Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis (PIN-CF)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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South Yorkshire
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Sheffield, South Yorkshire, Verenigd Koninkrijk, S5 7AU
- Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Behaviour change intervention
Intensive behaviour change intervention for 3 months, followed by a maintenance phase for 3 months
|
The behaviour change intervention consists of
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. |
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Ander: Wait-list Control
Usual care for 3 months, followed by intensive behaviour change intervention for 3 months
|
The behaviour change intervention consists of
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Percentage patiënten dat de uitnodiging om deel te nemen als indicator van haalbaarheid accepteerde
Tijdsspanne: 4 weken
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4 weken
|
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Proportion of people with CF who are randomised into the study after accepting the invitation to participate, as a marker of feasibility
Tijdsspanne: 4 weeks
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4 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Participants' opinion about the behavioural intervention
Tijdsspanne: 6 months
|
6 months
|
|
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Participant attrition rate and phases of study whereby the attrition occurs
Tijdsspanne: 6 months
|
6 months
|
|
|
Participants' opinion about the study processes
Tijdsspanne: 6 months
|
6 months
|
|
|
Participants' suggestions for further improvement of the intervention and study processes
Tijdsspanne: 6 months
|
6 months
|
|
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Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
Tijdsspanne: 2 weeks
|
2 weeks
|
|
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Resources needed by the investigators to deliver the intervention
Tijdsspanne: 6 months
|
6 months
|
|
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Proportion of days with missing nutritional data, as a marker for feasibility
Tijdsspanne: 6 months
|
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.
|
6 months
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Body mass index
Tijdsspanne: 6 months
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Unit is kg/m2
|
6 months
|
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Weight
Tijdsspanne: 6 months
|
unit is kg
|
6 months
|
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Beliefs about Medicines Questionnaire (BMQ) score
Tijdsspanne: 6 months
|
As a marker of patients' perception of their treatment
|
6 months
|
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The mean Self-Report Behavioural Automaticity Index (SRBAI) score
Tijdsspanne: 6 months
|
As a marker of habit formation
|
6 months
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Martin J Wildman, PhD, Sheffield Teaching Hospitals NHS Foundation Trust
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STH17327
- IRAS Project ID 139047 (Andere identificatie: Integrated Research Application System (IRAS))
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