Randomized Trial of Tapas Acupressure for Weight Loss Maintenance - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00526565

Purpose

This randomized clinical trial evaluates the efficacy of TAT(Tapas Acupressure Technique) compared to a Social Support (SS) group for the primary outcome of weight loss maintenance. We recruit obese adults from the Kaiser Permanente Northwest managed care setting. Those who meet eligibility criteria are entered into an intensive six-month weekly group-based behavioral weight loss program. Those who meet threshold weight loss criteria (n=~288) are randomly assigned to either TAT instruction or social support group. Participants in both groups attend the same schedule of group meetings with parallel contact hours. Participants in the TAT group are advised to practice the technique at home. Participants are weighed and questionnaires administered at entry, randomization, and at 12 and 18 months post entry. The main outcome measure is weight at 18 months.

Condition	Intervention	Phase
Obesity	Behavioral: Tapas Acupressure Technique Behavioral: Social support	Phase II Phase III

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Trial of Tapas Acupressure for Weight Loss Maintenance

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

weight [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

psychosocial measures, exercise, food frequency, and food cravings variables [ Time Frame: randomization, and @ months 12 and 18 ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	January 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental TAT	Behavioral: Tapas Acupressure Technique Practice of the TAT technique involves application of pressure to select acupoints combined with specific mental focus. Specifically, the TAT pose involves lightly touching the tips of the left thumb and fourth finger to the area 1/8 inch above the inner corner of each eye and the third finger to the point midway between the eyes and about ½ inch above eyebrow level. The right hand is on the back of the head, with the palm cradling the occiput and the thumb just above the hairline. Once in this position, the process is to 1) focus attention on the identified problem or behavior to be changed (such as over-eating); 2) focus on a positive thought in relation to the problem; 3) focus on the thought of healing or clearing the origins of the problem; and 4) focus on an awareness of healing or clearing any storage of the problem, at a cellular, mental, emotional, or energetic level.
2: Active Comparator SS (Social Support)	Behavioral: Social support The LIFE SS maintenance intervention will consist of a series of professionally facilitated social support groups where the session content is directed by the participants. The contact hours for SS will match those of the TAT intervention. The initial SS group session will orient participants to the basics of weight maintenance, and subsequent sessions will provide opportunities for participants to share experiences and ask questions. Participants may choose to use behavioral tools as desired. In addition to the basic materials about weight loss maintenance used in both maintenance interventions, will we use the materials already used in the weight loss program for the SS group as needed. We will measure adherence by taking attendance at the SS group sessions.

Arms

Assigned Interventions

1: Experimental

TAT

Behavioral: Tapas Acupressure Technique

Practice of the TAT technique involves application of pressure to select acupoints combined with specific mental focus. Specifically, the TAT pose involves lightly touching the tips of the left thumb and fourth finger to the area 1/8 inch above the inner corner of each eye and the third finger to the point midway between the eyes and about ½ inch above eyebrow level. The right hand is on the back of the head, with the palm cradling the occiput and the thumb just above the hairline. Once in this position, the process is to 1) focus attention on the identified problem or behavior to be changed (such as over-eating); 2) focus on a positive thought in relation to the problem; 3) focus on the thought of healing or clearing the origins of the problem; and 4) focus on an awareness of healing or clearing any storage of the problem, at a cellular, mental, emotional, or energetic level.

2: Active Comparator

SS (Social Support)

Behavioral: Social support

The LIFE SS maintenance intervention will consist of a series of professionally facilitated social support groups where the session content is directed by the participants. The contact hours for SS will match those of the TAT intervention. The initial SS group session will orient participants to the basics of weight maintenance, and subsequent sessions will provide opportunities for participants to share experiences and ask questions. Participants may choose to use behavioral tools as desired. In addition to the basic materials about weight loss maintenance used in both maintenance interventions, will we use the materials already used in the weight loss program for the SS group as needed. We will measure adherence by taking attendance at the SS group sessions.

Eligibility

Ages Eligible for Study:	30 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Men and women
- At least 30 years of age
- BMI 30-50 kg/m2 (inclusive)
- Weight <400 lbs
- Reside in Portland metropolitan area including Vancouver/Clark County, Washington
- Willing and able to participate in all aspects of the intervention
- Willing to attend the group-based weight loss program for 6 months
- Willing to follow a reduced calorie healthy dietary pattern
- Willing to exercise on a regular basis
- Willing to lose 10 pounds during the 6-month weight loss program
- Willing to accept random assignment to one of the two maintenance interventions
- Willing to provide informed consent

Exclusion Criteria:

• Medical conditions or treatments that would be contraindicated using a diet and exercise weight loss treatment
- Treatment for cancer (except for non-melanoma skin cancer) currently or in the past 2 years
- Diabetes treated with insulin; does not exclude diet-controlled, controlled with sulfonylurea (glyburide, glipizide, etc.) with primary physician's approval, or controlled with other oral agents (metformim, precose, glitazone.)
- Psychiatric hospitalization in past 2 years
- Conditions that require limitation of physical activity
- Congestive heart failure
- Cardiovascular disease (stroke, MI, CABG, ASCVD)
- Taking weight loss medications currently or within past 6 months
- Any history of gastric-bypass surgery or fundoplication (commonly called "stapling") for obesity, or scheduled surgery for this purpose
- Liposuction in the past 12 months
- Prior acupuncture or acupressure treatments for weight loss
- Planning to leave the area prior to the end of the program
- Body weight change > 20 pounds in the past 6 months
- Pregnant, breast feeding, or planning pregnancy prior to the end of participation
- Current participation in another clinical trial
- Investigator discretion for safety or adherence reasons
- Household member (living at the same address) of another participant in this study
- TRIM clinical trial staff member or family member of TRIM trial staff person

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526565

Contacts

Contact: Kristine Funk, MS RD

503 335 2443

Kristine.Funk@kpchr.org

Locations

United States, Oregon
Kaiser Permanente Center for Health Research	Recruiting
Portland, Oregon, United States, 97227
Principal Investigator: Charles R Elder, MD MPH
Sub-Investigator: Victor J Stevens, PhD
Sub-Investigator: Lynn L DeBar, PhD
Sub-Investigator: Christina Gullion, PhD

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Charles R Elder, MD

Kaiser Permanente

More Information

Responsible Party:	Kaiser Permanente Center for Health Research ( Charles Elder, MD MPH Clinical Investigator )
Study ID Numbers:	R01 AT003928-01A1
Study First Received:	September 6, 2007
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00526565
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 14, 2009