A Mediterranean dietary intervention in persons at high risk of colon cancer: recruitment and retention to an intensive study requiring biopsies.

This study recruited persons at increased risk of colon cancer to an intensive dietary intervention study that required biopsies of the colon by flexible sigmoidoscopy at baseline and after six months of intervention. A total of 1314 individuals contacted the study, and only 16 individuals indicated that the sigmoidoscopy procedure was an obstacle to study participation. A total of 270 individuals completed a screening visit and signed a screening consent form. Inquiries about the study tended to be fewer in the winter and late summer. Failure to return food records was the most common reason for exclusion. Dietary recall at enrollment indicated that subjects were consuming significantly more vegetables, lower sodium and a lower glycemic load on the day before starting the study vs. during the eligibility phase which might have an impact on biomarker measures. This makes it important to capture dietary changes in the period between determination of eligibility and enrollment. Subjects (n=120) were randomized to follow a Healthy Eating or a Mediterranean Diet, each of which required substantial dietary record-keeping. The study completion rate was 78%, and subjects reported high satisfaction with study participation. Of the 93 individuals who completed the study, only one refused the flexible sigmoidoscopy at the final visit. These findings suggest that flexible sigmoidoscopy does not appear to be a barrier for recruitment of high-risk individuals to an intensive dietary intervention trial, but that completing food records can be.

RCT Entities:   Population Interventions Outcomes