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.
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.
Study Type
OBSERVATIONAL
Enrollment
4,400
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.
Castle Downs Family YMCA
Edmonton, Alberta, Canada
NOT_YET_RECRUITINGHealth and Exercise Psychology Laboratory
Kelowna, British Columbia, Canada
RECRUITINGPrince George Family YMCA
Prince George, British Columbia, Canada
NOT_YET_RECRUITINGTong Louie Family YMCA
Surrey, British Columbia, Canada
NOT_YET_RECRUITINGYMCA of Brandon Health and Fitness Centre
Brandon, Manitoba, Canada
NOT_YET_RECRUITINGElmwood-Kildonan
Winnipeg, Manitoba, Canada
NOT_YET_RECRUITINGSaint John Regional Y
Saint John, New Brunswick, Canada
NOT_YET_RECRUITINGChes Penney Family YMCA
St. John's, Newfoundland and Labrador, Canada
NOT_YET_RECRUITINGJohn W. Lindsay YMCA
Halifax, Nova Scotia, Canada
NOT_YET_RECRUITINGYMCA 3 Rivers
Kitchener, Ontario, Canada
NOT_YET_RECRUITING...and 2 more locations
Type 2 diabetes status
Self reported HbA1c%
Time frame: 0, 12, and 24 months post intervention
Change in HbA1c
Venipuncture blood collection of HbA1c% through laboratory testing in a subsample of participants
Time frame: 0, 12 and 24 months post intervention
Adoption of SSBC
Proportion and representativeness of coaches and implementation support team obtained through program records
Time frame: 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
Time frame: 0, 52, 104, 156, 208 weeks
Dose Delivered
Number of SSBC sessions delivered by coaches (0-6) will be gathered through coach checklists
Time frame: 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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 104, 156, 208 weeks
Change in body weight
Measured in pounds
Time frame: 0, 4, 52, and 104 weeks
Change in cardiorespiratory fitness
Distance walked in the six minute walk test will be conducted at sites with access to a walking track.
Time frame: 0, 4, 52, and 104 weeks
Change in physical activity behaviour using the Godin Leisure Time Physical Activity Questionnaire
The Godin Leisure Time Physical Activity Questionnaire will be used to examine physical activity behaviour. Respondents report the frequency of strenuous, moderate, and mild physical activity for bouts of 15 or more minutes during a 7-day period. The scores are multiplied by weigths and summed into an overall score reports in metabolic equivalents of task (METs)/minutes of physical activity per week.
Time frame: 0, 4, 52, and 104 weeks
Changes in physical activity using the 2-item Physical Activity Vital Signs measure
The 2-item Physical Activity Vital Signs measure will be used to collect information on physical activity behaviour. Two questions are self-reported: 1) "How many days during the past week have you performed physical activity where your heart beats faster and your breathing is harder than normal for 30 minutes or more?" and 2) "How many days in a typical week do you perform activity such as this?" The responses are reported as days during the past week over days in a typical week, with scores ranging from 0 to 7 for each question.
Time frame: 0, 4, 52, and 104 weeks
Change in dietary intake
Assessed using the brief food frequency questionnaire. Participants are asked about their intake of five foods within the past week: fruits, vegetables, sweets, bread and rice/pasta. Items are rated on a 6-point scale. The questionnaire also uses a composite score for refined carbohydrates (sum of bread and rice/pasta).
Time frame: 0, 4, 52, and 104 weeks
Determinants of intervention implementation
Aspects of the larger social, political and economic environment that may influence delivery of the adapted intervention will be assessed by interview. These interviews will also gather qualitative data potential factors that impact delivery of SSBC at the site including context, acceptability, adaptability, feasibility, compatibility, cost, culture, complexity and self efficacy. These interviews will be conducted among coaches and managerial staff.
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Time frame: 52 weeks
Sustainability outcomes and determinants
Data will be collected on the number of sites continuing delivery, the number of coaches continuing delivery, the number of clients run through SSBC and the number of implementation strategies that are utilized. This data will be gathered through program records. Focus groups will be conducted at each site over the 2-year sustainability phase to gather information on the contextual factors that impact sustainment outcomes.
Time frame: 104, 156 and 208 weeks
Change in health-related quality of life (EQ-5D-5L Profile)
The EQ-5D-5L consists of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Participants are asked to indicate their level of functioning (from 1 "no problems" to 5 "extreme problems") on each of the five dimensions of the EQ-5D-5L. The EQ-5D-5 L describes 3125 distinct health states, with 11111 representing the best and 55555 the worst possible health states. The Canadian EQ-5D-5 L scoring algorithm will be applied to generate index scores which range from - 0.148 for the worst (55555) to 0.949 for the best (11111) health states.
Time frame: 0, 4, 52, and 104 weeks
Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale)
Health status will be assessed with the EQ-5D-5L visual analogue scale. Participants report on their health on a visual analogue scale from 0 (worst health) to 100 (best health)
Time frame: 0, 4, 52, and 104 weeks
Change in health resource utilization
The extent to which participants use medical services will be assessed using the Health Resource Utilization Survey. The information will be combined with the EQ-5D-5L health related quality of life profiles to calculate the cost-effectiveness of the program.
Time frame: 0, 52, and 104 weeks