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Open Access Highly Accessed Study protocol

Protocol for: Sheffield Obesity Trial (SHOT): A randomised controlled trial of exercise therapy and mental health outcomes in obese adolescents [ISRCNT83888112]

Amanda J Daley1*, Robert J Copeland2, Neil P Wright3 and Jerry KH Wales4

Author Affiliations

1 The Department of General Practice and Primary Care, The Medical School, Clinical Sciences Building, University of Birmingham, UK, B15 2TT

2 The Centre for Sport and Exercise Science, Sheffield Hallam University, Sheffield, S10 2BP, UK

3 Sheffield Children's NHS Trust, Sheffield, S10 2TH, UK

4 Academic Unit of Child Health, The Children's Hospital, Sheffield, S10 2TH, UK

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BMC Public Health 2005, 5:113  doi:10.1186/1471-2458-5-113

Published: 31 October 2005

Abstract

Background

While obesity is known to have many physiological consequences, the psychopathology of this condition has not featured prominently in the literature. Cross-sectional studies have indicated that obese children have increased odds of experiencing poor quality of life and mental health. However, very limited trial evidence has examined the efficacy of exercise therapy for enhancing mental health outcomes in obese children, and the Sheffield Obesity Trial (SHOT) will provide evidence of the efficacy of supervised exercise therapy in obese young people aged 11–16 years versus usual care and an attention-control intervention.

Method/design

SHOT is a randomised controlled trial where obese young people are randomised to receive; (1) exercise therapy, (2) attention-control intervention (involving body-conditioning exercises and games that do not involve aerobic activity), or (3) usual care. The exercise therapy and attention-control sessions will take place three times per week for eight weeks and a six-week home programme will follow this. Ninety adolescents aged between 11–16 years referred from a children's hospital for evaluation of obesity or via community advertisements will need to complete the study. Participants will be recruited according to the following criteria: (1) clinically obese and aged 11–16 years (Body Mass Index Centile > 98th UK standard) (2) no medical condition that would restrict ability to be active three times per week for eight weeks and (3) not diagnosed with insulin dependent diabetes or receiving oral steroids. Assessments of outcomes will take place at baseline, as well as four (intervention midpoint) and eight weeks (end of intervention) from baseline. Participants will be reassessed on outcome measures five and seven months from baseline. The primary endpoint is physical self-perceptions. Secondary outcomes include physical activity, self-perceptions, depression, affect, aerobic fitness and BMI.