Craving and Lifestyle Management Through Mindfulness Pilot Study

NCT ID: NCT00643344

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-12-31

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).

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CALMM+

Participants receiving CALMM intervention, ie program that combines stress reduction, mindful eating practices with diet and exercise

Group Type: EXPERIMENTAL

Craving and Lifestyle Management through Mindfulness(CALMM+)

Intervention Type: BEHAVIORAL

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).

TLC

Participants receiving diet and exercise classes only

Group Type: ACTIVE_COMPARATOR

Craving and Lifestyle Management through Mindfulness(CALMM+)

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

CALMM2

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Mount Zion Health Fund

OTHER

Sponsor Role: collaborator

Robert Deidrick Fund

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick Hecht, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF Osher Center for Integrative Medicine

Elissa Epel, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSF Department of Psychiatry

Jennifer Daubenmier, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSF Osher Center for Integrative Medicine

Locations

UCSF CTSI Clinical Research Center

San Francisco, California, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 15358875 (View on PubMed)

Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.

Reference Type: BACKGROUND

PMID: 12365955 (View on PubMed)

Epel ES, McEwen B, Seeman T, Matthews K, Castellazzo G, Brownell KD, Bell J, Ickovics JR. Stress and body shape: stress-induced cortisol secretion is consistently greater among women with central fat. Psychosom Med. 2000 Sep-Oct;62(5):623-32. doi: 10.1097/00006842-200009000-00005.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 16271645 (View on PubMed)

Epel E, Lapidus R, McEwen B, Brownell K. Stress may add bite to appetite in women: a laboratory study of stress-induced cortisol and eating behavior. Psychoneuroendocrinology. 2001 Jan;26(1):37-49. doi: 10.1016/s0306-4530(00)00035-4.

Reference Type: BACKGROUND

PMID: 11070333 (View on PubMed)

Epel E, Jimenez S, Brownell K, Stroud L, Stoney C, Niaura R. Are stress eaters at risk for the metabolic syndrome? Ann N Y Acad Sci. 2004 Dec;1032:208-10. doi: 10.1196/annals.1314.022.

Reference Type: BACKGROUND

PMID: 15677412 (View on PubMed)

Rebuffe-Scrive M, Walsh UA, McEwen B, Rodin J. Effect of chronic stress and exogenous glucocorticoids on regional fat distribution and metabolism. Physiol Behav. 1992 Sep;52(3):583-90. doi: 10.1016/0031-9384(92)90351-2.

Reference Type: BACKGROUND

PMID: 1409924 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15358437 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 12429875 (View on PubMed)

Other Identifiers

Protocol 5030

Identifier Type: -

Identifier Source: secondary_id

H7429-31882-01

Identifier Type: -

Identifier Source: org_study_id