Please select the outcome measures that correspond to the clinical trial below.
Title: Lifestyle Management of CKD in Obese Diabetic Patients
Brief Summary: The purpose of this randomized clinical trial is to evaluate the efficacy of 3 different technology-supported approaches to engaging 300 individuals with diabetes and concurrent chronic kidney disease in weight loss, dietary sodium restriction, and dietary restriction of inorganic phosphates when compared to usual care. 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 counseling (MONITORING), or a combination of SCT plus MONITORING conditions (COMBINED). Investigators will evaluate the intervention arms primarily in terms of weight reduction, urinary sodium excretion, and serum phosphorus and, secondarily in terms of physical activity, blood pressure, fasting lipids, medication requirements, and pulse wave velocity. Measurements will occur at baseline, 6, and 12 months. The statistical modeling of the baseline, 6 mos and 12 mos outcome variables 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). In separate analyses of the intervention arm only, investigators will model self-monitoring adherence and examine possible associations between self-monitoring adherence and outcomes. The mediating effect of self-efficacy on the primary outcomes will be evaluated using structural equation models.


Options:
A: Mean systematic blood pressure level (October 2010 - December 2012); 24 hour urinary sodium (October -December 2012)
B: Reduction in blood pressure (Six months)
C: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)
D: Weight in kgs will be obtained using a single, calibrated scale (Change from baseline in weight at 6 months); Serum phosphorus will be evaluated from a venipuncture sample (Change from baseline in Serum Phosphourous at 6 months); Urinary sodium will be determined from a time 24-hour urine sample (Change from baseline in Urinary sodium at 6 months); Weight in kgs will be obtained using a single, calibrated scale (Change from baseline in weight at 12 months); Serum phosphorus will be evaluated from a venipuncture sample (Change from baseline in Serum phosphorus at 12 months); Urinary sodium will be determined from a time 24-hour urine sample (Change from baseline in Urinary sodium at 12 months)

Answer: D