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Title
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Cost-effectiveness analysis of exercise in addition to diet on the reduction of ectopic fat in women with overweight study protocol for a randomised controlled trial
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Author
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Abstract
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| Background: Excess ectopic fat deposition is associated with the development of cardiovascular and metabolic diseases. This study investigates the added value of exercise to diet on ectopic fat reduction and metabolic factors. Objective: The purpose of this report is to present and discuss the rationale, design and methods of this randomized controlled trial and cost-effectiveness analysis. Method: Participants: Endocrinologists of the University Hospital of Antwerp are recruiting premenopausal women during consultations. Intervention: 60 potential participants meeting all a priori set inclusion and exclusion criteria are randomized by minimization method to get usual care (hypocaloric diet) or combined therapy (hypocaloric diet and physical fitness training) during 6 months. Outcome measures: Primary outcomes include ectopic fat deposition (intramyocellular lipids, intra hepatic lipids, epicardial adipose tissue and visceral adipose tissue) objectively assessed by imaging techniques. Patients were instructed to record all health-related care and costs through diaries. Secondary outcome parameters are metabolic parameters, anthropometrics and lifestyle parameters assessed by clinical examinations, blood analyses, anthropometric measures, questionnaires and activity trackers. Results/Conclusions: This is the first trial discussing the added value of supervised exercise to hypocaloric diet on ectopic fat deposition and secondary health parameters. Clinical and economic results are presented as changes in ectopic fat deposition, metabolic risk profile and quality-adjusted life years. This RCT provides novel evidence for the use of supervised exercise interventions besides energy restriction in people with overweight. |
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Language
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English
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Source (journal)
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Physioscience
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Publication
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2017
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DOI
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10.1055/S-0035-1567190
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Volume/pages
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13
:2
(2017)
, p. 80-87
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ISI
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000406431000005
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Full text (Publisher's DOI)
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