NCT04035941

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

August 5, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

July 19, 2019

Last Update Submit

July 24, 2019

Conditions

Keywords

physical activitycycling

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • Participant and Cycle Champion recruitment

    Measeurement of the recruitment of participants and cycle champions.

    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

    Change from baseline to 9 weeks

  • Participant adherence to the cycle training course

    Measurement of participant attendance to training sessions

    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)

    9 weeks

  • Participant questionnaire: Likert scale of training course acceptability

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

    9 weeks

Secondary Outcomes (19)

  • Objectively-measured incidental physical activity

    Change from baseline to 13 weeks

  • Participant questionnaire reported motivation: 15 item Likert scale

    Change from baseline to 13 weeks

  • Participant questionnaire measured work-related productivity: Likert scale

    Change from baseline to 13 weeks

  • Participant self-reported monthly cycling activity: number of rides and duration

    Change from baseline to 13 weeks

  • Participant self-reported dietry intake: DINE questionnaire

    Change from baseline to 13 weeks

  • +14 more secondary outcomes

Other Outcomes (2)

  • Blood pressure

    Change from baseline to 13 weeks

  • Homestasis Model Estimated Insulin Resistance (HOMA-IR)

    Change from baseline to 13 weeks

Study Arms (1)

Feasibility

EXPERIMENTAL

The cycle training intervention group

Behavioral: Cycle Nation Multicomponent Intervention

Interventions

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.

Feasibility

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Staff members who currently cycle more than once per month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Glasgow

Glasgow, G12 8QQ, United Kingdom

Location

Related Publications (24)

  • 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.

    PMID: 25344355BACKGROUND
  • 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.

    PMID: 24231462BACKGROUND
  • 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.

    PMID: 21450618BACKGROUND
  • 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.

    PMID: 10847255BACKGROUND
  • 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.

    PMID: 27895075BACKGROUND
  • 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.

    PMID: 28424154BACKGROUND
  • 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.

    PMID: 27799259BACKGROUND
  • 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.

    PMID: 30021805BACKGROUND
  • 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.

    PMID: 20543701BACKGROUND
  • 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.

    PMID: 12387651BACKGROUND
  • 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.

    PMID: 23776412BACKGROUND
  • 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.

    PMID: 23953354BACKGROUND
  • 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.

    PMID: 27403867BACKGROUND
  • 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.

    PMID: 29030265BACKGROUND
  • 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.

    PMID: 25273856BACKGROUND
  • 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.

    PMID: 29443821BACKGROUND
  • 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.

    PMID: 21496106BACKGROUND
  • 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.

    PMID: 18067515BACKGROUND
  • 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.

    PMID: 21708185BACKGROUND
  • 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.

    PMID: 25481703BACKGROUND
  • 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.

    PMID: 26740344BACKGROUND
  • 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.

    PMID: 21816732BACKGROUND
  • 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.

    PMID: 26275902BACKGROUND
  • 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.

    PMID: 23477577BACKGROUND

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jason MR Gill, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR
  • Cindy M Gray, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Greig RM Logan, PhD

CONTACT

Jason MR Gill, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Study design: A before-and-after feasibility study with follow up to six months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiometabolic Health

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 29, 2019

Study Start

August 5, 2019

Primary Completion

April 30, 2020

Study Completion

March 31, 2021

Last Updated

July 29, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

These data will only be handled by UoG researchers

Locations