Recruiting

Implementation Science

Sponsor:

University of British Columbia

Code:

NCT06440395

Conditions

PreDiabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Behavioural: Small Steps for Big Changes Diabetes Prevention Program

Study Details

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.

Conditions

PreDiabetes

Study ID

NCT06440395

Start date

Jun 3, 2024

Status verified date

Jul, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

4400 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Primary outcome measure

  • 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 ]
  • Membership rates [ Time Frame: 104, 156, 208 weeks ]

Central Contacts and Locations

Locations

Health and Exercise Psychology Laboratory

Recruiting

Kelowna, British Columbia, Canada, V1V 1V7

Contacts

Mary E June, PhD

250-807-8419mary.jung@ubc.ca

Principal Investigator:

Mary E Jung, PhD

More Information

Sponsor

University of British Columbia

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • Implementation Science
  • Exercise Behaviour
  • Diet Behaviour
  • Adherence
  • Health Behaviour Change

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-08-03.