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
  Purpose

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 Intervention Phase
Obesity
Behavioral: Craving and Lifestyle Management through Mindfulness
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Stress Reduction on Eating, Fat Distribution, and Cell Aging Among Overweight Women

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 53
Study Start Date: November 2006
Study Completion Date: July 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250509

Locations
United States, California
UCSF Osher Center for Integrative Medicine
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Mt Zion Health Fund
Investigators
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
  More Information

Publications:

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

Keywords provided by University of California, San Francisco:
Obesity
Mindfulness based stress reduction
Mindful eating
Stress
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014