Self-management group education to reduce fear of hypoglycaemia as a barrier to physical activity in people living with type 1 diabetes: A pilot randomised controlled trial.

Abstract Aim To evaluate the feasibility, acceptability, and preliminary efficacy of a theory-driven, group education intervention designed to reduce fear of hypoglycaemia (FoH) as a barrier to physical activity (PA) in adults with type 1 diabetes (T1D). Methods A pilot, single blinded pilot randomised controlled trial in adults aged between 18-65 years, living with T1D in Western Australia. Participants were randomised (1:1) to standard care or intervention - self-management education. Primary outcomes were feasibility and acceptability of the study procedures, and change to barriers to PA – FoH. Secondary outcomes were change to attitudes and intentions towards PA, self-reported participation in PA, self-efficacy, diabetes distress, and well-being. To calculate effect sizes, we used Bayesian comparison of the between group difference scores (i.e., [scoret2 – scoret1]TREATMENT vs [scoret2 – scoret1]CONTROL). Results We randomised 117 participants; 86 (74%) completed baseline data and attended initial workshops. Of those, 81% attended the booster workshop four-weeks later. Participants were 45 ±12 years of age, reported high levels of activity, and had been living with T1D for over 20 ±14 years. Small-moderate effect sizes in favour of the intervention were observed at 12-weeks for overall barriers to PA (ES=-0.38 [Highest Density Interval -0.92, 0.17]), self-efficacy for blood glucose management after PA (ES=0.45 [0, 0.91]), diabetes distress (ES=-0.29 [-0.77, 0.15]), and well-being (ES=0.36 [-0.12, 0.8]). Conclusions Quantitative findings indicate study procedures were acceptable to participants and feasible to deliver. A future definitive trial is justified to replicate preliminary efficacy and to determine the utility of the intervention in improving PA participation.