MalnutritionSMASNCT01647204
Southampton Mealtime Assistance Study
A study testing trained volunteer mealtime assistance in people with Malnutrition, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The primary objective of the study is to determine if the use of volunteers employed specifically to focus on mealtime assistance can increase food and nutrient intake of patients admitted to an acute Care of the Elderly ward. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Malnutrition
- What is being tested?
- trained volunteer mealtime assistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2009to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Patients will be recruited in a consecutive prospective manner.
- emergency admissions to acute medical wards and
- ability to gain consent from patient or relatives
Who cannot join
- Patient acutely unwell or palliative care
- Patient lacking capacity to consent and no assent given by relatives
- Patients who are tube fed or nil-by-mouth
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton
Southampton, Hampshire, SO16 6YD
About this study
Official title: Introduction of Mealtime Assistance Onto an Acute Medical Ward for Older People
The primary objective of the study is to determine if the use of volunteers employed specifically to focus on mealtime assistance can increase food and nutrient intake of patients admitted to an acute Care of the Elderly ward. The sustainability of providing helpers to increase dietary intake over a year will be assessed and linked to actual dietary intake. The secondary objectives are to assess the association between dietary intake resulting from mealtime assistance and patient satisfaction, malnutrition risk, body composition, grip strength, length of hospital stay and hospital mortality.
Read the detailed description
Poor nutritional status in older people acutely admitted to hospital is common with the risk of malnutrition estimated to be greater than 40%. Malnutrition is associated with major adverse clinical outcomes such as increased mortality, morbidity and length of stay at enormous cost to individuals and the health service. There is growing recognition that malnutrition is often unrecognised and untreated, and that many patients are discharged from hospital in a more malnourished state than when they were admitted. It is not surprising that complaints about nutrition and food services are amongst the commonest complaints in NHS hospitals.
The standard of mealtime care in UK hospitals has been an issue of concern for a number of years. A report last year from the Healthcare Commission found that one in five patients who wanted help eating did not get it. A secondary analysis of data provided by the Health Care Commission suggests that in some hospitals two out of five patients who wanted help with eating did not get it. Consistent with this, the recent Hungry to be Heard report found that nine out of ten nurses indicated they did not always have time to help ensure patients ate properly. They also suggested that some patients were not given appropriate assistance to eat. This problem is not unique to the UK and has been reported in other countries such as Australia and the USA.
The aim of the present study is to investigate if the use of volunteers employed specifically to focus on mealtime assistance in a Care of the Elderly Ward can increase food and nutrient intake, impact on body composition and improve clinical outcomes. The findings will inform service development in the nutritional care of older people across the Trust and wider.
- Conditions
- Malnutrition
- Being tested
- trained volunteer mealtime assistance
- Keywords
- Nutrition, older, hospital, volunteer
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trained volunteer mealtime assistanceOther
trained volunteers helped inpatients at lunchtimes with dinner tray preparation, encouragement and feeding if required
| Study group | Role | What they receive |
|---|---|---|
| usual mealtime care | No intervention | patients admitted to the control ward receiving no intervention but usual mealtime help from ward staff |
| mealtime assistance | Experimental | Additional lunchtime help from trained volunteer mealtime assistants to supplement help from the ward staff Receives: Other: trained volunteer mealtime assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean dietary intake of inpatients during a 24 hour period
The primary objective of the study is to determine if the use of volunteers employed specifically to focus on mealtime assistance can increase food and nutrient intake of patients admitted to an acute Care of the Elderly ward.
Dietary intake measured as energy and protein
Measured: end of year 1 and year 2
Secondary outcomes (6)
patient satisfaction
measured by patient interviews held during each year
Measured: end of year 1 and year2
malnutrition risk
MUST score will be abstracted from medical records
Measured: end of year 1 and year2
length of stay in hospital
taken from hospital records
Measured: end of year one and year two
grip strength
measured using a dynamometer
Measured: end of year 1 and year 2
body composition
triceps and mid upper arm measurement
Measured: end of year one and year two and year 3
mortality
abstracted from hospital records
Measured: end of year 1 year 2 and year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startNov 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton
- Responsible party
- Sponsor
- Investigators
- Helen C Roberts, MB ChB, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647204
- Sponsor's protocol ID
- 09/H0502/93
- Other IDs
- RHM MED0882
- Acronym
- SMAS
- Status last verified
- Nov 2014
- First submitted
- 11 Jul 2012
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Roberts HC, Pilgrim AL, Jameson KA, Cooper C, Sayer AA, Robinson S. The Impact of Trained Volunteer Mealtime Assistants on the Dietary Intake of Older Female In-Patients: The Southampton Mealtime Assistance Study. J Nutr Health Aging. 2017;21(3):320-328. doi: 10.1007/s12603-016-0791-1.
PubMed 28244573Roberts HC, Pilgrim AL, Elia M, Jackson AA, Cooper C, Sayer AA, Robinson SM. Southampton Mealtime Assistance Study: design and methods. BMC Geriatr. 2013 Jan 7;13:5. doi: 10.1186/1471-2318-13-5.
PubMed 23294981
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of Mealtime Assistance Onto an Acute Medical Ward for Older People
- ClinicalTrials.gov ID
- NCT01647204
- Acronym / sponsor ID
- SMAS / 09/H0502/93
- Conditions
- Malnutrition
- Keywords
- Nutrition, older, hospital, volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Southampton
- Study start
- Nov 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to determine if the use of volunteers employed specifically to focus on mealtime assistance can increase food and nutrient intake of patients admitted to an acute Care of the Elderly ward. The sustainability of providing helpers to increase dietary intake over a year will be assessed and linked to actual dietary intake. The secondary objectives are to assess the association between dietary intake resulting from mealtime assistance and patient satisfaction, malnutrition risk, body composition, grip strength, length of hospital stay and hospital mortality.
Detailed description
Poor nutritional status in older people acutely admitted to hospital is common with the risk of malnutrition estimated to be greater than 40%. Malnutrition is associated with major adverse clinical outcomes such as increased mortality, morbidity and length of stay at enormous cost to individuals and the health service. There is growing recognition that malnutrition is often unrecognised and untreated, and that many patients are discharged from hospital in a more malnourished state than when they were admitted. It is not surprising that complaints about nutrition and food services are amongst the commonest complaints in NHS hospitals.
The standard of mealtime care in UK hospitals has been an issue of concern for a number of years. A report last year from the Healthcare Commission found that one in five patients who wanted help eating did not get it. A secondary analysis of data provided by the Health Care Commission suggests that in some hospitals two out of five patients who wanted help with eating did not get it. Consistent with this, the recent Hungry to be Heard report found that nine out of ten nurses indicated they did not always have time to help ensure patients ate properly. They also suggested that some patients were not given appropriate assistance to eat. This problem is not unique to the UK and has been reported in other countries such as Australia and the USA.
The aim of the present study is to investigate if the use of volunteers employed specifically to focus on mealtime assistance in a Care of the Elderly Ward can increase food and nutrient intake, impact on body composition and improve clinical outcomes. The findings will inform service development in the nutritional care of older people across the Trust and wider.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual mealtime care | No intervention | –patients admitted to the control ward receiving no intervention but usual mealtime help from ward staff |
| mealtime assistance | Experimental | Other: trained volunteer mealtime assistanceAdditional lunchtime help from trained volunteer mealtime assistants to supplement help from the ward staff |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients will be recruited in a consecutive prospective manner.
- emergency admissions to acute medical wards and
- ability to gain consent from patient or relatives
Key exclusion criteria (3 listed)
- Patient acutely unwell or palliative care
- Patient lacking capacity to consent and no assent given by relatives
- Patients who are tube fed or nil-by-mouth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trained volunteer mealtime assistancetrained volunteers helped inpatients at lunchtimes with dinner tray preparation, encouragement and feeding if required | Other | mealtime assistance |
Primary outcome
mean dietary intake of inpatients during a 24 hour period
Time frame: end of year 1 and year 2
The primary objective of the study is to determine if the use of volunteers employed specifically to focus on mealtime assistance can increase food and nutrient intake of patients admitted to an acute Care of the Elderly ward. Dietary intake measured as energy and protein
6 secondary outcomes
patient satisfaction
Time frame: end of year 1 and year2
malnutrition risk
Time frame: end of year 1 and year2
length of stay in hospital
Time frame: end of year one and year two
grip strength
Time frame: end of year 1 and year 2
body composition
Time frame: end of year one and year two and year 3
mortality
Time frame: end of year 1 year 2 and year 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
- Derived from this study: PubMed 28244573Roberts HC, Pilgrim AL, Jameson KA, Cooper C, Sayer AA, Robinson S. The Impact of Trained Volunteer Mealtime Assistants on the Dietary Intake of Older Female In-Patients: The Southampton Mealtime Assistance Study. J Nutr Health Aging. 2017;21(3):320-328. doi: 10.1007/s12603-016-0791-1.
- Derived from this study: PubMed 23294981Roberts HC, Pilgrim AL, Elia M, Jackson AA, Cooper C, Sayer AA, Robinson SM. Southampton Mealtime Assistance Study: design and methods. BMC Geriatr. 2013 Jan 7;13:5. doi: 10.1186/1471-2318-13-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen C Roberts, MB ChB principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trained volunteer mealtime assistance in people with Malnutrition, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean dietary intake of inpatients during a 24 hour period (time frame: end of year 1 and year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647204, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2014.