Evaluation of a Behavioural Intervention Using App Technology in CF (EAT-CF)
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Behaviour change intervention
Sponsored by
About this trial
This is an interventional health services research trial for Cystic Fibrosis focused on measuring Nutrition, Weight, BMI, Behaviour change
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
Sites / Locations
- Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Behaviour change intervention
Arm Description
Intensive behaviour change for 6 weeks, followed by a maintenance phase for 6 weeks
Outcomes
Primary Outcome Measures
Proportion of patients who accepted invitation to participate as a marker of feasibility
Secondary Outcome Measures
Participants' opinion about the behavioural intervention
A semi-structured interview will be used for thematic analysis
Participant attrition rate and phases of the study whereby the attrition occurs
Participants' opinion about the study processes
A semi-structured interview will be used for thematic analysis
Participants' suggestions for further improvement of the intervention and study processes
A semi-structured interview will be used for thematic analysis
Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
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
Proportion of days with missing nutritional data, as a marker of feasibility
Full Information
NCT ID
NCT03782909
First Posted
December 17, 2018
Last Updated
February 11, 2021
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03782909
Brief Title
Evaluation of a Behavioural Intervention Using App Technology in CF
Acronym
EAT-CF
Official Title
Evaluation of a Behavioural Intervention Using App Technology in Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Nutrition, Weight, BMI, Behaviour change
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behaviour change intervention
Arm Type
Experimental
Arm Description
Intensive behaviour change for 6 weeks, followed by a maintenance phase for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Behaviour change intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of patients who accepted invitation to participate as a marker of feasibility
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Participants' opinion about the behavioural intervention
Description
A semi-structured interview will be used for thematic analysis
Time Frame
3 months
Title
Participant attrition rate and phases of the study whereby the attrition occurs
Time Frame
3 months
Title
Participants' opinion about the study processes
Description
A semi-structured interview will be used for thematic analysis
Time Frame
3 months
Title
Participants' suggestions for further improvement of the intervention and study processes
Description
A semi-structured interview will be used for thematic analysis
Time Frame
3 months
Title
Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
Time Frame
4 weeks
Title
Resources (time) needed by the investigators to deliver the intervention
Description
Time will be used as a measurement tool to quantify total time required to deliver the intervention
Time Frame
3 months
Title
Proportion of days with missing nutritional data, as a marker of feasibility
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Behavioural Intervention Using App Technology in CF
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