Craving and Lifestyle Management Through Mindfulness Pilot Study

Study Overview
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Brief Summary
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The purpose of this study is to determine whether an innovative program that combines mindfulness-based stress reduction and mindful eating practices with diet and exercise guidelines (CALMM+ intervention) will lead to greater weight loss and more favorable body fat distribution than a conventional weight-loss program(Diet-Ex intervention).

Detailed Description
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Obesity is an important growing epidemic, with about 65% of Americans overweight (Flegal, Carroll et al. 2002). 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. Chronic stress has also been shown to impair immune responses, including decreasing immune responses to vaccination. The proposed study will pilot test an innovative program that combines stress reduction and mindful eating practices with diet and exercise, Craving and Lifestyle Management through Mindfulness (CALMM+). This program will be compared with diet and exercise intervention alone (Diet-Ex). Approximately 20 persons will be randomized to the two groups, which will meet weekly for 16 weeks. Key outcome measures are weight, fat distribution (as measured by waist/hip ratio), perceived stress, and mood. These measures will be assessed in visits performed at baseline, 3 months, and 6 months. Data from this study are intended to provide pilot data for use in planning a larger randomized, controlled trial that will compare the effects of the CALMM+ and Diet-Ex interventions on the metabolic and psychological processes assessed in this pilot study.

Official Title
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Craving and Lifestyle Management Through Mindfulness Pilot Study

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Craving and Lifestyle Management through Mindfulness(CALMM+)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy female aged 18-50 BMI range 25-45 negative urine glucose test must be able to provide informed consent Exclusion Criteria: male age less than 18 or menopausal clinical diagnosis of eating disorder, diabetes, polycystic ovary syndrome, and coronary artery disease history of anginal chest pain without adequate evaluation substance abuse, mental health or medical condition that might interfere with study participation use of medications containing corticosteroids breastfeeding non- English speaker pregnant or planning to get pregnant in the next 6 months previous Mindfulness Based Stress Reduction training initiation of new class of psychiatric medications in past 2 months currently on a weight loss diet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CALMM+<br>Participants receiving CALMM intervention, ie program that combines stress reduction, mindful eating practices with diet and exercise | Behavioral: Craving and Lifestyle Management through Mindfulness(CALMM+)<br>* MBSR is a program that provides systematic training in mindfulness meditation and gentle yoga as a self-regulation approach to reduce stress and improve medical and psychological symptoms. In this randomized controlled pilot study, we aim to test a 16-week intervention that further integrates diet and exercise into the CALMM program (CALMM+). This novel program, which includes elements drawn from MBSR, will be actively compared with the conventional diet and exercise group(TLC). Both groups will receive about 7 hours of in-class and out-of-class activities per week. The activities includes exercise, keeping dietary records, and stress reduction practices (if they are assigned to the intervention group).<br>* Other names: CALMM2;|
| Active Comparator: TLC<br>Participants receiving diet and exercise classes only | Behavioral: Craving and Lifestyle Management through Mindfulness(CALMM+)<br>* MBSR is a program that provides systematic training in mindfulness meditation and gentle yoga as a self-regulation approach to reduce stress and improve medical and psychological symptoms. In this randomized controlled pilot study, we aim to test a 16-week intervention that further integrates diet and exercise into the CALMM program (CALMM+). This novel program, which includes elements drawn from MBSR, will be actively compared with the conventional diet and exercise group(TLC). Both groups will receive about 7 hours of in-class and out-of-class activities per week. The activities includes exercise, keeping dietary records, and stress reduction practices (if they are assigned to the intervention group).<br>* Other names: CALMM2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight |  | baseline, 3 month, and 6 month assessments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fat distribution |  | baseline, 3 month, and 6 month assessments | 
| perceived stress |  | baseline, 3 month, and 6 month assessments | 
| mood |  | baseline, 3 month, and 6 month assessments | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, mindfulness based stress reduction, diet and exercise, mindful eating, stress