Small Steps for Big Changes - Healthy Cities Implementation Science
HCIS
Small Steps for Big Changes: Implementing an Evidence-Based Diabetes Prevention Program Into Diverse Urban Communities
1 other identifier
observational
4,400
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2024
CompletedFirst Posted
Study publicly available on registry
June 3, 2024
CompletedStudy Start
First participant enrolled
June 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
January 14, 2025
January 1, 2025
5.2 years
May 13, 2024
January 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Type 2 diabetes status
Self reported HbA1c%
0, 12, and 24 months post intervention
Change in HbA1c
Venipuncture blood collection of HbA1c% through laboratory testing in a subsample of participants
0, 12 and 24 months post intervention
Adoption of SSBC
Proportion and representativeness of coaches and implementation support team obtained through program records
0, 52, 104, 156, 208 weeks
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
Dose Delivered
Number of SSBC sessions delivered by coaches (0-6) will be gathered through coach checklists
During delivery of the intervention
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
Number of adaptations of SSBC
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.
Prior to, and throughout delivery of the intervention (0-104 weeks), sustainment planning and delivery (104-208 weeks)
Types of adaptations of SSBC
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.
Prior to, and throughout delivery of the intervention (0-104 weeks), sustainment planning and delivery (104-208 weeks)
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)
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
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 Outcomes (10)
Change in body weight
0, 4, 52, and 104 weeks
Change in cardiorespiratory fitness
0, 4, 52, and 104 weeks
Change in physical activity behaviour using the Godin Leisure Time Physical Activity Questionnaire
0, 4, 52, and 104 weeks
Changes in physical activity using the 2-item Physical Activity Vital Signs measure
0, 4, 52, and 104 weeks
Change in dietary intake
0, 4, 52, and 104 weeks
- +5 more secondary outcomes
Other Outcomes (4)
Organizational readiness
0 weeks
Change in 24-hour movement
0, 4, 52, 104 weeks
Change in waist circumference
0, 4, 52, and 104 weeks
- +1 more other outcomes
Study Arms (1)
Small Steps for Big Changes: Diabetes Prevention Program
Diabetes Prevention Program (one-treatment group) The diabetes prevention program is a 4-week program that will introduce participants to a regular healthy behaviours that includes exercise and simple dietary strategies. There is no randomization to this program - all individuals enrolled will partake in the same program and will be followed up for 24 months after the program has concluded.
Interventions
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.
Eligibility Criteria
The investigators aim to recruit a community-based sample of adults at risk of type 2 diabetes
You may qualify if:
- Community-dwelling adults aged 18 years or older
- able to read and speak English
- has prediabetes assessed by one of the following means: (a) physician-diagnosed prediabetes, (b) HbA1c values between 5.7 - 6.4% (American Diabetes Association, 2012), (c) an American Diabetes Association risk questionnaire score indicating increased risk (\>5)
- Individuals who have previously been diagnosed with type 2 diabetes but who are in remission (defined as achieving glycated hemoglobin (A1C) of \< 6.4% without any diabetes-related medications for a minimum of 3 months) will be eligible to participate.
You may not qualify if:
- \- Patients currently diagnosed type 2 diabetes with an HbA1c of 6.5% or greater.
- Organizational partners
- \- Senior leadership and/or management of our Canadian YMCA delivery partner organizations
- Site leads/managers
- \- YMCA staff who manage/coordinate programs (e.g., general manager of health programs) for each site willing to act as SSBC site lead champion.
- Coaches
- Site staff certified as SSBC coaches to deliver the program.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Canadian Institutes of Health Research (CIHR)collaborator
- Public Health Agency of Canada (PHAC)collaborator
- McMaster Universitycollaborator
- Memorial University of Newfoundlandcollaborator
- Brock Universitycollaborator
- Arthritis Research Centre of Canadacollaborator
Study Sites (12)
Castle Downs Family YMCA
Edmonton, Alberta, T5X 6A3, Canada
Health and Exercise Psychology Laboratory
Kelowna, British Columbia, V1V 1V7, Canada
Prince George Family YMCA
Prince George, British Columbia, V2L 4V7, Canada
Tong Louie Family YMCA
Surrey, British Columbia, V3S 7S6, Canada
YMCA of Brandon Health and Fitness Centre
Brandon, Manitoba, R7A 3X2, Canada
Elmwood-Kildonan
Winnipeg, Manitoba, R2K 2M6, Canada
Saint John Regional Y
Saint John, New Brunswick, E2K 3E2, Canada
Ches Penney Family YMCA
St. John's, Newfoundland and Labrador, A1A 5G6, Canada
John W. Lindsay YMCA
Halifax, Nova Scotia, B3J 3Y3, Canada
YMCA 3 Rivers
Kitchener, Ontario, N2G 3C5, Canada
YMCA of Greater Toronto - Scarborough Health and Fitness Centre
Scarborough Village, Ontario, M1B 3C6, Canada
YMCA of Regina Health, Fitness and Aquatics Centre
Regina, Saskatchewan, S4X 2P9, Canada
Related Publications (1)
Weatherson K, Bourne JE, Cranston K, Braaten K, Grieve N, Kelly J, Jung ME. Scaling Up a Diabetes Prevention Program in Geographically and Ethnoculturally Diverse Urban Regions of Canada: Protocol for a Hybrid Type 2 Implementation-Effectiveness Study. JMIR Res Protoc. 2026 Jan 19;15:e80276. doi: 10.2196/80276.
PMID: 41553750DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 13, 2024
First Posted
June 3, 2024
Study Start
June 3, 2024
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
September 1, 2029
Last Updated
January 14, 2025
Record last verified: 2025-01