纳入 Group Lifestyle Balance™ 方案的实用随机对照试验研究方案：营养基因组学、超重/肥胖和体重管理试验（NOW 试验）。
Study protocol of a pragmatic randomized controlled trial incorporated into the Group Lifestyle Balance™ program: the nutrigenomics, overweight/obesity and weight management trial (the NOW trial).
机构信息
Health and Rehabilitation Sciences, The University of Western Ontario, London, ON, Canada.
School of Food and Nutritional Sciences, Brescia University College at The University of Western Ontario, London, ON, Canada.
出版信息
BMC Public Health. 2019 Mar 15;19(1):310. doi: 10.1186/s12889-019-6621-8.
BACKGROUND
The nutrigenomics, overweight/obesity and weight management trial (NOW Trial) is a pragmatic randomized controlled trial of community-dwelling adults recruited from the Group Lifestyle Balance™ (GLB™) Program. The GLB™ Program (formerly referred to as the Diabetes Prevention Program) is an evidence-based, intensive weight management program, which was offered to overweight/obese patients (BMI ≥ 25.0 kg/m) in a rural Ontario community.
METHODS
Patients enrolled in the GLB™ Program were invited to participate in this study. GLB™ groups were randomized 1:1 to receive either the standard GLB™ program + population-based lifestyle advice for weight management, or a modified GLB™ program + personalized, genetic-based lifestyle advice for weight management. The purpose of this study is to determine if the provision of genetic-based lifestyle guidelines is superior to the provision of population-based guidelines in a pragmatic clinical setting to promote changes in: body composition, weight, body mass index, dietary and physical activity habits, as well as attitudes, subjective norms, and behavioural control. The 12-month intervention protocol consists of 23 group-based sessions and 4 one-on-one sessions. Data collection time points include baseline in addition to 3, 6, and 12-month follow up. The comprehensive study design is described in the present manuscript, using both the extended CONSORT checklist for reporting pragmatic trials and the SPIRIT checklist as guidance during manuscript development.
DISCUSSION
Overall, this study seeks to pragmatically determine if the provision of DNA-based lifestyle advice leads to improved health and lifestyle outcomes compared to the provision of standard, population-based lifestyle advice. The results of this trial can be used to inform clinical and community nutrition practice guidelines.
TRIAL REGISTRATION
This study was registered with clinicaltrials.gov : NCT03015012 on January 9, 2017.
背景
营养基因组学、超重/肥胖和体重管理试验（NOW 试验）是一项针对社区居民的实用随机对照试验，这些居民是从 Group Lifestyle Balance™（GLB™）计划中招募的。GLB™计划（以前称为糖尿病预防计划）是一个基于证据的强化体重管理计划，为安大略省农村社区的超重/肥胖患者（BMI≥25.0kg/m）提供。
方法
参加 GLB™计划的患者被邀请参加这项研究。GLB™组以 1:1 的比例随机分为两组，一组接受标准 GLB™计划+基于人群的体重管理生活方式建议，另一组接受改良 GLB™计划+基于个性化、基因的体重管理生活方式建议。本研究的目的是确定在实用临床环境中，提供基于基因的生活方式指南是否优于提供基于人群的指南，以促进以下方面的变化：身体成分、体重、体重指数、饮食和体力活动习惯，以及态度、主观规范和行为控制。为期 12 个月的干预方案包括 23 次小组会议和 4 次一对一会议。数据收集时间点包括基线以及 3、6 和 12 个月的随访。本研究采用扩展的 CONSORT 报告实用试验清单和 SPIRIT 清单作为指导，详细描述了综合研究设计。
讨论
总的来说，这项研究旨在从实用的角度确定提供基于 DNA 的生活方式建议是否比提供标准的基于人群的生活方式建议能带来更好的健康和生活方式结果。该试验的结果可用于为临床和社区营养实践指南提供信息。
试验注册
该研究于 2017 年 1 月 9 日在 clinicaltrials.gov 上注册：NCT03015012。
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