Southampton Mealtime Assistance Study

NCT ID: NCT01647204

Last Updated: 2014-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

usual mealtime care

patients admitted to the control ward receiving no intervention but usual mealtime help from ward staff

Group Type NO_INTERVENTION

No interventions assigned to this group

mealtime assistance

Additional lunchtime help from trained volunteer mealtime assistants to supplement help from the ward staff

Group Type EXPERIMENTAL

trained volunteer mealtime assistance

Intervention Type OTHER

trained volunteers helped inpatients at lunchtimes with dinner tray preparation, encouragement and feeding if required

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

trained volunteer mealtime assistance

trained volunteers helped inpatients at lunchtimes with dinner tray preparation, encouragement and feeding if required

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients will be recruited in a consecutive prospective manner.

* emergency admissions to acute medical wards and
* ability to gain consent from patient or relatives

Exclusion Criteria

* 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
Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Southampton

OTHER

Sponsor Role collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Helen C Roberts, MB ChB

Role: PRINCIPAL_INVESTIGATOR

University of Southampton

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Southampton

Southampton, Hampshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28244573 (View on PubMed)

Roberts 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.

Reference Type DERIVED
PMID: 23294981 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RHM MED0882

Identifier Type: OTHER

Identifier Source: secondary_id

09/H0502/93

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Food as Medicine for Families
NCT06160973 COMPLETED NA
Meal Texture and Satiety
NCT04041752 UNKNOWN NA
Food Insecurity, Social Determinants of Health
NCT06784310 ACTIVE_NOT_RECRUITING NA