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

Primary Purpose

Obesity

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
qigong
acupressure-TAT
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Overweight, Weight loss maintenance, CAM therapy, Qigong, Acupressure, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Health Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 30, 2003
Last Updated
February 11, 2010
Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00069732
Brief Title
Study of Two Complementary and Alternative Medical Treatments for Maintenance of Weight Loss
Official Title
Pilot of Two CAM Treatments for Maintenance of Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Overweight, Weight loss maintenance, CAM therapy, Qigong, Acupressure, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
qigong
Intervention Type
Behavioral
Intervention Name(s)
acupressure-TAT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia J Elmer, PhD
Organizational Affiliation
Center for Health Research, Northwest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Health Research
City
Portland
State/Province
Oregon
Country
United States

12. IPD Sharing Statement

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

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