Craving and Lifestyle Management Through Mindfulness Pilot Study (CALMM)
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About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
15 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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