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

April 18, 2012 updated by: Amit Sood, Mayo Clinic

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Dietary Counseling
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.
Behavioral: Dietary Counseling
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.
Other: Mindfulness Training Program
The mindfulness training program will be administered over three 90-minute sessions by a physician and clinical dietician with expertise in mind-body medicine and nutrition.
Behavioral: Mindfulness Training Program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline to a healthier lifestyle.
Time Frame: 6 Months
Improvement in general health.
6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in vital signs.
Time Frame: 6 Months
Body mass index (BMI) and absolute and percentage weight loss will be compared.
6 Months
Change from baseline in laboratory values.
Time Frame: 6 Months
Peripheral blood telomere length and telomerase levels, and cardiovascular risk markers will be compared.
6 Months
Change from baseline in stress management.
Time Frame: 6 Months
Stress, anxiety, and quality of life will be measured on various study questionnaires.
6 Months
Change in baseline on different aspects of eating.
Time Frame: 6 Months
Mindful eating, self efficacy and self regulation in eating will be compared.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amit Sood, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11-001775

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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