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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Main Authors: 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
Format: Article
Language:English
Published: BMC 2022-08-01
Series:Trials
Subjects:
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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