Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

8-week Pilot Study of Relaxation for Weight Loss in Adults With Chronic Kidney Disease

This study has been completed.
Information provided by:
Edward Hines Jr. VA Hospital Identifier:
First received: July 21, 2009
Last updated: July 26, 2010
Last verified: July 2009

July 21, 2009
July 26, 2010
July 2009
October 2009   (final data collection date for primary outcome measure)
weight, waist circumference, measures of stress and mood and overall satisfaction [ Time Frame: 8 nweeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00944138 on Archive Site
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8-week Pilot Study of Relaxation for Weight Loss in Adults With Chronic Kidney Disease
Randomized 8-week Pilot Study of Relaxation Methods 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 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.

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Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Behavioral: Relaxation methods
Relaxation methods will include mindful meditation techniques for the intervention and listening to music for the control arm
  • Experimental: Mindful meditation
    Participants assigned to the mindful meditation plus standard care arm will receive individualized instruction on mindful meditation at the time they are randomized to this arm. The participants will be led through a 20 minute relaxation exercise. They will then be led through a brief eating exercise where they will be instructed to eat the food very slowly and pay attention to how the food tastes and the sensations of swallowing the food. This is done to enhance the person's awareness of what and how they are eating and enhance their intuitive sense of satiety. Finally, they will receive an MP3-player with several relaxation instructional audios loaded on the MP3 player.
    Intervention: Behavioral: Relaxation methods
  • Active Comparator: Music for relaxation
    Participants assigned to the control arm will receive the dietary counseling and will be told that relaxation can help reduce appetite. However, techniques to relax will not be taught. Instead, participants will be encouraged to sit quietly listening to music (of their choice) every day for 20 minutes. Participants assigned to the standard care arm will receive an MP3-player and will be given a choice of selection of music that they can load on their MP3 player (classical music, country music, jazz, etc.).
    Intervention: Behavioral: Relaxation methods
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • receive medical care at the Hines VA CKD clinics.
  • Presence of chronic kidney disease defined as an estimated glomerular filtration rate < 60 ml/min/1.73 m2 BSA or a spot urine albumin/creatinine ratio ≥ 30 mg/g
  • BMI ≥ 35 kg/m2 or a waist circumference ≥ 102 (40 inches) and ≥ 88 cm (35 inches) in men and women, respectively.

Exclusion Criteria:

  • Inability to give informed consent
  • inability to come to VA for two group sessions
  • inability to listen to an MP3 player using headphones
18 Years to 88 Years
Contact information is only displayed when the study is recruiting subjects
United States
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Holly Kramer, Edward Hines Jr. VA Hospital
Edward Hines Jr. VA Hospital
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Edward Hines Jr. VA Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP