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临床试验/NCT00944138
NCT00944138已完成3 期

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

Edward Hines Jr. VA Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
20
试验地点
2
主要终点
weight, waist circumference, measures of stress and mood and overall satisfaction

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Inability to give informed consent
  • inability to come to VA for two group sessions
  • inability to listen to an MP3 player using headphones

结局指标

主要结局

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

时间窗: 8 nweeks

次要结局

未报告次要终点

研究者

申办方类型
Fed

研究点 (2)

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