Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000503628
Ethics application status
Approved
Date submitted
3/05/2023
Date registered
17/05/2023
Date last updated
17/05/2023
Date data sharing statement initially provided
17/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of low volume vs. standard oral nutrition supplements on nutrition intakes and supplement wastage in hospital: a pilot comparative effectiveness trial
Scientific title
Effect of low volume vs. standard oral nutrition supplements on nutrition intakes and supplement wastage in hospital: a pilot comparative effectiveness trial
Secondary ID [1] 309586 0
None
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 329892 0
Condition category
Condition code
Diet and Nutrition 326804 326804 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral nutrition supplements - Fortisip Compact Protein
This is a pilot comparative effectiveness trial of low volume oral nutrition supplements (Fortisip Compact Protein, 2 x 125mL/day) vs standard oral nutrition supplements (Ensure Plus, 2 x 200mL/day).
The dose of the intervention product (Fortisip Compact Protein) is 125mL twice daily. The duration of its administration is 3-4 days (depending on hospital inpatients' length of stay). The mode is oral solution (milky-type drink). A research assistant will monitor adherence by collecting and weighing supplement drink containers after patient consumption. The intervention supplement differs to the standard supplement by volume (125mL vs 200mL) and protein content (18g per serve vs 12.5g per serve). Energy content is the same for both products (1263kJ per serve).
Intervention code [1] 326012 0
Treatment: Other
Comparator / control treatment
Oral nutrition supplements - Ensure Plus (2 x 200mL per day)
Ensure Plus is a 200mL volume supplement containing 1263kJ energy and 12.5g protein per serve.
Control group
Active

Outcomes
Primary outcome [1] 334647 0
Standard deviation (SD) of the intended primary outcome for a definitive trial (% grams wastage of oral nutrition supplements) to estimate sample size required for a definitive trial. To assess this, supplement bottles will be collected by researchers and weighed using digital scales to calculate the grams consumed / grams wasted.
Timepoint [1] 334647 0
Supplement wastage will be measured twice daily (after patient consumption of each prescribed supplement - 2 per day) by weighing the supplement container. This will occur for three days post-randomisation.
Secondary outcome [1] 421516 0
Oral nutrition supplement wastage (% grams wasted) between groups will be determined by a researcher collecting supplement bottles and weighing them using digital scales to calculate the grams consumed vs grams wasted.
Timepoint [1] 421516 0
Measured daily (by weighing oral nutrition supplement containers) for 3 days post-randomisation
Secondary outcome [2] 421517 0
Patient energy (kJ) intake of oral nutrition supplements between groups. This will be calculated by weighing supplement containers after consumption using digital scales and calculating energy consumed based on the product's nutritional information panel.
Timepoint [2] 421517 0
Daily for 3 days post-randomisation (calculated from data collected for secondary outcome 1)
Secondary outcome [3] 421859 0
Patient protein (grams) intake of oral nutrition supplements between groups. This will be calculated by weighing supplement containers after consumption using digital scales and calculating protein consumed based on the product's nutritional information panel.
Timepoint [3] 421859 0
Daily for 3 days post-randomisation (calculated from data collected for secondary outcome 1)

Eligibility
Key inclusion criteria
1. Able to provide informed consent (aged 18 years or older, cognitively intact, able to communicate in English); 2. Able to consume food and thin fluids orally; 3. Expected to stay in hospital for at least 2 days from recruitment; and 4. Inadequate oral intake requiring 2 x standard oral nutrition supplements/ day, as determined by ward dietitian.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior participation in the study; 2. Dying/palliative; and 3. Contraindications for oral nutrition supplements or study participation, determined by ward dietitian and nurse unit manager or delegate (e.g. eating disorder, uncontrolled diabetes, allergy to ONS ingredients).

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary aim of this pilot study is to accurately determine the standard deviation of the primary outcome, % grams of wasted Ensure Plus (control) oral nutrition supplement (ONS), to enable a reliable estimate of the sample size required for a full comparative effectiveness trial (CET). A secondary aim is to gain a clinical understanding of the difference in % grams wasted between Ensure Plus and a smaller volume ONS as an effect such that we can propose a minimum clinically important difference in % grams wasted. However, as the study procedure for the pilot study will be identical to that for the full CET, it is possible to roll the results obtained in the pilot into the subsequent CET. We can also estimate a sample size for the pilot that will optimize the sample size for the complete study by the method described by Whitehead et al. (2016). Based on a two sample t-test, for the main trial to have a power of 90% at a significance level of 0.05 and to detect a standardized effect size that would be considered small, we will need 25 participants in each arm of the pilot trial.
For the pilot’s secondary outcomes (i.e. the primary and secondary outcomes of the larger CET), all quantitative data will be entered into SPSS and a 10% random data check will be done to identify any errors. Demographic data will be presented using descriptive statistics (i.e., number/percent and mean/standard deviation [or median/interquartile range for non-normally distributed data]). ONS wastage (and compliance) and energy and protein provided by ONS will be compared between groups using t-test or non-parametric equivalent. Patient satisfaction, nutritional and hospital outcomes will also be compared between groups using t-test or chi-squared test (or non-parametric equivalents).
Reference: Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Statistical Methods in Medical Research. 2016; 25(3):1057-73.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/05/2023
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
8/09/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24669 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 40289 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 313771 0
Commercial sector/Industry
Name [1] 313771 0
Nutricia Australia Pty Ltd
Country [1] 313771 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road, Nathan QLD 4111 Australia
Country
Australia
Secondary sponsor category [1] 315602 0
None
Name [1] 315602 0
None
Address [1] 315602 0
N/A
Country [1] 315602 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312940 0
Gold Coast Hospital and Health Service HREC
Ethics committee address [1] 312940 0
Office for Research Governance & Development
Level 2, PED Building
1 Hospital Boulevard, Southport, QLD, 4215
Ethics committee country [1] 312940 0
Australia
Date submitted for ethics approval [1] 312940 0
13/03/2023
Approval date [1] 312940 0
03/05/2023
Ethics approval number [1] 312940 0
HREC/2023/QGC/94257

Summary
Brief summary
The purpose of this pilot comparative effectiveness trial is to estimate the standard deviation of the primary outcome (% grams wastage of oral nutrition supplements (ONS) among hospital patients) for a larger definitive trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126414 0
Dr Shelley Roberts
Address 126414 0
Room 2.69, Building G40, Griffith University, Gold Coast Campus, Southport QLD 4222
Country 126414 0
Australia
Phone 126414 0
+61422260302
Fax 126414 0
Email 126414 0
s.roberts@griffith.edu.au
Contact person for public queries
Name 126415 0
Dr Shelley Roberts
Address 126415 0
Room 2.69, Building G40, Griffith University, Gold Coast Campus, Southport QLD 4222
Country 126415 0
Australia
Phone 126415 0
+61422260302
Fax 126415 0
Email 126415 0
s.roberts@griffith.edu.au
Contact person for scientific queries
Name 126416 0
Dr Shelley Roberts
Address 126416 0
Room 2.69, Building G40, Griffith University, Gold Coast Campus, Southport QLD 4222
Country 126416 0
Australia
Phone 126416 0
+61422260302
Fax 126416 0
Email 126416 0
s.roberts@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per ethics approval, only aggregated data will be made publicly available to protect participant privacy and confidentiality


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.