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

NHS Foundation Trust

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Behavioral: Behaviour change intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03782909

STH20240

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Behaviour change intervention

Experimental group

Description:

Intensive behaviour change for 6 weeks, followed by a maintenance phase for 6 weeks

Treatment:

Behavioral: Behaviour change intervention