Original ResearchAn Evaluation of Alternative Technology-Supported Counseling Approaches to Promote Multiple Lifestyle Behavior Changes in Patients With Type 2 Diabetes and Chronic Kidney Disease
Introduction
Type 2 diabetes (T2D) is a chronic, progressive condition associated with a variety of complications.1, 2, 3, 4, 5, 6, 7, 8 Chronic kidney disease (CKD) is a common complication, affecting ∼40%-50% of T2D patients.9,10 In 2016, Medicare spending exceeded $79 billion for CKD and $35 billion for kidney failure.11 The United States Renal Data System Annual Data Report notes that reduction in expenditures could be achieved by reducing progression to kidney failure and preventing the development of related cardiovascular disease.11
Multiple modifiable factors appear to be involved in the development and progression of CKD to kidney failure, including obesity,12, 13, 14, 15, 16, 17, 18 lack of physical activity and sedentary behavior,19, 20, 21, 22, 23 and excess dietary sodium intake.24, 25, 26 Hyperphosphatemia, a well-recognized problem in patients with kidney failure, also may contribute to vascular calcification in earlier stages of CKD.27, 28, 29, 30, 31, 32 Lifestyle interventions have the potential to slow CKD progression by reducing obesity, increasing physical activity, and decreasing dietary sodium and phosphorus intake, but the effectiveness of this approach depends on the ability to produce sustained behavior change. Behavioral methods that target psychosocial determinants (e.g., attitudes, social influence, risk perceptions, and self-efficacy) are generally considered essential components of lifestyle and self-management interventions. However, theory-based behavior change research has traditionally targeted one behavior at a time and provided little guidance on best approaches for targeting multiple behaviors.33 We assert that behavioral methods alone may be insufficient for engaging patients in multiple behavior changes, due to the cognitive burden of paying attention to multiple aspects of one’s lifestyle,34,35 and the complexity of information required to make informed self-management decisions.36,37
The purpose of the Diabetes Healthy Hearts and Kidneys (HHK) Study is to evaluate alternative remotely delivered, technology-supported intervention approaches for engaging patients with T2D and concurrent CKD in multiple lifestyle behavior changes (weight loss, physical activity, and dietary restriction of sodium and phosphate additives). We compared the main effects of Social Cognitive Theory–based38 Behavioral Group Counseling (hereafter SCT), technology-based self-monitoring (to reduce vigilance and information burden, hereafter MONITORING), and their interaction (hereafter COMBINED), to baseline advice about weight loss, physical activity, and dietary intake of sodium and phosphate additives (hereafter ADVICE): We hypothesized that the magnitude of the effect of the interventions on the proportion of participants demonstrating ≥5% baseline body weight loss, and reductions in urinary excretion of sodium and phosphorus (primary outcomes) would be COMBINED > SCT > ADVICE. In exploratory analyses, we proposed to describe the impact of MONITORING on primary outcomes. We also proposed exploratory analyses of the impact of randomization assignment on hemoglobin A1c, serum lipids, blood pressure, and vascular stiffness.
Section snippets
Design
We previously published the study rationale, design, and pretrial pilot activities related to this study.39 In brief, HHK was a 2 × 2 factorial, randomized controlled trial of adults who were overweight or obese and had T2D and concurrent CKD. Using computer-generated permuted blocks, participants were randomized first to SCT or no-SCT and, within these groups, re-randomized to MONITORING or no-MONITORING. The 4 resulting groups were ADVICE, MONITORING, SCT, and COMBINED. Measurements were
Results
Participants were recruited from NYULH between January 2016 and April 2019. Of the 3,575 individuals who self-referred and were screened, 372 were interested and eligible, 256 were randomized, and 186 of randomized participants (73%) completed 6-month assessments. The CONSORT diagram is shown in Figure 1. As shown in Table 1, randomized participants tended to be older, obese, White individuals who were married or partnered and had a high school or greater education, health insurance, and
Discussion
Cardiovascular disease, rather than kidney failure, is the leading cause of death in patients with CKD, making obesity an important treatment target.46 While the 2020 update of the Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guideline for Nutrition in CKD does not recommend weight loss, neither does it prohibit it.47 A lifestyle intervention that includes weight loss may be beneficial for Stage 1-4 CKD patients, as it reduces the proteinuria and glomerular
Practical Applications
Managing information burden appears to be essential for engaging patients with T2D and concurrent CKD in multiple behavior changes. Behavioral counseling alone was no better than baseline advice, and demonstrated no interaction effect with self-monitoring. Behavioral counseling may be important for sustaining longer term behavior change (e.g., beyond 6 months), but must be confirmed with additional research. Future studies would be strengthened by selecting participants who are obese, have more
CrediT Authorship Contribution Statement
David E. St-Jules: Methodology, Validation, Data curation, Writing – original draft. Lu Hu: Methodology, Validation, Data curation, Writing – review & editing. Kathleen Woolf: Conceptualization, Funding acquisition, Methodology, Software, Validation, Data curation, Writing – review & editing. Chan Wang: Software, Data curation, Formal analysis, Data curation, Writing – review & editing. David S. Goldfarb: Conceptualization, Funding acquisition, Data curation, Writing – review & editing. Stuart
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Financial Disclosure: The authors declare that they have no relevant financial disclosures.
Support: The study was supported by the National Institutes of Health Grant R01-DK100492. We also acknowledge the support of New York University Langone’s Clinical and Translational Science Institute, which is supported by the National Center for Advancing Translational Sciences through Grant Award Number UL1TR001445. National Institutes of Health played no role in study design; collection, analysis, and interpretation of data; writing the report; or the decision to submit the report for publication.