ObesityPhase 2/3LIFENCT00526565
Randomized Trial of Tapas Acupressure for Weight Loss Maintenance
A Phase 2/3 study testing Tapas Acupressure Technique and Social support in people with Obesity, run by Kaiser Permanente.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Obesity
- What is being tested?
- Tapas Acupressure Technique and Social support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Feb 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
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
- Being tested
- Tapas Acupressure Technique, Social support
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapas Acupressure TechniqueBehavioural
Also called TAT
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.
Social supportBehavioural
Also called Social support groups
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | TAT (Tapas Acupressure Technique) Receives: Behavioral: Tapas Acupressure Technique |
| 2 | Active comparator | SS (Professionally facilitated social support groups) Receives: Behavioral: Social support |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Measured: 18 months
Secondary outcomes (1)
psychosocial measures, exercise, food frequency, and food cravings variables
Measured: randomization, and @ months 12 and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Charles R Elder, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526565
- Sponsor's protocol ID
- R01AT003928-01A1
- Other IDs
- R01AT003928-01A1
- Acronym
- LIFE
- Status last verified
- Oct 2011
- First submitted
- 6 Sep 2007
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22417316
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Tapas Acupressure for Weight Loss Maintenance
- ClinicalTrials.gov ID
- NCT00526565
- Acronym / sponsor ID
- LIFE / R01AT003928-01A1
- Conditions
- Obesity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Tapas Acupressure TechniqueTAT (Tapas Acupressure Technique) |
| 2 | Active comparator | Behavioral: Social supportSS (Professionally facilitated social support groups) |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapas Acupressure TechniqueAlso: TATPractice 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. | Behavioural | 1 |
| Social supportAlso: Social support groupsThe 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. | Behavioural | 2 |
Primary outcome
weight
Time frame: 18 months
1 secondary outcome
psychosocial measures, exercise, food frequency, and food cravings variables
Time frame: randomization, and @ months 12 and 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
- Derived from this study: PubMed 22417316Elder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles R Elder, MD principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tapas Acupressure Technique and Social support in people with Obesity, run by Kaiser Permanente.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00526565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2011; AzTrials last refreshed its copy on 6 Nov 2026.