Study of Two Complementary and Alternative Medical Treatments for Maintenance of Weight Loss

This study has been terminated.

Sponsor:

Collaborators:

National Center for Complementary and Alternative Medicine (NCCAM)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by:

Kaiser Permanente

ClinicalTrials.gov Identifier:

NCT00069732

First received: September 30, 2003

Last updated: February 11, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 30, 2003

Last Updated Date

February 11, 2010

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00069732 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Two Complementary and Alternative Medical Treatments for Maintenance of Weight Loss

Official Title ^ICMJE

Pilot of Two CAM Treatments for Maintenance of Weight Loss

Brief Summary

The goal of this study is to pilot test in a group of overweight-obese individuals the feasibility and acceptability and indications of efficacy of two CAM treatments, qigong, and acupressure-TAT, for improving long term maintenance of weight loss.

Detailed Description

The prevalence of obesity is at epidemic proportions, 60% of US adults are overweight or obese. Obesity contributes to chronic diseases (diabetes, cardiovascular disease [CVD], hypertension, cancer, and osteoarthritis) and to escalating health care costs. Weight loss can have a substantial impact on reducing these conditions. Substantial efforts have been made in developing effective short-term weight loss programs using behavioral treatments. However, long-term maintenance of weight loss continues to be problematic - many individuals regain the weight lost within a year. Innovative intervention options are critically needed to help people successfully maintain weight loss and to fight the obesity epidemic. Complementary and alternative medicine (CAM) approaches-mind-body, energy healing, and Traditional Chinese Medicine (TCM) approaches may hold great promise for helping improve the maintenance of weight loss.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Behavioral: qigong
Behavioral: acupressure-TAT

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

BMI 25-35 kg/m 2
Reside in Portland metropolitan area
Willing to complete the 12-week weight loss program
Willing to accept random assignment to one of the three maintenance treatment conditions
Willing to provide informed consent

Exclusion Criteria:

Medical conditions or treatments that would be contraindicated using a diet & exercise weight loss treatment
Cancer
Significant GI disease inappropriate for diet and physical activity intervention
Diabetes dependent on insulin or oral hypoglycemic medications
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
Previous history of complementary or alternative medicine (CAM) weight loss treatment
Current acupressure, or Qi Gong, or acupuncture
Reported consumption of more than 21 alcoholic drinks per week
Planning to leave the area prior to the end of the program
Body weight change > 10 pounds in the 6 months prior to Screening visit one
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 of another CAM WT participant
Unavailable for group sessions

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00069732

Other Study ID Numbers ^ICMJE

R21 AT001190-01A1, R21AT001190-01A1

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Kaiser Permanente

Collaborators ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators ^ICMJE

Principal Investigator:

Patricia J Elmer, PhD

Center for Health Research, Northwest

Information Provided By

Kaiser Permanente

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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