4. Discussion
CHRONIC DISEASE
The aim of this study was to test procedures, including methods of randomization and outcome measurement, to assess the feasibility and acceptability of implementing a pragmatic, scalable, and replicable food-based intervention that can be used for answering important research questions, especially pertaining to infant gut microbiome development. The purpose of reporting the results is to encourage other researchers to develop similar pragmatic food-based dietary interventions that may not have the same rigor as providing participants with 100% of their food intake—prepared, for example, in a metabolic kitchen—but would allow for lower cost testing of important diet-related research questions. As such, we report feasibility results for collecting a variety of survey data and biospecimens to indicate that this type of food-based diet intervention is a feasible approach to use for research during pregnancy in a rural population where access to health care is often a barrier to research participation.In our study population, this intervention was feasible and acceptable. Participation rates were high (93–100%) for all study components except the ASA-24 dietary recall. Self-administration of dietary recall via the ASA-24 was not well-liked by participants (n = 6 out of 25 participants who completed the final study visit noted this in a free text response on the satisfaction survey). However, for this study, we used the 2016 version of the ASA-24, which has now been updated three more times (2018, 2020, and 2022), in part to address some of the user-friendliness issues in previous versions (In terms of the composition of the food-based intervention, participants recommended providing choices in food selection to increase consumption (n = 6 out of 12 intervention participants who completed the final visit noted a version of this in a free text response). Usual care participants used their gift card incentives to buy healthy foods (n = 6 usual care group participants noted a version of this in a free text response) potentially leading to group contamination, which may be relevant for future research, depending on the study objectives. The main limitation of this work is the small sample size. We were able to test study procedures, but we are not able to make any inferences about the effect of the food-based diet intervention. However, by combining the usual care and intervention groups into a single study population, we have been able to ascertain important associations between diet, metabolites, and both adult and infant gut microbiota composition and diversity. In some small studies, nutrition education has been shown to have an impact on clinically important biomarkers. For example, in a study of 31 patients with chronic disease, an intensive nutrition education model with group and individual visits emphasizing whole, plant-based foods, significant improvements were shown in BMI, blood pressure, and cholesterol levels after 8 weeks [The scope of dietary Interventions designed specifically for pregnant women has recently been reviewed [