Craving and Lifestyle Management Through Mindfulness Study (CALMM)
|ClinicalTrials.gov Identifier: NCT01250509|
Recruitment Status : Completed
First Posted : November 30, 2010
Results First Posted : February 18, 2013
Last Update Posted : February 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Craving and Lifestyle Management through Mindfulness||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Stress Reduction on Eating, Fat Distribution, and Cell Aging Among Overweight Women|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||July 2008|
Participants receiving the 'Craving and Lifestyle Management through Mindfulness' intervention, i.e. program that combines stress reduction with mindful eating practices.
Behavioral: Craving and Lifestyle Management through Mindfulness
A preliminary, novel intervention was developed drawing on components from Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Cognitive Therapy (MBCT), and Mindfulness-Based Eating Awareness Training (MB-EAT). The intervention program consisted of nine 2.5-hour classes and one 7-hour silent day of guided meditation practice after class 6.
No Intervention: Waitlist Control
Participants were waitlisted for the intervention during the experimental phase.
- Change in Abdominal Fat [ Time Frame: 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.
- Weight [ Time Frame: Change in Weight (baseline and 4 months) ]
- Telomerase Activity [ Time Frame: 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) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01250509
|United States, California|
|UCSF Osher Center for Integrative Medicine|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Elissa Epel, PhD||UCSF Department of Psychiatry|
|Principal Investigator:||Frederick Hecht, MD||UCSF Osher Center for Integrative Medicine|
|Principal Investigator:||Jennifer Daubenmier, PhD||UCSF Osher Center for Integrative Medicine|