Craving and Lifestyle Management Through Mindfulness Study (CALMM)

This study has been completed.

Sponsor:

Collaborators:

National Center for Complementary and Integrative Health (NCCIH)

Mount Zion Health Fund

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01250509

First received: November 23, 2010

Last updated: January 16, 2013

Last verified: January 2013

History of Changes

Results First Received: May 29, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Obesity
Intervention:	Behavioral: Craving and Lifestyle Management through Mindfulness

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Female participants were recruited through media outlets and flyers posted in the San Francisco Bay Area. Three hundred twenty-two potential participants were screened for eligibility from November 2006 to March 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Fifty-three met eligibility criteria and chose to enroll, and 47 went on to the randomization stage. Before randomization, 5 participants dropped due to time constaints and 1 dropped due to illness.

Reporting Groups

	Description
CALMM	Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
Waitlist Control	Participants were waitlisted for the intervention during the experimental phase.

Participant Flow: Overall Study

	CALMM	Waitlist Control
STARTED	24	23
COMPLETED	19	21
NOT COMPLETED	5	2
Lost to Follow-up	5	2

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
CALMM	Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
Waitlist Control	Participants were waitlisted for the intervention during the experimental phase.
Total	Total of all reporting groups

Baseline Measures

	CALMM	Waitlist Control	Total
Overall Participants Analyzed [Units: Participants]	24	23	47

Age [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	24	23	47
>=65 years	0	0	0

Age [Units: Years] Mean (Standard Deviation)	40.4 (8.0)	41.4 (6.7)	40.9 (7.3)

Gender [Units: Participants]
Female	24	23	47
Male	0	0	0

Region of Enrollment [Units: Participants]
United States	24	23	47

Outcome Measures

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1. Primary:

Change in Abdominal Fat [ Time Frame: Change from Baseline in Abdominal Fat (baseline and 4 months) ]

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2. Secondary:

Weight [ Time Frame: Change in Weight (baseline and 4 months) ]

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3. Secondary:

Telomerase Activity [ Time Frame: Change from Baseline in Telomerase Activity at 4 months ]

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4. Secondary:

Change in Psychological Stress (Baseline and 4 Months) [ Time Frame: Change from Baseline in Psychological Stress ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Jennifer Daubenmier, PhD
Organization: University of California, San Francisco
phone: 415-514-8601
e-mail: jennifer.daubenmier@ucsf.edu

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
ClinicalTrials.gov Identifier:	NCT01250509 History of Changes
Other Study ID Numbers:	H11640-29259-03A K01AT004199 ( U.S. NIH Grant/Contract )
Study First Received:	November 23, 2010
Results First Received:	May 29, 2012
Last Updated:	January 16, 2013

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