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临床试验/NCT00536536
NCT00536536已完成不适用

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

University of Bristol1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2008年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 5 to <18 yrs old on day of recruitment
  • Children consulting their general practitioner or other primary care professional with a weight > 95th percentile

排除标准

  • Suspected underlying pathology or syndrome on primary consultation
  • Severe learning difficulties

研究组 & 干预措施

Hospital

Active Comparator

Care of Childhood Obesity Clinic (COCO)

干预措施: Obesity management framework (Behavioral)

Primary Care

Active Comparator

Primary care clinics (x2)

干预措施: Obesity management framework (Behavioral)

结局指标

主要结局

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.

时间窗: 12 months

To measure whether attendance and retention are similar in primary care clinic to hospital based clinic.

次要结局

  • Primary care staff training(12 months)
  • Defining outcomes for main RCT.(12 months)
  • Family expectations of locality based, weight management clinics.(12 months)
  • The protocol for GP screening to identify exclusions(3 months)
  • General practice engagement(12 months)
  • Sample size calculation (for main trial)(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julian Hamilton-Shield

Professor of Diabetes and metabolic Endocrinology

University of Bristol

研究点 (1)

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