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

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04863235
• Other study ID #: E2020:006E
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 2022

Study information

• Verified date: April 2021
• Source: University of Manitoba
• Contact: Shaelyn M Strachan, PhD
• Phone: 1-204-474-6363
• Email: shaelyn.strachan[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Control Group
Eight week behavioural change program aimed to increase physical activity plus information on general health topics among individuals with prediabetes.
• Intervention Group
Eight week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes.

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)