Table 2 List of PEDAL-2 study objectives, associated outcomes, data collection tools, time point measurements and analysis plan

1. Identify effective methods of recruiting individuals with T2DM

• # GP practices approached; # that agree to act as PIC

• # individuals identified through GP database searches; response rate to information letters

• # participants recruited from each recruitment setting

• # individuals that consent to be part of the study

Study records

X

Frequencies and percentages

2. Determine participants willingness to be randomized, study retention rates, adherence to the intervention and data collection methods and report harmful outcomes

• # participants retained in study following randomization

• # Individuals that complete follow-up testing

• # of participants that attend each of the intervention sessions and data collection sessions

• # of harmful events

Study records

X

Frequencies and percentages

3. Assess intervention fidelity

• # of training sessions attended by participants and additional contact with instructors

• Extent to which intervention content is completed as planned

Intervention checklists

X

Frequencies and Percentages

4. Estimate the potential effect of the intervention on a range of health and behaviour outcomes to inform outcome selection in future trials

• Weight, height, BMI

Tanita digital scales, SECA 700

X

X

Comparison of change scores between conditions

• Waist circumference

Non-stretch tape measure

X

X

• Fasting glucose, insulin, lipids, C-reactive protein, HOMA-IR, HOMA-B

8-mL blood sample

X

X

• OGTT outcomes: iAUC for glucose and insulin, Matsuda index, insulinogenic index and oral glucose disposition index

2 mL blood samples at 15, 30, 45, 60, 90, 120 min post 75 g of anhydrous glucose

X

X

Reporting of effect estimates with 95% CI

• Health-related quality of life: physical and mental summary

Short Form 36 Health Survey [39]

X

X

• Cardiorespiratory fitness

Maximum oxygen uptake using cycle ergometer

X

X

• Body composition: whole-body fat mass, regional fat mass, whole-body lean mass, regional fat mass

Dual-energy x-ray absorptiometry

X

X

Comparison of change scores between conditions

• Femur intermuscular adipose tissue, muscle density and muscle cross-sectional area

Peripheral quantitative computer tomography

• Total physical activity (time spent in moderate-to-vigorous physical activity)

Actigraph (GT3X)

X

X

Reporting of effect estimates with 95% CI

• Moderate to vigorous physical due to e-cycling and other modes of active travel

Actigraph (GT3X), Actiheart and QStarz GPS

• Transportation modes (walking, cycling, e-cycling, car, bus, train)

Actigraph (GT3X), Actiheart and QStarz GPS

X

X

• Trip purpose (e.g., commuting, business, education, escorting, shopping, visiting friends, entertainment, recreation)

Travel diary

X

X

• Estimated CO₂ emissions

Actigraph (GT3X) and QStarz GPS, travel diary following procedures by Neves and Brand [48]

X

X

• E-cycling behaviour: # journeys, distance travelled, pattern of e-bike use

Bike odometer and Garmin 130 GPS

X

Mean and SD

Qualitatively examine the acceptability of the intervention and study procedures to participants and instructors

• Acceptability of intervention to participants

• Acceptability of study procedures to participants

• Acceptability of intervention delivery to instructors

Semi-structured interviews

X

Thematic analysis based on objective

Qualitatively examine participants experiences of e-cycling

• Participants barriers and facilitators to e-cycling

Semi-structured interviews

X

Thematic analysis based on objective