Evaluation of a Behavioural Intervention Using App Technology in CF

Cystic Fibrosis Clinical Trial

— EAT-CF  

Official title:

Evaluation of a Behavioural Intervention Using App Technology in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782909
• Other study ID #: STH20240
• Status: Completed
• Phase: N/A
• Start date: May 8, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: February 2021
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• Behaviour change intervention
The behaviour change intervention consists of; Feedback via an app based food diary Coaching with problem solving and implementation plans The intensive phase consists of 2 home visits and 4 phone calls and the use of the app The maintenance phase consists of use of the app if the PWCF wishes to continue using it

Locations

Country	Name	City	State
United Kingdom	Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who accepted invitation to participate as a marker of feasibility		4 weeks
Secondary	Participants' opinion about the behavioural intervention	A semi-structured interview will be used for thematic analysis	3 months
Secondary	Participant attrition rate and phases of the study whereby the attrition occurs		3 months
Secondary	Participants' opinion about the study processes	A semi-structured interview will be used for thematic analysis	3 months
Secondary	Participants' suggestions for further improvement of the intervention and study processes	A semi-structured interview will be used for thematic analysis	3 months
Secondary	Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities		4 weeks
Secondary	Resources (time) needed by the investigators to deliver the intervention	Time will be used as a measurement tool to quantify total time required to deliver the intervention	3 months
Secondary	Proportion of days with missing nutritional data, as a marker of feasibility		3 months