Clinical trial NCT04863235: Examining the Impact of a Self-compassion Intervention on Physical Activity Behaviour Among People With Prediabetes
Official title: Examining the Impact of a Self-compassion Intervention on Physical Activity Behaviour: An Efficacy Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PreDiabetes
Keywords: self-compassion
physical activity
self-regulation
randomized controlled trial
emotions
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-04-28
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences between groups in moderate to vigorous physical activity at 8 weeks
timeFrame: Post-intervention (8 week time point).
measure: Differences between groups in moderate to vigorous physical activity at 14 weeks
timeFrame: 6 week Follow-up (14 week time point)
measure: Differences between groups in moderate to vigorous physical activity at 20 weeks
timeFrame: 12 week Follow-up (20 week time point)
measure: Changes in self-compassion from pre-intervention to post-intervention (8 weeks)
timeFrame: Baseline to Post-Intervention (0 - 8 weeks)
measure: Changes in self-compassion from pre-intervention to 6 week follow-up (14 weeks)
timeFrame: Baseline to 6 week follow-up (0 - 14 weeks)
measure: Changes in self-compassion from pre-intervention to 12 week follow-up (20 weeks)
timeFrame: Baseline to 12 week follow-up (0 - 20 weeks)
Secondary outcomes:
measure: Differences between groups in self-reported physical activity at 8 weeks
timeFrame: Post-Intervention (8 week time point)
measure: Differences between groups in self-reported physical activity at 14 weeks
timeFrame: 6 week Follow-up (14 week time point)
measure: Differences between groups in self-reported physical activity at 20 weeks
timeFrame: 12 week Follow-up (20 week time point)
measure: Negative Affect Related to Diabetes at 8 weeks as a potential mediator
timeFrame: Post Intervention (8 week time point)
measure: Negative Affect Related to Low Physical Activity Engagement at 8 weeks as a potential mediator
timeFrame: Post Intervention (8 week time point)
measure: Self-regulatory skill use as a potential mediator
timeFrame: Post Intervention (8 week time point)
measure: Differences between groups in health-promoting behaviours at 8 weeks
timeFrame: Post Intervention (8 week time point)
measure: Differences between groups in health-promoting behaviours at 14 weeks
timeFrame: 6 week Follow-up (14 week time point)
measure: Differences between groups in health-promoting behaviours at 20 weeks
timeFrame: 12 week Follow-up (20 week time point)
measure: Differences between groups in seeking medical attention at 8 weeks
timeFrame: Post Intervention (8 weeks)
measure: Differences between groups in seeking medical attention at 14 weeks
timeFrame: 6 weeks Follow-up (14 weeks)
measure: Differences between groups in seeking medical attention at 20 weeks
timeFrame: 12 week Follow-up (20 weeks)
measure: Differences between groups in nutrition at 8 weeks
timeFrame: Post Intervention (8 weeks)
measure: Differences between groups in nutrition at 14 weeks
timeFrame: 6 week Follow-up (14 weeks)
measure: Differences between groups in nutrition at 20 weeks
timeFrame: 12 week Follow-up (20 weeks)
measure: Personal Growth Initiative as a potential mediator
timeFrame: Post Intervention (8 weeks)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References: