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Trial registered on ANZCTR
Registration number
ACTRN12626000985381
Ethics application status
Approved
Date submitted
14/06/2026
Date registered
11/08/2026
Date last updated
11/08/2026
Date data sharing statement initially provided
11/08/2026
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effectiveness of Online Education Training (OET) for Nursing Staff on Enhancing Nutritional Care for Older Adults with Dementia in Chinese Nursing Homes: A Cluster Randomized Controlled Trial
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Scientific title
Effectiveness of Online Education Training (OET) for Nursing Staff on Enhancing Nutritional Care for Older Adults with Dementia in Chinese Nursing Homes: A Cluster Randomized Controlled Trial
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Additional trial identifiers [1]
317535
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
Malnutrition and dementia
342683
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Condition category
Condition code
Neurological
338454
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0
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Dementias
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Public Health
338821
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0
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Health promotion/education
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Diet and Nutrition
338822
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
Participants allocated to the intervention group will receive a structured person-centred mealtime care intervention in addition to usual nursing home care. The intervention will be delivered during routine mealtimes over a 12-week study period. For outcome observation and intervention monitoring, one routine meal will be observed for each participating resident at each assessment time point. The observed meal may be breakfast, lunch, or dinner, depending on the resident’s usual mealtime schedule and facility arrangements. The estimated duration of direct participant contact will depend on the resident’s usual meal duration, typically approximately 10–30 minutes per observed meal.
The intervention will include assessment of eating difficulties, individualized mealtime care planning, tailored feeding assistance, communication strategies, environmental strategies, and monitoring of mealtime duration and food intake during the observed meal. Feeding assistance may include verbal prompting, cueing, pacing, encouragement, positioning support, hand-over-hand assistance where appropriate, and assistance with utensils or food presentation. Communication strategies may include simple instructions, eye contact, reassurance, and allowing sufficient time for responses. Environmental strategies may include reducing distractions, ensuring comfortable seating, maintaining a calm mealtime environment, and presenting food clearly and accessibly.
The intervention will be delivered by trained nursing staff and/or care workers during routine meals under the supervision of the research team. Training will be provided before the intervention commences by members of the research team. The training will consist of one session of approximately two hours, delivered face-to-face or online depending on facility arrangements. Training will cover person-centred mealtime care, dementia-related eating difficulties, feeding assistance techniques, communication strategies, environmental modification, and documentation of intervention delivery.
Adherence will be monitored using study records, including mealtime observation checklists, staff documentation, and regular review by the research team to assess whether individualized mealtime care plans are being followed and intervention components are delivered as intended.
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Intervention code [1]
334369
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Behaviour
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Intervention code [2]
334370
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Lifestyle
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Description of the comparator or control
Participants allocated to the control group will receive usual nursing home care only. Usual care may include routine nutritional care, standard mealtime assistance, monitoring of food intake where normally provided, and access to existing medical, nursing, dietary, and personal care services according to each nursing home’s standard practice.
No structured person-centred mealtime care intervention, additional staff training, individualized mealtime care plan, or research-led feeding support programme will be provided to the control group during the intervention period. Control group participants will continue their usual mealtime routines and receive assistance from nursing home staff as normally available.
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Control group
Active
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Outcomes
Primary outcome [1]
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Nurses’ knowledge of person-centred mealtime care for older adults with dementia.
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Assessment method [1]
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Assessed using a structured questionnaire developed for the study . The questionnaire will assess nurses’ knowledge of dementia-related eating difficulties, nutritional risk, feeding assistance, communication strategies, environmental support, and person-centred mealtime care principles.
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Timepoint [1]
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Baseline, immediately after training, 3 months post-baseline (primary timepoint), and 6 months post-baseline.
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Primary outcome [2]
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Nurses’ attitudes towards person-centred mealtime care for older adults with dementia.
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Assessment method [2]
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Nurses’ attitudes towards person-centred mealtime care for older adults with dementia, assessed using a structured questionnaire validated Assisting Mealtime Scale for Dementia Care
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Timepoint [2]
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Before the first training session, immediately after training, 3 months after training (primary timepoint), and 6 months after training.
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Primary outcome [3]
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Nurses’ skills in providing person-centred mealtime care and feeding assistance for older adults with dementia.
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Assessment method [3]
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The nursing encouragement and practice assessment was developed specifically for this study and had not been previously validated. It was administered using a structured questionnaire designed to assess participants’ self-reported mealtime care skills. The skills component included items related to identifying eating difficulties, providing appropriate feeding assistance, using verbal prompting and cueing, pacing feeding support, supporting resident independence, communicating effectively during meals, and adapting the mealtime environment. Higher scores indicated better self-reported skills.
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Timepoint [3]
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Before the first training session, immediately after training, 3 months after training (primary timepoint), and 6 months after training.
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Secondary outcome [1]
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Older adults’ mealtime eating-challenge behaviours.
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Assessment method [1]
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Nurses’ person-centred mealtime care practice will be assessed using a structured observation audit checklist designed specifically for this study. The checklist was developed by the research team to record observable mealtime care practices, including verbal prompting, cueing, pacing, respectful communication, appropriate feeding assistance, positioning support, environmental modification, and allowing sufficient time for residents to eat. The checklist has not been formally validated.
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Timepoint [1]
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Baseline, immediately after training, 3 months post-baseline (primary timepoint), and 6 months post-baseline.
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Secondary outcome [2]
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Residents’ eating difficulties, assessed using the Feeding Difficulty Index. Higher scores indicate greater eating difficulty.
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Assessment method [2]
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Residents’ eating difficulties will be assessed using the Chinese Feeding Difficulty Index (Ch-FDI), a validated instrument developed by Liu et al. (2015) to assess feeding difficulties in people with dementia. The Ch-FDI includes 19 items and records observable feeding difficulty behaviours during mealtimes. Higher scores indicate greater feeding difficulty.
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Timepoint [2]
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Baseline, immediately after training, 3 months post-baseline (primary timepoint), and 6 months post-baseline.
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Secondary outcome [3]
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Residents’ nutritional status, assessed using the Mini Nutritional Assessment–Short Form. The total score will be used to classify residents as malnourished, at risk of malnutrition, or having normal nutritional status. Higher scores indicate better nutritional status. Assessments will be conducted at baseline and post-intervention.
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Assessment method [3]
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Mini Nutritional Assessment–Short Form
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Timepoint [3]
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Baseline, immediately after training, 3 months post-baseline (primary timepoint), and 6 months post-baseline.
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Eligibility
Key inclusion criteria
Inclusion criteria for nursing staff:
1. Aged 18 years or older.
2. Full-time, frontline clinical nursing staff who are actively engaged in assisting older people with dementia during mealtimes in Chinese nursing homes (CNHs).
3. Have access to a smart device, such as a computer, mobile phone, or tablet, with internet access to online platforms.
4. Proficient in Chinese.
Exclusion criteria for nursing staff:
1. Aged under 18 years.
2. Part-time, temporary, agency, or casual nursing staff.
3. Nursing staff who are not frontline clinical staff or are not actively involved in assisting older people with dementia during mealtimes.
4. Do not have access to a smart device, such as a computer, mobile phone, or tablet, with internet connectivity.
5. Not proficient in Chinese.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
Exclusion criteria for nursing staff:
Aged under 18 years.
Part-time, temporary, agency, or casual nursing staff.
Not frontline clinical nursing staff or not actively engaged in assisting older people with dementia during mealtimes.
No access to a smart device, such as a computer, mobile phone, or tablet, with internet connectivity.
Not proficient in Chinese.
Unable to participate in the intervention or outcome assessments during the study period due to extended leave, rotation, placement, or other reasons.
Exclusion criteria for older people with dementia:
Aged 60 years or younger.
Have resided in the nursing home for less than two weeks.
Do not have a formal diagnosis of dementia documented in medical records and have a Mini-Mental State Examination score above 23/30.
Have a feeding tube in place.
Do not take food orally.
Are able to eat independently without requiring verbal cues or physical assistance from others during mealtimes.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using a computer-generated randomisation sequence prepared by an independent researcher who is not involved in participant recruitment, intervention delivery, or outcome assessment. Group allocation will be stored in a password-protected file and will not be accessible to the researchers responsible for recruitment until after baseline assessment has been completed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be generated using a computer-generated random number sequence by an independent researcher who is not involved in recruitment, intervention delivery, or outcome assessment. Nursing homes or nursing units will be randomly allocated to either the intervention group or the control group in a 1:1 ratio.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
28/08/2025
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Date of last participant enrolment
Anticipated
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Actual
30/10/2025
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Date of last data collection
Anticipated
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Actual
28/02/2026
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Sample size
Target
145
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Accrual to date
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Final
147
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Recruitment outside Australia
Country [1]
28205
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China
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State/province [1]
28205
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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unfunded
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Address [1]
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Country [1]
322096
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Primary sponsor type
University
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Name
western Sydney university
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
324988
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Other collaborator category [1]
283992
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Other Collaborative groups
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Name [1]
283992
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jinxinkangyang aged care organization
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Address [1]
283992
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Country [1]
283992
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China
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Western Sydney Human Research Ethics Committee
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Ethics committee address [1]
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https://www.westernsydney.edu.au/research/research_ethics_and_integrity/human_ethics/apply_for_human_research_ethics_review
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Ethics committee country [1]
320624
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Australia
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Date submitted for ethics approval [1]
320624
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Approval date [1]
320624
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18/08/2025
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Ethics approval number [1]
320624
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Summary
Brief summary
Background: Malnutrition among older people with dementia in Chinese Nursing homes (CNHs) is a growing concern, with inadequate mealtime support from nursing staff being a contributing factor. Online education offers a practical solution to improve staff competencies in this area. Objective: This study aims to assess the effectiveness of an online training program, underpinned by Knowledge, Attitudes, and Practices (KAP) framework, in improving nursing staff’s knowledge, attitudes, and practices related to mealtime support for older people with dementia, and its impact on older people with dementias' eating behaviours and nutritional status. Methods: A cluster-randomised controlled trial with a single-blind design will be conducted across selected 10 CNHs. Nursing staff will be randomised to either an intervention group receiving online education training or a control group receiving usual training. Outcomes will be measured at baseline(T0), post-intervention(T1), 3-month(T3), and 6-month(T6) follow-ups. Nursing staff’s knowledge and attitudes will be assessed via questionnaires; practices will be evaluated using structured observation checklist. Outcome measures for older people with dementia outcomes include nutritional status (MNA-SF), food consummation, and feeding difficulty index (FDI). Discussion: This study addresses a critical gap in dementia care by evaluating a scalable, flexible intervention tailored to frontline staff. If effective, online training could enhance workforce capabilities and resident outcomes in CNHs, supporting broader implementation across similar settings in China. Findings will inform future dementia care policy, training models, and quality improvement initiatives focused on person-centred mealtime support.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Miss Hansen(Cindy) Tang
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Address
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Western Sydney University,Corner of James Ruse Drive and Victoria Road, Rydalmere, NSW 2116
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Country
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Australia
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Phone
151086
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+61420387138
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Fax
151086
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Email
151086
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[email protected]
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Contact person for public queries
Name
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Hansen(Cindy) Tang
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Address
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Western Sydney University,Corner of James Ruse Drive and Victoria Road, Rydalmere, NSW 2116
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Country
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Australia
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Phone
151087
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+61420387138
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Fax
151087
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Email
151087
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[email protected]
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Contact person for scientific queries
Name
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Hansen(Cindy) Tang
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Address
151088
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Western Sydney University Corner of James Ruse Drive and Victoria Road, Rydalmere, NSW 2116
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Country
151088
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Australia
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Phone
151088
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+61420387138
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Fax
151088
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Email
151088
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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.
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