Craving and Lifestyle Management Through Mindfulness Pilot Study (CALMM)

October 25, 2014 updated by: University of California, San Francisco
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94120
        • UCSF CTSI Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • CALMM2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight
Time Frame: baseline, 3 month, and 6 month assessments
baseline, 3 month, and 6 month assessments

Secondary Outcome Measures

Outcome Measure
Time Frame
fat distribution
Time Frame: baseline, 3 month, and 6 month assessments
baseline, 3 month, and 6 month assessments
perceived stress
Time Frame: baseline, 3 month, and 6 month assessments
baseline, 3 month, and 6 month assessments
mood
Time Frame: baseline, 3 month, and 6 month assessments
baseline, 3 month, and 6 month assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Center for Complementary and Integrative Health (NCCIH)
Mount Zion Health Fund
Robert Deidrick 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

October 28, 2014

Last Update Submitted That Met QC Criteria

October 25, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H7429-31882-01
  • Protocol 5030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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