An interventional study of Craving and Lifestyle Management through Mindfulness(CALMM+) in Obesity, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-28.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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).
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 15 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
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Exclusion Criteria:
Participants receiving CALMM intervention, ie program that combines stress reduction, mindful eating practices with diet and exercise
Behavioral: Craving and Lifestyle Management through Mindfulness(CALMM+)
Participants receiving diet and exercise classes only
Behavioral: Craving and Lifestyle Management through Mindfulness(CALMM+)
MBSR is a program that provides systematic training in mindfulness meditation and gentle yoga as a self-regulation approach to reduce stress and improve medical and psychological symptoms. In this randomized controlled pilot study, we aim to test a 16-week intervention that further integrates diet and exercise into the CALMM program (CALMM+). This novel program, which includes elements drawn from MBSR, will be actively compared with the conventional diet and exercise group(TLC). Both groups will receive about 7 hours of in-class and out-of-class activities per week. The activities includes exercise, keeping dietary records, and stress reduction practices (if they are assigned to the intervention group).
Also known as: CALMM2
weight
Time frame: baseline, 3 month, and 6 month assessments
fat distribution
Time frame: baseline, 3 month, and 6 month assessments
perceived stress
Time frame: baseline, 3 month, and 6 month assessments
mood
Time frame: baseline, 3 month, and 6 month assessments
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco