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

From: Electrically assisted cycling for individuals with type 2 diabetes mellitus: protocol for a pilot randomized controlled trial

Study objectivesOutcomeData collection method/toolTime point of measurementAnalysis plan
Baseline (T0)During interventionFollow-up (T1) 
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 recordsX  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, BMITanita digital scales, SECA 700X XComparison of change scores between conditions
• Waist circumferenceNon-stretch tape measureX X
• Fasting glucose, insulin, lipids, C-reactive protein, HOMA-IR, HOMA-B8-mL blood sampleX X
• OGTT outcomes: iAUC for glucose and insulin, Matsuda index, insulinogenic index and oral glucose disposition index2 mL blood samples at 15, 30, 45, 60, 90, 120 min post 75 g of anhydrous glucoseX XReporting of effect estimates with 95% CI
• Health-related quality of life: physical and mental summaryShort Form 36 Health Survey [39]X X
• Cardiorespiratory fitnessMaximum oxygen uptake using cycle ergometerX X
• Body composition: whole-body fat mass, regional fat mass, whole-body lean mass, regional fat massDual-energy x-ray absorptiometryX XComparison of change scores between conditions
• Femur intermuscular adipose tissue, muscle density and muscle cross-sectional areaPeripheral quantitative computer tomography
• Total physical activity (time spent in moderate-to-vigorous physical activity)Actigraph (GT3X)X XReporting of effect estimates with 95% CI
• Moderate to vigorous physical due to e-cycling and other modes of active travelActigraph (GT3X), Actiheart and QStarz GPS
• Transportation modes (walking, cycling, e-cycling, car, bus, train)Actigraph (GT3X), Actiheart and QStarz GPSX X
• Trip purpose (e.g., commuting, business, education, escorting, shopping, visiting friends, entertainment, recreation)Travel diaryX X
• Estimated CO2 emissionsActigraph (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 useBike 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  XThematic analysis based on objective
Qualitatively examine participants experiences of e-cycling• Participants barriers and facilitators to e-cyclingSemi-structured interviews  XThematic analysis based on objective
  1. T2DM type 2 diabetes mellitus, GP general practitioner, PIC participant identification center, HOMA-IR Homeostasis Model Assessment for assessing insulin resistance, HOMA-B homeostatic model assessment for assessing β-cell function, OGTT oral glucose tolerance test, iAUC incremental area under the curve, CO2 carbon dioxide, CI confidence interval, SD standard deviation