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Craving and Lifestyle Management Through Mindfulness Study (CALMM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01250509
Recruitment Status : Completed
First Posted : November 30, 2010
Results First Posted : February 18, 2013
Last Update Posted : February 18, 2013
National Center for Complementary and Integrative Health (NCCIH)
Mount Zion Health Fund
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The purpose of this study is to determine whether a mindfulness-based stress reduction and mindful eating program will lead to reductions in abdominal fat and total weight and improve cell aging in overweight and obese women compared to a waitlist control group.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Craving and Lifestyle Management through Mindfulness Phase 2

Detailed Description:
Obesity is the largest growing epidemic, with about 65% of Americans overweight (Flegal, Carroll et al. 2002). Obesity, in particular, abdominal obesity, confers increased risk for a host of diseases, including hypertension, Type 2 diabetes, and coronary heart disease, resulting in shortened life span (Fontaine, Redden et al. 2003). 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. The telomere maintenance system (telomerase activity and telomere length)are markers of cellular aging and predict mortality (Cawthon et al, 2003)and have been linked to both psychological stress and components of the metabolic syndrome. The proposed study adapts a program called Mindfulness-Based Stress Reduction (MBSR) that has been shown to be effective in a variety of other stress-related conditions. Fifty overweight, pre-menopausal women at risk for the Metabolic Syndrome will be randomized in a 1:1 distribution to either a 3-month intervention to reduce stress and overeating [Craving and Lifestyle Management with Mindfulness (CALMM)] or wait list control group. The primary outcome measures include amounts of abdominal fat, weight, and telomerase activity. Data from this study are intended to provide pilot data for use in planning a larger randomized, controlled trial that will investigate the effects of the CALMM intervention on the metabolic and psychological processes assessed in this pilot study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Stress Reduction on Eating, Fat Distribution, and Cell Aging Among Overweight Women
Study Start Date : November 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : July 2008

Arm Intervention/treatment
Experimental: CALMM
Participants receiving the 'Craving and Lifestyle Management through Mindfulness' intervention, i.e. program that combines stress reduction with mindful eating practices.
Behavioral: Craving and Lifestyle Management through Mindfulness
A preliminary, novel intervention was developed drawing on components from Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Cognitive Therapy (MBCT), and Mindfulness-Based Eating Awareness Training (MB-EAT). The intervention program consisted of nine 2.5-hour classes and one 7-hour silent day of guided meditation practice after class 6.

No Intervention: Waitlist Control
Participants were waitlisted for the intervention during the experimental phase.

Primary Outcome Measures :
  1. Change in Abdominal Fat [ Time Frame: Change from Baseline in Abdominal Fat (baseline and 4 months) ]
    Whole-body dual energy X-ray absorptiometry (DEXA) scans were performed to assess body fat distribution. The DEXA densitometry (GE Healthcare Lunar Prodigy, Madison, Wis, USA) was adjusted to the fan beam mode and EnCore software version 9.15 was used. The primary region of interest was fat tissue from a rectangular region in the abdominal area defined by the upper boundary of the second lumbar vertebra to the lower edge of the fourth lumbar vertebra. The vertical sides were defined as the continuation of the lateral sides of the rib cage.

Secondary Outcome Measures :
  1. Weight [ Time Frame: Change in Weight (baseline and 4 months) ]
  2. Telomerase Activity [ Time Frame: Change from Baseline in Telomerase Activity at 4 months ]
    Cryopreserved peripheral blood nuclear cells (PBMCs) were thawed and live cells counted using a hemocytometer by the Trypan blue exclusion method. For each sample, an extract of 5000 cells per microliter was made and two concentrations, corresponding to 5000 and 10,000 cells, were assayed for each sample to ensure the assay was in the linear range. Telomerase activity was assayed by the Telomerase Repeat Amplification Protocol (TRAP) using a commercial kit (TRAPeze, Telomerase Detection kit, Upstate/ CHEMICON, Temecula, CA). Baseline and post-intervention samples for the same participant were assayed in the same batch and run on the same gel to eliminate any differences caused by reaction or procedural batch-to-batch variations. Technicians were blind to group assignment. Telomerase activity is defined as 1 unit = the amount of product from one 293T cell/10,000 PBMCs, and was quantified using the software ImageQuant 5.2 (GE Healthcare, Piscataway, NJ).

  3. Change in Psychological Stress (Baseline and 4 Months) [ Time Frame: Change from Baseline in Psychological Stress ]
    The 10-item Perceived Stress Scale was used to evaluate perception of stressful events over the past month by using a 5-point Likert scale (0 = never to 4 = very often) (Cohen et al., 1983). The mean of the ten items was used in analysis. Higher scores indicate greater perceived stress.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Pre-menopausal
  • BMI (25 - 40)
  • Weight < 300 lbs.
  • Negative urine glucose test

Exclusion Criteria:

  • Inability to provide informed consent
  • Age < 21 or menopausal as determined by self-report
  • DSM-IV diagnosis of an eating disorder
  • Any substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the intervention
  • Factors that confound relations between stress and eating, including, drug abuse and use of medications containing corticosteroids.
  • Diabetes
  • Polycystic Ovary Syndrome
  • CHD
  • Breastfeeding (due to interference with stress hormone measurement)
  • Non English speaker
  • Pregnant as determined by pregnancy test at screening visit or planning to get pregnant in the next 6 months
  • Previous MBSR training and/or current meditation, yoga, or other mind-body practice
  • Initiation of new class of psychiatric medications in past 2 months.
  • Currently on a weight loss diet

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01250509

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United States, California
UCSF Osher Center for Integrative Medicine
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
Mount Zion Health Fund
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Principal Investigator: Elissa Epel, PhD UCSF Department of Psychiatry
Principal Investigator: Frederick Hecht, MD UCSF Osher Center for Integrative Medicine
Principal Investigator: Jennifer Daubenmier, PhD UCSF Osher Center for Integrative Medicine

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Responsible Party: University of California, San Francisco Identifier: NCT01250509    
Other Study ID Numbers: H11640-29259-03A
K01AT004199 ( U.S. NIH Grant/Contract )
First Posted: November 30, 2010    Key Record Dates
Results First Posted: February 18, 2013
Last Update Posted: February 18, 2013
Last Verified: January 2013
Keywords provided by University of California, San Francisco:
Mindfulness based stress reduction
Mindful eating
Nutrition Disorders
Body Weight
Signs and Symptoms
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight