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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
16
Six week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes
Six week behavioural change program aimed to increase physical activity plus information on general health topics.
University of Manitoba
Winnipeg, Manitoba, Canada
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.
Time frame: During the recruitment phase of the study
Most successful Recruitment Strategy
Participants will be asked to state how they heard about the study
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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"
Time frame: 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?"
Time frame: 6 weeks (end of intervention)
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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)
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)
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Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: baseline to 6 weeks (intervention end)