Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Zhang W

PROVIDER: S-EPMC7528564 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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

Zhang Wei W Liu Aiyi A Zhang Zhiwei Z Nansel Tonja T Halabi Susan S

The American journal of clinical nutrition 20201001 4

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 ca ...[more]

PMID: 32644103

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Project description:There has been great public health interest in estimating usual, i.e., long-term average, intake of episodically consumed dietary components that are not consumed daily by everyone, e.g., fish, red meat and whole grains. Short-term measurements of episodically consumed dietary components have zero-inflated skewed distributions. So-called two-part models have been developed for such data in order to correct for measurement error due to within-person variation and to estimate the distribution of usual intake of the dietary component in the univariate case. However, there is arguably much greater public health interest in the usual intake of an episodically consumed dietary component adjusted for energy (caloric) intake, e.g., ounces of whole grains per 1000 kilo-calories, which reflects usual dietary composition and adjusts for different total amounts of caloric intake. Because of this public health interest, it is important to have models to fit such data, and it is important that the model-fitting methods can be applied to all episodically consumed dietary components.We have recently developed a nonlinear mixed effects model (Kipnis, et al., 2010), and have fit it by maximum likelihood using nonlinear mixed effects programs and methodology (the SAS NLMIXED procedure). Maximum likelihood fitting of such a nonlinear mixed model is generally slow because of 3-dimensional adaptive Gaussian quadrature, and there are times when the programs either fail to converge or converge to models with a singular covariance matrix. For these reasons, we develop a Monte-Carlo (MCMC) computation of fitting this model, which allows for both frequentist and Bayesian inference. There are technical challenges to developing this solution because one of the covariance matrices in the model is patterned. Our main application is to the National Institutes of Health (NIH)-AARP Diet and Health Study, where we illustrate our methods for modeling the energy-adjusted usual intake of fish and whole grains. We demonstrate numerically that our methods lead to increased speed of computation, converge to reasonable solutions, and have the flexibility to be used in either a frequentist or a Bayesian manner.

Dataset Information

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

Publications

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

Similar Datasets

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