Change in food and drink provision in homes for the elderly: effects on health and wellbeing

ISRCTN	ISRCTN86057119
DOI	https://doi.org/10.1186/ISRCTN86057119
Protocol serial number	N/A
Sponsor	University of East Anglia (UK)
Funder	Norfolk County Council (UK)

Submission date: 03/07/2008
Registration date: 18/07/2008
Last edited: 14/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lee Hooper
Scientific

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

Phone	+44 (0)1603 591268
Email	l.hooper@uea.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised, cluster controlled, non-blinded trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	20/12/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	120
Key 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.
Key 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)
Date of first enrolment	25/06/2006
Date of final enrolment	20/12/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

School of Medicine, Health Policy and Practice

Norwich
NR4 7TJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	27/05/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes