Condition category
Not Applicable
Date applied
03/07/2008
Date assigned
18/07/2008
Last edited
14/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lee Hooper

ORCID ID

Contact details

School of Medicine
Health Policy and Practice
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603 591268
l.hooper@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of changes in food and drink provision on the health, wellbeing and nutritional status of elderly care home residents: a cluster-controlled trial

Acronym

Study hypothesis

This study assessed the effects of a change in provision of food and drink, that aimed to improve health and wellbeing of a frail elderly population, at three care homes compared with three control homes. Effects on residents' falls (primary outcome), anaemia, weight, dehydration, cognitive status, depression, serum lipids and satisfaction with food and drink provision were analysed.

Ethics approval

Ethics approval was received from the University of East Anglia, Institute of Health Ethics Committee on the 1st June 2006. A minor extension to this approval was granted on 13th February 2008.

Study design

Randomised, cluster controlled, non-blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Health and wellbeing

Intervention

The aim was to recruit 120 participants to this trial; given that three homes were changing their food and drink provision we aimed to recruit as many residents within those homes, and the three control homes as we could.

The changes in food and drink provision, implemented between July and December 2006 in the three intervention homes were intended to improve comfort during meals (making eating more like going to a restaurant than eating in a canteen), increase the level of choice available at meal times, making eating with others a pleasurable and more sociable experience and encourage fading appetites. They were also intended to widen the availability of drinks and snacks (to visitors as well as residents), encourage greater independence on the part of residents in choosing and obtaining their own snacks, and generally reduce the feeling of institutionalisation. Changes included spreading of meal times over 90 minutes (so residents can choose meal times and take as much time as they need) rather than all residents eating at a set time, decoration of the dining room, choice of hot or cold foods at all meals, menus on the tables, display of foods in the bain marie, fewer residents eating at any one time (making the atmosphere calmer and quieter), use of drinks machines providing cappuccino and other drinks for residents and visitors, and a wider selection of snacks available from the dining room and cooler 24 hours per day.

The control homes continued with their former provision until the end of the trial period (when they also switched to the new system).

Duration of follow up was 12 months after the change over for all participants.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcomes were falls - both numbers of residents falling, and number of falls per resident.

All outcomes were assessed at baseline (just before the change of food and drink provision in intervention homes) and at one year following that change over.

Secondary outcome measures

1. Satisfaction with meals (questionnaire, with five options)
2. Body weight (body mass index [BMI] was calculated and both weight and BMI were followed)
3. Dehydration (single observation of the tongue by a trained nurse)
4. Cognitive functioning (Mini-Mental State Exam [MMSE], score out of 30, lower score indicating more cognitive impairment)
5. Depression (Hospital Anxiety and Depression Score [HADS], score 0 - 21 for depression, score of 8 or more signified risk of depression)
6. Haemoglobin (g/dl, with less than 12.0 g/dl signifying anaemia)
7. Cholesterol levels (serum total cholesterol in mmol/L, with those with high or low values seen to be 'at risk')

All of the outcomes except body weight were assessed at baseline (just before the change of food and drink provision in intervention homes) and at one year following that change over. Body weight was taken from routinely collected data within the homes, and was collected over the year before and the year after the change.

Overall trial start date

25/06/2006

Overall trial end date

20/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Any residents (either sex) of the six care homes were eligible to participate if they gave informed consent. Residents could choose to consent to any or all of the following parts of the study:
1. Allowing researchers access to their routinely collected data (from a variety of sources, collectively referred to as 'care notes')
2. Participating in an interview
3. Providing a fasting blood sample

Home managers were approached to check whether any residents would be unable to provide informed consent due to impaired cognition - for such residents relatives were asked for informed consent (blood tests were not requested of such residents or their relatives). Where a relative provided informed consent an interview was only undertaken where the resident appeared quite happy and relaxed during the process - where this was not the case the interview was immediately terminated.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Residents did not want to participate
2. Visiting the home for a short stay only
3. Where appropriate written informed consent was not obtained (as above)

Recruitment start date

25/06/2006

Recruitment end date

20/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Medicine, Health Policy and Practice
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Organisation

University of East Anglia (UK)

Sponsor details

Bluebell Lane
Norwich
NR7 4TJ
United Kingdom

Sponsor type

University/education

Website

http://www1.uea.ac.uk/cm/Home

Funders

Funder type

Government

Funder name

Norfolk County Council (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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20507560
2. 2012 results in http://www.emeraldinsight.com/journals.htm?articleid=17037232

Publication citations

  1. Results

    Kenkmann A, Price GM, Bolton J, Hooper L, Health, wellbeing and nutritional status of older people living in UK care homes: an exploratory evaluation of changes in food and drink provision., BMC Geriatr, 2010, 10, 28, doi: 10.1186/1471-2318-10-28.

Additional files

Editorial Notes