Evaluation of a Behavioural Intervention Using App Technology in CF

NCT ID: NCT03782909

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-08
• Study Completion Date: 2020-03-01

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Behaviour change intervention

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

Group Type: EXPERIMENTAL

Behaviour change intervention

Intervention Type: BEHAVIORAL

The behaviour change intervention consists of;

1. Feedback via an app based food diary

2. 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

Interventions

Behaviour change intervention

The behaviour change intervention consists of;

1. Feedback via an app based food diary

2. 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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

STH20240

Identifier Type: -

Identifier Source: org_study_id