Nutritional education for management of osteodystrophy (NEMO) trial: Design and patient characteristics, Lebanon

ABSTRACT

This study aims to determine the effect of a trained dedicated dietitian on clinical outcomes among Lebanese hemodialysis (HD) patients and thus demonstrate a viable developing country model. This paper describes the study protocol and baseline data. The study was a multicenter randomized controlled trial with parallel-group design involving 12 HD units assigned to cluster A (n = 6) or B (n = 6). A total of 570 patients met the inclusion criteria. Patients in cluster A were randomly assigned as per dialysis shift to the following Dedicated Dietitian (DD) (n = 133) and Existing Practice (EP) (n = 138) protocols. Cluster B patients (n = 299) received Trained Hospital Dietitian (THD) protocol. Dietitians of the DD and THD groups were trained by the research team on Kidney Disease Outcomes Quality Initiative nutrition guidelines. DD protocol included individualized nutrition education for 2 hours/month/HD patient for 6 months focusing on renal osteodystrophy and using the Trans-theoretical theory for behavioral change. EP protocol included nutrition education given to patients by hospital dietitians who were blinded to the study. The THD protocol included nutrition education to patients given by hospital dietitian as per the training received but within hospital responsibilities, with no set educational protocol or tools. Baseline data revealed that 40% of patients were hyperphosphatemics (> 5.5 mg/dl) with low dietary adherence and knowledge of dietary P restriction in addition to inadequate daily protein intake (58.86%+/- 33.87% of needs) yet adequate dietary P intake (795.52 +/- 366.94 mg/day). Quality of life (QOL) ranged from 48-75% of full health. Baseline differences between the 3 groups revealed significant differences in serum P, malnutrition status, adherence to diet and P chelators and in 2 factors of the QOL physical and social functioning. The data show room for improvement in the nutritional status of the patients. The NEMO trial may be able to demonstrate a better nutritional management of HD patients.