Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Bristol、イギリス
- Bristol Primary Care Trust
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:Hospital
Care of Childhood Obesity Clinic (COCO)
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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.
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アクティブコンパレータ:Primary Care
Primary care clinics (x2)
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
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.
時間枠:12 months
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To measure whether attendance and retention are similar in primary care clinic to hospital based clinic.
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12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Primary care staff training
時間枠:12 months
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Can we train primary care staff to deliver the weight management intervention
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12 months
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General practice engagement
時間枠:12 months
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Is it possible to engage general practices in structured care of obese children
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12 months
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Family expectations of locality based, weight management clinics.
時間枠:12 months
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What parents and children would like to see in a community based service especially regarding access and retention in the service
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12 months
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Defining outcomes for main RCT.
時間枠:12 months
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The optimum outcome measures to be used in the main RCT especially for the health economics
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12 months
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The protocol for GP screening to identify exclusions
時間枠:3 months
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To produce a GP exclusion criteria list for main RCT.
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3 months
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Sample size calculation (for main trial)
時間枠:24 months
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The likely size of differences between the groups and thus the size of the main trial
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24 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Debbie Sharp、University of Bristol
- 主任研究者:Christopher Salisbury、University of Bristol
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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