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Intervention Group for Prediabetes

N/A
Waitlist Available
Research Sponsored by University of Manitoba
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
No Placebo-Only Group

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.

Eligible Conditions
  • Prediabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 week follow-up (0 - 20 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 week follow-up (0 - 20 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 more
Secondary study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
618 Previous Clinical Trials
206,629 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,386 Previous Clinical Trials
26,515,895 Total Patients Enrolled
~17 spots leftby Nov 2025