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

NCT04863235 | Unknown

• 1 other identifier: E2020:006E
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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).

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (16)

• Differences between groups in self-reported physical activity at 8 weeks

  Post-Intervention (8 week time point)

• Differences between groups in self-reported physical activity at 14 weeks

  6 week Follow-up (14 week time point)

• Differences between groups in self-reported physical activity at 20 weeks

  12 week Follow-up (20 week time point)

• Negative Affect Related to Diabetes at 8 weeks as a potential mediator

  Post Intervention (8 week time point)

• Negative Affect Related to Low Physical Activity Engagement at 8 weeks as a potential mediator

  Post Intervention (8 week time point)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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).

Behavioral: Control Group

Intervention Group

EXPERIMENTAL

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.

Behavioral: Intervention Group

Interventions

Control Group BEHAVIORAL

Eight week behavioural change program aimed to increase physical activity plus information on general health topics among individuals with prediabetes.

Control Group

Intervention Group BEHAVIORAL

Eight week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes.

Intervention Group

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Motor Activity; Self-Control

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Shaelyn M Strachan, PhD

CONTACT

1-204-474-6363; shaelyn.strachan@umanitoba.ca

Mary Jung, PhD

CONTACT

mary.jung@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The research assistant who is in charge of conducting the statistical analyses will not be involved in the randomization process or running the intervention or control groups. Research assistants who will be conducting in-person eligibility and/or follow-up visits (e.g. handing out accelerometers) will be blinded to participant group assignment. Participants will also be blinded to which group they are randomized into. The investigators will present the study as examining different education interventions to increase physical activity and will not let the participants know whether they are in the intervention or control condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 28, 2021
• Study Start: March 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CA (1)