Small Steps for Big Changes - Healthy Cities Implementation Science

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06440395
Study type	Observational
Source	University of British Columbia
Contact
Status	Recruiting
Phase
Start date	June 3, 2024
Completion date	September 2029

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05354245` - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)	N/A
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting	`NCT06115265` - Ketogenic Diet and Diabetes Demonstration Project	N/A
Completed	`NCT03188263` - Morning Light Treatment to Improve Glucose Metabolism	N/A
Recruiting	`NCT03821961` - 18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery	N/A
Completed	`NCT04303468` - Intervention With a GABA Supplement in Prediabetics	N/A
Recruiting	`NCT06094231` - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study	N/A
Completed	`NCT03675360` - Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial	N/A
Completed	`NCT01910051` - Explorative Assessment of Biomarkers in Overweight and Obese Subjects
Completed	`NCT03527368` - The Time-Restricted Intake of Meals Study	N/A
Not yet recruiting	`NCT06453278` - (DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
Completed	`NCT02899390` - Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes	N/A
Suspended	`NCT03240978` - Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese	N/A
Completed	`NCT03865342` - Prevention of Diabetes Using Mobile-enabled, Virtual Delivery of the National Diabetes Prevention Program	N/A
Recruiting	`NCT01972113` - Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)	N/A
Completed	`NCT01432509` - Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord)	N/A
Completed	`NCT01436916` - Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus	Phase 4
Completed	`NCT00990184` - Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)	Phase 3
Completed	`NCT00886340` - A Lifestyle Change Program to Prevent Type 2 Diabetes	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Small Steps for Big Changes - Healthy Cities Implementation Science — HCIS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms