将Keyto应用程序和设备与慧俪轻体（Weight Watchers）的减肥应用程序进行比较：一项随机试验的方案。
Comparing the Keyto App and Device with Weight Watchers' WW App for Weight Loss: Protocol for a Randomized Trial.
作者信息
Locke Sean R, Falkenhain Kaja, Lowe Dylan A, Lee Terry, Singer Joel, Weiss Ethan J, Little Jonathan P
机构信息
University of British Columbia, Kelowna, BC, Canada.
University of California San Francisco, San Francisco, CA, United States.
出版信息
JMIR Res Protoc. 2020 Aug 17;9(8):e19053. doi: 10.2196/19053.
BACKGROUND
Obesity and being overweight are major contributing factors for many diseases. Calorie restricted diets often fail to result in sustained long-term weight loss. Very low-carbohydrate, high-fat ketogenic diets have been suggested to have superior metabolic and weight loss effects. Keyto is a low-cost, highly scalable mobile health (mHealth) app paired with a noninvasive biofeedback tool aimed at facilitating weight loss through a personalized healthy and predominantly plant- and fish-based ketogenic diet.
OBJECTIVE
This protocol describes a randomized trial comparing the efficacy of the Keyto mHealth app and device intervention to that of Weight Watchers' WW app in individuals who are overweight or obese. The primary outcome is weight loss after 12 weeks. Secondary and exploratory outcomes, including metabolic and cardiovascular risk factors, will be assessed at 12, 24, and 48 weeks.
METHODS
A total of 144 participants will be recruited and randomized to either the Keyto program or Weight Watchers program. Study participants will be guided through the study via video conference or phone calls and will undergo a fasting blood analysis performed by a third-party diagnostic lab at weeks 0 and 12 to assess metabolic and cardiovascular risk markers. All participants will be asked to weigh themselves daily on a study-provided Bluetooth-enabled scale. Participants randomized to the Keyto arm will also be asked to measure their breath acetone levels, a measure of ketosis, with the Keyto device 3 times per day.
RESULTS
Recruitment started in December 2019. Rolling recruitment is expected to be completed by July 2020. Data collection and analysis of the primary intervention phase is expected to be completed in October 2020. The 24- and 48-week follow-ups are expected to be completed in January 2021 and July 2021, respectively.
CONCLUSIONS
This trial will provide high-quality evidence regarding the efficacy of the Keyto weight loss program in individuals who are overweight and obese in a free-living condition. This study also fills a gap by examining the impact of a ketogenic diet emphasizing plant- and fish-based fats on blood lipid profile and cardiovascular disease risk.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04165707; https://clinicaltrials.gov/ct2/show/NCT04165707.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19053.
背景
肥胖和超重是许多疾病的主要促成因素。限制热量的饮食往往无法带来持续的长期体重减轻。有人提出，极低碳水化合物、高脂肪的生酮饮食具有更好的代谢和减肥效果。Keyto是一款低成本、高度可扩展的移动健康（mHealth）应用程序，配有非侵入性生物反馈工具，旨在通过个性化的、以健康为主且主要基于植物和鱼类的生酮饮食促进减肥。
目的
本方案描述了一项随机试验，比较Keyto移动健康应用程序和设备干预与慧俪轻体（Weight Watchers）的WW应用程序对超重或肥胖个体的疗效。主要结局是12周后的体重减轻情况。次要和探索性结局，包括代谢和心血管危险因素，将在第12、24和48周进行评估。
方法
总共将招募144名参与者，并随机分为Keyto计划组或慧俪轻体计划组。研究参与者将通过视频会议或电话接受研究指导，并将在第0周和第12周接受由第三方诊断实验室进行的空腹血液分析，以评估代谢和心血管风险标志物。所有参与者将被要求每天使用研究提供的蓝牙秤称重。随机分配到Keyto组的参与者还将被要求每天使用Keyto设备测量3次呼气丙酮水平（一种酮症测量方法）。
结果
招募工作于2019年12月开始。预计滚动招募将于2020年7月完成。主要干预阶段的数据收集和分析预计将于2020年10月完成。24周和48周的随访预计分别于2021年1月和2021年7月完成。
结论
本试验将为Keyto减肥计划在自由生活状态下的超重和肥胖个体中的疗效提供高质量证据。本研究还通过研究强调基于植物和鱼类脂肪的生酮饮食对血脂谱和心血管疾病风险的影响填补了一项空白。
试验注册
ClinicalTrials.gov NCT04165707；https://clinicaltrials.gov/ct2/show/NCT04165707。
国际注册报告识别码（IRRID）：DERR1-10.2196/19053。
Zotero 插件