A Pilot Clinical Trial of a Nutrition Education Program on Quality of Life in Chronic Kidney Disease

Nutritional counseling plays a critical role in managing patients with chronic kidney disease. However, dietary restrictions may negatively impact quality of life (QoL) and nutritional status. This pilot randomized clinical trial evaluated a structured nutrition education program (NEP) based on a coaching methodology on QoL, morphofunctional status and other patient-reported outcomes. This single-center pilot trial was conducted in Málaga (Spain) between April 2021 and December 2022. Patients with chronic kidney disease (CKD) stages 4-5 not on dialysis were randomized to either an NEP group (personalized Mediterranean-style diet, educational workshops, and motivational coaching by a registered dietitian and specialized nurse) or a control group (general dietary recommendations). The primary outcome was three-month change in QoL measured by Kidney Disease Quality of Life Instrument (KDQOL-36™). Secondary outcomes included changes in morphofunctional status, anxiety and depressive symptoms, self-efficacy, CKD knowledge and dietary adherence. Data were collected using validated questionnaires, anthropometric measures, bioimpedance, handgrip strength, and laboratory tests. Between-group differences were analyzed using ANCOVA, adjusted for baseline values. Of 76 participants, 68 completed the trial N=33 in NEP arm; N=35 in control arm). Compared to controls, the NEP group showed greater improvements in QoL domains: "effects of kidney disease" (8.4 points; 95%CI [0, 16.8]) and "disease burden" (14.9 points; 95%CI [3.4, 26.4]). Significant differences were also observed in fat mass (-1.0 kg; 95%CI [-1.8, -0.1]), hip circumference (-2.7 cm; 95%CI [-4.4, -1.0]), triceps skinfold (-1.6 mm; 95%CI [-2.9, -0.2]), and physical performance (0.7 points; 95%CI [0.1, 1.3]). The NEP group also showed improvements in Mediterranean diet adherence (2.7 points; 95%CI [2.0, 3.5]), serum albumin (0.1 g/dl; 95% CI [0, 0.2]), 24-hour urine volume (262.8 ml/day; 95%CI [64.5 to 461.0]), depressive symptoms (-1.7 points; 95%CI [-3.3, -0.2]), self-efficacy (2.1 points; 95%CI [1.5, 2.7]), and CKD knowledge (0.2 points; 95%CI [0.1, 0.3]). This nutrition education program improved QoL, morphofunctional parameters, and patient-reported outcomes in patients with CKD, supporting its feasibility and potential clinical utility.