Self-Management Group Education to Reduce Fear of Hypoglycemia as a Barrier to Physical Activity in Adults Living With Type 1 Diabetes: A Pilot Randomized Controlled Trial.

Objectives: The aim of this study was to evaluate the feasibility, acceptability and preliminary efficacy of a theory-driven group education intervention designed to reduce fear of hypoglycemia (FoH) as a barrier to physical activity (PA) in adults with type 1 diabetes (T1D).
Methods: This study was a single-blinded, pilot randomized controlled trial of adults aged 18 to 65 years and living with T1D in Western Australia. Participants were randomized (1:1) to standard care or intervention with self-management education. Primary outcomes were feasibility and acceptability of the study procedures, and change to barriers to PA and FoH. Secondary outcomes were change to attitudes and intentions toward PA, self-reported participation in PA, self-efficacy, diabetes distress and well-being. To calculate effect sizes, we used a Bayesian comparison of the between-group difference scores (i.e. [score _t2  - score _t1 ] _TREATMENT vs [score _t2  - score _t1 ] _CONTROL ).
Results: We randomized 117 participants with T1D, 86 (74%) of whom provided baseline data and attended initial workshops. Of these participants, 81% attended the booster workshop 4 weeks later. They were 45±12 years of age, reported high levels of activity and had been living with T1D for 20±14 years. Small-to-moderate effect sizes [ESs] in favour of the intervention were observed at 12 weeks for overall barriers to PA (ES, -0.38; highest density interval, -0.92 to 0.17), self-efficacy for blood glucose management after PA (ES, 0.45; highest density interval, 0 to 0.91), diabetes distress (ES, -0.29; highest density interval, -0.77 to 0.15) and well-being (ES, 0.36; highest density interval, -0.12 to 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 for improving PA participation.
(Copyright © 2021 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.)