ObesityPhase 2NCT01264029
Efficacy of Mindful Tai Chi on Obese or Overweight Adults: A Randomized Controlled Clinical Trial
A Phase 2 study testing Mindful Tai Chi Intervention, Mindfulness Meditation and Mall Walking in people with Obesity and Adult, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial summary
Background: New weight-loss intervention programs are being studied to determine their effectiveness in helping overweight and obese individuals reach a healthy weight. However, these programs often have not been tested against each other, and researchers are interested in determining which interventions are most… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Mindful Tai Chi Intervention, Mindfulness Meditation and Mall Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2010to 5 Nov 2012
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female volunteers ages 18 and older with BMI between 25.0 and < 40 and a sedentary lifestyle. Sedentary lifestyle is defined as less than 60 minutes of deliberate health activities per week within the last month.
- Willing to be assigned to one of the two arms.
- Able to understand 5th grade English
- General ability and willingness to follow directions for home assignment.
- TC and mindfulness meditation naive within the last 2 years
- Can move all extremities freely and can ambulate without assistance.
- Weight fluctuation < 10 lbs during the last month
Who cannot join
- Individuals with psychological, physical, neuro-cognitive, or muscular impairments that interfere with MTC or HE participation. A diagnosis of psychosis, affective disorder, myocardial infarction, cardiovascular accident, or hospitalization related to other serious illnesses within the last 12 months and/or by H\&P examination conducted by MD or CRNP at NIH.
- Contradiction to blood drawing such as clotting disorders.
- Active drug or alcohol abuse: self report of any illicit drug or > 2 glasses of wine or equivalent alcohol consumption per day or positive urine drug test.
- Mini Mental Status Exam (MMSE) scores < 24.
- Peripheral neuropathies and neuro-musculoskeletal conditions that may increase the fall risk.
- Pregnancy as revealed by self report or positive urine test.
- Severe vertigo or Meniere s disease or history of known equilibrium problems.
- Taking weight loss medication or starting to take weight loss medicine during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Efficacy of Mindful Tai Chi Intervention on Obese and Overweight Adults: A Randomized Controlled Clinical Trial
Background:
- New weight-loss intervention programs are being studied to determine their effectiveness in helping overweight and obese individuals reach a healthy weight. However, these programs often have not been tested against each other, and researchers are interested in determining which interventions are most effective both immediately and over the long term in promoting and maintaining weight loss.
- Mindful Tai Chi is a combined form of the meditative martial art tai chi and the practice of mindfulness meditation. Tai chi and mindfulness meditation both have common philosophical underpinnings that address health promotion and well-being by applying the skill of non-judgmental awareness on a moment-to-moment daily basis. More research is needed on whether Mindful Tai Chi and mindfulness meditation can help improve various health factors in overweight and obese individuals.
Read more
Objectives:
- To compare the effects of Mindful Tai Chi, mindfulness meditation, walking, or a discussion group on the weight and well being of overweight and obese participants.
Eligibility:
- Healthy individuals at least 18 years of age who are either overweight or obese (body mass index between 25 and 40), have a sedentary lifestyle (have not engaged in more than 1 hour of aerobic exercise per week within the last month), and are willing to commit to a specific weight-loss intervention program.
Design:
- This study involves four visits for collecting information and 12 weeks of research study activities.
- During the first visit, participants will hear information about the study and may ask any questions. They will be screened with a medical history and physical examination, and those eligible will be assigned to one of the four study groups: Mindful Tai Chi (MTC), Mindfulness Meditation (MM), Mall Walking (MW), or Weekly Discussion (WD) group.
- For the second visit, participants will give blood and urine samples, receive an abdominal ultrasound, ride a stationary bicycle for 5 minutes, and fill out health-related questionnaires.
- For 12 weeks, participants will be involved in the following activities depending on their group:
- MTC: Class for 2 hours per week, emphasizing the meditation aspects of tai chi. Each session will include at least 20 minutes of meditation. Participants will receive written instructions and an accompanying DVD in comparable formats specifying a minimum of 30 minutes of daily home assignment. In weeks 2 and 8, participants will have a workshop for mindfulness skill application in daily activity.
- MM: Class for 2 hours per week of mindfulness meditation. Participants will receive written instructions and an accompanying DVD in comparable formats specifying a minimum of 30 minutes of daily home assignment. In weeks 2 and 8, participants will have a workshop for mindfulness skill application in daily activity.
- MW: Participants will meet at a designated mall location once a week for 2-hour walk.
- WD: Participants will meet at the National Institutes of Health for weekly weight-loss discussion.
- For the third and fourth visits, participants will receive the same procedures as those used in the second visit. These visits will occur at the end of the 12-week activity period and at a 3-month follow up visit.
Read the detailed description
Objective: The objective of this protocol is to pilot test the efficacy of a Mindful Tai Chi (MTC) intervention as an integrative approach to facilitate durable weight loss and well-being among sedentary obese and overweight individuals. Numerous interventions for obesity are available but the results are temporary, with most individuals returning to or exceeding their baseline weights. Contrasting with conventional emphases on quantitative weight reduction with factual didactics, exercise and diet, this protocol will focus on enhancing individuals integrative resources utilizing mindfulness principles facilitating changes in self healthcare behaviors.
MTC is a combined form of Tai Chi and mindfulness meditation. Tai Chi and mindfulness both have common philosophical underpinnings that address health promotion and well-being. Tai Chi is a gentle moving meditation that fosters individuals body-mind-spiritual integration through specific movements. MTC is a systemic intervention with multidimensional effects on health and well-being that facilitate healthy lifestyle by applying the skill of non-judgmental awareness on a moment-to-moment daily basis. We hypothesize improvements in health and well-being variables of the participants.
Study population: Healthy ambulatory volunteers 18 years and older with BMI between 25 and < 40 will be recruited from the greater Washington area. Exclusion criteria include mental or physical health limitations that impede participation in the treatments or assessment of outcome variables.
Design: A randomized controlled clinical trial: comparing the MTC group to an active health education (HE) control group. These groups will participate in the assigned activities in a 90 minute session twice a week for 10 weeks. All groups will be assessed at baseline and upon completion of the treatments at week 10 and at a 2 month follow-up.
Outcome measures: The primary outcomes are changes in weight and multiple domains of well-being. BMI and intra-abdominal fat by abdominal ultrasound will measure weight changes. Physical well-being variables include biomarkers (lipid profile, BP, CRP, Leptin, IL 6, and A1C), aerobic fitness from VO(2) max measurement with 6 to 10 minutes of a treadmill test, and telomerase activity in leukocytes. A battery of questionnaires will measure psychological, cognitive-affective, socio-spiritual and overall well-being. Secondary outcomes include mindfulness quality and lifestyle indices.
- Being tested
- Mindful Tai Chi Intervention, Mindfulness Meditation, Mall Walking, Weekly Discussion
- Keywords
- Well-Being, Tai Chi, Obesity, Mindfulness, Meditation, Overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Tai Chi InterventionBehavioural
Mindfulness MeditationBehavioural
Mall WalkingBehavioural
Weekly DiscussionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Movement meditation for 2 hours Receives: Behavioral: Mindful Tai Chi Intervention |
| Group B | Active comparator | Non-moving sitting meditation for 2 hours Receives: Behavioral: Mindfulness Meditation |
| Group C | Active comparator | Mall Walking for 2 hours Receives: Behavioral: Mall Walking |
| Group D | Active comparator | Weekly Discussion Receives: Behavioral: Weekly Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss (BMI, Intra-abdominal fat)
Well-being (physical, psychological, cognitive-affective, social-spiritual, and overall)
Secondary outcomes (3)
Mindfulness
Lifestyle indices
Telomerase activity (exploratory variable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study start9 Dec 2010
- Primary completion5 Nov 2012
- Study completion5 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Raymond A Dionne, D.D.S., Principal investigator, National Institute of Nursing Research (NINR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264029
- Sponsor's protocol ID
- 110030
- Other IDs
- 11-NR-0030
- Status last verified
- 5 Nov 2012
- First submitted
- 18 Dec 2010
- Last updated
- 29 Nov 2019
- Results posted
- No
Publications
Alperson SY. Tai Chi philosophy and nursing epistemology. ANS Adv Nurs Sci. 2008 Jan-Mar;31(1):E1-E15. doi: 10.1097/01.ANS.0000311532.65941.b8.
PubMed 20531257Andersson J, Boman K, Jansson JH, Nilsson TK, Lindahl B. Effect of intensive lifestyle intervention on C-reactive protein in subjects with impaired glucose tolerance and obesity. Results from a randomized controlled trial with 5-year follow-up. Biomarkers. 2008 Nov;13(7):671-9. doi: 10.1080/13547500802661266.
PubMed 19096961Arias AJ, Steinberg K, Banga A, Trestman RL. Systematic review of the efficacy of meditation techniques as treatments for medical illness. J Altern Complement Med. 2006 Oct;12(8):817-32. doi: 10.1089/acm.2006.12.817.
PubMed 17034289
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mindful Tai Chi Intervention on Obese and Overweight Adults: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01264029
- Acronym / sponsor ID
- 110030
- Keywords
- Well-Being, Tai Chi, Obesity, Mindfulness, Meditation, Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- 9 Dec 2010
- Primary completion
- 5 Nov 2012 (actual)
- Study completion
- 5 Nov 2012 (actual)
- First posted
- 21 Dec 2010 (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.
Background:
- New weight-loss intervention programs are being studied to determine their effectiveness in helping overweight and obese individuals reach a healthy weight. However, these programs often have not been tested against each other, and researchers are interested in determining which interventions are most effective both immediately and over the long term in promoting and maintaining weight loss.
- Mindful Tai Chi is a combined form of the meditative martial art tai chi and the practice of mindfulness meditation. Tai chi and mindfulness meditation both have common philosophical underpinnings that address health promotion and well-being by applying the skill of non-judgmental awareness on a moment-to-moment daily basis. More research is needed on whether Mindful Tai Chi and mindfulness meditation can help improve various health factors in overweight and obese individuals.
Objectives:
- To compare the effects of Mindful Tai Chi, mindfulness meditation, walking, or a discussion group on the weight and well being of overweight and obese participants.
Eligibility:
- Healthy individuals at least 18 years of age who are either overweight or obese (body mass index between 25 and 40), have a sedentary lifestyle (have not engaged in more than 1 hour of aerobic exercise per week within the last month), and are willing to commit to a specific weight-loss intervention program.
Design:
- This study involves four visits for collecting information and 12 weeks of research study activities.
- During the first visit, participants will hear information about the study and may ask any questions. They will be screened with a medical history and physical examination, and those eligible will be assigned to one of the four study groups: Mindful Tai Chi (MTC), Mindfulness Meditation (MM), Mall Walking (MW), or Weekly Discussion (WD) group.
- For the second visit, participants will give blood and urine samples, receive an abdominal ultrasound, ride a stationary bicycle for 5 minutes, and fill out health-related questionnaires.
- For 12 weeks, participants will be involved in the following activities depending on their group:
- MTC: Class for 2 hours per week, emphasizing the meditation aspects of tai chi. Each session will include at least 20 minutes of meditation. Participants will receive written instructions and an accompanying DVD in comparable formats specifying a minimum of 30 minutes of daily home assignment. In weeks 2 and 8, participants will have a workshop for mindfulness skill application in daily activity.
- MM: Class for 2 hours per week of mindfulness meditation. Participants will receive written instructions and an accompanying DVD in comparable formats specifying a minimum of 30 minutes of daily home assignment. In weeks 2 and 8, participants will have a workshop for mindfulness skill application in daily activity.
- MW: Participants will meet at a designated mall location once a week for 2-hour walk.
- WD: Participants will meet at the National Institutes of Health for weekly weight-loss discussion.
- For the third and fourth visits, participants will receive the same procedures as those used in the second visit. These visits will occur at the end of the 12-week activity period and at a 3-month follow up visit.
Detailed description
Objective: The objective of this protocol is to pilot test the efficacy of a Mindful Tai Chi (MTC) intervention as an integrative approach to facilitate durable weight loss and well-being among sedentary obese and overweight individuals. Numerous interventions for obesity are available but the results are temporary, with most individuals returning to or exceeding their baseline weights. Contrasting with conventional emphases on quantitative weight reduction with factual didactics, exercise and diet, this protocol will focus on enhancing individuals integrative resources utilizing mindfulness principles facilitating changes in self healthcare behaviors.
MTC is a combined form of Tai Chi and mindfulness meditation. Tai Chi and mindfulness both have common philosophical underpinnings that address health promotion and well-being. Tai Chi is a gentle moving meditation that fosters individuals body-mind-spiritual integration through specific movements. MTC is a systemic intervention with multidimensional effects on health and well-being that facilitate healthy lifestyle by applying the skill of non-judgmental awareness on a moment-to-moment daily basis. We hypothesize improvements in health and well-being variables of the participants.
Study population: Healthy ambulatory volunteers 18 years and older with BMI between 25 and < 40 will be recruited from the greater Washington area. Exclusion criteria include mental or physical health limitations that impede participation in the treatments or assessment of outcome variables.
Design: A randomized controlled clinical trial: comparing the MTC group to an active health education (HE) control group. These groups will participate in the assigned activities in a 90 minute session twice a week for 10 weeks. All groups will be assessed at baseline and upon completion of the treatments at week 10 and at a 2 month follow-up.
Outcome measures: The primary outcomes are changes in weight and multiple domains of well-being. BMI and intra-abdominal fat by abdominal ultrasound will measure weight changes. Physical well-being variables include biomarkers (lipid profile, BP, CRP, Leptin, IL 6, and A1C), aerobic fitness from VO(2) max measurement with 6 to 10 minutes of a treadmill test, and telomerase activity in leukocytes. A battery of questionnaires will measure psychological, cognitive-affective, socio-spiritual and overall well-being. Secondary outcomes include mindfulness quality and lifestyle indices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Mindful Tai Chi InterventionMovement meditation for 2 hours |
| Group B | Active comparator | Behavioral: Mindfulness MeditationNon-moving sitting meditation for 2 hours |
| Group C | Active comparator | Behavioral: Mall WalkingMall Walking for 2 hours |
| Group D | Active comparator | Behavioral: Weekly DiscussionWeekly Discussion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female volunteers ages 18 and older with BMI between 25.0 and < 40 and a sedentary lifestyle. Sedentary lifestyle is defined as less than 60 minutes of deliberate health activities per week within the last month.
- Willing to be assigned to one of the two arms.
- Able to understand 5th grade English
- General ability and willingness to follow directions for home assignment.
- TC and mindfulness meditation naive within the last 2 years
Key exclusion criteria (8 listed)
- Individuals with psychological, physical, neuro-cognitive, or muscular impairments that interfere with MTC or HE participation. A diagnosis of psychosis, affective disorder, myocardial infarction, cardiovascular accident, or hospitalization related to other serious illnesses within the last 12 months and/or by H\&P examination conducted by MD or CRNP at NIH.
- Contradiction to blood drawing such as clotting disorders.
- Active drug or alcohol abuse: self report of any illicit drug or > 2 glasses of wine or equivalent alcohol consumption per day or positive urine drug test.
- Mini Mental Status Exam (MMSE) scores < 24.
- Peripheral neuropathies and neuro-musculoskeletal conditions that may increase the fall risk.
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 |
|---|---|---|
| Mindful Tai Chi Intervention | Behavioural | Group A |
| Mindfulness Meditation | Behavioural | Group B |
| Mall Walking | Behavioural | Group C |
| Weekly Discussion | Behavioural | Group D |
Primary outcome
Weight loss (BMI, Intra-abdominal fat)
Well-being (physical, psychological, cognitive-affective, social-spiritual, and overall)
3 secondary outcomes
Mindfulness
Lifestyle indices
Telomerase activity (exploratory variable)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Background: PubMed 20531257Alperson SY. Tai Chi philosophy and nursing epistemology. ANS Adv Nurs Sci. 2008 Jan-Mar;31(1):E1-E15. doi: 10.1097/01.ANS.0000311532.65941.b8.
- Background: PubMed 19096961Andersson J, Boman K, Jansson JH, Nilsson TK, Lindahl B. Effect of intensive lifestyle intervention on C-reactive protein in subjects with impaired glucose tolerance and obesity. Results from a randomized controlled trial with 5-year follow-up. Biomarkers. 2008 Nov;13(7):671-9. doi: 10.1080/13547500802661266.
- Background: PubMed 17034289Arias AJ, Steinberg K, Banga A, Trestman RL. Systematic review of the efficacy of meditation techniques as treatments for medical illness. J Altern Complement Med. 2006 Oct;12(8):817-32. doi: 10.1089/acm.2006.12.817.
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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.
Raymond A Dionne, D.D.S. principal investigator
National Institute of Nursing Research (NINR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mindful Tai Chi Intervention, Mindfulness Meditation and Mall Walking in people with Obesity and Adult, run by National Institute of Nursing Research (NINR) 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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 29 Nov 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Weight loss (BMI, Intra-abdominal fat). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01264029, which also lists 3 linked publications.
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 29 Nov 2019.