PILOT-STUDY TO ENHANCE START-UP OF A MULTICENTER NUTRITION INTERVENTION TRIAL

Multicenter trials are important for answering questions that require large numbers of subjects. Such trials require standardized implementa tion of behavioral change programs across diverse populations, regions , and staff. Researchers involved with the Trial of Nonpharmacologic i nterventions in the Elderly conducted a 17-week pilot study of their m ost complex intervention (combined weight and sodium reduction) before actual start-up of the main study. This allowed staff to rehearse imp lementing the program and to identify and address intervention and sta ndardization issues. Registered dietitians in 4 US communities recruit ed 28 participants for the pilot study, using eligibility criteria sim ilar to those for the main trial. Participant evaluations reflected hi gh satisfaction with the program materials and overall approach. Minor protocol changes suggested by results of the pilot study were made ea sily in time for start-up of the main study. Reductions in weight and sodium intake were less than targeted but were sufficient to suggest t hat the intervention would be effective under optimal conditions. This partial achievement of goals in the pilot study underscored the need to allow for a learning curve, for without it standardization and outc omes of the main study would be compromised.