Craving and Lifestyle Management Through Mindfulness Study

NCT ID: NCT01250509

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-07-31

Brief Summary

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.

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.

Conditions

Obesity

Study Design

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

Study Groups

CALMM

Participants receiving the 'Craving and Lifestyle Management through Mindfulness' intervention, i.e. program that combines stress reduction with mindful eating practices.

Group Type: EXPERIMENTAL

Craving and Lifestyle Management through Mindfulness

Intervention Type: BEHAVIORAL

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.

Waitlist Control

Participants were waitlisted for the intervention during the experimental phase.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 21 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

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elissa Epel, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSF Department of Psychiatry

Frederick Hecht, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF Osher Center for Integrative Medicine

Jennifer Daubenmier, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSF Osher Center for Integrative Medicine

Locations

UCSF Osher Center for Integrative Medicine

San Francisco, California, United States

Countries

United States

References

Baer RA, Smith GT, Allen KB. Assessment of mindfulness by self-report: the Kentucky inventory of mindfulness skills. Assessment. 2004 Sep;11(3):191-206. doi: 10.1177/1073191104268029.

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

PMID: 11020091 (View on PubMed)

Oliver G, Wardle J, Gibson EL. Stress and food choice: a laboratory study. Psychosom Med. 2000 Nov-Dec;62(6):853-65. doi: 10.1097/00006842-200011000-00016.

Reference Type: BACKGROUND

PMID: 11139006 (View on PubMed)

Boggiano MM, Chandler PC, Viana JB, Oswald KD, Maldonado CR, Wauford PK. Combined dieting and stress evoke exaggerated responses to opioids in binge-eating rats. Behav Neurosci. 2005 Oct;119(5):1207-14. doi: 10.1037/0735-7044.119.5.1207.

Reference Type: BACKGROUND

PMID: 16300427 (View on PubMed)

Yusuf S, Hawken S, Ounpuu S, Bautista L, Franzosi MG, Commerford P, Lang CC, Rumboldt Z, Onen CL, Lisheng L, Tanomsup S, Wangai P Jr, Razak F, Sharma AM, Anand SS; INTERHEART Study Investigators. Obesity and the risk of myocardial infarction in 27,000 participants from 52 countries: a case-control study. Lancet. 2005 Nov 5;366(9497):1640-9. doi: 10.1016/S0140-6736(05)67663-5.

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)

Rosmond R. Role of stress in the pathogenesis of the metabolic syndrome. Psychoneuroendocrinology. 2005 Jan;30(1):1-10. doi: 10.1016/j.psyneuen.2004.05.007.

Reference Type: BACKGROUND

PMID: 15358437 (View on PubMed)

Roemmich JN, Wright SM, Epstein LH. Dietary restraint and stress-induced snacking in youth. Obes Res. 2002 Nov;10(11):1120-6. doi: 10.1038/oby.2002.152.

Reference Type: BACKGROUND

PMID: 12429875 (View on PubMed)

Other Identifiers

K01AT004199

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H11640-29259-03A

Identifier Type: -

Identifier Source: org_study_id