NCT04402710

Is Teaching People to be Self-compassionate Feasible and Acceptable for People Who Are Pre-diabetic

Examining the Feasibility and Acceptability of a Self-compassion Intervention on Physical Activity Behaviour Among People With Prediabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 40 Years – 74 Years
• Healthy volunteers: Accepted

Summary

The investigators plan to examine the feasibility and acceptability of an online, two arm intervention (\[self-compassion intervention + ideal care\] versus \[health information + ideal care\]) designed to increase physical activity among individuals at risk of type two diabetes. The aim of the self-compassion intervention is to teach people at risk of type two diabetes how to use self-compassion (orientation to care for oneself during difficult situations) in order to help them self-manage and increase their physical activity. In a group, online format people at risk for type 2 diabetes will learn about their type 2 diabetes risk and strategies to increase their physical activity, which represents the recommended information that people at risk for type two diabetes should receive (i.e. ideal care). In addition to this, some participants, but not all, will be taught to be self-compassionate in relation to their type two diabetes risk and their efforts to increase their physical activity (i.e. intervention group). The other participants (i.e. control group) will instead receive general health information in addition to ideal care. Feasibility outcomes will be assessed using Thabane and colleagues (2010) model including the study's process, resources, management and scientific outcomes. In addition, qualitative exit-interviews with participants and research personnel will be conducted to assess the acceptability and feasibility of the intervention. Lastly, investigators will explore whether the intervention leads to changes from pre- to post-intervention in the secondary outcomes. This study is important as it will help inform and ensure the larger efficacy trial is of high quality.

Detailed description

The primary research objective of this study is to test the feasibility and acceptability of an online, two arm (\[self-compassion intervention + ideal care\] versus \[health information + ideal care\]) intervention designed to increase physical activity among individuals at risk for type 2 diabetes. Primary research question: Is an online, two-arm intervention (\[self-compassion intervention + ideal care\] versus \[health information + ideal care\]) focused on increasing physical activity levels among individuals at risk of type two diabetes feasible using Thabane and colleagues model of feasibility (2010)? Secondary research question: Is an online, two-arm intervention (\[self-compassion intervention + ideal care\] versus \[health information + ideal care\]) focused on increasing physical activity levels among individuals at risk of type two diabetes acceptable to both participants and research personnel? The secondary research objective is to explore whether an online, two-arm intervention (\[self-compassion intervention + ideal care\] versus \[health information + ideal care\]) focused on increasing physical activity levels among individuals at risk of type two diabetes leads to changes from pre- to post-intervention in self-compassion, physical activity levels, nutrition, self-regulatory skill use, experience of exercise barriers, personal growth initiative, negative affect, and engagement in other health behaviours (e.g. stress management). This pilot and feasibility study is a single centre, randomized, active controlled, six week intervention with baseline and follow-up assessment at intervention-end, 6- and 12-weeks post-intervention. It follows a quantitative-dominant, mixed-methods design. They will supplement this trial with interviews after follow-up testing with participants and study personnel. These interviews will provide feasibility and acceptability information.

Conditions

• PreDiabetes

Interventions

Type	Name	Description
BEHAVIORAL	Self-compassion	Six week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes
BEHAVIORAL	Control Group	Six week behavioural change program aimed to increase physical activity plus information on general health topics.

Timeline

• Start date: 2020-09-01
• Primary completion: 2020-11-10
• Completion: 2021-02-02
• First posted: 2020-05-27
• Last updated: 2021-04-26

Locations

1 site across 1 country: Canada