Key Points:
An intervention with a nutrition education program improved several domains of quality of life and morphofunctional status parameters.
The nutrition education program reduced depressive symptoms and enhanced self-efficacy and CKD knowledge.
The intervention led to better dietary adherence and preserved serum albumin levels, without adversely affecting proteinuria or electrolyte balance.
Background: Nutritional counseling plays a critical role in managing patients with CKD. However, dietary restrictions may negatively affect 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.
Methods: This single-center pilot trial was conducted in Málaga (Spain) between April 2021 and December 2022. Patients with 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 3-month change in QoL measured by Kidney Disease Quality of Life Instrument. 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 analysis of covariance, adjusted for baseline values.
Results: Of 76 participants, 68 completed the trial (n=33 in NEP arm; n=35 in control arm). Compared with controls, the NEP group showed greater improvements in QoL domains: effects of kidney disease (8.4 points; 95% confidence interval [CI], 0 to 16.8) and disease burden (14.9 points; 95% CI, 3.4 to 26.4). Significant differences were also observed in fat mass (−1.0 kg; 95% CI, −1.8 to −0.1), hip circumference (−2.7 cm; 95% CI, −4.4 to −1.0), triceps skin-fold (−1.6 mm; 95% CI, −2.9 to −0.2), and physical performance (0.7 points; 95% CI, 0.1 to 1.3). The NEP group also showed improvements in Mediterranean diet adherence (2.7 points; 95% CI, 2.0 to 3.5), serum albumin (0.1 g/dl; 95% CI, 0 to 0.2), 24-hour urine volume (262.8 ml/d; 95% CI, 64.5 to 461.0), depressive symptoms (−1.7 points; 95% CI, −3.3 to −0.2), self-efficacy (2.1 points; 95% CI, 1.5 to 2.7), and CKD knowledge (0.2 points; 95% CI, 0.1 to 0.3).
Conclusions: This NEP improved QoL, morphofunctional parameters, and patient-reported outcomes in patients with CKD, supporting its feasibility and potential clinical utility.
Clinical Trial registry name and registration number::
ClinicalTrials.gov number:
Keywords: nutrition.