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Craving and Lifestyle Management Through Mindfulness Pilot 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.
 
ClinicalTrials.gov Identifier: NCT00643344
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : October 28, 2014
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Mount Zion Health Fund
Robert Deidrick Fund
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Behavioral: Craving and Lifestyle Management through Mindfulness(CALMM+) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Craving and Lifestyle Management Through Mindfulness Pilot Study
Study Start Date : January 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: CALMM+
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).
Other Name: CALMM2

Active Comparator: TLC
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).
Other Name: CALMM2




Primary Outcome Measures :
  1. weight [ Time Frame: baseline, 3 month, and 6 month assessments ]

Secondary Outcome Measures :
  1. fat distribution [ Time Frame: baseline, 3 month, and 6 month assessments ]
  2. perceived stress [ Time Frame: baseline, 3 month, and 6 month assessments ]
  3. mood [ Time Frame: baseline, 3 month, and 6 month assessments ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

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 ClinicalTrials.gov identifier (NCT number): NCT00643344


Locations
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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 Integrative Health (NCCIH)
Mount Zion Health Fund
Robert Deidrick Fund
Investigators
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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
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00643344    
Other Study ID Numbers: H7429-31882-01
Protocol 5030
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by University of California, San Francisco:
obesity
mindfulness based stress reduction
diet and exercise
mindful eating
stress
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms