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NCT00944138 · ClinicalTrials.gov registry record · Phase 3
8-week Pilot Study of Relaxation for Weight Loss in Adults With Chronic Kidney Disease
A Phase 3 study, sponsored by Edward Hines Jr. VA Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT00944138 is a Phase 3 study that has completed, run by Edward Hines Jr. VA Hospital. The registered enrollment target is 20 participants.
The verdict
NCT00944138, a Phase 3 study, has completed, sponsored by Edward Hines Jr. VA Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study Summary
Obesity plays a causal role for kidney disease incidence and progression. Moderate weight loss reduces the high metabolic demands on the kidney and decreases proteinuria in both diabetic and non-diabetic nephropathies. However, maintaining behavioral changes for weight loss is very challenging, and common chronic kidney disease (CKD) co-morbidities such as decreased exercise capacity only compound this difficulty. Moreover, no weight loss medications have been adequately tested in adults with CKD and most are contraindicated in this population. Mindful meditation or "mindfulness" in addition to other relaxation techniques may help adults lose weight by interrupting learned behavior, curbing compulsive eating, and reducing stress and appetite. Although mindful meditation and other relaxation techniques have gained the attention of the mainstream media for obesity treatment, scientific data on its efficacy remain limited. Due to the short duration of this study, substantial weight loss in any participant is not expected. Instead, the primary purpose of this study is to examine the feasibility of a randomized controlled trial of mindful meditation relaxation techniques combined with standard care compared to standard care alone for the treatment of obesity among Veterans with CKD.
Interventions
- BEHAVIORAL Relaxation methods
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-07 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00944138
The ClinicalTrials.gov registry entry for NCT00944138 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edward Hines Jr. VA Hospital, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Relaxation methods is the first listed.
NCT00944138 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00944138 about?
NCT00944138 is a clinical study titled "8-week Pilot Study of Relaxation for Weight Loss in Adults With Chronic Kidney Disease". Obesity plays a causal role for kidney disease incidence and progression. Moderate weight loss reduces the high metabolic demands on the kidney and decreases proteinuria in both diabetic and non-diabetic nephropathies. However, maintaining behavioral changes for weight loss is very challenging, and ...
What is the current status of trial NCT00944138?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2009-07. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00944138?
The interventions under investigation include: Relaxation methods (BEHAVIORAL).
Who is sponsoring clinical trial NCT00944138?
This trial is sponsored by Edward Hines Jr. VA Hospital, which has 3 total clinical trials registered on ClinicalTrials.gov.
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