Recruiting

Self-compassion Intervention

Sponsor:

University of Manitoba

Code:

NCT04863235

Conditions

PreDiabetes

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Control Group

Intervention Group

Study Details

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.

Conditions

PreDiabetes

Study ID

NCT04863235

Start date

Mar 1, 2021

Status verified date

Apr, 2021

Completion date

Sep, 2022

Anticipated

Primary completion date

Sep, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: 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. 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).

experimental: Intervention 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.

Interventions

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.

Primary outcome measure

  • Differences between groups in moderate to vigorous physical activity at 8 weeks [ Time Frame: Post-intervention (8 week time point). ]
  • Differences between groups in moderate to vigorous physical activity at 14 weeks [ Time Frame: 6 week Follow-up (14 week time point) ]
  • Differences between groups in moderate to vigorous physical activity at 20 weeks [ Time Frame: 12 week Follow-up (20 week time point) ]
  • Changes in self-compassion from pre-intervention to post-intervention (8 weeks) [ Time Frame: Baseline to Post-Intervention (0 - 8 weeks) ]
  • Changes in self-compassion from pre-intervention to 6 week follow-up (14 weeks) [ 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) [ Time Frame: Baseline to 12 week follow-up (0 - 20 weeks) ]

Central Contacts and Locations

Central contacts

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3T 2N2

Contacts

More Information

Sponsor

University of Manitoba

Last update posted

Apr 28, 2021

Last verified

Apr, 2021

Keywords

  • self-compassion
  • physical activity
  • self-regulation
  • randomized controlled trial
  • emotions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2021-04-28.