Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000174987
Ethics application status
Approved
Date submitted
9/02/2011
Date registered
15/02/2011
Date last updated
6/01/2014
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
Nil
Universal Trial Number (UTN)
U1111-1119-3538
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
Dementias
Diet and Nutrition 259289 259289 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
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
Lifestyle
Intervention code [3] 258008 0
Behaviour
Comparator / control treatment
Standard care – the mealtime procedures already operating within the residential care site.
Control group
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Deafness, blindness, acute illness

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/03/2011
Actual
13/05/2013
Date of last participant enrolment
Anticipated
Actual
17/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258466 0
Charities/Societies/Foundations
Name [1] 258466 0
Masonic Care Queensland
Country [1] 258466 0
Australia
Primary sponsor type
Individual
Name
Prof Elizabeth Beattie
Address
School of Nursing & Midwifery
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 257608 0
None
Name [1] 257608 0
Address [1] 257608 0
Country [1] 257608 0
Other collaborator category [1] 251810 0
Individual
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
Australia

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 260447 0
Approval date [1] 260447 0
04/11/2010
Ethics approval number [1] 260447 0
2/02/2002

Summary
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

Contacts
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
Australia
Phone 32186 0
+61 7 3138 3389
Fax 32186 0
Email 32186 0
[email protected]
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
Australia
Phone 15433 0
+61 7 3138 3057
Fax 15433 0
+61 7 3138 5941
Email 15433 0
[email protected]
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
Australia
Phone 6361 0
+61 7 3138 3389
Fax 6361 0
+61 7 3138 5941
Email 6361 0
[email protected]

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

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

Documents added automatically
No additional documents have been identified.