Efficacy of Mindful Tai Chi on Obese or Overweight Adults: A Randomized Controlled Clinical Trial

NCT01264029 | Terminated Phase 2

• 2 other identifiers: 11003011-NR-0030
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Adult; Healthy

Keywords

Well-Being; Tai Chi; Obesity; Mindfulness; Meditation; Overweight

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (4)

Group A

EXPERIMENTAL

Movement meditation for 2 hours

Behavioral: Mindful Tai Chi Intervention

Group B

ACTIVE COMPARATOR

Non-moving sitting meditation for 2 hours

Behavioral: Mindfulness Meditation

Group C

ACTIVE COMPARATOR

Mall Walking for 2 hours

Behavioral: Mall Walking

Group D

ACTIVE COMPARATOR

Weekly Discussion

Behavioral: Weekly Discussion

Interventions

Mindful Tai Chi Intervention BEHAVIORAL

Group A

Mindfulness Meditation BEHAVIORAL

Group B

Mall Walking BEHAVIORAL

Group C

Weekly Discussion BEHAVIORAL

Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 20531257 BACKGROUND

• Andersson 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.

  PMID: 19096961 BACKGROUND

• Arias 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.

  PMID: 17034289 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Raymond A Dionne, D.D.S.

  National Institute of Nursing Research (NINR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2010
• First Posted: December 21, 2010
• Study Start: December 9, 2010
• Primary Completion: November 5, 2012
• Study Completion: November 5, 2012
• Last Updated: November 29, 2019

Record last verified: 2012-11-05

Locations

US (1)