CClinicalTrials.gg
Status unknownNCT04035941Updated Jul 29, 2019

The Cycle Nation Project (Phase 2: Feasibility)

An interventional study of Cycle Nation Multicomponent Intervention in Health Behavior, sponsored by University of Glasgow. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-29.

Sponsored by University of Glasgow · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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:

  1. Can sufficient (\~20-30) employees per HSBC office be recruited to take part in the intervention?
  2. Can participants be retained in the study for up to three months?
  3. To what extent do participants receive the intervention as intended (exposure)?
  4. To what extent is the intervention acceptable to participants, those leading the intervention (local cycle champions), local HSBC office management and local bike providers?
  5. 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?
  6. Does the intervention have potential to increase cycling and cycle journeys (likely primary outcomes in a future RCT)?
  7. To what extent do participants improve on a range of behavioural, psychological, clinical and work-related outcomes?
  8. 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.

  1. 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.
  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. 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.
  3. 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).
  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.

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.

  1. 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.
  2. 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.
  3. work-related - productivity, job satisfaction, occupational stress, absenteeism and presenteeism.
  4. 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.

02

Conditions studied

  • Health Behavior

Keywords

  • physical activity
  • cycling
03

In context

Lead sponsor

University of Glasgow is the lead sponsor of 141 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Staff members who currently cycle more than once per month
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Feasibility

    The cycle training intervention group

    Behavioral: Cycle Nation Multicomponent Intervention

Interventions

  • BehavioralCycle Nation Multicomponent Intervention

    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.

06

What researchers measure

Primary outcomes

  1. Feasibility of intervention delivery: Investigator conducted session observations

    To measure the feasibility of delivery of all cycle training components by investigator conducted session observations.

    Time frame: 9 weeks

  2. 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.

    Time frame: 9 weeks

  3. 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.

    Time frame: Change from baseline to 13 weeks

  4. Participant and Cycle Champion recruitment

    Measeurement of the recruitment of participants and cycle champions.

    Time frame: Conducted pre baseline

  5. 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

    Time frame: Change from baseline to 9 weeks

  6. Participant adherence to the cycle training course

    Measurement of participant attendance to training sessions

    Time frame: Through study completion to 9 weeks

  7. Cycle Champion interviews: acceptability of cycle training course delivery

    Interview measured acceptability of all elements of intervention delivery (cycle champions)

    Time frame: 9 weeks

  8. Participant questionnaire: Likert scale of training course acceptability

    Self-reported questionnaire measured acceptability of all elements of intervention delivery

    Time frame: 9 weeks

Secondary outcomes

  1. Objectively-measured incidental physical activity

    Minutes spent in activity per day measured using the activPAL device.

    Time frame: Change from baseline to 13 weeks

  2. 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)

    Time frame: Change from baseline to 13 weeks

  3. 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)

    Time frame: Change from baseline to 13 weeks

  4. 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.

    Time frame: Change from baseline to 13 weeks

  5. 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.

    Time frame: Change from baseline to 13 weeks

  6. 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)

    Time frame: Change from baseline to 13 weeks

  7. 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)

    Time frame: Change from baseline to 13 weeks

  8. 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)

    Time frame: Change from baseline to 13 weeks

  9. 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.

    Time frame: Change from baseline to 13 weeks

  10. 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.

    Time frame: Change from baseline to 13 weeks

  11. 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

    Time frame: Change from baseline to 13 weeks

  12. Participant self-reported perceptions of cycling safety: 5 item Likert scale

    Questionnaire measured scale of perceptions of cycling safety

    Time frame: Change from baseline to 13 weeks

  13. Participant self-reported wellbeing: 14 item Warwick-Edinburgh Mental Wellbeing Scales - WEMWBS

    Questionnaire measured participant wellbeing.

    Time frame: Change from baseline to 13 weeks

  14. Participant self-reported self esteem: 10 item Rosenberg scale of self esteem

    Self-esteem questionnaire

    Time frame: Change from baseline to 13 weeks

  15. 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)

    Time frame: Change from baseline to 13 weeks

  16. Participant self-reported general physical health: EQ-5D-5L

    Questionnaire measure of health-related quality of life

    Time frame: Change from baseline to 13 weeks

  17. Body mass

    Body mass in kilograms

    Time frame: Change from baseline to 13 weeks

  18. Body Mass Index (BMI)

    Weight and height will be combined to report BMI in kg/m\^2

    Time frame: Change from baseline to 13 weeks

  19. Waist circumference

    Waist circumference in centimeters

    Time frame: Change from baseline to 13 weeks

Other outcomes

  1. Blood pressure

    Time frame: Change from baseline to 13 weeks

  2. Homestasis Model Estimated Insulin Resistance (HOMA-IR)

    Calculated from fasting insulin and glucose concentrations

    Time frame: Change from baseline to 13 weeks

07

Study locations

1 site
  • University of Glasgow
    Glasgow, G12 8QQ, United Kingdom
08

References and documents

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 ↗
  • Rasmussen MG, Overvad K, Tjonneland A, Jensen MK, Ostergaard L, Grontved A. Changes in Cycling and Incidence of Overweight and Obesity among Danish Men and Women. Med Sci Sports Exerc. 2018 Jul;50(7):1413-1421. doi: 10.1249/MSS.0000000000001577. PubMed 29443821 ↗
  • Oja P, Titze S, Bauman A, de Geus B, Krenn P, Reger-Nash B, Kohlberger T. Health benefits of cycling: a systematic review. Scand J Med Sci Sports. 2011 Aug;21(4):496-509. doi: 10.1111/j.1600-0838.2011.01299.x. Epub 2011 Apr 18. PubMed 21496106 ↗
  • de Geus B, Van Hoof E, Aerts I, Meeusen R. Cycling to work: influence on indexes of health in untrained men and women in Flanders. Coronary heart disease and quality of life. Scand J Med Sci Sports. 2008 Aug;18(4):498-510. doi: 10.1111/j.1600-0838.2007.00729.x. Epub 2007 Dec 7. PubMed 18067515 ↗
  • Moller NC, Ostergaard L, Gade JR, Nielsen JL, Andersen LB. The effect on cardiorespiratory fitness after an 8-week period of commuter cycling--a randomized controlled study in adults. Prev Med. 2011 Sep;53(3):172-7. doi: 10.1016/j.ypmed.2011.06.007. Epub 2011 Jun 25. PubMed 21708185 ↗
  • Crane M, Rissel C, Standen C, Greaves S. Associations between the frequency of cycling and domains of quality of life. Health Promot J Austr. 2014 Dec;25(3):182-5. doi: 10.1071/HE14053. PubMed 25481703 ↗
  • Mytton OT, Panter J, Ogilvie D. Longitudinal associations of active commuting with wellbeing and sickness absence. Prev Med. 2016 Mar;84:19-26. doi: 10.1016/j.ypmed.2015.12.010. Epub 2015 Dec 29. PubMed 26740344 ↗
  • Rojas-Rueda D, de Nazelle A, Tainio M, Nieuwenhuijsen MJ. The health risks and benefits of cycling in urban environments compared with car use: health impact assessment study. BMJ. 2011 Aug 4;343:d4521. doi: 10.1136/bmj.d4521. PubMed 21816732 ↗
  • Stewart G, Anokye NK, Pokhrel S. What interventions increase commuter cycling? A systematic review. BMJ Open. 2015 Aug 14;5(8):e007945. doi: 10.1136/bmjopen-2015-007945. PubMed 26275902 ↗
  • Bird EL, Baker G, Mutrie N, Ogilvie D, Sahlqvist S, Powell J. Behavior change techniques used to promote walking and cycling: a systematic review. Health Psychol. 2013 Aug;32(8):829-38. doi: 10.1037/a0032078. Epub 2013 Mar 11. PubMed 23477577 ↗

Individual participant data

Plan to share: No — These data will only be handled by UoG researchers

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04035941
Lead sponsor
University of Glasgow
Collaborators
University of Edinburgh
Responsible party
Professor Jason Gill (Professor of Cardiometabolic Health, University of Glasgow) — Principal investigator
First posted
Jul 29, 2019
Start date
Aug 5, 2019 (estimated)
Primary completion
Apr 30, 2020 (estimated)
Completion
Mar 31, 2021 (estimated)
Last update
Jul 29, 2019

Study contacts

Greig RM Logan, PhD
Contact
greig.logan@glasgow.ac.uk
01413304377
Jason MR Gill, PhD
Contact
jason.gill@glasgow.ac.uk
01413302916
Jason MR Gill, PhD
principal investigator · University of Glasgow
Cindy M Gray, PhD
principal investigator · University of Glasgow

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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