title: The functional and clinical outcomes of exercise training following a very low energy diet for severely obese women: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Clinical practice guidelines globally recommend lifestyle modification including diet and exercise training as first-line treatment for obesity. The clinical benefits of exercise training in adults with obesity is well-documented; however, there is no strong evidence for the effectiveness of exercise training for weight loss in class II and class III obesity. The purpose of the randomised controlled trial described in this protocol article is to examine the effect of exercise training, in addition to a very low energy diet (VLED), in clinically severe obese women for changes in body composition, physical function, quality of life, and markers of cardiometabolic risk.
  
  
  METHODS
  Sixty women, aged 18-50 years with a body mass index (BMI) greater than 34.9 kg.m(2) and at least one obesity-related co-morbidity, will be recruited for this 12-month study. Participants will be randomised to either exercise plus energy restriction (n = 30), or energy restriction alone (n = 30). All participants will follow an energy-restricted individualised diet incorporating a VLED component. The exercise intervention group will also receive exercise by supervised aerobic and resistance training and a home-based exercise programme totalling 300 minutes per week. Primary outcome measures include body composition and aerobic fitness. Secondary outcome measures include: physical function, cardiometabolic risk factors, quality of life, physical activity, and mental health. All outcome measures will be conducted at baseline, 3, 6 and 12 months.
  
  
  CONCLUSIONS
  Previous research demonstrates various health benefits of including exercise training as part of a healthy lifestyle at all BMI ranges. Although clinical practice guidelines recommend exercise training as part of first-line treatment for overweight and obesity, there are few studies that demonstrate the effectiveness of exercise in class II and class III obesity. The study aims to determine whether the addition of exercise training to a VLED provides more favourable improvements in body composition, physical function, quality of life, and markers of cardiometabolic risk for women with clinically severe obesity, compared to VLED alone.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry ( ACTRN12611000694910 ). Date registered: 4 July 2011.
authors.affiliation: School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, VIC, 3125, Australia. c.miller@deakin.edu.au.
authors.forename: Clint T
authors.initials: CT
authors.lastname: Miller
authors.affiliation: School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, VIC, 3125, Australia. steve.fraser@deakin.edu.au.
authors.forename: Steve F
authors.initials: SF
authors.lastname: Fraser
authors.affiliation: School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, VIC, 3125, Australia. steve.selig@deakin.edu.au.
authors.forename: Steve E
authors.initials: SE
authors.lastname: Selig
authors.affiliation: Human Neurotransmitters and Clinical Obesity Research Laboratory, Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia. toni.rice@bakerIDI.edu.au.
authors.forename: Toni
authors.initials: T
authors.lastname: Rice
authors.affiliation: Human Neurotransmitters and Clinical Obesity Research Laboratory, Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia. mariee.grima@bakeridi.edu.au.
authors.forename: Mariee
authors.initials: M
authors.lastname: Grima
authors.affiliation: Human Neurotransmitters and Clinical Obesity Research Laboratory, Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia. elisabeth.lambert@bakeridi.edu.au.
authors.forename: Nora E
authors.initials: NE
authors.lastname: Straznicky
authors.affiliation: Clinical Exercise Science Research Program, Institute of Sport, Exercise and Active Living (ISEAL), Victoria University, Melbourne, VIC, Australia. nora.straznicky@bakeridi.edu.au.
authors.forename: Itamar
authors.initials: I
authors.lastname: Levinger
authors.affiliation: Human Neurotransmitters and Clinical Obesity Research Laboratory, Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia. Itamar.Levinger@vu.edu.au.
authors.forename: Elisabeth A
authors.initials: EA
authors.lastname: Lambert
authors.affiliation: School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, VIC, 3125, Australia. dan.vandenhoek@deakin.edu.au.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: van den Hoek
authors.affiliation: Clinical Obesity Research Laboratory, Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia. john.dixon@bakeridi.edu.au.
authors.forename: John B
authors.initials: JB
authors.lastname: Dixon
mesh_terms: D000293:Adolescent; D000328:Adult; D001823:Body Composition; D031204:Caloric Restriction; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008603:Mental Health; D008875:Middle Aged; D009767:Obesity, Morbid / Q000150:complications / Q000178:diet therapy* / Q000503:physiopathology / Q000523:psychology; D010809:Physical Fitness; D011788:Quality of Life; D012107:Research Design; D055070:Resistance Training; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014739:Victoria; D015431:Weight Loss; D055815:Young Adult