Rationale and Protocol for a Randomized Controlled Trial Comparing Fast versus Slow Weight Loss in Postmenopausal Women with Obesity—The TEMPO Diet Trial
Radhika V. Seimon,
Alice A. Gibson,
Claudia Harper,
Shelley E. Keating,
Nathan A. Johnson,
Felipe Q. da Luz,
Hamish A. Fernando,
Michael R. Skilton,
Tania P. Markovic,
Ian D. Caterson,
Phillipa Hay,
Nuala M. Byrne,
Amanda Sainsbury
Affiliations
Radhika V. Seimon
Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, the Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Camperdown, NSW 2006, Australia
Alice A. Gibson
Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, the Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Camperdown, NSW 2006, Australia
Claudia Harper
Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, the Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Camperdown, NSW 2006, Australia
Shelley E. Keating
School of Human Movement and Nutrition Sciences, Centre for Research on Exercise, Physical Activity and Health, The University of Queensland, Brisbane, QLD 4072, Australia
Nathan A. Johnson
Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, the Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Camperdown, NSW 2006, Australia
Felipe Q. da Luz
Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, the Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Camperdown, NSW 2006, Australia
Hamish A. Fernando
Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, the Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Camperdown, NSW 2006, Australia
Michael R. Skilton
Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, the Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Camperdown, NSW 2006, Australia
Tania P. Markovic
Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, the Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Camperdown, NSW 2006, Australia
Ian D. Caterson
Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, the Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Camperdown, NSW 2006, Australia
Phillipa Hay
School of Medicine, Western Sydney University, Translational Health Research Institute (THRI), Locked Bag 1797, Penrith, NSW 2751, Australia
Nuala M. Byrne
School of Health Sciences, College of Health and Medicine, University of Tasmania, Launceston, TAS 7250, Australia
Amanda Sainsbury
Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, the Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Camperdown, NSW 2006, Australia
Very low energy diets (VLEDs), commonly achieved by replacing all food with meal replacement products and which result in fast weight loss, are the most effective dietary obesity treatment available. VLEDs are also cheaper to administer than conventional, food-based diets, which result in slow weight loss. Despite being effective and affordable, these diets are underutilized by healthcare professionals, possibly due to concerns about potential adverse effects on body composition and eating disorder behaviors. This paper describes the rationale and detailed protocol for the TEMPO Diet Trial (Type of Energy Manipulation for Promoting optimal metabolic health and body composition in Obesity), in a randomized controlled trial comparing the long-term (3-year) effects of fast versus slow weight loss. One hundred and one post-menopausal women aged 45–65 years with a body mass index of 30–40 kg/m2 were randomized to either: (1) 16 weeks of fast weight loss, achieved by a total meal replacement diet, followed by slow weight loss (as for the SLOW intervention) for the remaining time up until 52 weeks (“FAST” intervention), or (2) 52 weeks of slow weight loss, achieved by a conventional, food-based diet (“SLOW” intervention). Parameters of body composition, cardiometabolic health, eating disorder behaviors and psychology, and adaptive responses to energy restriction were measured throughout the 3-year trial.