Best (but oft-forgotten) practices: sample size and power calculation for a dietary intervention trial with episodically consumed foods.

Dietary interventions often target foods that are underconsumed relative to dietary guidelines, such as vegetables, fruits, and whole grains. Because these foods are only consumed episodically for some participants, data from such a study often contains a disproportionally large number of zeros due to study participants who do not consume any of the target foods on the days that dietary intake is assessed, thus generating semicontinuous data. These zeros need to be properly accounted for when calculating sample sizes to ensure that the study is adequately powered to detect a meaningful intervention effect size. Nonetheless, this issue has not been well addressed in the literature. Instead, methods that are common for continuous outcomes are typically used to compute the sample sizes, resulting in a substantially under- or overpowered study. We propose proper approaches to calculating the sample size needed for dietary intervention studies that target episodically consumed foods. Sample size formulae are derived for detecting the mean difference in the amount of intake of an episodically consumed food between an intervention and a control group. Numerical studies are conducted to investigate the accuracy of the sample size formulae as compared with the ad hoc methods. The simulation results show that the proposed formulae are appropriate for estimating the sample sizes needed to achieve the desired power for the study. The proposed method for sample size is recommended for designing dietary intervention studies targeting episodically consumed foods.