Small Steps for Big Changes - Healthy Cities Implementation Science

Last updated: January 12, 2025
Sponsor: University of British Columbia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Behavioural: Small Steps for Big Changes Diabetes Prevention Program

Clinical Study ID

NCT06440395
H23-01930
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

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-diagnosedprediabetes, (b) HbA1c values between 5.7 - 6.4% (American Diabetes Association, 2012), (c) an American Diabetes Association risk questionnaire score indicatingincreased risk (>5)

  • Individuals who have previously been diagnosed with type 2 diabetes but who are inremission (defined as achieving glycated hemoglobin (A1C) of < 6.4% without anydiabetes-related medications for a minimum of 3 months) will be eligible toparticipate.

Exclusion

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 partnerorganizations

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

Total Participants: 4400
Treatment Group(s): 1
Primary Treatment: Behavioural: Small Steps for Big Changes Diabetes Prevention Program
Phase:
Study Start date:
June 03, 2024
Estimated Completion Date:
September 30, 2029

Study 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.

Connect with a study center

  • Castle Downs Family YMCA

    Edmonton, Alberta T5X 6A3
    Canada

    Site Not Available

  • Health and Exercise Psychology Laboratory

    Kelowna, British Columbia V1V 1V7
    Canada

    Active - Recruiting

  • Prince George Family YMCA

    Prince George, British Columbia V2L 4V7
    Canada

    Site Not Available

  • Tong Louie Family YMCA

    Surrey, British Columbia V3S 7S6
    Canada

    Site Not Available

  • YMCA of Brandon Health and Fitness Centre

    Brandon, Manitoba R7A 3X2
    Canada

    Site Not Available

  • Elmwood-Kildonan

    Winnipeg, Manitoba R2K 2M6
    Canada

    Site Not Available

  • Saint John Regional Y

    Saint John, New Brunswick E2K 3E2
    Canada

    Site Not Available

  • Ches Penney Family YMCA

    Saint John's, Newfoundland and Labrador A1A 5G6
    Canada

    Site Not Available

  • John W. Lindsay YMCA

    Halifax, Nova Scotia B3J 3Y3
    Canada

    Site Not Available

  • YMCA 3 Rivers

    Kitchener, Ontario N2G 3C5
    Canada

    Site Not Available

  • YMCA of Greater Toronto - Scarborough Health and Fitness Centre

    Scarborough, Ontario M1B 3C6
    Canada

    Site Not Available

  • YMCA of Regina Health, Fitness and Aquatics Centre

    Regina, Saskatchewan S4X 2P9
    Canada

    Site Not Available

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