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| ID | Type | Description | Link |
|---|---|---|---|
| K01AT004199 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Mount Zion Health Fund | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CALMM | Experimental | Participants receiving the 'Craving and Lifestyle Management through Mindfulness' intervention, i.e. program that combines stress reduction with mindful eating practices. |
|
| Waitlist Control | No Intervention | Participants were waitlisted for the intervention during the experimental phase. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Craving and Lifestyle Management through Mindfulness | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Abdominal Fat | 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. | Change from Baseline in Abdominal Fat (baseline and 4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Change in Weight (baseline and 4 months) | |
| Telomerase Activity | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Osher Center for Integrative Medicine | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15358875 | Background | 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. | |
| 12365955 | Background | 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. |
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Fifty-three met eligibility criteria and chose to enroll, and 47 went on to the randomization stage. Before randomization, 5 participants dropped due to time constaints and 1 dropped due to illness.
Female participants were recruited through media outlets and flyers posted in the San Francisco Bay Area. Three hundred twenty-two potential participants were screened for eligibility from November 2006 to March 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | CALMM | Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices. |
| FG001 | Waitlist Control | Participants were waitlisted for the intervention during the experimental phase. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CALMM | Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices. |
| BG001 | Waitlist Control | Participants were waitlisted for the intervention during the experimental phase. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Abdominal Fat | 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. | Intent-to-treat analyses were conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values. | Posted | Mean | Standard Deviation | grams | Change from Baseline in Abdominal Fat (baseline and 4 months) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CALMM | Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Daubenmier, PhD | University of California, San Francisco | 415-514-8601 | jennifer.daubenmier@ucsf.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D050177 | Overweight |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Change from Baseline in Telomerase Activity at 4 months |
| Change in Psychological Stress (Baseline and 4 Months) | 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. | Change from Baseline in Psychological Stress |
| 11020091 | Background | 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. |
| 11139006 | Background | 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. |
| 16300427 | Background | 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. |
| 16271645 | Background | 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. |
| 11070333 | Background | 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. |
| 15677412 | Background | 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. |
| 1409924 | Background | 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. |
| 15358437 | Background | 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. |
| 12429875 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Waitlist |
|
|
| Secondary | Weight | Intention to treat analysis was conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values. | Posted | Mean | Standard Deviation | kg | Change in Weight (baseline and 4 months) |
|
|
|
| Secondary | Telomerase Activity | 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). | Intention-to-treat analysis was conducted. | Posted | Mean | Standard Deviation | Standard arbitrary units, see above | Change from Baseline in Telomerase Activity at 4 months |
|
|
|
| Secondary | Change in Psychological Stress (Baseline and 4 Months) | 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. | An intention-to-treat analysis was conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline in Psychological Stress |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Waitlist Control | Participants were waitlisted for the intervention during the experimental phase. | 0 | 47 | 0 | 47 |
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