Widman 2013.
| Methods | Randomised open‐label cross‐over study ‐ a pilot study of behavioural intervention for nutrition in CF. |
| Participants | Anticipate 30 into 2 groups. |
| Interventions | This is a feasibility study to try out a multi‐component behavioural intervention. The intervention is designed to help people with CF use their nutritional support to gain weight. The first group receive the behavioural intervention immediately. The second group receive the intervention after 3 months. All participants will be followed up for 6 months. Data will be collected every 6 weeks during clinic reviews. Experimental: Behaviour change intervention. Intensive behaviour change intervention for 3 months, followed by a maintenance phase for 3 months. Wait‐list ControlUsual care for 3 months, followed by intensive behaviour change intervention for 3 months. Note: Behavioral: Behaviour change intervention: the behaviour change intervention consists of feedback via a web‐based food diary 'coaching' with problem‐solving and implementation plansThe intensive intervention phase consists of 2 home visits, 8 telephone calls and 6 reminder emails.The maintenance phase consists of 3 telephone calls and 4 reminder emails. |
| Outcomes |
Primary outcome measures
1. Proportion of patients who accepted invitation to participate as a marker of feasibility
2. Proportion of people with CF who are randomised into the study after accepting the invitation to participate, as a marker of feasibility Secondary outcome measures 1. Participants' opinion about the behavioural intervention 2. Participant attrition rate and phases of study whereby the attrition occurs 3. Participants' opinion about the study processes 4. Participants' suggestions for further improvement of the intervention and study processes 5. Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities 6. Resources needed by the investigators to deliver the intervention 7. Proportion of days with missing nutritional data, as a marker for feasibility Participants are requested to fill in their nutritional intake daily on a web‐based food diary. The investigators are interested to find out what the proportion of such data will be missing to determine the feasibility of collecting data with the web‐based food diary. Other outcome measures 1. BMI 2. Weight 3. BMQ score 4. The mean SRBAI score |
| Notes | Start date: Feb 2014. Anticipated end date: March 2015. Country: UK. |