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 implementation of behavioral change programs across diverse populations, regions, and staff. Researchers involved with the Trial of Nonpharmacologic Interventions in the Elderly conducted a 17-week pilot study of their most complex intervention (combined weight and sodium reduction) before actual start-up of the main study. This allowed staff to rehearse implementing the program and to identify and address intervention and standardization issues. Registered dietitians in 4 US communities recruited 28 participants for the pilot study, using eligibility criteria similar to those for the main trial. Participant evaluations reflected high satisfaction with the program materials and overall approach. Minor protocol changes suggested by results of the pilot study were made easily in time for start-up of the main study. Reductions in weight and sodium intake were less than targeted but were sufficient to suggest that 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 outcomes of the main study would be compromised.