Obesity and other hyperalimentation, Metabolic disorders Nutritional, Metabolic, Endocrine
Conditions
Interventions
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
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate per month, assessed using the number of sites open, the total number participants recruited, and the number of participants recruited per site measured using data documented in the study notes at one time point 2. Engagement rate, assessed using the mean proportion of participants who attended 6 or more sessions during the 24 weeks (25% of sessions) and at least one of the last 3 sessions measured using data documented in the study notes at one time point at the end of the study 3. Adherence rate, assessed using the proportion of intervention participants with =5% weight loss at 12 weeks measured using data documented in the study notes at one time point 4. Retention rate, assessed using the proportion of randomised participants completing a 24 week follow up visit measured using data documented in the study notes at one time point 5. Safety profile assessed using related adverse events and expected related and unexpected related serious adverse events measured using data documented in the study notes at one time point | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight and body composition (weight, fat free mass, and fat mass) measured using scales at home at baseline, 4 , 12 and 24 weeks;Health-related quality of life (HRQoL) measured using the EuroQol health questionnaire (EQ-5D-5L) and AWESCORE (CF-specific quality of life score) at baseline and 24 weeks;Lung function (forced expiratory volume predicted (FEV1%) and forced vital capacity predicted (FVC %)) measured using home spirometry at baseline, 4 , 12 and 24 weeks;Fitness measured using the Sit to Stand Test by observed home measurement at baseline, 4 , 12 and 24 weeks;Respiratory exacerbation rate measured using data collected on respiratory exacerbations recorded as adverse events at study duration;Blood pressure measured using home blood pressure reading at baseline and 24 weeks;Glycaemic control – HbA1c measured using home blood test kit at baseline and 24 weeks;Blood lipid profile (Total cholesterol, HDL, LDL, and triglyceride levels) measured using home blood test kit at baseline and 24 weeks using home assessment;Adverse events measured using data collected on respiratory exacerbations recorded as adverse events at study duration | — |
Countries
England, United Kingdom
Contacts
Public ContactJoanna Snowball
Outcome results
None listed