Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000067572
Ethics application status
Approved
Date submitted
15/12/2023
Date registered
25/01/2024
Date last updated
11/04/2024
Date data sharing statement initially provided
25/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the effectiveness of a Meta-Health Clinic: Exercise, diet and lifestyle education to manage cardiometabolic health, quality of life and pain in people with type 2 diabetes and osteoarthritis
Scientific title
Examining the effectiveness of a Meta-Health Clinic: Exercise, diet and lifestyle education to manage cardiometabolic health, quality of life and pain in people with type 2 diabetes and osteoarthritis
Secondary ID [1] 311161 0
None
Universal Trial Number (UTN)
U1111-1301-6208
Trial acronym
MHC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 332325 0
Osteoarthritis 332326 0
Condition category
Condition code
Metabolic and Endocrine 329035 329035 0 0
Diabetes
Musculoskeletal 329036 329036 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Meta-Health Clinic
This project is a community based, wait-list controlled randomised trial. The program will be delivered and overseen by Accredited Exercise Physiologists (AEPs) and Accredited Practicing Dietitians (APDs), utilising the Medicare service item numbers, detailed in the below list:

Participant Group: Meta-Health Clinic Group Intervention
Initial Assessment (Week 9 - final assessment follow control period)
8 group face-to-face sessions
Frequency: Once a week (week 10 – 17)
Duration: 60 minutes
Session structure: exercise (approximately 40 minutes) and educational (approximately 20 minutes) components.
Final Assessment (Week 18)
Focus group (Week 19-20)
Medicare item numbers:
• 81110 x1 (AEP Exercise Physiology Service – Assessment for Group Services). Week 9
• 81115 x6 (Exercise Physiology Service – Group service item number). Weeks 10, 11, 13, 14, 15, 17
• 81112 x2 (APD Dietetics Service – Group Service). Weeks 12, 16)

Participant Group: Meta-Health Clinic Individual Telehealth Intervention
Initial Assessment (Week 9 - final assessment follow control period)
4 individual telehealth sessions
Frequency: Once every 2-3 weeks. (weeks 10, 12, 14, 17).
Duration: 60 minutes
Session structure: exercise (approximately 40 minutes) and educational (approximately 20 minutes) components.
Final Assessment (Week 9-10)
Focus group (Week 10-14)
Medicare item numbers:
• 10953 x1 (Exercise Physiology Services item number face to face). Week 0
• 93000 x4 (Allied Health Telehealth items). 2xAEP (Weeks 10, 14), 2xAPD (Weeks 12, 17)

Health outcomes for people living with T2D and OA will be compared between intervention/control and baseline/follow-up.

The Meta-Health Clinic (Assessments and Group services) will be delivered by an AEP and APD within the UNSW Medicine & Health Lifestyle Clinic. As the clinic operates as a learning and teaching facility, patients are advised that Exercise Physiology undergraduate students complete their clinical placement and work alongside the AEPs to deliver clinical services. As per industry guidelines, an AEP may supervise up to five students at a time. Therefore, up to five 4th year undergraduate exercise physiology students may support the AEP in the delivery of the service as is current practice within the UNSW Medicine Lifestyle Clinic. All students involved in the project will have undergone an induction to the Lifestyle Clinic, be trained by the research team and be added to the ethics application prior to being involved in the project. Two groups (6 participants per group) of The Meta-Health Clinic will take place over approximately 6 months (February 2024 - July 2024).

GROUP SESSIONS
Following initial assessment, each participant randomised to the group intervention will receive 8 group sessions at a frequency of once per week. Each session will run for 60 minutes and will include exercise (approximately 40 minutes) and educational (approximately 20 minutes) components.
The exercise component will be evidence based. The Meta-Health Clinic – Group intervention will be delivered face-to-face utilising the variety of exercise equipment available within the UNSW Medicine & Health Lifestyle Clinic. The Meta-Health Clinic – Individual Telehealth intervention will be delivered online utilising any home-based exercise equipment available to the participant or equipment free options. Nutritional information will be modified for each individual, with no one diet approach to be prescribed. Exercises will be modified for each individual based on ability and fitness. A combination of aerobic, resistance, balance and flexibility exercises will be prescribed as is suitable and relevant to the participant. The below exercise prescription guidelines as per ACSM will be followed:

AEROBIC EXERCISE
Frequency: 1xwk
Intensity: Light-Vigorous (Light: 40-55% HRmax, RPE 8-10; Moderate 55-70%HRmax, RPE 11-13; Vigorous 70-90%HRmax, RPE 14-16)
Time: 10-20 minutes
Type: Major muscle groups: cycling (upright/recumbent); elliptical (upright/recumbent), walking (treadmill, on the spot/corridor), rowing, stepping, boxing
Volume: Aerobic exercise: Frequency x intensity x time
Pattern: One continuous bout or multiple bouts (e.g. 30 minutes or 3 x 10 min)
Progression: Commence first exercise session in week 1 at low-moderate intensity (50-60%HRmax, RPE 9-13) and progress gradually as tolerated by the individual

RESISTANCE EXERCISE
Frequency: 1xwk
Intensity: Light-Vigorous (Light: 30-49%1RM, RPE 9-11; Moderate 50-69%1RM, RPE: 12-13; Vigorous: 70-84%1RM, RPE 14-17)
Time: 10-20 minutes
Type: Pin-loaded weight plate machines (e.g. Leg Press, Leg Extension, Leg Curl, Seated row, Chest Press, Lat Pulldown), body weight, free weights, exercise bands.
Sets: 1-3
Repetitions: 8-12
Volume: sets x reps x days
Pattern: 2 second concentric, 3 second eccentric. 1-2 minute rest between sets
Progression: Commence first exercise session in week 1 at low-moderate intensity (50-69%1RM, RPE 9-13) and progress gradually as tolerated by the individual

Balance and flexibility exercises will be prescribed and delivered as determined to be suitable to the individuals attending the group. The prescriptive elements of all exercises performed will be recorded in program training sheets each session to ensure all necessary detail is captured.

The below topics will be discussed across the educational sessions (including physical activity, nutrition, and lifestyle self-management) with the use of educational material developed by organisations including the National Diabetes Services Scheme, Arthritis NSW, the Australian Government Department of Health.

Session 1: Understanding diabetes
Session 2: Understanding Osteoarthritis
Session 3: Nutrition and healthy eating for type 2 diabetes and osteoarthritis - Part 1
Session 4: Exercise and type 2 diabetes
Session 5: Exercise and Osteoarthritis
Session 6: Adjusting to life with diabetes and osteoarthritis
Session 7: Nutrition and healthy eating for type 2 diabetes and osteoarthritis - Part 2
Session 8: Bringing everything together
Intervention code [1] 327599 0
Treatment: Other
Intervention code [2] 327600 0
Rehabilitation
Intervention code [3] 327601 0
Lifestyle
Comparator / control treatment
This project is a community based, waist-list controlled randomised trial. All participants will first complete a control period of usual medical care (receiving their usual care from their own GP or specialist with no additional care delivered by the research team) and one short phone call, not longer than 5 minutes, at week 5 from the research assistant (either AEP or APD with no exercise or nutrition advice) to check on their welfare and any adverse events. At completion of 10 week follow up testing, these participants will be re-randomised to either the Meta-Health Clinic Group or Individual Telehealth program.

Participant Group 1: Usual Medical Care (wait-list control)
Initial Assessment (Week 0)
Usual Medical care only. Welfare check (no exercise/nutrition advice).
Frequency: 1 phone call (week 5)
Duration: 5 minutes
Final Assessment (Week 9) – used as Initial Assessment for Re-randomisation into Group 2 or 3 Intervention group
Post Intervention Focus group only
No Medicare items
Control group
Active

Outcomes
Primary outcome [1] 336843 0
Feasibility outcomes
Timepoint [1] 336843 0
Assessed at the final assessment (No greater than 2 weeks following the completion of the eighth group session).
Primary outcome [2] 336844 0
Upper Body Muscular Strength
Timepoint [2] 336844 0
Upper body Muscular Strength will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session).
Primary outcome [3] 337085 0
Lower Body Muscular Strength
Timepoint [3] 337085 0
Lower body Muscular Strength will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session).
Secondary outcome [1] 429812 0
Glycaemic control
Timepoint [1] 429812 0
Closest GP requested pathology results to participant initial assessment and final assessment dates following completion of the final group or telehealth session.
Secondary outcome [2] 429813 0
Functional exercise capacity
Timepoint [2] 429813 0
Functional exercise capacity will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [3] 429814 0
Lower extremity functioning in older persons
Timepoint [3] 429814 0
Lower extremity functioning will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [4] 429815 0
Body Mass Index (BMI)
Timepoint [4] 429815 0
BMI will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [5] 429816 0
Waist Circumference.
Timepoint [5] 429816 0
Waist circumference will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [6] 429817 0
Blood Pressure
Timepoint [6] 429817 0
Resting blood pressure will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [7] 429821 0
Single leg balance
Timepoint [7] 429821 0
Single leg balance will be calculated at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [8] 429826 0
Cardiovascular risk profile
Timepoint [8] 429826 0
Cardiovascular risk profile will be calculated at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [9] 429827 0
Diabetes Self Management
Timepoint [9] 429827 0
Diabetes self-management will be calculated at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [10] 429828 0
Pain
Timepoint [10] 429828 0
Pain will be calculated at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [11] 430001 0
Mediterranean diet adherence
Timepoint [11] 430001 0
Mediterranean diet adherence will be calculated at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [12] 430002 0
General nutrition knowledge
Timepoint [12] 430002 0
General nutrition knowledge will be calculated at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [13] 430003 0
Perceived Physical Activity
Timepoint [13] 430003 0
Perceived Physical Activity will be calculated at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [14] 430004 0
Quality of life
Timepoint [14] 430004 0
Quality of life will be calculated at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [15] 430005 0
Sleep Quality
Timepoint [15] 430005 0
Sleep quality will be calculated at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [16] 430613 0
Quality of life
Timepoint [16] 430613 0
Quality of life will be calculated at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session)
Secondary outcome [17] 430614 0
Handgrip strength
Timepoint [17] 430614 0
Hand grip strength will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the final group or telehealth session).

Eligibility
Key inclusion criteria
Inclusion criteria for participants taking part in this study include:
1. Age 55 years and over
2. T2D diagnosis as diagnosed by participants GP
3. OA diagnosis as diagnosed by participants GP
4. Able to safely undertake study exercise without assistance
5. Have access to and able to use technology to facilitate telehealth services (e.g. device, internet/phone connection)
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for those who are not eligible to participate in the study include:
1. Diagnosed with diabetes other than type 2 (e.g. type 1 diabetes, gestational diabetes) as the study is specifically investigating the feasibility of the Diabetes Clinic for people with T2D.
2. Display an abnormal cardiovascular (heart rate/blood pressure) response to exercise (as seen during the baseline exercise test) and their doctor does not provide medical clearance to participate in the exercise sessions
3. Are unable to speak English and access to a translator to participate in the service is not available
4. Are deemed unsuitable for group exercise sessions following screening or initial assessment by an AEP within the UNSW Lifestyle Clinic (for example, due to other health conditions such as orthopedic or neuromuscular limitations), preventing the participant from participating in the exercise sessions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will then be concealed via placement of sequential group assignments into opaque sealed envelopes prepared by the independent researcher, which will be handed to the participant for opening by the AEP after completion of baseline testing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done by an independent researcher located offsite via a computer-generated randomisation scheme (www.randomization.com) after completion of baseline testing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Wait list control. Participants initially complete wait-list control, and are then randomised to one of the two intervention groups.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of twenty older Australians with T2D and OA is desired for the study. The plan is to enrol 36 subjects to complete the feasibility trial to accommodate the 10-20% drop out rate seen in exercise interventions.

Specifically, this sample size is comprised of the following samples from each of the participant groups:
1. Participant Group 1 Usual Medical Care n=36 (All participants complete wait-list control, then randomised to Group 2 OR 3)
2. Participant Group 2 Meta-Health Clinic Group intervention n=18
3. Participant Group 3 Telehealth Individual intervention n=18

This sample size is sufficient to meet the research aims and answer the research questions because this study does not intend to generalise to broader populations, but to gain an in-depth understanding on preliminary feasibility and efficacy on participant health outcomes and acceptability. As there is no other program like this that has been delivered in a clinical or research setting, the investigators believe n=36 will be sufficient to inform preliminary efficacy to then inform the sample size calculation for a larger scale clinical trial.

Participant outcome data will be captured and stored on UNSW OneDrive, a secured server that is regularly backed up. This study is a wait-list control versus two-armed intervention trial, pre-test/post-test design. Quantitative data will be analysed using SPSS. Descriptive statistics will be used to analyse frequency and distribution of responses to questionnaire and assessment responses. Qualitative data will be analysed using NVivo (version 12.0) from the focus group responses and will be analysed using reflexive thematic analysis.
Data will be checked for normality and reported as mean and standard deviation or median and range as appropriate. Comparisons between groups will be made via analysis of variance (ANOVA), at post-intervention (10-weeks). Within group change scores (and 95% confidence intervals) will be calculated for clinical outcomes using available data from initial and final assessments. Statistical significance will be set at p<0.05. No minimum number of training sessions for participant attendance will be required for their data to be eligible for analysis. All participants will be included in the primary analysis according to their randomly allocated treatment (intention-to-treat) with any missing outcome data (due to drop-out) imputed. A note of the reasons for non-attendance will be collected and reported. Linear mixed modelling will also be used to assess change in outcomes over 10 weeks across the two groups as it is more powerful and has the additional advantage to handle missing at random data. Statistical significance will be set at p<0.05. These analyses will be performed by a researcher experienced in these statistical analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/03/2024
Actual
3/04/2024
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
16/09/2024
Actual
Sample size
Target
36
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 41780 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 315416 0
University
Name [1] 315416 0
UNSW Sydney
Country [1] 315416 0
Australia
Primary sponsor type
University
Name
UNSW Sydney - delegate Dr Ted Rohr
Address
School of Health Sciences, Faculty of Medicine & Health, UNSW Sydney, Level 2 Wallace Wurth Building, UNSW Kensington Campus, NSW, Australia 2052
Country
Australia
Secondary sponsor category [1] 317513 0
None
Name [1] 317513 0
Address [1] 317513 0
Country [1] 317513 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314331 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 314331 0
Ethics committee country [1] 314331 0
Australia
Date submitted for ethics approval [1] 314331 0
04/09/2023
Approval date [1] 314331 0
23/10/2023
Ethics approval number [1] 314331 0
iRECS4448

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

Contacts
Principal investigator
Name 131210 0
Dr Kelly McLeod
Address 131210 0
UNSW Sydney. School of Health Sciences, Faculty of Medicine & Health, Level 2, Wallace Wurth Building, Sydney, NSW 2052
Country 131210 0
Australia
Phone 131210 0
+61 2 9065 7480
Fax 131210 0
Email 131210 0
[email protected]
Contact person for public queries
Name 131211 0
Kelly McLeod
Address 131211 0
UNSW Sydney. School of Health Sciences, Faculty of Medicine & Health, Level 2, Wallace Wurth Building, Sydney, NSW 2052
Country 131211 0
Australia
Phone 131211 0
+61 2 9065 7480
Fax 131211 0
Email 131211 0
[email protected]
Contact person for scientific queries
Name 131212 0
Kelly McLeod
Address 131212 0
UNSW Sydney. School of Health Sciences, Faculty of Medicine & Health, Level 2, Wallace Wurth Building, Sydney, NSW 2052
Country 131212 0
Australia
Phone 131212 0
+61 2 9065 7480
Fax 131212 0
Email 131212 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 participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, up until 7 years post conclusion of the trial
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([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.