- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00536536
Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Bristol, Regno Unito
- Bristol Primary Care Trust
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: 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.
|
Comparatore attivo: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
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.
Lasso di tempo: 12 months
|
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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Primary care staff training
Lasso di tempo: 12 months
|
Can we train primary care staff to deliver the weight management intervention
|
12 months
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General practice engagement
Lasso di tempo: 12 months
|
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.
Lasso di tempo: 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
|
Defining outcomes for main RCT.
Lasso di tempo: 12 months
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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
Lasso di tempo: 3 months
|
To produce a GP exclusion criteria list for main RCT.
|
3 months
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Sample size calculation (for main trial)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Debbie Sharp, University of Bristol
- Investigatore principale: Christopher Salisbury, University of Bristol
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PB-PG-0706-10090
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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