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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Dietary Counseling; Behavioral: Mindfulness Training Program

• Registration Number: NCT01375504
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-17
• Study Start: 2011-07
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary Counseling	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	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline to a healthier lifestyle.	6 Months	Improvement in general health.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in vital signs.	6 Months	Body mass index (BMI) and absolute and percentage weight loss will be compared.
Change from baseline in laboratory values.	6 Months	Peripheral blood telomere length and telomerase levels, and cardiovascular risk markers will be compared.
Change from baseline in stress management.	6 Months	Stress, anxiety, and quality of life will be measured on various study questionnaires.
Change in baseline on different aspects of eating.	6 Months	Mindful eating, self efficacy and self regulation in eating will be compared.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States