Efficacy of Mindful Tai Chi on Obese or Overweight Adults: A Randomized Controlled Clinical Trial
| Status: | Terminated |
|---|---|
| Conditions: | Healthy Studies, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/21/2019 |
| Start Date: | December 9, 2010 |
| End Date: | November 5, 2012 |
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.
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.
- 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.
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.
(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.
- INCLUSION CRITERIA:
- 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
EXCLUSION CRITERIA:
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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