Clinical trial NCT01250509: Craving and Lifestyle Management Through Mindfulness Study
Official title: Effects of Stress Reduction on Eating, Fat Distribution, and Cell Aging Among Overweight Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity
Mindfulness based stress reduction
Mindful eating
Stress
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Mount Zion Health Fund
First posted: 2010-11-30
Enrollment: 53
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Abdominal Fat
timeFrame: Change from Baseline in Abdominal Fat (baseline and 4 months)
Secondary outcomes:
measure: Weight
timeFrame: Change in Weight (baseline and 4 months)
measure: Telomerase Activity
timeFrame: Change from Baseline in Telomerase Activity at 4 months
measure: Change in Psychological Stress (Baseline and 4 Months)
timeFrame: Change from Baseline in Psychological Stress
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: UCSF Department of Psychiatry
name: Elissa Epel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF Osher Center for Integrative Medicine
name: Frederick Hecht, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF Osher Center for Integrative Medicine
name: Jennifer Daubenmier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.