The Cycle Nation Project (Phase 2: Feasibility)

July 24, 2019 updated by: Professor Jason Gill, University of Glasgow

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

Unknown

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Glasgow, United Kingdom, G12 8QQ
        • University of Glasgow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  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.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jason MR Gill, PhD, University of Glasgow
  • Principal Investigator: Cindy M Gray, PhD, University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 5, 2019

Primary Completion (ANTICIPATED)

April 30, 2020

Study Completion (ANTICIPATED)

March 31, 2021

Study Registration Dates

First Submitted

July 19, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (ACTUAL)

July 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 200180138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

These data will only be handled by UoG researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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