What next?
What next?
About this study
Malnutrition is when the someone doesn't get enough nutrients from food to meet the demands of the body. This can be due to a variety of reasons such as an increase in the energy requirements due to the lungs working harder. Or it could be due to the antifibrotic medication that can cause significant side effects, including poor appetite, diarrhoea, nausea, vomiting and weight loss.
The consequences of malnutrition can significantly impact quality of life, increase risk of infection and hospital admission, and is thought to potentially link with survival length. Very little research has been carried out to investigate how to best support people who are facing these challenges.
The DT-ILD study aims to find out if patients are willing to see a dietitian and if this can have a positive impact on their food intake.
There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.
A study involving people can be:
- Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
- Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).
There are 3 main phases of clinical trials:
- Phase 1 is the earliest stage of research, where there is often a focus on understanding if the treatment is safe or if it causes any side effects.
- Phase 2 still focuses on safety and side effects, but also tries to find out more about what is the best dose.
- Phase 3 often compares the new treatment to existing treatments or lookalike medications.
As drugs or interventions move into the different phases, the number of people taking part will increase. Not all studies will make it to the later phases, especially if the intervention is not found to be safe or effective in phase 1 and 2.
The recruitment aim is the number of people that researcher want to take part in the research study.
What is involved?
You will be assigned to one of two groups. One group will receive information about diet and poor appetite through a booklet. This will include general strategies to help improve your food intake and focuses on energy and protein intake. The other group will receive 5 sessions with a registered dietitian, and will include personalised nutritional advice to optimise intake. This will include focus on energy and protein intake, in addition to support to help you cope with the impact of symptoms that can affect food intake.
Both groups will have their nutritional status assessed at different timepoints throughout the study. This can include height, weight, handgrip strength. You will also be asked to write down your food and drink intake for three days, both at the start of the study and then again after 3 months. Your quality of life will also be assessed using a questionnaire.
Summary of involvement
Study duration of 3 months
Assigned to one of 2 groups:
Group 1 will be provided with a dietary advice booklet
Group 2 will have 5 personalised sessions with a dietitian
Nutritional assessment - such as height, weight, diet diaries
Questionnaires
Study can be run fully virtually or via the telephone
Can I take part?
You may be able to take part if you are diagnosed with a fibrotic interstitial lung disease and are malnourished.
In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see list below). Only the research team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point.
If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.
To find our more about other research opportunities visit our research finder main page.
BMI of 20 and below (if under the age of 75)
OR
BMI of 21 and below (if over the age of 75)
OR
In the last 12 months you have experienced significant unintentional weight loss, regardless of BMI
Other health conditions that require a specialised diet, such as enteral feeding
You have less than 6 weeks expected to live
Introduction of antifibrotic treatment (nintedanib or pirfenidone), immunosuppressive treatments or corticosteroids during the study
What difference could taking part make?
Research studies, such as this, have the potential to help develop new supportive options that could help improve the quality of people’s lives for those with PF, both now and in the future.
Taking part in this study may help researchers to understand if dietetic support can help people with fibrotic ILD who are facing challenges with their nutritional status and dietary intake.
Where does the study take place?
Study locations
Royal Brompton
Harefield Hospital
How to take part
If you are interested in taking part, please ask your healthcare team about the study or contact Rasleen Kahai by emailing ILD-Dietetics@rbht.nhs.uk or phoning on 020 7352 8121 ext 84454
Further information
This page is a summary which provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.
If you have any questions about this research study, please speak to your medical team.
r.kahai@rbht.nhs.ukThis study is supported by
APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.
Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email research@actionpf.org