Discussion
weight loss, CRC
DYSPLASTIC, RECRUITMENT
The study described in this protocol will address potential solutions to reduce the high risk of CRC among AA/B adults by testing the ability of a MedDiet, weight loss, or both to reduce biological risk markers of CRC. This study will also address a potential mechanistic underpinning, the gut microbiome-bile acid axis, leading the way to more precise interventions.To achieve these objectives, our study will use innovative and rigorous methods. First, measuring the exfoliome via excreted stool is less invasive than endoscopic sampling of the gut epithelium. It is also responsive to dietary interventions, can be used to measure the human gut transcriptome, and consists of epithelial cells which have been shown to become dysplastic even before stem cells do [Our study is not without potential pitfalls and alternative outcomes. We have prepared for some of these eventualities. For example, participants who are not randomized to their preferred arm may pursue weight loss or dietary change independent of the intervention. If, for instance, a Med-A participant loses 5% of their body weight, this may obscure differences in outcomes between Med-A and any other arm. To help avoid this, we have implemented adherence measures to be taken throughout the study so that we may intervene when appropriate. We will also perform a per-protocol analysis, including only those who are adherent to their intervention arm. Similarly, given antibiotics’ profound impact on the gut microbiota, we will perform a sensitivity analysis whereby those who consume antibiotics during the intervention will be excluded from analysis to determine if results change significantly. Lastly, delivering the intervention remotely and by social media/email may dissuade less tech savvy participants during recruitment or disengage them after randomization. We determined this was a necessity to improve recruitment, as many would be participants were concerned with in-person classes given the continuing COVID-19 pandemic. Also, many work and were unable to attend in-person, group classes during working hours. Besides, remote intervention delivery is more convenient than in-person classes which would have required substantial travel time for participants, thus potentially improving retention. If successful in a remote format, our intervention could improve recruitment and retention for future studies.