Clinical trial NCT03782909: Evaluation of a Behavioural Intervention Using App Technology in CF
Official title: Evaluation of a Behavioural Intervention Using App Technology in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Nutrition
Weight
BMI
Behaviour change
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 5
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cystic Fibrosis (CF) is a lifelong condition which causes the lungs and digestive system to become clogged with thick, sticky mucus. This leads to recurrent chest infections and reduced nutrient absorption from food. The average age at death is 31 years, usually from respiratory failure. The nutritional status of people with CF (PWCF) is important to help them live healthier and longer.

It is recommended that adults with CF achieve a BMI of 23 for males and 22 for females. However, fewer than 50% of adults with CF achieved that target BMI despite effective nutritional support to help weight gain. There is a clear need for a behavioural intervention that can help PWCF use the available nutritional support.

This is a feasibility study to try out a multi-component behavioural intervention supported by a nutrition app. The intervention is designed to help PWCF use their nutritional support to gain weight. It will focus on testing the methods and procedures to be used on a larger scale, improving the behavioural intervention and estimating how many people are needed for the larger trial.

Eligible patients will be invited to participate, and the investigators anticipate recruiting 6 participants. The participants will have 6 weeks of intensive intervention, which will include a mix of clinic visits, home visits and telephone calls followed by 6 weeks of maintenance phase. Data will be collected during clinic visits at baseline, week 6 and week 12 along with weight monitoring at home.

The investigators will interview each participant at the end of the study period to improve the intervention and study processes based on participant feedback.

The investigators hypothesised that using a nutrition app, along with regular input from a dietitian, will help PWCF to use the available nutritional support.


Eligibility criteria: Inclusion Criteria:

* adult people with CF looked after at the Sheffield Adult CF Centre
* best BMI of \<23 for males and \<22 for females between June 2018 and November 2018

Exclusion Criteria:

* patients in palliative phase of disease
* patients who are pregnant
* patients who have no capacity to consent to participate in the study
* patients who are unable to communicate by telephone for coaching

Primary outcomes:
measure: Proportion of patients who accepted invitation to participate as a marker of feasibility
timeFrame: 4 weeks
Secondary outcomes:
measure: Participants' opinion about the behavioural intervention
timeFrame: 3 months
measure: Participant attrition rate and phases of the study whereby the attrition occurs
timeFrame: 3 months
measure: Participants' opinion about the study processes
timeFrame: 3 months
measure: Participants' suggestions for further improvement of the intervention and study processes
timeFrame: 3 months
measure: Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
timeFrame: 4 weeks
measure: Resources (time) needed by the investigators to deliver the intervention
timeFrame: 3 months
measure: Proportion of days with missing nutritional data, as a marker of feasibility
timeFrame: 3 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
References: