Lifestyle Management of CKD in Obese Diabetic Patients
Obesity, Type 2 Diabetes, Chronic Kidney Disease (CKD)
About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
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:
- unable or unwilling to provide informed consent
- unable to participate meaningfully in an intervention that involves group sessions (e.g., due to uncorrected hearing impairment, non-English-speaking)
- unable to read or otherwise use an iPad to monitor dietary intake, physical activity, and weight (e.g., blind, illiterate)
- unwilling to accept randomization assignment
- 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
- weight loss of > 10% in the past 6 months except for postpartum weight loss
- unable to walk 0.25 miles in 10 minutes
- a major psychiatric disorder
- planning gastric bypass surgery in the next 12 months
- 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.
Sites / Locations
- NYU Langone Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Active Comparator
Active Comparator
Active Comparator
Usual Care (UC)
Social Cognitive Theory (SCT)
Monitoring
Combined
Participants randomized to UC will receive baseline advice about the value of losing weight, becoming more physically active, and limiting intake of sodium and inorganic phosphates followed by 12 mos of UC. We have elected not to use a control group in which we provide equivalent attention to both study arms. Behaviors are difficult to change and there is no reason to believe that simply giving participants attention would create behavioral changes sufficient to result in weight loss, reduce sodium excretion, or reduce serum phosphorus. Numerous weight loss studies, including Look AHEAD, have used attention control groups that did not demonstrate weight loss.
Participants will be exposed to a group behavioral intervention that is based on SCT, which focuses on the role played by self-referent thought in the maintenance of behavior change. Self- efficacy is derived from four major sources of information: mastery experiences, social modeling, verbal persuasion, and physiological states. Mastery experiences will include emphasizing past successes; setting incremental, easily achievable goals; identifying modifiable barriers to healthy behavior; receiving positive feedback on goal achievement; and practicing problem solving skills around barriers to adherence.
Participants will be taught how to use a lifestyle self-monitoring program to reduce information processing requirements, make readily available the information required to make good self-management decisions, deliver automated, real-time feedback about achievement of behavioral goals, and permit individualized guidance from an interventionist who uses the MyNetDiary® electronic log to provide targeted education and advice. The Monitoring intervention reduces information processing demands by making relevant nutritional information readily available. Technology-based self-monitoring also can be used by interventionists to reduce information processing burden by using it for targeted counseling
Participants randomized to COMBINED will receive all aspects of the SCT and MONITORING intervention conditions. Social Cognitive Theory based behavioral intervention in complex patients is strengthened when technology is used to manage information complexity, and weakened in its absence. The Monitoring intervention reduces information processing demands by making relevant nutritional information readily available. Technology-based self-monitoring also can be used by interventionists to reduce information processing burden by using it for targeted counseling