PreDiabetesNCT04863235
Examining the Impact of a Self-compassion Intervention on Physical Activity Behaviour Among People With Prediabetes
A study testing Intervention Group in people with PreDiabetes, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2021to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mary Jung, PhD contact
Canada1 site, 1 recruiting
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3T 2N2
Shaelyn M Strachan, PhD, 1 (204) 474-6363, shaelyn.strachan@umanitoba.ca
About this study
Official title: Examining the Impact of a Self-compassion Intervention on Physical Activity Behaviour: An Efficacy Trial
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.
Read the 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.
- Conditions
- PreDiabetes
- Being tested
- Control Group, Intervention Group
- Keywords
- self-compassion, physical activity, self-regulation, randomized controlled trial, emotions
- Medical subject headings
- Prediabetic State, Motor Activity, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupBehavioural
Eight week behavioural change program aimed to increase physical activity plus information on general health topics among individuals with prediabetes.
Intervention GroupBehavioural
Eight week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between groups in moderate to vigorous physical activity at 8 weeks
Physical activity as measured by GT3X+ accelerometers (1952 - >9498 counts per min)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to 12 week follow-up (0 - 20 weeks)
Secondary outcomes (16)
Differences between groups in self-reported physical activity at 8 weeks
Short International Physical Activity Questionnaire (Forde, 2018). 4-item scale; assesses walking, moderate intensity and vigorous intensity activities over the last 7 days.
Measured: Post-Intervention (8 week time point)
Differences between groups in self-reported physical activity at 14 weeks
Short International Physical Activity Questionnaire (Forde, 2018). 4-item scale; assesses walking, moderate intensity and vigorous intensity activities over the last 7 days.
Measured: 6 week Follow-up (14 week time point)
Differences between groups in self-reported physical activity at 20 weeks
Short International Physical Activity Questionnaire (Forde, 2018). 4-item scale; assesses walking, moderate intensity and vigorous intensity activities over the last 7 days.
Measured: 12 week Follow-up (20 week time point)
Negative Affect Related to Diabetes at 8 weeks as a potential mediator
Negative Affect Scale (Leary, Tate, Adams, Allen, \& Hancock, 2007); 7-point Likert scale ranging from 1 (not at all) to 7 (Extremely); Scale Range: 20 (low Negative Affect) - 140 (high Negative Affect)
Measured: Post Intervention (8 week time point)
Negative Affect Related to Low Physical Activity Engagement at 8 weeks as a potential mediator
Negative Affect Scale (Leary, Tate, Adams, Allen, \& Hancock, 2007); 7-point Likert scale ranging from 1 (not at all) to 7 (Extremely); Scale Range: 20 (low Negative Affect) - 140 (high Negative Affect)
Measured: Post Intervention (8 week time point)
Self-regulatory skill use as a potential mediator
Physical activity Self-Regulation scale-12 (Umstattd, Motl, Wilcox, Saunders, \& Watford, 2009); 5-point Likert scale ranging from 1 (never) to 5 (very often); Scale Range: 12 (low physical activity self-regulation) - 60 (high physical activity self-regulation)
Measured: Post Intervention (8 week time point)
Differences between groups in health-promoting behaviours at 8 weeks
Health-Promoting Lifestyle Profile II (Walker, Sechrist, \& Pender, 1995); 4-point Likert scale ranging from 1 (never) to 4 (routinely); Scale range: 52 (low engagement in health behaviours) to 208 (high engagement in health behaviours)
Measured: Post Intervention (8 week time point)
Differences between groups in health-promoting behaviours at 14 weeks
Health-Promoting Lifestyle Profile II (Walker, Sechrist, \& Pender, 1995); 4-point Likert scale ranging from 1 (never) to 4 (routinely); Scale range: 52 (low engagement in health behaviours) to 208 (high engagement in health behaviours)
Measured: 6 week Follow-up (14 week time point)
Differences between groups in health-promoting behaviours at 20 weeks
Health-Promoting Lifestyle Profile II (Walker, Sechrist, \& Pender, 1995); 4-point Likert scale ranging from 1 (never) to 4 (routinely); Scale range: 52 (low engagement in health behaviours) to 208 (high engagement in health behaviours)
Measured: 12 week Follow-up (20 week time point)
Differences between groups in seeking medical attention at 8 weeks
Seeking Medical Attention Scale (Terry, Leary, Mehta, \& Henderson, 2013); Participants indicate using a yes or no response whether they have sought out medical attention and/or resources (i.e., made a doctor appointment, inquired about community programs, reach out to friend/family member, sought out information, quit smoking, reduced weight)
Measured: Post Intervention (8 weeks)
Differences between groups in seeking medical attention at 14 weeks
Seeking Medical Attention Scale (Terry, Leary, Mehta, \& Henderson, 2013); Participants indicate using a yes or no response whether they have sought out medical attention and/or resources (i.e., made a doctor appointment, inquired about community programs, reach out to friend/family member, sought out information, quit smoking, reduced weight)
Measured: 6 weeks Follow-up (14 weeks)
Differences between groups in seeking medical attention at 20 weeks
Seeking Medical Attention Scale (Terry, Leary, Mehta, \& Henderson, 2013); Participants indicate using a yes or no response whether they have sought out medical attention and/or resources (i.e., made a doctor appointment, inquired about community programs, reach out to friend/family member, sought out information, quit smoking, reduced weight)
Measured: 12 week Follow-up (20 weeks)
Differences between groups in nutrition at 8 weeks
Dietary Screener Questionnaire; scoring algorithms convert responses to estimates of dietary intake for diary (cup equivalents), fruits and vegetables (cup equivalents), added sugars (tsp), whole grains (ounce equivalents), calcium (mg), fiber (g). Responses to processed meat and red meat questions are used qualitatively as no scoring algorithms are developed for these categories.
Measured: Post Intervention (8 weeks)
Differences between groups in nutrition at 14 weeks
Dietary Screener Questionnaire; scoring algorithms convert responses to estimates of dietary intake for diary (cup equivalents), fruits and vegetables (cup equivalents), added sugars (tsp), whole grains (ounce equivalents), calcium (mg), fiber (g). Responses to processed meat and red meat questions are used qualitatively as no scoring algorithms are developed for these categories.
Measured: 6 week Follow-up (14 weeks)
Differences between groups in nutrition at 20 weeks
Dietary Screener Questionnaire; scoring algorithms convert responses to estimates of dietary intake for diary (cup equivalents), fruits and vegetables (cup equivalents), added sugars (tsp), whole grains (ounce equivalents), calcium (mg), fiber (g). Responses to processed meat and red meat questions are used qualitatively as no scoring algorithms are developed for these categories.
Measured: 12 week Follow-up (20 weeks)
Personal Growth Initiative as a potential mediator
Personal Growth Initiative Scale-II (Robitschek, 2008); 6-point Likert scale ranging from 0 (disagree strongly) to 5 (agree strongly); Scale Range: 0 (low personal growth initiative) - 20 (high personal growth initiative)
Measured: Post Intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Mar 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863235
- Sponsor's protocol ID
- E2020:006E
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of a Self-compassion Intervention on Physical Activity Behaviour: An Efficacy Trial
- ClinicalTrials.gov ID
- NCT04863235
- Acronym / sponsor ID
- E2020:006E
- Conditions
- PreDiabetes
- Keywords
- self-compassion, physical activity, self-regulation, randomized controlled trial, emotions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Control GroupSession 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). |
| Intervention Group | Experimental | Behavioral: Intervention GroupSession 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. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupEight week behavioural change program aimed to increase physical activity plus information on general health topics among individuals with prediabetes. | Behavioural | Control Group |
| Intervention GroupEight week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes. | Behavioural | Intervention Group |
Primary outcome
Differences between groups in moderate to vigorous physical activity at 8 weeks
Time frame: Post-intervention (8 week time point).
Physical activity as measured by GT3X+ accelerometers (1952 - >9498 counts per min)
Differences between groups in moderate to vigorous physical activity at 14 weeks
Time frame: 6 week Follow-up (14 week time point)
Physical activity as measured by GT3X+ accelerometers (1952 - >9498 counts per min)
Differences between groups in moderate to vigorous physical activity at 20 weeks
Time frame: 12 week Follow-up (20 week time point)
Physical activity as measured by GT3X+ accelerometers (1952 - >9498 counts per min)
Changes in self-compassion from pre-intervention to post-intervention (8 weeks)
Time frame: Baseline to Post-Intervention (0 - 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
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)
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
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)
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
16 secondary outcomes
Differences between groups in self-reported physical activity at 8 weeks
Time frame: Post-Intervention (8 week time point)
Differences between groups in self-reported physical activity at 14 weeks
Time frame: 6 week Follow-up (14 week time point)
Differences between groups in self-reported physical activity at 20 weeks
Time frame: 12 week Follow-up (20 week time point)
Negative Affect Related to Diabetes at 8 weeks as a potential mediator
Time frame: Post Intervention (8 week time point)
Negative Affect Related to Low Physical Activity Engagement at 8 weeks as a potential mediator
Time frame: Post Intervention (8 week time point)
Self-regulatory skill use as a potential mediator
Time frame: Post Intervention (8 week time point)
Differences between groups in health-promoting behaviours at 8 weeks
Time frame: Post Intervention (8 week time point)
Differences between groups in health-promoting behaviours at 14 weeks
Time frame: 6 week Follow-up (14 week time point)
Differences between groups in health-promoting behaviours at 20 weeks
Time frame: 12 week Follow-up (20 week time point)
Differences between groups in seeking medical attention at 8 weeks
Time frame: Post Intervention (8 weeks)
Differences between groups in seeking medical attention at 14 weeks
Time frame: 6 weeks Follow-up (14 weeks)
Differences between groups in seeking medical attention at 20 weeks
Time frame: 12 week Follow-up (20 weeks)
Differences between groups in nutrition at 8 weeks
Time frame: Post Intervention (8 weeks)
Differences between groups in nutrition at 14 weeks
Time frame: 6 week Follow-up (14 weeks)
Differences between groups in nutrition at 20 weeks
Time frame: 12 week Follow-up (20 weeks)
Personal Growth Initiative as a potential mediator
Time frame: Post Intervention (8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Jung, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with PreDiabetes, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaelyn M Strachan, PhD (1-204-474-6363, shaelyn.strachan@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between groups in moderate to vigorous physical activity at 8 weeks (time frame: Post-intervention (8 week time point).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.