Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000111572
Ethics application status
Approved
Date submitted
14/11/2014
Date registered
6/02/2015
Date last updated
28/10/2019
Date data sharing statement initially provided
28/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Role Of Monitoring Meals On Wheels Recipients To Improve Physical And Mental Health
Scientific title
The Role Of Monitoring Meals On Wheels Recipients and Providing Social Support To Improve Physical And Mental Health; a Mixed Methods Study
Secondary ID [1] 285663 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition
 293512 0
Condition category
Condition code
Diet and Nutrition 293795 293795 0 0
Other diet and nutrition disorders
Public Health 294061 294061 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will aim to investigate the consumption patterns of clients in terms of Meals on Wheels meals and other meals, as well as physical activity levels to enable a better understanding of the current recipients of Meals on Wheels. It will also aim to investigate whether a short term intervention focused on assisting the clients with meal ordering and food provision improves the client’s physical and mental health. This intervention/support will be provided via a graduate of a health sciences course (non-expert in nutrition) through visiting the client's home for no longer than 30mins. There are 3 intervention groups, Group 1 will not receive any additional visits outside of usual care and Meal deliveries; Group 2 will receive a visit every 2 weeks for 12 weeks; Group 3 will a visit every month for 6 months. Participants will be randomly assigned to one of the three groups with 30 participants per group.
Intervention code [1] 290606 0
Lifestyle
Intervention code [2] 290607 0
Prevention
Intervention code [3] 290608 0
Treatment: Other
Comparator / control treatment
Standard care where clients receive their meals on wheels via the councils with their normal support processes
Control group
Active

Outcomes
Primary outcome [1] 293589 0
Malnutrition risk assessed using the Mini Nutritional Assessment screening tool
Timepoint [1] 293589 0
Baseline, 12 weeks, 6mths and 12mths
Primary outcome [2] 293590 0
Total energy intake determined via 3 x 24hr food recalls at Baseline, 12 weeks, 6mths and 12mths.
Timepoint [2] 293590 0
Baseline, 12 weeks, 6mths and 12 mths
Secondary outcome [1] 311416 0
Health status will be assessed using the 12 Item
Short Form Health Survey ( SF12; Ware, 1998)
Timepoint [1] 311416 0
Baseline, 12 weeks, 6mth and 12 mths
Secondary outcome [2] 311417 0
Kessler Psychological Distress scale (K6; Kessler et al., 2002)
Timepoint [2] 311417 0
Baseline, 12 weeks, 6mth and 12 mths
Secondary outcome [3] 311418 0
Health literacy will be assessed using the 44item
Health Literacy Questionnaire (Osborne et al., 2013)
Timepoint [3] 311418 0
Baseline and 12 mths
Secondary outcome [4] 311419 0
CogState brief battery of tests
Timepoint [4] 311419 0
Baseline, 12 weeks, 6mth and 12 mths
Secondary outcome [5] 311420 0
Measurement of Activity via Accelerometers for a 7 day period with the accelerometer worn 24hrs a day except when showering, bathing, or swimming.
Timepoint [5] 311420 0
Baseline, 12 weeks, 6mth and 12 mths

Eligibility
Key inclusion criteria
Clients who are receiving Meals on Wheels in the Macedon Ranges and North Western Melbourne Medicare Local region
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are unable to speak English would be excluded as would clients with cognitive issues that would make it difficult to respond to the questions, as well as provide informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
30 participants per group are required based on a more modest change in Nutritional intake compared to that employed by Charlton et al (2013), as this study utilised additional provision of food above and beyond that of the existing Meals on Wheels Service. To achieve a power of 90% and observe a 0.75 fold change between treatments, sample size required: n = ((2 x 0.812)/ 0.752) x 10.51 = 24.5 people with a 20% drop-out = 30 people, where: 0.81 is the standard deviation expected, and a is 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/12/2014
Actual
9/12/2014
Date of last participant enrolment
Anticipated
20/02/2015
Actual
3/03/2015
Date of last data collection
Anticipated
Actual
11/03/2016
Sample size
Target
90
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 8904 0
3011 - Footscray
Recruitment postcode(s) [2] 8905 0
3012 - Maidstone
Recruitment postcode(s) [3] 8906 0
3020 - Sunshine
Recruitment postcode(s) [4] 8907 0
3021 - St Albans
Recruitment postcode(s) [5] 8908 0
3023 - Deer Park
Recruitment postcode(s) [6] 8909 0
3031 - Flemington
Recruitment postcode(s) [7] 8910 0
3032 - Maribyrnong
Recruitment postcode(s) [8] 8911 0
3033 - Keilor East
Recruitment postcode(s) [9] 8912 0
3034 - Avondale Heights
Recruitment postcode(s) [10] 8913 0
3036 - Keilor
Recruitment postcode(s) [11] 8914 0
3037 - Calder Park
Recruitment postcode(s) [12] 8915 0
3038 - Taylors Lakes
Recruitment postcode(s) [13] 8917 0
3337 - Melton
Recruitment postcode(s) [14] 8918 0
3338 - Melton South
Recruitment postcode(s) [15] 8919 0
3429 - Sunbury
Recruitment postcode(s) [16] 8920 0
3437 - Gisborne
Recruitment postcode(s) [17] 8921 0
3434 - Romsey
Recruitment postcode(s) [18] 8922 0
3440 - Macedon
Recruitment postcode(s) [19] 8923 0
3444 - Kyneton
Recruitment postcode(s) [20] 8924 0
3340 - Bacchus Marsh

Funding & Sponsors
Funding source category [1] 290245 0
Government body
Name [1] 290245 0
Macedon Ranges and North Western Melbourne Medicare Local
Country [1] 290245 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Ballarat Rd, Footscray, Vic 3011
Country
Australia
Secondary sponsor category [1] 288951 0
None
Name [1] 288951 0
Address [1] 288951 0
Country [1] 288951 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291947 0
Victoria University Human Research Ethics Committee (VUHREC)
Ethics committee address [1] 291947 0
Ethics committee country [1] 291947 0
Australia
Date submitted for ethics approval [1] 291947 0
Approval date [1] 291947 0
08/09/2014
Ethics approval number [1] 291947 0
HRE14-179

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

Contacts
Principal investigator
Name 52786 0
A/Prof Andrew McAinch
Address 52786 0
Victoria University
St Albans Campus,
P.O. Box 14428
Melbourne Vic 8001
Country 52786 0
Australia
Phone 52786 0
+61 3 99192019
Fax 52786 0
Email 52786 0
[email protected]
Contact person for public queries
Name 52787 0
Andrew McAinch
Address 52787 0
Victoria University
St Albans Campus,
P.O. Box 14428
Melbourne Vic 8001
Country 52787 0
Australia
Phone 52787 0
+61 3 99192019
Fax 52787 0
Email 52787 0
[email protected]
Contact person for scientific queries
Name 52788 0
Andrew McAinch
Address 52788 0
Victoria University
St Albans Campus,
P.O. Box 14428
Melbourne Vic 8001
Country 52788 0
Australia
Phone 52788 0
+61 3 99192019
Fax 52788 0
Email 52788 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
Not stipulated in the original ethics application, only stipulated that de-identified grouped data would be available


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.