Craving and Lifestyle Management Through Mindfulness Study (CALMM)
2013年1月16日 更新者:University of California, San Francisco
Effects of Stress Reduction on Eating, Fat Distribution, and Cell Aging Among Overweight Women
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
53
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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California
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San Francisco、California、美国、94115
- UCSF Osher Center for Integrative Medicine
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:CALMM
Participants receiving the 'Craving and Lifestyle Management through Mindfulness' intervention, i.e. program that combines stress reduction with mindful eating practices.
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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.
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无干预:Waitlist Control
Participants were waitlisted for the intervention during the experimental phase.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Abdominal Fat
大体时间:Change from Baseline in Abdominal Fat (baseline and 4 months)
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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.
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Change from Baseline in Abdominal Fat (baseline and 4 months)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Weight
大体时间:Change in Weight (baseline and 4 months)
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Change in Weight (baseline and 4 months)
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Telomerase Activity
大体时间:Change from Baseline in Telomerase Activity at 4 months
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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).
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Change from Baseline in Telomerase Activity at 4 months
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Change in Psychological Stress (Baseline and 4 Months)
大体时间:Change from Baseline in Psychological Stress
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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.
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Change from Baseline in Psychological Stress
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Elissa Epel, PhD、UCSF Department of Psychiatry
- 首席研究员:Frederick Hecht, MD、UCSF Osher Center for Integrative Medicine
- 首席研究员:Jennifer Daubenmier, PhD、UCSF Osher Center for Integrative Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Baer RA, Smith GT, Allen KB. Assessment of mindfulness by self-report: the Kentucky inventory of mindfulness skills. Assessment. 2004 Sep;11(3):191-206. doi: 10.1177/1073191104268029.
- Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.
- Epel ES, McEwen B, Seeman T, Matthews K, Castellazzo G, Brownell KD, Bell J, Ickovics JR. Stress and body shape: stress-induced cortisol secretion is consistently greater among women with central fat. Psychosom Med. 2000 Sep-Oct;62(5):623-32. doi: 10.1097/00006842-200009000-00005.
- Oliver G, Wardle J, Gibson EL. Stress and food choice: a laboratory study. Psychosom Med. 2000 Nov-Dec;62(6):853-65. doi: 10.1097/00006842-200011000-00016.
- Boggiano MM, Chandler PC, Viana JB, Oswald KD, Maldonado CR, Wauford PK. Combined dieting and stress evoke exaggerated responses to opioids in binge-eating rats. Behav Neurosci. 2005 Oct;119(5):1207-14. doi: 10.1037/0735-7044.119.5.1207.
- Yusuf S, Hawken S, Ounpuu S, Bautista L, Franzosi MG, Commerford P, Lang CC, Rumboldt Z, Onen CL, Lisheng L, Tanomsup S, Wangai P Jr, Razak F, Sharma AM, Anand SS; INTERHEART Study Investigators. Obesity and the risk of myocardial infarction in 27,000 participants from 52 countries: a case-control study. Lancet. 2005 Nov 5;366(9497):1640-9. doi: 10.1016/S0140-6736(05)67663-5.
- Epel E, Lapidus R, McEwen B, Brownell K. Stress may add bite to appetite in women: a laboratory study of stress-induced cortisol and eating behavior. Psychoneuroendocrinology. 2001 Jan;26(1):37-49. doi: 10.1016/s0306-4530(00)00035-4.
- Epel E, Jimenez S, Brownell K, Stroud L, Stoney C, Niaura R. Are stress eaters at risk for the metabolic syndrome? Ann N Y Acad Sci. 2004 Dec;1032:208-10. doi: 10.1196/annals.1314.022.
- Rebuffe-Scrive M, Walsh UA, McEwen B, Rodin J. Effect of chronic stress and exogenous glucocorticoids on regional fat distribution and metabolism. Physiol Behav. 1992 Sep;52(3):583-90. doi: 10.1016/0031-9384(92)90351-2.
- Rosmond R. Role of stress in the pathogenesis of the metabolic syndrome. Psychoneuroendocrinology. 2005 Jan;30(1):1-10. doi: 10.1016/j.psyneuen.2004.05.007.
- Roemmich JN, Wright SM, Epstein LH. Dietary restraint and stress-induced snacking in youth. Obes Res. 2002 Nov;10(11):1120-6. doi: 10.1038/oby.2002.152.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年11月1日
初级完成 (实际的)
2007年10月1日
研究完成 (实际的)
2008年7月1日
研究注册日期
首次提交
2010年11月23日
首先提交符合 QC 标准的
2010年11月29日
首次发布 (估计)
2010年11月30日
研究记录更新
最后更新发布 (估计)
2013年2月18日
上次提交的符合 QC 标准的更新
2013年1月16日
最后验证
2013年1月1日
更多信息
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