Craving and Lifestyle Management Through Mindfulness Study (CALMM)

This study has been completed.
Sponsor:
Collaborators:
Mt 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

November 23, 2010
January 16, 2013
November 2006
October 2007   (final data collection date for primary outcome measure)
Change in Abdominal Fat [ Time Frame: Change from Baseline in Abdominal Fat (baseline and 4 months) ] [ Designated as safety issue: No ]
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.
Abdominal fat [ Time Frame: Change from Baseline in Abdominal Fat at 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01250509 on ClinicalTrials.gov Archive Site
  • Weight [ Time Frame: Change in Weight (baseline and 4 months) ] [ Designated as safety issue: No ]
  • Telomerase Activity [ Time Frame: Change from Baseline in Telomerase Activity at 4 months ] [ Designated as safety issue: No ]
    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).
  • Change in Psychological Stress (Baseline and 4 Months) [ Time Frame: Change from Baseline in Psychological Stress ] [ Designated as safety issue: No ]
    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.
  • Weight [ Time Frame: Change from Baseline in Weight at 3 months ] [ Designated as safety issue: No ]
  • Telomerase activity [ Time Frame: Change from Baseline in Telomerase Activity at 3 months ] [ Designated as safety issue: No ]
  • Psychological Stress [ Time Frame: Change from Baseline in Psychological Stress at 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Craving and Lifestyle Management Through Mindfulness Study
Effects of Stress Reduction on Eating, Fat Distribution, and Cell Aging Among Overweight Women

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
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.
  • Experimental: CALMM
    Participants receiving the 'Craving and Lifestyle Management through Mindfulness' intervention, i.e. program that combines stress reduction with mindful eating practices.
    Intervention: Behavioral: Craving and Lifestyle Management through Mindfulness
  • No Intervention: Waitlist Control
    Participants were waitlisted for the intervention during the experimental phase.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
July 2008
October 2007   (final data collection date for primary outcome measure)

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
Female
21 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01250509
H11640-29259-03A, K01AT004199
No
University of California, San Francisco
University of California, San Francisco
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • Mt Zion Health Fund
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
University of California, San Francisco
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP