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Abstract：
Adherence is a critical factor to consider when interpreting study results from randomized clinical trials (RCTs) comparing one diet to another, but it is frequently not reported by researchers. The purpose of this secondary analysis of the Keto-Med randomized trial was to provide a detailed examination and comparison of the adherence to the two study diets (Well Formulated Ketogenic Diet (WFKD) and Mediterranean Plus (Med-Plus)) under the two conditions: all food being provided (delivered) and all food being obtained by individual participants (self-provided). Diet was assessed at six time points including baseline (×1), week 4 of each phase when participants were receiving food deliveries (×2), week 12 of each phase when participants were preparing and providing food on their own (×2), and 12 weeks after participants completed both diet phases and were free to choose their own diet pattern (×1). The adherence scores for WFKD and Med-Plus were developed specifically for this study. Average adherence to the two diet patterns was very similar during both on-study time points of the intervention. Throughout the study, a wide range of adherence was observed among participants-for both diet types and during both the delivery phase and self-provided phase. Insight from this assessment of adherence may aid other researchers when answering the important question of how to improve behavioral adherence during dietary trials. This study is registered at clinicaltrials.gov NCT03810378.
摘要：
坚持是解释随机临床试验（RCT）比较一种饮食与另一种饮食的研究结果时需要考虑的关键因素。但研究人员经常没有报道。Keto-Med随机试验的二次分析的目的是提供对两种研究饮食（配方良好的生酮饮食（WFKD）和地中海加（Med-Plus））的依从性的详细检查和比较两种条件：所有食物都提供（交付），所有食物都由个体参与者获得（自备）。在包括基线（×1）在内的六个时间点评估饮食，参与者接受食物交付的每个阶段的第4周（×2），每个阶段的第12周，参与者自行准备和提供食物(×2)，在参与者完成两个饮食阶段并自由选择自己的饮食模式（×1）后12周。WFKD和Med-Plus的依从性评分是专门为这项研究开发的。在干预的两个研究时间点，对两种饮食模式的平均依从性非常相似。在整个研究过程中,参与者在两种饮食类型以及分娩阶段和自备阶段均观察到广泛的依从性.这种依从性评估的见解可能会帮助其他研究人员回答如何在饮食试验中提高行为依从性的重要问题。这项研究在clinicaltrials.govNCT03810378注册。
