Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001332819
Ethics application status
Approved
Date submitted
30/07/2021
Date registered
5/10/2021
Date last updated
15/09/2022
Date data sharing statement initially provided
5/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of partial meal replacements on weight loss for people awaiting knee or hip arthroplasty
Scientific title
Investigating the effect of partial meal replacements on weight loss for people awaiting knee or hip arthroplasty in Fairfield Orthopaedic Hip and Knee Service (FOHKS)
Secondary ID [1] 304798 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 322950 0
Obesity 322951 0
Condition category
Condition code
Diet and Nutrition 320523 320523 0 0
Obesity
Musculoskeletal 320524 320524 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who are awaiting a hip or knee replacement at the Fairfield Orthopaedic Hip and Knee Service (FOHKS) will be invited to attend a group education session of 5-10 people in each group either in person at the South Western Sydney Metabolic Rehabilitation and Bariatric Program (MRBP) or via a telehealth connection if pandemic related health restrictions are in place. There will be three education sessions, for 1 hour each, will be based on partial meal replacement (two meal) advice and lifestyle advice from a dietitian, and an app and educational material developed by collaborators from the Counterweight UK team. This dietitian will be supported by a dietitian from Counterweight UK, as well as an obesity specialist endocrinologist and metabolic Clinical Nurse Consultant from the South Western Sydney Metabolic Rehabilitation and Bariatric Program where required. The complete PMR plan will provide 1200 calories/day, and participants will be provided with meal replacement shakes to cover 2 meals per day for 12 weeks (168 in total) free of cost over the course of the study. The shakes provided are manufactured by Counterweight UK, and are commercially available. Counterweight UK have also developed an app as well as education materials for people on partial meal replacements which are part of their commercially available meal replacement programs. The intervention support includes access to this structured App with tracking, nutrition education content, and behavioural strategies to support weight loss; group education sessions at 0, 6 and 12 weeks, and readily available educational videos, (face to face with the option of video conferencing if pandemic related health restrictions remain at the time of the study). There will also be 3 x 1:1 15-30 minute telephone/telehealth support with a dietitian trained in motivational interviewing at weeks 2, 4 and 9, and the dietitian will discuss adherence to the intervention during the group sessions as well as the telephone/telehealth sessions. The recommendation will be for the app to be accessed at least once per week to log measurements (e.g., weight), read educational content and review goals/activities. The dietician will further review educational content read (in %) and measurements logged to assess the participant’s adherence to app usage. At each education session and telephone consultation , participants will receive general advice about the meal replacements and portion controlled meals, avoidance of snacking, fluid intake and will also have an opportunity to discuss any specific issues and their progress including queries regarding the app. At the 12-week visit, the dietitian will provide advice on weight loss maintenance with the option of participants continuing the recommended meal replacements (as part of portion control) at their own expense if they choose (using commercially available shakes). To assess whether weight loss is maintained without ongoing support, participants will be encouraged to aim for weight stabilisation prior to surgery and for all participants to be on a minimum 1600 calories/day by time of surgery, with a repeat assessment conducted at least 4 weeks after the 12-week visit.
Potential participants will be identified by Fairfield Orthopaedic Hip and Knee Service clinicians based on inclusion and eligibility criteria. The participants will be provided with the participant information sheet. Those that show interest will be asked permission from a member of the research team to contact them by telephone at least 24 hours later. Participants who meet study criteria will be invited to participate. Preference will be given to patients with a higher BMI (>35kg/m2)
Intervention code [1] 321235 0
Treatment: Other
Intervention code [2] 321440 0
Lifestyle
Comparator / control treatment
Data from historical cohort data of people with osteoarthritis waitlisted for total knee or total hip arthroplasty from the Fairfield Orthopaedic Hip and Knee Service will be used. The historical cohort data collection will be performed from the current waiting list from 2019 onwards, and the records in the historical cohort will be excluded if any individual has had partial or full meal replacement since joining the waiting list. The data collected from the historical cohort would be limited to demographics (such as age, gender, ethnicity), comorbidities (medical history), medication use, and anthropometric data (weight and height).
Control group
Historical

Outcomes
Primary outcome [1] 328347 0
To assess whether 5% or more weight loss is achievable for >50% of patients following a clinician-supported 12-week partial meal replacement weight loss program. The weight measurement will be recorded by a research team member (or self reported if pandemic related health restrictions remain in place).
Timepoint [1] 328347 0
12 weeks after commencing treatment (assessed at 10-16 weeks for participants' convenience),
Secondary outcome [1] 398673 0
To assess changes in fasting glucose in participants using fasting blood samples.
Timepoint [1] 398673 0
12 weeks after commencing treatment (assessed at 10-16 weeks for participants' convenience).
Secondary outcome [2] 398674 0
To assess the safety and the tolerability of the intervention (composite outcome) in patients awaiting total knee or total hip arthroplasty. This will be assessed by self-reported moderate to severe side effects as well as assessed from medical records, abnormalities in blood tests (exploratory outcome), as well as drop-out rate of patients which is assessed from participant food diaries and by the numbers of shakes dispatched.
Timepoint [2] 398674 0
12 weeks after commencing treatment (assessed at 10-16 weeks for participants' convenience)
Secondary outcome [3] 398675 0
To assess changes in patient-reported index joint pain and function. Assessed by Index joint symptoms (Oxford Knee or Hip Score).
Timepoint [3] 398675 0
12 weeks after commencing treatment (assessed at 10-16 weeks for participants' convenience)
Secondary outcome [4] 398676 0
Any change in weight over a period of 4 weeks after the clinician support has ceased, which will be assessed by a research team member (or self reported if pandemic related health restrictions are in place).
Timepoint [4] 398676 0
16 weeks after commencing treatment or pre-surgery (whatever comes first)
Secondary outcome [5] 398677 0
To assess willingness to pay for meal replacements (which will be assessed by a Likert scale item in the baseline and follow up questionnaires)
Timepoint [5] 398677 0
12 weeks after commencing treatment (assessed at 10-16 weeks for participants' convenience)
Secondary outcome [6] 399954 0
To assess changes in patient-reported quality of life. Assessed by today health rating (EuroQol 5- Dimension scale) questionnaire.
Timepoint [6] 399954 0
12 weeks after commencing treatment (assessed at 10-16 weeks for participants' convenience)
Secondary outcome [7] 399955 0
To assess changes in patient-reported physical activity. Assessed by Data on activity will be collected with the 7 day short International Physical Activity Questionnaire (IPAQ ).
Timepoint [7] 399955 0
12 weeks after commencing treatment (assessed at 10-16 weeks for participants' convenience)
Secondary outcome [8] 399992 0
To assess the adherence to the intervention in patients awaiting total knee or total hip arthroplasty. This will be assessed by drop-out rate of patients, patient report during consultations and logs on the app.
Timepoint [8] 399992 0
12 weeks after commencing treatment (assessed at 10-16 weeks for participants' convenience)
Secondary outcome [9] 401442 0
To assess changes in liver function (exploratory) in participants using fasting blood samples.
Timepoint [9] 401442 0
12 weeks after commencing treatment (assessed at 10-16 weeks for participants' convenience).
Secondary outcome [10] 401443 0
To assess changes in renal function (exploratory) in participants using fasting blood samples.
Timepoint [10] 401443 0
12 weeks after commencing treatment (assessed at 10-16 weeks for participants' convenience).
Secondary outcome [11] 401444 0
To assess changes in lipid profile in participants using fasting blood samples.
Timepoint [11] 401444 0
12 weeks after commencing treatment (assessed at 10-16 weeks for participants' convenience).
Secondary outcome [12] 401446 0
To assess changes in HbA1c in participants using fasting blood samples.
Timepoint [12] 401446 0
12 weeks after commencing treatment (assessed at 10-16 weeks for participants' convenience).

Eligibility
Key inclusion criteria
• Waitlisted for primary unilateral or bilateral total knee or total hip arthroplasty for knee or hip osteoarthritis
• Having a body mass index (BMI) of 30 kg/m2 or more at the time of screening (preference will be given to participants with a higher BMI)
• Willingness to give written consent and willingness to participate to and comply with partial meal replacements and the study protocol.
• Completion of screening for disordered eating
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients unable to understand spoken/written English
• Patients currently participating in a weight loss program or losing >5 kg in the last 3 months
• Patients who have had bariatric surgery within the last 2 years
• Patients with severe mental health problems or conditions that may interfere with the patient's ability to understand the requirements of the study.
• Patients with a primary diagnosis other than osteoarthritis.
• Patients taking insulin

Study design
Purpose of the study
Treatment
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
Safety/efficacy
Statistical methods / analysis
For the primary outcome, we will report the percentage achieving 5% or more weight loss from baseline weight. The historical data from the aforementioned pilot study conducted at Fairfield Orthopaedic Hip and Knee Service (FOHKS) will provide a useful comparison to contextualise the level of success together with concurrent deidentified data routinely collected by FOHKS around weight whilst waiting for surgery. Secondary outcomes will be reported descriptively - such as percentages achieving the outcome (for adherence, willingness to pay, tolerance) or the mean change across time for joint specific scores or changes in metabolic or inflammation markers. Changes across time for the continuous variables will be analysed using paired t-tests. The results will be adjusted to confounding variables by ANCOVA and regression. IBM SPSS Version 27 will be used for analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
17/01/2022
Date of last participant enrolment
Anticipated
31/03/2022
Actual
7/03/2022
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
30
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20065 0
Fairfield Hospital - Prairiewood
Recruitment hospital [2] 20072 0
Camden Hospital - Camden
Recruitment postcode(s) [1] 34771 0
2176 - Prairiewood
Recruitment postcode(s) [2] 34778 0
2570 - Camden

Funding & Sponsors
Funding source category [1] 309169 0
Charities/Societies/Foundations
Name [1] 309169 0
Whitlam Orthopaedic Research Centre
Country [1] 309169 0
Australia
Funding source category [2] 309239 0
Charities/Societies/Foundations
Name [2] 309239 0
Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network
Country [2] 309239 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University
Locked Bag Bag 1797
Penrith, NSW 2751
Australia
Country
Australia
Secondary sponsor category [1] 310205 0
None
Name [1] 310205 0
Address [1] 310205 0
Country [1] 310205 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309031 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 309031 0
Ethics committee country [1] 309031 0
Australia
Date submitted for ethics approval [1] 309031 0
Approval date [1] 309031 0
16/02/2021
Ethics approval number [1] 309031 0
2020/ETH03128

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

Contacts
Principal investigator
Name 112714 0
Dr Milan K Piya
Address 112714 0
Macarthur Clinical School
School of Medicine,
Western Sydney University
Campbelltown Campus
Locked Bag 1797, Penrith, NSW 2751
Country 112714 0
Australia
Phone 112714 0
+61246344028
Fax 112714 0
+61246344045
Email 112714 0
[email protected]
Contact person for public queries
Name 112715 0
Milan K Piya
Address 112715 0
Macarthur Clinical School
School of Medicine,
Western Sydney University
Campbelltown Campus
Locked Bag 1797, Penrith, NSW 2751
Country 112715 0
Australia
Phone 112715 0
+61246344028
Fax 112715 0
+61246344045
Email 112715 0
[email protected]
Contact person for scientific queries
Name 112716 0
Milan K Piya
Address 112716 0
Macarthur Clinical School
School of Medicine,
Western Sydney University
Campbelltown Campus
Locked Bag 1797, Penrith, NSW 2751
Country 112716 0
Australia
Phone 112716 0
+61246344028
Fax 112716 0
+61246344045
Email 112716 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




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.