An interventional study of Control Group and Intervention Group in PreDiabetes, sponsored by University of Manitoba. Status unknown at 1 site in Canada. Open to participants aged 40 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by University of Manitoba · Not applicable, Interventional, and Prevention
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.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's planned enrollment of 80 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
Differences 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)
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)
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Manitoba