Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Obesity management framework
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring Childhood, Obesity, Primary Care
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
Sites / Locations
- Bristol Primary Care Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hospital
Primary Care
Arm Description
Care of Childhood Obesity Clinic (COCO)
Primary care clinics (x2)
Outcomes
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.
To measure whether attendance and retention are similar in primary care clinic to hospital based clinic.
Secondary Outcome Measures
Primary care staff training
Can we train primary care staff to deliver the weight management intervention
General practice engagement
Is it possible to engage general practices in structured care of obese children
Family expectations of locality based, weight management clinics.
What parents and children would like to see in a community based service especially regarding access and retention in the service
Defining outcomes for main RCT.
The optimum outcome measures to be used in the main RCT especially for the health economics
The protocol for GP screening to identify exclusions
To produce a GP exclusion criteria list for main RCT.
Sample size calculation (for main trial)
The likely size of differences between the groups and thus the size of the main trial
Full Information
NCT ID
NCT00536536
First Posted
September 27, 2007
Last Updated
April 5, 2019
Sponsor
University of Bristol
1. Study Identification
Unique Protocol Identification Number
NCT00536536
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bristol
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood, Obesity, Primary Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hospital
Arm Type
Active Comparator
Arm Description
Care of Childhood Obesity Clinic (COCO)
Arm Title
Primary Care
Arm Type
Active Comparator
Arm Description
Primary care clinics (x2)
Intervention Type
Behavioral
Intervention Name(s)
Obesity management framework
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
To measure whether attendance and retention are similar in primary care clinic to hospital based clinic.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Primary care staff training
Description
Can we train primary care staff to deliver the weight management intervention
Time Frame
12 months
Title
General practice engagement
Description
Is it possible to engage general practices in structured care of obese children
Time Frame
12 months
Title
Family expectations of locality based, weight management clinics.
Description
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
Title
Defining outcomes for main RCT.
Description
The optimum outcome measures to be used in the main RCT especially for the health economics
Time Frame
12 months
Title
The protocol for GP screening to identify exclusions
Description
To produce a GP exclusion criteria list for main RCT.
Time Frame
3 months
Title
Sample size calculation (for main trial)
Description
The likely size of differences between the groups and thus the size of the main trial
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debbie Sharp
Organizational Affiliation
University of Bristol
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Salisbury
Organizational Affiliation
University of Bristol
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bristol Primary Care Trust
City
Bristol
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23505002
Citation
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.
Results Reference
derived
PubMed Identifier
22520658
Citation
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.
Results Reference
derived
PubMed Identifier
22520655
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study
We'll reach out to this number within 24 hrs