Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001194550
Ethics application status
Approved
Date submitted
8/08/2024
Date registered
30/09/2024
Date last updated
30/09/2024
Date data sharing statement initially provided
30/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation and evaluation of the Small Steps for Big Changes Diabetes Prevention Program in South-East Queensland, Australia
Scientific title
Implementation and evaluation of the Small Steps for Big Changes Diabetes Prevention Program for adults with elevated risk for type 2 diabetes in South-East Queensland, Australia
Secondary ID [1] 312392 0
NCT06440395
Universal Trial Number (UTN)
Trial acronym
SSBC-AUS
Linked study record
This study is related to NCT06440395, and is the Australian arm of the Healthy Cities funding grant. Deidentified data from this study will be pooled with the data collected in NCT06440395 to enable both combined and cross-country comparisons. It also builds on the previous work detailed in previous trials (NCT02164474, NCT03096002, NCT05962983).

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 334198 0
Condition category
Condition code
Metabolic and Endocrine 330861 330861 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

Small Steps for Big Changes is a diet and exercise coaching intervention targeting adults at risk of type 2 diabetes. It is delivered in the community by community persons who have been trained to deliver the intervention. This use of community persons as health coaches is a key implementation strategy. These health coaches are trained, via online modules, in motivational interviewing in order to provide a person-led approach the promotes autonomy for diet and exercise changes.
The intervention is designed to be delivered by this health coach one-on-one over six 1-on-1 sessions across a four week period. Each session incorporates guidance on healthy eating and active living (about 40 minutes) and structured, supervised moderate continuous activity or high intensity interval training aerobic exercise (20 to 30 minutes). The exercise intensity is measured through heart rate and the rate of perceived exertion (Borg test), with participants also taught the talk test. Delivery sites can choose to augment this core program with additional elements, such as strength training or a group-based offering or extend the delivery period out to up to six weeks.
The core components of the SSBC intervention are: self-monitoring (achieved via a client workbook); goal setting (done in collaboration with the health coach and reviewed each session); relapse prevention planning (through action planning and goal setting); diet and exercise education (targeting areas of: hidden sugar; physical sensations felt with exercise; carbohydrates, low and high GI food choices and a health plate; benefits of physical activity for diabetes prevention, identifying supports and addressing barriers to active living; and, managing setbacks and plans for post intervention); supervised choice-based moderate (e.g., steady walking on a treadmill or steady pedalling on a stationary bike) or high intensity aerobic exercise (e.g., brisk walking on a treadmill or fast pedalling on a stationary bike), with the option to do strength training as a home exercise or other appropriate exercise; and, reflection of behaviour change (done through the health coaching session and client workbook activities). Provision and take-up of any additions will be tracked. Session attendance, and delivery of these core elements of the intervention (i.e., use of motivational interviewing strategies; development and check-in of goals; self-monitoring; attendance at sessions) is tracked by the health coach as part of the session, with the health coach supported in this via scripts and prompts in REDCap.
Intervention code [1] 328894 0
Prevention
Intervention code [2] 328895 0
Behaviour
Intervention code [3] 329295 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338655 0
Change in moderate-to-vigorous intensity activity pre-post program (Effectiveness indicator)
Timepoint [1] 338655 0
End of program (end of session 6: typically 4 weeks after program commencement).
Primary outcome [2] 338656 0
Fidelity of SSBC delivery - (Implementation indicator)
Timepoint [2] 338656 0
End of program (end of session 6: typically 4 weeks after program commencement).
Secondary outcome [1] 438436 0
Proportion of certified health coaches of those undertaking training (Adoption indicator)
Timepoint [1] 438436 0
Tracked by research team throughout program and reported on annually with final reporting at project completion.
Secondary outcome [2] 438437 0
Number and reasons for health coaches and site withdrawals (Adoption indicator). This will be assessed as a composite outcome.
Timepoint [2] 438437 0
This will be tracked throughout the study as part of site monitoring process and will be reported on annually with final reporting at project completion.
Secondary outcome [3] 438439 0
Proportion of clients interested, eligible, consented, enrolled and completing the intervention (Reach indicator: assessed as composite outcome)
Timepoint [3] 438439 0
Assessed annually from the start of the program until project completion at year 4 of delivery.
Secondary outcome [4] 438440 0
Characteristics of the eligible and ineligible clients (Reach indicator). Please note that understanding Reach is an outcome of the trial.
Timepoint [4] 438440 0
Eligibility screening
Secondary outcome [5] 438441 0
Number and reasons for withdrawal client (this will be assessed as a composite outcome at the conclusion of the study)
Timepoint [5] 438441 0
Tracked throughout project and reported as part of annual reporting.
Secondary outcome [6] 438443 0
Membership rates -- the proportion of individuals who convert their one-month free pass to a facility membership (Maintenance indicator)
Timepoint [6] 438443 0
Reported annually and collected up to 4 years post initial implementation with final report at project completion.
Secondary outcome [7] 438444 0
Referral pathways into program for health coaches and clients (Reach indicator)
Timepoint [7] 438444 0
Collected throughout program and reviewed quarterly to understand referral pathways. Reported on as part of yearly reporting and summarised at project completion.
Secondary outcome [8] 438445 0
Change in weight (Effectiveness)
Timepoint [8] 438445 0
Change pre-program to end-program (end of session 6: typically 4 weeks after program commencement)
Change pre-program to 12 months post program commencement.
Secondary outcome [9] 438446 0
Change in cardio-respiratory fitness measured through the 2-minute step test (Effectiveness indicator)
Timepoint [9] 438446 0
Change pre- to post-program (end of session 6: typically 4 weeks after program commencement)
Change pre-program to 12 months post program commencement.
Secondary outcome [10] 438447 0
Change in strength (Effectiveness)
Timepoint [10] 438447 0
Change pre- to post-program (end of session 6: typically 4 weeks after program commencement)
Change pre-program to 12 months post program commencement.
Secondary outcome [11] 438448 0
Change in balance (Effectiveness)
Timepoint [11] 438448 0
Change pre- to post-program (end of session 6: typically 4 weeks after program commencement)
Change pre-program to 12 months post program commencement.
Secondary outcome [12] 438449 0
Change in health-related quality of life (Effectiveness)
Timepoint [12] 438449 0
Change from pre program to end of program (end of session 6: typically 4 weeks after program commencement) and to 3-months, 6-months and 12-months post program commencement.
Secondary outcome [13] 438450 0
Change in other activity behaviours (sedentary, light, sleep, strength sessions) (Effectiveness)
Timepoint [13] 438450 0
Change from pre-program to post-program (end of session 6: typically 4 weeks after program commencement)
Change from pre-program to 3-; 6- and 12-months post program commencement.
Secondary outcome [14] 438451 0
Change in dietary intake (Effectiveness)
Timepoint [14] 438451 0
Change from pre-program to post-program (end of session 6: typically 4 weeks after program commencement)
Change from pre-program to 3-; 6- and 12-months post program commencement.
Secondary outcome [15] 438452 0
Change in type 2 diabetes status (Effectiveness)
Timepoint [15] 438452 0
3-, 6- and 12-months post program
Secondary outcome [16] 438453 0
Change in social support
Timepoint [16] 438453 0
Change from pre-program to post-program (end of session 6: typically 4 weeks after program commencement)
Change from pre-program to 3-; 6- and 12-months post program commencement.
Secondary outcome [17] 438454 0
Number and type of adaptations made prior to delivery of SSBC and during SSBC delivery (Implementation)
Timepoint [17] 438454 0
Data will be collected from the adaptation workshop and pre-implementation meeting minutes and throughout the four years of program delivery in line with the site-determined meeting schedule. It will be reported on annually and summarised at project completion.
Secondary outcome [18] 438455 0
Number of adaptations needed for sustainability and during sustainment (Implementation)
Timepoint [18] 438455 0
Data will be collected annually up to 4 years post implementation commencement and summarised at project completion.
Secondary outcome [19] 438456 0
Cost of delivering SSBC (Implementation)
Timepoint [19] 438456 0
Data will be collected annually up to four years post implementation at the site and summarised at project completion.
Secondary outcome [20] 438457 0
Acceptability of SSBC among site staff and health coaches (Implementation)
Timepoint [20] 438457 0
Acceptability will be assessed at pre-implementation, and post program / post implementation at 2 months, then yearly (1, 2, 3, 4) post implementation.
Secondary outcome [21] 438458 0
Sustainability of the program (Maintenance): assessed as a composite outcome.
Timepoint [21] 438458 0
Data will be collected from program tracking with data reported annually and the final timepoint at four years post implementation.
Secondary outcome [22] 439539 0
Characteristics of certified health coaches (Adoption indicator)
Timepoint [22] 439539 0
Pre-training
Secondary outcome [23] 439540 0
Change in waist circumference (effectiveness)
Timepoint [23] 439540 0
Change from pre to end of program (after 6 sessions, typically 4 weeks)
Change pre-program to 12-months post program commencement.
Secondary outcome [24] 439555 0
Change in resting blood pressure
Timepoint [24] 439555 0
Change from pre to end of program (6 sessions, typically 4 weeks)
Change pre-program to 12 months post program commencement.
Secondary outcome [25] 439556 0
Change in resting heart rate
Timepoint [25] 439556 0
Change from pre to end of program (6 sessions, typically 4 weeks).
Change pre-program to 12 months post program commencement.
Secondary outcome [26] 439557 0
Appropriateness of the intervention (from the perspective of organisational leads, site leads, health coaches)
Timepoint [26] 439557 0
Measured pre-implementation, 2 months, 1 year, 2 year, 3 years, and 4 years post-program implementation.
Secondary outcome [27] 439558 0
Feasibility of the intervention (from the perspective of organisational leads, site leads, health coaches)
Timepoint [27] 439558 0
Measured pre-implementation, 2 months, 1 year, 2 year, 3 years, and 4 years post-program implementation.
Secondary outcome [28] 439759 0
Acceptability (clients)
Timepoint [28] 439759 0
Post program (after 6 sessions, typically 4 weeks post baseline).

Eligibility
Key inclusion criteria
COACH ELIGIBILITY
Adults (18 years or over)
Meet the site-level requirements for volunteers at their respective sites
Pass the competency assessment for SSBC intervention delivery

CLIENT ELIGIBILITY
Adults (18 years or over)
Able to read and speak English
Has elevated risk for diabetes, assessed by one of the following means:
a) an AUSDRISK (Australian diabetes risk assessment tool) score of 6 or over (considered intermediate risk),
b) HbA1c of 5.7-6.4%,
c) fasting blood glucose of 6.1 to 6.9 mmol/L (if provided)
Able to provide informed consent
Passed exercise screening / received clearance from GP for exercise
Able to attend a delivery site

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
CLIENT EXCLUSION CRITERIA
- aged <18 years
• currently pregnant
• currently diagnosed with type 2 diabetes with an HBA1c of 6.5% or greater
• score <6 on the AUSDRISK assessment tool
• unable to attend one of the five sites offering the program

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 42768 0
4551 - Caloundra
Recruitment postcode(s) [2] 42770 0
4131 - Meadowbrook
Recruitment postcode(s) [3] 42771 0
4165 - Victoria Point
Recruitment postcode(s) [4] 42772 0
4370 - Warwick
Recruitment postcode(s) [5] 42784 0
4006 - Bowen Hills

Funding & Sponsors
Funding source category [1] 316801 0
Government body
Name [1] 316801 0
National Health and Medical Research Council-Canadian Institutes of Health Research
Country [1] 316801 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 319023 0
University
Name [1] 319023 0
Deakin University
Address [1] 319023 0
Country [1] 319023 0
Australia
Other collaborator category [1] 283103 0
Government body
Name [1] 283103 0
UQ Health Care (Logan Healthy Living)
Address [1] 283103 0
Country [1] 283103 0
Australia
Other collaborator category [2] 283104 0
Charities/Societies/Foundations
Name [2] 283104 0
Y-Qld (YMCA)
Address [2] 283104 0
Country [2] 283104 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315571 0
The University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 315571 0
Ethics committee country [1] 315571 0
Australia
Date submitted for ethics approval [1] 315571 0
21/06/2024
Approval date [1] 315571 0
05/08/2024
Ethics approval number [1] 315571 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135110 0
Prof Genevieve Healy
Address 135110 0
Building 26B, School of Human Movement and Nutrition Sciences, The University of Queensland, Research Drive, St Lucia, QLD, 4072
Country 135110 0
Australia
Phone 135110 0
+61 7 3365 6240
Fax 135110 0
Email 135110 0
[email protected]
Contact person for public queries
Name 135111 0
Genevieve Healy
Address 135111 0
Building 26B, School of Human Movement and Nutrition Sciences, The University of Queensland, Research Drive, St Lucia, QLD, 4072
Country 135111 0
Australia
Phone 135111 0
+61 7 3365 6240
Fax 135111 0
Email 135111 0
[email protected]
Contact person for scientific queries
Name 135112 0
Genevieve Healy
Address 135112 0
Building 26B, School of Human Movement and Nutrition Sciences, The University of Queensland, Research Drive, St Lucia, QLD, 4072
Country 135112 0
Australia
Phone 135112 0
+61 7 3365 6240
Fax 135112 0
Email 135112 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual data underlying the published results
When will data be available (start and end dates)?
Within 6 months following publication; no end date
Available to whom?
Researchers who provide a methodologically sound proposal and appropriate ethical approval.
Available for what types of analyses?
To be used as per any approved methodological sound proposal (with ethical approval), including meta-analyses
How or where can data be obtained?
Contact principal investigator via email: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.