Clinical trial NCT00526565: Randomized Trial of Tapas Acupressure for Weight Loss Maintenance
Official title: Randomized Trial of Tapas Acupressure for Weight Loss Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2007-09-10
Enrollment: 472
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: weight
timeFrame: 18 months
Secondary outcomes:
measure: psychosocial measures, exercise, food frequency, and food cravings variables
timeFrame: randomization, and @ months 12 and 18
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: Charles R Elder, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.