Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440395
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-13
Brief Title:
Small Steps for Big Changes - Healthy Cities Implementation Science
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Small Steps for Big Changes Implementing an Evidence-Based Diabetes Prevention Program Into Diverse Urban Communities
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCIS
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 trainedpatients 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 eg 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 facilitiessites 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 trainedpatients 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 multimixed 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
Specifically the investigators aim to
1 Evaluate the implementation and sustainability of the program by examining the number of staff trainedpatients 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 multimixed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None