Home
Search
Study Topics
Glossary
|
|
|
|
|
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 † |
|
||||||||
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 |
|
||||||||
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:
Exclusion Criteria:
|
||||||||
Gender | Both | ||||||||
Ages | 5 Years to 17 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
|
||||||||
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 † |
|
||||||||
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. |