self-reported monthly cycling activity: number of rides and duration
Questionnaire measured of cycling activity adapted from Craig CL, Marshall AL, Sjostrom M, Bauman A, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P: International Physical Activity Questionnaire: 12-country reliability and validity. Medicine and Science in Sports and Exercise 2003, 35:1381-1395.
Craig CL, Marshall AL, Sjostrom M, Bauman A, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P: International Physical Activity Questionnaire: 12-country reliability and validity. Medicine and Science in Sports and Exercise 2003, 35:1381-1395.
Adapted DINE questionnaire: Roe L, Strong C, Whiteside C, Neil A, Mant D. Dietary intervention in primary care: validity of the DINE method for diet assessment. Fam Pract 1994; 11: 375-81.
Measured: Change from baseline to 13 weeks
Participant self-reported dietry intake: DINE questionnaire
Adapted DINE questionnaire: Roe L, Strong C, Whiteside C, Neil A, Mant D. Dietary intervention in primary care: validity of the DINE method for diet assessment. Fam Pract 1994; 11: 375-81.
Measured: Change from baseline to 13 weeks
Participant self-reported number of days of work-related absenteeism/presenteeism
Self reported days per month of absenteeism/presenteeism adapted from Kessler et al's World Health Organisation Health and Work Performance Questionnaire (HPQ)
Measured: Change from baseline to 13 weeks
Participant self reported job satisfaction: Likert scale
Questionnaire measured job satisfaction adapted from Kessler et al's World Health Organisation Health and Work Performance Questionnaire (HPQ)
Measured: Change from baseline to 13 weeks
Participant self-reported work-related stress: Likert scale
Questionnaire measured work-related stress adapted from Kessler et al's World Health Organisation Health and Work Performance Questionnaire (HPQ)
Measured: Change from baseline to 13 weeks
Participant self-reported autonomy: Likert scale
Questionnaire measured autonomy adapted from Bartholomew, K. J., Ntoumanis, N., Ryan, R. M., \& Thøgersen-Ntoumani, C. (2011). Journal of Sport \& Exercise Psychology, 33, 75e102.
Measured: Change from baseline to 13 weeks
Participant self-reported competence: 6 item Likert scale
Questionnaire measured competence adapted from Roberts, G.C., Treasure D. C., \& Balague, G. (1998). Achievement goals in sport: The development and validation of the Perception of Success Questionnaire. Journal of Sport Sciences. 19, 337-347.
Measured: Change from baseline to 13 weeks
Participant self-reported relatedness: 6 item Likert scale
Questionnaire measured relatedness adapted from Van den Broeck et al (2010). J Occup Organiz Psych 83:981-1002
Measured: Change from baseline to 13 weeks
Participant self-reported perceptions of cycling safety: 5 item Likert scale
Questionnaire measured scale of perceptions of cycling safety
Measured: Change from baseline to 13 weeks
Participant self-reported wellbeing: 14 item Warwick-Edinburgh Mental Wellbeing Scales - WEMWBS
Questionnaire measured participant wellbeing.
Measured: Change from baseline to 13 weeks
Participant self-reported self esteem: 10 item Rosenberg scale of self esteem
Self-esteem questionnaire
Measured: Change from baseline to 13 weeks
Participant self-reported vitality: 4 item Bostic scale
4-item scale of vitality (Bostic, T. J., McGartland-Rubio, D., \& Hood, M. (2000). A validation of the subjective vitality scale using structural equation modeling)
Measured: Change from baseline to 13 weeks
Participant self-reported general physical health: EQ-5D-5L
Questionnaire measure of health-related quality of life
Measured: Change from baseline to 13 weeks
Body mass
Body mass in kilograms
Measured: Change from baseline to 13 weeks
Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m^2
Measured: Change from baseline to 13 weeks
Waist circumference
Waist circumference in centimeters
Measured: Change from baseline to 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 201931 Mar 2021

First posted29 Jul 2019
Study start5 Aug 2019 (estimated)
Primary completion30 Apr 2020 (estimated)
Study completion31 Mar 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Health BehaviorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: Study design: A before-and-after feasibility study with follow up to six months.
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04035941
Sponsor's protocol ID: 200180138
Status last verified: Jul 2019
First submitted: 19 Jul 2019
Last updated: 29 Jul 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: These data will only be handled by UoG researchers

Publications

Kelly P, Kahlmeier S, Gotschi T, Orsini N, Richards J, Roberts N, Scarborough P, Foster C. Systematic review and meta-analysis of reduction in all-cause mortality from walking and cycling and shape of dose response relationship. Int J Behav Nutr Phys Act. 2014 Oct 24;11:132. doi: 10.1186/s12966-014-0132-x.
PubMed 25344355
Sahlqvist S, Goodman A, Simmons RK, Khaw KT, Cavill N, Foster C, Luben R, Wareham NJ, Ogilvie D. The association of cycling with all-cause, cardiovascular and cancer mortality: findings from the population-based EPIC-Norfolk cohort. BMJ Open. 2013 Nov 14;3(11):e003797. doi: 10.1136/bmjopen-2013-003797.
PubMed 24231462
Schnohr P, Marott JL, Jensen JS, Jensen GB. Intensity versus duration of cycling, impact on all-cause and coronary heart disease mortality: the Copenhagen City Heart Study. Eur J Prev Cardiol. 2012 Feb;19(1):73-80. doi: 10.1177/1741826710393196. Epub 2011 Feb 21.
PubMed 21450618
Andersen LB, Schnohr P, Schroll M, Hein HO. All-cause mortality associated with physical activity during leisure time, work, sports, and cycling to work. Arch Intern Med. 2000 Jun 12;160(11):1621-8. doi: 10.1001/archinte.160.11.1621.
PubMed 10847255
Oja P, Kelly P, Pedisic Z, Titze S, Bauman A, Foster C, Hamer M, Hillsdon M, Stamatakis E. Associations of specific types of sports and exercise with all-cause and cardiovascular-disease mortality: a cohort study of 80 306 British adults. Br J Sports Med. 2017 May;51(10):812-817. doi: 10.1136/bjsports-2016-096822. Epub 2016 Nov 28.
PubMed 27895075
Celis-Morales CA, Lyall DM, Welsh P, Anderson J, Steell L, Guo Y, Maldonado R, Mackay DF, Pell JP, Sattar N, Gill JMR. Association between active commuting and incident cardiovascular disease, cancer, and mortality: prospective cohort study. BMJ. 2017 Apr 19;357:j1456. doi: 10.1136/bmj.j1456.
PubMed 28424154
Blond K, Jensen MK, Rasmussen MG, Overvad K, Tjonneland A, Ostergaard L, Grontved A. Prospective Study of Bicycling and Risk of Coronary Heart Disease in Danish Men and Women. Circulation. 2016 Nov 1;134(18):1409-1411. doi: 10.1161/CIRCULATIONAHA.116.024651. No abstract available.
PubMed 27799259
Kubesch NJ, Therming Jorgensen J, Hoffmann B, Loft S, Nieuwenhuijsen MJ, Raaschou-Nielsen O, Pedersen M, Hertel O, Overvad K, Tjonneland A, Prescot E, Andersen ZJ. Effects of Leisure-Time and Transport-Related Physical Activities on the Risk of Incident and Recurrent Myocardial Infarction and Interaction With Traffic-Related Air Pollution: A Cohort Study. J Am Heart Assoc. 2018 Jul 18;7(15):e009554. doi: 10.1161/JAHA.118.009554.
PubMed 30021805
Hoevenaar-Blom MP, Wendel-Vos GC, Spijkerman AM, Kromhout D, Verschuren WM. Cycling and sports, but not walking, are associated with 10-year cardiovascular disease incidence: the MORGEN Study. Eur J Cardiovasc Prev Rehabil. 2011 Feb;18(1):41-7. doi: 10.1097/HJR.0b013e32833bfc87.
PubMed 20543701
Tanasescu M, Leitzmann MF, Rimm EB, Willett WC, Stampfer MJ, Hu FB. Exercise type and intensity in relation to coronary heart disease in men. JAMA. 2002 Oct 23-30;288(16):1994-2000. doi: 10.1001/jama.288.16.1994.
PubMed 12387651
Millett C, Agrawal S, Sullivan R, Vaz M, Kurpad A, Bharathi AV, Prabhakaran D, Reddy KS, Kinra S, Smith GD, Ebrahim S; Indian Migration Study group. Associations between active travel to work and overweight, hypertension, and diabetes in India: a cross-sectional study. PLoS Med. 2013;10(6):e1001459. doi: 10.1371/journal.pmed.1001459. Epub 2013 Jun 11.
PubMed 23776412
Laverty AA, Mindell JS, Webb EA, Millett C. Active travel to work and cardiovascular risk factors in the United Kingdom. Am J Prev Med. 2013 Sep;45(3):282-8. doi: 10.1016/j.amepre.2013.04.012.
PubMed 23953354
Rasmussen MG, Grontved A, Blond K, Overvad K, Tjonneland A, Jensen MK, Ostergaard L. Associations between Recreational and Commuter Cycling, Changes in Cycling, and Type 2 Diabetes Risk: A Cohort Study of Danish Men and Women. PLoS Med. 2016 Jul 12;13(7):e1002076. doi: 10.1371/journal.pmed.1002076. eCollection 2016 Jul.
PubMed 27403867
Mytton OT, Ogilvie D, Griffin S, Brage S, Wareham N, Panter J. Associations of active commuting with body fat and visceral adipose tissue: A cross-sectional population based study in the UK. Prev Med. 2018 Jan;106:86-93. doi: 10.1016/j.ypmed.2017.10.017. Epub 2017 Oct 10.
PubMed 29030265
Hollingworth M, Harper A, Hamer M. Dose-response associations between cycling activity and risk of hypertension in regular cyclists: The UK Cycling for Health Study. J Hum Hypertens. 2015 Apr;29(4):219-23. doi: 10.1038/jhh.2014.89. Epub 2014 Oct 2.
PubMed 25273856

Want to know more?

Greig RM Logan, PhD

01413304377

greig.logan@glasgow.ac.uk

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Cycle Nation Project: A Workplace Intervention to Increase the Number of People Cycling Regularly (Phase 2: Feasibility)
ClinicalTrials.gov ID: NCT04035941
Acronym / sponsor ID: 200180138
Conditions: Health Behavior
Keywords: physical activity, cycling
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: University of GlasgowUniversity, hospital or other
Collaborators: University of Edinburgh
Study start: 5 Aug 2019 (estimated)
Primary completion: 30 Apr 2020 (estimated)
Study completion: 31 Mar 2021 (estimated)
First posted: 29 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objective: To assess the feasibility of the novel multicomponent workplace cycling intervention that aims to support more employees to cycle regularly. There are eight related research questions:

Can sufficient (~20-30) employees per HSBC office be recruited to take part in the intervention?
Can participants be retained in the study for up to three months?
To what extent do participants receive the intervention as intended (exposure)?
To what extent is the intervention acceptable to participants, those leading the intervention (local cycle champions), local HSBC office management and local bike providers?
How feasible and acceptable is it to conduct a suite of measurements, including self-report questionnaires, objective physical activity and blood biomarkers of cardiovascular disease, in this setting?
Does the intervention have potential to increase cycling and cycle journeys (likely primary outcomes in a future RCT)?
To what extent do participants improve on a range of behavioural, psychological, clinical and work-related outcomes?
Does the intervention have potential to be cost-effective, and what are the range of cost and benefit outcomes that are to be considered?

Interventions:

The intervention has four main components.

Practical skills programme: this has two versions - a core six-week programme (intermediate), with an additional three weeks (nine weeks in total - foundation) covering basic cycling skills. It is designed to be delivered at HSBC offices by trained 'cycle champions' - ideally HSBC staff members. Each session includes group-based learning activities and in-saddle, off- and on-road practical cycle training. Participants will receive information delivered simply in handbook format with a "toolkit" of skills and behaviour change techniques (e.g. goal setting) participants can apply to increase their cycling and maintain this long-term.
Cycle provision scheme: participants will have the opportunity to have their own bicycles serviced or obtain a loaned bike or e-bike from local bike shops before the start of the programme. At the end of the programme, participants will be given support and advice to take part in the HSBC subsidised cycle purchase bike to work scheme.
Cycle-friendly workplace culture: all of the HSBC offices taking part in the study will have a minimum of secure bike locks as part of an ongoing roll-out of cycle infrastructure across HSBC UK offices. During training, the cycle champion will be asked to identify (and subsequently implement) other cycle-friendly features (e.g. availability of cycle tools and spares, flexible hours to avoid peak commuter traffic, flexible dress code, altruistic reward scheme for cycling).
Our Cycle Hub app: an adapted version of an existing HSBC app including route planning, goal setting and practical skills videos, as well as supportive social interaction among participants.

Outcomes:

behavioural - objectively-measured cycling and other physical activity (using the activPAL device and a new algorithm specifically-developed to detect cycling) and self-reported cycling activity, modes of transport, physical activity, sedentary behaviour, sleep, dietary intake.
psychological - self-reported motivation, autonomy, competence, relatedness and perceptions of safety in relation to cycling, wellbeing, self-esteem, vitality, quality of life and perceived general physical health.
work-related - productivity, job satisfaction, occupational stress, absenteeism and presenteeism.
clinical - objectively-measured weight, height, BMI, waist circumference, diastolic and systolic blood pressure. Cardio-metabolic disease risk biomarkers related to glucose, insulin, HbA1c, lipids and liver function will be assessed at baseline and 13 weeks only (opt in).

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Study design: A before-and-after feasibility study with follow up to six months.

Arm	Type	Receives
Feasibility	Experimental	Behavioral: Cycle Nation Multicomponent InterventionThe cycle training intervention group

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Any staff members who currently cycle less than once per month or not at all

Key exclusion criteria (1 listed)

Staff members who currently cycle more than once per month

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cycle Nation Multicomponent InterventionThis intervention group will receive 4 elements: 1. Practical skills programme: a workplace-based programme covering basic cycling skills, delivered by trained 'cycle champions' - HSBC staff members. 2. Cycle provision scheme: participants will have the opportunity to have their own bicycles serviced or obtain a loaned bike or e-bike from local bike shops before the start of the programme. 3. Cycle-friendly workplace culture: all offices taking part will have a minimum of secure bike parking facilities as part of an ongoing roll-out of cycle infrastructure across HSBC UK offices. 4. Our Cycle Hub app: an adapted version of an existing HSBC app including route planning, goal setting and practical skills videos, as well as supportive social interaction among participants.	Behavioural	Feasibility

Primary outcome

Feasibility of intervention delivery: Investigator conducted session observations
Time frame: 9 weeks
To measure the feasibility of delivery of all cycle training components by investigator conducted session observations.
Feasibility of intervention delivery: Investigator conducted interviews
Time frame: 9 weeks
To measure the feasibility of delivery of all cycle training components by investigator conducted interviews with cycle champions.
Cycling behaviour
Time frame: Change from baseline to 13 weeks
Self reported number of people cycling regularly (both monthly and weekly) and number of cycling journeys for transport or leisure in the last month.
Participant and Cycle Champion recruitment
Time frame: Conducted pre baseline
Measeurement of the recruitment of participants and cycle champions.
Participant and Cycle Champion retention
Time frame: Change from baseline to 9 weeks
Measurement of the number of participants and cycle champions who undertake the training course to completion, as well as participant drop-out
Participant adherence to the cycle training course
Time frame: Through study completion to 9 weeks
Measurement of participant attendance to training sessions
Cycle Champion interviews: acceptability of cycle training course delivery
Time frame: 9 weeks
Interview measured acceptability of all elements of intervention delivery (cycle champions)
Participant questionnaire: Likert scale of training course acceptability
Time frame: 9 weeks
Self-reported questionnaire measured acceptability of all elements of intervention delivery

19 secondary outcomes

Objectively-measured incidental physical activity
Time frame: Change from baseline to 13 weeks
Participant questionnaire reported motivation: 15 item Likert scale
Time frame: Change from baseline to 13 weeks
Participant questionnaire measured work-related productivity: Likert scale
Time frame: Change from baseline to 13 weeks
Participant self-reported monthly cycling activity: number of rides and duration
Time frame: Change from baseline to 13 weeks
Participant self-reported dietry intake: DINE questionnaire
Time frame: Change from baseline to 13 weeks
Participant self-reported number of days of work-related absenteeism/presenteeism
Time frame: Change from baseline to 13 weeks
Participant self reported job satisfaction: Likert scale
Time frame: Change from baseline to 13 weeks
Participant self-reported work-related stress: Likert scale
Time frame: Change from baseline to 13 weeks
Participant self-reported autonomy: Likert scale
Time frame: Change from baseline to 13 weeks
Participant self-reported competence: 6 item Likert scale
Time frame: Change from baseline to 13 weeks
Participant self-reported relatedness: 6 item Likert scale
Time frame: Change from baseline to 13 weeks
Participant self-reported perceptions of cycling safety: 5 item Likert scale
Time frame: Change from baseline to 13 weeks
Participant self-reported wellbeing: 14 item Warwick-Edinburgh Mental Wellbeing Scales - WEMWBS
Time frame: Change from baseline to 13 weeks
Participant self-reported self esteem: 10 item Rosenberg scale of self esteem
Time frame: Change from baseline to 13 weeks
Participant self-reported vitality: 4 item Bostic scale
Time frame: Change from baseline to 13 weeks
Participant self-reported general physical health: EQ-5D-5L
Time frame: Change from baseline to 13 weeks
Body mass
Time frame: Change from baseline to 13 weeks
Body Mass Index (BMI)
Time frame: Change from baseline to 13 weeks
Waist circumference
Time frame: Change from baseline to 13 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
Background: PubMed 25344355Kelly P, Kahlmeier S, Gotschi T, Orsini N, Richards J, Roberts N, Scarborough P, Foster C. Systematic review and meta-analysis of reduction in all-cause mortality from walking and cycling and shape of dose response relationship. Int J Behav Nutr Phys Act. 2014 Oct 24;11:132. doi: 10.1186/s12966-014-0132-x.
Background: PubMed 24231462Sahlqvist S, Goodman A, Simmons RK, Khaw KT, Cavill N, Foster C, Luben R, Wareham NJ, Ogilvie D. The association of cycling with all-cause, cardiovascular and cancer mortality: findings from the population-based EPIC-Norfolk cohort. BMJ Open. 2013 Nov 14;3(11):e003797. doi: 10.1136/bmjopen-2013-003797.
Background: PubMed 21450618Schnohr P, Marott JL, Jensen JS, Jensen GB. Intensity versus duration of cycling, impact on all-cause and coronary heart disease mortality: the Copenhagen City Heart Study. Eur J Prev Cardiol. 2012 Feb;19(1):73-80. doi: 10.1177/1741826710393196. Epub 2011 Feb 21.
Background: PubMed 10847255Andersen LB, Schnohr P, Schroll M, Hein HO. All-cause mortality associated with physical activity during leisure time, work, sports, and cycling to work. Arch Intern Med. 2000 Jun 12;160(11):1621-8. doi: 10.1001/archinte.160.11.1621.
Background: PubMed 27895075Oja P, Kelly P, Pedisic Z, Titze S, Bauman A, Foster C, Hamer M, Hillsdon M, Stamatakis E. Associations of specific types of sports and exercise with all-cause and cardiovascular-disease mortality: a cohort study of 80 306 British adults. Br J Sports Med. 2017 May;51(10):812-817. doi: 10.1136/bjsports-2016-096822. Epub 2016 Nov 28.
Background: PubMed 28424154Celis-Morales CA, Lyall DM, Welsh P, Anderson J, Steell L, Guo Y, Maldonado R, Mackay DF, Pell JP, Sattar N, Gill JMR. Association between active commuting and incident cardiovascular disease, cancer, and mortality: prospective cohort study. BMJ. 2017 Apr 19;357:j1456. doi: 10.1136/bmj.j1456.
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Individual participant dataSharing planned: No. These data will only be handled by UoG researchers

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Greig RM Logan, PhD contact

01413304377

greig.logan@glasgow.ac.uk

Jason MR Gill, PhD contact

01413302916

jason.gill@glasgow.ac.uk

Jason MR Gill, PhD principal investigator

University of Glasgow

Cindy M Gray, PhD principal investigator

University of Glasgow

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cycle Nation Multicomponent Intervention in people with Health Behavior, run by University of Glasgow at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Greig RM Logan, PhD (01413304377, greig.logan@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of intervention delivery: Investigator conducted session observations (time frame: 9 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04035941, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.