Randomized Trial of Tapas Acupressure for Weight Loss Maintenance - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 6, 2007

Last Updated Date

January 22, 2009

Start Date ^†

January 2008

Current Primary Outcome Measures ^†

weight [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00526565 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

psychosocial measures, exercise, food frequency, and food cravings variables [ Time Frame: randomization, and @ months 12 and 18 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Randomized Trial of Tapas Acupressure for Weight Loss Maintenance

Official Title ^†

Randomized Trial of Tapas Acupressure for Weight Loss Maintenance

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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Obesity

Intervention ^†

Behavioral: Tapas Acupressure Technique
Behavioral: Social support

Study Arms / Comparison Groups

Experimental: TAT
Active Comparator: SS (Social Support)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

450

Estimated Completion Date

February 2011

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

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 (metformim, precose, glitazone.)
- Psychiatric hospitalization in past 2 years
- Conditions that require limitation of physical activity
- Congestive heart failure
- Cardiovascular disease (stroke, MI, CABG, ASCVD)
- Taking weight loss medications currently or within past 6 months
- Any history of gastric-bypass surgery or fundoplication (commonly called "stapling") for obesity, or scheduled surgery for this purpose
- 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
- TRIM clinical trial staff member or family member of TRIM trial staff person

Gender

Both

Ages

30 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00526565

Responsible Party

Charles Elder, MD MPH Clinical Investigator, Kaiser Permanente Center for Health Research

Secondary IDs ^††

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

Charles R Elder, MD

Kaiser Permanente

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.