Evaluation of a Behavioural Intervention Using App Technology in CF

NCT03782909 | Completed

• 1 other identifier: STH20240
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

Nutrition; Weight; BMI; Behaviour change

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who accepted invitation to participate as a marker of feasibility

  4 weeks

Secondary Outcomes (7)

• Participants' opinion about the behavioural intervention

  3 months

• Participant attrition rate and phases of the study whereby the attrition occurs

  3 months

• Participants' opinion about the study processes

  3 months

• Participants' suggestions for further improvement of the intervention and study processes

  3 months

• Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities

  4 weeks

Study Arms (1)

Behaviour change intervention

EXPERIMENTAL

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

Behavioral: Behaviour change intervention

Interventions

Behaviour change intervention 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

Behaviour change intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis; Body Weight

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 20, 2018
• Study Start: May 8, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

GB (1)