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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julian Hamilton-Shield, University of Bristol
ClinicalTrials.gov Identifier:
NCT00536536
First received: September 27, 2007
Last updated: August 23, 2011
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Childhood Obesity
Behavioral: Obesity management framework
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Bristol:

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 ]

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 ]

Estimated Enrollment: 100
Study Start Date: April 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hospital
Care of Childhood Obesity Clinic (COCO)
Behavioral: Obesity management framework
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.
Active Comparator: Primary Care
Primary care clinics (x2)
Behavioral: Obesity management framework
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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536536

Locations
United Kingdom
Bristol Primary Care Trust
Bristol, United Kingdom
Sponsors and Collaborators
University of Bristol
Investigators
Principal Investigator: Debbie Sharp University of Bristol
Principal Investigator: Christopher Salisbury University of Bristol
  More Information

No publications provided by University of Bristol

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julian Hamilton-Shield, Professor of Diabetes and metabolic Endocrinology, University of Bristol
ClinicalTrials.gov Identifier: NCT00536536     History of Changes
Other Study ID Numbers: PB-PG-0706-10090
Study First Received: September 27, 2007
Last Updated: August 23, 2011
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Department of Health

Keywords provided by University of Bristol:
Childhood
Obesity
Primary Care

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014