Craving and Lifestyle Management Through Mindfulness Study

NCT01250509 | Completed Phase 2 Results

• 2 other identifiers: H11640-29259-03AK01AT004199
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Mindfulness based stress reduction; Mindful eating; Stress; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms

Outcome Measures

Primary Outcomes (1)

• Change in Abdominal Fat

  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.

  Change from Baseline in Abdominal Fat (baseline and 4 months)

Secondary Outcomes (3)

• Weight

  Change in Weight (baseline and 4 months)

• Telomerase Activity

  Change from Baseline in Telomerase Activity at 4 months

• Change in Psychological Stress (Baseline and 4 Months)

  Change from Baseline in Psychological Stress

Study Arms (2)

CALMM

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

Participants were waitlisted for the intervention during the experimental phase.

Interventions

Craving and Lifestyle Management through Mindfulness 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.

CALMM

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-menopausal
• BMI (25 - 40)
• Weight \< 300 lbs.
• Negative urine glucose test

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

UCSF Osher Center for Integrative Medicine

San Francisco, California, 94115, United States

Location

Related Publications (11)

• 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

• 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; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jennifer Daubenmier, PhD
• Organization: University of California, San Francisco

jennifer.daubenmier@ucsf.edu

415-514-8601

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 30, 2010
• Study Start: November 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: July 1, 2008
• Last Updated: February 18, 2013
• Results First Posted: February 18, 2013

Record last verified: 2013-01

Locations

US (1)