Adaptive Nutrition Intervention Stabilizes Serum Phosphorus Levels in Hemodialysis Patients: A Multicenter Decentralized Clinical Trial Using Real-World Data
- Authors
- Chung, Moon Kyung; Kim, Do Hyoung; Park, Ji In; Lee, Sunhwa; Park, Hayne Cho; Kim, Kyungmin; Kang, Young Sun; Ko, Kangji; Kim, Jieun; Koo, Hoseok; Kim, Hyeon Ji; Cha, Jin Joo; Kwon, Young Eun; Kim, Ju Han
- Issue Date
- Jan-2024
- Publisher
- W. B. Saunders Co., Ltd.
- Keywords
- hemodialysis; nutrition intervention; renal diet; adaptive design; real-world data; decentralized clinical trial
- Citation
- Journal of Renal Nutrition, v.34, no.1, pp 47 - 57
- Pages
- 11
- Indexed
- SCIE
SCOPUS
- Journal Title
- Journal of Renal Nutrition
- Volume
- 34
- Number
- 1
- Start Page
- 47
- End Page
- 57
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/65772
- DOI
- 10.1053/j.jrn.2023.07.004
- ISSN
- 1051-2276
1532-8503
- Abstract
- Objective: This study aims to evaluate the effect of an adaptive nutritional and educational intervention for patients on hemodialysis (HD) in a routine care setting, using real-world data from electronic health records. Methods: Decentralized clinical trial of seven HD facilities recruited patients who have been on HD for over 3 months (N = 153) for an 8-week adaptive intervention protocol. Patients were divided into four groups: (1) control (2) education intervention (3) meal intervention (4) education and meal interventions. Educational contents were digitally delivered via mobile phones and premade meals tailored on laboratory findings were home-delivered. Changes in serum electrolytes and malnutrition inflammation score (MIS) were analyzed. Results: Meal intervention statistically significantly stabilized serum phosphorus level (beta = -0.81 mg/dL, 95% confidence interval = [-1.40, -0.22]) at week 8, with increased likelihood of being within target serum value range (odds ratio = 1.21, 95% confidence interval = [1.04, 1.40]). Meal group showed better nutritional status (MIS = 3.65) than the education group (MIS = 5.10) at week 8 (adjusted p < .05). No significant changes were observed in serum potassium level, depression, and self-efficacy. Conclusion: It was demonstrated that an adaptive meal intervention in a real-world care setting may benefit serum phosphorus control and nutritional status of patients on HD, without negative effect on depression levels or self-efficacy. More work is needed to develop an effective educational intervention.
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