Clinical trial NCT04035941: The Cycle Nation Project (Phase 2: Feasibility)
Official title: The Cycle Nation Project: A Workplace Intervention to Increase the Number of People Cycling Regularly (Phase 2: Feasibility)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Keywords: physical activity
cycling
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
First posted: 2019-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study design: A before-and-after feasibility study with follow up to six months.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of intervention delivery: Investigator conducted session observations
timeFrame: 9 weeks
measure: Feasibility of intervention delivery: Investigator conducted interviews
timeFrame: 9 weeks
measure: Cycling behaviour
timeFrame: Change from baseline to 13 weeks
measure: Participant and Cycle Champion recruitment
timeFrame: Conducted pre baseline
measure: Participant and Cycle Champion retention
timeFrame: Change from baseline to 9 weeks
measure: Participant adherence to the cycle training course
timeFrame: Through study completion to 9 weeks
measure: Cycle Champion interviews: acceptability of cycle training course delivery
timeFrame: 9 weeks
measure: Participant questionnaire: Likert scale of training course acceptability
timeFrame: 9 weeks
Secondary outcomes:
measure: Objectively-measured incidental physical activity
timeFrame: Change from baseline to 13 weeks
measure: Participant questionnaire reported motivation: 15 item Likert scale
timeFrame: Change from baseline to 13 weeks
measure: Participant questionnaire measured work-related productivity: Likert scale
timeFrame: Change from baseline to 13 weeks
measure: Participant self-reported monthly cycling activity: number of rides and duration
timeFrame: Change from baseline to 13 weeks
measure: Participant self-reported dietry intake: DINE questionnaire
timeFrame: Change from baseline to 13 weeks
measure: Participant self-reported number of days of work-related absenteeism/presenteeism
timeFrame: Change from baseline to 13 weeks
measure: Participant self reported job satisfaction: Likert scale
timeFrame: Change from baseline to 13 weeks
measure: Participant self-reported work-related stress: Likert scale
timeFrame: Change from baseline to 13 weeks
measure: Participant self-reported autonomy: Likert scale
timeFrame: Change from baseline to 13 weeks
measure: Participant self-reported competence: 6 item Likert scale
timeFrame: Change from baseline to 13 weeks
measure: Participant self-reported relatedness: 6 item Likert scale
timeFrame: Change from baseline to 13 weeks
measure: Participant self-reported perceptions of cycling safety: 5 item Likert scale
timeFrame: Change from baseline to 13 weeks
measure: Participant self-reported wellbeing: 14 item Warwick-Edinburgh Mental Wellbeing Scales - WEMWBS
timeFrame: Change from baseline to 13 weeks
measure: Participant self-reported self esteem: 10 item Rosenberg scale of self esteem
timeFrame: Change from baseline to 13 weeks
measure: Participant self-reported vitality: 4 item Bostic scale
timeFrame: Change from baseline to 13 weeks
measure: Participant self-reported general physical health: EQ-5D-5L
timeFrame: Change from baseline to 13 weeks
measure: Body mass
timeFrame: Change from baseline to 13 weeks
measure: Body Mass Index (BMI)
timeFrame: Change from baseline to 13 weeks
measure: Waist circumference
timeFrame: Change from baseline to 13 weeks
Other outcomes:
measure: Blood pressure
timeFrame: Change from baseline to 13 weeks
measure: Homestasis Model Estimated Insulin Resistance (HOMA-IR)
timeFrame: Change from baseline to 13 weeks
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow
Study officials:
affiliation: University of Glasgow
name: Jason MR Gill, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Cindy M Gray, PhD
role: PRINCIPAL_INVESTIGATOR
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