Brassard Didier, Presse Nancy, Chevalier Stéphanie
School of Human Nutrition, McGill University, Sainte-Anne-de-Bellevue, QC, Canada.
Faculty of Medicine and Health Sciences, University of Sherbrooke, Sherbrooke, QC, Canada.
JMIR Res Protoc. 2025 Jan 23;14:e65182. doi: 10.2196/65182.
The 2019 Canada's Food Guide provides universal recommendations to individuals aged ≥2 years. However, the extent to which these recommendations are appropriate for older adults is unknown. Although ideal, conducting a large randomized controlled trial is unrealistic in the short term. An alternative is the target trial emulation framework for causal inference, a novel approach to improve the analysis of observational data.
This study aims to describe the protocol for a target trial emulation in older adults, with an emphasis on key aspects of a hypothetical sustained diet and physical activity intervention.
To emulate the target trial, nonexperimental data from the Quebec Longitudinal Study on Nutrition and Successful Aging (NuAge; N=1753 adults aged ≥67 years) will be used. NuAge includes 4 yearly measurements of dietary intakes, covariates, and outcomes. The per-protocol causal contrast will be the primary causal contrast of interest to account for nonadherence. The sustained intervention strategy will be modeled using the parametric g-formula. In the hypothetical trial, participants will be instructed to meet sex-specific minimal intakes for vegetables and fruits, whole grains, animal- and plant-based protein foods, milk and plant-based beverages, and unsaturated fats. The eligibility criteria, follow-up, intervention, outcomes, and causal contrast in the emulation will closely align with those of the target trial, with only minor modifications. We will attempt to emulate the randomization of treatment by adjusting for baseline covariates and prebaseline dietary habits.
Data collection for NuAge was completed in June 2008. For this study, the main analysis was started in May 2024. Submission of the manuscript is expected by February 2025.
Emulating a target trial will provide the first evidence of the adequacy of the 2019 Canada's Food Guide recommendations for older adults in relation to health outcomes.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/65182.
《2019年加拿大食物指南》为2岁及以上人群提供了通用建议。然而,这些建议对老年人的适用程度尚不清楚。虽然进行大规模随机对照试验是理想的,但短期内并不现实。一种替代方法是用于因果推断的目标试验模拟框架,这是一种改进观察性数据分析的新方法。
本研究旨在描述老年人目标试验模拟的方案,重点关注假设的持续饮食和身体活动干预的关键方面。
为了模拟目标试验,将使用来自魁北克营养与成功老龄化纵向研究(NuAge;N = 1753名67岁及以上成年人)的非实验数据。NuAge包括对饮食摄入量、协变量和结果的4次年度测量。符合方案的因果对比将是考虑不依从性的主要因果对比。持续干预策略将使用参数g公式进行建模。在假设试验中,将指导参与者达到针对不同性别的蔬菜和水果、全谷物、动物性和植物性蛋白质食物、牛奶和植物性饮料以及不饱和脂肪的最低摄入量。模拟中的纳入标准、随访、干预、结果和因果对比将与目标试验紧密一致,仅做微小修改。我们将尝试通过调整基线协变量和基线前饮食习惯来模拟治疗的随机化。
NuAge的数据收集于2008年6月完成。本研究的主要分析于2024年5月开始。预计2025年2月提交手稿。
模拟目标试验将首次提供证据,证明《2019年加拿大食物指南》针对老年人的建议在健康结果方面是否充分。
国际注册报告识别码(IRRID):DERR1-10.2196/65182