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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;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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.
No text entered.

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  
Number of Participants  
[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:


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01250509     History of Changes
Other Study ID Numbers: H11640-29259-03A
K01AT004199 ( US NIH Grant/Contract Award Number )
Study First Received: November 23, 2010
Results First Received: May 29, 2012
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board