Contact information
Type
Scientific
Primary contact
Dr Gary Frost
ORCID ID
Contact details
Hammersmith Hospital NHS Trust
Department of Nutrition and Dietetics
Hammersmith Hospitals NHS Trust
Ducane Road
London
W12 0HS
United Kingdom
+44 (0)20 8383 3948
Gfrost@hhnt.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDC00891
Study information
Scientific title
Acronym
Study hypothesis
Malnutrition has been estimated to cost the NHS £220 million a year because malnourished patients have longer hospital stays and increased morbidity. Malnutrition is particularly common in the elderly. Most intervention studies in this group have used liquid supplements but the results have been disappointing; even under surveillance, ill older patients often do not take enough supplement to improve their nutritional status. In routine clinical practice the situation is even worse because poor nutrition is often not recognised and compliance with supplements is even lower. Another approach is needed. This study examines whether health care assistants trained to provide support with all aspects of feeding can make a significant impact on nutritional intake and whether this improves outcome. The study is designed to determine: Does feeding support increase nutritional intake, lead to measurable changes in nutritional status (body mass index, arm circumference, serum albumin) and lead to improved outcome (infection rate, Barthel score, length of stay, readmission rate)?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Acute illness
Intervention
1. Feeding support from health care assistants trained to provide support with all aspects of feeding
2. Standard care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The study is designed to see whether feeding support improves the nutritional status of patients to an extent it will have a positive day to day effect on function, the time patients require to become medically fit for discharge and length of stay.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/1997
Overall trial end date
01/06/2000
Reason abandoned
Eligibility
Participant inclusion criteria
All patients over 65 admitted acutely to Medicine for the Elderly wards. Sample is estimate to be 750 people in each group.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
1500
Participant exclusion criteria
1. Patients unable to take food orally (e.g. unconscious, severe dysphagia)
2. Not expected to survive the current admission
3. Patients with a body mass index (BMI) greater or equal to 25
Recruitment start date
01/12/1997
Recruitment end date
01/06/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hammersmith Hospital NHS Trust
London
W12 0HS
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14757395
Publication citations
-
Results
Hickson M, Bulpitt C, Nunes M, Peters R, Cooke J, Nicholl C, Frost G, Does additional feeding support provided by health care assistants improve nutritional status and outcome in acutely ill older in-patients?--a randomised control trial., Clin Nutr, 2004, 23, 1, 69-77.