Randomized Trial of Tapas Acupressure for Weight Loss Maintenance

NCT ID: NCT00526565

Last Updated: 2011-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 472 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-02-28

Brief Summary

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

TAT (Tapas Acupressure Technique)

Group Type: EXPERIMENTAL

Tapas Acupressure Technique

Intervention Type: BEHAVIORAL

Practice of the TAT technique involves application of pressure to select acupoints combined with specific mental focus. The TAT pose involves lightly touching the tips of the left thumb and 4th finger to the area 1/8 inch above the inner corner of each eye and the 3rd finger to the point midway between the eyes, 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 (e.g., over-eating); 2) focus on a positive thought related 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

SS (Professionally facilitated social support groups)

Group Type: ACTIVE_COMPARATOR

Social support

Intervention Type: BEHAVIORAL

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.

Interventions

Tapas Acupressure Technique

Practice of the TAT technique involves application of pressure to select acupoints combined with specific mental focus. The TAT pose involves lightly touching the tips of the left thumb and 4th finger to the area 1/8 inch above the inner corner of each eye and the 3rd finger to the point midway between the eyes, 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 (e.g., over-eating); 2) focus on a positive thought related 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

TAT; Social support groups

Eligibility 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 (metformin, precose, glitazone.)
• Psychiatric hospitalization in past 2 years
• Conditions that require limitation of physical activity
• Congestive heart failure
• Cardiovascular disease (stroke, MI, CABG, angioplasty/stent) in the past 2 years
• Taking weight loss medications currently or within past 6 months
• Any history of weight loss surgery or scheduled surgery for weight loss.
• 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
• LIFE clinical trial staff member or family member of LIFE trial staff person

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles R Elder, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

References

Elder CR, Gullion CM, Debar LL, Funk KL, Lindberg NM, Ritenbaugh C, Meltesen G, Gallison C, Stevens VJ. Randomized trial of Tapas Acupressure Technique for weight loss maintenance. BMC Complement Altern Med. 2012 Mar 15;12:19. doi: 10.1186/1472-6882-12-19.

Reference Type: DERIVED

PMID: 22417316 (View on PubMed)

Other Identifiers

R01AT003928-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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R01AT003928-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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