Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study

Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study

Patrocinadores

Patrocinador principal: University of Bristol

Fuente University of Bristol
Resumen breve

Obesity affects one in five children in the UK and undoubtedly causes increased ill health with rising levels of childhood and adolescent diabetes, obesity induced liver disease and increased risk of early heart disease. There are few clinics offering effective treatment for childhood obesity. However, the clinic for childhood obesity at Bristol Royal Hospital for Children (BCH) has been successful in around 83% of cases. This pilot study aims to examine the feasibility of transferring the success of the hospital clinic to primary care in preparation for a full RCT. The study will entail training a practice nurse, community dietician and exercise specialist to deliver the same clinical service in primary care as that offered in BCH. Initial work will gather the views of staff delivering the hospital service and those of patients and parents to identify the crucial components of the intervention that are likely to be needed in primary care and to then to refine the intervention.A pilot trial will examine how feasible it is to recruit patients into the service and get some initial idea as to whether weight management is equally good, patient satisfaction and retention improves and what data needs to be collected for a full economic assessment. If found to be effective, the next step will be to use knowledge gained in this study to design and undertake a more extensive, formal study across Bristol in various primary care settings.This larger study will address how such a service can be delivered across a complete spectrum of primary care populations, so that similar services could be developed across the country.

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.

Estado general Completed
Fecha de inicio April 2008
Fecha de Terminación June 2010
Fecha de finalización primaria June 2010
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida 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. 12 months
Resultado secundario
Medida Periodo de tiempo
Primary care staff training 12 months
General practice engagement 12 months
Family expectations of locality based, weight management clinics. 12 months
Defining outcomes for main RCT. 12 months
The protocol for GP screening to identify exclusions 3 months
Sample size calculation (for main trial) 24 months
Inscripción 106
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Obesity management framework

Descripción: 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.

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 5 Years

Edad máxima: 17 Years

Voluntarios Saludables: No

Oficial general
Ubicación
Instalaciones: Bristol Primary Care Trust
Ubicacion Paises

United Kingdom

Fecha de verificación

April 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: University of Bristol

Nombre completo del investigador: Julian Hamilton-Shield

Título del investigador: Professor of Diabetes and metabolic Endocrinology

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Hospital

Tipo: Active Comparator

Descripción: Care of Childhood Obesity Clinic (COCO)

Etiqueta: Primary Care

Tipo: Active Comparator

Descripción: Primary care clinics (x2)

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov