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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Clint T. Miller, Steve F. Fraser, Steve E. Selig, Toni Rice, Mariee Grima, Nora E. Straznicky, Itamar Levinger, Elisabeth A. Lambert, Daniel J. van den Hoek, John B. Dixon

Published in: Trials | Issue 1/2016

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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/Design

Sixty women, aged 18–50 years with a body mass index (BMI) greater than 34.9 kg.m2 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.

Discussion

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.

Trial registration

Australian New Zealand Clinical Trials Registry (ACTRN12611000694​910). Date registered: 4 July 2011
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Metadata
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
Authors
Clint T. Miller
Steve F. Fraser
Steve E. Selig
Toni Rice
Mariee Grima
Nora E. Straznicky
Itamar Levinger
Elisabeth A. Lambert
Daniel J. van den Hoek
John B. Dixon
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1232-5

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