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Article: 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

TitleAssessing 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
Issue Date2011
PublisherBioMed Central Ltd. The Journal's web site is located at http://www.trialsjournal.com/
Citation
Trials, 2011, v. 12, article no. 242 How to Cite?
AbstractBackground: 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 > 98 th 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. © 2011 Christie et al; licensee BioMed Central Ltd.
Persistent Identifierhttp://hdl.handle.net/10722/171434
ISSN
2023 Impact Factor: 2.0
2023 SCImago Journal Rankings: 0.812
PubMed Central ID
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorChristie, Den_US
dc.contributor.authorHudson, Len_US
dc.contributor.authorMathiot, Aen_US
dc.contributor.authorCole, TJen_US
dc.contributor.authorKarlsen, Sen_US
dc.contributor.authorKessel, Aen_US
dc.contributor.authorKinra, Sen_US
dc.contributor.authorMorris, Sen_US
dc.contributor.authorNazareth, Ien_US
dc.contributor.authorSovio, Uen_US
dc.contributor.authorWong, ICKen_US
dc.contributor.authorViner, RMen_US
dc.date.accessioned2012-10-30T06:14:11Z-
dc.date.available2012-10-30T06:14:11Z-
dc.date.issued2011en_US
dc.identifier.citationTrials, 2011, v. 12, article no. 242en_US
dc.identifier.issn1745-6215en_US
dc.identifier.urihttp://hdl.handle.net/10722/171434-
dc.description.abstractBackground: 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 > 98 th 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. © 2011 Christie et al; licensee BioMed Central Ltd.en_US
dc.languageengen_US
dc.publisherBioMed Central Ltd. The Journal's web site is located at http://www.trialsjournal.com/en_US
dc.relation.ispartofTrialsen_US
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subject.meshBody Mass Index-
dc.subject.meshClinical Protocols-
dc.subject.meshLife Style-
dc.subject.meshObesity - psychology - therapy-
dc.subject.meshQuality of Life-
dc.titleAssessing 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 trialen_US
dc.typeArticleen_US
dc.identifier.emailWong, ICK:wongick@hku.hken_US
dc.identifier.authorityWong, ICK=rp01480en_US
dc.description.naturepublished_or_final_versionen_US
dc.identifier.doi10.1186/1745-6215-12-242en_US
dc.identifier.pmid22088133-
dc.identifier.pmcidPMC3267689-
dc.identifier.scopuseid_2-s2.0-81055148343en_US
dc.identifier.hkuros207193-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-81055148343&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume12en_US
dc.identifier.isiWOS:000300497800001-
dc.publisher.placeUnited Kingdomen_US
dc.identifier.scopusauthoridChristie, D=7102638286en_US
dc.identifier.scopusauthoridHudson, L=36522974400en_US
dc.identifier.scopusauthoridMathiot, A=54389537800en_US
dc.identifier.scopusauthoridCole, TJ=7201770477en_US
dc.identifier.scopusauthoridKarlsen, S=7004977062en_US
dc.identifier.scopusauthoridKessel, A=7007085407en_US
dc.identifier.scopusauthoridKinra, S=6603836017en_US
dc.identifier.scopusauthoridMorris, S=8370341900en_US
dc.identifier.scopusauthoridNazareth, I=7003265054en_US
dc.identifier.scopusauthoridSovio, U=6602392590en_US
dc.identifier.scopusauthoridWong, ICK=7102513915en_US
dc.identifier.scopusauthoridViner, RM=7005899067en_US
dc.identifier.citeulike10035566-
dc.identifier.issnl1745-6215-

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