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Completed

NCT Number: NCT00643344

Craving and Lifestyle Management Through Mindfulness Pilot Study

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).

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCSF CTSI Clinical Research Center

San Francisco, California, 94120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Craving and Lifestyle Management through Mindfulness(CALMM+)

Behavioral

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).

Other names: CALMM2

Primary outcomes

  1. weight

    Time frame: baseline, 3 month, and 6 month assessments

Secondary outcomes

  1. fat distribution

    Time frame: baseline, 3 month, and 6 month assessments

  2. perceived stress

    Time frame: baseline, 3 month, and 6 month assessments

  3. mood

    Time frame: baseline, 3 month, and 6 month assessments

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Mount Zion Health Fund
  • National Center for Complementary and Integrative Health (NCCIH)
  • Robert Deidrick Fund

Registry information

Acronym: CALMM

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 26, 2008
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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