Log2Lose的研究方案:一项随机对照试验,旨在评估成年肥胖患者饮食自我监控和中期减肥的经济激励。

IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Corrine I. Voils , Jennifer M. Gierisch , Jane F. Pendergast , Clemontina A. Davenport , Maren K. Olsen , Cherie Barnes , Michelle Bean , Lisa Cadmus-Bertram , Jamie Colon , Felix Elwert , Katya Garza , Kara L. Gavin , Sarah Jackson , Hailey Miller , Sarah Morton-Oswald , Samantha Pabich , Shelby D. Reed , William S. Yancy Jr. , Ryan J. Shaw
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引用次数: 0

摘要

虽然行为减肥计划对达到临床显著的减肥效果是有效的,但坚持这样的计划是可变的。在某些领域,通过小额财政激励的积极强化已显示出增加行为依从性和临床结果的希望。然而,对于体重管理来说,是激励行为(卡路里记录),结果(体重减轻),还是两者兼而有之,目前尚不清楚。我们报告了一项采用三期2 × 2因子设计的两点临床试验的基本原理和设计,以评估财务激励对卡路里记录和/或每周体重减轻的影响。第一阶段是为期26周的激励减肥期,每两周进行一次虚拟小组会议;第二阶段包括为期26周的奖励减肥维持期,每月进行3次小组会议和5次个人咨询电话;第三阶段是26周的减肥维持期,没有奖励,每个月打三个电话。参与者被要求在智能手机应用程序上记录他们的卡路里摄入量,并定期用体重秤称体重。每周对这些数据进行处理,以确定参与者是否有资格获得从0美元到10美元不等的经济奖励。主要结局是参与者在26 周时达到临床显著体重减轻至少5% %的比例。次要结果是52周和78 周时测量的相同比例,以及78 周时血压和心血管药物使用情况。减肥动机将作为治疗效果的潜在中介进行研究。将计算干预费用和成本效益,以便为实施提供信息。Clinicaltrials.gov注册:NCT04770909。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Study protocol for Log2Lose: A randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity
Although behavioral weight-loss programs are efficacious for achieving clinically significant weight loss, adherence to such programs is variable. Positive reinforcement through small financial incentives has shown promise for increasing adherence to behaviors and clinical outcomes in some domains. Yet, for weight management, it is unknown whether to incent the behavior (calorie logging), the outcome (weight loss), or both. We report the rationale and design for a two-site clinical trial employing a three-phase, 2 × 2 factorial design to evaluate the impact of financial incentives for calorie logging and/or weekly weight loss. Phase I involved a 26-week incentivized weight-loss period with virtual group sessions every two weeks; Phase II involved a 26-week incentivized weight-loss maintenance period with three monthly group sessions and five individual counseling telephone calls; and Phase III involved a 26-week weight-loss maintenance period without incentives with three bimonthly calls. Participants were asked to record their caloric intake on a smartphone application and to weigh themselves regularly on a cellular scale. These data were processed each week to determine if participants qualified for a financial incentive ranging from $0 to $10. The primary outcome was the proportion of participants achieving clinically significant weight loss of at least 5 % at 26 weeks. Secondary outcomes were the same proportions measured at 52 and 78 weeks, and blood pressure and cardiovascular medication use at 78 weeks. Motivation for weight loss will be examined as a potential mediator of the treatment effect. Intervention cost and cost-effectiveness will be calculated to inform implementation.
Clinicaltrials.gov registration: NCT04770909
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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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