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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving Nutritional Support for Nursing Home Residents: A Two-phase Project
Scientific title
In residential care facilities, does the use of an Evidence Based Nutrition Strategy (EBNS), in place of standard feeding practices, result in improved nutritional status for people with cognitive impairment?
Secondary ID [1] 253576 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 261134 0
Cognitive impairment 261135 0
Under-nutrition 261136 0
Condition category
Condition code
Neurological 259272 259272 0 0
Diet and Nutrition 259289 259289 0 0
Other diet and nutrition disorders

Study type
Description of intervention(s) / exposure
This study will use a four-element blended Intervention, the Evidence-based Nutrition Strategy (EBNS), comprising four elements known to support improved nutritional intake-the SIP (Supportive, Informative, Prescriptive) communication protocol; family-style group dining; high ambiance table presentation; and routine Dietary-Nutrition Champion supervision. The intervention will be applied over 10 randomly allocated mealtimes per week (excluding weekends) for a total of 8 weeks. The four elements of the intervention are detailed below: -

1. Communication Protocol: Supportive, informative & prescriptive
The SIP protocol consists of the systematic reinforcement of subject sitting-at-table and eating behaviours by using three dimensions of communication:
a) Style, i.e. general conversation about eating (generated by the use of the Supportive, Informative and Prescriptive categories from Six-Category Intervention)(Heron, 1976);
b) Form, i.e. specific elements of social behaviour (smiling, eye contact, nodding, laughing) and
c) Content (focus of the conversation) on the meal and providing encouragement to eat. Systematic stopping of table-leaving behaviour should be injected into the intervention as needed.

2. Family-style group dining
The preservation of homelike environments can be achieved through strategies such as:
a) Preparing food close to time eaten to maximize cooking odours as a stimulant
b) Keep former rituals as much as possible such as meal blessing
c) If food is in a different consistency to which the PwD is familiar then cue the PwD to the item
d) Eat in rooms where meals are usually served such as dining room
e) Encourage caregiver involvement and engage them in eating some of the meal

3. High ambiance table presentation
Physical presentation of meals and the use of very pleasant surroundings (table linen, china, flowers) has been shown to improve intake for PwD over a 6-week period

4. Dietary-nutrition champion supervision
Constitutes paying particular attention to what is eaten and how it is eaten, including the following: -
- Residents should be properly positioned to eat; that is, they should be sitting upright.
- Residents should have their dentures, glasses, and hearing aides, if needed.
- Resident requests for substitute food and fluid items should be honoured (and substitutes offered by staff if a resident doesn't seem to like the served meal).
- If a resident entirely consumes a particular food or beverage, offer a second helping, even if the food is a dessert.
- Residents should have access to their trays for up to 1 hour per meal (and no less than 30 minutes). Feeding assistance ends when each resident has refused all food and fluid items on his or her tray multiple times.
- An oral nutritional supplement should be offered at the end of the meal only to those residents who refused all other food and fluid items on their tray, consumed less than 75% of their meal, or requested a supplement.
- The nurse or nurse aide should follow a graduated prompting protocol to encourage residents to feed themselves. This standardized procedure instructs staff members to try nonverbal and verbal prompts to encourage residents to eat before offering physical guidance or assistance.
Intervention code [1] 258006 0
Treatment: Other
Intervention code [2] 258007 0
Intervention code [3] 258008 0
Comparator / control treatment
Standard care – the mealtime procedures already operating within the residential care site.
Control group

Primary outcome [1] 262098 0
Mealtime nutritional intake:
Measured by comparing food weight and fluid volume before and after every meal. Each food item on the plate (e.g. meat, vegetables, starches, fruits, liquids) will be dispensed at the table using the prescribed individual amounts for each person. Discarded or spilled food and fluid will be retrieved from the table, floor and clothing. Pre and post-meal plate photographs will be taken to enable proportion size and proportion eaten to be calculated, a reliable and valid method of measuring food intake. For this study, inadequate nutritional intake will be defined as less than 75% of the meal consumed and less than 240ml of fluid consumed.
Timepoint [1] 262098 0
At 10 randomly allocated mealtimes per week in weeks 1 - 8 of the intervention period
Secondary outcome [1] 273151 0
Table-leaving behaviour:
Measured on three dimensions: frequency, duration and stimulus. Duration comprises elapsed time from point of rising from the table to point of sitting down again. Stimulus for table-leaving will be recorded in brief narrative and explored for emergent themes. RAs will judge if the table-leaving episode was a) self initiated or b) other-initiated and note mode of return to the table (by self / other). Time spent at the table will be calculated by subtracting time away from the table from the standard 30 minutes of observation.
Timepoint [1] 273151 0
At 10 randomly allocated mealtimes per week in weeks 1 - 8 of the intervention period
Secondary outcome [2] 273152 0
Mealtime agitation using the Cohen-Mansfield Agitation Inventory (CMAI).
Timepoint [2] 273152 0
At 10 randomly allocated mealtimes per week in weeks 1 - 8 of the intervention period
Secondary outcome [3] 273153 0
Height, weight and Body Mass Index (BMI) using foot-to-foot bioelectrical impedance analysis (BIA)
Timepoint [3] 273153 0
At baseline and 1 week after the intervention period
Secondary outcome [4] 273154 0
Nutritional Status using the Mini Nutritional Assessment (MNA)
Timepoint [4] 273154 0
At baseline and 1 week after the intervention period

Key inclusion criteria
Cognitive impairment; independently ambulatory; restraint free; continuous resident on a unit for three months; vision and hearing adequate for normal conversation
Minimum age
No limit
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Deafness, blindness, acute illness

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation by off-site administrator not involved in data collection.
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
Blinded (masking used)
Who is / are masked / blinded?

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

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258466 0
Name [1] 258466 0
Masonic Care Queensland
Address [1] 258466 0
The Board of Benevolence
60 Wakefield St
Sandgate QLD 4017
Country [1] 258466 0
Primary sponsor type
Prof Elizabeth Beattie
School of Nursing & Midwifery
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Secondary sponsor category [1] 257608 0
Name [1] 257608 0
Address [1] 257608 0
Country [1] 257608 0
Other collaborator category [1] 251810 0
Name [1] 251810 0
Dr Elisabeth Isenring
Address [1] 251810 0
School of Human Movement
University of Queensland
St Lucia QLD 4072
Country [1] 251810 0

Ethics approval
Ethics application status
Ethics committee name [1] 260447 0
Masonic Care Queensland - Sandgate Human Research Ethics Committee
Ethics committee address [1] 260447 0
60 Wakefield St
Sandgate QLD 4017
Ethics committee country [1] 260447 0
Date submitted for ethics approval [1] 260447 0
Approval date [1] 260447 0
Ethics approval number [1] 260447 0

Brief summary
This proposed two-phase study is focused on improving nutritional intake in residents with cognitive impairment via a pilot randomised controlled trial of an intervention shown to increase intake. Phase one involves the collection of baseline data from the residents, identification of current meal time practices and family preferences for feeding interventions within the RACF. Phase two involves implementation of an intervention to improve nutritional intake of residents from baseline findings and determine if these interventions are efficient and effective.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 32186 0
Prof Elizabeth Beattie
Address 32186 0
Director, Dementia Collaborative Research Centre (DCRC): Carers, Consumers and Social Research School of Nursing & Midwifery, Queensland University of Technology Victoria Park, Kelvin Grove, 4059 Brisbane, QLD
Country 32186 0
Phone 32186 0
+61 7 3138 3389
Fax 32186 0
Email 32186 0
Contact person for public queries
Name 15433 0
Dr Dr Maria O’Reilly
Address 15433 0
School of Nursing & Midwifery, Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 15433 0
Phone 15433 0
+61 7 3138 3057
Fax 15433 0
+61 7 3138 5941
Email 15433 0
Contact person for scientific queries
Name 6361 0
Prof Prof Elizabeth Beattie
Address 6361 0
Director, Dementia Collaborative Research Centre (DCRC): Carers, Consumers and Social Research
School of Nursing & Midwifery, Queensland University of Technology
Victoria Park, Kelvin Grove, 4059
Brisbane, QLD
Country 6361 0
Phone 6361 0
+61 7 3138 3389
Fax 6361 0
+61 7 3138 5941
Email 6361 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary