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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
29/10/2024
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.
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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.
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Secondary ID [1]
312301
0
None
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Universal Trial Number (UTN)
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Trial acronym
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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.
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Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes
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Condition category
Condition code
Metabolic and Endocrine
330711
330711
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0
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Diabetes
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Public Health
330815
330815
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328770
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Lifestyle
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Intervention code [2]
328771
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Reach - ecofit participants
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Assessment method [1]
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Reach - ecofit participants, will be defined as the number of patients who download the ecofit app through the app and play store. It will also be defined as the number of downloads of workout booklets from the DAP+ website.
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Timepoint [1]
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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.
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Primary outcome [2]
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Reach - primary care clinicians
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Assessment method [2]
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Reach – primary care clinician is defined as the number of primary care clinicians who were introduced to ecofit through a brief training session and completed the baseline survey. This will be measured based on attendance records at upskilling sessions, multidisciplinary conferences and by the number of baseline primary care clinician surveys completed.
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Timepoint [2]
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Reach - primary care clinician will be assessed at the conclusion of clinician recruitment, 6-months after the beginning of the study (start of recruitment).
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Secondary outcome [1]
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HbA1c
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Assessment method [1]
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As part of the broader DAP+ study, HbA1c will be assessed by blood test at the baseline and follow-up (6-months) case conferences.
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Timepoint [1]
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Baseline case conference, 6 months post baseline case conference.
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Secondary outcome [2]
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Self-report physical activity
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Assessment method [2]
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During baseline and follow-up (6-months) case-conferencing, patients will complete a physical activity diary. The self-report physical activity of patients who use the ecofit app and those who do not use the ecofit app will be compared.
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Timepoint [2]
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Baseline case conference, 6 months post baseline case conference.
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Secondary outcome [3]
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Adoption
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Assessment method [3]
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Proportion of primary care staff in general practices that a part of DAP+ who have promoted ecofit to their patients. Assessed via Primary care worker follow-up survey designed specifically for this study.
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Timepoint [3]
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6 months following baseline case-conferencing where primary care staff complete the brief 20min ecofit training session
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Secondary outcome [4]
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Appropriateness
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Assessment method [4]
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Relevance of the content that primary care staff in DAP+ general practices use to promote ecofit. Assessed via Primary care worker follow-up survey designed specifically for this study.
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Timepoint [4]
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6 months following baseline case-conferencing where primary care staff complete the brief 20min ecofit training session
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Secondary outcome [5]
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Feasibility
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Assessment method [5]
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The extent to which the ecofit promotional resources provided to general practices can be used to promote the ecofit program. Assessed via Primary care worker follow-up survey designed specifically for this study.
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Timepoint [5]
436056
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6 months following baseline case-conferencing where primary care staff complete the brief 20min ecofit training session
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Secondary outcome [6]
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Fidelity
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Assessment method [6]
436057
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Whether primary care workers promoted ecofit using the ecofit promotional resources and which resources they used. Assessed via Primary care worker follow-up survey designed specifically for this study.
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Timepoint [6]
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6 months following baseline case-conferencing where primary care staff complete the brief 20min ecofit training session
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Secondary outcome [7]
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Acceptibility of intervention
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Assessment method [7]
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Assessing whether ecofit users (DAP+ patients who download the app and register an account) were satisfied with the ecofit program. Assessed via the process evaluation survey designed specifically fo rthis study. The survey is completed within the ecofit app.
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Timepoint [7]
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6 weeks after a patient downloads the ecofit app.
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Secondary outcome [8]
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Intervention dosage
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Assessment method [8]
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The proportion of participants logging at least one workout in the app over a 3-and 6-month time-period. Assessed via app metrics
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Timepoint [8]
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3- and 6-months after a patient registers an account on the app.
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Secondary outcome [9]
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Intervention dosage
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Assessment method [9]
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‘Usage’ will be evaluated by the number of views of the resource material (i.e., videos and text) across the smartphone and the web-based platform.
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Timepoint [9]
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3- and 6-months after a patient registers an account on the app.
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Secondary outcome [10]
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Intervention effectiveness
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Assessment method [10]
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App users will conduct and enter their own self-assessed upper (i.e., push ups on toes or knees) muscular fitness. Users complete the self-assessment using a tool built into the app, they will then enter their scores into the self-assessment section of the app
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Timepoint [10]
436061
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Upon account registration (baseline) and 3- and 6- months after a patient registers an account on the app.
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Secondary outcome [11]
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Cost effectiveness
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Assessment method [11]
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A cost-effectiveness analysis by calculating the resources spent on design, adaption and implementation of the implementation strategies. An audit of study-specific financial reports will be completed at the conclusion of the study.
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Timepoint [11]
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6-months post the final baseline case-conference visit included in this study.
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Secondary outcome [12]
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BMI
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Assessment method [12]
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As part of the broader DAP+ study, BMI (height determined by stadiometer and weight determined using balance scales) will be collected at the baseline and follow-up (6-months) case-conferences.
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Timepoint [12]
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Baseline case conference, 6 months post baseline case conference.
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Secondary outcome [13]
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Cholesterol
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Assessment method [13]
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As part of the broader DAP+ study, cholesterol will assessed via blood test at the baseline and follow-up (6-months) case-conferences.
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Timepoint [13]
436528
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Baseline case conference, 6 months post baseline case conference.
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Secondary outcome [14]
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Blood pressure
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Assessment method [14]
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As part of the broader DAP+ study, blood pressure will be assessed using a sphygmomanometer at the baseline and follow-up (6-months) case-conferences.
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Timepoint [14]
436529
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Baseline case conference, 6 months post baseline case conference.
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Secondary outcome [15]
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Intent
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Assessment method [15]
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Whether a health professional intends on promoting ecofit to patients with T2D. Assessed via health professional surveys (specifically designed for this study) at baseline and 6-month case-conference visits.
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Timepoint [15]
436530
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Baseline case-conference, 6-months post baseline case conference.
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Secondary outcome [16]
436531
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Self-efficacy
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Assessment method [16]
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Whether a health professional is confident to recommend ecofit to patients diagnosed with T2D. Assessed via health professional surveys (specifically designed for this study) at baseline and 6-month case-conference visits.
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Timepoint [16]
436531
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Baseline case-conference, 6-months post baseline case conference.
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Secondary outcome [17]
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Perceive benefit
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Assessment method [17]
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Perception among health professionals of the affect of ecofit on patients who use it. Assessed via health professional surveys (specifically designed for this study) at baseline and 6-month case-conference visits.
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Timepoint [17]
436532
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Baseline case-conference, 6-months post baseline case conference.
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Secondary outcome [18]
436533
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Health belief
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Assessment method [18]
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Health professionals opinion of the impact of physical activity on diabetes management. Assessed via health professional surveys (specifically designed for this study) at baseline and 6-month case-conference visits.
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Timepoint [18]
436533
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Baseline case-conference, 6-months post baseline case conference.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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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.
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2024
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Actual
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Date of last participant enrolment
Anticipated
1/05/2025
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Actual
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Date of last data collection
Anticipated
2/11/2026
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Colonial Foundation
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Address [1]
316693
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Country [1]
316693
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Australia
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Primary sponsor type
Hospital
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Name
Hunter Medical Research Institute
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Address
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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University of Newcastle
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Address [1]
318893
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Country [1]
318893
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315472
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The University of Newcastle Human Research Ethics Committee
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Ethics committee address [1]
315472
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http://www.newcastle.edu.au/research/research-services/human-ethics/
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Ethics committee country [1]
315472
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Australia
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Date submitted for ethics approval [1]
315472
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28/05/2024
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Approval date [1]
315472
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21/06/2024
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Ethics approval number [1]
315472
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H-2024-0150
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Ronald Plotnikoff
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Address
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ATC314, University of Newcastle, University Dr, Callaghan, NSW, 2308
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Country
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Australia
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Phone
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+61 0249854465
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ronald Plotnikoff
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Address
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ATC314, University of Newcastle, University Dr, Callaghan, NSW, 2308
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Country
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Australia
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Phone
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+61 0249854465
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Fax
134799
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ronald Plotnikoff
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Address
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ATC314, University of Newcastle, University Dr, Callaghan, NSW, 2308
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Country
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Australia
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Phone
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+61 0249854465
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Fax
134800
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
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When will data be available (start and end dates)?
Immediately following publication, no end date
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Available to whom?
Only researchers who provide a methodologically sound proposal
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Available for what types of analyses?
Any analyses
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How or where can data be obtained?
Access subject to approvals by Principal Investigator (Prof Ronald Plotnikoff,
[email protected]
)
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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.
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