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OpenTrials
Completed

NCT Number: NCT00944138

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 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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relaxation methods

Behavioral

Relaxation methods will include mindful meditation techniques for the intervention and listening to music for the control arm

Primary outcomes

  1. weight, waist circumference, measures of stress and mood and overall satisfaction

    Time frame: 8 nweeks

Sponsors and collaborators

Lead sponsor

Edward Hines Jr. VA Hospital

Fed

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 23, 2009
Registry last updated
Jul 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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