Cystic FibrosisPIN-CFNCT01957072
Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis
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 lung infections and reduced nutrients absorption from food. The average age at death is 26 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
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Dec 2014
- 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 Unit
- best BMI of < 23 for males and < 22 for females between Oct '12 and Oct '13
Who cannot join
- patients in the palliative phase of disease
- patients who are pregnant
- patients who have no capacity to consent to participate in the study
- patients who have no IT facilities to use the web-based food diary
- patients who are unable to communicate by telephone for coaching
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU
About this study
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 lung infections and reduced nutrients absorption from food. The average age at death is 26 years, usually from respiratory failure. Nonetheless, the nutritional status of people with CF (PWCF) is important help them live healthier and longer.
It is recommended that adult with CF achieve a BMI of 23 for males and 22 for females. However, fewer than 50% adult with CF achieved that target BMI despite effective nutritional support to help support 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. 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 the how many people are needed for the larger trial.
All eligible 75 PWCF in Sheffield will be invited to participate. The investigators anticipate recruiting 30 participants. Participants will be divided into two groups. The first group receive the behavioural intervention immediately. The second group receive the intervention after 3 months. All participants will be followed up for 6 months. Data will be collected every 6 weeks during clinic reviews.
These two groups will be compared against each other to estimate the potential impact of the behavioural intervention. The investigators will also interview some of the participants at the end of the study period to improve the intervention and the study processes based on participant feedback.
The investigators hypothesised that this study will recruit around 30 participants, around 80% of the participants will complete the study, a single full-time investigator can deliver the intervention to 15 participants over 3 months and data collection will be thorough (with less than 5% missing data). The investigators also hypothesised that this feasibility study will help improve the intervention and help the design of a larger trial.
- Conditions
- Cystic Fibrosis
- Being tested
- Behaviour change intervention
- Keywords
- Cystic fibrosis, 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 a web-based food diary
- 'coaching' with problem-solving and implementation plans
The intensive intervention phase consists of 2 home visits, 8 telephone calls and 6 reminder emails.
The maintenance phase consists of 3 telephone calls and 4 reminder emails.
| Study group | Role | What they receive |
|---|---|---|
| Behaviour change intervention | Experimental | Intensive behaviour change intervention for 3 months, followed by a maintenance phase for 3 months Receives: Behavioral: Behaviour change intervention |
| Wait-list Control | Other | Usual care for 3 months, followed by intensive behaviour change intervention for 3 months 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
Proportion of people with CF who are randomised into the study after accepting the invitation to participate, as a marker of feasibility
Measured: 4 weeks
Secondary outcomes (7)
Participants' opinion about the behavioural intervention
Measured: 6 months
Participant attrition rate and phases of study whereby the attrition occurs
Measured: 6 months
Participants' opinion about the study processes
Measured: 6 months
Participants' suggestions for further improvement of the intervention and study processes
Measured: 6 months
Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
Measured: 2 weeks
Resources needed by the investigators to deliver the intervention
Measured: 6 months
Proportion of days with missing nutritional data, as a marker for feasibility
Participants are requested to fill in their nutritional intake daily on a web-based food diary. The investigators are interested to find out what the proportion of such data will be missing to determine the feasibility of collecting data with the web-based food diary.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin J Wildman, PhD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957072
- Sponsor's protocol ID
- STH17327
- Other IDs
- IRAS Project ID 139047
- Acronym
- PIN-CF
- Status last verified
- Mar 2015
- First submitted
- 30 Sep 2013
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01957072
- Acronym / sponsor ID
- PIN-CF / STH17327
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Nutrition, Weight, BMI, Behaviour change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Oct 2013 (estimated)
- 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 lung infections and reduced nutrients absorption from food. The average age at death is 26 years, usually from respiratory failure. Nonetheless, the nutritional status of people with CF (PWCF) is important help them live healthier and longer.
It is recommended that adult with CF achieve a BMI of 23 for males and 22 for females. However, fewer than 50% adult with CF achieved that target BMI despite effective nutritional support to help support 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. 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 the how many people are needed for the larger trial.
All eligible 75 PWCF in Sheffield will be invited to participate. The investigators anticipate recruiting 30 participants. Participants will be divided into two groups. The first group receive the behavioural intervention immediately. The second group receive the intervention after 3 months. All participants will be followed up for 6 months. Data will be collected every 6 weeks during clinic reviews.
These two groups will be compared against each other to estimate the potential impact of the behavioural intervention. The investigators will also interview some of the participants at the end of the study period to improve the intervention and the study processes based on participant feedback.
The investigators hypothesised that this study will recruit around 30 participants, around 80% of the participants will complete the study, a single full-time investigator can deliver the intervention to 15 participants over 3 months and data collection will be thorough (with less than 5% missing data). The investigators also hypothesised that this feasibility study will help improve the intervention and help the design of a larger trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behaviour change intervention | Experimental | Behavioral: Behaviour change interventionIntensive behaviour change intervention for 3 months, followed by a maintenance phase for 3 months |
| Wait-list Control | Other | Behavioral: Behaviour change interventionUsual care for 3 months, followed by intensive behaviour change intervention for 3 months |
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 Unit
- best BMI of < 23 for males and < 22 for females between Oct '12 and Oct '13
Key exclusion criteria (5 listed)
- patients in the palliative phase of disease
- patients who are pregnant
- patients who have no capacity to consent to participate in the study
- patients who have no IT facilities to use the web-based food diary
- 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 a web-based food diary 2. 'coaching' with problem-solving and implementation plans The intensive intervention phase consists of 2 home visits, 8 telephone calls and 6 reminder emails. The maintenance phase consists of 3 telephone calls and 4 reminder emails. | Behavioural | Behaviour change intervention, Wait-list Control |
Primary outcome
Proportion of patients who accepted invitation to participate as a marker of feasibility
Time frame: 4 weeks
Proportion of people with CF who are randomised into the study after accepting the invitation to participate, as a marker of feasibility
Time frame: 4 weeks
7 secondary outcomes
Participants' opinion about the behavioural intervention
Time frame: 6 months
Participant attrition rate and phases of study whereby the attrition occurs
Time frame: 6 months
Participants' opinion about the study processes
Time frame: 6 months
Participants' suggestions for further improvement of the intervention and study processes
Time frame: 6 months
Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
Time frame: 2 weeks
Resources needed by the investigators to deliver the intervention
Time frame: 6 months
Proportion of days with missing nutritional data, as a marker for feasibility
Time frame: 6 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 11 Mar 2015.
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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.
Martin J Wildman, PhD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
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 5 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 11 Mar 2015. 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). The study lists 2 primary outcomes in all. 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 11 Mar 2015.