- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00536536
Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Bristol, Royaume-Uni
- Bristol Primary Care Trust
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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.
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Primary care staff training
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Debbie Sharp, University of Bristol
- Chercheur principal: Christopher Salisbury, University of Bristol
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PB-PG-0706-10090
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