Craving and Lifestyle Management Through Mindfulness Study
- Conditions
- Obesity
- Interventions
- Behavioral: Craving and Lifestyle Management through Mindfulness
- Registration Number
- NCT01250509
- Lead Sponsor
- University of California, San Francisco
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 53
- Pre-menopausal
- BMI (25 - 40)
- Weight < 300 lbs.
- Negative urine glucose test
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CALMM Craving and Lifestyle Management through Mindfulness Participants receiving the 'Craving and Lifestyle Management through Mindfulness' intervention, i.e. program that combines stress reduction with mindful eating practices.
- Primary Outcome Measures
Name Time Method Change in Abdominal Fat Change from Baseline in Abdominal Fat (baseline and 4 months) Whole-body dual energy X-ray absorptiometry (DEXA) scans were performed to assess body fat distribution. The DEXA densitometry (GE Healthcare Lunar Prodigy, Madison, Wis, USA) was adjusted to the fan beam mode and EnCore software version 9.15 was used. The primary region of interest was fat tissue from a rectangular region in the abdominal area defined by the upper boundary of the second lumbar vertebra to the lower edge of the fourth lumbar vertebra. The vertical sides were defined as the continuation of the lateral sides of the rib cage.
- Secondary Outcome Measures
Name Time Method Weight Change in Weight (baseline and 4 months) Telomerase Activity Change from Baseline in Telomerase Activity at 4 months Cryopreserved peripheral blood nuclear cells (PBMCs) were thawed and live cells counted using a hemocytometer by the Trypan blue exclusion method. For each sample, an extract of 5000 cells per microliter was made and two concentrations, corresponding to 5000 and 10,000 cells, were assayed for each sample to ensure the assay was in the linear range. Telomerase activity was assayed by the Telomerase Repeat Amplification Protocol (TRAP) using a commercial kit (TRAPeze, Telomerase Detection kit, Upstate/ CHEMICON, Temecula, CA). Baseline and post-intervention samples for the same participant were assayed in the same batch and run on the same gel to eliminate any differences caused by reaction or procedural batch-to-batch variations. Technicians were blind to group assignment. Telomerase activity is defined as 1 unit = the amount of product from one 293T cell/10,000 PBMCs, and was quantified using the software ImageQuant 5.2 (GE Healthcare, Piscataway, NJ).
Change in Psychological Stress (Baseline and 4 Months) Change from Baseline in Psychological Stress The 10-item Perceived Stress Scale was used to evaluate perception of stressful events over the past month by using a 5-point Likert scale (0 = never to 4 = very often) (Cohen et al., 1983). The mean of the ten items was used in analysis. Higher scores indicate greater perceived stress.
Trial Locations
- Locations (1)
UCSF Osher Center for Integrative Medicine
🇺🇸San Francisco, California, United States