Clinical trial NCT00643344: Craving and Lifestyle Management Through Mindfulness Pilot Study
Official title: Craving and Lifestyle Management Through Mindfulness Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
mindfulness based stress reduction
diet and exercise
mindful eating
stress
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
name: Robert Deidrick Fund
First posted: 2008-03-26
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
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 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).

Detailed description: Obesity is an important growing epidemic, with about 65% of Americans overweight (Flegal, Carroll et al. 2002). 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. Chronic stress has also been shown to impair immune responses, including decreasing immune responses to vaccination. The proposed study will pilot test an innovative program that combines stress reduction and mindful eating practices with diet and exercise, Craving and Lifestyle Management through Mindfulness (CALMM+). This program will be compared with diet and exercise intervention alone (Diet-Ex). Approximately 20 persons will be randomized to the two groups, which will meet weekly for 16 weeks. Key outcome measures are weight, fat distribution (as measured by waist/hip ratio), perceived stress, and mood. These measures will be assessed in visits performed at baseline, 3 months, and 6 months. Data from this study are intended to provide pilot data for use in planning a larger randomized, controlled trial that will compare the effects of the CALMM+ and Diet-Ex interventions on the metabolic and psychological processes assessed in this pilot study.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: weight
timeFrame: baseline, 3 month, and 6 month assessments
Secondary outcomes:
measure: fat distribution
timeFrame: baseline, 3 month, and 6 month assessments
measure: perceived stress
timeFrame: baseline, 3 month, and 6 month assessments
measure: mood
timeFrame: baseline, 3 month, and 6 month assessments
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF CTSI Clinical Research Center
state: California
Study officials:
affiliation: UCSF Osher Center for Integrative Medicine
name: Frederick Hecht, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF Department of Psychiatry
name: Elissa Epel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF Osher Center for Integrative Medicine
name: Jennifer Daubenmier, PhD
role: PRINCIPAL_INVESTIGATOR
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