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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 week follow-up (0 - 20 weeks)
Awards & highlights
Study Summary
Examining the Impact of a Self-compassion Intervention on Physical Activity Behaviour Among People With Prediabetes
Eligible Conditions
- Prediabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 week follow-up (0 - 20 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 week follow-up (0 - 20 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in self-compassion from pre-intervention to 12 week follow-up (20 weeks)
Changes in self-compassion from pre-intervention to 6 week follow-up (14 weeks)
Changes in self-compassion from pre-intervention to post-intervention (8 weeks)
+3 moreSecondary outcome measures
Differences between groups in health-promoting behaviours at 14 weeks
Differences between groups in health-promoting behaviours at 20 weeks
Differences between groups in health-promoting behaviours at 8 weeks
+13 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
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.
Group II: Control GroupActive Control1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention Group
2020
Completed Phase 2
~7240
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,446 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,337 Total Patients Enrolled
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