- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00536536
Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The care of childhood obesity clinic (COCO) at Bristol Royal Hospital for Children (BCH) provides a proven and effective treatment service for childhood obesity and is one of only a few specialist centres in the UK. The clinic service is based around a multidisciplanary team comprising: consultant; specialist nurses; dietitian: exercise specialist. This pilot study examines the feasibility of transferring the hospital clinic to a nurse led primary care setting in preparation for a full RCT. The study involves training a practice nurse to deliver the service in primary care alongside a dietitian and exercise specialist. Initial work will collect the views of staff delivering the hospital service and patients and parents which will enable us to identify the components of the service that will be needed to run a primary care based service. As a pilot we will focus on: (a) whether weight management is equally good in primary care; (b) whether recruitment, patient retention and satisfaction can be improved in primary care and (c) what data need to be collected for a full economic assessment.
Children will be recruited to the trial by GP via electronic referral form designed by the study team. Families of children fulfilling recruitment criteria (age: 5-16, BMI≥98th centile) will be sent a study pack and reply form, all those who do not respond will be contacted by the COCO consultant to clarify willingness to participate. Families declining participation will follow usual care pathway. Recruited families will be randomised to one of two primary care clinics or COCO clinic.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Bristol, Reino Unido
- Bristol Primary Care Trust
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 5 to <18 yrs old on day of recruitment
- Children consulting their general practitioner or other primary care professional with a weight > 95th percentile
Exclusion Criteria:
- Suspected underlying pathology or syndrome on primary consultation
- Severe learning difficulties
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Hospital
Care of Childhood Obesity Clinic (COCO)
|
Treatment in primary care will be compared to treatment in a secondary hospital setting.
Treatment in both cases will be provided by a multi-disciplinary team of: obesity or practice nurse, dietitian, exercise specialist with some input from medical team.
|
Comparador activo: Primary Care
Primary care clinics (x2)
|
Treatment in primary care will be compared to treatment in a secondary hospital setting.
Treatment in both cases will be provided by a multi-disciplinary team of: obesity or practice nurse, dietitian, exercise specialist with some input from medical team.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To investigate the feasibility of replicating a successful hospital based, childhood obesity clinic in primary care using trained primary care staff and undertake a pilot trial.
Periodo de tiempo: 12 months
|
To measure whether attendance and retention are similar in primary care clinic to hospital based clinic.
|
12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Primary care staff training
Periodo de tiempo: 12 months
|
Can we train primary care staff to deliver the weight management intervention
|
12 months
|
General practice engagement
Periodo de tiempo: 12 months
|
Is it possible to engage general practices in structured care of obese children
|
12 months
|
Family expectations of locality based, weight management clinics.
Periodo de tiempo: 12 months
|
What parents and children would like to see in a community based service especially regarding access and retention in the service
|
12 months
|
Defining outcomes for main RCT.
Periodo de tiempo: 12 months
|
The optimum outcome measures to be used in the main RCT especially for the health economics
|
12 months
|
The protocol for GP screening to identify exclusions
Periodo de tiempo: 3 months
|
To produce a GP exclusion criteria list for main RCT.
|
3 months
|
Sample size calculation (for main trial)
Periodo de tiempo: 24 months
|
The likely size of differences between the groups and thus the size of the main trial
|
24 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Debbie Sharp, University of Bristol
- Investigador principal: Christopher Salisbury, University of Bristol
Publicaciones y enlaces útiles
Publicaciones Generales
- Hollinghurst S, Hunt LP, Banks J, Sharp DJ, Shield JP. Cost and effectiveness of treatment options for childhood obesity. Pediatr Obes. 2014 Feb;9(1):e26-34. doi: 10.1111/j.2047-6310.2013.00150.x. Epub 2013 Mar 18.
- Banks J, Sharp DJ, Hunt LP, Shield JP. Evaluating the transferability of a hospital-based childhood obesity clinic to primary care: a randomised controlled trial. Br J Gen Pract. 2012 Jan;62(594):e6-12. doi: 10.3399/bjgp12X616319.
- Banks J, Williams J, Cumberlidge T, Cimonetti T, Sharp DJ, Shield JP. Is healthy eating for obese children necessarily more costly for families? Br J Gen Pract. 2012 Jan;62(594):e1-5. doi: 10.3399/bjgp12X616300.
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 (Actual)
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
- PB-PG-0706-10090
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Obesity management framework
-
Azienda Ospedaliero-Universitaria di ModenaPfizerActivo, no reclutandoDeficiencia de la hormona del crecimientoItalia
-
Charles Drew University of Medicine and ScienceRetirado
-
Baylor College of MedicineReclutamientoDesórdenes de ansiedad | Trastornos por uso de sustanciasEstados Unidos
-
Rema AfifiReclutamientoEstrés Psicológico | Salud mentalLíbano
-
George Washington UniversityTranscultural Psychosocial Organization NepalTerminado
-
Brigham and Women's HospitalTerminadoInsomnio al inicio del sueñoEstados Unidos
-
Klimmendaal RevalidatiespecialistenReclutamientoLesión cerebral adquirida | Disfunción ejecutiva | Capacitación en gestión de objetivos | Capacitación en estrategia compensatoria | Juegos seriosPaíses Bajos
-
Biotronik, Inc.Biotronik Australia Pty Ltd.; BIOTRONIK NeuroReclutamientoDolor lumbar crónico | Dolor crónico de piernasAustralia
-
Palo Alto UniversityNational Institute of Mental Health (NIMH); Stanford University; York University; Toronto Metropolitan UniversityReclutamientoTrastorno límite de la personalidad | Trastorno de estrés postraumáticoEstados Unidos
-
University of PittsburghRetiradoAdherencia a la medicación | Reacción adversa a la droga | Incumplimiento de la medicaciónEstados Unidos