Clinical trial NCT01375504: Effect of Self Regulation With Mindfulness Training on Body Mass Index and Cardiovascular Risk Markers in Obese Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Body Mass Index
Mindfulness Training
Attention and Interpretation Therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline to a healthier lifestyle.
timeFrame: 6 Months
Secondary outcomes:
measure: Change from baseline in vital signs.
timeFrame: 6 Months
measure: Change from baseline in laboratory values.
timeFrame: 6 Months
measure: Change from baseline in stress management.
timeFrame: 6 Months
measure: Change in baseline on different aspects of eating.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amit Sood, MD
role: PRINCIPAL_INVESTIGATOR
References: