PreDiabetesNCT04402710
Is Teaching People to be Self-compassionate Feasible and Acceptable for People Who Are Pre-diabetic
A study testing Self-compassion in people with PreDiabetes, run by University of Manitoba at 1 site in Canada.
Trial summary
The investigators plan to examine the feasibility and acceptability of an online, two arm intervention ([self-compassion intervention + ideal care] versus [health information + ideal care]) designed to increase physical activity among individuals at risk of type two diabetes. 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?
- Self-compassion
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2020to 2 Feb 2021
- 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.
About this study
Official title: Examining the Feasibility and Acceptability of a Self-compassion Intervention on Physical Activity Behaviour Among People With Prediabetes
The investigators plan to examine the feasibility and acceptability of an online, two arm intervention ([self-compassion intervention + ideal care] versus [health information + ideal care]) designed to increase physical activity among individuals at risk of type two diabetes. The aim of the self-compassion intervention is to teach people at risk of type two diabetes how to use self-compassion (orientation to care for oneself during difficult situations) in order to help them self-manage and increase their physical activity. In a group, online format 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 (i.e. ideal care). 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 (i.e. intervention group). The other participants (i.e. control group) will instead receive general health information in addition to ideal care. Feasibility outcomes will be assessed using Thabane and colleagues (2010) model including the study's process, resources, management and scientific outcomes. In addition, qualitative exit-interviews with participants and research personnel will be conducted to assess the acceptability and feasibility of the intervention. Lastly, investigators will explore whether the intervention leads to changes from pre- to post-intervention in the secondary outcomes. This study is important as it will help inform and ensure the larger efficacy trial is of high quality.
Read the detailed description
The primary research objective of this study is to test the feasibility and acceptability of an online, two arm ([self-compassion intervention + ideal care] versus [health information + ideal care]) intervention designed to increase physical activity among individuals at risk for type 2 diabetes.
Primary research question: Is an online, two-arm intervention ([self-compassion intervention + ideal care] versus [health information + ideal care]) focused on increasing physical activity levels among individuals at risk of type two diabetes feasible using Thabane and colleagues model of feasibility (2010)?
Secondary research question: Is an online, two-arm intervention ([self-compassion intervention + ideal care] versus [health information + ideal care]) focused on increasing physical activity levels among individuals at risk of type two diabetes acceptable to both participants and research personnel?
The secondary research objective is to explore whether an online, two-arm intervention ([self-compassion intervention + ideal care] versus [health information + ideal care]) focused on increasing physical activity levels among individuals at risk of type two diabetes leads to changes from pre- to post-intervention in self-compassion, physical activity levels, nutrition, self-regulatory skill use, experience of exercise barriers, personal growth initiative, negative affect, and engagement in other health behaviours (e.g. stress management).
This pilot and feasibility study is a single centre, randomized, active controlled, six 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. They will supplement this trial with interviews after follow-up testing with participants and study personnel. These interviews will provide feasibility and acceptability information.
- Conditions
- PreDiabetes
- Being tested
- Self-compassion, Control Group
- Keywords
- self-compassion, physical activity, self-regulation, randomized controlled trial, emotions, feasibility, acceptability
- 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.
Self-compassionBehavioural
Six week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes
Control GroupBehavioural
Six week behavioural change program aimed to increase physical activity plus information on general health topics.
| 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 and discuss benefits of engaging in 150 minutes of moderate-to-vigorous physical activity per week. Ideal Care will involve: Session 2: Introductions and Goal setting/planning. Session 3: Action-Coping Planning and Monitoring Physical Activity Session 4: Goal re-visitation and adjustment and building self-efficacy. Session 5: Physical Activity Enjoyment and Barriers/Solutions. Session 6: Relapse prevention and commitment to exercise. 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, antibiotic use, oral health, osteoporosis and vitamin D). Receives: Behavioral: Control Group |
| Intervention Group | Experimental | Session 1: Participants will meet individually with a research assistant to discuss their type 2 risk and discuss benefits of engaging in 150 minutes of moderate-to-vigorous physical activity per week. 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: Learn about fear of self-compassion and the benefits of self-compassion. Session 3: Yin and Yang of self-compassion. Session 4: Mindfulness. Session 5: Dealing with difficult emotions, loving Kindness and Self-Compassionate motivation. Session 6: Living deeply, self-appreciation and stages of progress. Receives: Behavioral: Self-compassion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants screened/showed interest in partaking in the study during the recruitment period and how many of these individuals get successfully recruited into the study.
Measured: During the recruitment phase of the study
Most successful Recruitment Strategy
Participants will be asked to state how they heard about the study
Measured: During the recruitment phase of the study
Retention Rates
The number of people who begin the study relative to the number of people who drop out at any point during the study.
Measured: Week 1 (baseline) to Week 18 (follow-up)
Compliance
This will consist of online class attendance and through participant responses using a text messaging system (e.g. responding 'yes' or 'no' to whether they completed their at home practice), and will be determined by the number of individuals who wear their accelerometer for the recommended 4 days, 10 hours per day.
Measured: Week 1 (baseline) to Week 18 (follow-up)
Instructor Fidelity
How well facilitators conduct class sessions and activities compared to the set protocol. This will be determined by a checklist with a protocol for each session where facilitators will identify what components they did/did not complete and whether they followed the session protocol accordingly. With participant approval, facilitators will video record 15% of all sessions and the principal investigator will assess the adherence to the planned intervention, presentation skills, and will assess the adherence to the planned intervention, presentation skills, and will rate communication skills. The principal investigator will rate each component on a 5-point Likert scale.
Measured: Week 1 (baseline) to Week 6 (end of intervention)
Capacity
This will be determined by evaluating whether the number of hours it takes study personnel to complete study tasks stays under the total cost that was budgeted for personnel hours for this study.
Measured: Week 1 (baseline) to Week 18 (follow-up)
Process Time
How much time it takes to send out the initial eligibility email questionnaire, determine the participant's eligibility, and contact the eligible participant for the next steps of the study.
Measured: During the recruitment phase of the study
Study Personnel Challenges and Insights
Through a semi-structured exit-interview study personnel will be asked whether they encountered any challenges throughout the study or have any reccomendations.
Measured: 6 weeks (end of intervention)
Participant safety will be assessed by asking participants to explain their thoughts and feelings about whether the study impacted their physical and psychological safety through a semi-structured exit interview.
To determine whether participants felt safe while participating in this study, they will be asked to explain their thoughts and feelings through a semi-structured exit-interview. A sample question is, "Did you feel safe physically and psychologically during each session"
Measured: 6-weeks (end of intervention)
Acceptability as assessed by semi-structured exit interviews with participants which will include questions related to their thoughts and feelings about the study and whether they believed the study was acceptable (e.g. content, timing).
To assess participant satisfaction and their experience with the study, they will be asked a variety of questions to understand their thoughts and feelings during the semi-structured exit-interview. An example question participants will be asked is, "what components of the intervention did you like/dislike?"
Measured: 6 weeks (end of intervention)
Secondary outcomes (11)
Change in Moderate to Vigorous Physical Activity from baseline to 6 weeks (intervention end)
Physical activity as measured by GT3X+ accelerometers (1952 - >9498 counts per min)
Measured: baseline to 6 weeks (intervention end)
Change in self-report Moderate to Vigorous Physical Activity from baseline to 6 weeks (intervention end)
Physical activity as measured by GT3X+ accelerometers (1952 - >9498 counts per min)
Measured: baseline to 6 weeks (intervention end)
Change in Self-Compassion from baseline to 6 weeks (intervention end)
Self-Compassion Scale (Neff, 2003); 6-point Likert scale ranging from a mean value of 1 (low self-compassion) to 5 (high self-compassion)
Measured: baseline to 6 weeks
Change in Mild Physical Activity from baseline to 6 weeks (intervention end)
Measured by GT3X Accelerometers (100 - 1952 counts per min)
Measured: baseline to 6 weeks (intervention end)
Change in Sporadic Physical Activity from baseline to 6 weeks (intervention end)
Measured by GT3X Accelerometers (bouts of moderate to vigorous physical activity less than 10 minutes with no drop in intensity)
Measured: baseline to 6 weeks (intervention end)
Change in Negative Affect Related to Diabetes Risk from baseline to 6 weeks (intervention end)
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: baseline to 6-weeks (intervention end)
Change in Negative Affect Related to Low Physical Activity Levels from baseline to 6 weeks (intervention end)
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: 6-weeks (intervention end)
Change in Health Promoting Behaviors from baseline to 6 weeks (intervention end)
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: baseline to 6 weeks (intervention end)
Change in Fear of Self-Compassion from baseline to 6 weeks (intervention end)
Fear of Self-compassion Scale (Gilbert et al., 2011); 5-point Likert scale ranging from 0 (not fearful) - 60 (very fearful)
Measured: baseline week 1
Change in Exercise barriers from baseline to 6 weeks (intervention end)
Exercise Barrier Scale (Sechrist et al., 1987). 4-point Likert scale ranging from 1 (strongly agree) to 4 (strongly disagree); 14 items; participants are asked to indicate the degree to which they have different barriers to exercise. Higher scores indicate less exercise barriers. Overall score ranges from 14 to 56.
Measured: baseline to 6 weeks (intervention end).
Change in Cognitive Emotion Regulation strategies from baseline to 6 weeks (intervention end)
Cognitive Emotion Regulation Questionnaire (Garnefski et al. 2001). 5-point Likert scale ranging from 1 (almost never) to 5 (almost always); 36 items; Participants are asked the extent to which they make use of certain cognitive coping strategies. Nine different subscales: self-blame, other-blame, rumination, catastrophizing, putting into perspective, positive refocusing, positive reappraisal, acceptance, refocus on planning. Each subscale is totaled with higher scores indicating higher use of that cognitive emotional strategy. Scores for each subscale can range from 4 to 20.
Measured: baseline to 6 weeks (intervention end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Sep 2020
- Primary completion10 Nov 2020
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Participants will be randomized to either a control group or the intervention group. Both sessions will run concurrently.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
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
- NCT04402710
- Sponsor's protocol ID
- E2020:006
- Status last verified
- Mar 2020
- First submitted
- 9 Apr 2020
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Signore AK, Jung ME, Semenchuk B, Kullman SM, Tefft O, Webber S, Ferguson LJ, Kowalski K, Fortier M, McGavock J, Ahmed R, Orr M, Strachan S. A pilot and feasibility study of a randomized clinical trial testing a self-compassion intervention aimed to increase physical activity behaviour among people with prediabetes. Pilot Feasibility Stud. 2022 May 27;8(1):111. doi: 10.1186/s40814-022-01072-6.
PubMed 35624519
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Feasibility and Acceptability of a Self-compassion Intervention on Physical Activity Behaviour Among People With Prediabetes
- ClinicalTrials.gov ID
- NCT04402710
- Acronym / sponsor ID
- E2020:006
- Conditions
- PreDiabetes
- Keywords
- self-compassion, physical activity, self-regulation, randomized controlled trial, emotions, feasibility, acceptability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 27 May 2020 (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 the feasibility and acceptability of an online, two arm intervention ([self-compassion intervention + ideal care] versus [health information + ideal care]) designed to increase physical activity among individuals at risk of type two diabetes. The aim of the self-compassion intervention is to teach people at risk of type two diabetes how to use self-compassion (orientation to care for oneself during difficult situations) in order to help them self-manage and increase their physical activity. In a group, online format 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 (i.e. ideal care). 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 (i.e. intervention group). The other participants (i.e. control group) will instead receive general health information in addition to ideal care. Feasibility outcomes will be assessed using Thabane and colleagues (2010) model including the study's process, resources, management and scientific outcomes. In addition, qualitative exit-interviews with participants and research personnel will be conducted to assess the acceptability and feasibility of the intervention. Lastly, investigators will explore whether the intervention leads to changes from pre- to post-intervention in the secondary outcomes. This study is important as it will help inform and ensure the larger efficacy trial is of high quality.
Detailed description
The primary research objective of this study is to test the feasibility and acceptability of an online, two arm ([self-compassion intervention + ideal care] versus [health information + ideal care]) intervention designed to increase physical activity among individuals at risk for type 2 diabetes.
Primary research question: Is an online, two-arm intervention ([self-compassion intervention + ideal care] versus [health information + ideal care]) focused on increasing physical activity levels among individuals at risk of type two diabetes feasible using Thabane and colleagues model of feasibility (2010)?
Secondary research question: Is an online, two-arm intervention ([self-compassion intervention + ideal care] versus [health information + ideal care]) focused on increasing physical activity levels among individuals at risk of type two diabetes acceptable to both participants and research personnel?
The secondary research objective is to explore whether an online, two-arm intervention ([self-compassion intervention + ideal care] versus [health information + ideal care]) focused on increasing physical activity levels among individuals at risk of type two diabetes leads to changes from pre- to post-intervention in self-compassion, physical activity levels, nutrition, self-regulatory skill use, experience of exercise barriers, personal growth initiative, negative affect, and engagement in other health behaviours (e.g. stress management).
This pilot and feasibility study is a single centre, randomized, active controlled, six 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. They will supplement this trial with interviews after follow-up testing with participants and study personnel. These interviews will provide feasibility and acceptability information.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either a control group or the intervention group. Both sessions will run concurrently.
| 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 and discuss benefits of engaging in 150 minutes of moderate-to-vigorous physical activity per week. Ideal Care will involve: Session 2: Introductions and Goal setting/planning. Session 3: Action-Coping Planning and Monitoring Physical Activity Session 4: Goal re-visitation and adjustment and building self-efficacy. Session 5: Physical Activity Enjoyment and Barriers/Solutions. Session 6: Relapse prevention and commitment to exercise. 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, antibiotic use, oral health, osteoporosis and vitamin D). |
| Intervention Group | Experimental | Behavioral: Self-compassionSession 1: Participants will meet individually with a research assistant to discuss their type 2 risk and discuss benefits of engaging in 150 minutes of moderate-to-vigorous physical activity per week. 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: Learn about fear of self-compassion and the benefits of self-compassion. Session 3: Yin and Yang of self-compassion. Session 4: Mindfulness. Session 5: Dealing with difficult emotions, loving Kindness and Self-Compassionate motivation. Session 6: Living deeply, self-appreciation and stages of progress. |
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 |
|---|---|---|
| Self-compassionSix week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes | Behavioural | Intervention Group |
| Control GroupSix week behavioural change program aimed to increase physical activity plus information on general health topics. | Behavioural | Control Group |
Primary outcome
Recruitment Rate
Time frame: During the recruitment phase of the study
Number of participants screened/showed interest in partaking in the study during the recruitment period and how many of these individuals get successfully recruited into the study.
Most successful Recruitment Strategy
Time frame: During the recruitment phase of the study
Participants will be asked to state how they heard about the study
Retention Rates
Time frame: Week 1 (baseline) to Week 18 (follow-up)
The number of people who begin the study relative to the number of people who drop out at any point during the study.
Compliance
Time frame: Week 1 (baseline) to Week 18 (follow-up)
This will consist of online class attendance and through participant responses using a text messaging system (e.g. responding 'yes' or 'no' to whether they completed their at home practice), and will be determined by the number of individuals who wear their accelerometer for the recommended 4 days, 10 hours per day.
Instructor Fidelity
Time frame: Week 1 (baseline) to Week 6 (end of intervention)
How well facilitators conduct class sessions and activities compared to the set protocol. This will be determined by a checklist with a protocol for each session where facilitators will identify what components they did/did not complete and whether they followed the session protocol accordingly. With participant approval, facilitators will video record 15% of all sessions and the principal investigator will assess the adherence to the planned intervention, presentation skills, and will assess the adherence to the planned intervention, presentation skills, and will rate communication skills. The principal investigator will rate each component on a 5-point Likert scale.
Capacity
Time frame: Week 1 (baseline) to Week 18 (follow-up)
This will be determined by evaluating whether the number of hours it takes study personnel to complete study tasks stays under the total cost that was budgeted for personnel hours for this study.
Process Time
Time frame: During the recruitment phase of the study
How much time it takes to send out the initial eligibility email questionnaire, determine the participant's eligibility, and contact the eligible participant for the next steps of the study.
Study Personnel Challenges and Insights
Time frame: 6 weeks (end of intervention)
Through a semi-structured exit-interview study personnel will be asked whether they encountered any challenges throughout the study or have any reccomendations.
Participant safety will be assessed by asking participants to explain their thoughts and feelings about whether the study impacted their physical and psychological safety through a semi-structured exit interview.
Time frame: 6-weeks (end of intervention)
To determine whether participants felt safe while participating in this study, they will be asked to explain their thoughts and feelings through a semi-structured exit-interview. A sample question is, "Did you feel safe physically and psychologically during each session"
Acceptability as assessed by semi-structured exit interviews with participants which will include questions related to their thoughts and feelings about the study and whether they believed the study was acceptable (e.g. content, timing).
Time frame: 6 weeks (end of intervention)
To assess participant satisfaction and their experience with the study, they will be asked a variety of questions to understand their thoughts and feelings during the semi-structured exit-interview. An example question participants will be asked is, "what components of the intervention did you like/dislike?"
11 secondary outcomes
Change in Moderate to Vigorous Physical Activity from baseline to 6 weeks (intervention end)
Time frame: baseline to 6 weeks (intervention end)
Change in self-report Moderate to Vigorous Physical Activity from baseline to 6 weeks (intervention end)
Time frame: baseline to 6 weeks (intervention end)
Change in Self-Compassion from baseline to 6 weeks (intervention end)
Time frame: baseline to 6 weeks
Change in Mild Physical Activity from baseline to 6 weeks (intervention end)
Time frame: baseline to 6 weeks (intervention end)
Change in Sporadic Physical Activity from baseline to 6 weeks (intervention end)
Time frame: baseline to 6 weeks (intervention end)
Change in Negative Affect Related to Diabetes Risk from baseline to 6 weeks (intervention end)
Time frame: baseline to 6-weeks (intervention end)
Change in Negative Affect Related to Low Physical Activity Levels from baseline to 6 weeks (intervention end)
Time frame: 6-weeks (intervention end)
Change in Health Promoting Behaviors from baseline to 6 weeks (intervention end)
Time frame: baseline to 6 weeks (intervention end)
Change in Fear of Self-Compassion from baseline to 6 weeks (intervention end)
Time frame: baseline week 1
Change in Exercise barriers from baseline to 6 weeks (intervention end)
Time frame: baseline to 6 weeks (intervention end).
Change in Cognitive Emotion Regulation strategies from baseline to 6 weeks (intervention end)
Time frame: baseline to 6 weeks (intervention end)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Derived from this study: PubMed 35624519Signore AK, Jung ME, Semenchuk B, Kullman SM, Tefft O, Webber S, Ferguson LJ, Kowalski K, Fortier M, McGavock J, Ahmed R, Orr M, Strachan S. A pilot and feasibility study of a randomized clinical trial testing a self-compassion intervention aimed to increase physical activity behaviour among people with prediabetes. Pilot Feasibility Stud. 2022 May 27;8(1):111. doi: 10.1186/s40814-022-01072-6.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-compassion 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: finished, as of the sponsor's last update on 26 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: During the recruitment phase of the study). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04402710, which also lists 1 linked publication.
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 26 Apr 2021.