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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amit Sood, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01375504
First received: June 13, 2011
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Dietary Counseling
Behavioral: Mindfulness Training Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change from baseline to a healthier lifestyle. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Improvement in general health.


Secondary Outcome Measures:
  • Change from baseline in vital signs. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Body mass index (BMI) and absolute and percentage weight loss will be compared.

  • Change from baseline in laboratory values. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Peripheral blood telomere length and telomerase levels, and cardiovascular risk markers will be compared.

  • Change from baseline in stress management. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Stress, anxiety, and quality of life will be measured on various study questionnaires.

  • Change in baseline on different aspects of eating. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Mindful eating, self efficacy and self regulation in eating will be compared.


Enrollment: 36
Study Start Date: July 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375504

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Amit Sood, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Amit Sood, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01375504     History of Changes
Other Study ID Numbers: 11-001775
Study First Received: June 13, 2011
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Obesity
Body Mass Index
Mindfulness Training
Attention and Interpretation Therapy

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014