Small Steps for Big Changes - Healthy Cities Implementation Science

Official title

Small Steps for Big Changes: Implementing an Evidence-Based Diabetes Prevention Program Into Diverse Urban Communities

Overview

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.

Detailed description

In partnership with YMCAs in Canada spanning 8 provinces (overseeing 44 distinct community facilities/sites), the investigators will adapt and deliver our evidence-based diabetes prevention program, Small Steps for Big Changes. The purpose of this project is to evaluate the implementation and effectiveness of SSBC across diverse urban communities.

Specifically, the investigators aim to:

1. Evaluate the implementation and sustainability of the program by examining the number of staff trained/patients enrolled, attendance, sessions delivered as planned, delivery costs, and number of sites continuing to deliver the program. 2. Examine clinical-effectiveness of the program on: T2D status (self-report and HbA1c; primary outcomes), cardiorespiratory fitness, anthropometric (weight, waist circumference, resting heart rate), health behaviours (exercise, diet). 3. Examine cost-effectiveness of the program on: healthcare resource utilization, and health-related quality of life (secondary outcomes).

Research Design:

A hybrid type 2 implementation-effectiveness study design (Curran et al., 2012) with multi/mixed methods will be used to evaluate the implementation and effectiveness of SSBC.

SSBC program:

SSBC will be administered and facilitated by the community facility trainers at YMCA locations. SSBC consists of 6 sessions delivered over 4 consecutive weeks, with each session comprising brief (20-30 mins) counselling that support participants self-regulatory skills to promote independence and long-term adherence to healthy dietary behaviours and regular exercise, followed by 20-30 mins of supervised aerobic exercise.

Interventions

• Behavioral 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 s

Primary outcome measures

• Type 2 diabetes status [Time frame: 0, 12, and 24 months post intervention]
• Change in HbA1c [Time frame: 0, 12 and 24 months post intervention]
• Adoption of SSBC [Time frame: 0, 52, 104, 156, 208 weeks]
• Reach of SSBC [Time frame: 0, 52, 104, 156, 208 weeks]
• Dose Delivered [Time frame: During delivery of the intervention]
• Fidelity of SSBC delivery [Time frame: During delivery of the intervention]
• Number of adaptations of SSBC [Time frame: Prior to, and throughout delivery of the intervention (0-104 weeks), sustainment planning and delivery (104-208 weeks)]
• Types of adaptations of SSBC [Time frame: 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 [Time frame: 4, and 52 weeks (patients), during delivery (staff)]
• Cost of Delivering SSBC [Time frame: 104, 156, 208 weeks]

Secondary outcome measures (10)

• Change in body weight [Time frame: 0, 4, 52, and 104 weeks]
• Change in cardiorespiratory fitness [Time frame: 0, 4, 52, and 104 weeks]
• Change in physical activity behaviour using the Godin Leisure Time Physical Activity Questionnaire [Time frame: 0, 4, 52, and 104 weeks]
• Changes in physical activity using the 2-item Physical Activity Vital Signs measure [Time frame: 0, 4, 52, and 104 weeks]
• Change in dietary intake [Time frame: 0, 4, 52, and 104 weeks]
• Determinants of intervention implementation [Time frame: 52 weeks]
• Sustainability outcomes and determinants [Time frame: 104, 156 and 208 weeks]
• Change in health-related quality of life (EQ-5D-5L Profile) [Time frame: 0, 4, 52, and 104 weeks]
• Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale) [Time frame: 0, 4, 52, and 104 weeks]
• Change in health resource utilization [Time frame: 0, 52, and 104 weeks]

Eligibility criteria

Patients

Inclusion criteria

• 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.

Exclusion criteria

\- Patients currently diagnosed type 2 diabetes with an HbA1c of 6.5% or greater.

Organizational partners

Inclusion criteria

\- Senior leadership and/or management of our Canadian YMCA delivery partner organizations

Exclusion criteria: N/A

Site leads/managers

Inclusion criteria

\- YMCA staff who manage/coordinate programs (e.g., general manager of health programs) for each site willing to act as SSBC site lead champion.

Exclusion criteria: N/A

Coaches

Inclusion criteria

Site staff certified as SSBC coaches to deliver the program.

Exclusion criteria: N/A

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Canada · 12 centers

• Castle Downs Family YMCA — Edmonton
• Health and Exercise Psychology Laboratory — Kelowna
• Prince George Family YMCA — Prince George
• Tong Louie Family YMCA — Surrey
• YMCA of Brandon Health and Fitness Centre — Brandon
• Elmwood-Kildonan — Winnipeg
• Saint John Regional Y — Saint John
• Ches Penney Family YMCA — St. John's
• … and 4 more centers

Publications

• 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 41553750

Identifiers

NCT: NCT06440395 · H23-01930

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗