NCT01647204

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

3.2 years

First QC Date

July 11, 2012

Last Update Submit

November 3, 2014

Conditions

Malnutrition

Keywords

Nutritionolderhospitalvolunteer

Outcome Measures

Primary Outcomes (1)

  • 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

    end of year 1 and year 2

Secondary Outcomes (6)

  • patient satisfaction

    end of year 1 and year2

  • malnutrition risk

    end of year 1 and year2

  • length of stay in hospital

    end of year one and year two

  • grip strength

    end of year 1 and year 2

  • body composition

    end of year one and year two and year 3

  • +1 more secondary outcomes

Study Arms (2)

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

Other: trained volunteer mealtime assistance

Interventions

trained volunteer mealtime assistanceOTHER

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

mealtime assistance

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients will be recruited in a consecutive prospective manner.
  • emergency admissions to acute medical wards and
  • ability to gain consent from patient or relatives

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 28244573DERIVED

  • 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.

    PMID: 23294981DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Helen C Roberts, MB ChB

    University of Southampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 23, 2012

Study Start

November 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 4, 2014

Record last verified: 2014-11

Locations

GB(1)