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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
80
Eight week behavioural change program aimed to increase physical activity plus information on general health topics among individuals with prediabetes.
Eight week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes.
University of Manitoba
Winnipeg, Manitoba, Canada
RECRUITINGDifferences between groups in moderate to vigorous physical activity at 8 weeks
Physical activity as measured by GT3X+ accelerometers (1952 - \>9498 counts per min)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to 12 week follow-up (0 - 20 weeks)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
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Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: Post Intervention (8 weeks)