Comparison of weight loss induced by daily caloric restriction versus intermittent fasting (DRIFT) in individuals with obesity: study protocol for a 52-week randomized clinical trial
Abstract Background The standard of care for treating overweight and obesity is daily caloric restriction (DCR). While this approach produces modest weight loss, adherence to DCR declines over time and weight regain is common. Intermittent fasting (IMF) is an alternative dietary strategy for reducin...
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BMC
2022-08-01
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Online Access: | https://doi.org/10.1186/s13063-022-06523-2 |
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author | Danielle M. Ostendorf Ann E. Caldwell Adnin Zaman Zhaoxing Pan Kristen Bing Liza T. Wayland Seth A. Creasy Daniel H. Bessesen Paul MacLean Edward L. Melanson Victoria A. Catenacci |
author_facet | Danielle M. Ostendorf Ann E. Caldwell Adnin Zaman Zhaoxing Pan Kristen Bing Liza T. Wayland Seth A. Creasy Daniel H. Bessesen Paul MacLean Edward L. Melanson Victoria A. Catenacci |
author_sort | Danielle M. Ostendorf |
collection | DOAJ |
description | Abstract Background The standard of care for treating overweight and obesity is daily caloric restriction (DCR). While this approach produces modest weight loss, adherence to DCR declines over time and weight regain is common. Intermittent fasting (IMF) is an alternative dietary strategy for reducing energy intake (EI) that involves >60% energy restriction on 2–3 days per week, or on alternate days, with habitual intake on fed days. While numerous studies have evaluated IMF as a weight loss strategy, there are several limitations including lack of a standard-of-care DCR control, failure to provide guideline-based behavioral support, and failure to rigorously evaluate dietary and PA adherence using objective measures. To date, only three longer-term (52-week) trials have evaluated IMF as a weight loss strategy. None of these longer-duration studies reported significant differences between IMF and DCR in changes in weight. However, each of these studies has limitations that prohibit drawing generalizable conclusions about the relative long-term efficacy of IMF vs. DCR for obesity treatment. Methods The Daily Caloric Restriction vs. Intermittent Fasting Trial (DRIFT) is a two-arm, 52-week block randomized (1:1) clinical weight loss trial. The two intervention arms (DCR and IMF) are designed to prescribe an equivalent average weekly energy deficit from baseline weight maintenance energy requirements. Both DCR and IMF will be provided guideline-based behavioral support and a PA prescription. The primary outcome is change in body weight at 52 weeks. Secondary outcomes include changes in body composition (dual-energy x-ray absorptiometry (DXA)), metabolic parameters, total daily energy expenditure (TDEE, doubly labeled water (DLW)), EI (DLW intake-balance method, 7-day diet diaries), and patterns of physical activity (PA, activPAL device). Discussion Although DCR leads to modest weight loss success in the short-term, there is wide inter-individual variability in weight loss and poor long-term weight loss maintenance. Evidence-based dietary approaches to energy restriction that are effective long-term are needed to provide a range of evidence-based options to individuals seeking weight loss. The DRIFT study will evaluate the long-term effectiveness of IMF vs. DCR on changes in objectively measured weight, EI, and PA, when these approaches are delivered using guideline-based behavioral support and PA prescriptions. |
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spelling | doaj.art-ebba84a1c4684553a3b25c30cb6c1afa2022-12-22T02:23:14ZengBMCTrials1745-62152022-08-0123111910.1186/s13063-022-06523-2Comparison of weight loss induced by daily caloric restriction versus intermittent fasting (DRIFT) in individuals with obesity: study protocol for a 52-week randomized clinical trialDanielle M. Ostendorf0Ann E. Caldwell1Adnin Zaman2Zhaoxing Pan3Kristen Bing4Liza T. Wayland5Seth A. Creasy6Daniel H. Bessesen7Paul MacLean8Edward L. Melanson9Victoria A. Catenacci10Department of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical CampusDepartment of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical CampusDepartment of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical CampusDepartment of Biostatistics and Informatics, University of Colorado Anschutz Medical CampusDepartment of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical CampusDepartment of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical CampusDepartment of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical CampusDepartment of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical CampusDivision of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado Anschutz Medical CampusDivision of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado Anschutz Medical CampusDepartment of Medicine, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical CampusAbstract Background The standard of care for treating overweight and obesity is daily caloric restriction (DCR). While this approach produces modest weight loss, adherence to DCR declines over time and weight regain is common. Intermittent fasting (IMF) is an alternative dietary strategy for reducing energy intake (EI) that involves >60% energy restriction on 2–3 days per week, or on alternate days, with habitual intake on fed days. While numerous studies have evaluated IMF as a weight loss strategy, there are several limitations including lack of a standard-of-care DCR control, failure to provide guideline-based behavioral support, and failure to rigorously evaluate dietary and PA adherence using objective measures. To date, only three longer-term (52-week) trials have evaluated IMF as a weight loss strategy. None of these longer-duration studies reported significant differences between IMF and DCR in changes in weight. However, each of these studies has limitations that prohibit drawing generalizable conclusions about the relative long-term efficacy of IMF vs. DCR for obesity treatment. Methods The Daily Caloric Restriction vs. Intermittent Fasting Trial (DRIFT) is a two-arm, 52-week block randomized (1:1) clinical weight loss trial. The two intervention arms (DCR and IMF) are designed to prescribe an equivalent average weekly energy deficit from baseline weight maintenance energy requirements. Both DCR and IMF will be provided guideline-based behavioral support and a PA prescription. The primary outcome is change in body weight at 52 weeks. Secondary outcomes include changes in body composition (dual-energy x-ray absorptiometry (DXA)), metabolic parameters, total daily energy expenditure (TDEE, doubly labeled water (DLW)), EI (DLW intake-balance method, 7-day diet diaries), and patterns of physical activity (PA, activPAL device). Discussion Although DCR leads to modest weight loss success in the short-term, there is wide inter-individual variability in weight loss and poor long-term weight loss maintenance. Evidence-based dietary approaches to energy restriction that are effective long-term are needed to provide a range of evidence-based options to individuals seeking weight loss. The DRIFT study will evaluate the long-term effectiveness of IMF vs. DCR on changes in objectively measured weight, EI, and PA, when these approaches are delivered using guideline-based behavioral support and PA prescriptions.https://doi.org/10.1186/s13063-022-06523-2Weight lossCalorie restrictionIntermittent fastingModified fastObesityRandomized controlled trial |
spellingShingle | Danielle M. Ostendorf Ann E. Caldwell Adnin Zaman Zhaoxing Pan Kristen Bing Liza T. Wayland Seth A. Creasy Daniel H. Bessesen Paul MacLean Edward L. Melanson Victoria A. Catenacci Comparison of weight loss induced by daily caloric restriction versus intermittent fasting (DRIFT) in individuals with obesity: study protocol for a 52-week randomized clinical trial Trials Weight loss Calorie restriction Intermittent fasting Modified fast Obesity Randomized controlled trial |
title | Comparison of weight loss induced by daily caloric restriction versus intermittent fasting (DRIFT) in individuals with obesity: study protocol for a 52-week randomized clinical trial |
title_full | Comparison of weight loss induced by daily caloric restriction versus intermittent fasting (DRIFT) in individuals with obesity: study protocol for a 52-week randomized clinical trial |
title_fullStr | Comparison of weight loss induced by daily caloric restriction versus intermittent fasting (DRIFT) in individuals with obesity: study protocol for a 52-week randomized clinical trial |
title_full_unstemmed | Comparison of weight loss induced by daily caloric restriction versus intermittent fasting (DRIFT) in individuals with obesity: study protocol for a 52-week randomized clinical trial |
title_short | Comparison of weight loss induced by daily caloric restriction versus intermittent fasting (DRIFT) in individuals with obesity: study protocol for a 52-week randomized clinical trial |
title_sort | comparison of weight loss induced by daily caloric restriction versus intermittent fasting drift in individuals with obesity study protocol for a 52 week randomized clinical trial |
topic | Weight loss Calorie restriction Intermittent fasting Modified fast Obesity Randomized controlled trial |
url | https://doi.org/10.1186/s13063-022-06523-2 |
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