Diabetes CKD Lifestyle Technology Study

The purpose of this study is to develop and pilot test a lifestyle intervention in obese
individuals with t2dm and concurrent stage 2-4 ckd. The counseling intervention will be based
on social cognitive theory and supported by mobile (ipad) self-monitoring. Mobile
self-monitoring is featured in the intervention to encourage vigilance to the diet in a
manner that is not burdensome, enhance self-efficacy by integrating complex information
regarding the ckd dietary regimen with a calorie-restricted diet, and permit real-time
monitoring of weight, blood glucose, blood pressure, and self-reported diet and physical
activity by the study team.

Specifically, the investigators will develop the methods for and pilot test the ckd lifestyle
intervention in stage 2-4 ckd patients and explore the impact of the intervention on: (a)
weight and fat mass, (b) blood pressure, (c) physical activity, (d) urinary sodium excretion,
(e) serum phosphorus and calcium-phosphorus product, (f) kidney function as measured by serum
cystatin-c, and (g) serum lipids. Additionally, we will evaluate the feasibility and
acceptability of this intervention in terms of: (h) recruitment and retention, (i) time and
cost associated with training ckd patients in technology-based self-monitoring and in
delivering the intervention, (j) patterns of self-monitoring adherence over time, and (k)
participant satisfaction with the intervention. Finally, we will describe: (l) the extent to
which the intervention differentially adversely affects the nutritional health of
participants as evidenced by low serum albumin or serum prealbumin; a body mass index (bmi)
that falls below 20kg/m2; and subjective assessment of nutritional risk (e.g. Nausea,
diarrhea, anorexia).

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:

- Those with the following characteristics will be excluded by the investigators:

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; and (7)
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).

will exclude from the study those with underlying diseases which 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. A recent
Institute of Medicine report suggests that reducing dietary sodium below 1,840 mg/day in
those with mid- to late-stage heart failure may increase adverse events or mortality. Thus
investigators will exclude those with heart failure.

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.