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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Relaxation methods
Sponsored by
Edward Hines Jr. VA Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, meditation, chronic kidney disease

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Edward Hines, Jr. VA Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindful meditation

Music for relaxation

Arm Description

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.

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.).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 21, 2009
Last Updated
July 26, 2010
Sponsor
Edward Hines Jr. VA Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00944138
Brief Title
8-week Pilot Study of Relaxation for Weight Loss in Adults With Chronic Kidney Disease
Official Title
Randomized 8-week Pilot Study of Relaxation Methods for Weight Loss in Adults With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Edward Hines Jr. VA Hospital

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, meditation, chronic kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindful meditation
Arm Type
Experimental
Arm Description
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.
Arm Title
Music for relaxation
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Relaxation methods
Intervention Description
Relaxation methods will include mindful meditation techniques for the intervention and listening to music for the control arm
Primary Outcome Measure Information:
Title
weight, waist circumference, measures of stress and mood and overall satisfaction
Time Frame
8 nweeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Edward Hines, Jr. VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States

12. IPD Sharing Statement

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

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