Craving and Lifestyle Management Through Mindfulness Pilot Study

NCT00643344 | Completed DMC

• 2 other identifiers: H7429-31882-01Protocol 5030
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity

Keywords

obesity; mindfulness based stress reduction; diet and exercise; mindful eating; stress

Outcome Measures

Primary Outcomes (1)

• weight

  baseline, 3 month, and 6 month assessments

Secondary Outcomes (3)

• fat distribution

  baseline, 3 month, and 6 month assessments

• perceived stress

  baseline, 3 month, and 6 month assessments

• mood

  baseline, 3 month, and 6 month assessments

Study Arms (2)

CALMM+

EXPERIMENTAL

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+)

TLC

ACTIVE COMPARATOR

Participants receiving diet and exercise classes only

Behavioral: Craving and Lifestyle Management through Mindfulness(CALMM+)

Interventions

Craving and Lifestyle Management through Mindfulness(CALMM+) 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).

Also known as: CALMM2

CALMM+; TLC

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy female
• aged 18-50
• BMI range 25-45
• negative urine glucose test
• must be able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Mount Zion Health Fund: collaborator
• Robert Deidrick Fund: collaborator

Study Sites (1)

UCSF CTSI Clinical Research Center

San Francisco, California, 94120, United States

Location

Related Publications (12)

• 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.

  PMID: 15358875 BACKGROUND

• 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.

  PMID: 12365955 BACKGROUND

• 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.

  PMID: 11020091 BACKGROUND

• Dallman MF, Pecoraro N, Akana SF, La Fleur SE, Gomez F, Houshyar H, Bell ME, Bhatnagar S, Laugero KD, Manalo S. Chronic stress and obesity: a new view of "comfort food". Proc Natl Acad Sci U S A. 2003 Sep 30;100(20):11696-701. doi: 10.1073/pnas.1934666100. Epub 2003 Sep 15.

  PMID: 12975524 BACKGROUND

• 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.

  PMID: 11139006 BACKGROUND

• 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.

  PMID: 16300427 BACKGROUND

• 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.

  PMID: 16271645 BACKGROUND

• 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.

  PMID: 11070333 BACKGROUND

• 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.

  PMID: 15677412 BACKGROUND

• 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.

  PMID: 1409924 BACKGROUND

• 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.

  PMID: 15358437 BACKGROUND

• 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.

  PMID: 12429875 BACKGROUND

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Frederick Hecht, MD

  UCSF Osher Center for Integrative Medicine

  PRINCIPAL INVESTIGATOR

• Elissa Epel, PhD

  UCSF Department of Psychiatry

  PRINCIPAL INVESTIGATOR

• Jennifer Daubenmier, PhD

  UCSF Osher Center for Integrative Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 26, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

US (1)