Small Steps for Big Changes - Healthy Cities Implementation Science

Condition(s) studied

Investigational drug(s) / intervention(s)

Behavioural: Small Steps for Big Changes Diabetes Prevention Program: The 4-week behaviour change program will introduce participants to a regular healthy lifestyle including exercise and dietary changes for reducing sugar intake, reducing refined/processed carbohydrate intake, increasing vegetable consumption. The 4-week program will include six supervised exercise sessions and three exercise sessions performed independently (e.g., at home or outside of the YMCA). The supervised session will include brief behavioural counselling sessions that teach participants self-regulatory skills to promote independence and long-term adherence to exercising and dietary changes.

Study summary

Small Steps for Big Changes (SSBC) is a diet and exercise counselling program that significantly reduces the risk of developing Type 2 Diabetes (T2D). In partnership with YMCAs in Canada spanning 8 provinces, the aim of this study is to scale-up program delivery and evaluate the implementation and effectiveness of SSBC. To evaluate implementation, the number of staff trained/patients enrolled, attendance, sessions delivered as planned, delivery costs, and number of sites continuing to deliver the program will be examined. To evaluate program effectiveness, changes in patient health (e.g., T2D status, blood glucose, weight, exercise, diet) will be measured over 2 years following program completion.

Eligibility

Primary outcome measure(s)

• Type 2 diabetes status — 0, 12, and 24 months post intervention
  Self reported HbA1c%
• Change in HbA1c — 0, 12 and 24 months post intervention
  Venipuncture blood collection of HbA1c% through laboratory testing in a subsample of participants
• Adoption of SSBC — 0, 52, 104, 156, 208 weeks
  Proportion and representativeness of coaches and implementation support team obtained through program records
• Reach of SSBC — 0, 52, 104, 156, 208 weeks
  Proportion of patients' enrolled and completing the intervention, proportion of implementation staff trained and retained. Demographics of the patients and staff
• Dose Delivered — During delivery of the intervention
  Number of SSBC sessions delivered by coaches (0-6) will be gathered through coach checklists
• Fidelity of SSBC delivery — During delivery of the intervention
  Frequency with which clients recieve each core component and quality of counselling skills measured using session checklists.
• Number of adaptations of SSBC — Prior to, and throughout delivery of the intervention (0-104 weeks), sustainment planning and delivery (104-208 weeks)
  Number 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.
• Types of adaptations of SSBC — Prior to, and throughout delivery of the intervention (0-104 weeks), sustainment planning and delivery (104-208 weeks)
  Type of adaptations made prior to delivery of SSBC and during SSBC delivery. Adaptation information will be gathered through meeting minutes with site leads, annual reports from delivery sites and through interviews with coaches and site leads.
• Receptivity to SSBC among patients' and staff — 4, and 52 weeks (patients), during delivery (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.
• Cost of Delivering SSBC — 104, 156, 208 weeks
  Costs incurred for implementing SSBC at the delivery sites will be collected through annual reporting from the delivery sites.
• Membership rates — 104, 156, 208 weeks
  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.

Trial sites (12)

More University of British Columbia trials in Canada

Other trials for the same condition