Cystic FibrosisEAT-CFNCT03782909
Evaluation of a Behavioural Intervention Using App Technology in CF
A study testing Behaviour change intervention in people with Cystic Fibrosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Behaviour change intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: 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.
Read more
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
- Being tested
- Behaviour change intervention
- Keywords
- Nutrition, Weight, BMI, Behaviour change
- Medical subject headings
- Cystic Fibrosis, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behaviour change interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Behaviour change intervention | Experimental | Intensive behaviour change for 6 weeks, followed by a maintenance phase for 6 weeks Receives: Behavioral: Behaviour change intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who accepted invitation to participate as a marker of feasibility
Measured: 4 weeks
Secondary outcomes (7)
Participants' opinion about the behavioural intervention
A semi-structured interview will be used for thematic analysis
Measured: 3 months
Participant attrition rate and phases of the study whereby the attrition occurs
Measured: 3 months
Participants' opinion about the study processes
A semi-structured interview will be used for thematic analysis
Measured: 3 months
Participants' suggestions for further improvement of the intervention and study processes
A semi-structured interview will be used for thematic analysis
Measured: 3 months
Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
Measured: 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
Measured: 3 months
Proportion of days with missing nutritional data, as a marker of feasibility
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start8 May 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782909
- Sponsor's protocol ID
- STH20240
- Acronym
- EAT-CF
- Status last verified
- Feb 2021
- First submitted
- 17 Dec 2018
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Behavioural Intervention Using App Technology in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03782909
- Acronym / sponsor ID
- EAT-CF / STH20240
- Conditions
- Cystic Fibrosis
- Keywords
- Nutrition, Weight, BMI, Behaviour change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behaviour change intervention | Experimental | Behavioral: Behaviour change interventionIntensive behaviour change for 6 weeks, followed by a maintenance phase for 6 weeks |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behaviour change interventionThe 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 | Behavioural | Behaviour change intervention |
Primary outcome
Proportion of patients who accepted invitation to participate as a marker of feasibility
Time frame: 4 weeks
7 secondary outcomes
Participants' opinion about the behavioural intervention
Time frame: 3 months
Participant attrition rate and phases of the study whereby the attrition occurs
Time frame: 3 months
Participants' opinion about the study processes
Time frame: 3 months
Participants' suggestions for further improvement of the intervention and study processes
Time frame: 3 months
Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
Time frame: 4 weeks
Resources (time) needed by the investigators to deliver the intervention
Time frame: 3 months
Proportion of days with missing nutritional data, as a marker of feasibility
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behaviour change intervention in people with Cystic Fibrosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who accepted invitation to participate as a marker of feasibility (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.