The Cycle Nation Project (Phase 2: Feasibility)

Health Behavior Clinical Trial

Official title:

The Cycle Nation Project: A Workplace Intervention to Increase the Number of People Cycling Regularly (Phase 2: Feasibility)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04035941
• Other study ID #: 200180138
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2019
• Source: University of Glasgow
• Contact: Greig RM Logan, PhD
• Phone: 01413304377
• Email: greig.logan[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 31, 2021
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• Cycle Nation Multicomponent Intervention
This intervention group will receive 4 elements: Practical skills programme: a workplace-based programme covering basic cycling skills, delivered by trained 'cycle champions' - HSBC staff members. 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. 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. 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.

Locations

Country	Name	City	State
United Kingdom	University of Glasgow	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

References & Publications (24)

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. — View Citation

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. Review. — View Citation

Blond K, Jensen MK, Rasmussen MG, Overvad K, Tjønneland A, Østergaard L, Grøntved A. Prospective Study of Bicycling and Risk of Coronary Heart Disease in Danish Men and Women. Circulation. 2016 Nov 1;134(18):1409-1411. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Dec 7. — View Citation

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. — View Citation

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. — View Citation

Kelly P, Kahlmeier S, Götschi 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. Review. — View Citation

Kubesch NJ, Therming Jørgensen J, Hoffmann B, Loft S, Nieuwenhuijsen MJ, Raaschou-Nielsen O, Pedersen M, Hertel O, Overvad K, Tjønneland 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). pii: e009554. doi: 10.1161/JAHA.118.009554. — View Citation

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. — View Citation

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. — View Citation

Møller NC, Østergaard 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Rasmussen MG, Grøntved A, Blond K, Overvad K, Tjønneland A, Jensen MK, Østergaard 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. — View Citation

Rasmussen MG, Overvad K, Tjønneland A, Jensen MK, Østergaard L, Grøntved 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure		Change from baseline to 13 weeks
Other	Homestasis Model Estimated Insulin Resistance (HOMA-IR)	Calculated from fasting insulin and glucose concentrations	Change from baseline to 13 weeks
Primary	Feasibility of intervention delivery: Investigator conducted session observations	To measure the feasibility of delivery of all cycle training components by investigator conducted session observations.	9 weeks
Primary	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.	9 weeks
Primary	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.	Change from baseline to 13 weeks
Primary	Participant and Cycle Champion recruitment	Measeurement of the recruitment of participants and cycle champions.	Conducted pre baseline
Primary	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	Change from baseline to 9 weeks
Primary	Participant adherence to the cycle training course	Measurement of participant attendance to training sessions	Through study completion to 9 weeks
Primary	Cycle Champion interviews: acceptability of cycle training course delivery	Interview measured acceptability of all elements of intervention delivery (cycle champions)	9 weeks
Primary	Participant questionnaire: Likert scale of training course acceptability	Self-reported questionnaire measured acceptability of all elements of intervention delivery	9 weeks
Secondary	Objectively-measured incidental physical activity	Minutes spent in activity per day measured using the activPAL device.	Change from baseline to 13 weeks
Secondary	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)	Change from baseline to 13 weeks
Secondary	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)	Change from baseline to 13 weeks
Secondary	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.	Change from baseline to 13 weeks
Secondary	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.	Change from baseline to 13 weeks
Secondary	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)	Change from baseline to 13 weeks
Secondary	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)	Change from baseline to 13 weeks
Secondary	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)	Change from baseline to 13 weeks
Secondary	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.	Change from baseline to 13 weeks
Secondary	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.	Change from baseline to 13 weeks
Secondary	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	Change from baseline to 13 weeks
Secondary	Participant self-reported perceptions of cycling safety: 5 item Likert scale	Questionnaire measured scale of perceptions of cycling safety	Change from baseline to 13 weeks
Secondary	Participant self-reported wellbeing: 14 item Warwick-Edinburgh Mental Wellbeing Scales - WEMWBS	Questionnaire measured participant wellbeing.	Change from baseline to 13 weeks
Secondary	Participant self-reported self esteem: 10 item Rosenberg scale of self esteem	Self-esteem questionnaire	Change from baseline to 13 weeks
Secondary	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)	Change from baseline to 13 weeks
Secondary	Participant self-reported general physical health: EQ-5D-5L	Questionnaire measure of health-related quality of life	Change from baseline to 13 weeks
Secondary	Body mass	Body mass in kilograms	Change from baseline to 13 weeks
Secondary	Body Mass Index (BMI)	Weight and height will be combined to report BMI in kg/m^2	Change from baseline to 13 weeks
Secondary	Waist circumference	Waist circumference in centimeters	Change from baseline to 13 weeks