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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Relaxation methods

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Hines, Illinois, United States, 60141
      • Edward Hines, Jr. VA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Relaxation methods; Relaxation methods will include mindful meditation techniques for the intervention and listening to music for the control arm
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.).	Behavioral: Relaxation methods; Relaxation methods will include mindful meditation techniques for the intervention and listening to music for the control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
weight, waist circumference, measures of stress and mood and overall satisfaction	8 nweeks

Collaborators and Investigators

• Sponsor: Edward Hines Jr. VA Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: July 21, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Estimate): July 28, 2010
• Last Update Submitted That Met QC Criteria: July 26, 2010
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Obesity; chronic kidney disease; meditation
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Body Weight; Body Weight Changes; Kidney Diseases; Renal Insufficiency, Chronic; Weight Loss
• Other Study ID Numbers: PROMISE#0001