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Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study

5 april 2019 uppdaterad av: Julian Hamilton-Shield, University of Bristol
Obesity affects one in five children in the UK and undoubtedly causes increased ill health with rising levels of childhood and adolescent diabetes, obesity induced liver disease and increased risk of early heart disease. There are few clinics offering effective treatment for childhood obesity. However, the clinic for childhood obesity at Bristol Royal Hospital for Children (BCH) has been successful in around 83% of cases. This pilot study aims to examine the feasibility of transferring the success of the hospital clinic to primary care in preparation for a full RCT. The study will entail training a practice nurse, community dietician and exercise specialist to deliver the same clinical service in primary care as that offered in BCH. Initial work will gather the views of staff delivering the hospital service and those of patients and parents to identify the crucial components of the intervention that are likely to be needed in primary care and to then to refine the intervention.A pilot trial will examine how feasible it is to recruit patients into the service and get some initial idea as to whether weight management is equally good, patient satisfaction and retention improves and what data needs to be collected for a full economic assessment. If found to be effective, the next step will be to use knowledge gained in this study to design and undertake a more extensive, formal study across Bristol in various primary care settings.This larger study will address how such a service can be delivered across a complete spectrum of primary care populations, so that similar services could be developed across the country.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

106

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

5 år till 17 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Aktiv komparator: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.
Tidsram: 12 months
To measure whether attendance and retention are similar in primary care clinic to hospital based clinic.
12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Primary care staff training
Tidsram: 12 months
Can we train primary care staff to deliver the weight management intervention
12 months
General practice engagement
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 3 months
To produce a GP exclusion criteria list for main RCT.
3 months
Sample size calculation (for main trial)
Tidsram: 24 months
The likely size of differences between the groups and thus the size of the main trial
24 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Debbie Sharp, University of Bristol
  • Huvudutredare: Christopher Salisbury, University of Bristol

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2008

Primärt slutförande (Faktisk)

1 juni 2010

Avslutad studie (Faktisk)

1 juni 2010

Studieregistreringsdatum

Först inskickad

27 september 2007

Först inskickad som uppfyllde QC-kriterierna

27 september 2007

Första postat (Uppskatta)

28 september 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 april 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 april 2019

Senast verifierad

1 april 2019

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • PB-PG-0706-10090

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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