The More Life with CF co-design study
| ISRCTN | ISRCTN18226594 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18226594 |
| Integrated Research Application System (IRAS) | 355378 |
| National Institute for Health and Care Research (NIHR) | 301286 |
| Protocol serial number | RG_25-019 |
| Sponsor | University of Birmingham |
| Funder | National Institute for Health and Care Research |
- Submission date
- 23/11/2025
- Registration date
- 09/02/2026
- Last edited
- 09/02/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Cystic fibrosis (CF) is a condition that some people are born with. It causes lung issues, digestive problems and a shorter life expectancy. Because it was hard to gain weight, people living with CF were advised to eat a high-calorie diet. This diet helped people living with CF to become well-nourished and live longer. More recently, some people have now become overweight or obese. This is because new treatments called highly effective modulator therapies (HEMT), e.g.Kaftrio®, Kalydeco®, Symkevi®, which are helping to treat CF, have reduced the need for a high-calorie diet. As a result, people living with CF who are overweight or obese need to have a diet that is lower in calories and be more active. This will help them to manage their weight and prevent the development of other health problems such as heart disease, diabetes and cancer.
This study aims to co-design, with people living with CF and CF health care professionals, a CF-specific weight management programme (CF WMP) to support people living with CF and overweight or obesity to eat a healthy diet and become active. The programme will be designed to support people living with CF to adjust to their new diet and activity needs that have resulted from improved health with HEMT. It will be co-designed to be delivered alongside an existing NHS digital weight management programme.
Who can participate?
People living with CF and overweight or obesity, CF Health Care Professionals and weight management professional stakeholders.
What does the study involve?
The Person-Based Approach (PBA) will be used to develop the programme. This approach focuses on developing programmes that are easy to use, helpful and interesting to the people they are designed for, by working with them throughout the design process.
Planning the Programme- a group of 20-30 people living with CF and overweight/obesity on HEMT will be asked to record what they eat, and their activity will be measured using an activity monitor. They will then be interviewed about what influences how they eat and how active they are. CF health care professionals will also be interviewed about their experience of advising people living with CF to eat fewer calories and become more active. The results from these studies will be used to choose what additional content the CF-specific weight management programme needs to provide that is not provided by the NHS digital weight management programme and meet the specific needs of people living with CF and overweight/obesity.
Co-designing the Programme- a group of people living with CF, CF health care professionals and weight loss experts will work together to design the CF-specific weight management programme. The results of the planning stage and known methods that can help people change their diet and physical activity habits will be shared with the group. The group will decide on what should be included to make the programme easy to use, helpful to people living with CF and overweight/obesity.
Refining the Programme- people living with CF will be asked to provide feedback on the programme. The co-design group will use this feedback to make changes to the programme before it is tested in a future study.
What are the possible benefits and risks of participating?
The possible benefits of taking part in this study are contributing to research that will help design a diet and physical activity programme tailored for people with CF to support weight management.
There are no anticipated risks beyond the potential discomfort of being video recorded during interviews and discussions, which may cause discomfort or possible emotional distress when reflecting on diet, activity, or health behaviours. If this occurs, access to psychological support will be provided.
Where is the study run from?
The study will be conducted at the University of Birmingham and the University Hospitals Birmingham NHS Foundation Trust.
When is the study starting and how long is it expected to run for?
December 2025 to July 2027
Who is funding the study?
The National Institute for Health and Care Research (NIHR) under its HEE/NIHR Doctoral Fellowship scheme, UK.
Who is the main contact?
Joanne Barrett, Specialist Cystic Fibrosis Dietitian and NIHR Doctoral Fellow, joanne.barrett2@nhs.net
Contact information
Public, Principal investigator, Scientific
West Midlands Adult Cystic Fibrosis Centre, University Hospitals Birmingham NHS Foundation Trust, Bordesley Green East
Birmingham
B9 5SS
United Kingdom
 ORCID ID |
0000-0002-5601-4028 |
|---|---|
| Phone | +44 (0)121 424 1788 |
| joanne.barrett2@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Qualitative co-design study |
| Scientific title | The co-design of a cystic fibrosis weight management programme to be delivered alongside an existing NHS digital weight management programme (MoreLife®) |
| Study acronym | ML-CF |
| Study objectives | This study aims to co-design a CF-specific weight management programme (CF WMP) to be delivered alongside an existing NHS digital weight management programme (MoreLife®). |
| Ethics approval(s) |
1. Approved 12/09/2025, Yorkshire and Humber - Bradford and Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 1048083; bradfordleeds.rec@hrs.nhs.uk), ref: 25/YH/0189 2. Approved 25/07/2024, Northern Ireland Research Ethics Committee (Business Services Organisation Unit 4, Lissue Industrial Estate, West Rathdown Walk, Moira Road, Lisburn, BT28 2RF, United Kingdom; +44 (0)28 9536 1400; info.orecni@hscni.net), ref: 24/NI/0098 |
| Health condition(s) or problem(s) studied | Adults with cystic fibrosis who are living with overweight or obesity |
| Intervention | This study aims to co-design, with people living with CF and CF health care professionals - a CF-specific weight management programme (CF WMP) to support people living with CF and overweight or obesity to eat a healthy diet and become more physically active. The programme will be designed to support people living with CF adjust to their new diet and activity needs that have resulted from improved health with Highly Effective Modulator Therapies (HEMT). It will be co-designed to be delivered alongside an existing NHS digital weight management programme. Co-development process: The Person-Based Approach (PBA) will be used to develop the programme. This approach focuses on developing programmes that are easy to use, helpful and interesting to the people they are designed for, by working with them throughout the design process. Planning the programme: A group of 20-30 people living with CF and overweight/obesity on HEMT will be asked to record what they eat, and their activity will be measured using an activity monitor. They will then be interviewed about what influences how they eat and how active they are. CF health care professionals will also be interviewed about their experience of advising people living with CF to eat fewer calories and become more active. The results from these studies will be used to choose what additional content the CF-specific weight management programme needs to provide that is not provided by the NHS digital weight management programme and meet the specific needs of people living with CF and overweight/obesity. Co-designing the programme: A group of people living with CF, CF health care professionals and weight loss experts will work together to design the CF-specific weight management programme. The results of the planning stage and known methods that can help people to change their diet and physical activity habits will be shared with the group. The group will decide on what should be included to make the programme easy to use, helpful to people with living with CF and overweight/obesity. Refining the programme: People living with CF will be asked to provide feedback on the programme. The co-design group will use this feedback to make changes to the programme before it is tested. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
CF-specific weight management programme is co-designed, ready to test in a subsequent feasibility study, measured by the production of a CF weight management prototype at the end of the optimisation stage (stage 3) |
| Key secondary outcome measure(s) |
1. Key context-specific barriers and facilitators to eating a healthy diet and being physically active experienced by people living with CF and overweight or obesity as qualitative themes and subthemes mapped to COM-B domains during the planning stage (stage 1) |
| Completion date | 01/07/2027 |
Eligibility
| Participant type(s) | Health professional, Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | All |
| Target sample size at registration | 32 |
| Key inclusion criteria | 1. A person with lived experience of CF and overweight or obesity (eligible for participation in co-design workshops and think aloud interviews) 2. A registered Clinical Nurse Specialist, Physiotherapist, Dietitian, Psychologist, or Physician working at a UK adult CF centre or registered Clinical Nurse Specialist, Physiotherapist, Dietitian, Psychologist, or Physician working in adult weight management services(eligible for participation in co-design workshops only) 3. Able to access Zoom© or MS Teams© video conferencing platform (if a co-design group participant) 4. Able to be locate themselves in a private room to take part in the workshops ( if a co-design group participant) 5. Over 18 years of age 6. Able to provide informed consent |
| Key exclusion criteria | 1. Not a registered Clinical Nurse Specialist, Physiotherapist, Dietitian, Psychologist, or Physician working at a UK adult CF centre 2. Not a registered Clinical Nurse Specialist, Physiotherapist, Dietitian, Psychologist, or Physician working in adult weight management services 3. Not a person living with CF and overweight or obesity |
| Date of first enrolment | 15/01/2026 |
| Date of final enrolment | 01/07/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Bordesley Green
Birmingham
B9 5SS
England
Birmingham
B15 2TT
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The datasets generated and analysed during the study will be stored in a publicly available repository https://edata.bham.ac.uk/ |
Editorial Notes
24/11/2025: Study's existence confirmed by the HRA.
