Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Organizational readiness |
Organizational readiness for change measured by the Organizational Readiness for Implementing Change (Shea et al., 2014) |
0 weeks |
|
Other |
Change in 24-hour movement |
Change in 24-hour movement will be examined using a 4-item measure to collect information on time spent in activity, sitting and sleeping in hours and minutes |
0, 4, 52, 104 weeks |
|
Other |
Change in waist circumference |
Measured at level of Iliac crest in centimetres by the coach |
0, 4, 52, and 104 weeks |
|
Other |
Baseline self-compassion |
Patients' self-compassion will be assessed at baseline using the short form self-compassion scale (Raes et al., 2011). This 12-item measure has participants rate the extent to which they engage in certain behaviours on a 5-point response scale from 1 (almost never) to 5 (almost always). Sub scales can be computed by adding item scores. A total self-compassion score is computed. |
0 weeks |
|
Primary |
Type 2 diabetes status |
Self reported HbA1c% |
0, 12, and 24 months post intervention |
|
Primary |
Change in HbA1c |
Venipuncture blood collection of HbA1c% through laboratory testing in a subsample of participants |
0, 12 and 24 months post intervention |
|
Primary |
Adoption of SSBC |
Proportion and representativeness of coaches and implementation support team obtained through program records |
0, 52, 104, 156, 208 weeks |
|
Primary |
Reach of SSBC |
Proportion of patients' enrolled and completing the intervention, proportion of implementation staff trained and retained. Demographics of the patients and staff |
0, 52, 104, 156, 208 weeks |
|
Primary |
Dose Delivered |
Number of SSBC sessions delivered by coaches (0-6) will be gathered through coach checklists |
During delivery of the intervention |
|
Primary |
Fidelity of SSBC delivery |
Frequency with which clients recieve each core component and quality of counselling skills measured using session checklists. |
During delivery of the intervention |
|
Primary |
Adaptations of SSBC |
Number and type of adaptations made prior to delivery of SSBC and during SSBC delivery. Number of adaptations needed for sustainment and during sustainment. Adaptation information will be gathered through meeting minutes with site leads, annual reports from delivery sites and through interviews with coaches and site leads. |
Prior to, and throughout delivery of the intervention (0-104 weeks), sustainment planning and delivery (104-208 weeks) |
|
Primary |
Receptivity to SSBC among patients' and staff |
Patient acceptability and satisfaction will be assessed using the 1-item net promoter score, overall satisfaction measure developed in house and the theoretical framework of acceptability measure. Interviews will be conducted with a subsample of patients at each site (2-3 per site) after completing SSBC. Staff satisfaction and burden will be assessed using brief surveys a various points through the program delivery with coaches (baseline, after 5, 10, 20 clients) and site leads (baseline and at the end of SSBC delivery). Satisfaction and acceptability will also be examined among staff using qualitative interviews. |
4, and 52 weeks (patients), during delivery (staff) |
|
Primary |
Cost of Delivering SSBC |
Costs incurred for implementing SSBC at the delivery sites will be collected through annual reporting from the delivery sites. |
104, 156, 208 weeks |
|
Primary |
Membership rates |
The proportion of individuals who convert their one-month free pass to a facility membership and the retention of this membership over time will be calculated. This information will be collected from annual reports from delivery sites and client surveys. |
104, 156, 208 weeks |
|
Secondary |
Change in body weight |
Measured in pounds |
0, 4, 52, and 104 weeks |
|
Secondary |
Change in cardiorespiratory fitness |
Distance walked in the six minute walk test will be conducted at sites with access to a walking track. |
0, 4, 52, and 104 weeks |
|
Secondary |
Change in physical activity behaviour using the Godin Leisure Time Physical Activity Questionnaire |
The Godin Leisure Time Physical Activity Questionnaire will be used to examine physical activity behaviour. Respondents report the frequency of strenuous, moderate, and mild physical activity for bouts of 15 or more minutes during a 7-day period. The scores are multiplied by weigths and summed into an overall score reports in metabolic equivalents of task (METs)/minutes of physical activity per week. |
0, 4, 52, and 104 weeks |
|
Secondary |
Changes in physical activity using the 2-item Physical Activity Vital Signs measure |
The 2-item Physical Activity Vital Signs measure will be used to collect information on physical activity behaviour. Two questions are self-reported: 1) "How many days during the past week have you performed physical activity where your heart beats faster and your breathing is harder than normal for 30 minutes or more?" and 2) "How many days in a typical week do you perform activity such as this?" The responses are reported as days during the past week over days in a typical week, with scores ranging from 0 to 7 for each question. |
0, 4, 52, and 104 weeks |
|
Secondary |
Change in dietary intake |
Assessed using the brief food frequency questionnaire. Participants are asked about their intake of five foods within the past week: fruits, vegetables, sweets, bread and rice/pasta. Items are rated on a 6-point scale. The questionnaire also uses a composite score for refined carbohydrates (sum of bread and rice/pasta). |
0, 4, 52, and 104 weeks |
|
Secondary |
Determinants of intervention implementation |
Aspects of the larger social, political and economic environment that may influence delivery of the adapted intervention will be assessed by interview. These interviews will also gather qualitative data potential factors that impact delivery of SSBC at the site including context, acceptability, adaptability, feasibility, compatibility, cost, culture, complexity and self efficacy. These interviews will be conducted among coaches and managerial staff. |
52 weeks |
|
Secondary |
Sustainability outcomes and determinants |
Data will be collected on the number of sites continuing delivery, the number of coaches continuing delivery, the number of clients run through SSBC and the number of implementation strategies that are utilized. This data will be gathered through program records. Focus groups will be conducted at each site over the 2-year sustainability phase to gather information on the contextual factors that impact sustainment outcomes. |
104, 156 and 208 weeks |
|
Secondary |
Change in health-related quality of life (EQ-5D-5L Profile) |
The EQ-5D-5L consists of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Participants are asked to indicate their level of functioning (from 1 "no problems" to 5 "extreme problems") on each of the five dimensions of the EQ-5D-5L. The EQ-5D-5 L describes 3125 distinct health states, with 11111 representing the best and 55555 the worst possible health states. The Canadian EQ-5D-5 L scoring algorithm will be applied to generate index scores which range from - 0.148 for the worst (55555) to 0.949 for the best (11111) health states. |
0, 4, 52, and 104 weeks |
|
Secondary |
Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale) |
Health status will be assessed with the EQ-5D-5L visual analogue scale. Participants report on their health on a visual analogue scale from 0 (worst health) to 100 (best health) |
0, 4, 52, and 104 weeks |
|
Secondary |
Change in health resource utilization |
The extent to which participants use medical services will be assessed using the Health Resource Utilization Survey. The information will be combined with the EQ-5D-5L health related quality of life profiles to calculate the cost-effectiveness of the program. |
0, 52, and 104 weeks |
|