A pilot and feasibility study of a randomized clinical trial testing a self-compassion intervention aimed to increase physical activity behaviour among people with prediabetes

Abstract

Background Seventy-five per cent of individuals with prediabetes will eventually be diagnosed with type 2 diabetes. Physical activity is a cornerstone in reducing type 2 diabetes risk but can be a challenging behaviour to adopt for those living with prediabetes. Individuals with prediabetes experience difficult emotions associated with being at risk for a chronic disease, which can undermine self-regulation. Self-compassion enhances self-regulation because it mitigates difficult emotions and promotes adaptive coping. We performed a pilot randomized controlled trial to determine the feasibility and acceptability of a self-compassion informed intervention to increase physical activity for persons with prediabetes. Methods This explanatory mixed methods study tested the feasibility and acceptability of a two-arm, randomized, single-blind, actively controlled, 6-week online intervention. Using a 1:1 allocation ratio, participants (identified as people with prediabetes, low physical activity, and low self-compassion) were randomized to a self-compassion (Mage = 60.22 years) or control condition (Mage = 56.13 years). All participants received behaviour change education (e.g. SMART goals, action-coping planning) and either other health knowledge (control condition: e.g. sleep, benefits of water) or self-compassion training (intervention condition: practising mindfulness, writing a letter to themselves offering the same support that they would offer to a friend). The primary outcome was to determine the feasibility and acceptability of the trial. To be considered feasible, our outcomes needed to meet or surpass our pre-determined criteria (e.g. time for group formation: 14–20 participants per month). Feasibility was assessed by examining the recruitment rates, retention, adherence, fidelity, and capacity. Semi-structured interviews were conducted with participants to determine trial acceptability. As a secondary purpose, we examined the means on key study variables (secondary and exploratory variables; see Table 1) at all planned time points (baseline, intervention-end, 6- and 12-week follow-up) to identify if they are suitable to include in the efficacy trial (see Additional Table 3). Results Eighteen participants were screened and randomized to one of two conditions. Retention, instructor fidelity, safety, capacity, adherence to most of the study aspects, and acceptability by participants and facilitators all met the criteria for feasibility. Recruitment rate, process time, and adherence to home practice were below our criteria, and we offer ways to address these shortcomings for the efficacy trial. Conclusion The results from this study suggest that it should be feasible to deliver our intervention while highlighting the alterations to components that may be altered when delivering the efficacy trial. We outline our changes which should improve and enhance the feasibility and acceptability of our planned intervention. Funding for this study was from the Canadian Institutes of Health Research (CIHR). Trial registration ClinicalTrials.gov, NCT04402710. Registered on 09 April 2020.

Experiences and perceptions of self‐management in people with prediabetes: A qualitative meta‐synthesis

“…In the primary studies included, participants' descriptions of these two parts had something in common, so they were analysed together. Through information synthesis, it is found that many patients were able to understand the importance of medical management and were willing to take actions to prevent diabetes when they learned that proper diet control and exercise therapy could bring physical and psychological benefits and change the development of the disease at the same time (Abel et al, 2018; Andersson et al, 2008; Bean et al, 2020; Duan et al, 2017; Hansen et al, 2011; Li et al, 2015; Moin et al, 2015; Penn et al, 2008; Schmidt et al, 2022; Signore et al, 2022; Strachan et al, 2018).

Just recognizing and knowing that even short bouts of exercise can make a difference… that really helped to motivate me to go ok you know what.

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“…No more excuses! (Signore et al, 2022).

I removed all pasta, potatoes, white bread and it was nice to substitute this with greens.

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“…Whereas prior to that, it was more a matter of, well I was looking more at the obstacles and the challenges instead of looking at, again, if I can do this small change, I can do this small change, I can do this small change; I have these four small things and now I have a big change. (Signore et al, 2022).

I adjust our operating hours.

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“…While ensuring a diversity of information content, it is important to consider the receptivity of different groups and to provide information in various forms, not limited to pictures and videos. People with prediabetes have different needs for access to information (Fukuoka et al, 2011; Signore et al, 2022), and a variety of medical service platforms should be provided so that patients can freely choose. The guidelines recommend at least 150 min of moderate intensity exercise per week for people at high risk of diabetes (American Diabetes, 2021; Colberg et al, 2016).…”

“…With continuous accumulation of experiences in the process of self-management, some patients can choose different coping strategies according to their own situation. They relieved stress through psychological adjustment and behavioural coping, maintained a normal pace of life and managed the role of patients(Azzi et al, 2020;Dyer et al, 2020;Kuo et al, 2014;Schmidt et al, 2022;Signore et al, 2022;Yoon et al, 2022;Yost et al, 2020).… Really, I'm in control of this, and I can do this. I can change these things and I can do this.…”