Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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. |
During the recruitment phase of the study |
|
| Primary |
Most successful Recruitment Strategy |
Participants will be asked to state how they heard about the study |
During the recruitment phase of the study |
|
| Primary |
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. |
Week 1 (baseline) to Week 18 (follow-up) |
|
| Primary |
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. |
Week 1 (baseline) to Week 18 (follow-up) |
|
| Primary |
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. |
Week 1 (baseline) to Week 6 (end of intervention) |
|
| Primary |
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. |
Week 1 (baseline) to Week 18 (follow-up) |
|
| Primary |
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. |
During the recruitment phase of the study |
|
| Primary |
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. |
6 weeks (end of intervention) |
|
| Primary |
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" |
6-weeks (end of intervention) |
|
| Primary |
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?" |
6 weeks (end of intervention) |
|
| Secondary |
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) |
baseline to 6 weeks (intervention end) |
|
| Secondary |
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) |
baseline to 6 weeks (intervention end) |
|
| Secondary |
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) |
baseline to 6 weeks |
|
| Secondary |
Change in Mild Physical Activity from baseline to 6 weeks (intervention end) |
Measured by GT3X Accelerometers (100 - 1952 counts per min) |
baseline to 6 weeks (intervention end) |
|
| Secondary |
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) |
baseline to 6 weeks (intervention end) |
|
| Secondary |
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) |
baseline to 6-weeks (intervention end) |
|
| Secondary |
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) |
6-weeks (intervention end) |
|
| Secondary |
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) |
baseline to 6 weeks (intervention end) |
|
| Secondary |
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) |
baseline week 1 |
|
| Secondary |
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. |
baseline to 6 weeks (intervention end). |
|
| Secondary |
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. |
baseline to 6 weeks (intervention end) |
|
