Craving and Lifestyle Management Through Mindfulness Study (CALMM)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Behavioral: Craving and Lifestyle Management through Mindfulness

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01250509

K01AT004199 (U.S. NIH Grant/Contract)

H11640-29259-03A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: Female

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

CALMM

Experimental group

Description:

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

Treatment:

Behavioral: Craving and Lifestyle Management through Mindfulness

Waitlist Control

No Intervention group

Description:

Participants were waitlisted for the intervention during the experimental phase.