Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04255654 |
| Other study ID # |
CoventryU |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 28, 2019 |
| Est. completion date |
January 21, 2020 |
Study information
| Verified date |
April 2020 |
| Source |
Coventry University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
1 in 10 people in the UK cannot afford enough nutritious food to eat, to help them and their
family stay healthy.
We aim to find out what it would be like for both dietitians and their clients to be asked,
routinely in a dietetic appointment, about having enough food to eat. Your dietitian will ask
you 2 questions about your access to food and, if you want, they will discuss some options
which might be helpful for you if your access to food is limited. Some of the discussions
that take place (regarding the intervention only) will be audio recorded with your consent to
check they are being done correctly.
If options which might be helpful for you to get more access to food were required you will
then be asked to take part in a telephone interview, which will be audio recorded and will
involve discussing your experience of the intervention and what you did with the information
provided. After this telephone interview, this will be the end of the study for you.
Description:
Background:
Food insecurity is an international priority. This global issue is affecting developing and
developed countries (FAO, IFAD, UNICEF, WFP and WHO 2018). 1 in 10 people within the UK are
experiencing food insecurity (Taylor and Loopstra 2016). The prevalence of food insecurity is
projected to increase due to continual cuts in the welfare state and introduction of
universal credit. A study conducted by the United Nations looking at the food insecurity
landscape in the UK identified 8.4million individuals (13%) were food insecure in 2014
(Taylor and Loopstra 2016). In comparison to other European countries the UK has the 11th
highest prevalence of food insecurity (10.1%) out of 28 European countries. Put simply food
insecurity is not having physical access to enough nutritious food to eat well for good
health. When food becomes scarce, hygiene, safety and nutrition are often ignored as people
shift to less nutritious diets and consume more 'unsafe foods' (WHO 2018). The United States
Department of Agriculture (2018) use the definition of food insecurity provided by Anderson
(1990) 'the limited or uncertain availability of nutritionally adequate and safe foods or
limited or uncertain ability to acquire acceptable foods in socially acceptable ways'.
Food insecurity can lead to negative health and wellbeing outcomes (Gunderson and Ziliak
2015). For example, those children who are identified as food insecure are more likely to
have asthma, behavioural problems and worse oral health. Mothers who are food insecure are
twice as likely to report mental health problems. Diabetic adults who are food insecure are
more likely to have poorer health outcomes due to the impact food insecurity can have on
adherence to medical recommendations such as following a healthy diet for diabetes management
(Gunderson and Ziliak 2015). New ways of tackling the increased socio-economic and health
burden of food insecurity needs to be considered. Identifying and acting on food insecurity
is fundamental for health professionals working in clinical practice.
Dietitians are best placed to discuss food insecurity as their consultations are focused on
diet, food and nutrition, however food insecurity is not routinely discussed or screened for
in UK dietetic practice. Dietetic consultations in the UK are increasingly more holistic and
brief interventions to make every contact count regarding smoking cessation and physical
activity are being promoted. Making every contact count refers to the opportunity every
health care professional has to raise health promoting issues irrespective of the reason for
the consultation (Health Education England 2018). Commonly mood, physical activity, alcohol
intake and smoking status can be raised in a consultation as part of the making every contact
count initiative. The evidence around brief interventions being conducted by a variety of
healthcare professionals, for several health behaviours, is growing (Lewis et al. 2013).
These interventions use the 3 A's approach (ask, advise and act) and should only take a
moment of a consultation time.
In the US, Canada and Australia screening for food insecurity is already happening in some
areas of clinical practice. The American Academy of Paediatrics released a policy statement
in October 2015 that recommends all paediatricians screen all children for food insecurity.
The policy statement identifies the short and long term adverse health impacts of food
insecurity and recommends the referral to community resources (The American Academy of
Paediatrics 2015). There is also emerging evidence in adult care that screening for food
insecurity in diabetes and HIV care can have positive outcomes on treatment and now forms
part of usual practice (Thomas et al. 2017 and Young et al. 2008).
However, there is little investigation of screening for food insecurity in dietitian led
clinics, and no trial to test this practice has been conducted in the UK. The evidence so far
suggests that this is a feasible intervention to trial. We therefore propose to test the
feasibility of a brief intervention for food insecurity in dietetic practice, by screening
and referring on for food support using a food insecurity screening tool. The brief
intervention will be based on the making every contact count initiative adopting an ask
advise act concept. The brief intervention utilises 'social prescribing'.
Aims and objectives
Research aims
- To test the feasibility and acceptability of implementing a Brief Intervention for Food
Insecurity in Dietetic Practice
- To explore the experience of administering a Brief Intervention for Food Insecurity from
a Dietitian and Dietitian service user perspective considering opportunities and
barriers.
Research objectives
- To complete a brief intervention for food insecurity in a dietitian clinic
- To complete an audio recording of some of the brief interventions to check for fidelity
- To monitor response rates for completion of the brief intervention in dietetic practice
- To complete a semi-structured interview with the dietitian service user to explore their
experience (including barriers and opportunities) of the brief intervention for food
insecurity via telephone
- To complete a focus group with the dietitians to explore their experience (including
barriers and opportunities) of the brief intervention for food insecurity
Methodology
Study design
Feasibility study with mixed methods design
Intervention
The brief intervention will screen for food insecurity by a dietitian asking 2 questions to
the dietitian service user. A pre-developed 2 item validated screening tool that assesses for
food insecurity will be used. It uses the first two questions from the 18 item U.S. Household
Food Security Survey. The two-item screen was validated by Hager et al. (2010) who reported a
sensitivity of 97% and specificity 83% for identifying an affirmative response for either
question. The tool has been validated in U.S as a shorter more practical tool in clinical
practice. This is what The American Academy of Paediatrics (2015) endorse.
Once the dietitian has asked the two questions they will use the screening flow chart to
advise why food security is important for good health and the clinical outcomes of their
dietetic treatment, and then recommend what can be done to help act on food insecurity if
present. To do this the dietitian will use two resources as appropriate (BDA Food Fact Sheet,
Eat Well Spend Less and resource list for local food aid support). If trained, a referral
voucher to a local foodbank will also be completed if appropriate. The dietitian will record
the actions they take on the data collection tool.
There may be cases where a dietetic service user is recruited to participate in the study,
but the dietitian does not complete the intervention (the 2 screening questions). it is
important that the dietetic service user is advised how to access these food aid support
resources if the intervention is not completed as their expectations may be raised that they
are going to receive this information and they are not fulfilled. The dietetic service user
will be advised on the participant information sheet 'Should the dietitian at your
appointment not ask you the questions about food insecurity but you would like resources
about this, please ask the researcher in the waiting area or contact the lead researcher
(contact details on page 3) for this information'.
Training of the dietitian
The dietitian will receive specific training prior to commencing the study as per the
training protocol. The principal method of delivery will be a video tutorial, designed
specifically for the study, which will be available to dietitians before and during the
study. The video tutorial will be a filmed consultation which will assimilate the necessary
skills and confidence required of the dietitian to successfully implement the intervention.
The video tutorial will address the lack of knowledge and hence confidence to intervene on
food insecurity. There will also be a suggested script to follow. Also included in the
training protocol is useful information about food insecurity. If there is any uncertainty
about the brief intervention delivery, then the dietitian will be able to contact the lead
researcher for clarification.
We need to consider the different learning styles of the dietitians. Some may learn better
from reading the materials others may learn from discussing the materials with the lead
researcher and others may learn better from observing the materials be delivered. Research
suggests delivery of information from a blended learning approach is the best. The blended
learning approach is hoped to overcome any concerns or queries the dietitian may have prior
to delivering the intervention.
Fidelity checking
To examine the fidelity of the intervention, the brief intervention component of a proportion
of consultations by each dietitian will be audio-recorded to ensure that the dietitian is
correctly implementing the screening tool as per the training protocol (1 in 10 brief
interventions will be audio recorded by each dietitian). Audio recording is less intrusive
and more cost effective than implementing video recording or observations. The aim is to
produce the least invasive way of checking fidelity. We also do not want to make the
participant to feel uncomfortable.
Population
Dietitian service users attending NHS dietitian led clinics in the Coventry locality.
Where possible we want to target the dietitian clinics that are ran in the most deprived
areas of Coventry for example Foleshill and Hillfields. Coventry is the chosen setting for
the intervention as this is where the first study for this PhD has taken place and Coventry
has a good food aid support network for those in need. Coventry Foodbank is one of the
largest foodbanks in England and is further developed than many UK foodbanks in relation to
the additional services they provide. It has been identified as a pioneering foodbank centre
that aims to educate, empower and advance the social circumstances of clients attending. This
has arisen due to the high prevalence of poverty and food poverty in Coventry and the growing
need for this community support service. Coventry is a marmot city.
Sampling strategy
Dietetic service user: purposive sampling, all dietitian service users attending dietitian
clinic where the dietitian is trained to deliver the brief intervention will be invited to
participate in the research
Dietitian: purposive sampling, dietitians who undertake dietitian clinics will be invited to
participate in the research
Sample size
A sample size has not been predicted as it is a feasibility study. The study needs enough
time to test the process and ensure that food insecure individuals are attending clinic where
the research is being tested.
It is anticipated to recruit 5 dietitians and attend 10 of their clinics. Each clinic on
average has 5 people in it and a 20% DNA rate. This exposes potentially 200 potential
recruits to the study.
Consent and recruitment of participants
Dietitian service user
All dietitian services users attending dietitian clinics where the brief intervention is
being tested will be invited to participate in the research. Recruitment of the dietitian
service user will take place in the dietitian waiting area whilst they are waiting for their
appointment. The potential participants will first be approached by the researcher in which a
verbal explanation and a copy of the participant information sheet will be given. The
dietetic service user will be provided with adequate time to consider their participation in
the study. They will have time to read the participant information sheet and will have the
opportunity to ask any questions they may have, in order to decide whether they wish to
participate in the study or not. If the dietitian service user is willing to participate in
the study, they will keep the participant information sheet and sign the consent form.
Dietitian
Recruitment of the dietitian will take place at the dietitian main department. A member of
the research team will be invited to attend a department meeting to recruit. The potential
participants will be introduced to the research using the participation information sheet and
a verbal explanation given by the researcher. The dietitian will be provided with adequate
time (with up to 24 hours) to consider their participation in the study. They will have time
to read the participant information sheet and will be given an opportunity to ask any
questions they may have in order to decide whether they wish to participate in the study or
not. If the dietitian is willing to participate in the study, they will keep the participant
information sheet and sign the consent form. They will also be provided with information on
how to access the necessary training to complete the brief intervention for food insecurity.
Withdrawal
The participant can withdraw at any time from the study without giving a reason(s) and
without their medical care or rights being affected. Data collected up to the point of
withdrawal can only be used after withdrawal if the participant has consented to this.
As the dietetic service user will be asked two questions which may be considered sensitive,
if the patient becomes distressed during the study they will be able to withdraw at any time,
without giving a reason(s).
Duration
It is anticipated that the study period to gather all the necessary data will be 6 months.
Study commencement July 2019. Recruitment of the dietitian to take place in July 2019. Data
collection in Coventry clinics July 2019 - February 2020.
Analysis
Quantitative data analysis
Quantitative results will be reported using descriptive statistics, they will present the
percentage of individual's eligible to take part, percentage consenting, percentage screened
by the dietitian, percentage food insecure and percentage acting on advice. This data will be
analysed using the statistical software package, IBM SPSS Statistics for Windows, Version
25.0 (2017).
Qualitative data analysis
A semi structured interview will be completed with the dietitian service user via telephone
and a face to face focus group will be completed with the dietitians to assess the
feasibility and acceptability of the implementation of the brief intervention in clinical
practice, exploring the opportunities and barriers.
The semi structured interviews and focus group will be transcribed and then analysed using
framework analysis. The data will be organised, analysed and coded using the qualitative
software package, NVIVO 12.1 (QSR International Pty Ltd. 2018). The framework for analysis is
a pre-constructed and validated coding frame called the Theoretical Domains Framework (TDF)
(Atkins et al. 2017). Alongside the coding frame emergent coding will also be completed to
'mop up' any aspects of the semi-structured interviews or focus group that may not have been
captured by the coding framework. A sample of the coding completed by the lead researcher
will be peer reviewed by a member of the research team. Member checking will be undertaken
verbally by the researcher reflecting back at the time of the focus group or semi structured
interview, to check what the researcher has understood is what the participant meant.
The Theoretical Domains Framework was developed by a collaboration of behavioural scientists
and implementation researchers to provide a comprehensive theory informed approach to
identify determinants of behaviour. It was first developed in 2005 and then validated in
2012. It allows people to assess implementation problems and support intervention design when
implementing new practices that require changes in behaviour of relevant actors. The
framework provides a theoretical basis for implementation studies (Atkins et al. 2017).
Behavioural theories are relevant to investigating implementation problems and informing
implementation interventions because they provide psychological processes hypothesised to
regulate behaviour and behaviour change. The Theoretical Domains Framework synthesises 33
theories of behaviour and behaviour change into 14 domains (originally 12). It provides an
overview of the potential influences on behaviour - cognitive, affective, social and
environmental. The framework is relevant to changing behaviours in both health professionals
and patient behaviours (Atkins et al. 2017).
Reflexivity will be considered by the lead researcher writing a reflexivity chapter. The lead
researcher will also keep a reflexive researcher diary throughout the process.
Publication and dissemination
The results of this study may be summarised in published articles, reports and presentations.
Funding
There is no funding for this study. The study is being completed for a PhD programme.
Sponsorship
Coventry University is the sponsor for the study.
Data protection and confidentiality
The study will comply with the current data protection regulations and regular checks and
monitoring will be undertaken.
Storage of data on manual files will occur, they will be appropriately filed and stored
securely. This is mainly referring to the essential documentation for the study.
Confidentiality will be maintained by using a password protected university computer,
anonymising all participants at the time of consent and storing manual files in a locked
cupboard on an entry card protected site, to which only members of the research team will
have access to. It is not anticipated that a portable laptop device will be required for this
study. Contact details will be collected from the participants at the time of informed
consent. The details will be anonymised and only available to the member of the research team
who requires access.
Audio recording devices will be required for the study (1 in 10 brief interventions will be
audio recorded for fidelity checking, dietetic service user semi structured interviews via
telephone will be audio recorded and the dietitian focus group will be audio recorded). A
hand-held audio recording device will be used. At the end of each day the file will be
transferred to a password protected computer and the file on the audio recorder will be
deleted. This data will be filed and stored securely.
Anonymity will be maintained when publishing the results. No information discussed is going
to lead to individuals being identifiable. Member checking of data will be used.
Ethical approval and research governance
The study will be conducted in compliance with the principles of the ICH GCP (International
Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for
Human Use, Good Clinical Practice) guidelines and in accordance with all applicable
regulatory guidance, including, but not limited to, the UK Policy Framework for Health and
Social Care Research. Ethical approval for this study will be sought from Coventry University
Ethics Committee, the Research Ethics Committee (REC) combined with The Health Research
Authority (HRA) approval. No study activities will commence until favourable ethical opinion
and HRA approval has been obtained. Progress reports and a final report at the conclusion of
the study will be submitted to the approving REC within the timelines defined by the
committee.
Conclusion
The aim of this study is to test the feasibility of a brief opportunistic intervention for
food insecurity in dietetic practice in the UK. To the research team's knowledge, no studies
have investigated this feasibility.
If successful, trial results could make the case for brief interventions of food insecurity
to be implemented as a simple treatment method in dietetic practice akin to the NHS stop
smoking service as part of the MECC initiative.
