- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01375504
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
36
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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
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
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
Investigators
- 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
July 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
June 13, 2011
First Submitted That Met QC Criteria
June 16, 2011
First Posted (Estimate)
June 17, 2011
Study Record Updates
Last Update Posted (Estimate)
April 19, 2012
Last Update Submitted That Met QC Criteria
April 18, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Dietary Counseling
-
IRCCS Policlinico S. MatteoRecruitingNutritional SupportItaly
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedCaloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast CancerBreast Carcinoma | Endometrial Carcinoma | Prostate CarcinosarcomaUnited States
-
Boston Children's HospitalTerminated
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCancer SurvivorUnited States
-
University of MinnesotaCompleted
-
University of PennsylvaniaCompletedPolycystic Ovary Syndrome (PCOS)United States
-
University of Massachusetts, AmherstNational Cancer Institute (NCI)RecruitingInflammation | Diet, Healthy | Risk Reduction | Breast Cancer Female | Postpartum Weight RetentionUnited States
-
Federal University of Health Science of Porto AlegreMinistry of Health, Brazil; Federal University of Bahia; Federal University of...CompletedHealth Knowledge, Attitudes, Practice | Feeding Patterns | Infant Nutrition DisordersBrazil
-
Lawson Health Research InstituteOntario Lung AssociationCompletedObstructive Sleep ApneaCanada