Lifestyle Management of CKD in Obese Diabetic Patients

Investigators will conduct a 2x2 factorial, randomized clinical trial. All participants will
receive usual care. Prior to randomization, participants will be stratified by recruitment
siteParticipants 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

II. CHARACTERISTICS OF THE RESEARCH POPULATION

1. Number of subjects. Investigators will recruit 300 participants to the study.
Investigators will focus our study on those with diabetic CKD as this form of the disease
progresses more rapidly than other forms of CKD. Focusing on diabetic CKD also allows us to
expand logically upon Look AHEAD, and build upon our work in T2DM patients with the ENHANCE
study. Investigators will recruit participants from 3 clinical sites in New York City:
Nephrology Family Group Practice at NYU Langone Medical Center (NYULMC), the Bellevue
Hospital Diabetes Clinic, and New York Harbor VA. Preliminary data from these 3 practice
settings indicate that investigators will have access to 4,292 potentially eligible patients
from which investigators must recruit only 7.0% to enroll 300. Our prior studies suggest that
investigators will retain 80% resulting in a final sample of 240. Investigators are
projecting 64 participant measurement visits in Year 1; 248 in Year 2; 288 in Year 3; 244 in
Year 4; and 56 in Year 5.

Unless otherwise noted, measurements occur at baseline, 6, and 12 mos. Data are collected
with visits to NYU Clinical and Translational Resource Center (CTRC). Information to be
obtained from participants at each visit includes height and weight, serum and urine samples;
blood pressure; investigator administered instruments (sociodemographics, comorbid
conditions, Mini Mental Status Exam, and self-efficacy instruments), medication inventories,
and Pulse Wave Velocity. Eight blood tests will be performed: cystatin-C, lipids, phosphorus,
calcium, PTH or parathyroid hormone, vitamin D, pre-albumin and albumin. These tests are
estimated to require, in total, approximately 45 mls (of blood.

One week before their scheduled measurement visit, a 24-hour urine specimen container and
instructions for collection are mailed to the participant. Participants are contacted 2 days
prior to their appointment to remind them of their measurement visit, collect their urine,
fast, and abstain from caffeine for 12 hours prior to their appointment. Laboratory tests are
collected, spun, refrigerated, batched and sent for processing in the CLIA-certified NYU CTSI
Translational Research Laboratories by personnel blinded to group assignment. The PWV of the
brachial-ankle (baPWV) and carotid-femoral (cfPWV) will be collected by trained research
associates at the CTRC.

Inclusion Criteria:

- In order to be eligible for the study, the individual must be 40 years of age or older

- Have a DRG Code of T2DM, GFR of 15-89 ml/min/1.73m2 and a BMI >30 kg/m2.

- The participant's physician of record will have verified that his/her patient can
safely participant in an intervention study that involves weight loss and a goal of
150 minutes/week of moderate physical activity comparable to brisk walking.

Exclusion Criteria:

- Investigators will exclude from participation those with the following
characteristics:

1. unable or unwilling to provide informed consent

2. unable to participate meaningfully in an intervention that involves group
sessions (e.g., due to uncorrected hearing impairment, non-English-speaking)

3. unable to read or otherwise use an iPad to monitor dietary intake, physical
activity, and weight (e.g., blind, illiterate)

4. unwilling to accept randomization assignment

5. pregnant, or plans to become pregnant in the next 12 months, less than 3 months
postpartum, or nursing or within 6 weeks of having completed nursing

6. weight loss of > 10% in the past 6 months except for postpartum weight loss

7. unable to walk 0.25 miles in 10 minutes

8. a major psychiatric disorder

9. planning gastric bypass surgery in the next 12 months

10. individuals who are institutionalized (e.g., in a nursing home or personal care
facility, or those who are incarcerated and have no control over their diet).

- Investigators will exclude from the study those with underlying diseases that would
increase the risk of participating in an intervention involving caloric restriction
and physical activity.

- Such individuals would include those requiring treatment for cancer, exclusive of skin
cancer other than melanoma, in the past 2 years; infectious diseases including
untreated AIDS and active tuberculosis; uncontrolled hypertension of >190 mmHg SBP or
>105 mmHg DBP despite treatment; stroke or TIA in the past 6 months; conditions
requiring the use of home oxygen; or other chronic disease or condition likely to
limit life span to < 1 year.

- Because of the dietary requirements of a pregnant woman, and the nature of weight loss
and gain with pregnancy, inclusion of pregnant women in the study would confound the
study results. Those who become pregnant during the study will be withdrawn from the
study.