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

Study Overview
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Brief Summary
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The investigators plan to examine whether teaching people at risk for type two diabetes to use self-compassion (orientation to care for oneself during difficult situations) helps them self-manage and increase their physical activity. 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. 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. The investigators expect that people who receive the additional training about how to be self-compassionate will engage in more physical activity than people who do not and they will do so because of self-compassion's positive effect on aspects of self-management - adaptive reactions and a tendency to use strong self-management skills. This study is important for health promotion because it allows the investigators to determine whether they can improve how they currently help people prevent type 2 diabetes through engaging in physical activity.

Detailed Description
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The primary research objective of this efficacy trial is to determine if a self-compassion intervention can lead to a clinically significant increase in engagement in physical activity as compared to usual care (best behaviour change practice) in individuals with prediabetes. Primary research question: Will a self-compassion intervention that augments usual care lead to greater increases in physical activity over 12 weeks post-intervention follow-up than usual care alone among people with prediabetes? Primary hypothesis: Self-compassion will lead to greater increases in physical activity than usual care at intervention-end and at 6- and 12-weeks. Secondary research question: Will the effects of a self-compassion intervention on physical activity at 6- and 12-weeks post intervention be mediated by (i) negative affect (ii) physical activity self-regulatory skills and (iii) personal growth at baseline and intervention-end? Secondary hypothesis: The effects of self-compassion on physical activity behaviour at 6- and 12-weeks will be mediated by i) affect and ii) self-regulatory skill use assessed at baseline and intervention-end. Tertiary research question: Will a self-compassion intervention that augments usual care lead to greater increases in other health-promoting behaviours (e.g., nutrition, stress management, seeking medical attention)? Tertiary hypothesis: Self-compassion will lead to greater increases in health-promoting behaviours than usual care at intervention end, 6-weeks and 12-weeks post intervention. This efficacy trial is a single centre, randomized, active controlled, eight 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. The investigators will compare the change in physical activity of community-dwelling people with prediabetes randomized to usual care in the form of behaviour change + attention (control condition) to that of participants who receive usual care + self-compassion training (intervention condition). The investigators will also examine potential mediators of the intervention (i.e., negative affect, physical activity self-regulatory skill use). They will supplement this trial with interviews after follow-up testing with a subsample of self-compassion intervention participants. These interviews will provide feasibility information from participants (e.g., receptivity) as well as provide a qualitative assessment of the investigators' outcome measures.

Official Title
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Examining the Impact of a Self-compassion Intervention on Physical Activity Behaviour: An Efficacy Trial

Conditions
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PreDiabetes

Intervention / Treatment
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* Behavioral: Control Group
* Behavioral: Intervention Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medium to high type 2 diabetes risk (assessed with the CANRISK tool) Age 40 - 74 No current medical treatment for type 2 diabetes Safe to engage in physical activity No non-study self-reported current type 2 diabetes/behaviour change education that may interfere with the intervention Available for all sessions and testing Insufficient physical activity relative to guidelines of 150 minutes of moderate to vigorous physical activity per week. Below the mean on the self-compassion scale Exclusion Criteria: Be under 40 years old, or over the age of 74 Have a medical condition which would not allow them to participate safely in physical activity Already are part of a different behavioural change/ type 2 diabetes education group Already engage in over 150 minutes of moderate to vigorous physical activity per week Already have high levels of self-compassion (over the mean) Could not commit to the intervention/control sessions

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Session 1: Participants will meet individually with a research assistant to discuss their type 2 risk, discuss benefits of engaging in 150 minutes of moderate-to-vigorous physical activity per week, and set a physical activity goal. Ideal Care will involve: Session 2: Introductions and Goal setting/planning. Session 3: Monitoring Physical Activity Session 4: Action and Coping Planning. Session 5: Self-Efficacy (master and vicarious experiences). Session 6: Self-Efficacy (modeling experiences, verbal persuasion). Session 7: Physical Activity Enjoyment and Barriers. Session 8: Making long-term Change. The last 30 minutes of sessions 2-6, control participants will receive 30-minutes of non-self-compassion or physical activity related health education (i.e., sleep, screen time, blood pressure, cholesterol, benefits of water, benefits of vitamin D, the Infodemic). | Behavioral: Control Group<br>* Eight week behavioural change program aimed to increase physical activity plus information on general health topics among individuals with prediabetes.<br>|
| Experimental: Intervention Group<br>Session 1: Participants will meet individually with a research assistant to discuss their type 2 risk, discuss benefits of engaging in 150 minutes of moderate-to-vigorous physical activity per week and set a physical activity goal. First 30 minutes of each subsequent session will be ideal care (as described above in the control group). Last 30 minutes of sessions 2-6, self-compassion condition participants will learn to apply self-compassion to their prediabetes experience and physical activity. Session 2: Introduction to self-compassion. Session 3: Yin and Yang of self-compassion. Session 4: Mindfulness. Session 5: Mindfulness and Resistance. Session 6: Meeting Difficult Emotions. Session 7: Embracing the Good. Session 8: Applying Self-compassion to Physical Activity and Moving Forward. | Behavioral: Intervention Group<br>* Eight week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between groups in moderate to vigorous physical activity at 8 weeks | Physical activity as measured by GT3X+ accelerometers (1952 - >9498 counts per min) | Post-intervention (8 week time point). | 
| Differences between groups in moderate to vigorous physical activity at 14 weeks | Physical activity as measured by GT3X+ accelerometers (1952 - >9498 counts per min) | 6 week Follow-up (14 week time point) | 
| Differences between groups in moderate to vigorous physical activity at 20 weeks | Physical activity as measured by GT3X+ accelerometers (1952 - >9498 counts per min) | 12 week Follow-up (20 week time point) | 
| Changes in self-compassion from pre-intervention to post-intervention (8 weeks) | The Self-Compassion Scale (Neff, 2003a); 26-item scale; assess individuals' current level of self-compassion. The scale has 6 subscales (self-kindness, self-judgment, mindfulness, over-identification, isolation, common humanity. Participants respond to a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). Subscale means are first calculated and then an overall mean is calculated to give you a total self-compassion score | Baseline to Post-Intervention (0 - 8 weeks) | 
| Changes in self-compassion from pre-intervention to 6 week follow-up (14 weeks) | The Self-Compassion Scale (Neff, 2003a); 26-item scale; assess individuals' current level of self-compassion. The scale has 6 subscales (self-kindness, self-judgment, mindfulness, over-identification, isolation, common humanity. Participants respond to a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). Subscale means are first calculated and then an overall mean is calculated to give you a total self-compassion score | Baseline to 6 week follow-up (0 - 14 weeks) | 
| Changes in self-compassion from pre-intervention to 12 week follow-up (20 weeks) | The Self-Compassion Scale (Neff, 2003a); 26-item scale; assess individuals' current level of self-compassion. The scale has 6 subscales (self-kindness, self-judgment, mindfulness, over-identification, isolation, common humanity. Participants respond to a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). Subscale means are first calculated and then an overall mean is calculated to give you a total self-compassion score | Baseline to 12 week follow-up (0 - 20 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between groups in self-reported physical activity at 8 weeks | Short International Physical Activity Questionnaire (Forde, 2018). 4-item scale; assesses walking, moderate intensity and vigorous intensity activities over the last 7 days. | Post-Intervention (8 week time point) | 
| Differences between groups in self-reported physical activity at 14 weeks | Short International Physical Activity Questionnaire (Forde, 2018). 4-item scale; assesses walking, moderate intensity and vigorous intensity activities over the last 7 days. | 6 week Follow-up (14 week time point) | 
| Differences between groups in self-reported physical activity at 20 weeks | Short International Physical Activity Questionnaire (Forde, 2018). 4-item scale; assesses walking, moderate intensity and vigorous intensity activities over the last 7 days. | 12 week Follow-up (20 week time point) | 
| Negative Affect Related to Diabetes at 8 weeks as a potential mediator | Negative Affect Scale (Leary, Tate, Adams, Allen, & Hancock, 2007); 7-point Likert scale ranging from 1 (not at all) to 7 (Extremely); Scale Range: 20 (low Negative Affect) - 140 (high Negative Affect) | Post Intervention (8 week time point) | 
| Negative Affect Related to Low Physical Activity Engagement at 8 weeks as a potential mediator | Negative Affect Scale (Leary, Tate, Adams, Allen, & Hancock, 2007); 7-point Likert scale ranging from 1 (not at all) to 7 (Extremely); Scale Range: 20 (low Negative Affect) - 140 (high Negative Affect) | Post Intervention (8 week time point) | 
| Self-regulatory skill use as a potential mediator | Physical activity Self-Regulation scale-12 (Umstattd, Motl, Wilcox, Saunders, & Watford, 2009); 5-point Likert scale ranging from 1 (never) to 5 (very often); Scale Range: 12 (low physical activity self-regulation) - 60 (high physical activity self-regulation) | Post Intervention (8 week time point) | 
| Differences between groups in health-promoting behaviours at 8 weeks | Health-Promoting Lifestyle Profile II (Walker, Sechrist, & Pender, 1995); 4-point Likert scale ranging from 1 (never) to 4 (routinely); Scale range: 52 (low engagement in health behaviours) to 208 (high engagement in health behaviours) | Post Intervention (8 week time point) | 
| Differences between groups in health-promoting behaviours at 14 weeks | Health-Promoting Lifestyle Profile II (Walker, Sechrist, & Pender, 1995); 4-point Likert scale ranging from 1 (never) to 4 (routinely); Scale range: 52 (low engagement in health behaviours) to 208 (high engagement in health behaviours) | 6 week Follow-up (14 week time point) | 
| Differences between groups in health-promoting behaviours at 20 weeks | Health-Promoting Lifestyle Profile II (Walker, Sechrist, & Pender, 1995); 4-point Likert scale ranging from 1 (never) to 4 (routinely); Scale range: 52 (low engagement in health behaviours) to 208 (high engagement in health behaviours) | 12 week Follow-up (20 week time point) | 
| Differences between groups in seeking medical attention at 8 weeks | Seeking Medical Attention Scale (Terry, Leary, Mehta, & Henderson, 2013); Participants indicate using a yes or no response whether they have sought out medical attention and/or resources (i.e., made a doctor appointment, inquired about community programs, reach out to friend/family member, sought out information, quit smoking, reduced weight) | Post Intervention (8 weeks) | 
| Differences between groups in seeking medical attention at 14 weeks | Seeking Medical Attention Scale (Terry, Leary, Mehta, & Henderson, 2013); Participants indicate using a yes or no response whether they have sought out medical attention and/or resources (i.e., made a doctor appointment, inquired about community programs, reach out to friend/family member, sought out information, quit smoking, reduced weight) | 6 weeks Follow-up (14 weeks) | 
| Differences between groups in seeking medical attention at 20 weeks | Seeking Medical Attention Scale (Terry, Leary, Mehta, & Henderson, 2013); Participants indicate using a yes or no response whether they have sought out medical attention and/or resources (i.e., made a doctor appointment, inquired about community programs, reach out to friend/family member, sought out information, quit smoking, reduced weight) | 12 week Follow-up (20 weeks) | 
| Differences between groups in nutrition at 8 weeks | Dietary Screener Questionnaire; scoring algorithms convert responses to estimates of dietary intake for diary (cup equivalents), fruits and vegetables (cup equivalents), added sugars (tsp), whole grains (ounce equivalents), calcium (mg), fiber (g). Responses to processed meat and red meat questions are used qualitatively as no scoring algorithms are developed for these categories. | Post Intervention (8 weeks) | 
| Differences between groups in nutrition at 14 weeks | Dietary Screener Questionnaire; scoring algorithms convert responses to estimates of dietary intake for diary (cup equivalents), fruits and vegetables (cup equivalents), added sugars (tsp), whole grains (ounce equivalents), calcium (mg), fiber (g). Responses to processed meat and red meat questions are used qualitatively as no scoring algorithms are developed for these categories. | 6 week Follow-up (14 weeks) | 
| Differences between groups in nutrition at 20 weeks | Dietary Screener Questionnaire; scoring algorithms convert responses to estimates of dietary intake for diary (cup equivalents), fruits and vegetables (cup equivalents), added sugars (tsp), whole grains (ounce equivalents), calcium (mg), fiber (g). Responses to processed meat and red meat questions are used qualitatively as no scoring algorithms are developed for these categories. | 12 week Follow-up (20 weeks) | 
| Personal Growth Initiative as a potential mediator | Personal Growth Initiative Scale-II (Robitschek, 2008); 6-point Likert scale ranging from 0 (disagree strongly) to 5 (agree strongly); Scale Range: 0 (low personal growth initiative) - 20 (high personal growth initiative) | Post Intervention (8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emotions, self-compassion, physical activity, self-regulation, randomized controlled trial