Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Bristol、英国
- Bristol Primary Care Trust
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器: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.
|
有源比较器: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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
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.
大体时间:12 months
|
To measure whether attendance and retention are similar in primary care clinic to hospital based clinic.
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Primary care staff training
大体时间:12 months
|
Can we train primary care staff to deliver the weight management intervention
|
12 months
|
General practice engagement
大体时间: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.
大体时间: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.
大体时间: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
大体时间:3 months
|
To produce a GP exclusion criteria list for main RCT.
|
3 months
|
Sample size calculation (for main trial)
大体时间:24 months
|
The likely size of differences between the groups and thus the size of the main trial
|
24 months
|
合作者和调查者
调查人员
- 首席研究员:Debbie Sharp、University of Bristol
- 首席研究员:Christopher Salisbury、University of Bristol
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Obesity management framework的临床试验
-
Azienda Ospedaliero-Universitaria di ModenaPfizer主动,不招人
-
George Washington UniversityTranscultural Psychosocial Organization Nepal完全的