- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04035941
The Cycle Nation Project (Phase 2: Feasibility)
The Cycle Nation Project: A Workplace Intervention to Increase the Number of People Cycling Regularly (Phase 2: Feasibility)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Greig RM Logan, PhD
- Phone Number: 01413304377
- Email: greig.logan@glasgow.ac.uk
Study Contact Backup
- Name: Jason MR Gill, PhD
- Phone Number: 01413302916
- Email: jason.gill@glasgow.ac.uk
Study Locations
-
-
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Glasgow, United Kingdom, G12 8QQ
- University of Glasgow
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any staff members who currently cycle less than once per month or not at all
Exclusion Criteria:
- Staff members who currently cycle more than once per month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Feasibility
The cycle training intervention group
|
This intervention group will receive 4 elements:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
9 weeks
|
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.
|
9 weeks
|
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.
|
Change from baseline to 13 weeks
|
Participant and Cycle Champion recruitment
Time Frame: Conducted pre baseline
|
Measeurement of the recruitment of participants and cycle champions.
|
Conducted pre baseline
|
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
|
Change from baseline to 9 weeks
|
Participant adherence to the cycle training course
Time Frame: Through study completion to 9 weeks
|
Measurement of participant attendance to training sessions
|
Through study completion to 9 weeks
|
Cycle Champion interviews: acceptability of cycle training course delivery
Time Frame: 9 weeks
|
Interview measured acceptability of all elements of intervention delivery (cycle champions)
|
9 weeks
|
Participant questionnaire: Likert scale of training course acceptability
Time Frame: 9 weeks
|
Self-reported questionnaire measured acceptability of all elements of intervention delivery
|
9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objectively-measured incidental physical activity
Time Frame: Change from baseline to 13 weeks
|
Minutes spent in activity per day measured using the activPAL device.
|
Change from baseline to 13 weeks
|
Participant questionnaire reported motivation: 15 item Likert scale
Time Frame: Change from baseline to 13 weeks
|
15 item scale adapted from Markland, D. & Tobin, V. (2004).
Journal of Sport and Exercise Psychology, 26, 191-196 (BREQ-2 for PA)
|
Change from baseline to 13 weeks
|
Participant questionnaire measured work-related productivity: Likert scale
Time Frame: Change from baseline to 13 weeks
|
Likert scale of productivity adapted from Kessler et al's World Health Organisation Health and Work Performance Questionnaire (HPQ)
|
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
|
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. |
Change from baseline to 13 weeks
|
Participant self-reported dietry intake: DINE questionnaire
Time Frame: Change from baseline to 13 weeks
|
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.
|
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
|
Self reported days per month of absenteeism/presenteeism adapted from Kessler et al's World Health Organisation Health and Work Performance Questionnaire (HPQ)
|
Change from baseline to 13 weeks
|
Participant self reported job satisfaction: Likert scale
Time Frame: Change from baseline to 13 weeks
|
Questionnaire measured job satisfaction adapted from Kessler et al's World Health Organisation Health and Work Performance Questionnaire (HPQ)
|
Change from baseline to 13 weeks
|
Participant self-reported work-related stress: Likert scale
Time Frame: Change from baseline to 13 weeks
|
Questionnaire measured work-related stress adapted from Kessler et al's World Health Organisation Health and Work Performance Questionnaire (HPQ)
|
Change from baseline to 13 weeks
|
Participant self-reported autonomy: Likert scale
Time Frame: Change from baseline to 13 weeks
|
Questionnaire measured autonomy adapted from Bartholomew, K. J., Ntoumanis, N., Ryan, R. M., & Thøgersen-Ntoumani, C. (2011).
Journal of Sport & Exercise Psychology, 33, 75e102.
|
Change from baseline to 13 weeks
|
Participant self-reported competence: 6 item Likert scale
Time Frame: Change from baseline to 13 weeks
|
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.
|
Change from baseline to 13 weeks
|
Participant self-reported relatedness: 6 item Likert scale
Time Frame: Change from baseline to 13 weeks
|
Questionnaire measured relatedness adapted from Van den Broeck et al (2010).
J Occup Organiz Psych 83:981-1002
|
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
|
Questionnaire measured scale of perceptions of cycling safety
|
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
|
Questionnaire measured participant wellbeing.
|
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
|
Self-esteem questionnaire
|
Change from baseline to 13 weeks
|
Participant self-reported vitality: 4 item Bostic scale
Time Frame: Change from baseline to 13 weeks
|
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)
|
Change from baseline to 13 weeks
|
Participant self-reported general physical health: EQ-5D-5L
Time Frame: Change from baseline to 13 weeks
|
Questionnaire measure of health-related quality of life
|
Change from baseline to 13 weeks
|
Body mass
Time Frame: Change from baseline to 13 weeks
|
Body mass in kilograms
|
Change from baseline to 13 weeks
|
Body Mass Index (BMI)
Time Frame: Change from baseline to 13 weeks
|
Weight and height will be combined to report BMI in kg/m^2
|
Change from baseline to 13 weeks
|
Waist circumference
Time Frame: Change from baseline to 13 weeks
|
Waist circumference in centimeters
|
Change from baseline to 13 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: Change from baseline to 13 weeks
|
Change from baseline to 13 weeks
|
|
Homestasis Model Estimated Insulin Resistance (HOMA-IR)
Time Frame: Change from baseline to 13 weeks
|
Calculated from fasting insulin and glucose concentrations
|
Change from baseline to 13 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jason MR Gill, PhD, University of Glasgow
- Principal Investigator: Cindy M Gray, PhD, University of Glasgow
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 200180138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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