Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000801516
Ethics application status
Approved
Date submitted
11/06/2024
Date registered
28/06/2024
Date last updated
28/06/2024
Date data sharing statement initially provided
28/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation and referral of the ecofit physical activity intervention within Diabetes Alliance Program Plus among regional and remote type 2 diabetes patients in a primary care setting.
Scientific title
Implementation and referral of the ecofit physical activity intervention within Diabetes Alliance Program Plus among regional and remote type 2 diabetes patients in a primary care setting.
Secondary ID [1] 312301 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is occurring within ACTRN12622001438741. All recruitment and patient clinical data collection will happen as part of ACTRN12622001438741. Patients in the aforementioned study may be referred to the current study to increase physical activity participation.

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 334038 0
Condition category
Condition code
Metabolic and Endocrine 330711 330711 0 0
Diabetes
Public Health 330815 330815 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a component of Diabetes Alliance Program Plus (DAP+)As part of DAP+, which has been registered with ANZCTR (ACTRN12622001438741).
ecofit is a community-based multi-component resistance and aerobic-based physical activity intervention with established efficacy in adults at risk of/diagnosed with Type 2 diabetes, and effectiveness in community-dwelling adults failing to satisfy physical activity recommendations. A scaled up community-based hybrid type III implementation study is currently being undertaken in Newcastle/Lake Macqurie, NSW, Australia (ACTRN12624000261516). This current study will outline the steps in implementing ecofit in a primary care setting in regional and rural Australia, within the larger DAP+ study.

As part of DAP+, consenting patients will attend two 40-minute case conferences at baseline and 6-month follow-up. The case conferences take place at the patient’s general practice/AMS and are attended by a visiting tertiary specialist team, a GP and practice nurse or Aboriginal health practitioner. Several clinical outcomes will be measured during these appointments. During case conferences, patients can be referred to one of the three lifestyle modules (physical activity, nutrition and mental health). ecofit is the physical activity module in the DAP+ study. Patients will also complete a nutrition and physical activity diary at each timepoint. This study will not report on the nutrition and mental health modules.

In mid-late 2024 general practices involved in DAP+ will start to be provided with resources to promote ecofit. A record of general practices provided with resources will be kept. The resources include a trifold brochure with information for each DAP+ lifestyle module (includes QR codes that redirect people to the ecofit website), an ecofit information sheet for health professionals, talking points for encouraging patients to use ecofit and a short introductory video about ecofit. Individual general practices and diabetes educators will decide if they promote ecofit and how they do it. If a patient chooses to participate in ecofit, they will download the ecofit mobile application (app) from Google Play or the Apple App Store, or download PDF resources (same content as mobile app) from the DAP+ website (https://www.dapplus.org.au/). App users will be able to complete ecofit workouts using pre-generated workouts based on their skill and experience level, or they can create their own workouts. The app will also contain resources designed for encouragement and motivation based on behavior change theory, which has been assessed by a relevant consumer group. App usage will be at the users discretion. They can allow the app to send them reminders to complete workouts. Users will use the app for as long as they choose, there is no minimum or maximum time of app engagement. The app will prescribe predominantly muscle strengthening exercises with some aerobic exercises. Muscle strength exercises include bodyweight exercises, the use of household items (cans of food, plastic water bottles) as weights, and the use of outdoor gym equipment. Muscle strength exercises are placed into 4 levels, ranging from very simple (i.e. sit to stand, arm circles), to difficult (i.e. pull up, squats). Aerobic exercises include walking, running and the use of stationary exercises bikes and ellipticals found in outdoor gyms. App metrics will be used to measure app usage for participants 3-months after a patient registers an account with the app. All data will be de-identified.

Primary care professionals will be provided with brief 20 minute training to promote ecofit to their patients in different settings. During case-conferences visits, staff of general practices will be provided with training to promote ecofit to the patients in the DAP+ study. Primary care workers attending larger DAP+ multidisciplinary conferences will also receive training to promote ecofit to patients. Conference presentations will range from 15 minutes to 30 minutes.
The research team will provide training to the diabetes educators (DE) who attend each DAP+ case-conferencing session, prior to the first DAP+ case-conference visit that involved ecofit resources. A record of DEs who complete the training will be kept, When DEs train primary care staff in general practices, the research team will be informed of how many staff were trained. General practice staff will also complete a short survey that will indicate to the research team who has been trained to promote ecofit.
Intervention code [1] 328770 0
Lifestyle
Intervention code [2] 328771 0
Behaviour
Comparator / control treatment
This study will use baseline data collected during the DAP+ case conferences to describe the demographics (age, sex, physical activity levels, education levels) of participants who registered an account on the ecofit platform. Differences in baseline patient characteristics, baseline clinical outcomes and baseline self-reported physical activity between those who register an account compared to with those who do not, will also be evaluated.
The ecofit research team has ethical approval to access the demographic, clinical and self-report physical activity data for all patients who are enrolled in DAP+ and have provided informed consent.

There will not be any comparison between those who do use ecofit and do not use the ecofit app at follow-up, this study is only interested in observing baseline characteristics.

DAP+ patients using ecofit will be identified using their emails. Patients who download and create an ecofit account will provide their email address. Ecofit users whose email addresses match those used in the DAP+ study (enrolled in the study described in ACTRN12622001438741) will be included in the analysis for all patient outcomes measured in the current study.
Control group
Active

Outcomes
Primary outcome [1] 338469 0
Reach
Timepoint [1] 338469 0
Reach will be assessed at 6-months post the final baseline case-conference visit that is included in this study. This is at the conclusion of the final follow-up DAP+ case-conferences.
Primary outcome [2] 338579 0
Reach
Timepoint [2] 338579 0
Reach will be assessed at 6-months post the final baseline case-conference visit that is included in this study. This is at the conclusion of the final follow-up DAP+ case-conferences.
Secondary outcome [1] 436052 0
HbA1c
Timepoint [1] 436052 0
Baseline case conference, 6 months post baseline case conference.
Secondary outcome [2] 436053 0
Self-report physical activity
Timepoint [2] 436053 0
Baseline case conference, 6 months post baseline case conference.
Secondary outcome [3] 436054 0
Adoption
Timepoint [3] 436054 0
6 months following baseline case-conferencing where primary care staff complete the brief 20min ecofit training session
Secondary outcome [4] 436055 0
Appropriateness
Timepoint [4] 436055 0
6 months following baseline case-conferencing where primary care staff complete the brief 20min ecofit training session
Secondary outcome [5] 436056 0
Feasibility
Timepoint [5] 436056 0
6 months following baseline case-conferencing where primary care staff complete the brief 20min ecofit training session
Secondary outcome [6] 436057 0
Fidelity
Timepoint [6] 436057 0
6 months following baseline case-conferencing where primary care staff complete the brief 20min ecofit training session
Secondary outcome [7] 436058 0
Acceptibility of intervention
Timepoint [7] 436058 0
6 weeks after a patient downloads the ecofit app.
Secondary outcome [8] 436059 0
Intervention dosage
Timepoint [8] 436059 0
3 months after a patient registers an account on the app.
Secondary outcome [9] 436060 0
Intervention dosage
Timepoint [9] 436060 0
3 months after a patient registers an account on the app.
Secondary outcome [10] 436061 0
Intervention effectiveness
Timepoint [10] 436061 0
Upon account registration (baseline) and 3 months after a patient registers an account on the app.
Secondary outcome [11] 436062 0
Cost effectiveness
Timepoint [11] 436062 0
6-months post the final baseline case-conference visit included in this study.
Secondary outcome [12] 436496 0
BMI
Timepoint [12] 436496 0
Baseline case conference, 6 months post baseline case conference.
Secondary outcome [13] 436527 0
Intervention effectiveness
Timepoint [13] 436527 0
Upon account registration (baseline) and 3 months after a patient registers an account on the app.
Secondary outcome [14] 436528 0
Cholesterol
Timepoint [14] 436528 0
Baseline case conference, 6 months post baseline case conference.
Secondary outcome [15] 436529 0
Blood pressure
Timepoint [15] 436529 0
Baseline case conference, 6 months post baseline case conference.
Secondary outcome [16] 436530 0
Intent
Timepoint [16] 436530 0
Baseline case-conference, 6-months post baseline case conference.
Secondary outcome [17] 436531 0
Self-efficacy
Timepoint [17] 436531 0
Baseline case-conference, 6-months post baseline case conference.
Secondary outcome [18] 436532 0
Perceive benefit
Timepoint [18] 436532 0
Baseline case-conference, 6-months post baseline case conference.
Secondary outcome [19] 436533 0
Health belief
Timepoint [19] 436533 0
Baseline case-conference, 6-months post baseline case conference.

Eligibility
Key inclusion criteria
Patients who are (i) 18 years of age or older diagnosed with T2D, (ii) from a general practice/Aboriginal Medical Services (AMS) enrolled in DAP+, and (iii) provide informed consent, will be eligible to participate in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include patients who are (i) from a general practice/AMS not enrolled in DAP+, (ii) under 18 years of age, (iii) diagnosed with another type of diabetes (e.g., Type 1, gestational, undetermined), (iv) pregnant, or (v) unwilling to provide informed consent.

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
Other
Other design features
This study will have access to demographic, clinical and self-report physical activity data for all patients enrolled in DAP+ who complete baseline case conferencing. Patients who do not engage with the app, but complete baseline case conferencing when ecofit is being promoted will act as a comparator group for baseline measures (demographic, clinical outcomes, self-report physical activity). These outcomes will be compared at baseline to analyse similarities and differences between patients who do and patients who do not use the ecofit app. The two groups will only be compared at baseline, there will be no comparison at follow-up timepoints.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
While the overall DAP+ (ACTRN12622001438741) collects data at baseline (i.e., the first case conference) and follow-up (i.e., 6-months post baseline), this study will consider ‘baseline’ for app-related measures as the time-point participants register an account on the ecofit platform and follow-up as three months post registration. For ecofit app measures, data from baseline, and three-month follow-up will be analysed in this study.

App survey process outcomes will be reported descriptively (i.e. means, standard deviations). App usage data will be reported descriptively (i.e. means, standard deviations and counts). Self-report push up and sit-to-stand test data will be analysed by T-tests.

Clinical data (from the DAP+ database) for patients who participate in ecofit will be assessed by T-tests on clincal measures (HbA1c, BMI, cholesterol, blood pressure) at baseline and six-months.

Cross-sectional questionnaire data from DAP+ conferences/masterclasses will be assessed by descriptive statistics (i.e. mean, standard deviations, percentages/proportions).

Baseline and six-month follow-up data from the case-conference health professional surveys will be analysed by descriptive statistics (i.e. mean, standard deviation, percentages/proportions). T-tests will be enacted on congruent items that are assessed at each of the two timepoints.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
1/01/2025
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316693 0
Charities/Societies/Foundations
Name [1] 316693 0
Colonial Foundation
Country [1] 316693 0
Australia
Primary sponsor type
Hospital
Name
Hunter Medical Research Institute
Address
Country
Australia
Secondary sponsor category [1] 318893 0
University
Name [1] 318893 0
University of Newcastle
Address [1] 318893 0
Country [1] 318893 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315472 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 315472 0
http://www.newcastle.edu.au/research/research-services/human-ethics/
Ethics committee country [1] 315472 0
Australia
Date submitted for ethics approval [1] 315472 0
28/05/2024
Approval date [1] 315472 0
21/06/2024
Ethics approval number [1] 315472 0
H-2024-0150

Summary
Brief summary
This study aims to evaluate the ecofit program (which comprises an app and web-based resources) across remote and rural primary health care settings in the Hunter New England Health District for patients with T2D within the Diabetes Alliance Project Plus study. The current study will assess the reach, adoption, appropriateness, feasibility, fidelity and reach of the ecofit program among general practitioners and general practice staff. The study will also assess the reach, acceptability dosage and effectiveness of the ecofit program among DAP+ patients, It is hypothesized that the effective implementation of the ecofit program within DAP+ as a physical activity resource for adults with T2D will result in DAP+ patients participating in increased physical activity and experiencing the associated health benefits.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134798 0
Prof Ronald Plotnikoff
Address 134798 0
ATC314, University of Newcastle, University Dr, Callaghan, NSW, 2308
Country 134798 0
Australia
Phone 134798 0
+61 0249854465
Fax 134798 0
Email 134798 0
ron.plotnikoff@newcastle.edu.au
Contact person for public queries
Name 134799 0
Ronald Plotnikoff
Address 134799 0
ATC314, University of Newcastle, University Dr, Callaghan, NSW, 2308
Country 134799 0
Australia
Phone 134799 0
+61 0249854465
Fax 134799 0
Email 134799 0
ron.plotnikoff@newcastle.edu.au
Contact person for scientific queries
Name 134800 0
Ronald Plotnikoff
Address 134800 0
ATC314, University of Newcastle, University Dr, Callaghan, NSW, 2308
Country 134800 0
Australia
Phone 134800 0
+61 0249854465
Fax 134800 0
Email 134800 0
ron.plotnikoff@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Prof Ronald Plotnikoff, ron.plotnikoff@newcastle.edu.au)


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.