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

February 11, 2010 updated by: Kaiser Permanente

Pilot of Two CAM Treatments for Maintenance of Weight Loss

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States
        • Center for Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Patricia J Elmer, PhD, Center for Health Research, Northwest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 30, 2003

First Submitted That Met QC Criteria

October 2, 2003

First Posted (Estimate)

October 3, 2003

Study Record Updates

Last Update Posted (Estimate)

February 12, 2010

Last Update Submitted That Met QC Criteria

February 11, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT001190-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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