Weight loss intervention with specialist dietitian behavioural support for people with cystic fibrosis who have excess weight: the EASE-CF randomised controlled feasibility trial.
Obesity and other hyperalimentation, Metabolic disorders
This is a randomised controlled trial to assess the feasibility of progression to a definitive trial that would assess whether the weight loss intervention programme can help people living with cystic fibrosis reduce their excess weight. The study aims to recruit 30 participants from Cystic Fibrosis centres in NHS Hospitals across England. Participants are expected to be involved in the study for a period of 24 weeks. Study assessments will be conducted at baseline, 4 weeks, 12 weeks and 24 weeks. All study assessments will conducted remotely with the equipment required to perform the measurements provided free of charge and delivered to their home. At baseline and 24 weeks they will be asked to fill in questionnaires remotely (online)and take part in video and audio-recorded video interviews about their experience in the trial and taking part in the intervention. They will be asked to provide consent to be reapproached 6 months after the end of the trial to participate in a follow up interview. Eligible participants will be randomised into the intervention group (20 participants) or usual care (10 participants) stratified by presence of CF-related diabetes (yes/no) and age over or under or equal to 40 years. Randomisation can be performed following the baseline assessment once all baseline data including blood sample results have been received. The unique randomisation codes will be generated using a central computer software (Sealed Envelope) which can be accessed by a member of the study team at sites via a secure login. Once the screening assessment has been completed, if the participant meets the eligibility criteria and is keen to proceed with the study, the participant should be randomised. Queries on eligibility must be resolved before randomisation and participants who do not meet all the eligibility criteria must not be randomised. A member of the local study team will enter the participant details to the randomisation system (initials, participant ID a
1. Participant is willing and able to give informed consent for participation in the study 2. Established diagnosis of cystic fibrosis, including those who have previously received a lung or liver transplant 3. Forced expiratory volume (FEV1) > = 25% predicted 4. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial 5. Able to communicate in English or has a relative/friend/carer acting as interpreter 6. Aged 18 years or above 7. BMI >= 27 kg/m2 (or BMI >= 25 kg/m2 for people of Black, Asian, or minority ethnic origin)
1. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial 2. >= 10% self-reported weight loss in the 6 months before the screening visit 3. Documented decompensated liver disease 4. Documented stage 4-5 kidney disease 5. Actively using enteral feeding 6. Currently taking part in other interventional clinical trials, unless agreed in advance by all trial teams (participation in observational studies is allowed) 7. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial