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

Sponsor:	Edward Hines Jr. VA Hospital
Information provided by:	Edward Hines Jr. VA Hospital
ClinicalTrials.gov Identifier:	NCT00944138

Purpose

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.

Condition	Intervention	Phase
Obesity	Behavioral: Relaxation methods	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized 8-week Pilot Study of Relaxation Methods for Weight Loss in Adults With Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Edward Hines Jr. VA Hospital:

Primary Outcome Measures:

weight, waist circumference, measures of stress and mood and overall satisfaction [ Time Frame: 8 nweeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	July 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Mindful meditation: Experimental 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
Music for relaxation: Active Comparator 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

Arms

Assigned Interventions

Mindful meditation: Experimental

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

Music for relaxation: Active Comparator

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

Eligibility

Ages Eligible for Study:	18 Years to 88 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944138

Contacts

Contact: Holly Kramer, MD MPH

7083279039

hkramer@lumc.edu

Locations

United States, Illinois
Edward Hines, Jr. VA Hospital	Recruiting
Hines, Illinois, United States, 60141
Contact: Holly Kramer, MD MPH 708-202-8387 ext 24231 hkramer@lumc.edu
Principal Investigator: Holly Kramer, MD MPH
Sub-Investigator: David Leehey, MD
Sub-Investigator: Anu Wadwa, MD
Principal Investigator: Frances Weaver, PhD
Sub-Investigator: Subash Popli, MD

Sponsors and Collaborators

Edward Hines Jr. VA Hospital

More Information

No publications provided

Responsible Party:	Edward Hines Jr. VA Hospital ( Holly Kramer )
Study ID Numbers:	PROMISE#0001
Study First Received:	July 21, 2009
Last Updated:	July 22, 2009
ClinicalTrials.gov Identifier:	NCT00944138 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Edward Hines Jr. VA Hospital:

Obesity
meditation
chronic kidney disease

Additional relevant MeSH terms:

Obesity
Renal Insufficiency
Kidney Failure, Chronic
Overweight
Body Weight
Signs and Symptoms
Urologic Diseases

Renal Insufficiency, Chronic
Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on February 08, 2010