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

Mayo Clinic

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Dietary Counseling; Behavioral: Mindfulness Training Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01375504

11-001775

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Dietary Counseling

Active Comparator group

Description:

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.

Treatment:

Behavioral: Dietary Counseling

Mindfulness Training Program

Other group

Description:

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.

Treatment:

Behavioral: Mindfulness Training Program