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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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South Yorkshire
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Sheffield, South Yorkshire, Reino Unido, S5 7AU
- Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
|
Otro: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Proporción de pacientes que aceptaron la invitación a participar como marcador de factibilidad
Periodo de tiempo: 4 semanas
|
4 semanas
|
|
Proportion of people with CF who are randomised into the study after accepting the invitation to participate, as a marker of feasibility
Periodo de tiempo: 4 weeks
|
4 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Participants' opinion about the behavioural intervention
Periodo de tiempo: 6 months
|
6 months
|
|
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Participant attrition rate and phases of study whereby the attrition occurs
Periodo de tiempo: 6 months
|
6 months
|
|
|
Participants' opinion about the study processes
Periodo de tiempo: 6 months
|
6 months
|
|
|
Participants' suggestions for further improvement of the intervention and study processes
Periodo de tiempo: 6 months
|
6 months
|
|
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Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
Periodo de tiempo: 2 weeks
|
2 weeks
|
|
|
Resources needed by the investigators to deliver the intervention
Periodo de tiempo: 6 months
|
6 months
|
|
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Proportion of days with missing nutritional data, as a marker for feasibility
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body mass index
Periodo de tiempo: 6 months
|
Unit is kg/m2
|
6 months
|
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Weight
Periodo de tiempo: 6 months
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unit is kg
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6 months
|
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Beliefs about Medicines Questionnaire (BMQ) score
Periodo de tiempo: 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
Periodo de tiempo: 6 months
|
As a marker of habit formation
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Martin J Wildman, PhD, Sheffield Teaching Hospitals NHS Foundation Trust
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STH17327
- IRAS Project ID 139047 (Otro identificador: Integrated Research Application System (IRAS))
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