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Published in: Trials 1/2011

Open Access 01-12-2011 | Study protocol

Assessing the efficacy of the healthy eating and lifestyle programme (HELP) compared with enhanced standard care of the obese adolescent in the community: study protocol for a randomized controlled trial

Authors: Deborah Christie, Lee Hudson, Anne Mathiot, Tim J Cole, Saffron Karlsen, Anthony Kessel, Sanjay Kinra, Steve Morris, Irwin Nazareth, Ulla Sovio, Ian CK Wong, Russell M Viner

Published in: Trials | Issue 1/2011

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Abstract

Background

The childhood obesity epidemic is one of the foremost UK health priorities. Childhood obesity tracks into adult life and places individuals at considerable risk for diabetes, cardiovascular disease, liver disease and other morbidities. There is widespread need for paediatric lifestyle programmes as change may be easier to accomplish in childhood than later in life.

Study Design/Method

The study will evaluate the management of adolescent obesity by conducting a Medical Research Council complex intervention phase III efficacy randomised clinical trial of the Healthy Eating Lifestyle Programme within primary care. The study tests a community delivered multi-component intervention designed for adolescents developed from best practice as identified by National Institute for Health and Clinical Excellence. The hospital based pilot reduced body mass index and improved health-related quality of life.
Subjects will be individually randomised to receiving either the Healthy Eating Lifestyle Programme (12 fortnightly family sessions) or enhanced standard care. Baseline and follow up assessments will be undertaken blind to allocation status. A health economic evaluation is also being conducted.
200 obese young people (13-17 years, body mass index > 98th centile for age and sex) will be recruited from primary care within the greater London area.
The primary hypothesis is that a motivational and solution-focused family-based weight management programme delivered over 6 months is more efficacious in reducing body mass index in obese adolescents identified in the community than enhanced standard care.
The primary outcome will be body mass index at the end of the intervention, adjusted for baseline body mass index, age and sex.
The secondary hypothesis is that the Healthy Eating Lifestyle Programme is more efficacious in improving quality of life and psychological function and reducing waist circumference and cardiovascular risk factors in obese adolescents than enhanced standard care assessed at 6 and 12 months post baseline assessment.
Improvement in quality of life predicts on-going lifestyle change and maximises the chances of long-term weight reduction. We will explore whether improvement in QOL may be intermediate on the pathway between the intervention and body mass index change.

Trial registration

ISRCTN: ISRCTN99840111
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Metadata
Title
Assessing the efficacy of the healthy eating and lifestyle programme (HELP) compared with enhanced standard care of the obese adolescent in the community: study protocol for a randomized controlled trial
Authors
Deborah Christie
Lee Hudson
Anne Mathiot
Tim J Cole
Saffron Karlsen
Anthony Kessel
Sanjay Kinra
Steve Morris
Irwin Nazareth
Ulla Sovio
Ian CK Wong
Russell M Viner
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Trials / Issue 1/2011
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-12-242

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