Small Steps for Big Changes: Implementing an Evidence-Based Diabetes Prevention Program Into Diverse Urban Communities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,400
- 试验地点
- 24
- 主要终点
- Type 2 diabetes status
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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).
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •- 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
- •Inclusion criteria:
- •Site staff certified as SSBC coaches to deliver the program.
- •Exclusion criteria: N/A
结局指标
主要结局
Type 2 diabetes status
时间窗: 0, 12, and 24 months post intervention
Self reported HbA1c%
Dose Delivered
时间窗: During delivery of the intervention
Number of SSBC sessions delivered by coaches (0-6) will be gathered through coach checklists
Change in HbA1c
时间窗: 0, 12 and 24 months post intervention
Venipuncture blood collection of HbA1c% through laboratory testing in a subsample of participants
Adoption of SSBC
时间窗: 0, 52, 104, 156, 208 weeks
Proportion and representativeness of coaches and implementation support team obtained through program records
Reach of SSBC
时间窗: 0, 52, 104, 156, 208 weeks
Proportion of patients' enrolled and completing the intervention, proportion of implementation staff trained and retained. Demographics of the patients and staff
Cost of Delivering SSBC
时间窗: 104, 156, 208 weeks
Costs incurred for implementing SSBC at the delivery sites will be collected through annual reporting from the delivery sites.
Fidelity of SSBC delivery
时间窗: During delivery of the intervention
Frequency with which clients recieve each core component and quality of counselling skills measured using session checklists.
Number of adaptations of SSBC
时间窗: Prior to, and throughout delivery of the intervention (0-104 weeks), sustainment planning and delivery (104-208 weeks)
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.
Types of adaptations of SSBC
时间窗: Prior to, and throughout delivery of the intervention (0-104 weeks), sustainment planning and delivery (104-208 weeks)
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.
Receptivity to SSBC among patients' and staff
时间窗: 4, and 52 weeks (patients), during delivery (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.
Membership rates
时间窗: 104, 156, 208 weeks
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.
次要结局
- Change in body weight(0, 4, 52, and 104 weeks)
- Change in cardiorespiratory fitness(0, 4, 52, and 104 weeks)
- Change in physical activity behaviour using the Godin Leisure Time Physical Activity Questionnaire(0, 4, 52, and 104 weeks)
- Changes in physical activity using the 2-item Physical Activity Vital Signs measure(0, 4, 52, and 104 weeks)
- Change in dietary intake(0, 4, 52, and 104 weeks)
- Determinants of intervention implementation(52 weeks)
- Sustainability outcomes and determinants(104, 156 and 208 weeks)
- Change in health-related quality of life (EQ-5D-5L Profile)(0, 4, 52, and 104 weeks)
- Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale)(0, 4, 52, and 104 weeks)
- Change in health resource utilization(0, 52, and 104 weeks)
研究者
Mary Jung
Associate Professor
University of British Columbia