Ignite Creation Date:
2024-05-05 @ 11:07 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01264029
Status:
TERMINATED
Last Update Posted:
2019-11-29
First Post:
2010-12-18
Brief Title:
Efficacy of Mindful Tai Chi on Obese or Overweight Adults A Randomized Controlled Clinical Trial
Sponsor:
National Institute of Nursing Research NINR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Efficacy of Mindful Tai Chi Intervention on Obese and Overweight Adults A Randomized Controlled Clinical Trial
Status:
TERMINATED
Status Verified Date:
2012-11-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 VO2 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 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 VO2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11-NR-0030 | None | None | None |