Status:
COMPLETED
Diabetes CKD Lifestyle Technology Study
Lead Sponsor:
NYU Langone Health
Conditions:
Chronic Kidney Disease
Diabetes
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The purpose of this study is to pilot test an mHealth technology-supported behavioral intervention designed to engage patients with diabetes and concurrent chronic kidney disease (CKD) in multiple beh...
Detailed Description
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 cogniti...
Eligibility Criteria
Inclusion
- 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
- Those with the following characteristics will be excluded by the investigators:
- 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.
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2019
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT02266823
Start Date
October 1 2015
End Date
November 8 2019
Last Update
January 22 2020
Active Locations (1)
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1
NYU Langone Medical Center
New York, New York, United States, 10016