Phase 2
N=47
Craving and Lifestyle Management Through Mindfulness Study
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01250509 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Change in Abdominal Fat — 68.2; 50.0 grams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Craving and Lifestyle Management through Mindfulness (Behavioral)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Abdominal Fat |
68.2; 50.0 | — |
| SECONDARY Weight |
-0.03; 0.38 | — |
| SECONDARY Telomerase Activity |
0.24; 0.15 | — |
| SECONDARY Change in Psychological Stress (Baseline and 4 Months) |
-0.20; 0.03 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01250509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.