Clinical trial NCT06440395: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PreDiabetes
Keywords: Implementation Science
Exercise Behaviour
Diet Behaviour
Adherence
Health Behaviour Change
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Public Health Agency of Canada (PHAC)
name: McMaster University
name: Memorial University of Newfoundland
name: Brock University
name: Arthritis Research Centre of Canada
First posted: 2024-06-03
Enrollment: 4400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators aim to recruit a community-based sample of adults at risk of type 2 diabetes

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.

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.

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

Primary outcomes:
measure: Type 2 diabetes status
timeFrame: 0, 12, and 24 months post intervention
measure: Change in HbA1c
timeFrame: 0, 12 and 24 months post intervention
measure: Adoption of SSBC
timeFrame: 0, 52, 104, 156, 208 weeks
measure: Reach of SSBC
timeFrame: 0, 52, 104, 156, 208 weeks
measure: Dose Delivered
timeFrame: During delivery of the intervention
measure: Fidelity of SSBC delivery
timeFrame: During delivery of the intervention
measure: Number of adaptations of SSBC
timeFrame: Prior to, and throughout delivery of the intervention (0-104 weeks), sustainment planning and delivery (104-208 weeks)
measure: Types of adaptations of SSBC
timeFrame: Prior to, and throughout delivery of the intervention (0-104 weeks), sustainment planning and delivery (104-208 weeks)
measure: Receptivity to SSBC among patients' and staff
timeFrame: 4, and 52 weeks (patients), during delivery (staff)
measure: Cost of Delivering SSBC
timeFrame: 104, 156, 208 weeks
measure: Membership rates
timeFrame: 104, 156, 208 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: 0, 4, 52, and 104 weeks
measure: Change in cardiorespiratory fitness
timeFrame: 0, 4, 52, and 104 weeks
measure: Change in physical activity behaviour using the Godin Leisure Time Physical Activity Questionnaire
timeFrame: 0, 4, 52, and 104 weeks
measure: Changes in physical activity using the 2-item Physical Activity Vital Signs measure
timeFrame: 0, 4, 52, and 104 weeks
measure: Change in dietary intake
timeFrame: 0, 4, 52, and 104 weeks
measure: Determinants of intervention implementation
timeFrame: 52 weeks
measure: Sustainability outcomes and determinants
timeFrame: 104, 156 and 208 weeks
measure: Change in health-related quality of life (EQ-5D-5L Profile)
timeFrame: 0, 4, 52, and 104 weeks
measure: Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale)
timeFrame: 0, 4, 52, and 104 weeks
measure: Change in health resource utilization
timeFrame: 0, 52, and 104 weeks
Other outcomes:
measure: Organizational readiness
timeFrame: 0 weeks
measure: Change in 24-hour movement
timeFrame: 0, 4, 52, 104 weeks
measure: Change in waist circumference
timeFrame: 0, 4, 52, and 104 weeks
measure: Baseline self-compassion
timeFrame: 0 weeks
Locations:
city: Edmonton
country: Canada
facility: Castle Downs Family YMCA
state: Alberta
city: Kelowna
country: Canada
facility: Health and Exercise Psychology Laboratory
state: British Columbia
city: Prince George
country: Canada
facility: Prince George Family YMCA
state: British Columbia
city: Surrey
country: Canada
facility: Tong Louie Family YMCA
state: British Columbia
city: Brandon
country: Canada
facility: YMCA of Brandon Health and Fitness Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Elmwood-Kildonan
state: Manitoba
city: Saint John
country: Canada
facility: Saint John Regional Y
state: New Brunswick
city: Saint John's
country: Canada
facility: Ches Penney Family YMCA
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: John W. Lindsay YMCA
state: Nova Scotia
city: Kitchener
country: Canada
facility: YMCA 3 Rivers
state: Ontario
city: Scarborough
country: Canada
facility: YMCA of Greater Toronto - Scarborough Health and Fitness Centre
state: Ontario
city: Regina
country: Canada
facility: YMCA of Regina Health, Fitness and Aquatics Centre
state: Saskatchewan
Study officials:
References: