The purpose of this randomized clinical trial is to evaluate, when compared to usual care, the efficacy of 3 different technology-supported approaches to engaging 300 individuals with diabetes and concurrent chronic kidney disease in weight loss, physical activity, dietary sodium restriction, and dietary restriction of inorganic phosphates. Participants will be randomized to 1 of 4 groups, Usual Care (UC), Social Cognitive Theory-based Group Counseling (SCT), Mobile self-monitoring with tailored feedback and advice (MONITORING), or a combination of SCT plus MONITORING conditions (COMBINED). We will evaluate the intervention arms primarily in terms of weight reduction, urinary sodium excretion, and serum phosphorus. We will explore the impact on physical activity, blood pressure, fasting lipids, medication requirements, and pulse wave velocity. Measurements will occur at baseline, 6, and 12 months. Interaction effects will be examined using a 2-way ANOVA. Statistical modeling of baseline, 6 mos and 12 mos outcomes will be based on logistic generalized linear mixed models (for binary outcomes) linear mixed models (for continuous outcomes), and random effects multinomial models (for outcomes with more than 2 levels, such as changes in medication management). The mediating effect of self-efficacy on the primary outcomes will be evaluated using structural equation models.

Public Health Relevance

Obese individuals with type 2 diabetes and concurrent chronic kidney disease (CKD) should make multiple lifestyle behavior changes in order to slow CKD progression. These behaviors include weight loss through calorie restriction and physical activity, and restriction of dietary sodium and inorganic phosphates. The purpose of this study is to evaluate, compared to usual care, 3 different technology- supported behavioral interventions for engaging older, obese, diabetic individuals with concurrent CKD in these multiple behavior changes.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project (R01)
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Nursing and Related Clinical Sciences Study Section (NRCS)
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Narva, Andrew
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New York University
Internal Medicine/Medicine
Schools of Medicine
New York
United States
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Sevick, Mary Ann; Woolf, Kathleen; Mattoo, Aditya et al. (2018) The Healthy Hearts and Kidneys (HHK) study: Design of a 2×2 RCT of technology-supported self-monitoring and social cognitive theory-based counseling to engage overweight people with diabetes and chronic kidney disease in multiple lifestyle changes. Contemp Clin Trials 64:265-273
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