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Completed

NCT Number: NCT01375504

Effect of Self Regulation With Mindfulness Training on Body Mass Index and Cardiovascular Risk Markers in Obese Adults

This study is designed to assess the effect of a mindfulness training program with special focus on diet and nutrition vs. dietary counseling in 40 obese adults (BMI range 30-40) and their partner/spouses (irrespective of their BMI), in a 6-month pilot randomized controlled trial.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

Obesity is associated with deficits in self regulation. Approaches that foster increased non-judgmental present moment awareness and increased acceptance have been demonstrated to enhance self regulation. One commonly used approach that synthesizes these concepts is mindfulness training. This study is designed to assess the effect of a mindfulness training program with special focus on diet and nutrition, on body mass index, cardiovascular risk markers, peripheral blood telomere length and telomerase levels in obese adults. The mindfulness training program is adapted from the Attention and Interpretation Therapy developed by study investigators at Mayo Clinic. The study is designed as a 6-month pilot randomized controlled trial involving 40 obese adults and their partners/spouses with standard dietary counseling as the control intervention. Promising feasibility and efficacy data from the study will prompt us to pursue a larger, multi-center trial to more definitively test this program as well as apply this intervention in clinical practice.

Who can participate

Healthy volunteers accepted: No

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

PRIMARY PARTICIPANT

Inclusion criteria

  • Obese adults (BMI ≥ 30)
  • Currently working at Mayo Clinic Rochester
  • Able to provide informed consent
  • Stable weight (within + 10 pounds) during the three months prior to enrolling in the study

Exclusion criteria

  • Currently (in the past six months) attending a weight loss program
  • Underlying genetic or endocrine cause for weight gain
  • Current cancer
  • Medications known to affect weight (corticosteroids, antidepressants, anti psychotics, mood stabilizers, and anti-epileptic medications)
  • Musculoskeletal conditions affecting the ability to adequately perform general physical activity
  • Active smoking
  • Substance abuse
  • Quitting smoking within 6 months of enrolling in the study
  • Have clinically significant acute unstable neurological, psychiatric, hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
  • Have an established practice of meditation for three or more months
  • Not willing to complete study outcome measures.

PARTNER/SPOUSE

Inclusion criteria

  • Able to provide informed consent

Exclusion criteria

  • Have clinically significant acute unstable neurological,Psychiatric, hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
  • Have an established practice of meditation for three or more months

Treatment and study plan

Dietary Counseling

Behavioral

The control group will receive two sessions of dietary counseling (with instruction to follow a weight loss program) provided by a clinical dietician, consistent with current routine care for adults with obesity.

Mindfulness training program

Behavioral

The mindfulness program will be administered over three 90-minute sessions by a physician and clinical dietician with expertise in mind-body medicine and nutrition.

Primary outcomes

  1. Change from baseline to a healthier lifestyle.

    Time frame: 6 Months

    Improvement in general health.

Secondary outcomes

  1. Change from baseline in vital signs.

    Time frame: 6 Months

    Body mass index (BMI) and absolute and percentage weight loss will be compared.

  2. Change from baseline in laboratory values.

    Time frame: 6 Months

    Peripheral blood telomere length and telomerase levels, and cardiovascular risk markers will be compared.

  3. Change from baseline in stress management.

    Time frame: 6 Months

    Stress, anxiety, and quality of life will be measured on various study questionnaires.

  4. Change in baseline on different aspects of eating.

    Time frame: 6 Months

    Mindful eating, self efficacy and self regulation in eating will be compared.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Enhancing Self Regulation With Mindfulness Training and Its Effect on Body Mass Index and Cardiovascular Risk Markers in Obese Adults: A Randomized Pilot Clinical Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 17, 2011
Registry last updated
Apr 19, 2012

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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