Abstract
BACKGROUND: The global incidence of type 2 diabetes mellitus (T2DM) is increasing. Given the many complications associated with T2DM, effective management of the disease is crucial. Physical activity is considered to be a key component of T2DM management. However, people with T2DM are generally less physically active than individuals without T2DM and adherence to physical activity is often poor following completion of lifestyle interventions. As such, developing interventions that foster sustainable physical activity is of high priority. Electrically assisted bicycles (e-bikes) have been highlighted as a potential strategy for promoting physical activity in this population. E-bikes provide electrical assistance to the rider only when pedalling and could overcome commonly reported barriers to regular cycling. This paper describes the protocol of the PEDAL-2 pilot randomized controlled trial, an e-cycling intervention aimed at increasing physical activity in individuals with T2DM. METHODS: A parallel-group two-arm randomized waitlist-controlled pilot trial will be conducted. Forty individuals with T2DM will be randomly assigned, in a 1:1 allocation ratio, to an e-cycling intervention or waitlist control. Recruitment and screening will close once 20 participants have been randomized to each study arm. The intervention will involve e-bike training with a certified cycle instructor and provision of an e-bike for 12 weeks. Data will be collected at baseline, during the intervention and immediately post-intervention using both quantitative and qualitative methods. In this trial, the primary interests are determination of effective recruitment strategies, recruitment and consent rates, adherence and retention and delivery and receipt of the intervention. The potential impact of the intervention on a range of clinical, physiological and behaviour outcomes will be assessed to examine intervention promise. Data analyses will be descriptive. DISCUSSION: This paper describes the protocol for the PEDAL-2 pilot randomized controlled trial. Results from this trial will provide information on trial feasibility and identify the promise of e-cycling as a strategy to positively impact the health and behaviour of individuals with T2DM. If appropriate, this information can be used to design and deliver a fully powered definitive trial. TRIAL REGISTRATION: ISRCTN, ISRCTN67421464. Registered 03/01/2019.