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NCT02276742 · ClinicalTrials.gov registry record · NA
Lifestyle Management of CKD in Obese Diabetic Patients
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 269
- Enrollment target
NCT02276742 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 269 participants.
The verdict
NCT02276742, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 269 participants
- Enrollment target
Study 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.
Interventions
- OTHER Monitoring
- BEHAVIORAL Social Cognitive Theory
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2014-10 |
| Est. Completion | 2019-11-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02276742
The ClinicalTrials.gov registry entry for NCT02276742 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 269 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Monitoring is the first listed.
NCT02276742 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02276742 about?
NCT02276742 is a clinical study titled "Lifestyle Management of CKD in Obese Diabetic Patients". 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 co...
What is the current status of trial NCT02276742?
This trial is currently completed. It is a NA study. The enrollment target is 269 participants. The study started on 2014-10. Estimated completion is 2019-11-08.
What interventions are being tested in trial NCT02276742?
The interventions under investigation include: Monitoring (OTHER), Social Cognitive Theory (BEHAVIORAL).
Who is sponsoring clinical trial NCT02276742?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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