The Cycle Nation Project (Phase 2: Feasibility)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Health Behavior

Intervention / Treatment
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* Behavioral: Cycle Nation Multicomponent Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Study design: A before-and-after feasibility study with follow up to six months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feasibility<br>The cycle training intervention group | Behavioral: Cycle Nation Multicomponent Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objectively-measured incidental physical activity | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Questionnaire measured participant wellbeing. | Change from baseline to 13 weeks | 
| Participant self-reported self esteem: 10 item Rosenberg scale of self esteem | Self-esteem questionnaire | Change from baseline to 13 weeks | 
| 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 | 
| Participant self-reported general physical health: EQ-5D-5L | Questionnaire measure of health-related quality of life | Change from baseline to 13 weeks | 
| Body mass | Body mass in kilograms | Change from baseline to 13 weeks | 
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2 | Change from baseline to 13 weeks | 
| Waist circumference | Waist circumference in centimeters | Change from baseline to 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, cycling