Craving and Lifestyle Management Through Mindfulness Pilot Study - Full Text View

Sponsors and Collaborators:	University of California, San Francisco National Center for Complementary and Alternative Medicine (NCCAM) Mt Zion Health Fund Robert Deidrick Fund
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00643344

Purpose

The purpose of this study is to determine whether an innovative program that combines mindfulness-based stress reduction and mindful eating practices with diet and exercise guidelines (CALMM+ intervention) will lead to greater weight loss and more favorable body fat distribution than a conventional weight-loss program(Diet-Ex intervention).

Condition	Intervention
Obesity	Behavioral: Craving and Lifestyle Management through Mindfulness(CALMM+)

MedlinePlus related topics: Diets Exercise and Physical Fitness Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Craving and Lifestyle Management Through Mindfulness Pilot Study

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

weight [ Time Frame: baseline, 3 month, and 6 month assessments ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

fat distribution [ Time Frame: baseline, 3 month, and 6 month assessments ] [ Designated as safety issue: No ]
perceived stress [ Time Frame: baseline, 3 month, and 6 month assessments ] [ Designated as safety issue: No ]
mood [ Time Frame: baseline, 3 month, and 6 month assessments ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CALMM+: Experimental Participants receiving CALMM intervention, ie program that combines stress reduction, mindful eating practices with diet and exercise	Behavioral: Craving and Lifestyle Management through Mindfulness(CALMM+) MBSR is a program that provides systematic training in mindfulness meditation and gentle yoga as a self-regulation approach to reduce stress and improve medical and psychological symptoms. In this randomized controlled pilot study, we aim to test a 16-week intervention that further integrates diet and exercise into the CALMM program (CALMM+). This novel program, which includes elements drawn from MBSR, will be actively compared with the conventional diet and exercise group(TLC). Both groups will receive about 7 hours of in-class and out-of-class activities per week. The activities includes exercise, keeping dietary records, and stress reduction practices (if they are assigned to the intervention group).
TLC: Active Comparator Participants receiving diet and exercise classes only	Behavioral: Craving and Lifestyle Management through Mindfulness(CALMM+) MBSR is a program that provides systematic training in mindfulness meditation and gentle yoga as a self-regulation approach to reduce stress and improve medical and psychological symptoms. In this randomized controlled pilot study, we aim to test a 16-week intervention that further integrates diet and exercise into the CALMM program (CALMM+). This novel program, which includes elements drawn from MBSR, will be actively compared with the conventional diet and exercise group(TLC). Both groups will receive about 7 hours of in-class and out-of-class activities per week. The activities includes exercise, keeping dietary records, and stress reduction practices (if they are assigned to the intervention group).

Arms

Assigned Interventions

CALMM+: Experimental

Participants receiving CALMM intervention, ie program that combines stress reduction, mindful eating practices with diet and exercise

Behavioral: Craving and Lifestyle Management through Mindfulness(CALMM+)

MBSR is a program that provides systematic training in mindfulness meditation and gentle yoga as a self-regulation approach to reduce stress and improve medical and psychological symptoms. In this randomized controlled pilot study, we aim to test a 16-week intervention that further integrates diet and exercise into the CALMM program (CALMM+). This novel program, which includes elements drawn from MBSR, will be actively compared with the conventional diet and exercise group(TLC). Both groups will receive about 7 hours of in-class and out-of-class activities per week. The activities includes exercise, keeping dietary records, and stress reduction practices (if they are assigned to the intervention group).

TLC: Active Comparator

Participants receiving diet and exercise classes only

Behavioral: Craving and Lifestyle Management through Mindfulness(CALMM+)

MBSR is a program that provides systematic training in mindfulness meditation and gentle yoga as a self-regulation approach to reduce stress and improve medical and psychological symptoms. In this randomized controlled pilot study, we aim to test a 16-week intervention that further integrates diet and exercise into the CALMM program (CALMM+). This novel program, which includes elements drawn from MBSR, will be actively compared with the conventional diet and exercise group(TLC). Both groups will receive about 7 hours of in-class and out-of-class activities per week. The activities includes exercise, keeping dietary records, and stress reduction practices (if they are assigned to the intervention group).

Detailed Description:

Obesity is an important growing epidemic, with about 65% of Americans overweight (Flegal, Carroll et al. 2002). Psychological stress is widely cited anecdotally as a factor that causes people to engage in overeating, and studies provide strong evidence that stress can promote obesity. Stress induces selective preference of sweet, high-fat food and increases visceral fat depots. Chronic stress has also been shown to impair immune responses, including decreasing immune responses to vaccination. The proposed study will pilot test an innovative program that combines stress reduction and mindful eating practices with diet and exercise, Craving and Lifestyle Management through Mindfulness (CALMM+). This program will be compared with diet and exercise intervention alone (Diet-Ex). Approximately 20 persons will be randomized to the two groups, which will meet weekly for 16 weeks. Key outcome measures are weight, fat distribution (as measured by waist/hip ratio), perceived stress, and mood. These measures will be assessed in visits performed at baseline, 3 months, and 6 months. Data from this study are intended to provide pilot data for use in planning a larger randomized, controlled trial that will compare the effects of the CALMM+ and Diet-Ex interventions on the metabolic and psychological processes assessed in this pilot study.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy female
aged 18-50
BMI range 25-45
negative urine glucose test
must be able to provide informed consent

Exclusion Criteria:

male
age less than 18 or menopausal
clinical diagnosis of eating disorder, diabetes, polycystic ovary syndrome, and coronary artery disease
history of anginal chest pain without adequate evaluation
substance abuse, mental health or medical condition that might interfere with study participation
use of medications containing corticosteroids
breastfeeding
non- English speaker
pregnant or planning to get pregnant in the next 6 months
previous Mindfulness Based Stress Reduction training
initiation of new class of psychiatric medications in past 2 months
currently on a weight loss diet

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643344

Locations

United States, California
UCSF CTSI Clinical Research Center
San Francisco, California, United States, 94120

Sponsors and Collaborators

University of California, San Francisco

National Center for Complementary and Alternative Medicine (NCCAM)

Mt Zion Health Fund

Robert Deidrick Fund

Investigators

Principal Investigator:	Frederick Hecht, MD	UCSF Osher Center for Integrative Medicine
Principal Investigator:	Elissa Epel, PhD	UCSF Department of Psychiatry
Principal Investigator:	Jennifer Daubenmier, PhD	UCSF Osher Center for Integrative Medicine

More Information

Publications:

Baer RA, Smith GT, Allen KB. Assessment of mindfulness by self-report: the Kentucky inventory of mindfulness skills. Assessment. 2004 Sep;11(3):191-206.

Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7.

Epel ES, McEwen B, Seeman T, Matthews K, Castellazzo G, Brownell KD, Bell J, Ickovics JR. Stress and body shape: stress-induced cortisol secretion is consistently greater among women with central fat. Psychosom Med. 2000 Sep-Oct;62(5):623-32.

Oliver G, Wardle J, Gibson EL. Stress and food choice: a laboratory study. Psychosom Med. 2000 Nov-Dec;62(6):853-65.

Boggiano MM, Chandler PC, Viana JB, Oswald KD, Maldonado CR, Wauford PK. Combined dieting and stress evoke exaggerated responses to opioids in binge-eating rats. Behav Neurosci. 2005 Oct;119(5):1207-14.

Yusuf S, Hawken S, Ounpuu S, Bautista L, Franzosi MG, Commerford P, Lang CC, Rumboldt Z, Onen CL, Lisheng L, Tanomsup S, Wangai P Jr, Razak F, Sharma AM, Anand SS; INTERHEART Study Investigators. Obesity and the risk of myocardial infarction in 27,000 participants from 52 countries: a case-control study. Lancet. 2005 Nov 5;366(9497):1640-9.

Epel E, Lapidus R, McEwen B, Brownell K. Stress may add bite to appetite in women: a laboratory study of stress-induced cortisol and eating behavior. Psychoneuroendocrinology. 2001 Jan;26(1):37-49.

Epel E, Jimenez S, Brownell K, Stroud L, Stoney C, Niaura R. Are stress eaters at risk for the metabolic syndrome? Ann N Y Acad Sci. 2004 Dec;1032:208-10.

Rebuffé-Scrive M, Walsh UA, McEwen B, Rodin J. Effect of chronic stress and exogenous glucocorticoids on regional fat distribution and metabolism. Physiol Behav. 1992 Sep;52(3):583-90.

Rosmond R. Role of stress in the pathogenesis of the metabolic syndrome. Psychoneuroendocrinology. 2005 Jan;30(1):1-10. Review.

Roemmich JN, Wright SM, Epstein LH. Dietary restraint and stress-induced snacking in youth. Obes Res. 2002 Nov;10(11):1120-6.

Responsible Party:	University of California, San Francisco, Osher Center for Integrative Medicine ( Frederick Hecht, MD )
Study ID Numbers:	H7429-31882-01, Protocol 5030
Study First Received:	March 24, 2008
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00643344 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

obesity
mindfulness based stress reduction
diet and exercise
mindful eating
stress

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Stress
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009