Evaluation of a Behavioural Intervention Using App Technology in CF (EAT-CF)

Evaluation of a Behavioural Intervention Using App Technology in Cystic Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: Behaviour change intervention

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
      • Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behaviour change intervention; Intensive behaviour change for 6 weeks, followed by a maintenance phase for 6 weeks	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who accepted invitation to participate as a marker of feasibility	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' opinion about the behavioural intervention	A semi-structured interview will be used for thematic analysis	3 months
Participant attrition rate and phases of the study whereby the attrition occurs		3 months
Participants' opinion about the study processes	A semi-structured interview will be used for thematic analysis	3 months
Participants' suggestions for further improvement of the intervention and study processes	A semi-structured interview will be used for thematic analysis	3 months
Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities		4 weeks
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
Proportion of days with missing nutritional data, as a marker of feasibility		3 months

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Nutrition; BMI; Weight; Behaviour change
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: STH20240

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No