PreDiabetesHCISNCT06440395
Small Steps for Big Changes - Healthy Cities Implementation Science
An observational study of PreDiabetes, run by University of British Columbia at 12 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Behavioural: Small Steps for Big Changes Diabetes Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,400 participants
- Where
- 12 sitesCanada
- Study dates
- 3 Jun 2024to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators aim to recruit a community-based sample of adults at risk of type 2 diabetes
Who may be able to join
- 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.
- Senior leadership and/or management of our Canadian YMCA delivery partner organizations
- YMCA staff who manage/coordinate programs (e.g., general manager of health programs) for each site willing to act as SSBC site lead champion.
- Site staff certified as SSBC coaches to deliver the program.
Who cannot join
- Patients currently diagnosed type 2 diabetes with an HbA1c of 6.5% or greater.
- Organizational partners
- Site leads/managers
- Coaches
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Canada12 sites, 12 recruiting
- Not yet recruiting
YMCA of Brandon Health and Fitness Centre
Brandon, Manitoba, R7A 3X2
Lon Cullen, lon.cullen@ymanitoba.ca
Diana Sherifali
- Not yet recruiting
Castle Downs Family YMCA
Edmonton, Alberta, T5X 6A3
Jody Kyle, jody.kyle@northernalberta.ymca.ca
Linda Li
- Not yet recruiting
John W. Lindsay YMCA
Halifax, Nova Scotia, B3J 3Y3
Joy Chiekwe, joy.chiekwe@halifax.ymca.ca
Katie Wadden
- Recruiting
Health and Exercise Psychology Laboratory
Kelowna, British Columbia, V1V 1V7
Mary E June, PhD, 250-807-8419, mary.jung@ubc.ca
Mary E Jung, PhD
- Not yet recruiting
YMCA 3 Rivers
Kitchener, Ontario, N2G 3C5
Crystal Hughes, (613) 921-4159, Crystal.Hughes@ytr.ymca.ca
Diana Sherifali
- Not yet recruiting
Prince George Family YMCA
Prince George, British Columbia, V2L 4V7
Alyssa O'Connor, 250 562 9341 ext. 2116, alyssa.oconnor@bc.ymca.ca
Linda Li
- Not yet recruiting
YMCA of Regina Health, Fitness and Aquatics Centre
Regina, Saskatchewan, S4X 2P9
Steve Compton, Steve.compton@regina.ymca.ca
Linda Li
- Not yet recruiting
Saint John Regional Y
Saint John, New Brunswick, E2K 3E2
Sherry Fitzgerald, S.Fitzgerald@saintjohny.ca
Katie Wadden
- Not yet recruiting
YMCA of Greater Toronto - Scarborough Health and Fitness Centre
Scarborough Village, Ontario, M1B 3C6
Samantha Casmey, Samantha.Casmey@YMCAGTA.ORG
Diana Sherifali
- Not yet recruiting
Ches Penney Family YMCA
St. John's, Newfoundland and Labrador, A1A 5G6
Sherry Squires, sherry.squires@nl.ymca.ca
Katie Wadden
- Not yet recruiting
Tong Louie Family YMCA
Surrey, British Columbia, V3S 7S6
Alyssa O'Connor, 604.320-5846, alyssa.oconnor@bc.ymca.ca
Linda Li
- Not yet recruiting
Elmwood-Kildonan
Winnipeg, Manitoba, R2K 2M6
Casie Nishi, 204-831-2972, casie.nishi@ymanitoba.ca
Diana Sherifali
About this study
Official title: Small Steps for Big Changes: Implementing an Evidence-Based Diabetes Prevention Program Into Diverse Urban Communities
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.
Read the 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:
- 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.
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.
- Conditions
- PreDiabetes
- Being tested
- Behavioural: Small Steps for Big Changes Diabetes Prevention Program
- Keywords
- Implementation Science, Exercise Behaviour, Diet Behaviour, Adherence, Health Behaviour Change
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural: Small Steps for Big Changes Diabetes Prevention ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Small Steps for Big Changes: Diabetes Prevention Program | Diabetes Prevention Program (one-treatment group) The diabetes prevention program is a 4-week program that will introduce participants to a regular healthy behaviours that includes exercise and simple dietary strategies. There is no randomization to this program - all individuals enrolled will partake in the same program and will be followed up for 24 months after the program has concluded. Receives: Behavioral: Behavioural: Small Steps for Big Changes Diabetes Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 diabetes status
Self reported HbA1c%
Measured: 0, 12, and 24 months post intervention
Change in HbA1c
Venipuncture blood collection of HbA1c% through laboratory testing in a subsample of participants
Measured: 0, 12 and 24 months post intervention
Adoption of SSBC
Proportion and representativeness of coaches and implementation support team obtained through program records
Measured: 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
Measured: 0, 52, 104, 156, 208 weeks
Dose Delivered
Number of SSBC sessions delivered by coaches (0-6) will be gathered through coach checklists
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 104, 156, 208 weeks
Secondary outcomes (10)
Change in body weight
Measured in pounds
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 0, 52, and 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start3 Jun 2024
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC), McMaster University, Memorial University of Newfoundland, Brock University, Arthritis Research Centre of Canada
- Responsible party
- Principal investigator, Mary Jung, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440395
- Sponsor's protocol ID
- H23-01930
- Acronym
- HCIS
- Status last verified
- Jul 2026
- First submitted
- 13 May 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Weatherson K, Bourne JE, Cranston K, Braaten K, Grieve N, Kelly J, Jung ME. Scaling Up a Diabetes Prevention Program in Geographically and Ethnoculturally Diverse Urban Regions of Canada: Protocol for a Hybrid Type 2 Implementation-Effectiveness Study. JMIR Res Protoc. 2026 Jan 19;15:e80276. doi: 10.2196/80276.
PubMed 41553750
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Steps for Big Changes: Implementing an Evidence-Based Diabetes Prevention Program Into Diverse Urban Communities
- ClinicalTrials.gov ID
- NCT06440395
- Acronym / sponsor ID
- HCIS / H23-01930
- Conditions
- PreDiabetes
- Keywords
- Implementation Science, Exercise Behaviour, Diet Behaviour, Adherence, Health Behaviour Change
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,400 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC), McMaster University, Memorial University of Newfoundland, Brock University, Arthritis Research Centre of Canada
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Small Steps for Big Changes: Diabetes Prevention Program | – | Behavioral: Behavioural: Small Steps for Big Changes Diabetes Prevention ProgramDiabetes Prevention Program (one-treatment group) The diabetes prevention program is a 4-week program that will introduce participants to a regular healthy behaviours that includes exercise and simple dietary strategies. There is no randomization to this program - all individuals enrolled will partake in the same program and will be followed up for 24 months after the program has concluded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators aim to recruit a community-based sample of adults at risk of type 2 diabetes
Key inclusion criteria (7 listed)
- 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.
- Senior leadership and/or management of our Canadian YMCA delivery partner organizations
Key exclusion criteria (4 listed)
- Patients currently diagnosed type 2 diabetes with an HbA1c of 6.5% or greater.
- Organizational partners
- Site leads/managers
- Coaches
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioural: Small Steps for Big Changes Diabetes Prevention ProgramThe 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. | Behavioural | Small Steps for Big Changes: Diabetes Prevention Program |
Primary outcome
Type 2 diabetes status
Time frame: 0, 12, and 24 months post intervention
Self reported HbA1c%
Change in HbA1c
Time frame: 0, 12 and 24 months post intervention
Venipuncture blood collection of HbA1c% through laboratory testing in a subsample of participants
Adoption of SSBC
Time frame: 0, 52, 104, 156, 208 weeks
Proportion and representativeness of coaches and implementation support team obtained through program records
Reach of SSBC
Time frame: 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
Dose Delivered
Time frame: During delivery of the intervention
Number of SSBC sessions delivered by coaches (0-6) will be gathered through coach checklists
Fidelity of SSBC delivery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Cost of Delivering SSBC
Time frame: 104, 156, 208 weeks
Costs incurred for implementing SSBC at the delivery sites will be collected through annual reporting from the delivery sites.
Membership rates
Time frame: 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.
10 secondary outcomes
Change in body weight
Time frame: 0, 4, 52, and 104 weeks
Change in cardiorespiratory fitness
Time frame: 0, 4, 52, and 104 weeks
Change in physical activity behaviour using the Godin Leisure Time Physical Activity Questionnaire
Time frame: 0, 4, 52, and 104 weeks
Changes in physical activity using the 2-item Physical Activity Vital Signs measure
Time frame: 0, 4, 52, and 104 weeks
Change in dietary intake
Time frame: 0, 4, 52, and 104 weeks
Determinants of intervention implementation
Time frame: 52 weeks
Sustainability outcomes and determinants
Time frame: 104, 156 and 208 weeks
Change in health-related quality of life (EQ-5D-5L Profile)
Time frame: 0, 4, 52, and 104 weeks
Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale)
Time frame: 0, 4, 52, and 104 weeks
Change in health resource utilization
Time frame: 0, 52, and 104 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Derived from this study: PubMed 41553750Weatherson K, Bourne JE, Cranston K, Braaten K, Grieve N, Kelly J, Jung ME. Scaling Up a Diabetes Prevention Program in Geographically and Ethnoculturally Diverse Urban Regions of Canada: Protocol for a Hybrid Type 2 Implementation-Effectiveness Study. JMIR Res Protoc. 2026 Jan 19;15:e80276. doi: 10.2196/80276.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PreDiabetes, run by University of British Columbia at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type 2 diabetes status (time frame: 0, 12, and 24 months post intervention). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06440395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.