Craving and Lifestyle Management Through Mindfulness Study (CALMM)
16 de enero de 2013 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
53
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94115
- UCSF Osher Center for Integrative Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
21 años a 50 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Sin intervención: Waitlist Control
Participants were waitlisted for the intervention during the experimental phase.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Abdominal Fat
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Weight
Periodo de tiempo: Change in Weight (baseline and 4 months)
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Change in Weight (baseline and 4 months)
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Telomerase Activity
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elissa Epel, PhD, UCSF Department of Psychiatry
- Investigador principal: Frederick Hecht, MD, UCSF Osher Center for Integrative Medicine
- Investigador principal: Jennifer Daubenmier, PhD, UCSF Osher Center for Integrative Medicine
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2006
Finalización primaria (Actual)
1 de octubre de 2007
Finalización del estudio (Actual)
1 de julio de 2008
Fechas de registro del estudio
Enviado por primera vez
23 de noviembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
29 de noviembre de 2010
Publicado por primera vez (Estimar)
30 de noviembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
18 de febrero de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
16 de enero de 2013
Última verificación
1 de enero de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H11640-29259-03A
- K01AT004199 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .