Lifestyle Management of CKD in Obese Diabetic Patients
Public ClinicalTrials.gov record NCT02276742. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02276742
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 269 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2014
- Primary completion
- Nov 7, 2019
- Completion
- Nov 7, 2019
- Last update posted
- Jul 13, 2020
2014 – 2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10016 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02276742, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 13, 2020 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02276742 live on ClinicalTrials.gov.