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Trial registered on ANZCTR


Registration number
ACTRN12625000089437
Ethics application status
Approved
Date submitted
6/01/2025
Date registered
28/01/2025
Date last updated
28/01/2025
Date data sharing statement initially provided
28/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bone-Health Nutrition Training for Food Service Staff in Aged Care: A Food-Based Approach to Manage Fracture Risk
Scientific title
Evaluating the efficacy of a Bone-Health Nutrition Training Program for Food Service Staff in Aged Care: A Food-Based Approach to Improve Protein and Calcium Intakes in Residents
to Manage Fracture Risk
Secondary ID [1] 313637 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractures 336201 0
Malnutrition 336202 0
Condition category
Condition code
Diet and Nutrition 332736 332736 0 0
Other diet and nutrition disorders
Injuries and Accidents 332737 332737 0 0
Fractures
Musculoskeletal 332738 332738 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 12-week cluster-randomised intervention involving 16 aged care homes. Food service and other staff from intervention homes will participate in a bone health food service training program that will be delivered either face-to-face or on-line at baseline and receive on-going support for 12 weeks to implement the learnings from the training in their aged care homes.

The training program combines learning materials / notes and activities and is divided into 5 modules.
(i) Nutritional care for older adults
(ii) Protein and older adults
(iii) Protein distribution
(iv) Bone health food strategies
(v) Building a bone healthy menu

Learning materials consist of summary pages of the information delivered in each module. Participants can add their own points to these material.

Activities consist of participants re-designing their own one-week menu as they proceed through the modules. There are also multiple choice questions at the end of each module.

The program is designed to be delivered in a single 4 hour session involving all relevant staff. The mode of delivery (length, number and timing of sessions) can be altered to accomodate specific requirement of the homes and staff. Attendance is recorded at the session.

To facilitate implementation of the learnings, staff are provided with recipes, tip sheets and specific weekly menu ideas for their menu, that are provided by the research team. Research staff are available during the intervention period. All assistance is recorded.

All materials (e.g. recipes, tip sheets, etc) were specifically developed for this study.
Intervention code [1] 330330 0
Treatment: Other
Comparator / control treatment
Control homes will continue with their usual menus without any bone health training or ongoing support.
Control group
Active

Outcomes
Primary outcome [1] 340264 0
Protein intake in aged care residents
Timepoint [1] 340264 0
Baseline and week 12 post-baseline
Secondary outcome [1] 443532 0
Nutritional status of aged care residents
Timepoint [1] 443532 0
Baseline and week 12 post-baseline
Secondary outcome [2] 443533 0
Quality of Life in aged care residents
Timepoint [2] 443533 0
Baseline and week 12 post-baseline
Secondary outcome [3] 443534 0
Food service satisfaction of aged care residents
Timepoint [3] 443534 0
Baseline and week 12 post-baseline
Secondary outcome [4] 443535 0
Change in nutrition knowledge (Food Service and Aged Care Staff)
Timepoint [4] 443535 0
Baseline and week 12 post-baseline
Secondary outcome [5] 443536 0
Exploratory - Change in food service purchase patterns
Timepoint [5] 443536 0
12 weeks pre intervention / 12 weeks during intervention
Secondary outcome [6] 443537 0
Exploratory - Oral nutritional supplement use in aged care residents
Timepoint [6] 443537 0
12 weeks pre intervention / 12 weeks during intervention
Secondary outcome [7] 443538 0
Body weight of aged care residents
Timepoint [7] 443538 0
Weekly for 12 weeks pre intervention / 12 weeks during intervention.
Secondary outcome [8] 443976 0
Exploratory - barriers and facilitators to implement menu changes by staff
Timepoint [8] 443976 0
Baseline and Post 12 week intervention period

Eligibility
Key inclusion criteria
Aged Care home is accredited with the Aged Care Quality Agency
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Aged care home - not accredited
Residents - not permanent residency

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)
Permuted block randomisation
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2024
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
128
Accrual to date
88
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318105 0
Government body
Name [1] 318105 0
Victorian Government
Country [1] 318105 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 320481 0
Charities/Societies/Foundations
Name [1] 320481 0
Bone Health Foundation
Address [1] 320481 0
Country [1] 320481 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316751 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 316751 0
Ethics committee country [1] 316751 0
Australia
Date submitted for ethics approval [1] 316751 0
20/10/2023
Approval date [1] 316751 0
29/02/2024
Ethics approval number [1] 316751 0

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

Contacts
Principal investigator
Name 138894 0
Dr Sandra Iuliano
Address 138894 0
Endocrinology, Level 2 Centaur Building, Heidelberg Repatriation Hospital, Waterdale Rd, West Heidelberg, VIC, 3081
Country 138894 0
Australia
Phone 138894 0
+61438215615
Fax 138894 0
Email 138894 0
sandraib@unimelb.edu.au
Contact person for public queries
Name 138895 0
Sandra Iuliano
Address 138895 0
Endocrinology, Level 2 Centaur Building, Heidelberg Repatriation Hospital, Waterdale Rd, West Heidelberg, VIC, 3081
Country 138895 0
Australia
Phone 138895 0
+61438215615
Fax 138895 0
Email 138895 0
sandraib@unimelb.edu.au
Contact person for scientific queries
Name 138896 0
Sandra Iuliano
Address 138896 0
Endocrinology, Level 2 Centaur Building, Heidelberg Repatriation Hospital, Waterdale Rd, West Heidelberg, VIC, 3081
Country 138896 0
Australia
Phone 138896 0
+61438215615
Fax 138896 0
Email 138896 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
Individual data will be available to the participant, their next of kin / legal guardian or the aged care home or medical practitioner if consented by the participant or next of kin. The individual data will not be publicly 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.