Randomized Trial of Tapas Acupressure for Weight Loss Maintenance (LIFE)
Primary Purpose
Obesity
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tapas Acupressure Technique
Social support
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
Inclusion criteria for the Phase I weight loss program:
- 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 for the Phase I weight loss program
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
TAT (Tapas Acupressure Technique)
SS (Professionally facilitated social support groups)
Outcomes
Primary Outcome Measures
weight
Secondary Outcome Measures
psychosocial measures, exercise, food frequency, and food cravings variables
Full Information
NCT ID
NCT00526565
First Posted
September 6, 2007
Last Updated
October 4, 2011
Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00526565
Brief Title
Randomized Trial of Tapas Acupressure for Weight Loss Maintenance
Acronym
LIFE
Official Title
Randomized Trial of Tapas Acupressure for Weight Loss Maintenance
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
472 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
TAT (Tapas Acupressure Technique)
Arm Title
2
Arm Type
Active Comparator
Arm Description
SS (Professionally facilitated social support groups)
Intervention Type
Behavioral
Intervention Name(s)
Tapas Acupressure Technique
Other Intervention Name(s)
TAT
Intervention Description
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
Intervention Name(s)
Social support
Other Intervention Name(s)
Social support groups
Intervention Description
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.
Primary Outcome Measure Information:
Title
weight
Time Frame
18 months
Secondary Outcome Measure Information:
Title
psychosocial measures, exercise, food frequency, and food cravings variables
Time Frame
randomization, and @ months 12 and 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria for the Phase I weight loss program:
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 for the Phase I weight loss program
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles R Elder, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22417316
Citation
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.
Results Reference
derived
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Randomized Trial of Tapas Acupressure for Weight Loss Maintenance
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