- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00536536
Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Bristol, 영국
- Bristol Primary Care Trust
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: 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.
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
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.
기간: 12 months
|
To measure whether attendance and retention are similar in primary care clinic to hospital based clinic.
|
12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Primary care staff training
기간: 12 months
|
Can we train primary care staff to deliver the weight management intervention
|
12 months
|
General practice engagement
기간: 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.
기간: 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.
기간: 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
기간: 3 months
|
To produce a GP exclusion criteria list for main RCT.
|
3 months
|
Sample size calculation (for main trial)
기간: 24 months
|
The likely size of differences between the groups and thus the size of the main trial
|
24 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Debbie Sharp, University of Bristol
- 수석 연구원: Christopher Salisbury, University of Bristol
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Obesity management framework에 대한 임상 시험
-
Göteborg UniversityRegion Halland모병
-
Dartmouth-Hitchcock Medical CenterCenters for Disease Control and Prevention완전한
-
Dartmouth-Hitchcock Medical CenterCenters for Disease Control and Prevention모병
-
naomi goldsteinNational Institute of Mental Health (NIMH)완전한
-
Parnassia Addiction Research CentreAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Leiden University Medical... 그리고 다른 협력자들아직 모집하지 않음대마초 사용 장애
-
National Institute on Drug Abuse (NIDA)완전한