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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944138
• Other study ID #: PROMISE#0001
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2009
• Last updated: July 26, 2010
• Start date: July 2009
• Est. completion date: October 2009

Study information

• Verified date: July 2009
• Source: Edward Hines Jr. VA Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Obesity
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Edward Hines Jr. VA Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight, waist circumference, measures of stress and mood and overall satisfaction		8 nweeks	No