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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
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  • 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

    First Posted
    September 6, 2007
    Last Updated
    October 4, 2011
    Sponsor
    Kaiser Permanente
    Collaborators
    National Center for Complementary and Integrative Health (NCCIH)
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    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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