NCT00536536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

September 27, 2007

Last Update Submit

April 5, 2019

Conditions

Keywords

ChildhoodObesityPrimary Care

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (6)

  • Primary care staff training

    12 months

  • General practice engagement

    12 months

  • Family expectations of locality based, weight management clinics.

    12 months

  • Defining outcomes for main RCT.

    12 months

  • The protocol for GP screening to identify exclusions

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Hospital

ACTIVE COMPARATOR

Care of Childhood Obesity Clinic (COCO)

Behavioral: Obesity management framework

Primary Care

ACTIVE COMPARATOR

Primary care clinics (x2)

Behavioral: Obesity management framework

Interventions

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.

HospitalPrimary Care

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to \<18 yrs old on day of recruitment
  • Children consulting their general practitioner or other primary care professional with a weight \> 95th percentile

You may not qualify if:

  • Suspected underlying pathology or syndrome on primary consultation
  • Severe learning difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol Primary Care Trust

Bristol, United Kingdom

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Debbie Sharp

    University of Bristol

    PRINCIPAL INVESTIGATOR
  • Christopher Salisbury

    University of Bristol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Diabetes and metabolic Endocrinology

Study Record Dates

First Submitted

September 27, 2007

First Posted

September 28, 2007

Study Start

April 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations