TY - JOUR
T1 - A Self-management Approach for Dietary Sodium Restriction in Patients With CKD
T2 - A Randomized Controlled Trial
AU - Humalda, Jelmer K.
AU - Klaassen, Gerald
AU - de Vries, Hanne
AU - Meuleman, Yvette
AU - Verschuur, Lara C.
AU - Straathof, Elisabeth J.M.
AU - Laverman, Gozewijn D.
AU - Bos, Willem Jan W.
AU - van der Boog, Paul J.M.
AU - Vermeulen, Karin M.
AU - Blanson Henkemans, Olivier A.
AU - Otten, Wilma
AU - de Borst, Martin H.
AU - van Dijk, Sandra
AU - Navis, Gerjan J.
AU - SUBLIME Investigators
N1 - Funding Information:
P.J.M. van der Boog, S. van Dijk, G.J. Navis (project leaders); J.K. Humalda (project coordination); G. Klaassen, Y. Meuleman, L.C. Verschuur, E.J.M. Straathof, O.A. Blanson Henkemans, W.J.W. Bos, M.H. de Borst, G.D. Laverman, W. Otten, K.M. Vermeulen, and H. de Vries (investigators). Jelmer K. Humalda, MD, PhD, Gerald Klaassen, MSc, Hanne de Vries, MD, Yvette Meuleman, PhD, Lara C. Verschuur, MD, Elisabeth J.M. Straathof, MD, Gozewijn D. Laverman, MD, PhD, Willem Jan W. Bos, MD, PhD, Paul J.M. van der Boog, MD, PhD, Karin M. Vermeulen, PhD, Olivier A. Blanson Henkemans, PhD, Wilma Otten, PhD, Martin H. de Borst, MD, PhD, Sandra van Dijk, PhD, and Gerjan J. Navis, MD, PhD. Research idea and study design: JKH, GK, YM, GDL, WJWB, PJMB, SvD, GJN; intellectual contributions/data interpretation: JKH, GK, HdV, YM, LCV, EJMS, GDL, WJWB, PJMB, MHdB, SvD, GJN; statistical analysis: JKH, GK, YM; cost analysis: KMV; independent focus groups: OABH, WO. Each author contributed important intellectual content during manuscript drafting or revision and accepts accountability for the overall work by ensuring that questions pertaining to the accuracy or integrity of any portion of the work are appropriately investigated and resolved. The SUBLIME study was funded by a grant from the Netherlands Organization for Health Research and Development (ZonMw; project number 837001005 of the ?Doelmatigheidsonderzoek 2013-2015? program) and by the Dutch Kidney Foundation (project code PV48). The funding body was involved in the study design and data collection (ie, assessment of costs of the intervention vs routine care, and our collection of these data was mandated by the funding body). The funders were not involved in the analyses, reporting, or decision to submit for publication. The e-health module was developed by Bonstato, in collaboration with S. van Dijk and Y. Meuleman. The authors declare that they have no relevant financial interests. We acknowledge the contribution of E. Buskens, C. van Daelen, M.W. Dijk-Schaap, B. Gabel, J.D. de Groot, E. van Houdt, C.G.J. Indemans, T. Kok, I.N. Kunnekes, H. Piels, T. R?vekamp, I. Schultze, A. Spijker, M. Storm, I.M. van Weverwijk, D. Wiefferink, and Nefrovisie. The trial protocol and deidentified participant data are available upon reasonable request until 2 years after publication, via the corresponding author. The data can be made available to researchers who provide a methodologically sound proposal in their request. Reuse of the data can be permitted upon reasonable request via the corresponding author. Received February 26, 2019. Evaluated by 2 external peer reviewers, with direct editorial input from a Statistics/Methods Editor, an Associate Editor, and the Editor-in-Chief. Accepted in revised form October 21, 2019.
Funding Information:
The SUBLIME study was funded by a grant from the Netherlands Organization for Health Research and Development ( ZonMw ; project number 837001005 of the “Doelmatigheidsonderzoek 2013-2015” program) and by the Dutch Kidney Foundation (project code PV48). The funding body was involved in the study design and data collection (ie, assessment of costs of the intervention vs routine care, and our collection of these data was mandated by the funding body). The funders were not involved in the analyses, reporting, or decision to submit for publication. The e-health module was developed by Bonstato, in collaboration with S. van Dijk and Y. Meuleman.
Publisher Copyright:
© 2019 National Kidney Foundation, Inc.
PY - 2020/6/1
Y1 - 2020/6/1
N2 - Rationale & Objective: Patients with chronic kidney disease (CKD) are particularly sensitive to dietary sodium. We evaluated a self-management approach for dietary sodium restriction in patients with CKD. Study Design: Randomized controlled trial. Setting & Participants: Nephrology outpatient clinics in 4 Dutch hospitals. 99 adults with CKD stages 1 to 4 or a functioning (estimated glomerular filtration rate ≥ 25 mL/min/1.73 m2) kidney transplant, hypertension, and sodium intake >130 mmol/d. Intervention: Routine care was compared with routine care plus a web-based self-management intervention including individual e-coaching and group meetings implemented over a 3-month intervention period, followed by e-coaching over a 6-month maintenance period. Outcomes: Primary outcomes were sodium excretion after the 3-month intervention and after the 6-month maintenance period. Secondary outcomes were blood pressure, proteinuria, costs, quality of life, self-management skills, and barriers and facilitators for implementation. Results: Baseline estimated glomerular filtration rate was 55.0 ± 22.0 mL/min/1.73 m2. During the intervention period, sodium excretion decreased in the intervention group from 188 ± 8 (SE) to 148 ± 8 mmol/d (P < 0.001), but did not change significantly in the control group. At 3 months, mean sodium excretion was 24.8 (95% CI, 0.1-49.6) mmol/d lower in the intervention group (P = 0.049). At 3 months, systolic blood pressure (SBP) decreased in the intervention group from 140 ± 3 to 132 ± 3 mm Hg (P < 0.001), but was unchanged in the control group. Mean difference in SBP across groups was −4.7 (95% CI, −10.7 to 1.3) mm Hg (P = 0.1). During the maintenance phase, sodium excretion increased in the intervention group, but remained lower than at baseline at 160 ± 8 mmol/d (P = 0.01), while it decreased in the control group from 174 ± 9 at the end of the intervention period to 154 ± 9 mmol/d (P = 0.001). Consequently, no difference in sodium excretion between groups was observed after the maintenance phase. There was no difference in SBP between groups after the maintenance phase. Limitations: Limited power, postrandomization loss to follow-up, Hawthorne effect, lack of dietary data, short-term follow-up. Conclusions: A coaching intervention reduced sodium intake at 3 months. Efficacy during the maintenance phase was diminished, possibly due to inadvertent adoption of the intervention by the control group. Funding: Grant funding from the Netherlands Organization for Health Research and Development and the Dutch Kidney Foundation. Trial registration: Registered at ClinicalTrials.gov with study number NCT02132013.
AB - Rationale & Objective: Patients with chronic kidney disease (CKD) are particularly sensitive to dietary sodium. We evaluated a self-management approach for dietary sodium restriction in patients with CKD. Study Design: Randomized controlled trial. Setting & Participants: Nephrology outpatient clinics in 4 Dutch hospitals. 99 adults with CKD stages 1 to 4 or a functioning (estimated glomerular filtration rate ≥ 25 mL/min/1.73 m2) kidney transplant, hypertension, and sodium intake >130 mmol/d. Intervention: Routine care was compared with routine care plus a web-based self-management intervention including individual e-coaching and group meetings implemented over a 3-month intervention period, followed by e-coaching over a 6-month maintenance period. Outcomes: Primary outcomes were sodium excretion after the 3-month intervention and after the 6-month maintenance period. Secondary outcomes were blood pressure, proteinuria, costs, quality of life, self-management skills, and barriers and facilitators for implementation. Results: Baseline estimated glomerular filtration rate was 55.0 ± 22.0 mL/min/1.73 m2. During the intervention period, sodium excretion decreased in the intervention group from 188 ± 8 (SE) to 148 ± 8 mmol/d (P < 0.001), but did not change significantly in the control group. At 3 months, mean sodium excretion was 24.8 (95% CI, 0.1-49.6) mmol/d lower in the intervention group (P = 0.049). At 3 months, systolic blood pressure (SBP) decreased in the intervention group from 140 ± 3 to 132 ± 3 mm Hg (P < 0.001), but was unchanged in the control group. Mean difference in SBP across groups was −4.7 (95% CI, −10.7 to 1.3) mm Hg (P = 0.1). During the maintenance phase, sodium excretion increased in the intervention group, but remained lower than at baseline at 160 ± 8 mmol/d (P = 0.01), while it decreased in the control group from 174 ± 9 at the end of the intervention period to 154 ± 9 mmol/d (P = 0.001). Consequently, no difference in sodium excretion between groups was observed after the maintenance phase. There was no difference in SBP between groups after the maintenance phase. Limitations: Limited power, postrandomization loss to follow-up, Hawthorne effect, lack of dietary data, short-term follow-up. Conclusions: A coaching intervention reduced sodium intake at 3 months. Efficacy during the maintenance phase was diminished, possibly due to inadvertent adoption of the intervention by the control group. Funding: Grant funding from the Netherlands Organization for Health Research and Development and the Dutch Kidney Foundation. Trial registration: Registered at ClinicalTrials.gov with study number NCT02132013.
KW - behavioral intervention
KW - blood pressure (BP)
KW - chronic kidney disease (CKD)
KW - co-creation
KW - dietary modification
KW - hypertension
KW - lifestyle
KW - modifiable risk factor
KW - randomized controlled trial (RCT)
KW - self-regulation
KW - Sodium
KW - sodium intake
KW - transplantation
UR - http://www.scopus.com/inward/record.url?scp=85077932523&partnerID=8YFLogxK
U2 - 10.1053/j.ajkd.2019.10.012
DO - 10.1053/j.ajkd.2019.10.012
M3 - Article
C2 - 31955921
SN - 0272-6386
VL - 75
SP - 847
EP - 856
JO - American Journal of Kidney Diseases
JF - American Journal of Kidney Diseases
IS - 6
ER -