Obesity
Conditions
Keywords
Obesity, Mindfulness based stress reduction, Mindful eating, Stress, Overnutrition, Nutrition Disorders, Overweight, Body Weight, Signs and Symptoms
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.
Interventions
BEHAVIORALCraving 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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Mount Zion Health Fund
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| CALMM Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices. | 24 |
| Waitlist Control Participants were waitlisted for the intervention during the experimental phase. | 23 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 2 |
Baseline characteristics
| Characteristic | Waitlist Control | CALMM | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 24 Participants | 47 Participants |
| Age Continuous | 41.4 years STANDARD_DEVIATION 6.7 | 40.4 years STANDARD_DEVIATION 8 | 40.9 years STANDARD_DEVIATION 7.3 |
| Region of Enrollment United States | 23 participants | 24 participants | 47 participants |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 |
Outcome results
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.
Time frame: Change from Baseline in Abdominal Fat (baseline and 4 months)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CALMM | Change in Abdominal Fat | 68.2 grams | Standard Deviation 318.9 |
| Waitlist | Change in Abdominal Fat | 50.0 grams | Standard Deviation 305.4 |
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.
Time frame: Change from Baseline in Psychological Stress
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CALMM | Change in Psychological Stress (Baseline and 4 Months) | -0.20 units on a scale | Standard Deviation 0.5 |
| Waitlist | Change in Psychological Stress (Baseline and 4 Months) | 0.03 units on a scale | Standard Deviation 0.6 |
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).
Time frame: Change from Baseline in Telomerase Activity at 4 months
Population: Intention-to-treat analysis was conducted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CALMM | Telomerase Activity | 0.24 Standard arbitrary units, see above | Standard Deviation 0.5 |
| Waitlist | Telomerase Activity | 0.15 Standard arbitrary units, see above | Standard Deviation 0.3 |
Secondary
Weight
Time frame: Change in Weight (baseline and 4 months)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CALMM | Weight | -0.03 kg | Standard Deviation 2.7 |
| Waitlist | Weight | 0.38 kg | Standard Deviation 1.9 |