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Trial registered on ANZCTR


Registration number
ACTRN12612000986875
Ethics application status
Approved
Date submitted
7/09/2012
Date registered
13/09/2012
Date last updated
13/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Are community dwelling older adults receiving Meals on Wheels achieving dietary targets?
Scientific title
Pilot Study - Are community dwelling older adults receiving Meals on Wheels achieving dietary targets?
Secondary ID [1] 281181 0
Nil
Universal Trial Number (UTN)
Trial acronym
Meals On Wheels (MOW)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutritional risk in the elderly 287350 0
Impaired cognition in the elderly 287351 0
Depression in the elderly 287352 0
Falls/Fractures in the elderly 287353 0
Condition category
Condition code
Diet and Nutrition 287685 287685 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thirty eligible elderly individuals who are new clients of Meals on Wheels (SA) and who agree to pay for the MOW service, will be randomly allocated to receive either:
Arm 1 - standard meal (Standard), or
Arm 2 - high protein high energy (HEHP) meal.

The meals will all consist of a soup, main hot dish (i.e. meat/fish and vegetables, or casserole), and dessert which will be delivered at lunchtime.

The prescribed 'Standard' meal will provide 30 % of the target population's daily estimated requirements for energy and 50 % for protein. In addition, it will provide at least 30 % of all other nutrients. The prescribed macronutrient composition will be 2.5 MJ energy, 32 g of protein, 23 g fat 65 g carbohydrate.

The prescribed 'HEHP' meal will provide 65 % of the target population's daily estimated requirements for energy and 100 % for protein (daily estimated protein requirements are based on the current reccomendation of ~0.8-1 g per kg of body weight). The prescribed macronutrient composition will be 5 MJ energy, 65 g of protein, 65 g fat 99 g carbohydrate.

Each subject will be asked to consume their allocate meal type five days per week for 12 weeks.
Intervention code [1] 285633 0
Treatment: Other
Intervention code [2] 285634 0
Prevention
Intervention code [3] 285635 0
Lifestyle
Comparator / control treatment
Arm 3 (Control) - Fifteen eligible elderly individuals who have recently (i.e. within last 3 months) been referred to MOW but who declined to receive the MOW service will be offered a 'standard-care' management plan (i.e. one-on-one nutritional education from a qualified dietitian for 60 min on a monthly basis for the duration of the study) to assist them in meeting their estimated daily energy and protein requirements inorder to improve their nutritional status.
Control group
Active

Outcomes
Primary outcome [1] 287930 0
Change in nutritional status. Assessed using the validated Mini-nutritional assessment and SNAQ questionnaire, and measurement of body weight and height, and body mass index.
Timepoint [1] 287930 0
Baseline, 12 weeks
Primary outcome [2] 287931 0
Change in number and duration of hospital admissions. Self-reported number and duration.
Timepoint [2] 287931 0
Baseline, 12 weeks
Primary outcome [3] 287932 0
Change in Quality of Life score.
Assessment of the subjects perceptions about their general well being and quality of life using the AQoL-8 questionnaire.
Timepoint [3] 287932 0
Baseline, 12 weeks
Secondary outcome [1] 299070 0
Change in hand grip strength score.
Measured using a calibrated dynamometer.
Timepoint [1] 299070 0
Baseline, 12 weeks
Secondary outcome [2] 299071 0
Change in three meter walk score.
Clinical measurement of gait speed (meters/sec to the nearest 0.1 sec).
Timepoint [2] 299071 0
Baseline, 12 weeks
Secondary outcome [3] 299072 0
Change in mean geriatric depression score.
The Geriatric depression questionnaire will be administered to assess the subjects psychological well-being.
Timepoint [3] 299072 0
Baseline, 12 weeks
Secondary outcome [4] 299073 0
Change in skinfold at mid-arm.
Clinical measurement using calibrated skinfold calipers
Timepoint [4] 299073 0
Baseline, 12 weeks
Secondary outcome [5] 299074 0
Change in circumference at mid-calf.
Clinical measurement using a measuring tape.
Timepoint [5] 299074 0
Baseline, 12 weeks
Secondary outcome [6] 299075 0
Change in circumference at mid-arm.
Clinical measurement using a measuring tape.
Timepoint [6] 299075 0
Baseline, 12 weeks
Secondary outcome [7] 299076 0
Knee height.
Clinical measurement using a measuring tape.
Timepoint [7] 299076 0
Baseline, 12 weeks
Secondary outcome [8] 299077 0
Mean energy and macronutirent intake.
Multipass dietary recall will be performed at baseline and week 12, and also at weeks 4 and 8, to assess the subjects' food intake over 3 consecutive days in the preceding week (2 week and 1 weekend day)
Timepoint [8] 299077 0
Baseline, and weeks 4, 8 and 12
Secondary outcome [9] 299078 0
Change in perceptions regarding the meals.
Assessment will be done using a survey designed for this study which contains a number of questions related to the perception the meal and subjects will indicate their responses using a likert-scale scoring system
Timepoint [9] 299078 0
Baseline, 4, 8 and 12 weeks
Secondary outcome [10] 299079 0
Change in perceptions regarding the service offered by MOW.
Assessment will be done using a survey designed for this study which contains a number of questions related to the service offered by MOW and subjects will indicate their responses using a likert-scale scoring system
Timepoint [10] 299079 0
Baseline, 4, 8 and 12 weeks

Eligibility
Key inclusion criteria
1) Must be a new referrals to the 'MOW' service in South Australia
2) Must be ‘at risk’ from poor nutrition according to MOW(SA)Inc. criteria which are: staff/doctorcarer or client themselves percieves client as underweight/frail; has self-reported a reduced appetite or unintentional weight loss over the past year; or is unable to shop or prepare food for self.
3) Must be aged 75 years, or greater
4) Must have the cognitive capacity to consent to study, and complete study assessments, by themselves
5) Must have the functional capacity to complete all assessments
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Elderly people who have been reffered to MOW but who have been identified by their GP or MOW assessment team, as having:
1) significant dementia, or short- or long-term memory loss,
2) significant depression,
3) too frail to complete all assessments

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)
Subject enrollment will be done over 2 phases:
1) Elderly persons who are newly referred to 'Meals On Wheels' (MOW) will be assessed by the MOW staff. If eligible to participate in the study, they will be invited to sign a Consent form stating their desire to participate in the research. Upon receipt, the MOW staff will notify the university research staff of interested subjects and contact details will be forwarded.

2) The University research team will then send the interested person a 'Particpant information' package that describes the study in detail. Within 1-2 weeks, a member of the research team will contact the person by telephone to make sure they have understood the Participant Information Sheet and consent to joining the study. Upon consenting to participate, subects will be given an unique study specific number and they will be randomly assigned to either Arm 1, or 2.

Allocation of subjects to 'Arm 1' or 'Arm 2' will be done by a collaborator not involved in subject recruitment, or data collection and analysis. Sealed opaque envelopes will be used to conceal the treatment. When the investigator repsonsible for screening, deems a subject as 'eligible' they will call the investigator responsible for 'allocatiion' to be told whether the subject is randomised to Arm 1 or 2.
The codes for Arm 1 and 2 will be released only after all data from the last recruited study has been entered.

Allocation of subjects to Arm 3 (the control group) cannot be randomised because that group will consist of elderly persons who meet the inclusion criteria and who wish to particpate in the study asssessments but do not want to be recipients of the 'MOW' service (i.e. Arm 3 is the CONTROL group who get 'standard-care' which is intensive nutiritional education of what they need to eat to improve their nutiritonal status).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Free software “Research Randomiser” (Urbaniak, 2011), will be used to generate treatment allocation to individuals. The staff delivering meals and those performing the assessments will be blinded to the randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5734 0
5000

Funding & Sponsors
Funding source category [1] 285969 0
University
Name [1] 285969 0
University of Adelaide
Country [1] 285969 0
Australia
Funding source category [2] 285970 0
University
Name [2] 285970 0
Flinders University
Country [2] 285970 0
Australia
Funding source category [3] 285971 0
Charities/Societies/Foundations
Name [3] 285971 0
Meals On Wheels South Australia Inc.
Country [3] 285971 0
Australia
Primary sponsor type
Individual
Name
Dr Natalie Luscombe-Marsh
Address
Discipline of Medicine and CCRE in Nutritional Physiology,
Room 21, Level 6, The Eleanor Harrald building, The Royal Adelaide Hospital
The University of Adelaide,
Frome Rd, Adelaide
South Australia,
AUSTRALIA 5000
Country
Australia
Secondary sponsor category [1] 284793 0
Individual
Name [1] 284793 0
A/Prof Michelle Miller
Address [1] 284793 0
Flinders University Nutrition & Dietetics, Level 7 Flinders Medical Centre, Flinders Drive, Bedford Park,
South Australia, 5042
Country [1] 284793 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288002 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 288002 0
Ethics committee country [1] 288002 0
Australia
Date submitted for ethics approval [1] 288002 0
16/08/2012
Approval date [1] 288002 0
23/08/2012
Ethics approval number [1] 288002 0
1/11/0510
Ethics committee name [2] 288050 0
University of Adelaide Human Research Ethics
Ethics committee address [2] 288050 0
Ethics committee country [2] 288050 0
Australia
Date submitted for ethics approval [2] 288050 0
Approval date [2] 288050 0
06/09/2012
Ethics approval number [2] 288050 0
1/11/0510

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

Contacts
Principal investigator
Name 34678 0
Address 34678 0
Country 34678 0
Phone 34678 0
Fax 34678 0
Email 34678 0
Contact person for public queries
Name 17925 0
Dr Natalie Luscombe
Address 17925 0
Discipline of Medicine and CCRE in Nutritional Physiology,
Level 6, The Eleanor Harrald building, The Royal Adelaide Hospital
The University of Adelaide,
Frome Rd,
Adelaide,
South Australia
5000
Country 17925 0
Australia
Phone 17925 0
+61 8 8222 5038
Fax 17925 0
+61 8 8223 3870
Email 17925 0
natalie.luscombe@adelaide.edu.au
Contact person for scientific queries
Name 8853 0
Dr Natalie Luscombe
Address 8853 0
Discipline of Medicine and CCRE in Nutritional Physiology,
Level 6, The Eleanor Harrald building, The Royal Adelaide Hospital
The University of Adelaide,
Frome Rd,
Adelaide
South Australia 5000
Country 8853 0
Australia
Phone 8853 0
+61 8 8222 5038
Fax 8853 0
+61 8 8223 3870
Email 8853 0
natalie.luscombe@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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