Is Teaching People to be Self-compassionate Feasible and Acceptable for People Who Are Pre-diabetic
Condition: PreDiabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

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.
    

Intervention name(s): Self-compassion; Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Six week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes; Six week behavioural change program aimed to increase physical activity plus information on general health topics.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to either a control group or the intervention group. Both sessions will run concurrently.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: self-compassion; physical activity; self-regulation; randomized controlled trial; emotions; feasibility; acceptability