Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000228785
Ethics application status
Approved
Date submitted
20/02/2013
Date registered
26/02/2013
Date last updated
3/12/2020
Date data sharing statement initially provided
3/12/2020
Date results information initially provided
3/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing falls and fractures in low-level aged-care residents by increasing dairy food intake by two serves per day.
Scientific title
Correcting the deficiency of dietary dairy produce in elderly low-level aged care residents reduces fractures and preserves bone strength.
Secondary ID [1] 281963 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 288386 0
Fractures 288387 0
Sarcopenia 308992 0
Malnutrition 308993 0
Condition category
Condition code
Diet and Nutrition 288731 288731 0 0
Other diet and nutrition disorders
Musculoskeletal 288732 288732 0 0
Osteoporosis
Public Health 307894 307894 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Addition of two serves of dairy foods per day to the menu of low-level aged care residents for 2 years. Dairy foods provided will be a combination of milk, cheese, yoghurt and custard, using standard serving sizes (250ml of milk, 30g of cheese, 200g of yoghurt or custard.
Intervention code [1] 286562 0
Prevention
Intervention code [2] 286601 0
Lifestyle
Intervention code [3] 301972 0
Treatment: Other
Comparator / control treatment
Residents consume food from their normal menus.
Control group
Active

Outcomes
Primary outcome [1] 288913 0
Fractures
Determined from incident reports, that are mandatory to complete for all incidences in aged care facilities. Fractures will be verified from hospital medical records.
Timepoint [1] 288913 0
2 years
Secondary outcome [1] 301320 0
Falls
Determined from incident reports, that are mandatory to complete for all incidences in aged care facilities
Timepoint [1] 301320 0
2 years
Secondary outcome [2] 301428 0
Body composition
Determined using densitometry (DXA)
Timepoint [2] 301428 0
Baseline, 12 months, 24 months
Secondary outcome [3] 301429 0
Bone structure at the tibia and radius (high resolution peripheral quantitative computed tomography)
Bone density at the femoral neck and lumbar spine(DXA)
Timepoint [3] 301429 0
Baseline, 12 months, 25 months
Secondary outcome [4] 301431 0
Muscle strength at the ankle, knee and hip
(Nicholas Manual Muscle tester)
Hand-grip strength
(Dynomometer)
Physical function
(timed up and go, walk velocity, short physical performance battery)
Timepoint [4] 301431 0
Baseline, 3 months, 12 months, 24 months
Secondary outcome [5] 301432 0
Bone metabolism / metabolic regulation
(Serum sample)
Timepoint [5] 301432 0
Baseline, 3 months, 12 months, 24 months
Secondary outcome [6] 349972 0
Malnutrition. Nutritional status is determined using the Mini Nutrition Assessment Tool.
Timepoint [6] 349972 0
Baseline, month 3, month 12
Secondary outcome [7] 349973 0
All-cause mortality determined from the Australian Institute Health and Welfare Death Registry.
Timepoint [7] 349973 0
24 months
Secondary outcome [8] 349974 0
Quality of Life assessed using ED-5D, ICE-CAP
Timepoint [8] 349974 0
Baseline, month 3, month 12
Secondary outcome [9] 349975 0
Activities of Daily Living assessed using the Bristol ADL questionnaire
Timepoint [9] 349975 0
Baseline, months 3 and 12
Secondary outcome [10] 349976 0
Health status assessed using the SP-36 (Health) questionnaire
Timepoint [10] 349976 0
Baseline, months 3 and 12
Secondary outcome [11] 349977 0
Depression risk assessed using the Geriatric Depression Scale.
Timepoint [11] 349977 0
Baseline and months 3 and 12

Eligibility
Key inclusion criteria
Low-level aged care resident.
Dietary calcium intake below 600 mg/day
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Dietary calcium intake above 600 mg/day

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 involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary outcome of this study is the time to fragility fracture, and the secondary outcome is falls. The incidence rate of outcomes will be expressed as the percentage of events per years of follow-up, taking into account the censorship of follow-up data. Kaplan – Meier estimates will be used to obtain the proportion of subjects who would have an event during the follow-up period. The Cox’s proportional hazards model will be used to examine the effect of intervention on fracture risk according to the intention-to-treat principle. Occurrences of outcomes will be compared with the use of hazard ratio and 95% confidence limits. Since the events of fracture and fall are expected to be correlated (i.e., most fractures result from falls) we will use the multi-state Cox-Markov model to account for the correlation. The R statistical environment will be used for the statistical analysis.
We will apply modern statistical methods to deal with attrition in this cluster randomised clinical trial. Two main methods for dealing with missing outcomes are Bayesian analyses and imputation. In the Bayesian approach, we will generate the posterior distribution of outcome using Monte Carlo methods. Combining this estimate with the known outcome provides a numerator for estimating the incidence of fractures and falls. Under certain assumptions about the missing data, it has been shown that valid inferences can be obtained through a Bayesian analysis. In the imputation approach, missing data will be imputed with one or more suitable estimates prior to the analysis according to the methods described by Little and Rubin.
The distribution of continuous covariates e.g. bone turnover markers will be checked for normality by the standard Shapiro's statistic test. Differences in baseline covariates between treatment groups will be tested by unpaired t-test (for continuous variables) or Binomial test (for categorical variables). The effect of intervention on variables e.g. bone remodelling will be analysed by the mixed-effects model, in which the change in bone markers will be modelled as a function of treatment group, time of follow-up, and covariates. The R statistical package will be used for the mixed-effects analysis. Data were presented as mean ± SD unless stated otherwise. The p-value less than 0.05 is considered statistically significant, but values < 0.1 will be reported to indicate trends.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2013
Actual
12/04/2013
Date of last participant enrolment
Anticipated
Actual
1/04/2016
Date of last data collection
Anticipated
31/08/2018
Actual
31/08/2018
Sample size
Target
3000
Accrual to date
Final
7195
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286770 0
Other
Name [1] 286770 0
Dairy Australia
(Not for profit organisation)
Country [1] 286770 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Studley Road,
Heidelberg, VIC,
3084
Country
Australia
Secondary sponsor category [1] 285550 0
University
Name [1] 285550 0
Melbourne University
Address [1] 285550 0
Royal Pde,
Parkville, VIC, 3052
Country [1] 285550 0
Australia
Other collaborator category [1] 280257 0
University
Name [1] 280257 0
University of California
Address [1] 280257 0
1 Shields Ave, Davis, CA 95616, USA
Country [1] 280257 0
United States of America
Other collaborator category [2] 280258 0
University
Name [2] 280258 0
Wageningen University
Address [2] 280258 0
6708 PB Wageningen, Netherlands
Country [2] 280258 0
Netherlands
Other collaborator category [3] 280259 0
University
Name [3] 280259 0
Aarhus University
Address [3] 280259 0
Nordre Ringgade 1, 8000 Aarhus C, Denmark
Country [3] 280259 0
Denmark

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288837 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 288837 0
Ethics Office,
Level 5 HSB,
Austin Health,
Studley Rd,
Heidelberg, VIC, 3084
Ethics committee country [1] 288837 0
Australia
Date submitted for ethics approval [1] 288837 0
18/01/2013
Approval date [1] 288837 0
12/04/2013
Ethics approval number [1] 288837 0
H2013 / 04958

Summary
Brief summary
Falls and fracture rates are highest in elderly in low-level aged-care than those in nursing homes or in the community, so this is the highest risk group and most likely to benefit from interventions. Drugs cannot be given to large numbers of people so non-drug approaches are needed to reduce the burden of fractures, but must be effective, safe, easily administered, readily available and low cost.

Low protein and calcium intakes increase falls and fracture risk because muscles weaken, balance worsens and bone breaks down more quickly making them more susceptible to fractures. On average low-level aged-care residents consume two or less serves of dairy foods per day with more than 75% of residents below the recommended intakes levels for protein and calcium. Dairy foods are a good source of protein and calcium, and fulfill the requirements of safe, accessible, easy to administer and low cost. We aim to determine if two additional serves of dairy food per day will corrected these deficiencies and reduce the rate of falls and fractures in low-level aged-care residents by maintaining muscle mass and function and slowing bone loss. We will study this over 2 years by ensuring that residents consume 4 serves of dairy foods per day. Food service staff with be trained and supported to modify the menus to improve dairy food intake.

We will recruit 3000 residents in 60 aged care facilities; 30 facilities will be randomized to intervention and 30 serving as controls. Residents will be transported under supervision to the Heidelberg Repatriation Hospital for bone, balance and body composition measures. Fractures will be monitored in residents from incident reports and verified using hospital medical records. Bone turnover will be measured using serum bone metabolic markers, bone structure measured using high resolution peripheral quantitative computed tomography (HR-pQCT) and bone density and body composition measured using densitometry (DXA). Strength and physical function and questionnaires will be assessed at facilities. All tests are performed before the intervention begins, bloods and strength re-assessed at 3 months and bone structure, density and body composition measured again at 12 months.

This study will be the first to assess the anti-fracture efficacy of dairy foods, and the mechanisms and structural basis for this reduction in fracture risk. If anti-fracture efficacy is demonstrated it will provide evidence for a safe, low cost, widely available approach to reduce the burden of fractures in the community.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37894 0
Dr Sandra Iuliano
Address 37894 0
Endocrinology,
Level 2 Centaur Building
Heidelberg Repatriation Hospital
Waterdale Rd,
West Heidelberg, VIC, 3081
Country 37894 0
Australia
Phone 37894 0
+61 438215615
Fax 37894 0
Email 37894 0
sandraib@unimelb.edu.au
Contact person for public queries
Name 37895 0
Dr Sandra Iuliano
Address 37895 0
Endocrinology,
Level 2 Centaur Building
Heidelberg Repatriation Hospital
Waterdale Rd,
West Heidelberg, VIC, 3081
Country 37895 0
Australia
Phone 37895 0
+61 438215615
Fax 37895 0
Email 37895 0
sandraib@unimelb.edu.au
Contact person for scientific queries
Name 37896 0
Dr Sandra Iuliano
Address 37896 0
Endocrinology,
Level 2 Centaur Building
Heidelberg Repatriation Hospital
Waterdale Rd,
West Heidelberg, VIC, 3081
Country 37896 0
Australia
Phone 37896 0
+61 438215615
Fax 37896 0
Email 37896 0
sandraib@unimelb.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


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  sandraib@unimelb.edu.au
Ethical approval  sandraib@unimelb.edu.au
Informed consent form  sandraib@unimelb.edu.au


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDairy food supplementation may reduce malnutrition risk in institutionalised elderly.2017https://dx.doi.org/10.1017/S000711451600461X
EmbaseEffect of dietary sources of calcium and protein on hip fractures and falls in older adults in residential care: Cluster randomised controlled trial.2021https://dx.doi.org/10.1136/bmj.n2364
Dimensions AIFood provision in Australian aged care homes does not meet protein needs of residents: A call for reform2023https://doi.org/10.1111/1747-0080.12851
N.B. These documents automatically identified may not have been verified by the study sponsor.