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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 27, 2007

Last Updated Date

February 17, 2009

Start Date ^†

April 2008

Current Primary Outcome Measures ^†

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00536536 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To determine Whether we can train primary care staff to deliver the intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To determine Whether we can engage general practices in structured care of obese children [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To determine What parents and children would like to see in a community based service especially regarding access and retention in the service [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To determine The optimum outcome measures to be used in the main RCT especially for the health economics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To determine The protocol for GP screening to identify exclusions [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To determine The likely size of differences between the groups and thus the size of the main trial [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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 crucail 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.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Condition ^†

Childhood Obesity

Intervention ^†

Behavioral: Obesity management framework

Study Arms / Comparison Groups

Active Comparator: Care of Childhood Obesity Clinic (COCO)
Active Comparator: Primary care clinics (x2)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

100

Estimated Completion Date

July 2010

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

5 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Julian P Hamilton-Shield, MD

00 44 117 342 0159

j.p.h.shield@bristol.ac.uk

Location Countries ^†

United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00536536

Responsible Party

Dr Julian Paul Hamilton-Shield, University of Bristol

Secondary IDs ^††

Study Sponsor ^†

University of Bristol

Collaborators ^††

Investigators ^†

Principal Investigator:	Debbie Sharp	University of Bristol
Principal Investigator:	Christopher Salisbury	University of Bristol

Information Provided By

University of Bristol

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.