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

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

doi:10.1186/s13063-016-1232-5

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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

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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

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 and John B Dixon

Trials, Vol.17(1), pp.1-12

2016

DOI: https://doi.org/10.1186/s13063-016-1232-5

PMCID: PMC4784287

PMID: 26956987

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Abstract

obesity

exercise

body composition

fitness

very low energy diet

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 (ACTRN12611000694910). Date registered: 4 July 2011

Details

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 (Corresponding Author) - Deakin University
Steve F Fraser (Author) - Deakin University
Steve E Selig (Author) - Deakin University
Toni Rice (Author) - Baker Heart and Diabetes Institute
Mariee Grima (Author) - Baker Heart and Diabetes Institute
Nora E Straznicky (Author) - Baker Heart and Diabetes Institute
Itamar Levinger (Author) - Victoria University
Elisabeth A Lambert (Author) - Baker Heart and Diabetes Institute
Daniel J van den Hoek (Author) - Deakin University
John B Dixon (Author) - Baker Heart and Diabetes Institute
Publication details: Trials, Vol.17(1), pp.1-12
Publisher: BioMed Central Ltd.
Date published: 2016
DOI: 10.1186/s13063-016-1232-5
ISSN: 1745-6215
PMID: 26956987; PMC4784287
Copyright note: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Organisation Unit: School of Health - Sports & Exercise Science
Language: English
Record Identifier: 99716193302621
Output Type: Journal article

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