ObesityNCT01375504
Effect of Self Regulation With Mindfulness Training on Body Mass Index and Cardiovascular Risk Markers in Obese Adults
A study testing Dietary Counseling and Mindfulness Training Program in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Dietary Counseling and Mindfulness Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Able to provide informed consent
Who cannot join
- 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
Show all 14Show fewer
- 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
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Dietary Counseling, Mindfulness Training Program
- Keywords
- Obesity, Body Mass Index, Mindfulness Training, Attention and Interpretation Therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary CounselingBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Counseling | Active comparator | 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. Receives: Behavioral: Dietary Counseling |
| Mindfulness Training Program | Other | 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. Receives: Behavioral: Mindfulness Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to a healthier lifestyle.
Improvement in general health.
Measured: 6 Months
Secondary outcomes (4)
Change from baseline in vital signs.
Body mass index (BMI) and absolute and percentage weight loss will be compared.
Measured: 6 Months
Change from baseline in laboratory values.
Peripheral blood telomere length and telomerase levels, and cardiovascular risk markers will be compared.
Measured: 6 Months
Change from baseline in stress management.
Stress, anxiety, and quality of life will be measured on various study questionnaires.
Measured: 6 Months
Change in baseline on different aspects of eating.
Mindful eating, self efficacy and self regulation in eating will be compared.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Sood, Mayo Clinic
- Investigators
- Amit Sood, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375504
- Sponsor's protocol ID
- 11-001775
- Status last verified
- Apr 2012
- First submitted
- 13 Jun 2011
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01375504
- Acronym / sponsor ID
- 11-001775
- Conditions
- Obesity
- Keywords
- Obesity, Body Mass Index, Mindfulness Training, Attention and Interpretation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 17 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Counseling | Active comparator | Behavioral: Dietary CounselingThe 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 | Other | Behavioral: Mindfulness Training ProgramThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Able to provide informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary CounselingThe 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. | Behavioural | Dietary Counseling |
| Mindfulness Training ProgramThe mindfulness program will be administered over three 90-minute sessions by a physician and clinical dietician with expertise in mind-body medicine and nutrition. | Behavioural | Mindfulness Training Program |
Primary outcome
Change from baseline to a healthier lifestyle.
Time frame: 6 Months
Improvement in general health.
4 secondary outcomes
Change from baseline in vital signs.
Time frame: 6 Months
Change from baseline in laboratory values.
Time frame: 6 Months
Change from baseline in stress management.
Time frame: 6 Months
Change in baseline on different aspects of eating.
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Sood, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Counseling and Mindfulness Training Program in people with Obesity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to a healthier lifestyle. (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2012.