ANZCTR - Registration

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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

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]

NIL

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteoporosis

Fractures

Sarcopenia

Malnutrition

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Musculoskeletal

Osteoporosis

Public Health

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

Treatment: Other

Comparator / control treatment

Residents consume food from their normal menus.

Control group

Active

Outcomes

Primary outcome [1]

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]

2 years

Secondary outcome [1]

Falls
Determined from incident reports, that are mandatory to complete for all incidences in aged care facilities

Timepoint [1]

2 years

Secondary outcome [2]

Body composition
Determined using densitometry (DXA)

Timepoint [2]

Baseline, 12 months, 24 months

Secondary outcome [3]

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]

Baseline, 12 months, 25 months

Secondary outcome [4]

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]

Baseline, 3 months, 12 months, 24 months

Secondary outcome [5]

Bone metabolism / metabolic regulation
(Serum sample)

Timepoint [5]

Baseline, 3 months, 12 months, 24 months

Secondary outcome [6]

Malnutrition. Nutritional status is determined using the Mini Nutrition Assessment Tool.

Timepoint [6]

Baseline, month 3, month 12

Secondary outcome [7]

All-cause mortality determined from the Australian Institute Health and Welfare Death Registry.

Timepoint [7]

24 months

Secondary outcome [8]

Quality of Life assessed using ED-5D, ICE-CAP

Timepoint [8]

Baseline, month 3, month 12

Secondary outcome [9]

Activities of Daily Living assessed using the Bristol ADL questionnaire

Timepoint [9]

Baseline, months 3 and 12

Secondary outcome [10]

Health status assessed using the SP-36 (Health) questionnaire

Timepoint [10]

Baseline, months 3 and 12

Secondary outcome [11]

Depression risk assessed using the Geriatric Depression Scale.

Timepoint [11]

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]

Other

Name [1]

Dairy Australia
(Not for profit organisation)

Address [1]

Level 5, IBM Centre,
Southbank, VIC, 3006

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

Studley Road,
Heidelberg, VIC,
3084

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Melbourne University

Address [1]

Royal Pde,
Parkville, VIC, 3052

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

University of California

Address [1]

1 Shields Ave, Davis, CA 95616, USA

Country [1]

United States of America

Other collaborator category [2]

University

Name [2]

Wageningen University

Address [2]

6708 PB Wageningen, Netherlands

Country [2]

Netherlands

Other collaborator category [3]

University

Name [3]

Aarhus University

Address [3]

Nordre Ringgade 1, 8000 Aarhus C, Denmark

Country [3]

Denmark

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Ethics Office,
Level 5 HSB,
Austin Health,
Studley Rd,
Heidelberg, VIC, 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/01/2013

Approval date [1]

12/04/2013

Ethics approval number [1]

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

Dr Sandra Iuliano

Address

Endocrinology,
Level 2 Centaur Building
Heidelberg Repatriation Hospital
Waterdale Rd,
West Heidelberg, VIC, 3081

Country

Australia

Phone

+61 438215615

Fax

sandraib@unimelb.edu.au

Contact person for public queries

Name

Sandra Iuliano

Address

Endocrinology,
Level 2 Centaur Building
Heidelberg Repatriation Hospital
Waterdale Rd,
West Heidelberg, VIC, 3081

Country

Australia

Phone

+61 438215615

Fax

sandraib@unimelb.edu.au

Contact person for scientific queries

Name

Sandra Iuliano

Address

Endocrinology,
Level 2 Centaur Building
Heidelberg Repatriation Hospital
Waterdale Rd,
West Heidelberg, VIC, 3081

Country

Australia

Phone

+61 438215615

Fax

sandraib@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email
9961	Study protocol	sandraib@unimelb.edu.au
9962	Ethical approval	sandraib@unimelb.edu.au
9963	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

Source	Title	Year of Publication	DOI
Embase	Dairy food supplementation may reduce malnutrition risk in institutionalised elderly.	2017	https://dx.doi.org/10.1017/S000711451600461X
Embase	Effect of dietary sources of calcium and protein on hip fractures and falls in older adults in residential care: Cluster randomised controlled trial.	2021	https://dx.doi.org/10.1136/bmj.n2364
Dimensions AI	Food provision in Australian aged care homes does not meet protein needs of residents: A call for reform	2023	https://doi.org/10.1111/1747-0080.12851

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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